no health without mental health – european clinical psychology takes responsibility letter to the editor | commentary no health without mental health – european clinical psychology takes responsibility 1st european congress on clinical psychology and psychological treatment in dresden, germany, october 31 – november 2, 2019 katja beesdo-baum a, tanja endrass a, jürgen hoyer a, corinna jacobi a, philipp kanske a [a] institute of clinical psychology and psychotherapy, technische universität dresden, dresden, germany. clinical psychology in europe, 2019, vol. 1(1), article e34220, https://doi.org/10.32872/cpe.v1i1.34220 published (vor): 2019-03-29 corresponding author: philipp kanske, institute of clinical psychology and psychotherapy, technische universität dresden, chemnitzer str. 46, 01187 dresden, phone +49 (0)351 463-42225, fax +49 (0)351 463-36984. e-mail: philipp.kanske@tu-dresden.de the european association of clinical psychology and psychological treatment (eaclpt) was founded in 2017 with the goal of promoting european collaborations on research and education about mental health problems as well as their treatment. in 2019, the association’s first congress will take place to foster such collaborations from october 31st to november 2nd in dresden, germany. it will be the first international meeting in the field of clinical psychology at a european level. the conference theme “no health without mental health european clinical psy‐ chology takes responsibility” expresses our goal of moving mental health into societal focus. mental disorders are among the most debilitating conditions and clinical psycholo‐ gy offers a wide range of preventive and therapeutic interventions. the discussion of these, as well as underlying etiological models, will be at the heart of the conference. keynote speakers include claudi bockting, susan bögels (university of amsterdam), da‐ vid clark (university of oxford), stefan hofmann (boston university) and maria karekla (university of cyprus). we invite submissions for symposia and poster presentations on the full range of clin‐ ical psychological research: diagnostics and classification, psychological and psychobio‐ logical mechanisms, psychological treatments, prevention and rehabilitation. we particu‐ larly encourage early career researchers to join the conference. targeted pre-conference workshops, mentoring and financial support can be offered. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.34220&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ the conference will be a unique chance to discuss current challenges for mental health in europe and initiate collaborations and joint projects with colleagues from all over the continent. we look forward to seeing you in dresden! for details on the conference and registration visit: www.clinicalpsychologycongress2019.eu no health without mental health 2 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org http://www.clinicalpsychologycongress2019.eu https://www.leibniz-psychology.org/ https://www.psychopen.eu/ some guidelines for reporting national regulations on clinical psychology for papers in the section “politics and education” of cpe politics and education some guidelines for reporting national regulations on clinical psychology for papers in the section “politics and education” of cpe anton-rupert laireiter ab, winfried rief c, cornelia weise c [a] faculty of psychology, university of vienna, vienna, austria. [b] division of psychotherapy and gero-psychology, department of psychology, university of salzburg, salzburg, austria. [c] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2019, vol. 1(3), article e39435, https://doi.org/10.32872/cpe.v1i3.39435 published (vor): 2019-09-20 corresponding author: anton-rupert laireiter, faculty of psychology, university of vienna, liebiggasse 5, 1010 vienna, austria. e-mail: anton-rupert.laireiter@univie.ac.at as pointed out in the editorial paper by laireiter and weise (2019)1, manuscripts submit‐ ted to this section should address the following two topics: (1) legal regulations on educa‐ tion, training, and practice in clinical psychology and psychological treatment in the cor‐ responding country, (2) specific aspects related to politics and education, e.g. prerequi‐ sites for, and contents of, training in various psychological treatments, or the relationship between clinical psychology and psychological treatment in the respective country. in addition, commentaries on university studies (e.g. master's or doctorate level), european harmonization, or pan-european regulations (e.g. by the european federation of psycho‐ logists' associations or other organizations) are also welcome. to facilitate writing of papers but also to make presentations from different countries equivalent and comparable, the editors decided to refine the general criteria by offering more specific guidelines for reporting national regulations in clinical psychology. these guidelines are not a must, but can be seen as a reference and support for structuring pa‐ pers in this section of cpe. additionally, authors are not bound to report about all points; they may select parts of it or even focus on only a few of them. • legal or state regulations for psychology: do legal regulations for psychology exist in your country? are they for psychology in general or for clinical psychology (or any other field of psychology) in specific? please describe. 1) https://doi.org/10.32872/cpe.v1i1.34406 this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.39435&domain=pdf&date_stamp=2019-09-20 https://doi.org/10.32872/cpe.v1i1.34406 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ • legal or state regulations for psychological treatment: are there (different/ further) legal regulations for psychotherapy? what is the relation between clinical psychology and psychotherapy, e.g. are they independent from each other (i.e. two independent professions), or is one part of the other? which one is superior? are other professions also subject to state regulations in your country (e.g., social workers)? • details of legal regulations: what are the details of national regulations for (clinical) psychologists? is there, for example, a state law or act on psychology? does this refer to clinical psychology? what other fields of psychology are also part of this act? please describe the main structure of the regulations in clinical psychology. do other state laws, e.g. insurance acts, national health system acts, regulate clinical psychology and their professional activities? • professional status of clinical psychologists: what is the professional status of clinical psychologists in your country? is it a “free” profession in which clinical psychologists are allowed to take up residence and work autonomously and without instruction and supervision by any other profession (e.g. psychiatrists, physicians) in the national health system (nhs) of your country? is its professional activity limited to specific sectors of the nhs, e.g. to inpatient medical settings, psychiatry or psychosomatics? do patients have direct and independent access to psychological treatment, or is access to it dependent on the referral by physicians? • core professional activities: what are the core professional activities of clinical psychologists provided by legal regulations in your country (e.g. assessment/ diagnostics, psychological treatment/psychotherapy, emergency interventions, preventive interventions, health promotion, counseling/coaching, supervision, teaching, research)? • training in (clinical) psychology: what kind of university training and postgraduate training is required to provide clinical psychological diagnostics and treatment? give an overview on the criteria (e.g. master in (clinical) psychology, additional requirements) and elements of training (theory, supervision, practice etc.) including hours/training units. please comment on the curricula: are there specific regulations for certain treatment traditions or approaches or limitations to specific traditions, e.g. psychodynamic, cbt, humanistic? are internships in outpatient and inpatient treatment centers required and to what extent? are there specific trainings and regulations for clinical psychologists for adults versus for children and adolescents? • licensing/public register: is there any kind of licensing for clinical psychologists? what are the main criteria for receiving a license (or any other kind of public approval) as a clinical psychologist? how many clinical psychologists in your country are licensed or have another kind of public approval (e.g. being listed in a public register for clinical psychologists), for example compared to psychiatrists or (other) psychotherapists? guidelines for papers in the section “politics and education” 2 clinical psychology in europe 2019, vol.1(3), article e39435 https://doi.org/10.32872/cpe.v1i3.39435 https://www.psychopen.eu/ • financial situation: are clinical psychological activities (e.g. assessment, treatment, psychotherapy) part of the national health insurance system? if yes, which activities specifically, e.g. assessment, treatment, psychotherapy, any other? what are the similarities and differences between psychological and medical psychotherapists related to payment and rights? do clinical psychologists receive a regular salary during postgraduate training/internships? • clinical psychological research: what are the implications of the legal or state regulations for research, especially at university departments of clinical psychology and psychological treatments? do outpatient clinics at university departments exist? can patients easily access those treatment centers at psychological university institutes? what kind of obstacles do exist for research in clinical psychology and psychotherapy in your country? • conclusion: final and concluding evaluation of the situation of clinical psychology in your country. necessary changes, current discussions or concerns, goals for the future, etc. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. laireiter, rief, & weise 3 clinical psychology in europe 2019, vol.1(3), article e39435 https://doi.org/10.32872/cpe.v1i3.39435 https://www.psychopen.eu/ announcement of the registered report “can a variant of the implicit association test detect nonsuicidal self-injury in a clinical population? a registered report” announcements announcement of the registered report “can a variant of the implicit association test detect nonsuicidal selfinjury in a clinical population? a registered report” femke cathelyn 1 § , tilia linthout 1 § , pieter van dessel 1 , laurence claes 2,3 , jan de houwer 1 [1] department of experimental clinical and health psychology, ghent university, ghent, belgium. [2] faculty of psychology and educational sciences, university of leuven, leuven, belgium. [3] faculty of medicine and health sciences, university of antwerp, antwerp, belgium. §these authors contributed equally to this work. clinical psychology in europe, 2023, vol. 5(1), article e11499, https://doi.org/10.32872/cpe.11499 published (vor): 2023-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: tilia linthout, department of experimental clinical and health psychology, ghent university, h. dunantlaan 2, 9000 ghent, belgium. tel: +32 479 19 31 25. e-mail: tilia.linthout@ugent.be editor's note: this is an announcement of a registered report which received in-principalacceptance (ipa) to be published in “clinical psychology in europe”. the study protocol is publicly accessible at https://doi.org/10.23668/psycharchives.12576. in this announcement, a brief summary of the study protocol is presented. background nonsuicidal self-injury (nssi) is a severe and prevalent mental health problem (nock, 2010). measures to detect which individuals are at risk for nssi would be valuable for clinical practice. however, we still lack strong predictors of future nssi behaviour, with the most notable exception being prior nssi behaviour (franklin et al., 2017; griep & mackinnon, 2022; kiekens et al., 2018; turner et al., 2013; whitlock et al., 2013). yet, the measurement of prior nssi behaviour with self-report measures can be difficult because individuals may be motivated to conceal this harmful behaviour (long, 2018; macdonald et al., 2020; simone & hamza, 2020). to overcome this problem, an implicit measure has been developed that assesses automatic responding to statements about prior nssi behaviour (i.e., the past nonsuicidal self-injury implicit association test: p-nssi-iat; this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.11499&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0003-4073-0465 https://orcid.org/0000-0001-7448-179x https://orcid.org/0000-0002-3401-780x https://orcid.org/0000-0002-2287-3158 https://orcid.org/0000-0003-0488-5224 https://doi.org/10.23668/psycharchives.12576 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ cathelyn et al., 2021). previous studies tested the predictive utility of this measure in online studies with samples of at risk participants and produced promising results (franklin et al., 2017; sohn et al., 2021). aims the main aim of this study is to validate the p-nssi-iat by assessing its ability to detect prior nssi behaviour in a sample of clinical patients. method we will target patients who receive outpatient treatment for various conditions. partici­ pants will first complete the p-nssi-iat. next, they will be asked how many times they have intentionally cut or carved their skin without intending to kill themselves in the past twelve months and the past 30 days and how likely they would be to intentionally cut or carve their skin without intending to kill themselves in the future. discussion the registered study is the first to examine the clinical utility of a new implicit measure for prior nssi behaviour (the p-nssi-iat). it will provide an answer to the question whether the p-nssi-iat allows detection of self-rated prior nssi and future likelihood of nssi in a sample of clinical patients. funding: this manuscript is supported by ghent university grant bof16/met_v/002 to jdh. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. s u p p l e m e n t a r y m a t e r i a l s the study protocol for this registered report is publicly accessible via psycharchives.org (see index of supplementary materials below). index of supplementary materials cathelyn, f., linthout, t., van dessel, p., claes, l., & de houwer, j. (2023). supplementary materials to "announcement of the registered report “can a variant of the implicit association test detect nonsuicidal self-injury in a clinical population? a registered report”" [pre-registration protocol]. psycharchives. https://doi.org/10.23668/psycharchives.12576 registered report announcement 2 clinical psychology in europe 2023, vol. 5(1), article e11499 https://doi.org/10.32872/cpe.11499 https://doi.org/10.23668/psycharchives.12576 https://www.psychopen.eu/ r e f e r e n c e s cathelyn, f., van dessel, p., & de houwer, j. (2021). predicting nonsuicidal self‐injury using a variant of the implicit association test. suicide and life-threatening behavior, 51(6), 1259–1271. https://doi.org/10.1111/sltb.12808 franklin, j. c., ribeiro, j. d., fox, k. r., bentley, k. h., kleiman, e. m., huang, x., musacchio, k. m., jaroszewski, a. c., chang, b. p., & nock, m. k. (2017). risk factors for suicidal thoughts and behaviors: a meta-analysis of 50 years of research. psychological bulletin, 143(2), 187–232. https://doi.org/10.1037/bul0000084 griep, s. k., & mackinnon, d. f. (2022). does nonsuicidal self-injury predict later suicidal attempts? a review of studies. archives of suicide research, 26(2), 428–446. https://doi.org/10.1080/13811118.2020.1822244 kiekens, g., hasking, p., boyes, m., claes, l., mortier, p., auerbach, r. p., cuijpers, p., demyttenaere, k., green, j. g., kessler, r. c., myin-germeys, i., nock, m. k., & bruffaerts, r. (2018). the associations between non-suicidal self-injury and first onset suicidal thoughts and behaviors. journal of affective disorders, 239, 171–179. https://doi.org/10.1016/j.jad.2018.06.033 long, m. (2018). ‘we’re not monsters … we’re just really sad sometimes:’ hidden self-injury, stigma and help-seeking. health sociology review, 27(1), 89–103. https://doi.org/10.1080/14461242.2017.1375862 macdonald, s., sampson, c., turley, r., biddle, l., ring, n., begley, r., & evans, r. (2020). patients’ experiences of emergency hospital care following self-harm: systematic review and thematic synthesis of qualitative research. qualitative health research, 30(3), 471–485. https://doi.org/10.1177/1049732319886566 nock, m. k. (2010). self-injury. annual review of clinical psychology, 6(1), 339–363. https://doi.org/10.1146/annurev.clinpsy.121208.131258 simone, a. c., & hamza, c. a. (2020). examining the disclosure of nonsuicidal self-injury to informal and formal sources: a review of the literature. clinical psychology review, 82, article 101907. https://doi.org/10.1016/j.cpr.2020.101907 sohn, m. n., mcmorris, c. a., bray, s., & mcgirr, a. (2021). the death-implicit association test and suicide attempts: a systematic review and meta-analysis of discriminative and prospective utility. psychological medicine, 51(11), 1789–1798. https://doi.org/10.1017/s0033291721002117 turner, b. j., layden, b. k., butler, s. m., & chapman, a. l. (2013). how often, or how many ways: clarifying the relationship between non-suicidal self-injury and suicidality. archives of suicide research, 17(4), 397–415. https://doi.org/10.1080/13811118.2013.802660 whitlock, j., muehlenkamp, j., eckenrode, j., purington, a., baral abrams, g., barreira, p., & kress, v. (2013). nonsuicidal self-injury as a gateway to suicide in young adults. journal of adolescent health, 52(4), 486–492. https://doi.org/10.1016/j.jadohealth.2012.09.010 cathelyn, linthout, van dessel et al. 3 clinical psychology in europe 2023, vol. 5(1), article e11499 https://doi.org/10.32872/cpe.11499 https://doi.org/10.1111/sltb.12808 https://doi.org/10.1037/bul0000084 https://doi.org/10.1080/13811118.2020.1822244 https://doi.org/10.1016/j.jad.2018.06.033 https://doi.org/10.1080/14461242.2017.1375862 https://doi.org/10.1177/1049732319886566 https://doi.org/10.1146/annurev.clinpsy.121208.131258 https://doi.org/10.1016/j.cpr.2020.101907 https://doi.org/10.1017/s0033291721002117 https://doi.org/10.1080/13811118.2013.802660 https://doi.org/10.1016/j.jadohealth.2012.09.010 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. registered report announcement 4 clinical psychology in europe 2023, vol. 5(1), article e11499 https://doi.org/10.32872/cpe.11499 https://www.psychopen.eu/ the list of competences of clinical psychologists as a professional asset editorial the list of competences of clinical psychologists as a professional asset martin grosse holtforth a [a] university of bern & inselspital bern, bern, switzerland. clinical psychology in europe, 2019, vol. 1(2), article e37420, https://doi.org/10.32872/cpe.v1i2.37420 published (vor): 2019-06-28 corresponding author: martin grosse holtforth, university of bern, clinical psychology and psychotherapy, fabrikstr. 8, ch-3012 bern and psychosomatic competence center, inselspital, haus c.l.lory, u1 59, ch-3010 bern. e-mail: martin.grosse@psy.unibe.ch the eaclipt task force on “competences of clinical psychologists” (this issue; eaclipt, 2019) has proposed a list of core competences of european clinical psycholo‐ gists. the document is a discussion paper that outlines a competence profile that covers both, professional knowledge as well as clinical skills. the list of criteria is not consid‐ ered final, is open to discussion, and shall be updated regularly in interaction with chang‐ ing environments, new scientific evidence as well as national and/or cultural specificities. the list extends existing lists of competences (e.g., by the university college of london, n.d.) by not only defining the competences of psychotherapists as a major sub‐ group of clinical psychologists, but also listing e.g. diagnostic and methodological compe‐ tences. thereby, the list covers a wider and more comprehensive range of knowledge and skills of clinical psychologists. importantly, the task force refrained from defining compe‐ tences of clinical psychologists in reference to overarching theoretical models or schools. by that, clinical psychologists’ competences as well as the quality of their services are defined and may be evaluated regardless of potentially underlying theoretical orienta‐ tion. with the presented list, the task force provides an important service to patients and families, to the profession of clinical psychologists as a whole, to society, to educational institutions and students/trainees, as well as to research. for patients and their families, the list of competencies transparently defines what pa‐ tients can expect to receive from professionals justifiably calling themselves “clinical psy‐ chologist.” thereby, the list may assist potential “customers” and/or patients to navigate through the “psycho-jungle” in search of help for psychological problems and may enable patients to better distinguish between good and not-so-good services. relatedly, the list this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.37420&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ may also help pinpointing potential malpractice by incompetent, wrong, or fraudulent practice of clinical psychologists. for clinical psychologists as a profession, the list may help to define themselves as a psychology profession, to support the development of a professional identity, as well as to unite clinical psychologists as a group in political and/or professional struggles within respective health care systems. the list may also facilitate communication and coopera‐ tion with health care providers of other professions as well as their societies. depending on the respective national health care system, the list of competences may also help clini‐ cal psychologists to receive reimbursement by health insurances. an internationally agreed-upon list of competences of clinical psychologists will foster clinicians’ mobility across europe by defining standard criteria of clinical psychologists’ expertise and there‐ by facilitate accreditation of professional titles by foreign health care systems. a europe‐ an definition of competences will also facilitate international professional exchange and collaboration within europe and beyond. as strauß and kohl (2009) have shown for the subgroup of psychotherapists, the con‐ ditions of training and practice of clinical psychologists in europe greatly vary depend‐ ing on the respective national health care system and can be expected to vary even more if not only psychotherapists are considered. having an agreed-upon list of competences of clinical psychologists in europe will surely make professional life easier for practising clinical psychologists as well as health administrators. in case the title of “clinical psy‐ chologist” is not yet legally protected and regulated in a particular european country, the list of competences will help to develop legislation related to mental health services in general and clinical psychology in specific. as part of this, the list may also help to devel‐ op and refine quality criteria as well as ethical standards and thereby strengthen the trust in clinical psychologists as a profession. for educational institutions offering teaching and training of future clinical psycholo‐ gists, the list of competences helps to specify the knowledge and skills that students and trainees should attain to receive an academic degree and/or professional title. however, the question which knowledge and which skills should be taught/trained at which level (bachelor, master, postgraduate training) and by which institution(s) will have to be an‐ swered by specialists within a respective national educational and health care system in coordination with respective authorities. future development of potential hierarchies of competences to be sequentially at‐ tained may help to develop curricula at different levels of expertise and thereby poten‐ tially “streamline” teaching and training in clinical psychology. an according optimiza‐ tion by levels of training may reduce the time and money spent by clinical psychologists in training as well as by the society. furthermore, the list of competences may not only help to structure curricula, but in turn, practical experiences with implementing the cri‐ teria within curricula will inform the continuous refinement, extension and revision of the criteria and the curricula. the list of competences of clinical psychologists as a professional asset 2 clinical psychology in europe 2019, vol.1(2), article e37420 https://doi.org/10.32872/cpe.v1i2.37420 https://www.psychopen.eu/ research may also profit from the explication of competence criteria by the eaclipt list. for example, the teaching and training of single skills, such as interpersonal skills, may be evaluated and may lead to scientifically founded recommendations for eventual modifications of training contents and/or procedures. also, the explication of clinical skills will facilitate research including diverse therapists and will help to identify poten‐ tial moderators of skill acquisition. identification of moderators of skill acquisition may aid the individualization of trainings. furthermore, the explication of clinical skills nicely parallels the systematic differentiation and research of moderators, mechanisms, and pro‐ cesses of change in psychotherapy (crits-christoph, connolly gibbons, & mukherjee, 2013; doss, 2004), which may to be applied for examining the wider range of clinical psy‐ chology and may be brought together to advance our theoretical and clinical knowledge. like the list of competences itself, the list of beneficiaries and benefits of the eaclipt list of competences has to be incomplete and can be extended. overall, clinical psychologists having acquired competences as defined by the eaclipt list will have an excellent foundation for their professional practice of clinical psychology in service of fostering the best possible mental health of their patients. r e f e r e n c e s crits-christoph, p., connolly gibbons, m. b., & mukherjee, d. (2013). psychotherapy processoutcome research. in m. j. lambert (ed.), bergin and garfield’s handbook of psychotherapy and behavior change (6th ed., pp. 298–340). new york, ny, usa: wiley. doss, b. d. (2004). changing the way we study change in psychotherapy. clinical psychology: science and practice, 11(4), 368-386. https://doi.org/10.1093/clipsy.bph094 eaclipt task force on “competences of clinical psychologists”. (2019). competences of clinical psychologists. clinical psychology in europe, 1(2), article e35551. https://doi.org/10.32872/cpe.v1i2.35551 strauß, b., & kohl, s. (2009). entwicklung der psychotherapie und der psychotherapieausbildung in europäischen ländern [development of psychotherapy and psychotherapy training in european countries]. psychotherapeut, 54(6), 457-463. https://doi.org/10.1007/s00278-009-0703-5 university college of london. (n.d.). competence frameworks. retrieved from https://www.ucl.ac.uk/pals/research/clinical-educational-and-health-psychology/researchgroups/core/competence-frameworks grosse holtforth 3 clinical psychology in europe 2019, vol.1(2), article e37420 https://doi.org/10.32872/cpe.v1i2.37420 https://doi.org/10.1093/clipsy.bph094 https://doi.org/10.32872/cpe.v1i2.35551 https://doi.org/10.1007/s00278-009-0703-5 https://www.ucl.ac.uk/pals/research/clinical-educational-and-health-psychology/research-groups/core/competence-frameworks https://www.ucl.ac.uk/pals/research/clinical-educational-and-health-psychology/research-groups/core/competence-frameworks https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. the list of competences of clinical psychologists as a professional asset 4 clinical psychology in europe 2019, vol.1(2), article e37420 https://doi.org/10.32872/cpe.v1i2.37420 https://www.psychopen.eu/ is singing under the christmas tree psychologically recommended? a scientific evaluation editorial is singing under the christmas tree psychologically recommended? a scientific evaluation philipp kanske 1, winfried rief 2 [1] clinical psychology and behavioral neuroscience, faculty of psychology, technische universität dresden, dresden, germany. [2] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2022, vol. 4(4), article e10841, https://doi.org/10.32872/cpe.10841 published (vor): 2022-12-22 corresponding author: philipp kanske, technische universität dresden, faculty of psychology, clinical psychology and behavioral neuroscience, chemnitzer str. 46, 01062 dresden, germany. phone +49 (0)351 463-42225. e-mail: philipp.kanske@tu-dresden.de clinical psychology in europe cpe wants to present latest scientific findings, but also highlight their societal impact, and practical relevance. following the tradition of our first three years, we integrate these aims in a special christmas editorial, that can be taken seriously, but there is no need to be overly serious with it. many european families build a christmas tree into a living room, although this room was kept clean and proper for the other times of the year, and no dirt from outside was allowed. this surprising activity for inside decoration follows old egyptian, chinese, jewish and northern tribal traditions to put some green into buildings during cold winter days. however, it is unique that these trees seem to trigger some urgent need to sing along, preferably together in families. we will analyze whether, from a psychological perspective, it can be recommended to follow this urgent need, or whether we should give priority to stop this tradition. it is not easy to find someone who does not know at least one christmas carol. why is that? if anything, it suggests that singing under the christmas tree is not particularly aversive. in fact, for most people singing is surprisingly fun; using a preto post-design to evaluate singing, your mood seems to improve (schladt et al., 2017). and it is not the same if you just listen to music, singing yourself is what seems to do the trick (kreutz et al., 2004). so, dig up all those christmas carols from memory and sing to your heart’s content? now there is one further ingredient that may make the festive singing so pleasurable. the positive mood effect is considerably increased by singing together with others this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10841&domain=pdf&date_stamp=2022-12-22 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ (schladt et al., 2017). this could be due to a whole range of social effects of joint singing. singing with others seems to have an “ice-breaker effect”. faster than other group activities like crafting, it will increase social bonding and felt closeness (pearce et al., 2015), potentially because performing music together, requires a considerable amount of social coordination. in order to really sing together, you need to anticipate the sounds produced by others, divide attention between yourself and others and constantly adjust your timing to that of the group (keller, 2008). this social attentiveness and adaptation increases group cohesion and accordingly, group singing even promotes feelings of social inclusion (welch et al., 2014). christmas is the feast of charity. according to christian tradition, jesus was born in a stable and the big churches take the occasion of christmas to collect money for people in need. singing could actually benefit such altruistic behavior. it enhances empa­ thy, the capacity to share others’ suffering, and also compassionate feelings for others (mcdonald et al., 2022). these social emotions, in turn, increase people’s willingness to help, especially when the other is in need (lehmann et al., 2022). maybe this is a reason why churches of different traditions also encourage to sing along. you probably learned the songs that you are singing already as a child. and this is part of the reason why christmas carols may have a particular magic about them. in contrast to music that we encountered later in life, the songs we were exposed to as children have a special potential to calm us in the face of stress and act as emotional regulators (gabard-durnam et al., 2018). already at six months of age, we seem to prefer our mother singing to us compared to her speaking (nakata & trehub, 2004). and sing­ ing with others leads to spontaneous cooperative and helpful behavior in four-year-olds (kirschner & tomasello, 2010). so take some time to sing with your kids. it will not only improve your mood, but also help in creating some peace and harmony in the family. this could be a helpful game changer if other education attempts have failed. even on a bodily level, music in general and singing in groups in particular have astonishing effects. it increases secretory immunoglobulin a, a marker of immune com­ petence that can only be helpful at the height of the latest flu wave when winter really hits and in the late outbreaks of the covid pandemic (kreutz et al., 2004). the broad positive effects of singing have led to the development of a number of clinical interventions making use of mainly group singing for diverse health conditions ranging from somatic (e.g. reagon et al., 2017) to neurodegenerative (baird, 2018) and mental health conditions (williams et al., 2018). among others, depression could be shown to be reduced during an eight weeks group singing intervention (petchkovsky et al., 2013). meta-analytically, group singing effects for mental health conditions reach moderate to large effect sizes in wellbeing and mental health improvements, mainly attributable to improved emotional states, sense of belonging and self-confidence in patients (williams et al., 2018). is singing under the christmas tree psychologically recommended? 2 clinical psychology in europe 2022, vol. 4(4), article e10841 https://doi.org/10.32872/cpe.10841 https://www.psychopen.eu/ there seems to be little to no downside to singing and given that almost everyone knows a christmas carol, christmas might really be the one occasion to actually do it, for yourself, your family, your children and their children, since it is the early songs we learn that we will never forget. therefore, the conclusion of this scientific evaluation is quite straight forward: just do it, let’s sing together. on behalf of the whole cpe editorial board, we wish you a relaxing time of the year, and a happy and peaceful new year 2023. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s baird, a. (2018). group singing enhances positive affect in people with parkinson’s disease. music and medicine, 10(1), 13–17. https://doi.org/10.47513/mmd.v10i1.570 gabard-durnam, l. j., hensch, t. k., & tottenham, n. (2018). music reveals medial prefrontal cortex sensitive period in childhood. biorxiv, 412007. https://doi.org/10.1101/412007 keller, p. e. (2008). joint action in music performance. in f. morganti, a. carassa, & g. riva (eds.), enacting intersubjectivity: a cognitive and social perspective on the study of interactions (pp. 205– 221). ios press. kirschner, s., & tomasello, m. (2010). joint music making promotes prosocial behavior in 4-yearold children. evolution and human behavior, 31(5), 354–364. https://doi.org/10.1016/j.evolhumbehav.2010.04.004 kreutz, g., bongard, s., rohrmann, s., hodapp, v., & grebe, d. (2004). effects of choir singing or listening on secretory immunoglobulin a, cortisol, and emotional state. journal of behavioral medicine, 27(6), 623–635. https://doi.org/10.1007/s10865-004-0006-9 lehmann, k., böckler, a., klimecki, o., müller-liebmann, c., & kanske, p. (2022). empathy and correct mental state inferences both promote prosociality. scientific reports, 12(1), article 16979. https://doi.org/10.1038/s41598-022-20855-8 mcdonald, b., böckler, a., & kanske, p. (2022). soundtrack to the social world: emotional music enhances empathy, compassion, and prosocial decisions but not theory of mind. emotion, 22(1), 19–29. https://doi.org/10.1037/emo0001036 nakata, t., & trehub, s. e. (2004). infants’ responsiveness to maternal speech and singing. infant behavior and development, 27(4), 455–464. https://doi.org/10.1016/j.infbeh.2004.03.002 pearce, e., launay, j., & dunbar, r. i. (2015). the ice-breaker effect: singing mediates fast social bonding. royal society open science, 2(10), article 150221. https://doi.org/10.1098/rsos.150221 kanske & rief 3 clinical psychology in europe 2022, vol. 4(4), article e10841 https://doi.org/10.32872/cpe.10841 https://doi.org/10.47513/mmd.v10i1.570 https://doi.org/10.1101/412007 https://doi.org/10.1016/j.evolhumbehav.2010.04.004 https://doi.org/10.1007/s10865-004-0006-9 https://doi.org/10.1038/s41598-022-20855-8 https://doi.org/10.1037/emo0001036 https://doi.org/10.1016/j.infbeh.2004.03.002 https://doi.org/10.1098/rsos.150221 https://www.psychopen.eu/ petchkovsky, l., robertson-gillam, k., kropotov, j., & petchkovsky, m. (2013). using qeeg parameters (asymmetry, coherence, and p3a novelty response) to track improvement in depression after choir therapy. advances in mental health, 11(3), 257–267. https://doi.org/10.5172/jamh.2013.11.3.257 reagon, c., gale, n., dow, r., lewis, i., & van deursen, r. (2017). choir singing and health status in people affected by cancer. european journal of cancer care, 26(5), article e12568. https://doi.org/10.1111/ecc.12568 schladt, t. m., nordmann, g. c., emilius, r., kudielka, b. m., de jong, t. r., & neumann, i. d. (2017). choir versus solo singing: effects on mood, and salivary oxytocin and cortisol concentrations. frontiers in human neuroscience, 11, article 430. https://doi.org/10.3389/fnhum.2017.00430 welch, g. f., himonides, e., saunders, j., papageorgi, i., & sarazin, m. (2014). singing and social inclusion. frontiers in psychology, 5, article 803. https://doi.org/10.3389/fpsyg.2014.00803 williams, e., dingle, g. a., & clift, s. (2018). a systematic review of mental health and wellbeing outcomes of group singing for adults with a mental health condition. european journal of public health, 28(6), 1035–1042. https://doi.org/10.1093/eurpub/cky115 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. is singing under the christmas tree psychologically recommended? 4 clinical psychology in europe 2022, vol. 4(4), article e10841 https://doi.org/10.32872/cpe.10841 https://doi.org/10.5172/jamh.2013.11.3.257 https://doi.org/10.1111/ecc.12568 https://doi.org/10.3389/fnhum.2017.00430 https://doi.org/10.3389/fpsyg.2014.00803 https://doi.org/10.1093/eurpub/cky115 https://www.psychopen.eu/ missed opportunities in clinical psychology: what about running factorial design internet trials and using other outcomes than self-report? editorial missed opportunities in clinical psychology: what about running factorial design internet trials and using other outcomes than self-report? gerhard andersson 1,2 [1] department of behavioural sciences and learning and department of biomedical and clinical sciences, linköping university, linköping, sweden. [2] department of clinical neuroscience, karolinska institutet, stockholm, sweden. clinical psychology in europe, 2023, vol. 5(2), article e12063, https://doi.org/10.32872/cpe.12063 published (vor): 2023-06-29 corresponding author: gerhard andersson, department of behavioural sciences and learning, linköping university, se-581 83 linköping, sweden. e-mail: gerhard.andersson@liu.se clinical psychology and in particular research on and implementation of psychological treatments can be regarded as a success story (hofmann et al., 2012). many treatment guidelines and recommendations now acknowledge that psychological treatments can serve as adjuncts to pharmacological treatments, and they are also described as standalone and first-line recommended treatments for mild to moderate psychological prob­ lems and diagnoses like major depression and the anxiety disorders. the reason for this is not based on opinion and consensus (which used to be the case in medicine and psychiatry 100 years ago), but increasingly well conducted research studies inform health care and the practice of clinical psychology. not only controlled intervention studies change practice but also research on mechanisms and processes including self-report measures, brain-imaging and tests of information processing, to give a few examples. in particular, when it comes to cognitive-behavioural treatments (cbt), it can rightfully be argued that there is less need for new studies repeating the same finding that getting cbt is often better than not getting it (there might still be a need to study different psy­ chotherapy orientations like psychodynamic psychotherapy). one way to bring interven­ tion research forward is to use factorial designs in order to discern effective components (watkins & newbold, 2020). as i will return to it has not been possible to obtain large enough sample sizes in regular clinical research to run factorial design trials but the use of the internet and modern information technology has changed this (andersson et al., 2019). this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.12063&domain=pdf&date_stamp=2023-06-29 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ a r e t h e r e a n y p r o b l e m s ? but there are problems. being an intervention researcher having done many controlled trials i am aware of the fact that almost all outcome studies in clinical psychology only rely on self-report measures. these are relevant, valid, and sensitive to change and should not be removed from research. a treatment study on say major depression should definitely include a validated measure of symptoms of depression (like for example the beck depression inventory). trials also benefit from adding measures of other constructs like quality of life, health care consumption and sometimes also repeated administration of self-report measures to capture change processes and study mediation. however, what happened to actual behaviour? in my phd i had a trial on older adults with hearing loss including a behavioural test of communication skills (andersson et al., 1995). later when we began doing trials on the internet we included a behavioural approach test in studies on specific phobia (e.g., andersson et al., 2013). more recently i was part of a trial on virtual reality exposure for spider phobia using the standard behavioural approach task (miloff et al., 2019). but with those and a few other exceptions most of the trials i have been involved with have not included any direct observation of behaviour. it is important to note the ecological momentary assessment (ema) very often is just another format for self-report of behaviour. there are exceptions, for example sleep and activity monitoring, but overall modern information technology and smartphones have not been used often as ways to collect behavioural outcomes, in spite of calls for such research (mohr et al., 2017). m o d e r n i n f o r m a t i o n t e c h n o l o g y a s a w a y t o s p e e d u p t h e p r o c e s s clinical psychology and psychotherapy research overall has benefitted much from tech­ nological innovations and in particular computerized assessments and treatment delivery over the internet. now internet intervention trials can be larger, less costly, reach more people and also suffer less from data loss compared to traditional studies (schuster et al., 2021). as i mentioned it is now also possible to run factorial design trials with better power than used to be the case in traditional face-to-face studies. i will use an example of a factorial design trial in which we both measured and manipulated one crucial aspect of most psychological treatments namely knowledge and the role of learning support. we began studying knowledge acquisition more than 10 years back (andersson et al., 2012), but returned to the topic and were also inspired by harvey and co-workers (2014). in berg et al. (2020) we included 120 adolescents who suffered from mixed anxiety/depres­ sion. they were randomised to one of four treatment groups, in a 2×2 design with two factors: with or without learning support and/or chat-sessions. we did not have a waitlist control group. interestingly and in addition to large improvements overall we found missed opportunities in clinical psychology 2 clinical psychology in europe 2023, vol. 5(2), article e12063 https://doi.org/10.32872/cpe.12063 https://www.psychopen.eu/ that adding learning support (different ways to boost learning of treatment material) lead to larger effects on the beck anxiety inventory (d = 0.38), and also increased knowledge gain (d = 0.42), when compared against the group who did not receive this boost of learning. to our surprise chat-sessions did not have any additional effects. the point here is that knowledge has not been the focus of much research in spite of the fact that in particular cbt focus on psychoeducation and that clients both understand and remember the rationale behind the treatment techniques. my second point is that internet intervention research can speed up our understanding of what works for whom and more rapidly test new ideas by for example adding behavioural outcomes. f u t u r e h o p e s f o r p s y c h o l o g i s t s i hope future research can inform us more about actual behavioural change including cognitive aspects of everyday function. there is so much more to do. to take one exam­ ple, prospective cognition is something we use on a daily basis. examples of prospective cognition can be for example to remember to take medication, call a friend or pick up milk at the grocery store when passing the dairy section in the store. prospective cogni­ tion is most likely crucial for a client who has been in therapy when confronted with an unexpected trigger for anxiety (with avoidance being a likely reaction). the former client then needs to recall and practice what was learned and rehearsed in therapy (which can be years back). surprisingly, this has not been studied much and we basically do not know how important it is for long term outcome following therapy. in conclusion, i hope we can move our field forward by having larger samples, using factorial design and focus more on outcomes that have either been forgotten (behavioural change) or not even studied much (prospective cognition and knowledge). funding: the author is supported by linköping university, sweden. acknowledgments: the author thanks his coworkers and fellow researchers. competing interests: the author has declared that no competing interests exist. r e f e r e n c e s andersson, g., carlbring, p., furmark, t., & sofie research group. (2012). therapist experience and knowledge acquisition in internet-delivered cbt for social anxiety disorder: a randomized controlled trial. plos one, 7(5), article e37411. https://doi.org/10.1371/journal.pone.0037411 andersson 3 clinical psychology in europe 2023, vol. 5(2), article e12063 https://doi.org/10.32872/cpe.12063 https://doi.org/10.1371/journal.pone.0037411 https://www.psychopen.eu/ andersson, g., melin, l., scott, b., & lindberg, p. (1995). an evaluation of a behavioural treatment approach to hearing impairment. behaviour research and therapy, 33(3), 283–292. https://doi.org/10.1016/0005-7967(94)00040-q andersson, g., titov, n., dear, b. f., rozental, a., & carlbring, p. (2019). internet-delivered psychological treatments: from innovation to implementation. world psychiatry, 18(1), 20–28. https://doi.org/10.1002/wps.20610 andersson, g., waara, j., jonsson, u., malmaeus, f., carlbring, p., & öst, l.-g. (2013). internetbased vs. one-session exposure treatment of snake phobia: a randomized controlled trial. cognitive behaviour therapy, 42(4), 284–291. https://doi.org/10.1080/16506073.2013.844202 berg, m., rozental, a., de brun mangs, j., näsman, m., strömberg, k., viberg, l., wallner, e., öhman, h., silfvernagel, k., zetterqvist, m., topooco, n., capusan, a., & andersson, g. (2020). the role of learning support and chat-sessions in guided internet-based cognitive behavioural therapy for adolescents with anxiety: a factorial design study. frontiers in psychiatry, 11, article 503. https://doi.org/10.3389/fpsyt.2020.00503 harvey, a. g., lee, j., williams, j., hollon, s. d., walker, m. p., thompson, m. a., & smith, r. (2014). improving outcome of psychosocial treatments by enhancing memory and learning. perspectives on psychological science, 9(2), 161–179. https://doi.org/10.1177/1745691614521781 hofmann, s. g., asnaani, a., vonk, i. j. j., sawyer, a. t., & fang, a. (2012). the efficacy of cognitive behavioral therapy: a review of meta-analyses. cognitive therapy and research, 36(5), 427–440. https://doi.org/10.1007/s10608-012-9476-1 miloff, a., lindner, p., dafgård, p., deak, s., garke, m., hamilton, w., heinsoo, j., kristoffersson, g., rafi, j., sindermark, k., sjölund, j., zenger, m., reuterskiöld, l., andersson, g., & carlbring, p. (2019). automated virtual reality exposure therapy for spider phobia vs. in-vivo one-session treatment: a randomized non-inferiority trial. behaviour research and therapy, 118, 130–140. https://doi.org/10.1016/j.brat.2019.04.004 mohr, d. c., zhang, m., & schueller, s. m. (2017). personal sensing: understanding mental health using ubiquitous sensors and machine learning. annual review of clinical psychology, 13, 23– 47. https://doi.org/10.1146/annurev-clinpsy-032816-044949 schuster, r., kaiser, t., terhorst, y., messner, e. m., strohmeier, l.-m., & laireiter, a.-r. (2021). sample size, sample size planning, and the impact of study context: systematic review and recommendations by the example of psychological depression treatment. psychological medicine, 51(6), 902–908. https://doi.org/10.1017/s003329172100129x watkins, e. r., & newbold, a. (2020). factorial designs help to understand how psychological therapy works. frontiers in psychiatry, 11, article 429. https://doi.org/10.3389/fpsyt.2020.00429 missed opportunities in clinical psychology 4 clinical psychology in europe 2023, vol. 5(2), article e12063 https://doi.org/10.32872/cpe.12063 https://doi.org/10.1016/0005-7967(94)00040-q https://doi.org/10.1002/wps.20610 https://doi.org/10.1080/16506073.2013.844202 https://doi.org/10.3389/fpsyt.2020.00503 https://doi.org/10.1177/1745691614521781 https://doi.org/10.1007/s10608-012-9476-1 https://doi.org/10.1016/j.brat.2019.04.004 https://doi.org/10.1146/annurev-clinpsy-032816-044949 https://doi.org/10.1017/s003329172100129x https://doi.org/10.3389/fpsyt.2020.00429 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. andersson 5 clinical psychology in europe 2023, vol. 5(2), article e12063 https://doi.org/10.32872/cpe.12063 https://www.psychopen.eu/ missed opportunities in clinical psychology (introduction) are there any problems? modern information technology as a way to speed up the process future hopes for psychologists (additional information) funding acknowledgments competing interests references reflecting on psychotherapy practice for psychologists: towards guidelines for competencies and practices politics and education reflecting on psychotherapy practice for psychologists: towards guidelines for competencies and practices anne plantade-gipch a, nady van broeck b, koen lowet c, eleni karayianni d, maria karekla d [a] school of practitioners psychologists, paris, france. [b] university of leuven, leuven, belgium. [c] flemish association of clinical psychologists, beringen, belgium. [d] university of cyprus, nicosia, cyprus. clinical psychology in europe, 2020, vol. 2(4), article e2601, https://doi.org/10.32872/cpe.v2i4.2601 received: 2019-12-20 • accepted: 2020-10-19 • published (vor): 2020-12-23 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: anne plantade-gipch, 23 rue du montparnasse, 75006 paris, france. tel: +33 6 37 11 30 14. e-mail: aplantade@psycho-prat.fr abstract in 2017, the european federation of psychologists associations made a statement on psychotherapy. it recognizes that psychotherapy is a “special competence” practiced by psychologists, and that psychologists practicing psychotherapy receive specific education, including supervision. the statement also stresses that they have demonstrated competencies in scientifically validated or established theories on human emotions, cognitions, and behavior, and on processes of development, as well as the application of these methods to achieve change. moreover, the declaration recognizes that they are trained in the scientific application of the methods of change based upon these theories. within the standing committee of psychology and health in collaboration with the s-eac, the group on psychotherapy is presently working on a conceptual framework and on guidelines for psychotherapy practiced by psychologists. this document is starting to define the necessary skills and competencies for european psychologists practicing psychotherapy. it also makes recommendations for basic training, for the development of practical skills and competencies, for continuing professional development, and for ethical decision making. it especially puts forward psychologists’ scientific approach to psychotherapy. keywords psychotherapy, competencies, specificities of psychotherapy practiced by psychologists, psychologists’ scientific approach to psychotherapy in europe, the practice of psychotherapy among psychologists is diverse. as such, it is important to identify the common ground for the work of european psychologists practicing psychotherapy. the european federation of psychologists associations (efpa) this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.2601&domain=pdf&date_stamp=2020-12-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ offers the possibility of obtaining a europsy specialist certificate in psychotherapy1 for psychologists who meet specified requirements. this certificate can be awarded to psychologists individuals who already possess a basic europsy certificate and who meet the specified training and supervised practice criteria laid out by the specialist certificate. also, in 2016, a reflection on the skills and competencies of psychologists practicing psychotherapy was launched in france, under the auspices of the french federation of psychologists and psychology. a first working document was developed, which served as a basis to build upon the proposed guidelines. in 2017, during its general assembly, the european federation of psychologists associations (efpa) created the psychotherapy group within the standing committee of psychology and health, which started an exploration around the practices of european psychologists practicing psychotherapy. at the time, the group included representatives from portugal, belgium, cyprus, and france. one of the core principles specified is that the practice of psychotherapy by psychologists is based on scientific evidence. in its two year’s work plan, the group focused on several topics relating to practice, such as skills and competencies, basic training, continuing professional development, and ethical decision making. the current paper presents the work on skills and competencies of this group so far. it is formulated in terms of expectations concerning european psychologists’ practice of psychotherapy. this work will continue to be developed in the years to come. p s y c h o t h e r a p y d e f i n i t i o n : a d i f f i c u l t c o n s e n s u s t o r e a c h working on guidelines for psychologists practicing psychotherapy is not simple. indeed, such a reflection requires a clear definition of psychotherapy. despite various descrip‐ tions of what constitutes psychotherapy provided by both researchers and professional psychologist associations, there is no consensus regarding its definition, especially as uniquely practiced by psychologists. existing descriptions present a tendency to polarize psychotherapy, either highlighting the active psychological treatment components or emphasizing the therapeutic relationship and encounter. this split is often related to schools of thoughts, whose epistemological foundations diverge, especially from the point of view of human nature and development, which results in different underlying intervention objectives. also, a chasm often seems to separate research and practice, which is problematic as it hinders achieving one complete and comprehensive definition of psychotherapy (goldfried et al., 2014). traditionally, the practice of psychotherapy by psychologists was part of a continuum of care, with, on the one hand, interventions promoting self-exploration, and on the other, therapeutic actions based on counseling 1) the s-eac-psypt is an efpa body functioning under the eac (europsy awarding committtee) who is responsible for the granting of the europsy specialist certificate for psychologists specialized in psychotherapy. reflecting on psychotherapy practice for psychologists 2 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ principles. for efpa, the following definition of psychotherapy suggested by norcross (1990) attained consensus in 2017 between member associations: “psychotherapy is the informed and intentional application of clinical methods and interpersonal stances derived from established psychological principles for the purpose of assisting people to modify their behaviors, cognitions, emotions, and/or other personal characteristics in directions that the participants deem desirable” (efpa, 2017; norcross, 1990). this definition served as a basis for drawing up the initial recommendations made in this paper, concerning the skills expected of psychologists practicing psychotherapy. the practice of psychotherapy in our profession is based on the acquisition and use of established evidence-based psychotherapeutic methods and techniques and scientific knowledge. psychologists practicing psychotherapy stay informed about the most recent scientific developments concerning methods and techniques, as well as the effectiveness of the therapeutic approaches. the scientific approach to psychotherapy, as practiced by psychologists, is grounded in sound explanatory models of human behavior, emotion, personality, and development. this scientific approach includes the importance of deriv‐ ing interventions on evidence-based data, as well as adjusting the intervention to the particular situation of the patient, taking into account life contexts, personal characteris‐ tics, culture, preferences and values (american psychological association [apa], 2006). in this group we believe that scientific investigation of our therapeutic approaches and techniques should be an aim, to ensure that individuals in need receive the best care possible for their problem and circumstances. the practice of psychotherapy by psychologists is overall characterized by a concern for the mental health and overall functioning of the patient, as well as by the rigor of its methods, resulting from scientific data and practical reasoning, as well as based on sound theoretical grounds (efpa, 2005). the advanced skills and competencies outlined in this paper for psychologists practicing psychotherapy are at their infancy and the work is yet to be finished. in the coming years, this work will be expanded through a project group especially formed by efpa, and competencies and skills of psychologists practicing psychotherapy will be further developed. p s y c h o l o g i c a l a s s e s s m e n t , d i a g n o s i s , a n d c a s e c o n c e p t u a l i z a t i o n p r i o r t o i n t e r v e n t i o n psychologists’ basic training places great importance to the thorough assessment of the mental state, psychopathological symptoms and problems, and the life situation of the patient(s). the practice of psychotherapy by psychologists always includes assessment of functioning and of the patient’s context, for the case conceptualization and the formula‐ tion of hypotheses. assessment can be carried out throughout the psychotherapy process according to patient’s problems and demand (ggz standaarden, 2020). assessment is a specific work methodology of the profession that is supported by the scientific literature plantade-gipch, van broeck, lowet et al. 3 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ (apa, 2006). more specifically, psychologists practicing psychotherapy have extensive knowledge in the field of psychopathology, diagnosis, and its assessment using a variety of methods and tools. included in their assessment are means to establish a historical account of difficulties and any previous therapeutic attempts (including medical and pharmacological interventions), contributing and maintaining factors, contextual factors, psychopathological symptoms and variables, and comorbid medical and psychological conditions. for these purposes, it is important that psychologists practicing psychothera‐ py possess a basic knowledge of psychopharmacology as well as the effects of medical problems and treatment on psychopathology. based on their assessment, they first estab‐ lish a case conceptualization where they evaluate the psychological and mental state of the patient, the symptoms and level of functioning within context and in relation to social influences and the person's environment. they establish a diagnosis when relevant (e.g., based on the dsm or icd). they also assess the patients motives and needs for the therapy, their personal and external resources, as well as the subjective and environ‐ mental factors that could hinder the intervention. as a prerequisite to the treatment, psychologists practicing psychotherapy build an intervention plan in collaboration with the patient, which then allows both patient and therapist to be able to appraise the ther‐ apeutic progress. the case formulation constitutes a working hypothesis, in that based on new knowledge and a continuous assessment process during therapy, changes may be made to it and treatment goals modified accordingly. progress is also continuously assessed and utilized to further guide the case conceptualization and therapy (duncan et al., 2010). a n e x p e r t i s e i n i n t e r v i e w i n g a n d p s y c h o t h e r a p e u t i c p r e v e n t i o n a n d i n t e r v e n t i o n t e c h n i q u e s psychologists practicing psychotherapy have an expertise in interviewing techniques, utilizing basic clinical skills, which help to be able to mobilize a patient to talk about their problem. the aim is also to collect valuable information during their assessment. psychologists practicing psychotherapy consider the patient's right to self-determination, respecting the rules linked to the therapeutic framework, such as, for examples, neutral‐ ity and abstinence (efpa, 2005). psychologists practicing psychotherapy have a thorough knowledge of intervention techniques belonging to at least one psychological theoretical approach. they utilize a variety of techniques based on the needs of the patient and the context at hand. they work within the limits of a therapeutic framework and a contract, which can be negotiated with the patient. based on their theoretical approach, psychologists practicing psychotherapy possess an amalgam of psychotherapeutic prevention and intervention techniques and tools that can be used to achieve the aims and goals for each specific patient. in addition, reflecting on psychotherapy practice for psychologists 4 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ they possess skills to evaluate the effectiveness of the therapeutic process in a dynamic manner. they make changes in the direction of the intervention as needed, to be able to result in effective behavior change and alleviation of suffering in the patient(s) they serve. a c o m p r e h e n s i v e u n d e r s t a n d i n g o f t h e p a t i e n t ' s d i f f i c u l t i e s during their basic training, psychologists deepen their knowledge of the major psycho‐ logical theories of human behavior, development, and psychopathology. subsequently, they continue to deepen their knowledge in at least one psychotherapeutic theory, grounded in a substantial body of scientific knowledge, and recognized in its applications by the profession of psychologist. psychologists practicing psychotherapy can justify and explain the interventions they suggest to the patient, based on their case conceptual‐ ization and theoretical grounding models. when the situation of the patient requires it and based on their psychotherapy training and their expertise, they may utilize psycho‐ logical intervention techniques arising from other models than their preferred one, in accordance with the patient’s needs and the empirical literature. they consider the limits of their competence and upon agreement of the patient refer to other professionals or theoretical models when needed (efpa, 2005). they perceive the difference between the objectives of their own approach, knowledge and expertise, and the needs and demands of the patient. they are aware of the competences of other health care professionals and are trained to collaborate with other health care disciplines when indicated and agreed upon by the client. m a i n t a i n i n g a t h e r a p e u t i c r e l a t i o n s h i p a n d a n a l l i a n c e scientific research on evidence-based therapeutic relationships has significantly devel‐ oped over the last 30 years. emphasis on the therapeutic relationship heavily influenced the training of practicing psychologists. psychologists practicing psychotherapy are aware of the factors affecting the therapeutic relationship and their effectiveness as therapists, that allow the patients to reach their therapeutic goals (barkham et al., 2017). research demonstrates that certain intrapersonal therapist characteristics (e.g., self-relat‐ edness) may interact with patient characteristics and pathology (baldwin & imel, 2013; heinonen & nissen-lie, 2020). these can aid or alternatively hinder the therapeutic process. psychologists practicing psychotherapy acknowledge these factors and attempt to capitalize on their strengths while aiming to improve on any of their identified weaknesses. they work on taking a step back from the interpersonal difficulties arising plantade-gipch, van broeck, lowet et al. 5 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ in psychotherapy. they give themselves means to analyze these, such as being involved in supervision or peer consultations, or conduct research relating to factors affecting effectiveness (milne, 2009; wampold, 2017). they recognize their own contribution to the therapeutic relationship and consider variations in the alliance (ackerman et al., 2001; castonguay et al., 2006; muran & barber, 2010). specific assessment techniques can be recommended to assess parameters of the therapeutic relationship and to monitor the patients experience of the therapeutic sessions and process (gondek et al., 2016). s e l f a s s e s s m e n t a n d p r o f e s s i o n a l h e l p i n d i f f i c u l t s i t u a t i o n s psychologists practicing psychotherapy evaluate the effects of their interventions as well as the satisfaction of the patient. they recognize their own limits and engage in psychotherapeutic work for which they have demonstrated in depth knowledge and competency. when necessary, they refer to other professionals or approaches having the patients’ needs and well-being as guides. in case of referring out a patient, they ensure a favorable transition to the continuation of treatment (efpa, 2005). continuously learning and updating skills, knowledge, and tools, is an integral part of being a professional. psychologists practicing psychotherapy are required to demonstrate this with continuing education practices. one area that has entered into the practice of assessment and therapy for which previous generations of therapists had not received training is the digitalization of health and mental health and the availability of new opportunities to utilize technology in therapists’ repertoire of practices (van daele et al., 2020). psychologists practicing psychotherapy should demonstrate flexibility and a drive for new learning and updating. m a i n t a i n i n g p a t i e n t s ’ m e n t a l h e a l t h a n d w e l l b e i n g a t t h e c e n t e r o f t h e p s y c h o t h e r a p y psychologists practicing psychotherapy remain aware of the evolving needs of the pa‐ tient. their intervention is always carried by their professional ethics. they know their code of ethics and how to apply it. they constantly give themselves the means of improving and analyzing situations. the therapeutic process concludes for the benefit of the patients and the consolidation of their therapeutic achievements whilst ensuring that plans are made and resources are known for dealing with difficulties in the future (efpa, 2005). reflecting on psychotherapy practice for psychologists 6 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ c o n c l u s i o n this paper presented an overview of skills and competencies drafted by the efpa group on psychotherapy. there seems to be a relative consensus between member associations of efpa that the practice of psychotherapy by psychologists is based on scientific evi‐ dence and on practitioners’ expertise. psychotherapy, its scientific approach, and practice are at the heart of the identity of the profession of psychologists. in the next few years, the psychotherapy project group of the efpa standing committee on psychology and health will enlist experts from all around europe to tackle issues related to psychothera‐ py as practiced by psychologists. in collaboration with the europsy specialist certificate awarding committee, the work of the group will expand particularly from the point of development of competencies, training new professionals, professional parameters, and ethics. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: special thanks to the european federation of psychologists associations for the institutional support. r e f e r e n c e s ackerman, s. j., benjamin, l. s., beutler, l. e., gelso, c. j., goldfried, m. r., hill, c., . . . rainer, j. 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clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. plantade-gipch, van broeck, lowet et al. 9 clinical psychology in europe 2020, vol.2(4), article e2601 https://doi.org/10.32872/cpe.v2i4.2601 https://www.psychopen.eu/ reflecting on psychotherapy practice for psychologists (introduction) psychotherapy definition: a difficult consensus to reach psychological assessment, diagnosis, and case conceptualization prior to intervention an expertise in interviewing and psychotherapeutic prevention and intervention techniques a comprehensive understanding of the patient's difficulties maintaining a therapeutic relationship and an alliance self-assessment and professional help in difficult situations maintaining patients’ mental health and well-being at the center of the psychotherapy conclusion (additional information) funding competing interests acknowledgments references clinical psychology in lithuania: current developments in training and legislation politics and education clinical psychology in lithuania: current developments in training and legislation evaldas kazlauskas a, neringa grigutyte a [a] center for psychotraumatology, institute of psychology, vilnius university, vilnius, lithuania. clinical psychology in europe, 2020, vol. 2(1), article e2835, https://doi.org/10.32872/cpe.v2i1.2835 received: 2019-10-19 • accepted: 2020-02-13 • published (vor): 2020-03-31 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: evaldas kazlauskas, center for psychotraumatology, institute of psychology, vilnius university, ciurlionio 29-203, vilnius, lt-01300 lithuania. e-mail: evaldas.kazlauskas@fsf.vu.lt abstract this paper presents an overview of the current status in training and legislation of clinical psychology in lithuania. clinical psychology training at the university level in lithuania started soon after the collapse of the soviet union in the 1990s and was influenced by the social context and historical-political situation in the country. currently, legislation for clinical psychology in lithuania is in progress, and several promising regulations for psychology in health care were introduced in the last decade. however, psychologists, including clinical psychologists, are not licensed in lithuania. the lack of legislation for psychology is the main obstacle for the recognition and establishment of clinical psychology in the country. in health care, the title ‘clinical psychologist’ is not common; ‘medical psychologist’ is the title used instead to refer to both clinical psychologists and health psychologists. we conclude that while the development of clinical psychology in lithuania is promising, there is still a long way to go to establish clinical psychology as an important profession in lithuania. keywords lithuania, clinical psychology, legislation, training, education, policy this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2835&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • university training in clinical psychology started in the 1990s after the collapse of the soviet union. • legislation for clinical psychology in lithuania is in progress and issues regarding the title and licensing of clinical psychologists are associated with the lack of regulation of psychology in the country in general. • in lithuania, the title ‘clinical psychologist’ is not used in health care, and the titles of psychologists or clinical psychologists are not protected by law. clinical psychology in the baltic states remains unknown and somewhat of a ‘white zone’ on the global map of psychology. this paper aims to present the status of clinical psychology in one of the baltic states – lithuania, with a brief overview of the training and legislation for clinical psychology in the country. the current paper is an update of the previous reports on the history of lithuanian psychology (bagdonas, pociute, rimkute, & valickas, 2008), and is an extension of the overview of lithuanian clinical psychology published two decades ago (gailiene, 2000) with a focus on current national developments in clinical psychology. grounded on the development of clinical psycholo‐ gy in lithuania this paper is informative in understanding the challenges and diverse pathways of establishing clinical psychology at a national level in different countries. historical background lithuania is a country with a population of around three million, situated in the northeastern part of europe. it has been an eu member state since 2004, together with the other two baltic states – latvia and estonia. lithuania’s history is marked by occupa‐ tions and fights for freedom. established as the independent republic of lithuania after world war i in 1918, lithuania was occupied by the soviet army in 1940-1941, followed by nazi occupation in 1941-1944, and soviet occupation again in 1944-1990 (eidintas, bumblauskas, kulakauskas, & tamošaitis, 2015). lithuania was one of the republics of the former soviet union until 1990. the political situation in the country during the soviet regime was very restrictive and oppressive. political violence and oppression that lasted for decades during the soviet regime resulted in a loss of a large proportion of the population (eidintas et al., 2015). narratives of historical traumas are still vivid in the majority of families living in the country (kazlauskas, gailiene, vaskeliene, & skeryte-kazlauskiene, 2017; kazlauskas & zelviene, 2016). furthermore, the memory of occupation and fights for freedom continue to have a profound impact on politics, socioeconomic situation, science, and culture in the country up to this day. the development of clinical psychology in lithuania was closely related to the political situation of 20th century europe. in lithuania, as well as in other post-com‐ munist countries in the region, particularly in the former soviet republics, psychology clinical psychology in lithuania 2 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ was restricted and oppressed by the soviet regime (gailiene, 2000). despite negative attitudes held by the soviet regime towards psychology, the growing interest in psychol‐ ogy resulted in the establishment of the lithuanian psychological association (lpa) in 1958 (bagdonas et al., 2008), with almost 300 founding members. the first professional five-year psychology diploma-training program in lithuania was opened at vilnius uni‐ versity in 1969, producing the first graduates of this psychology program in 1974. this program was focused on engineering and work psychology, as it was the only way it could be deemed acceptable by the soviet regime (gailiene, 2000). officially, when psychology training was launched in 1969, it was not possible to study or practice clinical psychology. however, since the very start of the psychology program at the university, psychology students were interested in clinical psychology and first psychologists managed to get positions and started to work in psychiatric hospitals in the 1970s (bagdonas et al., 2008). during the 1970s and the 1980s, the field of clinical psychology was evolving through the initiatives of local professionals, as well as with the assistance of lithuanian expats from the united states. during the soviet era, u.s. psychology professors managed to sneak across the ‘iron curtain’ into lithuania often under the pretense of visiting relatives and delivered clinical psychology training workshops and supervisions (bieliauskas, 1977; gailiene, 2000) which was a significant contribution to the development of clinical psychology at that time. t r a i n i n g i n c l i n i c a l p s y c h o l o g y the start of clinical psychology training a turning point in clinical psychology in lithuania was a two-year master’s degree program in clinical psychology launched at vilnius university in 1994, which marked the start of professional training of clinical psychologists’ in lithuania. this ambitious aim to start the training of clinical psychologists was initiated by a group of psychologists from the department of psychology at vilnius university who had previous interest in clinical psychology and psychotherapy and had relevant clinical experience. the master’s degree in clinical psychology program aimed to fulfill the needs of society to have professionally trained clinical psychologists. soviet legacy significantly impacted the training of clinical psychologists in lithua‐ nia and the start of clinical psychology training was challenging. clinical psychology research in lithuania was almost non-existent during the soviet occupation. moreover, research methods and psychological assessment measures were not compatible with international standards due to the ‘iron curtain’ preventing the circulation of knowledge between the former soviet union and the rest of the world until the 1990s. lithuania as part of the soviet union experienced even more restrictions in comparison to other eastern and central european post-communist countries outside of the soviet union kazlauskas & grigutyte 3 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ (gailiene, 2000). access to international scientific knowledge of psychology, scientific papers, books, or modern assessment measures was restricted in the country until the 1990s. thus, training in clinical psychology, especially in clinical psychological assess‐ ment, was significantly influenced by the soviet approach to psychopathology and psychiatry. for example, psychological assessment training was focused on the use of soviet cognitive assessment instruments, which were available at the time but not used outside of the soviet union. current clinical psychology training psychology training is currently regulated by the ministry of education and science of the republic of lithuania which approved standards for training of psychology in 2015 (ministry of education and science of the republic of lithuania, 2015). the nation‐ al education standards in psychology are in line with the standards of the other eu member states and in accordance with the european certificate in psychology (europsy) which was approved by the european federation of psychologists’ associations (efpa) (european federation of psychologists' associations [efpa], 2019; lunt, peiró, poortinga, & roe, 2014). furthermore, the training of psychologists in lithuania is based on bologna regulations for higher education across europe (laireiter & weise, 2019) and includes three cycles: bachelor’s degree, master’s degree, and doctoral degree. psychologists are trained at six universities in lithuania. bachelor’s degree programs in psychology take 3.5-4 years and master’s degree programs take two years to complete with a focus in various areas of psychology, such as clinical, health, educational, work and organizational, and forensic. psychology degree programs offered at the universities are evaluated and accredited by the national agency responsible for the accreditation of all study programs in the country. lpa does not accredit psychology study programs; however, it was closely involved in the development of the national regulations for the training of psychologists. the clinical psychology master’s degree program in lithuania is a two-year program with 120 european credit transfer and accumulation study (ects) credits. content of the program allows students to develop core competencies of clinical psychologists listed by the european society for clinical psychology and psychological intervention (eaclipt) task force on ‘competences of clinical psychologists’ (eaclipt task force on “competences of clinical psychologists”, 2019). the majority of the study credits (67 ects credits) are dedicated to clinical psychology courses. additionally, the master’s the‐ sis research project is 30 ects credits, and supervised practice is 23 ects credits, which is a 4-month full-time internship in a clinical setting outside the university. the core courses of the curriculum are all clinical and include counselling skills training; adult and child clinical psychological assessment; introduction to the diversity of approaches in clinical psychology, with psychodynamic, existential, cognitive-behavioral and biopsy‐ clinical psychology in lithuania 4 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ chosocial approaches equally covered; developmental psychopathology; trauma and crisis psychology; and research methods in clinical psychology. in lithuania, around 30 students are admitted to the master’s program in clinical psychology annually, and the competition to enter the program is high. the admission numbers to master’s degree programs are regulated by the government, but the universi‐ ty and study program committees have the flexibility of establishing admission quotas based on the available resources each year. the majority of students in the clinical psychology program are funded by the state, with up to 30% of students being self-fun‐ ded. by 2020, more than 400 clinical psychologists have graduated from the clinical psychology program in lithuania. for over 25 years, the master’s degree program in clinical psychology at vilnius university remained the only training program for clinical psychologists in lithuania. however, over the past few decades, other psychology master’s degree programs in the field of clinical and health psychology were launched in addition to the aforementioned clinical psychology program at a number of lithuanian universities. master’s study programs in health psychology were launched at vilnius university, vytautas magnus university and the lithuanian university of health sciences. furthermore, the master’s degree program in counselling psychology was recently launched at klaipeda university. there are two four-year doctoral study programs in psychology in lithuania, one at vilnius university, and the other is a joint ph.d. program of mykolas romeris university and vytautas magnus university. up to 10 ph.d. students are admitted annually to both of these programs. around one-third of all ph.d. students choose to conduct research in the clinical psychology field. however, as ph.d. studies in lithuania are research-based, ph.d. students are expected to conduct research and publish papers, and no clinical training is included in the program. l e g i s l a t i o n f o r c l i n i c a l p s y c h o l o g y issues with the use of the title ‘clinical psychologist’ due to negative attitudes by the soviet regime towards clinical psychology and psycho‐ therapy, psychologists were labeled ‘medical psychologists’ (gailiene, 2000) since they started to work in health care institutions in the 1970s. all psychologists in national health care are still referred to as ‘medical psychologists’. surprisingly, the term ‘medical psychologist’ persisted in lithuania, and resulted in the title ‘clinical psychologist’ not existing. thus, according to official statistics, there are zero clinical psychologists in lithuania, but this is only because the term ‘clinical psychology’ is not used in the country’s health care system. there are, in fact, many graduates of clinical and health psychology programs who work in health care institutions or private practice across the country. kazlauskas & grigutyte 5 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ this attitudinal legacy from the soviet era adds to the confusion in the legislation of clinical psychology in lithuania. despite the fact that the masters’ degree program in clinical psychology has existed for over 25 years, the profession of clinical psychology is not yet fully recognized or established in lithuania. the titles ‘clinical psychologist’ and ‘psychologist’ in contrast to many other european countries are not protected. furthermore, the title of clinical psychology is not used in psychology practice but only in training and education. introduction of regulation there was no regulation for psychologists in health care in lithuania until 2012 (ministry of health of the republic of lithuania, 2011). moreover, there were no minimal training standards set in the field of clinical and health psychology prior to 2012. for decades, it was up to the employer to decide what training standards were considered as training standards to apply for psychologists in health care until the regulation was introduced. when it came to medical psychologists, health care institutions mostly used to employ psychologists with a five-year psychology diploma or master’s degree in any area of psychology, but occasionally psychologists with no more than a 4-year bachelor’s degree or even ‘professionals’ without a diploma could be employed before 2012. it was only in 2012 that psychologists were included in the system of the lithuanian national accreditation agency for health professions. consequently, health care institu‐ tions could only hire registered medical psychologists with a master’s degree in health or clinical psychology. this new regulation was introduced with collaborative efforts between the ministry of health and lpa, which insisted that a bachelor’s degree in psy‐ chology and master’s degree with a specialization in health or clinical psychology should be a minimum requirement for psychologists to practice in health care. several years of a transition period ensured that psychologists who started work before clinical and health psychology training became available in lithuania and had substantial experience in clinical work could be registered as psychologists eligible to work in the health care setting. this regulation did not include psychologists working outside the public health care setting, which is why psychologists providing psychological counselling or psychothera‐ py in private practice are not yet registered or regulated. psychological services of regis‐ tered medical psychologists in licensed health care institutions are reimbursed by the national health care insurance. however, due to the lack of staff and resources, access to psychologists’ services is restricted and there are long waiting lines. psychologist’s services in private practice outside of health care institutions are not reimbursed by the national health care insurance. in reality, even non-professionals can declare themselves psychotherapists or clinical psychologists and start delivering services in private practice without any formal training in psychology in lithuania. this is because law in lithuania clinical psychology in lithuania 6 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ regulates neither the psychologist’s profession nor psychological services nor does it protect the psychologist’s title. debates about the regulation of psychology legislation for clinical psychologists is part of the national regulation of psychology. until 2020, psychology in lithuania was not regulated by national laws and not included in the list of the licensed professions, except for school psychologists working in the national education system (european parliament, 2016). debates about the standards for professional psychologists have been intense for over a decade. there are conflicting opinions among psychologists regarding the mini‐ mal training standards or regarding which institutions should license psychologists in lithuania. over the past decade, several proposals for a new law have been brought in the lithuanian parliament. these proposals included various requirements for minimal training, ranging from licensing psychologists for independent practice with only a bachelor’s degree in psychology to requirements of holding bachelor’s and specialized master’s degree in addition to having one-year experience of supervised practice in the field of intended practice, such as clinical and health psychology, educational psychology, or work and organizational psychology, which would be in line with the efpa’s europsy regulations (european federation of psychologists' associations [efpa], 2019). while most psychologists in lithuania agreed that at least a master’s degree is needed to be granted a psychologist’s license, debates on the licensing agency still are ongoing. proposals as to which organization should play the role of the licensing agency ranged from self-regulation of professionals by lpa to the establishment of a new chamber of psychologists or choosing one of the governmental institutions. regulation of psychologists in health care despite the lack of regulation on the national level, an important step for psychologists working in public health care was the document ‘medical norm’ issued by the ministry of health of the republic of lithuania in 2018 (ministry of health of the republic of lithuania, 2018). this document defined the aim, the area of practice, and the meth‐ ods of psychologists who work in the national health care system under the title of ‘medical psychologists’. however, the professional title ‘clinical psychologist’ was not included in this document. up until 2020, there has been no clear distinction between health and clinical psychology in terms of regulation and fields of practice in health care. current legislation in lithuania allows for graduates of either health or clinical psychology master’s programs to work in health care in positions of psychologists in primary care, mental health care, prevention, rehabilitation, or in hospitals with patients who have somatic diseases. the regulation of medical psychologists in health care does not include differentiation between a child and adult psychologists, psychologists who kazlauskas & grigutyte 7 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ provide assessment and those who mostly provide psychological counselling or use various methods of psychotherapy. clinical psychology, psychotherapy, and psychiatry the present work focused solely on training and legislation for clinical psychology, therefore, it does not extend to the situation of psychotherapy in lithuania. there are multiple psychotherapy schools that offer post-diploma training in various psychothera‐ py approaches in lithuania, such as cognitive-behavioral, psychodynamic, child psycho‐ dynamic, group analysis, existential, gestalt, jungian analysis, family therapy, and others. training in specialized psychological therapies for posttraumatic stress disorder (ptsd), such as eye movement desensitization and reprocessing (emdr), is also available in the country (schäfer et al., 2018). majority of psychologists who work in health care or private practice pursue psychotherapy training after having obtained a master’s degree from the university. however, there are no statistics available on how many psycholo‐ gists have had additional psychotherapy training after the completion of psychology studies at university. the legal distinction between psychotherapy and clinical psychol‐ ogy remains unclear since law in lithuania does not yet regulate psychotherapy. the relationship between psychiatry and clinical psychology is also not part of this paper. while these fields share a mutual interest in psychopathology and treatment of mental disorders, they also have a history of diverse interactions. f u t u r e d i r e c t i o n s this brief report presented struggles in establishing clinical psychology as a profession in lithuania, a post-communist eu country. our review demonstrated that the development of clinical psychology in lithuania has been rather successful with a history of over 25 years of clinical psychology training available at the university level. furthermore, regulations and standards for psychologists in health care have recently been introduced in lithuania. however, our review also revealed controversies surrounding the use of the title ‘clinical psychologist’ and difficulties in establishing clinical psychology as an important field and profession in lithuanian society. several future directions could be identified for further progress of clinical psycholo‐ gy in lithuania: • the term ‘clinical psychologist’ should be used officially to identify psychologists who provide services in health care and have training in clinical psychology. • continuing education in clinical psychology is needed to constantly update the knowledge of psychologists who work in lithuania. legislation and licensing of psychological practice should include a formal requirement for continuing education in the field of clinical psychology after university graduation. clinical psychology in lithuania 8 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://www.psychopen.eu/ • training of clinical psychologists should be more focused on research. potentially this could be achieved by more intense international collaboration and learning from countries that have more expertise in research and training in clinical psychology. the staff of clinical psychology programs could focus more on staff exchange with other international institutions to modernize training in lithuania. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s bagdonas, a., pociute, b., rimkute, e., & valickas, g. (2008). the history of lithuanian psychology. european psychologist, 13(3), 227-237. https://doi.org/10.1027/1016-9040.13.3.227 bieliauskas, v. j. (1977). mental health care in the ussr. the american psychologist, 32, 376-379. https://doi.org/10.1037/0003-066x.32.5.376 eaclipt task force on “competences of clinical psychologists”. (2019). competences of clinical psychologists. clinical psychology in europe, 1(2), article e35551. https://doi.org/10.32872/cpe.v1i2.35551 eidintas, a., bumblauskas, a., kulakauskas, a., & tamošaitis, m. (2015). the history of lithuania. vilnius, lithuania: publishing house “eugrimas.” european federation of psychologists’ associations (efpa). (2019). europsy – european certificate in psychology. retrieved from https://www.europsy.eu/_webdata/europsy_regulations_july_2019_moscow.pdf european parliament. (2016). mutual evaluation of regulated professions: overview of the regulatory framework in the health services sector – psychologists and related professions. retrieved from https://ec.europa.eu/docsroom/documents/16683 gailiene, d. (2000). perspectives from lithuania. in a. s. bellack & m. hersen (eds.), comprehensive clinical psychology (vol. 10, pp. 325–334). amsterdam, the netherlands: elsevier. kazlauskas, e., gailiene, d., vaskeliene, i., & skeryte-kazlauskiene, m. (2017). intergenerational transmission of resilience? sense of coherence is associated between lithuanian survivors of political violence and their adult offspring. frontiers in psychology, 8, article 1677. https://doi.org/10.3389/fpsyg.2017.01677 kazlauskas, e., & zelviene, p. (2016). trauma research in the baltic countries: from political oppression to recovery. european journal of psychotraumatology, 7(1), article 29259. https://doi.org/10.3402/ejpt.v7.29295 kazlauskas & grigutyte 9 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://doi.org/10.1027/1016-9040.13.3.227 https://doi.org/10.1037/0003-066x.32.5.376 https://doi.org/10.32872/cpe.v1i2.35551 https://www.europsy.eu/_webdata/europsy_regulations_july_2019_moscow.pdf https://ec.europa.eu/docsroom/documents/16683 https://doi.org/10.3389/fpsyg.2017.01677 https://doi.org/10.3402/ejpt.v7.29295 https://www.psychopen.eu/ laireiter, a.-r., & weise, c. (2019). the heterogeneity of national regulations in clinical psychology and psychological treatment in europe. clinical psychology in europe, 1(1), article 34406. https://doi.org/10.32872/cpe.v1i1.34406 lunt, i., peiró, j. m., poortinga, y., & roe, r. a. (2014). europsy: standards and quality in education for psychologists. https://doi.org/10.1027/00438-000 ministry of education and science of the republic of lithuania. (2015). descriptor of the study field of psychology (v-923). retrieved from https://www.skvc.lt/uploads/lawacts/docs/229_19635725da19d5b0c50a341a3d08ea4a.pdf ministry of health of the republic of lithuania. (2011). approval of the rules on registration number of health care professionals (v-754) [in lithuanian]. retrieved from https://e-seimas.lrs.lt/portal/legalact/lt/tad/tais.404693 ministry of health of the republic of lithuania. (2018). order on lithuanian medical norm 162:2018 “medical psychologist” approval (v-627) [in lithuanian]. retrieved from https://e-seimas.lrs.lt/portal/legalact/lt/tad/c0c8f68164c911e8b7d2b2d2ca774092? jfwid=2r1mprf1 schäfer, i., hopchet, m., vandamme, n., ajdukovic, d., el-hage, w., egreteau, l., . . . murphy, d. (2018). trauma and trauma care in europe. european journal of psychotraumatology, 9(1), article 1556553. https://doi.org/10.1080/20008198.2018.1556553 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. clinical psychology in lithuania 10 clinical psychology in europe 2020, vol.2(1), article e2835 https://doi.org/10.32872/cpe.v2i1.2835 https://doi.org/10.32872/cpe.v1i1.34406 https://doi.org/10.1027/00438-000 https://www.skvc.lt/uploads/lawacts/docs/229_19635725da19d5b0c50a341a3d08ea4a.pdf https://e-seimas.lrs.lt/portal/legalact/lt/tad/tais.404693 https://e-seimas.lrs.lt/portal/legalact/lt/tad/c0c8f68164c911e8b7d2b2d2ca774092?jfwid=2r1mprf1 https://e-seimas.lrs.lt/portal/legalact/lt/tad/c0c8f68164c911e8b7d2b2d2ca774092?jfwid=2r1mprf1 https://doi.org/10.1080/20008198.2018.1556553 https://www.psychopen.eu/ clinical psychology in lithuania (introduction) historical background training in clinical psychology the start of clinical psychology training current clinical psychology training legislation for clinical psychology issues with the use of the title ‘clinical psychologist’ introduction of regulation debates about the regulation of psychology regulation of psychologists in health care clinical psychology, psychotherapy, and psychiatry future directions (additional information) funding competing interests acknowledgments references ok computer? a time analysis of google searches about symptoms research article ok computer? a time analysis of google searches about symptoms keith j. petrie a, kate mackrill a, connor silvester a, greg d. gamble b, nicola dalbeth b, james w. pennebaker c [a] department of psychological medicine, university of auckland, auckland, new zealand. [b] department of medicine, university of auckland, auckland, new zealand. [c] department of psychology, university of texas, austin, tx, usa. clinical psychology in europe, 2019, vol. 1(2), article 32774, https://doi.org/10.32872/cpe.v1i2.32774 received: 2019-01-01 • accepted: 2019-04-02 • published (vor): 2019-06-28 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: keith j. petrie, psychological medicine, faculty of medical and health sciences, university of auckland, private bag 92019, auckland, new zealand. e-mail: kj.petrie@auckland.ac.nz abstract background: google searches are now a popular way for individuals to seek information about the significance of common symptoms and whether they should seek medical assistance. as analysis of search patterns may help understand the demand for medical care, we examined what times over a 24-hour period and on what days of the week people searched google for information about common symptoms. method: we analysed google searches for symptoms in the united kingdom during the week from july 30 to august 5, 2018 using google trends. we recorded the time points with the highest search volume for 50 common symptoms relative to other searches, and the day of the week with the highest search peak for each particular symptom. results: all of the peak searches for the symptoms we examined occurred during the night between 10pm and 8am. the majority 32/50 (64%) occurred between 3am to 6am with 12/50 (24%) between midnight and 3am. most symptom searches were more common during the week and lowest during the weekend. typically, searches for a particular symptom peaked at a similar time each night over the week. conclusions: searches for symptoms are significantly more common during night-time hours, and particularly between 3 and 6am. symptom searches show relatively stable diurnal and weekly patterns. keywords google searches, symptoms, health anxiety, internet, time of day this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.32774&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • google searches for health information are common and individuals regularly search for their specific symptoms before deciding whether to seek medical care. • searches for common symptoms are significantly more likely to occur, relative to other searches, during the night-time hours and are highest during the working week and lowest at weekends. • the majority of symptom searches show relatively stable diurnal and weekly patterns. experiencing physical symptoms is very common but it is often difficult for individuals to determine whether the symptom is serious and needs medical attention (pennebaker, 1982; petrie & broadbent, 2019). a recent general population survey showed that individ‐ uals experience an average of five symptoms in a week, while 23% of the sample reported experiencing 10 or more symptoms (petrie, faasse, crichton, & grey, 2014). the meaning of symptoms can often be uncertain and individuals have in the past sought advice from family and friends about whether a symptom is a sign of a serious illness (hartzband & groopman, 2010). however, google is now being used as an alternative resource for un‐ derstanding symptoms, with google searches frequently used by the public to determine the significance and threat posed by particular symptoms and whether medical assistance should be sought (jacobs, amuta, & jeon, 2017). perhaps it is google’s anonymity, accessibility and information availability that has seen health-related searches become the second most searched thematic area amongst all searches (sullivan, 2016), with searches for symptoms now accounting for approximately 1% of the three billion searches each day (pinchin, 2016). in patients specifically, a recent survey of those attending an emergency department found that 49% regularly use the in‐ ternet for health information and 35% had searched for information on their specific symptoms before presenting (cocco et al., 2018). patients can also check their symptoms using online symptom checking algorithms that can provide advice about whether to seek medical care (semigran, linder, gidengil, & mehrotra, 2015). there has been concern raised that such searches may lead to a baseless increase in health anxiety or “cyberchondria” due to the fact that searches for common symptoms are often linked to rare, serious or fatal illnesses (filipkowski et al., 2010; north, ward, varkey, & tulledge-scheitel, 2012; white & horvitz, 2009). given the impact that health anxiety has shown in areas such as healthcare utilisation (barsky, ettner, horsky, & bates, 2001), there is surprisingly little information available on when individuals search for symptoms and how this may relate to utilisation of health care and the demand for out of hours care. time-analysis of google searches 2 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://www.psychopen.eu/ the access to google search data through google trends has enabled research on how often particular search terms are entered relative to the total volume of searches. this data can also be aggregated for different parts of the world or different time periods. analyses of search terms by google trends has been used to estimate the level of influ‐ enza illness in a population (lampos, miller, crossan, & stefansen, 2015), stock market trends (preis, moat, & stanley, 2013), and to investigate sensitive topics like sexual behav‐ iour, where surveys are likely to lead to misleading data (stephens-davidowitz, 2017). analysis of google trends for symptom searches can provide aggregated data on precise‐ ly when during the day or the week people are more likely to be looking for informa‐ tion about their symptoms and thus offer information about the likely demand for nonurgent care. in this study we examined when individuals searched for common symp‐ toms across a 24-hour period and on what days of the week. based on previous work on the non-urgent demand for emergency department visits in the united kingdom, which showed that the majority of non-urgent attendance occurs late at night or in the early hours of the morning (o’keeffe, mason, jacques, & nicholl, 2018), we hypothesized that google searches about symptoms would follow a similar pattern. m e t h o d symptoms we used a list of 50 common symptoms to investigate the peak search period for each symptom. forty-seven symptoms were drawn from a previous study investigating the frequency of symptom complaints in a general population sample (petrie et al., 2014). these included common symptoms such as back pain, fatigue, headache, insomnia and joint pain. we also added three other terms to the list. this included “hangover”, due to the frequency of this condition reported in general population studies (gjerde et al., 2010; tolstrup, stephens, & grønbaek, 2014) and its association with emergency room and pri‐ mary care visits (cherpitel & ye, 2015). as it has often been acknowledged that searching benign symptoms in google can produce results suggesting cancer or imminent death (north et al., 2012; white & horvitz, 2009), we included both “cancer” and “death” in the list. google search data google trends (trends.google.com) is a publicly available online tool that allows people to analyse how often a specific term or phrase has been searched in google over a speci‐ fied time period or in a particular geographic region, relative to other searches (nuti et al., 2014). google trends adjusts the data by taking a random sample of searches for a term and computing its popularity relative to the total number of google searches over petrie, mackrill, silvester et al. 3 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://www.psychopen.eu/ the same period of time. the time point with highest search volume for a term has the value of 100, while a score of 50 indicates half the popularity. a google trends search for the 50 symptoms or conditions of interest in the united kingdom was conducted. if a symptom phrase contained ‘or’, as in fever or increased temperature, this was changed to + in the google trend search. symptoms such as back or neck pain became back pain + neck pain. prior to searching, computer clocks were changed to london time to ensure that the google trend results corresponded to the cor‐ rect time zone. the time period of the search was the week from july 30 to august 5, 2018. we chose this week during the summer period so the data was less likely to be af‐ fected by winter colds and flu viruses. as minutes are only available for time periods of 24-hours or less, wednesday august 1 was taken as the representative day of the week and the time (hours and minutes) that each symptom was searched the most on this day was recorded. the day of the week that had the greatest number of searches for each symptom was also examined. collecting data over short periods, such as the week used in the present study, has demonstrated strong predictive power and representation of fu‐ ture data. for example, collecting data from one saturday-sunday period can forecast economic trends for subsequent months (choi & varian, 2012). the rate of google searches during the day (6am to midnight) and night were calcula‐ ted using www.openepi.com and compared using a mid-p exact method. the median number of symptoms searched for on google during the hours 6am to midnight was compared to the number at night (midnight to 6am) using the wilcoxon non-parametric method and a poisson regression model was to determine whether the number of google searches performed per hour differed. analyses were performed in sas (v 9.4, sas insti‐ tute inc, cary, nc). the significance level was set at p < .05. r e s u l t s we examined the peak time for searches for each of the 50 symptoms and these are illus‐ trated in figure 1. all of the peak searches for symptoms occur between 10pm and 8am. only 3 searches for symptoms (cancer, increased appetite and sexual problems) peak be‐ fore midnight and only 2 (muscle pain and difficulty concentrating) are after 6am. of the remaining symptom searches, the majority 32/50 (64%) occur between 3am to 6am, while 12/50 (24%) are between midnight and 3pm; these include death at 1.48am. the hour with the most symptom searches is 4-5am with 16 (32%) conducted during this period. time-analysis of google searches 4 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 http://www.openepi.com https://www.psychopen.eu/ figure 1. peak of searches for common symptoms in united kingdom during the week of july 30 to august 5, 2018. in total there were 45 symptoms reported in the 6 hours from midnight to 6 am (nighttime) (7.5 searched per hour, 95% ci [5.5, 9.9]). during the day (6am to midnight) there were 5 searches in 18 hours (0.28 searches per hour, 95% ci [.01, 0.62]). there were there‐ fore about 7 searches fewer per hour in the day than at night (rate difference -7.2 (-9.4, -5.0) (mid-p exact comparison of rates (p < .0001). significantly fewer symptoms were re‐ ported during the day than at night (median (min, max) 0 (0,2) v 5.5 (0,17) respectively, p = .001). there was a significant difference in the number of counts observed between hour blocks (poisson regression, p < .0001). we next examined the distribution of symptom search peaks over the days of the week we sampled. we found that monday, tuesday and friday had the greatest numbers of peaks of searches for symptoms, each with 10. saturday was lowest with 3 symptoms, while wednesday had 7, thursday 4 and sunday 6. most symptoms (76%) did not differ in the peak pattern of searching across the week. this is illustrated in the top two panels of figure 2, which shows the pattern of searches for cough and vomiting. death also shows a similar daily pattern. an exception is searches for hangover, which show a strong weekly pattern with higher levels over the weekend and lower numbers of searches for hangover symptoms during the week (bottom of figure 2). petrie, mackrill, silvester et al. 5 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://www.psychopen.eu/ figure 2. weekly pattern of symptom searching for cough, vomiting, death and hangover symptoms. the other symptoms that did not show a strong weekly pattern were increased appetite, sexual problems, low blood pressure, difficulty urinating, muscle weakness, dizziness, bruising easily, agitation, depressed mood, ear or hearing problems and difficulty concen‐ trating. d i s c u s s i o n we found searches for symptoms are much more likely to occur relative to other searches during the night-time hours, and particularly between 3 and 6am. most symptom search‐ es show a consistent pattern over the week, with peaks at similar times of night. symp‐ tom searches are more common during the week and lowest during the weekend. the results suggest that individuals with high levels of health anxiety may be advised to re‐ strict google symptom searches during the night-time in order to avoid unnecessary worry and healthcare use brought on by anxiety-provoking search results. another im‐ plication may be for clinicians to ask about, and treat, sleeping problems in patients with high levels of somatic complaints. the pattern of searches for symptoms during the night-time hours is consistent with previous research showing that people are most likely to notice symptoms when they are alone, not distracted by other activity and have time to focus on sensations that they time-analysis of google searches 6 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://www.psychopen.eu/ rarely notice when immersed in daily life (pennebaker, 1982). the night-time period is also a time when it is difficult to consult medical services about symptom concerns. pre‐ vious analysis of google trends has also noted that searches for the “big” questions such as “what is the meaning of life?” and “is there life on other planets?” also peak between 2 and 4 am (stephens-davidowitz, 2017). the study also highlights the use that can be made of google trends for understanding patient search behaviour around health issues. analysis of google searches has been used recently for understanding how patients man‐ age their gout and arthritis (jordan, pennebaker, petrie, & dalbeth, 2018), whether using google is associated with statin intolerance (khan, holbrook, & shah, 2018) and for see‐ ing if particular internet searches were associated with a subsequent diagnosis of pancre‐ atic cancer (paparrizos, white, & horvitz, 2016). some limitations of the study should be acknowledged. the data is limited to those with internet access and who use google as opposed to other search engines. the data is from only one country and needs replication in other locations and in non-english speaking populations. as we used symptoms as specific search terms, we do not know what exactly the search was about or its context. it is also not possible to get absolute rather than relative numbers of searches. it should also be noted that there is a lack of information on how data from google trends is derived, including the proportion of total searches sampled and the algorithms involved (nuti et al., 2014). bearing these limita‐ tions in mind, it is likely that google trends may in the future provide more insights into how patients use the internet to seek information on health topics and as a driver for seeking health care. it is also important to consider that google searches may have positive effects for pa‐ tients and healthcare professionals alike. for example, a recent survey of adult patients presenting to an emergency department demonstrated that searching for symptoms on google and seeking information online resulted in a more positive doctor-patient interac‐ tion and did not reduce adherence to treatment (cocco et al., 2018). for these patients, it may be that the internet serves as a supplementary resource that provides information that supports the doctor’s opinions and enhances this relationship (wald, dube, & anthony, 2007). however, this is dependent on the information being searched for re‐ flecting the opinion of the health professional; in cases where the two information sour‐ ces are incongruent, the relationship can be negatively affected and patients may become more likely to ignore healthcare professional advice (russ, giveon, catarivas, & yaphe, 2011). as such, while searching for symptoms may have some beneficial outcomes, the extent of this is limited by the accuracy the information searches provide. this research has various implications for health professionals. firstly, a greater un‐ derstanding of patterns of high internet symptom searching may help health professio‐ nals better understand and determine the health anxiety levels of a patient, and how that may contribute to the experience of symptoms. given that patients with higher anxiety levels may be more likely to misattribute general symptoms to an illness (severeijns, petrie, mackrill, silvester et al. 7 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://www.psychopen.eu/ vlaeyen, van den hout, & picavet, 2004) and are more likely to seek out information about symptoms online (eastin & guinsler, 2006), asking about online search activity may be valuable clinical information. secondly, this research may have significant applications at a population level such as better management of healthcare services. recent research has demonstrated that visits to health websites the preceding night can be used to predict emergency department traf‐ fic on the following day (ekström, kurland, farrokhnia, castrén, & nordberg, 2015). this logic may also be applied to searches for symptoms, where the number of symptoms goo‐ gled may predict emergency department traffic. further research should investigate the predictive validity of google symptom searches, and whether deviations of such from the times and days outlined in the current study have differential implications for healthcare service traffic. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e 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(2009). experiences with web search on medical concerns and self diagnosis. amia ... annual symposium proceedings amia symposium, 2009, 696-700. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. time-analysis of google searches 10 clinical psychology in europe 2019, vol.1(2), article 32774 https://doi.org/10.32872/cpe.v1i2.32774 https://blog.google/products/search/im-feeling-yucky-searching-for-symptoms https://doi.org/10.1038/srep01684 https://doi.org/10.1136/bmj.h3480 https://doi.org/10.1037/0278-6133.23.1.49 http://searchengineland.com/google-nowhandles-2-999-trillion-searches-per-year-250247 https://doi.org/10.1111/acer.12238 https://doi.org/10.1016/j.pec.2007.05.016 https://www.psychopen.eu/ time-analysis of google searches (introduction) method symptoms google search data results discussion (additional information) funding competing interests acknowledgments references education and training in clinical psychology and psychological psychotherapy in switzerland politics and education education and training in clinical psychology and psychological psychotherapy in switzerland marius rubo a, chantal martin-soelch b, simone munsch a [a] clinical psychology and psychotherapy, department of psychology, university of fribourg, fribourg, switzerland. [b] clinical psychology and health psychology, department of psychology, university of fribourg, fribourg, switzerland. clinical psychology in europe, 2020, vol. 2(3), article e2991, https://doi.org/10.32872/cpe.v2i3.2991 received: 2020-03-24 • accepted: 2020-07-15 • published (vor): 2020-09-30 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: marius rubo, clinical psychology and psychotherapy, department of psychology, university of fribourg, 2, rue de faucigny, ch-1700 fribourg/ switzerland. tel.: +41 26 300 76 61. e-mail: marius.rubo@unifr.ch abstract switzerland offers education in clinical psychology in the german and french language and training in psychotherapy in german, french and italian. both education and training are structured along centralized guidelines and recognized at a federal level. after finishing one’s studies, becoming a psychological psychotherapist requires between two and six years of postgraduate training and a financial investment of tens of thousands of swiss francs. historically, it is quite common for swiss psychotherapy trainings to incorporate a mix or combination of several psychotherapy schools such as cognitive behavioral, psychodynamic, systemic and humanistic. foreign degrees obtained in eu countries are generally recognized, and the fulfillment of criteria is evaluated on an individual basis. graduates find a diverse job market with opportunities to work in clinics and psychotherapeutical practices, but the absence of direct reimbursement via mandatory health insurance plans for psychological psychotherapists (not psychiatrists) lead many to work on patients’ private payments or as a psychiatrist’s employee. the ordering model, a potential new regulation allowing for the direct reimbursement of psychological psychotherapists’ work, is planned to be decided upon throughout 2020. keywords education in clinical psychology, psychotherapy training, switzerland, employment models, reimbursement, ordering model this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.2991&domain=pdf&date_stamp=2020-09-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • switzerland offers education in clinical psychology in german and french. • trainings in psychological psychotherapy often incorporate content from various psychotherapy schools. • degrees obtained in eu countries can be acknowledged. • several employment models exist for psychological psychotherapists, and the profession hopes to see improvements in the reimbursement situation throughout this year. e d u c a t i o n i n c l i n i c a l p s y c h o l o g y goals in switzerland – a federal parliamentary republic consisting of four broad geographic and language regions and of 26 cantons – private and state universities as well as universities of applied sciences are centrally evaluated by the governmental institution swissuniversities (www.swissuniversities.ch). altogether 12 universities are currently ac‐ credited and fulfill the criteria of the federal higher education law (hochschulförderungsund koordinationsgesetz, hfkg) and six of them (universities of basel, bern, fribourg, geneva, lausanne and zurich, but also the zurich university of applied sciences) offer education programs in clinical psychology in german or french language. the universi‐ ty in fribourg furthermore offers a bilingual curriculum (german-french) with courses in english. similar to most countries in europe, the swiss education in clinical psychology includes a three years’ bachelor and a two years’ master program. the bachelor pro‐ gram includes basics of psychology such as human cognition, experimental psychology, personality, development, emotions, and psychopathology. subsequent master programs in clinical psychology focus on psychopathological and related biological processes, knowledge on evidence-based diagnostic and interventions and more strongly emphasize the ability to critically assess and process the scientific literature in the field. these skills allow students to pursue careers both in clinical settings (and particularly to pursue a federally accredited postgraduate training in psychotherapy or health psychology) as well as in research. a master diploma in psychology leads to the title “psychologist” that is recognized at federal level. contents, structure and costs the contents of bachelor programs in psychology and master programs in clinical psy‐ chology are similarly structured and comparable across all swiss universities according to the guidelines of the konferenz der schweizer psychologie-institute (k-psych), which will be updated in june 2020. bachelor programs include three years of studies and training in psychotherapy in switzerland 2 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 http://www.swissuniversities.ch https://www.psychopen.eu/ 180 ects, while master programs consist of two years of studies and 120 ects. a two-month full time practical experience which is mandatory in master programs can be completed in clinical settings, but also in research groups. evaluation the bachelor program in psychology includes three consecutive years of studies. after the first year, students are required to pass written propaedeutic exams (except at the fernuni, zhaw and fhnw). subsequent examinations during the second and third year are individually organized by the universities and include oral and written exams as well as written essays or presentations. costs swiss universities open all their education programs for a semester fee from chf 500 up to chf 1300 (swissuniversities, n.d.). granting of studentships depends on the parental income and eligibility is usually organized by the canton of domicile of the student. l e g a l f r a m e w o r k swiss education in psychology, clinical psychology and psychotherapy in 2013, the law on psychology professions (bundesamt für gesundheit [bag], 2020a, psyg/lpsy) was introduced with the overall purpose of reinforcing public health and protecting customers and people in need for psychological opinion, counseling or treat‐ ment from fraud. with the new law, the title “psychologist” is now protected in switzer‐ land. obtaining a master degree in clinical psychology in switzerland qualifies students to enter accredited postgraduate specialized trainings in neuropsychology, psycholog‐ ical psychotherapy, health psychology, clinical psychology and children and youth psychology. these are the 5 specialized post-graduate titles defined in the psyg/lpsy. all swiss postgraduate trainings are evaluated and accredited by the federal commission on psychology professions (bag, 2019b). this commission also evaluates and decides the recognition of foreign degrees. following the implementation of the psyg in 2013 and until end of 2018, all existing training programs in psychological psychotherapy from different stakeholders in switzerland underwent an evaluation process, which is required to be repeated every seven years, under the lead of the commission of psychology professions. rubo, martin-soelch, & munsch 3 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ recognition of foreign degrees relying on the swiss-eu bilateral agreement on the free movement of persons (afmp), switzerland has adopted the eu’s system of mutual recognition of professional qualifica‐ tions (state secretariat for education, resarch and innovation [seri], n.d.), in which a university degree or a degree from a university of applied science from abroad is recognized if it is acknowledged in the country of origin. nonetheless, each application is evaluated on an individual basis and additional requirements may be determined before a title is validated as equivalent. requests from countries outside of europe are processed equally. as switzerland is relatively unique in europe in requiring 5 years of advanced training, additional parts of training regularly have to be caught up here. register of psychology professions psychologists with a title in psychological psychotherapy (and any other postgraduate training accredited by the federal department of health as e.g. child and youth psychol‐ ogist, neuropsychologist, health psychologist and clinical psychologists) are obliged to enlist in the register of psychology profession (bag, 2020b). in the case of psychological psychotherapists, the list includes information about whether the person is entitled to autonomously offer psychotherapeutic treatment. the register aims at increasing the transparency of offers across cantons and to ensure the quality of treatment offers to the swiss inhabitants. the completion of the register is currently still ongoing. t r a i n i n g i n p s y c h o l o g i c a l p s y c h o t h e r a p y diverse options for therapy trainings in switzerland, different institutions offer training programs in psychological psycho‐ therapy. in 2013, after the introduction of the psyg/lpsy, a total of 62 postgraduate curricula in psychological psychotherapy were accredited temporarily until 2018, which means that these diplomas were recognized by the government independent of an evalu‐ ation according to the before mentioned conditions. these psychotherapy training offers were diverse and encompassed cognitive-behavioral, humanistic, psychodynamic and systemic approaches. until 2019, 41 of these initial programs have been accredited by the federal department of health. currently, three german universities, two french uni‐ versities, one german/french university and the zhaw university of applied sciences from switzerland offer a total of 12 postgraduate psychotherapy trainings for applicants holding an accredited master's degree. the remaining 29 postgraduate psychotherapy trainings are offered outside the university. of the 41 psychotherapy trainings, the following therapy schools are represented: (1) 8 in cognitive behavioral therapy; (2) 11 in psychoanalytic therapy; (3) 10 in systemic therapy; (4) 4 in humanistic methods; (5) training in psychotherapy in switzerland 4 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ 8 in various mixed forms and integrative approaches. notably, it is common for the abovementioned programs to incorporate content from other “schools”. in switzerland, adult and child/adolescent psychotherapy are currently not consid‐ ered to be separate psychological professions by law. therefore, a postgraduate diploma in psychological psychotherapy entitles psychotherapists to offer treatment to the full age range. nevertheless, some training programs focus more on adults whereas others focus explicitly on children, adolescents and young adults. goals postgraduate trainees are expected to have established a profound understanding of human experience and behavior as well as their biological underpinnings during the bachelor and master program in clinical psychology. they are already skilled to assess and evaluate complex human experience and behavior in diverse developmental stages and psychosocial contexts. building on these skills, postgraduate trainings in psychologi‐ cal psychotherapy (ppt) then teach to autonomously offer and evaluate psychotherapeu‐ tic treatment. specifically, trainees learn to employ evidence-based psychotherapeutic theories, techniques and methods, reflect professional activities based on theoretical and practical expertise and reflecting societal and legal aspects, cooperate with other health experts, respect cost-efficiency in their professional activities, and others. contents and structure altogether, obtaining the title of a psychological psychotherapist requires between four and six years of fulltime postgraduate training and is prolonged if the training is executed in part time. resulting in a sum of 5430 units (one unit equals 45 minutes), the training consists of theory and competences (500 units), supervision (at least 150 units, 50 of which in a single setting), self-experience (at least 100 units, 50 of which in a single setting), individual and practical experiences under supervision (at least 500 units, with at least 10 case reports), and altogether at least 2 years of fulltime practical experiences in an institution of primary psychosocial health care, with at least one year in psychotherapeutic or psychiatric primary health care (edi, 2016). in case of part time employment, the duration is automatically prolonged. no less than 50% part time employment is allowed. these are basic and mandatory requirements. most institutions offering psychotherapeutic training ask for more hours than legally required, especially for more units of theory and practical competence training. evaluation at the end of postgraduate trainings in psychological psychotherapy, the responsible teaching and supervising experts of the program examine the trainees’ theoretical and clinical competences and evaluate whether all units have been acquired. during the rubo, martin-soelch, & munsch 5 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ training process, supervisors and experts repeatedly comment on the trainee’s professio‐ nal development and their patients’ therapeutic processes and discuss the trainees’ case reports examination procedures during or at the end of the program depend on the individual institute offering the postgraduate training and may include oral or written theoretical exams and oral exams on case reports of the trainees. costs the total costs of postgraduate psychotherapy training vary strongly, ranging from a minimum of 35200 chf to a maximum of 91700 chf. number of psychologists and psychotherapists according to the most recent representative survey initiated by the swiss federation of psychologists (fsp, https://www.psychologie.ch; stettler, stocker, gardiol, bischof, & künzi, 2013) in 2012, switzerland counted 15 000 psychologists or 1.8 psychologists per 1000 inhabitants, while there were 0.4 fulltime working psychological psychotherapists per 1000 inhabitants. in 2012, 32% of all psychological psychotherapists reported working according to the psychoanalytic, 19% to the cognitive-behavioral, 17% to the humanistic and 12% to the systemic orientation, and an additional fraction reported to adhere to multiple schools (grosse holtforth, kramer, & dauwalder, 2015). in 2019, around 8600 (79% female) students were enrolled in psychology at a swiss university (not including phd students and persons pursuing postgraduate trainings (bundesamt für statistik, 2019). after the implementation of the law on psychology professions, from april 2013 until december 2019, a total of 2218 degrees in psychology and 359 degrees in psychotherapy from abroad have been accredited. altogether 80% of these candidates had pursued their education and psychotherapy training in italy, germany, france, portugal and in austria. the remaining 20% applications came from south america and from mid and eastern europe (bag, 2020c). advanced training for psychotherapists after receiving a diploma in psychological psychotherapy from an accredited training program, psychotherapists are obliged to participate in regular advanced trainings in order to refresh and renew their theoretical and practical competences. nevertheless, up to date, neither contents nor hours of advanced training have been defined. t r a i n i n g s i n o t h e r s p e c i a l i z a t i o n t i t l e s for neuropsychology, there is one accredited curriculum in french and one accredi‐ ted training in german, offered in collaboration between universities and the swiss training in psychotherapy in switzerland 6 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychologie.ch https://www.psychopen.eu/ society of neuropsychology. neuropsychologist are the only specialized psychologists reimbursed by the mandatory health insurance. for health psychology, there is at the moment only one french-speaking curriculum offered by french-speaking universities (fribourg, geneva and lausanne, leading house fribourg) in collaboration with the swiss society for health psychology under the insti‐ tutional cover of the rector conference of french-speaking universities in switzerland (the so-called triangle azur). the delivered title is a mas in health psychology, the accreditation process will begin soon. for clinical psychology, there is one french-speaking curriculum offered by 3 frenchspeaking universities (geneva, lausanne and fribourg, leading house geneva) in col‐ laboration with the swiss association of clinical psychologists, also under the institu‐ tional cover of the rector conference of french-speaking universities in switzerland (the so-called triangle azur). the delivered title is a mas in clinical psychology, the accreditation process will begin soon. the swiss association of clinical psychologists offer a complete curriculum in german and one in italian, leading the title of specialist in clinical psychology recognized by the swiss federation of psychologists, but not accredi‐ ted by the federal commission on psychology professions yet. the clinical psychology specialization is particularly aimed at the employment in mental health hospitals with in-patients. for children and youth psychology, there is only one training option offered by the swiss association of children and youth psychologists, that is not accredited yet. e m p l o y m e n t s i t u a t i o n f o r p s y c h o l o g i c a l p s y c h o l o g i s t s i n s w i t z e r l a n d psychotherapy in the swiss health system the total annual costs for health services which are reimbursed by mandatory insurances in switzerland amount to chf 9,86 billion of which 11% (chf 1,08 billion) are generated in the field of psychiatry (including psychological psychotherapy). specifically, 2.9% of the total annual health costs covered by mandatory insurances (chf 286 million) are generated by psychological services (grosse holtforth, kramer, & dauwalder, 2015). these numbers do not include the costs of psychological psychotherapy covered by private insurances or paid by patients personally. according to a study by the schweizerisches gesundheitsobservatorium, around 470,000 individuals (7% of the population above 15 years of age) sought psychotherapeutic treat‐ ment in 2009, 88% of who were treated in an outpatient and 12% in an inpatient setting (rüesch, baenziger, & juvalta, 2013). psychological psychotherapists in particular, treat 259 000 of these patients each year (stettler et al., 2013). on average, each psychological psychotherapist treats 84 patients per year, and each patient receives 29 sessions within 17 months of treatment. a majority of psychological psychotherapists reports having rubo, martin-soelch, & munsch 7 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ a wait list (59%). 43% therapists report that they do not have any current availability (stettler et al., 2013). quantitative research on treatment gaps in psychotherapy in swit‐ zerland is relatively scarce. estimates of the percentage of individuals suffering from a mental disorder who do not receive even minimal treatment range from 40% to 65% (stocker et al., 2016). the reimbursement of psychological psychotherapy in the swiss health-care system is divided into three main financing sources. firstly and most importantly, 67% of the psychotherapeutic services are reimbursed by the mandatory health insurance plans. secondly, 29% of the psychotherapeutic services are paid by the patients themselves or by their private complementary insurances, and, thirdly, 4% of the psychotherapeutic services are financed by public social services. (stettler et al., 2013). employment models for psychological psychotherapists the fact that there is so far no direct reimbursement of psychological psychotherapy by the mandatory health insurances influences the current employment models. about a third of all psychological psychotherapists work in private practice, where their patients privately pay for psychotherapeutic treatment or receive partial reimbursement via a private insurance plan. another group of psychological psychotherapists of about 40% work in so-called “delegated” practice (stettler et al., 2013). as a “delegated psychothera‐ pist” the psychological psychotherapist is an employee of and works in the rooms of a psychiatrist. according to the current legislation, this means that the psychiatrist “delegates” psychotherapy and that the psychological psychotherapist works under the psychiatrist’s legal responsibility and supervision. the psychiatrist gets reimbursed for the psychotherapy provided by the psychologist via mandatory basic insurance plans. the payment of the psychological psychotherapists varies from employer to employer (psychiatrist). strikingly, the reimbursement for delegated psychotherapy is only around two thirds of that for psychotherapy offered by psychiatrists. psychological psychotherapists further work in outpatient clinics within larger insti‐ tutions, where patients either pay privately (if a psychological psychologist is head of the unit), or the patients get reimbursed for their psychotherapies (if a psychiatrist is head of the clinic). finally, around 13% of psychological psychotherapists work in psychiatric hospitals and provide primary mental health care as well as psychotherapy. (possibly) better working conditions in the future the system of delegated psychotherapy is highly controversial in switzerland. it was originally implemented as a temporary solution to improve access to mental health care until the psychological profession were regulated in detail and – again supposedly temporarily treats psychological psychotherapists as auxiliary employees of psychia‐ trist-psychotherapists receiving a lesser payment. although the rationale behind the training in psychotherapy in switzerland 8 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ delegated model has become obsolete with the „law on psychology professions“ intro‐ duced in 2013, adaption has been postponed until today. remarkably, the delegation model has remained unchanged despite clearly standing at contrast with psychological psychotherapists’ official authorization to execute their profession independently and to their own full responsibility (www.psyeg.admin.ch). the law however changed the situation of neuropsychologists who are now reimbursed by the mandatory law. recently, a potential new regulation called the “ordering model” is being discussed and evaluated by the government. in the ordering model, a psychological psychotherapist would work self-employed and in his/her own office, and a physician’s prescription would suffice for the reimbursement of a limited number of psychotherapy sessions by mandatory health insurance plans. after a period of more than 7 years of internal evaluations, the federal council opened a consultation phase regarding the planned new legal regulations in july 2019 (bag, 2019a). while the federal department of health supports the new regulation, there have been heated debates since the consultation phase has been opened, most prominently between psychologists, psychiatrists and politics. as a result, the decision on the implementation of the ordering model, which was originally scheduled for early 2020, has been post‐ poned and seems unlikely to be processed in due time. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors thank alexander ariu for his help in collecting information. r e f e r e n c e s bundesamt für gesundheit (bag). (2018). akkreditierung von weiterbildungsgängen der psychologieberufe. retrieved february 27, 2020, from https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/akkreditierunggesundheitsberufe/akkreditierung-vonweiterbildungsgaengen-im-bereichpsychologieberufe.html bundesamt für gesundheit (bag). (2019a). änderung kvv und klv betreffend neuregelung der psychologischen psychotherapie und der zulassungsvoraussetzungen nicht-ärztlicher leistungserbringer. retrieved february 27, 2020, from https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/ krankenversicherung-revisionsprojekte/aenderungen-psychotherapienichtaerztlicheleistungserbringer.html bundesamt für gesundheit (bag). (2019b). psychologieberufekommission (psyko). retrieved february 26, 2020, from rubo, martin-soelch, & munsch 9 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 http://www.psyeg.admin.ch https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/akkreditierung-gesundheitsberufe/akkreditierung-vonweiterbildungsgaengen-im-bereich-psychologieberufe.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/akkreditierung-gesundheitsberufe/akkreditierung-vonweiterbildungsgaengen-im-bereich-psychologieberufe.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/akkreditierung-gesundheitsberufe/akkreditierung-vonweiterbildungsgaengen-im-bereich-psychologieberufe.html https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte/aenderungen-psychotherapie-nichtaerztlicheleistungserbringer.html https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte/aenderungen-psychotherapie-nichtaerztlicheleistungserbringer.html https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte/aenderungen-psychotherapie-nichtaerztlicheleistungserbringer.html https://www.psychopen.eu/ https://www.bag.admin.ch/bag/de/home/das-bag/organisation/ausserparlamentarischekommissionen/psychologieberufekommission-psyko.html bundesamt für gesundheit (bag). (2020a). häufige fragen (faq) zum psychologieberufsgesetz (psyg). retrieved february 26, 2020, from https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/faqpsyg.html bundesamt für gesundheit (bag). (2020b). psychologieberuferegister psyreg. retrieved february 27, 2020, from https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/ psychologieberuferegister-psyreg.html bundesamt für gesundheit (bag). (2020c). statistiken anerkennungen psychologieberufe. retrieved february 27, 2020, from https://www.bag.admin.ch/bag/de/home/zahlen-und-statistiken/statistiken-berufe-imgesundheitswesen/statistiken-anerkennungen-psychologieberufe.html bundesamt für statistik. (2019). tertiärstufe, universitäre hochschulen: studierende nach hochschule und fachbereich. retrieved february 27, 2020, from https://www.bfs.admin.ch/bfs/de/home/aktuell/neueveroeffentlichungen.assetdetail.7746943.html eidgenössisches departement des innern (edi). (2016). verordnung des edi über umfang und akkreditierung der weiterbildungsgänge der psychologieberufe. retrieved february 27, 2020, from https://www.admin.ch/opc/de/classified-compilation/20132533/index.html#app1ahref2 grosse holtforth, m., kramer, u., & dauwalder, j.-p. (2015). psychological psychotherapy in switzerland: moving towards transparency and quality. santé mentale au québec, 40(4), 51-58. https://doi.org/10.7202/1036093ar rüesch, p., baenziger, a., & juvalta, s. (2013). regionale psychiatrische inanspruchnahme und versorgungsbedarf in der schweiz (obsan dossier 23). neuchâtel, switzerland: schweizerisches gesundheitsobservatorium obsan. state secretariat for education, resarch and innovation (seri). (n.d.). recognition of foreign qualifications. retrieved february 26, 2020, from https://www.sbfi.admin.ch/sbfi/en/home/bildung/recognition-of-foreign-qualifications.html stettler, p., stocker, d., gardiol, l., bischof, s., & künzi, k. (2013). strukturerhebung zur psychologischen psychotherapie in der schweiz 2012 [survey of psychological psychotherapy in switzerland 2012]. bern, switzerland: federation of swiss psychologists (fsp). stocker, d., stettler, p., jäggi, j., bischof, s., guggenbühl, t., abrassart, a., ... künzi, k. (2016). versorgungssituation psychisch erkrankter personen in der schweiz. bern, switzerland: büro für arbeitsund sozialpolitische studien bass. swissuniversities. (n.d.). semestergebühren hochschulen-2019/2020. retrieved january 16, 2020, from https://www.swissuniversities.ch/fileadmin/swissuniversities/dokumente/lehre/ hochschulraum/gebuehren.pdf training in psychotherapy in switzerland 10 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.bag.admin.ch/bag/de/home/das-bag/organisation/ausserparlamentarische-kommissionen/psychologieberufekommission-psyko.html https://www.bag.admin.ch/bag/de/home/das-bag/organisation/ausserparlamentarische-kommissionen/psychologieberufekommission-psyko.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/faq-psyg.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/faq-psyg.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/psychologieberuferegister-psyreg.html https://www.bag.admin.ch/bag/de/home/berufe-im-gesundheitswesen/psychologieberufe/psychologieberuferegister-psyreg.html https://www.bag.admin.ch/bag/de/home/zahlen-und-statistiken/statistiken-berufe-im-gesundheitswesen/statistiken-anerkennungen-psychologieberufe.html https://www.bag.admin.ch/bag/de/home/zahlen-und-statistiken/statistiken-berufe-im-gesundheitswesen/statistiken-anerkennungen-psychologieberufe.html https://www.bfs.admin.ch/bfs/de/home/aktuell/neue-veroeffentlichungen.assetdetail.7746943.html https://www.bfs.admin.ch/bfs/de/home/aktuell/neue-veroeffentlichungen.assetdetail.7746943.html https://www.admin.ch/opc/de/classified-compilation/20132533/index.html#app1ahref2 https://doi.org/10.7202/1036093ar https://www.sbfi.admin.ch/sbfi/en/home/bildung/recognition-of-foreign-qualifications.html https://www.swissuniversities.ch/fileadmin/swissuniversities/dokumente/lehre/hochschulraum/gebuehren.pdf https://www.swissuniversities.ch/fileadmin/swissuniversities/dokumente/lehre/hochschulraum/gebuehren.pdf https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. rubo, martin-soelch, & munsch 11 clinical psychology in europe 2020, vol.2(3), article e2991 https://doi.org/10.32872/cpe.v2i3.2991 https://www.psychopen.eu/ training in psychotherapy in switzerland education in clinical psychology goals contents, structure and costs evaluation costs legal framework swiss education in psychology, clinical psychology and psychotherapy recognition of foreign degrees register of psychology professions training in psychological psychotherapy diverse options for therapy trainings goals contents and structure evaluation costs number of psychologists and psychotherapists advanced training for psychotherapists trainings in other specialization titles employment situation for psychological psychologists in switzerland psychotherapy in the swiss health system employment models for psychological psychotherapists (possibly) better working conditions in the future (additional information) funding competing interests acknowledgments references the european association of clinical psychology and psychological treatment (eaclipt): a new organization for the future! editorial the european association of clinical psychology and psychological treatment (eaclipt): a new organization for the future! gerhard andersson ab [a] department of behavioural sciences and learning, linköping university, linköping, sweden. [b] department of clinical neuroscience, karolinska institute, stockholm, sweden. clinical psychology in europe, 2019, vol. 1(1), article e33241, https://doi.org/10.32872/cpe.v1i1.33241 published (vor): 2019-03-29 corresponding author: gerhard andersson, department of clinical neuroscience (cns), k8, cpf kcp, liljeholmstorget 7b plan 6 117 63 stockholm, sweden. e-mail: gerhard.andersson@liu.se the european association of clinical psychology and psychological treatment (eaclipt) was founded in 2017 with representatives of many european countries. at its launch, many people were surprised to hear that such an organization did not already exist given the role of clinical psychology both as a branch of psychology and psycholog‐ ical research, but also as a renowned profession. we knew several national organizations existed for clinical psychologist practitioners and researchers across europe, as well as european and international organizations for various subdisciplines of psychology and forms of psychotherapy. but we regarded the absence of a targeted organization for europe as a serious omission. thus, the eaclipt aims to strengthen science, practice and political representation in relation to clinical psychology. in this editorial we will briefly describe the aims of the eaclipt and also our ach‐ ievements to date. finally, we will outline our wishes for the future. the eaclipt’s aims are broad. we want to foster research, education and dissemina‐ tion of scientifically evaluated findings, and address the following topics: • diagnostics and classification of mental health conditions • psychological and psychobiological mechanisms of health and disease • psychological treatments, psychotherapy • prevention and rehabilitation • healthcare issues in mental health conditions this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.33241&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ • dissemination and implementation of evidence-based psychological treatments • education in clinical psychology • representation of clinical psychology in politics across europe. although the eaclipt focuses on clinical psychology, we are also dedicated to both re‐ search and practice. it is, however, by no means an organization exclusively for clini‐ cians, since we also have a strong interest in the status of clinical psychology as a re‐ search area and as an important profession from a policy perspective. thus, policy and research are regarded as more urgent areas for eaclipt to focus on than the actual prac‐ tice of clinical psychology. the latter has many national and international organizations and, when it comes to psychotherapy brands, also several psychotherapy organizations. the eaclipt is needed right now for several reasons. first, we believe that clinical psychology is more than psychotherapy. second, the world, and indeed europe, is shrink‐ ing as practitioners and patients move across borders. this requires european-wide standards both in research and in clinical practice, and also cross-border collaboration. the profession of clinical psychology is also expanding into medicine and healthcare in general. this necessitates research into disorders and health problems that have often been regarded as extraneous to psychology. good practice in research and clinical tasks demand that we define quality criteria for training in and provision of clinical psycholog‐ ical healthcare, and that we improve comparability of training programs in european countries. what have we done so far? following our initial gathering in amsterdam, the nether‐ lands, in 2017, we arranged a small closed inaugural conference in linköping, sweden, in 2018. in between those two meetings we formed a board which then convened in am‐ sterdam. we also had regular monthly board meetings by phone and developed a website www.eaclipt.org. and, as you can see, the journal was initiated and launched its first is‐ sue in 2019. the board has also actively sought to recruit members, find national representatives and attend important meetings at eu-level (e.g., parliament). we have also had to deal with numerous practical matters that accompany an organization’s launch. we have also initiated a newsletter. although the exact number of our members is unknown at this ed‐ itorial’s publication, membership topped 400 at the time of writing. we have also began planning for our first conference. the first european congress of the eaclipt will be held in germany, dresden, 31 oct 02 nov 2019, under the topic: “no health without mental health: european clinical psychology takes responsibility”. finally we should mention our expectations. we hope that the eaclipt will help ad‐ vancing the field of clinical psychology and all connected academic and clinical fields in europe. we expect clinical psychology to be even more relevant in the future than it is today. clinical psychology has already had a favourable impact on the treatment of men‐ tal health conditions and, increasingly, other health problems too. this has been driven the eaclipt: a new organization for the future! 2 clinical psychology in europe 2019, vol.1(1), article e33241 https://doi.org/10.32872/cpe.v1i1.33241 http://www.eaclipt.org https://www.psychopen.eu/ by progress in research. but it is not enough just to know what works when it comes to clinical problems (including both assessment and treatment procedures). we also need to make an effort to disseminate that knowledge, not least at policy level. finally, we hope that the profession of both researchers and clinicians (sometimes the same person serv‐ ing in both functions) will benefit from the eaclipt and that we will manage to develop policy documents and research collaborations across europe. gerhard andersson, president eaclipt further board members: claudi bockting, roman cieślak, céline douillez, thomas ehring, andreas maercker, winfried rief andersson 3 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org https://www.leibniz-psychology.org/ https://www.psychopen.eu/ widespread recommendations can change our habits of hand-washing and physical distance during the covid-19 pandemic research articles widespread recommendations can change our habits of hand-washing and physical distance during the covid-19 pandemic stefanie c. biehl a , melissa schmidmeier a, theresa f. wechsler a, leon o. h. kroczek a, andreas mühlberger a [a] department of clinical psychology and psychotherapy, university of regensburg, regensburg, germany. clinical psychology in europe, 2021, vol. 3(1), article e3061, https://doi.org/10.32872/cpe.3061 received: 2020-04-07 • accepted: 2020-10-28 • published (vor): 2021-03-10 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: stefanie c. biehl, department of clinical psychology and psychotherapy, university of regensburg, universitaetsstraße 31, 93053 regensburg, germany. phone: +49 (0)941 943 6043. e-mail: stefanie.biehl@psychologie.uni-regensburg.de supplementary materials: materials [see index of supplementary materials] abstract background: habits and behaviors in everyday life currently need to be modified as quickly as possible due to the covid-19 pandemic. two of the most effective tools to prevent infection seem to be regular and thorough hand-washing and physical distancing during interpersonal interactions. method: two hundred and eighty-four participants completed a short survey to investigate how previous habits regarding hand-washing and physical distancing have changed in the general population as a function of the current pandemic and the thereby increased information and constant recommendations regarding these behaviors. results: participants aged 51 and older reported a greater change in everyday hand-washing behavior than younger participants. in addition, participants aged 31 and older selected significantly greater distances to have a conversation than younger participants. however, that was not the case if participants had to actively stop their conversational partner from approaching. conclusion: participants aged 51 years and older seem to be well aware of their at-risk status during the current pandemic and might therefore be willing to change their behavior more strongly than younger survey participants. nevertheless, they seem to struggle with enforcing the current rules towards others. the group aged between 31 and 50 years, however, reports a this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3061&domain=pdf&date_stamp=2021-03-10 https://orcid.org/0000-0002-1232-4200 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ comparable level of fear, but no corresponding change in hand-washing behavior. future surveys should try to provide more insight into why this might be the case. keywords covid-19 pandemic, everyday habits, hand-washing, physical distancing highlights • habits and behaviors need to be modified quickly during the current covid-19 pandemic. • participants aged 51 years and older seem to be willing to change their behavior more strongly. • however, they seem to struggle with enforcing some of the current rules towards others. the current covid-19 pandemic forces us to change our everyday lives and associ­ ated habits as quickly as possible. regular thorough hand-washing and physical distanc­ ing have been recommended as two of the most effective tools to prevent infection (bundeszentrale für gesundheitliche aufklärung, 2020). habits regulating these behav­ iors, however, are triggered by similar contextual circumstances, can be implemented using minimal resources, and can be used to predict future behavior in a similar situation (for a review see ouellette & wood, 1998). habitual behavior thus needs to be modified by consciously inhibiting previously established habitual behavior and implementing alternative responses (for a review see gardner, 2015). social psychological models fur­ thermore suggest that social behavior is not only driven by a reflective system based on consequences and probabilities, but also by an impulsive system based on spreading acti­ vation (strack & deutsch, 2004), which can cause fear to at least co-determine behavior. regular thorough hand-washing is already recommended during periods of increased probability of infections to prevent the spreading of infectious diseases like influenza (bundeszentrale für gesundheitliche aufklärung, 2018). previous population-based re­ search, however, does not show a clear reduction in influenza transmission (simmerman et al., 2011) or acute respiratory tract infections (merk, kühlmann-berenzon, linde, & nyrén, 2014) as a function of self-reported hand-washing. of note, the latter inves­ tigation suggested a protective effect for health-care workers, leading the authors to conclude that the knowledge regarding adequate hand-washing might be insufficient in the general population. we implemented a short survey to investigate how previous habits regarding hand­ washing were changed in the general population as a function of the current pandemic and the thereby increased information and constant recommendations regarding ade­ quate hand-washing. we also assessed whether the general public is aware of and able change of habits during the covid-19 pandemic 2 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ to follow further recommendations, particularly with regard to physical distancing in interpersonal situations. m e t h o d assessment data were collected for the duration of twelve days, starting on the day of the imple­ mentation of movement restrictions in bavaria (march 21st, 2020) and ending on april 1st. the questionnaire was implemented via evasys (electric paper evaluationssysteme gmbh, lueneburg, germany), an online questionnaire tool operated by the university of regensburg. it consisted of seven questions assessing the frequency of hand-washing in different situations as well as possible changes since the outbreak of the corona virus sars-cov-2. situations were chosen to cover a range of everyday situations, in which hand-washing is recommended (before eating, after entering your flat/house, after blowing your nose, after coughing/sneezing in your hand, after touching another person not living in the same household, after touching an object that is also touched by other people) as well as a baseline item (after using the bathroom). participants were asked to report both the frequency of and the change in hand-washing in these situations on a five-point scale (“0 = never” to “4 = always” and “0 = unchanged” to “4 = very much more”, respectively). data were aggregated to form mean scores across situations with self-reference (before eating, after entering your flat/house, after blowing one’s nose, after coughing/sneezing in your hand) and with other-reference (after touching another person/an object touched by other people), both for frequency and change since the outbreak of the virus. in addition, the questionnaire assessed the use of soap/disinfectant, the adherence to further recommendations to avoid infection (not touching one’s face and physical dis­ tancing), the subjective importance of following the recommendations regarding hand­ washing, and the attention to observing adequate physical distance during interactions. participants were also asked to select interpersonal distances where they a) were current­ ly most comfortable with (passive distancing) and b) would stop someone else from approaching (active distancing) from one of three standardized virtual reality pictures showing an agent at the distances of 1m, 1.5m, and 2m (see figure 1), which were taken as still frames from a virtual reality scenario (vtplus gmbh, würzburg, germany). furthermore, participants’ fear of covid-19 for themselves and for relatives as well as the incidence of pathological hand-washing as occurring in obsessive compulsive disorder (ocd; i.e. washing one’s hands more frequently and longer than necessary) were assessed. biehl, schmidmeier, wechsler et al. 3 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ figure 1 virtual reality pictures used in the assessment of physical distancing note. standardized pictures from virtual reality with an agent at the distances of 1.5m (1), 1m (2), and 2m (3) taken from an experimental vr-paradigm, joint project optapeb. ©vtplus. participants were informed beforehand that participation in the survey was entirely voluntary and that they could end the survey at any time, in which case no data were transmitted. to comply with current regulations of data protection and to ensure de facto anonymity, age was only collected in the form of age ranges (5 years per range except for 18 to 21 years). care was furthermore taken to keep the survey as short as possible and to not include questionnaires that might cause distress in survey participants (e.g. assess­ ing mental health problems). all participants gave their informed consent to participate in the survey. a link to access the questionnaire was distributed via personal contacts, social media, university mailing lists, and a press release on the university’s home page. participants a total of 284 adults (205 women) between 18 and 75 years of age participated in the survey. while participants’ place of residence was not obtained to ensure anonymity, 93.7% of the sample (266 participants) reported movement restrictions at their place of residence when taking the survey. as this was not the case for 62.5% of the german federal states at the time of data collection (steinmetz, batzdorfer, & bosnjak, 2020), it is likely that most participants lived in bavaria at the time of the survey. overall, 72.2% of participants were aged 40 years or younger, with the largest percentage of participants (30.6%) in the 21 to 25 years age group. to facilitate analyses, participants were assigned to one of the age groups: “young age” (ya, 18-30 years of age; 150 participants); “middle age” (ma, 31-50 years of age; 86 participants), and “best/older age” (oa, >50 years of age; 48 participants). the category “best/older age” was chosen to include all participants with a theoretically increased risk for severe or critical course of covid-19, as the robert koch-institute lists older people as having a steadily increased risk for a severe course of the disease, starting at age 50 to 60. (robert koch-institut, 2021). there was a trend for a greater proportion of women in the ya group, χ2(2) = 5.2, p = .074; see table change of habits during the covid-19 pandemic 4 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ 1 for descriptive data. most participants (78.9%) reported high-school level education (abitur), with 39.4% of the sample currently attending university. r e s u l t s descriptive data showed a mean frequency of hand-washing across all age groups and situations slightly below the “3 = often” scale point (m = 2.7, sd = 0.8) on a five-point scale (“0 = never” to “4 = always”), and a mean change in hand-washing frequency slightly above the “2 = somewhat changed” scale point (m = 2.3, sd = 1.0), also on a five-point scale (“0 = unchanged” to “4 = very much more”). a repeated measures analysis of variance (anova) for frequency of hand-washing with the factors age group (ya, ma, oa) and situation (self-reference, other-reference) showed a main effect for situation, with participants reporting more frequent hand­ washing in situations with self-reference as compared to situations with other-reference, f(1, 281) = 18.50, p < .001, ηp2 = .062. there was no significant main effect of age group (p = .474) and no significant interaction (p = .879; see figure 2, panel a). figure 2 mean hand-washing frequency and change note. mean hand-washing frequency (a.) and mean change in hand-washing frequency (b.) in situations with self-reference and other-reference for the three age groups (young age, middle age, and best/older age). mean hand-washing frequency on a scale from “0 = never” to “4 = always” (a.) and mean change in hand-washing frequency on a scale from “0 = unchanged” to “4 = very much more” (b.). error bars denote standard error of the mean. **p < .01. ***p < .001. biehl, schmidmeier, wechsler et al. 5 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ a repeated measures anova for change in hand-washing with the factors age group (ya, ma, oa) and situation (self-reference, other-reference) also showed a main effect for situation. participants reported a greater change of hand-washing in situations with other-reference as compared to situations with self-reference, f(1, 281) = 67.37, p < .001, ηp2 = .193. in addition, there was a significant main effect of age group, f(2, 281) = 6.24, p = .002, ηp2 = .043. post-hoc t-tests for independent samples revealed a greater change in the oa group as compared to the ya group (p = .001) and the ma group (p = .003). the ya and the ma groups were not significantly different (p = .788). there was no significant interaction of age group and situation (p = .756; see figure 2, panel b). importantly, the univariate anova for the baseline item (after using the bathroom) showed no significant effect of age group for either frequency of (p = .130) or change in (p = .834) hand-washing. the repeated measures anova for everyday physical distancing with the factors age group (ya, ma, oa) and distancing (passive, active) showed a main effect for distancing, f(1, 281) = 337.75, p < .001, ηp2 = .546, with participants selecting greater physical distan­ ces in passive than in active distancing. there was no main effect of age group (p = .222). there was, however, a significant interaction of age group and distancing, f(2, 281) = 7.28, p = .001, ηp2 = .049. post-hoc t-tests for independent samples showed significantly higher passive distancing in the oa group compared to the ya group (p = .001) but not to the ma group (p = .200), which also showed higher passive distancing than the ya group (p = .022). in contrast, there were no significant differences between the three groups for active everyday distancing (all ps > .2; see figure 3, panel a). a repeated measures anova for fear of covid-19 with the factors age group (ya, ma, oa) and fear target (self, relatives) showed a main effect for fear target, with participants reporting more fear of covid-19 for relatives than for themselves, f(1, 281) = 404.54, p < .001, ηp2 = .590, and a main effect of age group, f(2, 281) = 4.61, p = .011, ηp2 = .032, with the ya reporting less overall fear than the ma group (p = .007) and the oa group (p = .039). in addition, there was a significant interaction of age group and fear target, f(2, 281) = 3.32, p = .037, ηp2 = .023. post-hoc t-tests for independent samples showed significantly lower fear for themselves in the ya group compared to the ma group (p = .001) and the oa group (p = .005), which were not significantly different (p = .882). in contrast, there were no significant differences between the three groups for fear for relatives (all ps > .1; see figure 3, panel b). change of habits during the covid-19 pandemic 6 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ figure 3 mean passive and active physical distancing and mean fear of covid-19 note. mean passive and active physical distancing (a.) and mean fear of covid-19 for self and for relatives (b.) for the three age groups (young age, middle age, and best/older age). mean fear of covid-19 on a scale from “0 = not at all” to “4 = very much”. error bars denote standard error of the mean. *p < .05. **p < .01. ***p < .001. general fear of covid-19 was further investigated by calculating bivariate correlations with change in hand-washing frequency, physical distancing, and pathological hand­ washing across all participants. of note, there were significant associations of change in hand-washing frequency and passive physical distancing with both participants’ fear for themselves, r(282) = .19, p = .002 and r(282) = .19, p = .002, respectively, and for relatives, r(282) = .26, p < .001 and r(282) = .17, p = .005, respectively. participants reporting higher fear levels also reported greater changes in hand-washing frequency and more passive physical distancing. in contrast, active physical distancing was not associated with gen­ eral fear of covid-19 (both ps > .08). in addition, general fear of covid-19 for both themselves as well as for relatives was correlated with pathological hand-washing, r(282) = .22, p < .001 and r(282) = .20, p = .001, respectively. participants reporting higher fear levels also reported washing their hands more frequently and longer than necessary (see supplementary materials for group-specific correlations). univariate anovas with the factor age group (ya, ma, oa) yielded no age group differences with regard to the use of soap (p = .103) or disinfectant (p = .448), trying not to touch one’s face (p = .699), the average amount of people not belonging to one’s household met per day (p = .633), or pathological hand-washing (p = .248; see table 1 for all means and standard deviations). biehl, schmidmeier, wechsler et al. 7 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ table 1 descriptive data for the younger age (ya), middle age (ma), and best/older age (oa) groups behavior ya ma oa m sd m sd m sd use of soap 3.8 0.4 3.7 0.6 3.9 0.5 use of disinfectant 1.4 1.1 1.2 1.0 1.3 1.1 trying not to touch one’s face 2.6 1.0 2.6 1.0 2.7 1.1 average number of people met per daya 3.2 10.6 2.1 5.9 2.5 3.8 pathological hand-washing 1.4 1.1 1.1 1.1 1.4 1.3 importance of observing hand-washing 3.6 0.7 3.6 0.6 3.9 0.4 attention to physical distance 3.4 0.7 3.6 0.6 3.8 0.5 n n female n n female n n female 150 116 86 59 48 30 note. means and standard deviations for use of soap and disinfectant, trying not to touch one’s face, average amount of people met per day, pathological hand-washing, subjective importance of hand-washing, and atten­ tion to physical distancing (on 5-point scales starting at 0) for the three groups. anot belonging to one’s household. there was, however, a marginally significant main effect of age group for the subjective importance of observing the recommendations regarding hand-washing, f(2, 281) = 2.88, p = .058, ηp2 = .020, with the oa group perceiving the observation of these recommenda­ tions as significantly more important than the ya group (p = .025) and the ma group (p = .032). in addition, there was a significant main effect of age group for attention to observing adequate physical distancing during interactions, f(2, 281) = 5.09, p = .007, ηp2 = .035, with the oa group reporting significantly more attention than the ya group (p = .002) and also marginally more attention than the ma group (p = .076). d i s c u s s i o n this survey provides some insight into how health behavior habits in different age groups recently changed based on the actual pandemic situation and current recommen­ dations for the prevention of infections. importantly, the survey shows an increase in hand-washing after situations carrying a direct risk of infection by others (touching another person or an object touched by other people). however, conditions might still not allow for consistent hand-washing in these situations as the overall hand-washing is still lower than after situations that do not involve direct contact with others. this should urgently be investigated in further surveys. importantly, overall change in hand-washing frequency was highest in the best/older age group, compared to both the young and the middle age group. it could thus be change of habits during the covid-19 pandemic 8 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ hypothesized that the best/older age group is well aware of their at-risk status and is therefore willing to change their behavior more strongly than the younger survey participants. indeed, general fear of covid-19 correlated positively with changes in hand-washing frequency and with passive physical distancing. in addition, the best/older age group reports a significantly higher fear of contracting covid-19 than the younger age group. in contrast, the middle age group reports a comparable level of fear, but no corresponding change in behavior. however, when fear of contracting covid-19 was included as a covariate, effect sizes decreased but the reported results still retained significance. previous research showed increased health behavior when the framing of the health message matched participants’ emotional states (gerend & maner, 2011). given the uncertain situation and the emphasis on age as the main risk factor at the beginning of the pandemic, it is understandable that older participants were generally more scared than younger participants. the initial “loss-framed” campaigns focusing on the risk of insufficient hand-washing and physical distancing thus might have led to stronger behavior changes in this age group. should the pandemic worsen again in the future, it might therefore be worthwhile to also focus on “gain-framed” campaigns for the younger age groups stressing the (societal) benefits of hand-washing and physical distancing. in addition, health behavior can be promoted by correcting misperceptions of injunctive norms (reid & aiken, 2013). it might therefore be helpful to provide self-tests of hand­ washing frequency and physical distancing that allow people to compare their own perceptions of acceptable behavior to the parameters actually considered acceptable by a representative sample. with regard to age group differences, the young age group is somewhat less consis­ tent implementing physical distancing in real life. when confronted with a selection of varying physical distances in an interpersonal situation, 12% of survey participants aged 30 or younger chose a distance of only 1 meter to have a conversation. this percentage was significantly lower in both older age groups. however, all participants seem to strug­ gle with enforcing an appropriate physical distance when their conversational partner is not following recommendations. about half of the younger participants (53%) would actively stop their conversational partner from approaching any further at a distance of only 1 meter, with this percentage rising in the middle age group (57%) to almost two thirds (65%) of the best/older age group. as this group is most at-risk for complications from covid-19, clinical psychologists might be called upon to provide assistance by instructing the general public on socially acceptable assertive behavior (e.g. based on hinsch & pfingsten, 2007). clinical psychological research should also monitor the incidence of compulsive washing as seen in obsessive compulsive disorder (ocd). it seems worrisome that fear of contracting covid-19 was associated with self-reported more frequent and longer hand-washing than necessary across all age groups in our sample. according to the biehl, schmidmeier, wechsler et al. 9 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ classic model of ocd by salkovskis (1985), the reduction of anxiety through neutralizing behavior (i.e. hand-washing) provides powerful negative reinforcement, thereby increas­ ing the likelihood of its occurrence in the future. as the knowledge about ocd in the general public is still rather low (coles, heimberg, & weiss, 2013), clinical psychologists should try to offer expert opinions on the chance of increasing rates of ocd in the wake of the pandemic whenever possible. on a related note, recommendations regarding physical and social distancing could be detrimental for people suffering from depressive disorders or social phobia. this should also be closely monitored in the future. there are also several limitations: the sample in this survey is rather small, self-se­ lected, and probably highly educated, with many participants reporting a high degree of formal schooling and almost 40% attending university at the time of data collection. it would therefore be worthwhile to investigate a larger and more representative sample. as our current sample was too small for meaningful analyses with regard to gender, it would be especially informative for future surveys to examine how the general recom­ mendations are perceived and implemented in men as compared to women and if this changes with increasing age. unfortunately, we did not inquire whether participants were experiencing covid-19 symptoms at the time of taking the survey. future surveys should include this question to allow for more in-depth analyses. in addition, the ob­ served findings were quite likely heavily influenced by the time period of data collection as infections were rising quickly and it was uncertain if and how the epidemic could be controlled in germany at the time. while it is important to have assessed the data for this period in the pandemic, it would be worthwhile to revisit the survey questions at present (after many of the restrictions have been lifted) and examine if the behavioral changes reported earlier are still being maintained. in addition, results might be specific for germany, as government reactions to the pandemic differed in different countries. it would therefore be informative to gather and compare similar data from other countries. overall, it has to be noted that all age groups rate their observance of recommenda­ tions regarding hand-washing and physical distancing as very important and that the use of soap during hand-washing was very high in this sample, suggesting a good knowledge and acceptance of the current recommendations (bundeszentrale für gesundheitliche aufklärung, 2020). a sharp decrease on this year’s influenza rates also testify to the effectivity of the current overall measures with regard to physical distancing (buchholz, buda, & prahm, 2020). our results furthermore show that recommendations given in a pandemic situation can in fact break through relevant habits. whether this effect is mainly based on reflective decision-making (e.g. salient recommendation) or on impul­ sive processes (e.g. actual fear) should be further investigated. an additional challenge is now the long-term maintenance of these new adaptive behaviors as well as the manage­ ment of potential negative effects of physical distancing and increased hand-washing on mental health. change of habits during the covid-19 pandemic 10 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://www.psychopen.eu/ funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the english translation of the items analyzed in the manu­ script (the original items are available from the authors upon request) and group-specific correla­ tions and p-values for fear and age group (for access see index of supplementary materials below). index of supplementary materials biehl, s. c., schmidmeier, m., wechsler, t. f., kroczek, l. o. h., & mühlberger, a. (2021). supplementary materials to "widespread recommendations can change our habits of handwashing and physical distance during the covid-19 pandemic" [additional information]. psychopen. https://doi.org/10.23668/psycharchives.4558 r e f e r e n c e s buchholz, u., buda, s., & prahm, k. (2020). abrupter rückgang der raten an atemwegserkrankungen in der deutschen bevölkerung [sharp decrease in rates of respiratory tract disease in the german population]. epidemiologisches bulletin, 16, 3-5. https://doi.org/10.25646/6636 bundeszentrale für gesundheitliche aufklärung. (2018, april). grippe (influenza). informationen über krankheitserreger beim menschen – impfen und hygiene schützen! [influenza. information on disease-causing agents in humans – vaccination and hygiene protect!]. retrieved from https://www.infektionsschutz.de/erregersteckbriefe/grippe-influenza.html bundeszentrale für gesundheitliche aufklärung. 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(1985). obsessional-compulsive problems: a cognitive-behavioural analysis. behaviour research and therapy, 23(5), 571-583. https://doi.org/10.1016/0005-7967(85)90105-6 simmerman, j. m., suntarattiwong, p., levy, j., jarman, r. g., kaewchana, s., gibbons, r. v., . . . chotipitayasunondh, t. (2011). findings from a household randomized controlled trial of hand washing and face masks to reduce influenza transmission in bangkok, thailand. influenza and other respiratory viruses, 5(4), 256-267. https://doi.org/10.1111/j.1750-2659.2011.00205.x steinmetz, h., batzdorfer, v., & bosnjak, m. (2020, june). the zpid lockdown measures dataset for germany. https://doi.org/10.23668/psycharchives.3019 strack, f., & deutsch, r. (2004). reflective and impulsive determinants of social behavior. personality and social psychology review, 8(3), 220-247. https://doi.org/10.1207/s15327957pspr0803_1 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. change of habits during the covid-19 pandemic 12 clinical psychology in europe 2021, vol.3(1), article e3061 https://doi.org/10.32872/cpe.3061 https://doi.org/10.1186/1471-2334-14-509 https://doi.org/10.1037/0033-2909.124.1.54 https://doi.org/10.1037/a0028140 https://www.rki.de/de/content/infaz/n/neuartiges_coronavirus/steckbrief.html https://doi.org/10.1016/0005-7967(85)90105-6 https://doi.org/10.1111/j.1750-2659.2011.00205.x https://doi.org/10.23668/psycharchives.3019 https://doi.org/10.1207/s15327957pspr0803_1 https://www.psychopen.eu/ change of habits during the covid-19 pandemic (introduction) method assessment participants results discussion (additional information) funding competing interests acknowledgments supplementary materials references the role of psychotherapy in the german health care system: training requirements for psychological psychotherapists and child and adolescent psychotherapists, legal aspects, and health care implementation politics and education the role of psychotherapy in the german health care system: training requirements for psychological psychotherapists and child and adolescent psychotherapists, legal aspects, and health care implementation nikolaus melcop ab, thomas von werder b, nina sarubin b, andrea benecke ac [a] federal chamber of psychotherapists, berlin, germany. [b] bavarian chamber of psychotherapists, munich, germany. [c] chamber of psychotherapists of rhineland-palatinate, mainz, germany. clinical psychology in europe, 2019, vol. 1(4), article e34304, https://doi.org/10.32872/cpe.v1i4.34304 received: 2019-03-05 • accepted: 2019-10-27 • published (vor): 2019-12-17 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: nikolaus melcop, bavarian chamber of psychotherapists, postfach 151506, d-80049 münchen, germany. tel.: 0049-89-515555-17. e-mail: melcop@ptk-bayern.de abstract in germany every citizen must acquire either public or private health insurance from companies which then cover the expenses for psychotherapeutic in-patient and out-patient treatments within a given set of regulations. since the commencement of the psychotherapists' law in 1999, psychological psychotherapists and child and adolescent psychotherapists are permitted to diagnose and treat mental disorders with psychotherapy under their own responsibility as a legally defined healing profession. psychotherapists have to use scientifically approved psychotherapeutic approaches for treatment. the qualification and licensure of psychotherapists are highly regulated by the psychotherapists' law, which is currently undergoing a process of change. keywords german mental health care system, psychotherapists' law, qualification and licensure, psychological psychotherapists, child and adolescent psychotherapists, guidelines for psychotherapy, federal chamber of psychotherapists, planning for demand this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.34304&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • 2.86 million patients are in outpatient or inpatient psychotherapeutic care per year in germany, tendency rising. • psychotherapeutic care is highly regulated, only scientifically approved approaches are admitted. • psychological and child and adolescent psychotherapists treat patients under their own responsibility. • future courses of study and advanced training for psychotherapists will be similarly structured to those of the medical profession. in germany with its 83 million inhabitants expenditures on health in 2015 totalled 343.5 billion euros, equalling 11.3% of the gross domestic product (gesundheitsberichterstattung des bundes, 2017). the costs caused directly by mental and behavioural disorders amounted to 44.3 billion euros (statistisches bundesamt, 2015). mental health care is becoming increasingly more important. health insurance is provided through either public or private health insurance. public health insurance is open to everybody, regardless of whether they are employed, self-em‐ ployed, or unemployed. german citizens who are mentally or physically ill are entitled to all available treatments necessary for healing. m e n t a l h e a l t h c a r e mental health care in germany is mainly provided by office-based psychotherapists, psy‐ chiatrists and eligible medical doctors, psychiatric hospitals, psychosomatic clinics and psychiatric outpatient clinics. in addition rehabilitation centres, community mental health care centres, and different types of residential facilities provide a broad spectrum of nonmedical vocational, residential, and psychosocial counselling services (salize, rössler, & becker, 2007). sundmacher et al. (2018) calculated that 1.9 million patients per year are treated in outpatient psychotherapeutic care. gallas, kächele, kraft, kordy, and puschner (2008) found a median therapy duration of 16 months, ranging from 13 months (cognitive be‐ havioral therapy) to 24 months (psychoanalytic psychotherapy). approximately a further 960,000 patients per year are treated in psychiatric and psychosomatic inpatient care. the average treatment duration for mental disorders in hospitals in 2017 was 24.2 days in to‐ tal, 27.4 days for female and 21.2 days for male patients, respectively (augurzky, hentschker, pilny, & wübker, 2018), with huge differences between psychiatric (23.8 days) and psychosomatic (42.9 days) inpatient care (statistisches bundesamt, 2017). psychotherapy in the german health care system 2 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ access to mental health care is basically free of (extra) charges for most people in germany which is an uncommon feature among member states of the european union (strauß, 2009). r e g u l a t i o n s f o r p s y c h o t h e r a p i s t s unlike some other european countries clinical psychology is not an independent profes‐ sion in germany. in 1999 the legal basis was laid for psychologists to ultimately practice independently and on their own authority. in germany the profession of psychotherapist has been regulated by law since 1999 (gesetz über die berufe des psychologischen psychotherapeuten und des kinderund jugendlichenpsychotherapeuten, psychthg, 1999). the psychotherapists' law (german: psychotherapeutengesetz, psychthg) regu‐ lates the practice of psychotherapy as well as the qualification and licensing procedure of nonmedical professions, e.g., psychologists. in this article, we specifically focus on the le‐ gal requirements for training and licensing psychological psychotherapists and child and adolescent psychotherapists. for medical doctors there are different regulations. the law (psychthg, 1999) legally created two new professions, namely psychological psychotherapists and child and adolescent psychotherapists (who are allowed to treat on‐ ly children and adolescents under the age of 21). in 2018 this law was undergoing a major change and will be set into place by the end of 2019. according to the new law in future there will be only one profession called psychotherapist. the old and the new law define psychotherapy as a practice using scientifically ap‐ proved psychotherapeutic approaches for the assessment, cure, or alleviation of mental disorders. this has implications for postgraduate training because the scientific advisory council for psychotherapy, which is formed in equal parts by scientific representatives of psychotherapists and specialised medical doctors, has currently only approved psycho‐ analysis, psychodynamic psychotherapy, cognitive behavioural therapy, and family ther‐ apy for the treatment of mental disorders. for the treatment of injuries or illnesses of the brain neuropsychological therapy is approved. consequently, students are restricted to becoming licensed in the aforementioned approaches. q u a l i f i c a t i o n a n d l i c e n s u r e – t h e c u r r e n t s t a t u s according to the "old law" currrently the qualification of psychological psychotherapists and child and adolescent psychotherapists is regulated separately for each profession (ausbildungsund prüfungsverordnung für kinderund jugendlichenpsychotherapeuten, kjpsychth-aprv, 1998; ausbildungsund prüfungsverordnung für psychologische psychotherapeuten, psychth-aprv, 1998). academic social workers and educators who have obtained a master's degree complete an equivalent postgraduate training in child melcop, von werder, sarubin, & benecke 3 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ and adolescent psychotherapy, but the educational framework is identical to that of psy‐ chological therapists. overall, the qualification process has to have a minimum duration of three (full-time) or five (part-time) years of postgraduate specialist practical training in psychotherapy and certification in an approved psychotherapeutic approach. this long-term, postgradu‐ ate training for psychotherapists is unique within the european union (strauß & kohl, 2009). in order to register for the state examination, psychotherapists in training need to complete four modules comprising theoretical education, practical internships, practical supervised training, and self-experience (see table 1). in particular, students have to com‐ plete 600 hours of continuing coursework, 1,800 hours of clinical experience in an inpa‐ tient setting (a minimum of 1,200 hours in a psychiatric hospital and 600 hours in a reha‐ bilitation hospital or in a licensed outpatient setting), 600 supervised outpatient treat‐ ment sessions of at least 6 patients (including 150 hours of accompanying supervision), and an additional 930 hours of unspecified psychotherapy-related coursework. further‐ more, self-experience plays an important role in the training of psychotherapists, as fu‐ ture psychotherapists are required to complete 120 hours of one-to-one or group sessions or a mixture of both settings. in practice the described demands in training can be signifi‐ cantly higher, i.e. for the psychoanalytic approach. after these requirements are met, psychotherapists in training then need to pass a state examination comprising a written and an oral exam. after passing the state exami‐ nation, candidates are licensed. this structured postgraduate training in psychotherapy is organised by universities and state-licensed institutes. in total, 254 postgraduate training programs were offered by 215 state-licensed educational institutes and 39 universities (unith e.v., 2018). nearly 2,700 students took part in the written state exams in 2016, 1,900 for a license in psychological psychotherapy and around 800 for child and adolescent psychotherapy. this shows an increase of 17% of graduates compared to 2015 and an in‐ crease of 61% compared to the previous five-year period. q u a l i f i c a t i o n a n d l i c e n s u r e i n t h e f u t u r e the german psychotherapists' law had to undergo long-overdue adjustments and an ed‐ ucational reform for several reasons. the first reason is that the current graduation sys‐ tem is not adjusted to the structure of bachelor and master degrees which was not imple‐ mented in germany in higher education until 2013. the federal state government agen‐ cies need more precise legal specifications to be able to fulfil their statutory responsibili‐ ties (i.e. standardised admission requirements to the postgraduate training) and thus en‐ sure a high-quality standard of postgraduate psychotherapy training nation-wide. anoth‐ er area that needs significant improvement is the very low level of payment during post‐ graduation training. at the moment their legal employment status is not properly regula‐ ted (wissenschaftsrat, 2018). additionally psychotherapists in training have substantial psychotherapy in the german health care system 4 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ financial expenditures. students have to pay between 20,000 and 30,000 euros on average in tuition fees (strauß et al., 2009). furthermore, the development of psychotherapeutic knowledge is developing very rapidly and subsequently adaptations of the training ac‐ quirements are necessary. m o d e r n i s a t i o n o f c u r r e n t p s y c h o t h e r a p y t r a i n i n g in 2014, the german psychotherapists' meeting (german: deutscher psychotherapeuten‐ tag, dpt) passed a resolution, after a two-thirds vote, to campaign for a reform of the current psychotherapeutic training and a modernisation of the underlying psychothera‐ pists' law (bundespsychotherapeutenkammer, 2014). the core idea is to adapt the structure of the (postgraduate) training program for psy‐ chotherapists to the structure of education of medical doctors. a central part of this pro‐ posal is the implementation of a consecutive bachelor's and master's (of science) degree in psychotherapy studies as a requirement for the admission to the postgraduate ad‐ vanced training program. it is suggested that during this advanced training phase, psy‐ chotherapy trainees specialise in either the treatment of adults or of children and adoles‐ cents in an approved psychotherapy approach, e.g. psychodynamic, behavioural or sys‐ temic psychotherapy (bundespsychotherapeutenkammer, 2014). during the discussion of the role of future psychotherapists in the german health care system, the question arose of whether and to what extent traditional competences of psychotherapists should be expanded (e.g. regarding certificates for sick leave from work). in contrast to the current system, there is a given set of regulations for the mandatory contents of basic scientific and practical psychotherapeutic knowledge in the bachelor and master courses. in addition to the master's exam, a state-controlled exam is mandato‐ ry for receiving the formal psychotherapy licence (in german: "approbation"). this li‐ cence is the prerequisite for entering the subsequent advanced psychotherapy training. in the advanced training program psychotherapists will be employed in specialised hos‐ pitals or outpatient clinics (legally, the advanced training program will be officially regu‐ lated by the state chambers). currently, the federal chamber of psychotherapists consid‐ ers a duration of 5 years (full-time employment) as necessary for the advanced training (with a minimum of 2 years in an outpatient setting and 2 years in a hospital setting). the advanced training will contain the training in an approved psychotherapy approach and either in the treatment of adults or in the treatment of children and adolescents. the official licence of treatment for psychotherapists in an own practice (that allows for re‐ muneration by the insurance companies) will require a successful completion of ad‐ vanced training. melcop, von werder, sarubin, & benecke 5 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ the new law was passed by the german parliament (bundestag) in september 2019 and approved of the parliament of the governments in the federal states (bundesrat) in november 2019. the new educational system for psychotherapists is due to start in octo‐ ber 2020. table 1 current and future structure of the qualification and licensure of psychotherapists in germany current structurea future structure course of study psychology graduate degree: bachelor’s and master's degree psychotherapy focus: scientific and practical psychotherapeutic knowledge graduate degree: bachelor's and master's degree additional state examination: licensure ("approbation")education science graduate degree: bachelor's and master's degree social work graduate degree: bachelor's and master's degree training postgraduate training advanced training status during training apprentice employee duration minimum 3 years full-time minimum 5 years full-time payment very low level of payment regular salary components of the training • internship in a psychiatric hospital (1200 hours) and in a rehabilitation hospital or in a licensed outpatient setting (600 hours) • supervised outpatient treatment (minimum 600 sessions, at least six different patients) • self-experience / supervision / theory • psychotherapist in a (psychiatric) clinic (minimum 2 years) • outpatient treatment (minimum 2 years) • possible: specialiced centers (1 year) • self-experience / supervision / theory specialisation scientifically approved psychotherapeutic approach scientifically approved psychotherapeutic approach state examination: licensure ("approbation") exam (conducted by the state psychotherapist chambers) degree psychological psychotherapist / or / child and adolescent psychotherapist specialiced psychotherapist for: children and adolescents / or / for: adults admission admission to statutary health insurence care system admission to statutary health insurence care system aa successfully completed consecutive master's degree in either social work or education science only allows admission to postgraduate training in child and adolescent psychotherapy. a successfully completed consecu‐ tive master's degree in psychology allows admission to postgraduate training in psychotherapy for adults as well as children and adolescents. psychotherapy in the german health care system 6 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ p r o f e s s i o n a l o r g a n i s a t i o n in germany, state law requires psychotherapists (psychological psychotherapists, child and adolescent psychotherapists and all future psychotherapists) to be compulsory members of a state psychotherapist chamber (heilberufe-kammergesetz, 2002). its princi‐ pal responsibility is the supervision of occupational standards. the state chambers, which are organised on a national level in the federal chamber of psychotherapists (bundespsychotherapeutenkammer, bptk), therefore work as public corporations. the bptk represents some 50,000 psychotherapists in germany and is thus the only professio‐ nal organisation to represent all psychological psychotherapists and child and adolescent psychotherapists in germany. in 2015, two thirds of its members were working in an out‐ patient setting and their mean age was 52 years; one third are even 60 years or older. sev‐ enty two percent of its members were female. this ratio is likely to shift even more in favour of female members in the next decade. among the age group of 35 year-olds and younger, the percentage of female psychotherapists is already close to 91% (bundespsychotherapeutenkammer, 2016). o u t p a t i e n t p s y c h o t h e r a p y the federal joint committee (german: gemeinsamer bundesausschuss, g-ba) is the highest decision-making body of the joint self-government of physicians and psycho‐ therapists, dentists, hospitals, and health insurance funds in germany. it specifies which services in medical care are reimbursed for more than 70 million people within the statu‐ tory health system and also specifies measures for quality assurance in outpatient areas of the health care system. the guidelines for psychotherapy are published by the g-ba to ensure that all patients in outpatient psychotherapy are cared for in a qualified and adequate way (psychotherapie-richtlinie, 2017). nevertheless, psychotherapy is limited to specific diagnoses according to the international classification of diseases chapter 5 (f) german modification (icd-10 gm, dilling, mombour, & schmidt, 1991). indications are adjustment-, affective-, anxiety-, compulsive-, conversion-, dissociative-, eating-, sex‐ ual-, sleep-, somatoform-, personality-, and psychotic disorders as well as behavioural and emotional disorders in children. psychotherapy can also be approved if psychological factors are pathogenetic or impair somatic health. patients can choose their therapist freely from a pool of licensed psychotherapists. after consultation and possible probationary sessions, a subsequent application for psy‐ chotherapy is evaluated by an experienced psychotherapist based on a psychological re‐ port which includes anamnesis and biography, diagnosis, treatment planning, and prog‐ nosis. approval of psychotherapy is thus based on professional opinion rather than health insurance company personnel. for outpatient treatment of mental disorders, the statutory health system covers only psychoanalysis, psychodynamic psychotherapy, and melcop, von werder, sarubin, & benecke 7 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ cognitive behavioural therapy. the costs of neuropsychological therapy are also covered for the treatment of injuries or illnesses of the brain. limitations are set in terms of ses‐ sion quotas for each psychotherapeutic approach (e.g., for psychotherapy with adults in cognitive behavioural therapy: up to 80 individual sessions; psychodynamic therapy: up to 100 sessions; psychoanalysis: up to 300 individual sessions). as of 2018, systemic ther‐ apy has been approved by the g-ba and is in the process of becoming a psychological treatment which is eligible for reimbursement of treatment costs for adult patients (gemeinsamer bundesausschuss, 2018). even though many more methods and techni‐ ques of psychological treatment have become familiar in the field of psychotherapy re‐ search today, the g-ba's approval policy remains rather conservative. private insurance companies differ from each other in their medical service tariffs, but they are oriented towards the g-ba's guideline for psychotherapy. in contrast, there are less stringent regulations for psychological interventions in psy‐ chiatric and psychosomatic hospitals and rehabilitation centres because inpatient treat‐ ment expenses are assigned to another cost unit of health insurance funds. furthermore, in hospitals and rehabilitation centres the treatment responsibility is held by executive medical doctors. their ability to freely chose and adequately provide treatment is guar‐ anteed by a less narrow, i.e., less specific legal definition of medical practice in compari‐ son to psychotherapists. d e s i r a b l e c h a n g e s t o m e n t a l h e a l t h c a r e r e g u l a t i o n s changes need to be made in the areas of provision, planning for future demand and the educational training system for psychotherapists. health economic analyses of the ger‐ man mental health care system have shown that most of the financial resources are spent for inpatient treatment and outpatient drug prescriptions, while with approximately 2 billion euros only a small fraction of the budget is spent for outpatient psychotherapy (jacobi et al., 2014; kilian & salize, 2010). the planning for demand of psychotherapeutic outpatient practices through regula‐ tions by the g-ba is outdated. there are up to three times more psychotherapists li‐ censed per 100,000 inhabitants in urban areas than in rural areas (bundespsychotherapeutenkammer, 2018). consequently, the average waiting period for outpatient psychotherapy in the social insurance health system is around four months in metropolitan areas and five to six months in rural areas (bundespsychotherapeutenkammer, 2018). recently the g-ba decided to change these regulations to improve the situation. consequently, in the short term, there will be some improvement via additional psychotherapists but in the long term this new system im‐ plies a further deterioration of outpatient care of menatlly ill persons. psychotherapy in the german health care system 8 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ this discrepancy and an increasing economic burden of mental illness point to the need for further improvement (jacobi et al., 2014; murray & lopez, 1996; whiteford et al., 2013). it is expected that the effectiveness and efficiency of the german mental health care system can be significantly improved by an even further shift of resources from in‐ patient to outpatient care (karow et al., 2012). a reform of the regulation system for the admission of statutory health care providers should therefore lead to quotas based on morbidity instead of location. c o n s e q u e n c e s o f t h e g e r m a n r e g u l a t i o n s f o r r e s e a r c h i n p s y c h o t h e r a p y the establishment of outpatient services within postgraduate training programs makes it easier to include patients in research projects. most of the psychology departments in german universitites run a post-graduate program and thus have more possibilities to combine the outpatient service with research studies. but there are also some important limitations. as mentioned above the g-ba approved psychotherapeutic approaches are the basis for financing psychotherapy within the health care system. the admission to the health care system is also orientated on these traditional lines. clinical psychology units provide professional experience and training-programs mainly for cognitive behav‐ ioural therapy and therefore there is a huge lack in possibilities for research for the other psychotherapeutic approaches. in the process of the reform the chambers and other pro‐ fessional organisations demand, that there should be more personnel at the universities with specific qualifications for teaching these other psychotherapeutic approaches. c o n c l u s i o n since the psychotherapists' law came into effect in 1999, the professional title "psycho‐ therapist" has been protected by law and the training for becoming a psychotherapist is regulated on a high professional level. every german citizen can rely on this high quality of training and subsequently expect professional treatment. nationwide data show that more and more people with mental disorders are seeking help from psychotherapists. in consequence, the waiting period for professional treatment has become longer over the years. despite increasing numbers of psychotherapists, even more psychotherapists for outpatient treatment are needed, particularly in rural areas. this situation is very similar in hospitals and specialized clinics for mental disorders. consequently, evidence-based treatments following international guidelines cannot be offered to every patient due to a lack of qualified psychotherapists (both in outpatient and inpatient settings). the re‐ newed law is expected to improve the training conditions for future psychotherapists and also meet the necessities of the health care system. therefore, in the coming years the melcop, von werder, sarubin, & benecke 9 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.psychopen.eu/ psychotherapeutic profession will appeal more to young students and will play an even more important role in the german health care system. funding: the authors have no funding to report. competing interests: nm is vice president of the federal chamber of psychotherapists in germany and president of the bavarian chamber of psychotherapists. tvw and ns are members of the bavarian chamber of psychotherapists. ab is vice president of the federal chamber of psychotherapists in germany and vice president of the chamber of psychotherapists of rhineland-palatinate. acknowledgments: the authors have no support to report. r e f e r e n c e s augurzky, b., hentschker, c., pilny, 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(2018). perspektiven der psychologie in deutschland. retrieved from https://www.wissenschaftsrat.de/download/archiv/6825-18.pdf clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. psychotherapy in the german health care system 12 clinical psychology in europe 2019, vol.1(4), article e34304 https://doi.org/10.32872/cpe.v1i4.34304 https://www.g-ba.de/downloads/39-261-3493/2018-09-20_endbericht-gutachten-weiterentwickklung-bedarfsplanung.pdf https://www.g-ba.de/downloads/39-261-3493/2018-09-20_endbericht-gutachten-weiterentwickklung-bedarfsplanung.pdf https://www.unith.de/unith-ev/ueber-uns https://doi.org/10.1016/s0140-6736(13)61611-6 https://www.wissenschaftsrat.de/download/archiv/6825-18.pdf https://www.psychopen.eu/ psychotherapy in the german health care system (introduction) mental health care regulations for psychotherapists qualification and licensure – the current status qualification and licensure in the future modernisation of current psychotherapy training professional organisation outpatient psychotherapy desirable changes to mental health care regulations consequences of the german regulations for research in psychotherapy conclusion (additional information) funding competing interests acknowledgments references cognitive-behavioral and emotion-focused couple therapy: similarities and differences scientific update and overview cognitive-behavioral and emotion-focused couple therapy: similarities and differences guy bodenmann a, mirjam kessler a, rebekka kuhn a, lauren hocker b, ashley k. randall b [a] clinical psychology for children/adolescents and couples/families, university of zurich, zurich, switzerland. [b] counseling and counseling psychology, arizona state university, tempe, az, usa. clinical psychology in europe, 2020, vol. 2(3), article e2741, https://doi.org/10.32872/cpe.v2i3.2741 received: 2019-07-03 • accepted: 2020-06-21 • published (vor): 2020-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: guy bodenmann, university of zurich, department of psychology, binzmuehlestrasse 14, box 1, 8050 zurich/switzerland, phone +41 (0)44 635 71 51. e-mail: guy.bodenmann@psychologie.uzh.ch abstract background: couples and families often seek therapy to deal with relational distress, which is a result of external or internal factors of the relationship. two approaches are acknowledged to be most effective in dealing with relationship distress or psychological disorders in couples: (a) cognitive behavioral couple therapy with new directions (cbct) and (b) emotion-focused couple therapy (efct). in this article we investigate how much cbct and efct really differ with regard to working with emotions, which is claimed to be a major focus of efct, and whether there exist significant differences in efficacy between these two approaches. method: this article critically reviews the theoretical background, process, techniques and outcomes associated with cbct and efct in an effort to challenge the assumptions noted above. results: there is no evidence that efct is more emotion-focused than cbct. both approaches were repeatedly examined with rct studies with follow-ups. in sum, no significant differences in effect size were found between cbct and efct. conclusion: cbct and efct are both effective in reducing couples’ distress. keywords couple therapy, cognitive behavioral couple therapy, emotion-focused couple therapy, efficacy this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.2741&domain=pdf&date_stamp=2020-09-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • cbct and efct are both effective in helping couples deal with relationship distress. • both are similarly effective in helping couples to better understand and cope with their presenting concerns. • both approaches address the importance of personal schema, triggering relevant cognitions and emotions. • both approaches help couples wherein one partner has been diagnosed with a clinical disorder. for couples seeking couple therapy, there is broad international empirical evidence advocating that couple therapy is advantageous in reducing relationship distress and improving relationship quality. overall, couple therapy exhibits excellent efficacy with an internationally established mean effect size of d = 0.95, ranging from d = 0.59 to 1.03 (e.g., shadish & baldwin, 2003, 2005). among a large range of different therapeutic approaches, cognitive-behavioral couple therapy (cbct) and emotion-focused couple therapy (efct) are amongst the most wide‐ ly applied couples’ interventions. cbct as well as efct have repeatedly been examined regarding their efficacy. some claim that efct outperforms cbct and represents the most effective approach for treating relationship problems (e.g., roesler, 2018). howev‐ er, an ancient meta-analysis revealed only marginal differences between the various approaches (shadish & baldwin, 2005). the purpose of this review is to analyze recent studies on efficacy of both approaches and to test the assumption that efct (attachment based) is more emotion-focused than cbct (learning based). b r i e f r e v i e w o f t h e t h e o r e t i c a l u n d e r p i n n i n g s o f c b c t a n d e f c t in this section, we will provide a brief overview of the theoretical underpinnings and common methods used in cbct and efct. denominations of emotion-focused versus cognition-focused are tested regarding their meaning for clinical work. cognitive-behavioral couple therapy background cognitive-behavioral couple therapy (cbct) relies on principles from social learning theories and focuses on the interplay between partners’ cognitions, behaviors, and emotional responses to help them improve their communication and problem-solving (epstein & zheng, 2017). cbct draws on concepts stemming from behavioral couple cognitive-behavioral and emotion-focused couple therapy 2 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ therapy, cognitive therapy, as well as empirical findings in basic research (baucom et al., 2008). therapists working from a cbct lens aim to improve partners’ skills (e.g., com‐ munication and problem-solving skills), modify dysfunctional cognitions and attitudes, in an attempt to improve relationship quality and decrease emotional distress such as anger, sadness or disgust (epstein & baucom, 2002; epstein & zheng, 2017). process the goal of cbct is to help partners restructure cognitions that may yield relational distress, which include unrealistic expectations, dysfunctional attributions and irrational assumptions (epstein & zheng, 2017). cbct operates under the premise that cognitions cause emotions and subsequent behaviors (e.g., the cognition “you do not care about me” may lead to emotions such as anger and sadness that motivates coercive behavior to get more attention). thus, the assumption of cbct is that negative mood (dissatisfaction) and emotions (anger, disappointment, frustration, resignation), reflected in deleterious behaviors (i.e., generalized criticism, defensiveness, belligerence, contempt, aggression or violence), are a major motive why couples seek for interventions (bradbury & bodenmann, 2020). techniques one of the common techniques used in cbct is cognitive restructuring, wherein the clinician guides partners to “identify and evaluate cognitions as they occur” (epstein & zheng, 2017, p. 143). dysfunctional cognitions, either regarding irrational beliefs, dysfunctional expectancies or negative attribution styles are viewed as the causes of negative emotions (bradbury & fincham, 1990). cbct aims to strengthen partners’ communication skills in order to allow partners to safely disclose their needs and emo‐ tions, without risk of their partner’s negative reactions. therefore, instead of blaming the partner, partners learn to express their sentiments and needs using speaker-listener rules and techniques. cbct also applies cognitive-emotional techniques such as cognitive restructuring (i.e., identifying and disputing irrational thoughts leading to negative emo‐ tions) (e.g., baucom et al., 2019). more recent approaches such as the integrative behavioral couple therapy (ibct; jacobson & christensen, 1996) and coping-oriented couple therapy (coct; bodenmann, 2010) also refer to cbct principles. however, ibct focuses on acceptance in addition to the above-mentioned techniques and tries to improve couples’ mutual tolerance. coct focuses on stress and its impact on couples’ functioning. this approach addresses mutual emotional understanding facing stress-related negative behaviors towards the partner. by means of the 3-phase-method, partners learn to engage in deepened emotional self-dis‐ closure, empathic listening and providing emotion-focused support (i.e., dyadic coping) that matches the partners’ needs. by doing this, emotional bonding, mutual intimacy and closeness as well as mutual trust between partners are enhanced (bodenmann & randall, bodenmann, kessler, kuhn et al. 3 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ 2020). in sum, techniques used in cbct aim at improving partners’ skills in an attempt to modify dysfunctional cognitions, emotions and behaviors or to accept them under specific circumstances. outcomes cbct has shown to be effective in improving couples’ function. in addition, positive effects are reported regarding partner’s psychological (e.g., ptsd and ocd) and physical health (e.g. cancer), as well as other severe stressors that may yield relational concerns (for a review see epstein & zheng, 2017). emotion-focused couple therapy background emotionally focused couple therapy (efct) is an experiential, humanistic and systemic therapy grounded in attachment theory and social neuroscience (greenman, johnson, & wiebe, 2019). efct does not directly focus on skill training, rather, the focus is to build new emotional experiences between partners that foster attachment security (wiebe & johnson, 2016). the original framework of efct proposed that distress in the relation‐ ship could be repaired though regulation of emotions by the other partner (greenberg & johnson, 1988). this was later adapted to include foundations of attachment theory as well as working to increase both partner’s emotional self-regulation and other regulation (greenberg & goldman, 2008; johnson, 2004). efct primarily aims to facilitate the expression of primary emotions (such as feelings of hurt, feelings of inadequacy and deprivation of love, respect and appreciation) and to understand these feelings behind secondary emotions such as anger or contempt (greenberg & johnson, 1988). process the overarching goals of efct is to have partners access and reprocess their emotional experiences to restructure partners’ interaction patterns. the outcome of this approach is to help partners learn new aspects about themselves and develop a more functional pattern of interaction with their partner that is matching with their specific attachment needs (johnson, 2019). within efct, the therapist tries to strengthen the attachment bond between partners by addressing the intrapsychic (attachment-related experiences) and interpersonal perspective regarding dysfunctional interaction patterns of distressed partners. emotion-focused couple therapy understands these patterns as the result of an insecure attachment bond where both partners signal attachment distress in a way that inadvertently keeps their partner at a distance (greenman et al., 2019). typically, efct is differentiated in three stages (greenman et al., 2019). in the first stage (cycle de-escalation), the therapist tracks and reflects the pattern of interaction with the couple and tries to identify negative patterns wherein the partners may “criticize/at‐ cognitive-behavioral and emotion-focused couple therapy 4 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ tack” one another, which is often followed by “defensiveness/distance”. these interaction patterns are viewed as hindering constructive emotional exchange. the goal of the first stage is to gain a meta-perspective of the couples’ interaction by realizing that the partners’ dysfunctional interaction maintains both partners’ attachment insecurity and causes emotional distress. in the second stage (restructuring interactions), the therapist tries to give insight into new emotional experiences by facilitating new interactions, which will help lead to secure bonding. the therapist helps to explore attachment vul‐ nerabilities that partners share with each other. in this method, partners learn how to respond to the other in an emotionally attuned and supportive way. instead of blaming or withdrawing from the partner, partners learn to become more responsive to the other; increasing their awareness of their partner’s attachment needs. instead of negativity, primary emotions such as sadness, fear or shame are expressed. the therapist helps the speaker to find adequate wording for their emotional state. in the third stage (consolida‐ tion), partners learn new ways of solving problems that become possible based on their secure attachment experience. techniques a primary focus in efct is helping couples learn how to communicate their emotions more effectively with one another (gladding, 2015). couples are instructed to better perceive their emotions and to engage more in mutual responsiveness and dyadic en‐ gagement (burgess moser & johnson, 2008). hence, in efct, couples are encouraged to explore here-and-now emotional experiencing (greenman et al., 2019). instead of sharing primary emotions, distressed couples often communicate secondary emotions expressed in attacking, nagging, and withdrawing. as such, the efct therapists help guide each partner to uncover primary emotions (sadness, fear, shame, etc.). the therapist guides both partners, working out primary emotions for one, and showing the other partner how to listen emotionally engaged and how to respond in an emotionally attuned way. the “new emotional music then elicits new responses and, gradually, changes the dance between partners” which means that new behavioral interaction patterns can be estab‐ lished (wiebe & johnson, 2016, p. 390). common techniques within efct include bonding and enactments. therapists guide couples through the conversations about emotion and encourage each partner to engage in a release of that emotion, to increase self-awareness (gladding, 2015). this process leads to the therapeutic technique of bonding, which is when the partner who is hearing the emotional response can become more aware of their partner’s perception, thus in‐ creasing empathy. enactments, reminiscent of gestalt therapy, help each partner explore and express deeper emotions by engaging in role-play or two-chair techniques (gladding, 2015). bodenmann, kessler, kuhn et al. 5 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ outcomes various studies have shown efct’s effectiveness with couples in distress, couples coping with post-traumatic stress disorder (ptsd), and couples coping with chronic illness (bailey, 2002; beckerman, 2004; bradley & johnson, 2005). additionally, efct has been effective in increasing intimacy between partners (soltani et al., 2013). similarities and differences between both approaches cbct and efct approaches are grounded in different theories and, as such have a different conceptualization of the development and maintenance of relationship distress. traditional cbct is skill-oriented and aimed at teaching couples’ new ways of communi‐ cation and conflict resolution. methods are a highly structured and often manualized, such as the communication training. new directions in cbct, like the acceptance ap‐ proach (jacobson & christensen, 1996) or 3-phase-method (bodenmann, 2010) further expand these methods by focusing on insight-oriented empathic understanding and deepened emotional experiences in the case of the latter approach. all techniques in cbct, however, focus on the interplay between cognitions and emotions as the major outcome of interest. however, instead of working directly with emotions, therapists address dysfunctional thinking and information processing, negative and unrealistic or exaggerated attitudes towards the partner and their impact on couple’s emotional experi‐ ences and behaviors. thus, techniques utilized in cbct focus on modifying cognitive distortions with the goal to tap into the emotional exchange between partners. coct and ibct further offer techniques directly allowing shared emotional experiences like this is the case in the 3-phase-method or the empathic joining technique. efct is considered an experiential approach that enables partners to develop new feelings and interaction patterns. it primarily focuses on attachment schemas or personal needs of belonging, being respected and validated. partners learn to understand that negative emotions and dysfunctional interaction patterns result from the non-fulfilment of these attachment needs. instead of a structured training like in cbct, the efct-thera‐ pists work with emotional experiences during partners’ interactions by making them visible and tangible. creating emotional and cognitive awareness of the partner’s insecure attachment is a key component of this approach. efct-therapists explain emotional reactions and search together with the partners for an attachment-based understanding. thus, the goals are somewhat similar in efct and cbct (compare 3-phase-method), however, the methods vary. efct-therapists are not teaching skills, their approach is less structured and thera‐ pists are more active in uncovering processes. cbct-therapists are similarly allowing emotional experiences and emotional understanding, but by using techniques such as socratic questioning or the method of prompting (therapists explore and reinforce rele‐ vant cognitions and deeper emotions, ask open-ended questions and guide smoothly to cognitive-behavioral and emotion-focused couple therapy 6 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ the personally relevant construct that may be an attachment scheme, but can also be any other type of schema). in sum, both cbct and efct approaches aim to address relationship distress, with the goal of helping couples deal more effectively with negative emotions. both approaches work with partners’ emotional experience, however, the ways in which each method addresses them is different. efficacy of cbct and efct in psychotherapy research, minimal differences in outcomes of the various approaches are reported (wampold et al., 2002). while some psychotherapies show higher effective‐ ness in treating specific disorders (e.g., cbct for anxiety disorders), in general, common factors such as the therapeutic alliance account for more variance than specific treatment modality. correspondingly, wampold et al. (2002) report that only 1% of the variability of treatment outcome can be explained by a specific treatment. findings are similar in couple therapy and again, differences between various ap‐ proaches are minimal (christensen & heavey, 1999). efficacy of cbct cbct is considered one of the most widely evaluated therapeutic approaches for work‐ ing with couples. since the 1980ies, several dozens of rct-studies have supported the effectiveness and efficacy of cbct (bradbury & bodenmann, 2020). 70% of the couples improved after cbct (baucom et al., 1998), and 50% show stable effects over a period of five years (christensen et al., 2010). christensen et al. (2004) reported 71% of clinical recovery in integrated cbct compared to 54% in classical cbct. according to this study, cbct proves to be efficient in the long term, with an effect size of d = 0.92 at the 5-year follow-up, slightly outperformed by icbt (d = 1.03) (christensen & glynn, 2019). bodenmann et al. (2008) reported effect sizes of d = 1.46 at the 6-months follow-up and d = 1.74 at the one-year follow-up of coping-oriented cbct in treating depression. in the various meta-analysis, effect sizes for cbct ranged from d = 0.53 (rathgeber et al., 2019) up to d = 0.95 (byrne et al., 2004). efficacy of efct the efficacy of efct has been examined in 10 rct-studies, all which support its efficacy. however, these studies do not always present classical effect sizes. in the meta-analysis by johnson et al. (1999), including four randomized trials, an effect size of d = 1.31 is reported. more recently, beasley and ager (2019) published a new meta-analysis that included studies that were conducted and published since the last meta-analysis, covering a period of 19 years. in this meta-analysis, nine rct studies were included. however, authors did not calculate cohen’s d, but hedges’s g. thus, results are not bodenmann, kessler, kuhn et al. 7 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ directly comparable with previous research or studies related to cbct. hedges’s g was 2.09 (beasley & ager, 2019). in earlier research on efct, johnson and talitman (1997) report an improvement in relationship quality in 50% of couples (no rct-study) at post-test, while 70% showed recovery at 3-month follow-up. in a recent study (wiebe et al., 2017), 61% fully recovered, 11% improved (but no recovery), 25% remained unchanged and 4% showed a deteriora‐ tion. comparison of intervention studies and meta-analyses statements on the efficacy of cbct are based on a great number of studies (n = 86 studies in the different meta-analyses), usually relatively large samples, and randomized controlled trials (which represent the golden standard in treatment evaluation studies). the evaluation of efct is based on fewer studies (n = 32 studies in the different metaanalyses), not always rct designs and usually smaller samples. the above-cited most recent meta-analysis by beasley and ager (2019) on the effectiveness of efct included only four methodologically sound rct studies, and the first meta-analysis (johnson et al., 1999) had also included only four trials. only 0.01% of all conducted evaluation studies in efct could be included in this latest meta-analysis because of insufficient methods or sample sizes or other statistical shortfalls. thus, only four follow-up studies out of nine met inclusion criteria within the last 19 years (beasley & ager, 2019). the mean sample size in these studies was considerably small with nmean = 14 in the interven‐ tion group versus nmean = 13 in the intervention group. three out of nine studies were rated to not meet criteria for treatment integrity and the others were at least acceptable (beasley & ager, 2019). often studies were not in the context of relationship distress but related to other problems such as medical issues (e.g., infertility, end-stage cancer or psychological disorders such social anxiety, depression). they represented no “pure” studies on effects of efct on relationship distress. more interesting than reviews and meta-analyses on one single approach are studies directly comparing both approaches. the meta-analysis with 33 suitable primary studies by rathgeber et al. (2019) is such an example (n = 21 studies on cbct, n = 12 studies on efct). in this study, a total of 2,730 participants were included. results reveal a medium overall effect size at post-test g = 0.60 (behavioral cognitive therapy (bct): g = 0.53; efct: g = 0.73). after 6 months smaller effects were reported (overall: g = 0.44; bct: g = 0.35; efct: g = 0.66). most important, no significant differences in effect sizes were found between the two couple therapy approaches. this finding echoes results of the study by byrne et al. (2004), where large effect sizes for both treatments (dbct = 0.95, defct = 1.27) on quality of couples’ relationships compared to waiting-list controls are reported. “taken together, meta-analyses of existing efficacy studies continue to support an approximate d of at least 0.80 for bct and efct, with 60–72% of couples experiencing reliable pre–post improvements in satisfaction” (bradbury & bodenmann, 2020, p. 102). cognitive-behavioral and emotion-focused couple therapy 8 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://www.psychopen.eu/ c o n c l u s i o n in sum, cbct and efct are both effective in helping couples deal with relationship distress (bradbury & bodenmann, 2020). based on our review of the literature, it is im‐ portant to acknowledge that while both approaches have their strengths and weaknesses, both are similarly effective in helping couples to better understand and cope with their presenting concerns. additionally, both approaches address the importance of personal schema, triggering relevant cognitions and emotions. the assumption that cbct is purely behavioral, focusing on cognitions and neglecting emotions is often wrongly derived from the designation, but lacks any theoretical and practical basis. cbct and efct both address similarly the emotional experiences between partners; however, each approach does so differently. both approaches have been found to be beneficial in improving relationship distress and helping couples overcome their relational difficul‐ ties, in addition to helping couples wherein one partner has been diagnosed with a clinical disorder. it is important that clinicians and policy makers are aware of these two evidence-based approaches, and expand their application to other areas wherein couples may be experiencing distress (e.g., health psychology). therefore, publications building public awareness for the use of couple therapy in treating psychological disorders are important (fischer et al., 2016; leuchtmann & bodenmann, 2017). funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s bailey, g. 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(2016). a review of the research in emotionally focused therapy for couples. family process, 55(3), 390-407. https://doi.org/10.1111/famp.12229 wiebe, s. a., johnson, s. m., lafontaine, m.-f., burgess moser, m., dalgleish, t. l., & tasca, g. a. (2017). two‐year follow‐up outcomes in emotionally focused couple therapy: an investigation of relationship satisfaction and attachment trajectories. journal of marital and family therapy, 43(2), 227-244. https://doi.org/10.1111/jmft.12206 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. cognitive-behavioral and emotion-focused couple therapy 12 clinical psychology in europe 2020, vol.2(3), article e2741 https://doi.org/10.32872/cpe.v2i3.2741 https://doi.org/10.1111/j.1752-0606.2003.tb01694.x https://doi.org/10.1037/0022-006x.73.1.6 https://doi.org/10.1016/j.sbspro.2013.06.293 https://doi.org/10.1016/s0165-0327(00)00287-1 https://doi.org/10.1111/famp.12229 https://doi.org/10.1111/jmft.12206 https://www.psychopen.eu/ cognitive-behavioral and emotion-focused couple therapy (introduction) brief review of the theoretical underpinnings of cbct and efct cognitive-behavioral couple therapy emotion-focused couple therapy similarities and differences between both approaches efficacy of cbct and efct conclusion (additional information) funding competing interests acknowledgments references symptom perception from a predictive processing perspective scientific update and overview symptom perception from a predictive processing perspective giovanni pezzulo a, domenico maisto b, laura barca a, omer van den bergh c [a] institute of cognitive sciences and technologies, national research council, rome, italy. [b] institute for high performance computing and networking, national research council, naples, italy. [c] health psychology, university of leuven, leuven, belgium. clinical psychology in europe, 2019, vol. 1(4), article e35952, https://doi.org/10.32872/cpe.v1i4.35952 received: 2019-05-06 • accepted: 2019-08-13 • published (vor): 2019-12-17 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: giovanni pezzulo, institute of cognitive sciences and technologies, national research council, via san martino della battaglia 44, 00185 rome, italy. e-mail: giovanni.pezzulo@istc.cnr.it abstract background: bodily symptoms are highly prevalent in psychopathology, and in some specific disorders, such as somatic symptom disorder, they are a central feature. in general, the mechanisms underlying these symptoms are poorly understood. however, also in well-known physical diseases there seems to be a variable relationship between physiological dysfunction and self-reported symptoms challenging traditional assumptions of a biomedical disease model. method: recently, a new, predictive processing conceptualization of how the brain works has been used to understand this variable relationship. according to this predictive processing view, the experience of a symptom results from an integration of both interoceptive sensations as well as from predictions about these sensations from the brain. results: in the present paper, we introduce the predictive processing perspective on perception (predictive coding) and action (active inference), and apply it to asthma in order to understand when and why asthma symptoms are sometimes strongly, moderately or weakly related to physiological disease parameters. conclusion: our predictive processing view of symptom perception contributes to understanding under which conditions misperceptions and maladaptive action selection may arise. keywords somatic symptom disorder, medically unexplained symptoms, symptom perception, predictive coding, active inference this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.35952&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • there is a variable relationship between physiological dysfunction and selfreported symptoms. • we conceptualize symptom perception (and misperception) within a predictive processing perspective. • in this view, symptom perception integrates sensations and predictions about these sensations. • failures of such integration can produce misperceptions and maladaptive action selection. • we use the perception (and misperception) of asthma symptoms as an example. new developments in the conceptualization of how the brain works have recently emerged. these conceptualizations emphasize the predictive nature of the brain, hence are known as predictive coding or predictive processing views (clark, 2013; friston, 2010; hohwy, 2013). although the basic ideas underlying this conceptualization have been de‐ veloped by von helmholtz in the late 19th century, a strong impetus in recent years has been given by the thorough study of perception, especially of visual illusions. many per‐ ceptual phenomena can only be understood by assuming that meaningful perception is not just a matter of processing incoming information, but that it is also largely reliant on pre-existing (prior) information: often the brain unconsciously and compellingly assumes (or infers) non-given information to construct a meaningful percept. predictive processing views and their implications are currently explored in an in‐ creasing number of scientific areas. in neuroscience, the theory of "predictive coding" (friston, 2005; rao & ballard, 1999) describes how sensory (e.g., visual) hierarchies in the brain may combine prior knowledge and sensory evidence, by continuously exchanging top-down (predictions) and bottom-up (prediction error) signals. besides, interest in cre‐ ating intelligent systems enhanced the need to extend the predictive processing perspec‐ tive beyond perceptual processing, to address also action and planning (aka active infer‐ ence). pioneering work towards this goal has been done by karl friston and colleagues (friston et al., 2016; friston, fitzgerald, rigoli, schwartenbeck, & pezzulo, 2017; friston et al., 2015; friston, samothrakis, & montague, 2012; pezzulo, rigoli, & friston, 2018). in the present paper, we will first introduce some basic concepts of the predictive processing view of perception (called "predictive coding") and its extension to the action domain (called "active inference"). next, we will briefly describe their implications for symptom perception. the remainder of this paper will sketch a formal model of symptom percep‐ tion as viewed from a predictive processing perspective. symptom perception and predictive processing 2 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ p r e d i c t i v e p r o c e s s i n g d u r i n g p e r c e p t i o n ( p r e d i c t i v e c o d i n g ) a n d a c t i o n ( a c t i v e i n f e r e n c e ) a basic task of the brain is to construct an adaptive model of the (external and internal) world, while its only source of information to do so is the spatial and temporal patterning of its own neural activity. in order to achieve this goal, the brain uses information from neural activity that is triggered by peripheral input (sense organs and receptors in the peripheral body), but also from neural activity that is generated by the brain itself (aka spontaneous dynamics), reflecting previous experiences and “built in” information. this leads to two counterflowing streams of neural activation across several hierarchical lev‐ els of the brain: stimulation by peripheral input (called “likelihood” in the context of bayesian inference) interacts with activations generated by the brain that act as modelbased predictions of the input (“priors”) within a specific context. for example, if one is waiting for jeff in a crowded street, the brain generates neural patterns acting as priors that will facilitate spotting jeff in the crowd. the theory of "predictive coding" specifies how the brain may mechanistically imple‐ ment this kind of bayesian inference. according to predictive coding, input at each hier‐ archical level that is predicted is cancelled out (“explained away”), while unpredicted in‐ put creates prediction errors that are relayed to the next hierarchical level where it meets priors generating new prediction errors. prediction errors are thus propagated through the brain from very basic and concrete to higher abstract levels of representation to even‐ tually settle on a "posterior" belief (to be understood in the technical sense of a neural probability distribution, not as a conscious belief) that accounts for the stimulation with the least overall prediction errors. the posterior belief can subsequently act as prior for new input leading to further adaption in an iterative process. in the case of waiting for jeff: the benefit of having an a priori belief in the brain representing jeff is that it helps to quickly recognize him and to prime a network of related information for further interac‐ tion. obviously, there is also a downside of having highly active priors about jeff arriving soon: whenever input is downgraded to some extent, any person that resembles jeff will easily be mistaken for jeff. in sum, the theory of "predictive coding" postulates that the brain continuously strives to minimize its prediction error (and the difference between predictions and sensations). it does so by accommodating the prior hypothesis (or belief) and/or the model producing such hypothesis, to fit unpredicted information. for exam‐ ple, if jeff was expected but a female appears, the brain can revise the prior belief. fur‐ thermore, if jeff is wearing a fancy new cap and sunglasses which is discrepant infor‐ mation compared to previous encounters the model of jeff in the brain may be adapted (for example, by reducing the weight given to these aspects of visual input). the theory of "active inference" extends this view to also account for active compo‐ nents of perceptual processing (active perception) and goal-directed behavior. in this per‐ pezzulo, maisto, barca, & van den bergh 3 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ spective, the brain does not passively wait for sensory stimulations, but it can initiate ac‐ tivity to produce input that is consistent with its adaptive model. waiting for jeff may prompt the person to move towards a location providing a better overview of the passing crowd and/or to increase the scanning rate generating more detailed information to help spotting him; or even going to jeff's house, if he does not appear. as these examples of active inference illustrate, acting is just another way to reduce prediction error. in other words, while in predictive coding one reduces prediction errors by changing the prior be‐ lief to fit the world, in active inference one reduces prediction errors by changing the world to fit the prior belief (e.g., that one will encounter jeff). as this latter example illus‐ trates, in active inference the prior belief is much more than a prediction: it can play the role of a cognitive goal that triggers a goal-directed plan (e.g., a plan to go to jeff's house). the importance of precision control priors and prediction errors (pe’s) can be thought of as probability distributions of neural activity capturing statistical regularities associated with a specific input. these distribu‐ tions are characterized by a variance, or its inverse: precision. highly precise priors and prediction errors reflect that a neural pattern has a high probability of being associated with a particular input, and conversely for low precise priors and pe’s. if jeff is unusually tall, both priors and pe’s representing jeff’s height are highly precise, resulting in a quick and reliable recognition of jeff. repeated encounters will also generate precision expecta‐ tions, that is: not only is the perceptual information related to jeff’s “height” highly pre‐ cise, the brain will learn to consider “height” as a highly precise prior for recognizing jeff. precision parameters of both pe’s and priors are used as weighting factors in bayesi‐ an inference and predictive coding: they determine the relative contributions of prior in‐ formation and sensory evidence to the brain's "posterior belief" and thus the content of perception. highly precise priors and low precise pe’s will shift the posterior belief to‐ wards the prior, while the reverse is true with low precise priors and highly precise pe’s (see figure 1 for a graphical illustration of integration of prior and sensory evidence in bayesian inference). for example, when it is dark, there is a high probability to recognize jeff in any tall person, reflecting a strong effect of the prior on the eventual perception. conversely, on a sunny day it is less likely to take any tall person for jeff and this likeli‐ hood is even further reduced if one is not waiting for jeff. symptom perception and predictive processing 4 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ figure 1. integration of prior knowledge and sensory evidence (likelihood) in bayesian inference. note. the top panel shows that if prior and likelihood have the same precision (i.e., inverse variance of the gaussian distribution), the posterior belief is in between. the second and third panels show that higher precision prior and likelihood "attract" the posterior, respectively. note that in all cases, the precision of the posterior increases compared to the prior. see the main text for explanation. precision parameters of sensory events play an additional role in (active) perceptual in‐ ference and information gathering. information sources that are assumed to bring more precise information are preferentially sampled, while those that are assumed to bring im‐ precise information can be ignored (e.g., looking for jeff in the total dark is useless and thus avoided). in sum, perception can be considered a dynamic constructive process balancing exter‐ nal input and pre-existing information: under some conditions, the eventual percept closely reflects the external input, while in other conditions it may more closely reflect pre-existing information that act as (implicit) prior expectations. perceptual illusions can be considered extreme cases where the percept is (almost) entirely determined by prior expectations (pezzulo, 2014; sterzer et al., 2018). furthermore, perception has active (in‐ formation gathering) components that permit sampling information from the most pre‐ cise information sources but can lead to inattention or even neglect when precision pa‐ rameters are not set correctly (parr & friston, 2018). pezzulo, maisto, barca, & van den bergh 5 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ p r e d i c t i v e p r o c e s s i n g a n d s y m p t o m p e r c e p t i o n one of the research areas for which these new conceptualizations are particularly fruitful is interoception, which is considered to play an important role in the experience of the self, agency, emotion and psychopathology (allen, levy, parr, & friston, 2019; barca & pezzulo, 2019; iodice, porciello, bufalari, barca, & pezzulo, 2019; pezzulo, barca, & friston, 2015; pezzulo, maisto, barca, & van den bergh, 2019; pezzulo, rigoli, & friston, 2015; seth, 2013; tsakiris & preester, 2018). the embodied predictive interoception cod‐ ing model (epic; barrett & simmons, 2015) describes the neural architecture and func‐ tional characteristics of interoception, suggesting a critical role for active inference: vis‐ ceromotor cortices generate autonomic, hormonal and immunological predictions to ade‐ quately deal with anticipated demands while pe’s are fed back to the brain to adapt and modify subsequent predictions. because visceromotor cortices are overall relatively in‐ sensitive to somatic input, interoception is largely dominated by prior expectations (“a construction of beliefs that are kept in check by the actual state of the body”, barrett & simmons, 2015, p. 424). being critical for symptom perception, this account of interocep‐ tion allows and suggests important variability in the relationship between symptoms and peripheral bodily dysfunction. this has tremendous conceptual and practical implications for medicine. indeed, while the relationship between self-reported symptoms and parameters of pe‐ ripheral bodily dysfunction is generally strong in acute monosymptomatic health condi‐ tions, it becomes typically much weaker in chronic multisymptomatic conditions (janssens, verleden, de peuter, van diest, & van den bergh, 2009). in a substantial num‐ ber of cases no relationship with physiological dysfunction can be found at all. hence, the latter are often called “medically unexplained symptoms” (mus). the prevalence of mus in primary care consultations is estimated around one third, while prevalence rates in secondary care are even higher (de waal, arnold, eekhof, & van hemert, 2004; nimnuan, hotopf, & wessely, 2001). in secondary care general medicine, the symptoms often appear as functional syndromes, such as chronic fatigue, fibromyalgia, irritable bowel disease, multiple chemical sensitivity, bodily distress disorder, while in psychiatry they are labeled as somatic symptom disorder, somatization disorder, conversion disorder, etc. however, also placebo and nocebo phenomena which are abundantly present in ev‐ eryday medicine are difficult to understand within a strict biomedical disease model. the predictive processing perspective allows to describe the conditions moderating the relationship between symptoms and bodily dysfunction (van den bergh, witthöft, petersen, & brown, 2017), to explain pseudoneurological symptoms and conversion (edwards, adams, brown, pareés, & friston, 2012), persistent physical symptoms (henningsen et al., 2018), placebo effects (büchel, geuter, sprenger, & eippert, 2014) and pain perception (wiech, 2016). however, most current models appeal to the mechanisms of predictive coding, while disregarding action components (or active inference) that are equally important to understand symptoms and psychopathological conditions. symptom perception and predictive processing 6 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ below, we discuss a worked example of symptom perception in terms of underlying predictive coding and active inference dynamics. our example focuses on asthma percep‐ tion. asthma relies on a well-known physiological dysfunction but often the symptoms do not clearly relate to that dysfunction, which is a rather prevalent clinical problem (de peuter et al., 2005; janssens et al., 2009). our example describes the conditions for a strong, weak or absent relationship between symptoms and bodily input. a w o r k e d e x a m p l e o f s y m p t o m s a n d t h e b o d y : t h e c a s e o f a s t h m a p e r c e p t i o n consider the simplified case of an asthmatic person who feels two bodily sensations (e.g., wheezing, breathlessness) that sometimes indicate the beginning of an asthma episode. the person has to infer whether it is an asthma episode (hypothesis 1) or not (hypothe‐ sis 2), based on what he currently feels (e.g., wheezing, breathlessness) and his prior be‐ lief (e.g., the fact that he/she is in the bedroom where he usually has asthma episodes). generative model and inference from the formal perspective of predictive coding (and more broadly, bayesian inference), the brain makes this inference using a so-called "generative model" of how its sensations are generated. the "generative model" has two essential components. the first one ("like‐ lihood model") describes the probabilistic mapping between sensations (e.g., wheezing, breathlessness) and the two competing hypotheses (hypothesis 1: this is an asthma epi‐ sode; hypothesis 2: this is not) which in this context are also called "hidden" states, be‐ cause they cannot be directly observed but need to be inferred. for example, a good like‐ lihood model of asthma may represent the fact that under hypothesis 1 (this is an asthma episode), the probability of feeling wheezing is high (e.g., 0.8). however, under hypothe‐ sis 2 (this is not an asthma episode), the probability of feeling wheezing is very low (e.g., 0.05). in other words, the person should expect to feel wheezing (only) if he is experienc‐ ing an asthma episode. furthermore, the likelihood model may represent the fact that breathlessness has the same probability (e.g., 0.6) under hypotheses 1 and 2 (and more broadly, that one can feel breathless for many other reasons, such as because one has done physical exercise). a consequence of having this particular likelihood model is that while wheezing is very informative (i.e., feeling wheezing tells me with high probability that hypothesis 1 is true; and not feeling wheezing tells me with high probability that hypothesis 2 is true), breathlessness is not, as it cannot disambiguate between hypothe‐ ses 1 and 2. the second component of the generative model is the person’s "prior belief" about the two hypotheses 1 and 2. for example, if the asthmatic person is in the bedroom where he frequently experienced asthma episodes in the past, he may have a high prior pezzulo, maisto, barca, & van den bergh 7 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ belief (e.g., 0.7) for hypothesis 1. if we assume for simplicity that hypotheses 1 and 2 are mutually exclusive, and there are no alternative hypotheses, then the prior probability of hypothesis 2 is just one minus the prior probability of hypothesis 1; that it, 0.3. we can use these figures to calculate the (posterior) probability of the two (mutually exclusive) hypotheses 1 and 2, according to bayes' rule: posterior of hyp1 = prior of hyp1 * likelihood of hyp1prior of hyp1 * likelihood of hyp1 + prior of hyp2 * likelihood of hyp2 posterior of hyp2 = 1  −  posterior of hyp1 imagine the person is currently experiencing wheezing and is in the bedroom where he frequently experiences asthma episodes. we can use the numbers above to calculate the posterior probability (or belief) about hypotheses 1 and 2, as follows: posterior of hyp1 = 0.7 * 0.80.7 * 0.8  + 0.3 * 0.05   =   0.9739 therefore, in this example, the posterior probability of hyp1 is 0.9739 and the posterior probability of hyp2 is one minus 0.9739, that is, 0.026. this means that in this situation, the person would have a very strong belief (in probabilistic terms) about an asthma epi‐ sode. it is possible to use the same formula to simulate other possible situations. imagine that the same person is in the same room but does not feel any wheezing or breathless‐ ness. in this second example, the belief about an asthma episode would be much smaller (0.474 for hyp1) and the person should conclude that hypothesis 2 is correct. from bayes' rule to predictive coding note that we have illustrated our two examples in terms of bayesian inference, which cannot be directly computed by the brain. however, the theory of predictive coding sug‐ gests that the brain solves something analogous to the above bayes' formula, using a hi‐ erarchical neural architecture1. in this architecture, predictions (derived from prior beliefs) are propagated in a top-down manner, and they are compared with perceptual and inter‐ oceptive evidence (via the likelihood model). the result of the comparison is called pre‐ diction error, and is propagated bottom-up in the hierarchy, to help updating the (posteri‐ or) probability of the initial hypothesis. in our first example above, the brain would propagate a strong top-down prediction about an asthma episode (as the prior of hypothesis 1 is high); and because the intero‐ ceptive evidence (wheezing) is largely compatible with this hypothesis, the resulting pre‐ diction error that is propagated bottom-up would be relatively low. iterating this top1) note that predictive coding uses continuous probability distributions (e.g., gaussian) rather than the discrete distri‐ bution that we considered in the example of bayes' rule. for simplicity, we ignore this difference here. symptom perception and predictive processing 8 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ down (prediction) and bottom-up (prediction error) message passing would permit refin‐ ing the initial hypotheses, setting the posterior probability of hyp1 to a value where pre‐ diction error is minimized which in this case is (close to) 0.9739. in our second example above, the brain would propagate a strong prediction about an asthma episode, too. however, because the interoceptive evidence (not wheezing) is in‐ compatible with this hypothesis, the resulting prediction error would be very high and after some iterations, the inference would settle to a (posterior) probability of 0.474 for hyp1. precision weighting and its mis-regulation in psychopathology yet there is another aspect of bayesian inference and predictive coding that we have ig‐ nored for now but is central to theories of psychopathologies. all the aforementioned top-down and bottom-up signals are weighted by their precision. technically, precision is the inverse variance of a probability distribution (e.g., a continuous distribution, such as a gaussian) and it can be used as a weight to each of the elements (priors and likelihoods) of the above bayes' rule with the effect that the more precise information has a stronger effect on the computations of the posterior probability, see figure 1. precision weighting is a convenient way to give more credit to the most reliable information sources and dis‐ card noisy evidence. for example, there may be conditions in which i cannot be sure about my sensory or interoceptive evidence (e.g., i don't know how i feel); in these cases, the evidence has to be down-weighted and thus the prior dominates the inference. trusting the prior is of course something sensible to do when evidence is scarce or unreliable. however, there are other and more pathological cases in which the prior may acquire a very high precision and dominate the inference, even if this is not optimal; and this may constitute a route to mus. let's expand our second example above (i.e., the case when one has a strong prior but no evidence for an asthma episode) by also considering that both the prior and the likelihood are weighted according to some precision value. if the precision of the prior is (for some reason) excessively high, one can obtain posterior probabilities for hyp1 that are much higher than our previous example (i.e., very close to prior probabilities, as in the central panel of figure 1). the person would thus conclude incorrectly that he/she is experiencing an asthma episode. furthermore, given that the predictive coding architecture continuously generates predictions about what it expects, the same person may also predict or "hallucinate" the wheezing that he is not experienc‐ ing (because it is highly compatible with the winning hypothesis 1). this example illustrates that priors that have acquired an excessively high precision may dominate the inference and fail to be correctly updated based on empirical evidence thus potentially producing mus. how can priors acquire unwarrantedly high precision? while accurate predictive coding requires the precision of top-down and bottom-up sig‐ nals to be optimized (and would thus not produce mus), there may be various pathologi‐ cal conditions that can lead to their mis-regulation. these may include deficits of neuro‐ pezzulo, maisto, barca, & van den bergh 9 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ modulators like dopamine and noradrenaline, which in predictive coding are carriers of precision signals; or the exposure to the "wrong" environmental statistics, like when growing up with a chronically ill or health-anxious parent. these and other condition may lead to the formation of excessively precise priors that resist updating; and it is un‐ der these conditions that mus may emerge. a second possible way mus (or similar phenomena) may emerge is the converse of the above example; and namely, when likelihoods have excessively (pathologically) low precision. some pathologies may be related to deficits of interoceptive processing, in which one "does not know how he/she feels" (e.g. alexithymia, affective agnosia; lane, weihs, herring, hishaw, & smith, 2015) or cannot easily attribute some interoceptive sensation (e.g., wheezing) to some cause (e.g., an asthma episode). in these cases, because the interoceptive signals are assigned a vanishingly small precision, they would be large‐ ly ignored during the inference and again, the prior would dominate it. from predictive coding to active inference we discussed how, under a predictive coding scheme, deficits of precision weighting in either the prior or the likelihood (or both) can lead to maladaptive perceptual inference and mus. the theory of active inference expands this view, by introducing additional ways these deficits may hinder correct inference and action selection. here we focus on just one aspect of active inference: the fact that it induces an active sampling of informa‐ tion that is expected to have informative value, i.e., to gather relevant evidence. when describing the asthmatic person's generative model, we have considered that wheezing is more informative than breathlessness, as the presence or absence of the for‐ mer (but not the latter) disambiguates between hypotheses 1 and 2. active inference as‐ sumes that informative evidence is not passively gathered (as in predictive coding) but actively sampled; for example, by monitoring or directing attention to the relevant infor‐ mation sources (e.g., "attention to bodily signals"). active inference would thus predict that under normal conditions, the asthmatic person should preferentially monitor and di‐ rect attention to its most informative signal: wheezing. yet, one can imagine a degenerate (technically, high-entropy) likelihood function, in which wheezing as a source of interoceptive evidence has degraded to a sensation that has exactly the same probability under both hypotheses 1 and 2. in this case, monitoring wheezing would be useless, as it would bring exactly the same evidence for the two hy‐ potheses. if a person's (likelihood) model of his bodily signals were degenerate, not only he would fail to recognize asthma symptoms, but he would also cease to attend to them and more broadly, to pay attention to his bodily signals, similar to a form of "neglect" (parr & friston, 2018). in this case, he would only be able to infer asthma from the prior belief or other, non-bodily sources of information (e.g., what the others around me be‐ lieve about my asthma) that may not be particularly reliable. ignoring bodily signals symptom perception and predictive processing 10 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://www.psychopen.eu/ would thus render this person prone to mus, as well as to deficits of body schema and self-representations that may have a strong bodily basis (pezzulo, 2014; seth, 2013). a degenerate (likelihood) model of bodily signals may arise from neurological or pe‐ ripheral disorders that make bodily signals noisier. however, it can also be the conse‐ quence of a poor learning and developmental processes, which can lead to the acquisition of internal models that are insufficiently differentiated and do not permit to appropriate‐ ly categorize one's own interoceptive signals (petersen, schroijen, mölders, zenker, & van den bergh, 2014). c o n c l u s i o n s we discussed symptom perception and mus from the perspective of predictive coding and active inference. our examples illustrate the fact that there are various ways by which the components of a person's generative model (prior and likelihood) can be as‐ signed too high or too low precision or become "unbalanced". this, in turn, may produce (momentary) incorrect inference or action selection or (more chronic) psychopathologi‐ cal conditions. formal theories like predictive coding and active inference can help dissecting these possibilities and identifying their markers during development. however, these conceptu‐ al models also imply important challenges to test and validate them. one way is to flesh out a computational version of the model involving a clear mechanistic description of the critical variables and their interactions, to run simulations and compare the results with evidence from real life (friston et al., 2017; petzschner, weber, gard, & stephan, 2017; stephan et al., 2016). funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. r e f e r e n c e s allen, m., levy, a., parr, t., & friston, k. j. 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(2016). deconstructing the sensation of pain: the influence of cognitive processes on pain perception. science, 354(6312), 584-587. https://doi.org/10.1126/science.aaf8934 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. symptom perception and predictive processing 14 clinical psychology in europe 2019, vol.1(4), article e35952 https://doi.org/10.32872/cpe.v1i4.35952 https://doi.org/10.1016/j.biopsych.2018.05.015 https://doi.org/10.1016/j.neubiorev.2017.01.015 https://doi.org/10.1126/science.aaf8934 https://www.psychopen.eu/ symptom perception and predictive processing (introduction) predictive processing during perception (predictive coding) and action (active inference) the importance of precision control predictive processing and symptom perception a worked example of symptoms and the body: the case of asthma perception generative model and inference from bayes' rule to predictive coding precision weighting and its mis-regulation in psychopathology from predictive coding to active inference conclusions (additional information) funding competing interests acknowledgments references clinical psychology in spain: history, regulation and future challenges politics and education clinical psychology in spain: history, regulation and future challenges javier prado-abril a, sergio sánchez-reales b, alberto gimeno-peón c, josé antonio aldaz-armendáriz a [a] department of mental health, aragón healthcare service (spanish national health system), zaragoza, spain. [b] department of mental health, murcia healthcare service (spanish national health system), murcia, spain. [c] department of mental health, principality of asturias healthcare service (spanish national health system), gijón, spain. clinical psychology in europe, 2019, vol. 1(4), article e38158, https://doi.org/10.32872/cpe.v1i4.38158 received: 2019-07-10 • accepted: 2019-09-25 • published (vor): 2019-12-17 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: javier prado-abril, aragón healthcare service, plaza de la convivencia, 2, 50017 zaragoza, spain. e-mail: jpradoabril@gmail.com abstract the heterogeneity of national regulations in clinical psychology and psychological treatment across europe requires a detailed description of every regulation to start a shared discussion. in the current paper, we describe the history, legal regulations, a specialized training program, the current status and some future challenges for clinical psychology in spain. the evolution of clinical psychology in the spanish national health system (nhs) towards a health specialty regulated by law, exemplifies a balanced process of expansion, social recognition and professional settlement. overall, the growth of clinical psychology in spain may depend on access to leadership and management positions in the nhs that would allow a better organization of care resources to improve citizens’ access to psychological treatment. keywords clinical psychology, psychological treatment, training, education, national regulation, spain this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.38158&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • spanish regulation of clinical psychology is mediated by socio-cultural and political changes that occurred in the late 70's and 80’s in the country. • recognition as a licensed clinical psychologist is obtained through a 4-year training system as an intern resident psychologist (pir). • pir is a training system of supervised internships, with increasing autonomy in various healthcare departments in the national health system (nhs). • achieving independent clinical psychology services within the nhs in order to organize, implement and deliver evidence-based practices is currently one of our biggest challenges in the near future. spanish clinical psychology welcomes the creation of the european association of clinical psychology and psychological treatment (eaclipt) and its journal clinical psychology in europe (cpe). in its first issue, laireiter and weise (2019) reviewed and updated the het‐ erogeneity of national regulations in clinical psychology and psychological treatment in europe and invited european clinicians to start a discussion on the matter. as suggested by van broeck and lietaer (2008), this heterogeneity is influenced at least by political is‐ sues, the organization of health care and educational aspects. this paper tries to contrib‐ ute to the discussion with a description of the history, development and current status of clinical psychology in spain. a b r i e f h i s t o r y o f c l i n i c a l p s y c h o l o g y i n s p a i n spain endured a dictatorship from the end of our civil war (1936-1939) until 1975. the subsequent democratization process ushered in a series of key events, the appreciation of which is necessary in order to understand the development of clinical psychology as a health specialty in our country. in 1978, the new democratic constitution stated in article 43 that spaniards should be entitled to health protection. more specifically, the constitu‐ tion emphasized that public authorities should provide appropriate measures to assist people with mental health problems. in 1986, the general health law (law 14/1986) de‐ veloped the constitutional mandate and established the basis of a public national health system (nhs). from the very beginning, governmental policies tried to develop the high‐ est healthcare standards and welfare benefits for our citizens. likewise, the key element of quality of care became the responsibility of health specialists who had to meet strict and demanding training programs (sánchez-reales, prado-abril, & aldaz-armendáriz, 2013). simultaneously, so-called psychiatric reform in 1985 brought about a significant change in psychiatric care policies in spain: (i) the development of new mental health management structures with an extensive community network of outpatient mental clinical psychology in spain 2 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.psychopen.eu/ health centers, (ii) the integration of care for psychiatric patients into the general health care system, and (iii) the adoption of an interdisciplinary clinical approach (vázquezbarquero & garcía, 1999). interdisciplinary mental health teams allowed psychologists to gradually become part of mental health units in the newly created nhs. at the same time, new faculties of psychology opened in several spanish universities (olabarría & garcía, 2011). prior to this, psychologists did not receive a specific education or bache‐ lor’s degree in psychological science. they used to graduate with a philosophy and let‐ ters degree and obtained a mention in psychology after following a certain academic tra‐ jectory. the institutionalization of psychology was then at its infancy. in the meantime, the nhs created its own training system in the early 80’s mainly for medical specialties (royal decree [rd] 127/1984). the training of health specialists was now entrusted to the nhs rather than universities or other educational institutions. specialized training now fell under the auspices of the nhs and regulated and exclusively controlled by central government (olabarría & garcía, 2011; sánchez-reales et al., 2013). specialties were to be approved by rd at the proposal of the ministries of health and education (rd 639/2014), and competence in non-specialized education was left to universities alone (prado-abril, sánchez-reales, & aldaz-armendáriz, 2014). from 1986 until late into the first decade of the 21st century, spain experienced a po‐ litical process of decentralization. nowadays, health care is provided by autonomous re‐ gional governments (arg). they manage health care plans and are the main public health care providers. nonetheless, certain national controls are preserved to guarantee equal access to nhs services and healthcare assistance (law 16/2003). some arg as‐ sumed health competences before others. these regions pioneered training programs in clinical psychology. these training programs followed the training model that was al‐ ready established for medical specialties based on internship and placements. the princi‐ pality of asturias was the first arg to promote a clinical psychology training program in 1983 (garcía solar et al., 1986). andalusia and castile-leon in 1986 and navarre in 1988 followed (aparicio, 1990). training was based on several supervised internships on dif‐ ferent mental health placements in hospitals and other public health services. this was professionalizing and remunerated employment. trainees were allowed increasing clini‐ cal autonomy and responsibilities during the three-year training. in 1993, the first national call took place once regional trial programs were considered successful (olabarría, 1998). access to training was based on a national psychology test. since then, the pir test call (for its acronym in spanish, test of access to specialized health training as intern resident psychologist) has taken place every year. access is based on principles of equality, merit and ability (e.g., ministerial order scb/947/2018). later, in 1998, the title of psychologist specialized in clinical psychology (rd 2490/1998) was created and regulated after a complex process of political and professional negotia‐ tions (anpir, 2018). this rd regulates the health specialty in clinical psychology and es‐ prado-abril, sánchez-reales, gimeno-peón, & aldaz-armendáriz 3 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.psychopen.eu/ tablishes the pir system as the only way to obtain this title. however, a transitory homolo‐ gation process was established for practicing psychologists. currently, it is estimated that there could be up to 9,000 clinical psychologists in our country although there is no official register in spain as yet (duro, 2019). as for other health professionals, there are probably three psychiatrists for each clinical psychologist if we take into account that there are twice as many training posts per year for psychia‐ trists and their specialized education began some years before ours. psychotherapy is not a regulated health profession. however, the ministry of health has launched a national register of health professionals1. this will enable us to know, in the near future, the exact number of professionals in each of the regulated health specialties. the process by which clinical psychology became a health specialty regulated by law (rd 2490/1998), with similar administrative, organizational and competence status as medical specialties (law 44/2003), shows how a balanced approach of growth, social rec‐ ognition and professional settlement took place in spain over the past three decades. this was a process that also suffered socio-political, economic, and organizational constraints some of which came from professional psychology corporations (olabarría, 1998; olabarría & garcía, 2011; sánchez-reales et al., 2013). therefore, the presence of clinical psychology in the nhs is intimately related to the process of democratization in spain. legally regulated tasks such as (clinical) assessment, diagnosis, (psychological) treatment, management and team leadership were now recognized as part of the scope of roles of clinical psychologists within the nhs. clinical psychologists now hold full professional autonomy and clinical responsibility without interference from any other health profes‐ sionals and enjoy a similar legal status to any other health specialty (law 44/2003) such as, for example, psychiatrists or neurologists. p i r t e s t a c c e s s , p i r t r a i n i n g s y s t e m a n d p s y c h o l o g i s t s p e c i a l i z e d i n c l i n i c a l p s y c h o l o g y nowadays, clinical psychology is structured in three different stages: bachelor’s degree in psychology (4 years and 240 ects), non-academic postgraduate specialized training (pir), and continuing education (ce) for specialists or independent practice as psycholo‐ gists specialized in clinical psychology (law 44/2003). however, other educational trajec‐ tories which can improve basic health training are currently under discussion (gonzálezblanch, 2015; prado-abril et al., 2014; sánchez-reales et al., 2013). specifically, the socalled degree-master-pir itinerary is being proposed as the standard access to the pir ex‐ am call from a master’s degree level of university education. this sequential education could be useful to support the progressive acquisition of skills and competences from lower to higher level of expertise. similarly, it would foster a needed mutual understand‐ 1) https://www.mscbs.gob.es/profesionales/registroestatal/home.htm clinical psychology in spain 4 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.mscbs.gob.es/profesionales/registroestatal/home.htm https://www.psychopen.eu/ ing and collaboration between academics and clinicians. it may also promote a reduction in the gap between research and practice. pir posts are annually announced by the ministry of health (141 vacancies this 2019; ministerial order scb/947/2018) and psychologists, who have finished their undergradu‐ ate education, can apply. the exam usually takes place around february every year. those who obtain the best scores can opt for different training placements throughout the nhs and begin their pir specialized training (tables 1, 2) in may. table 1 pir specialized training: distribution and duration of supervised internships periods training program duration (in months) (p1) community care, outpatient mental health and primary care support 12 (p2) primary care 3 (p3) addictions 4 (p4) psychosocial rehabilitation and recovery 6 (p5) acute psychiatric ward, hospitalization and emergencies 4 (p6) clinical health psychology and liaison 6 (p7) child and adolescent clinical psychology 6 (p8) specific training areas 4 (p9) free disposal 3 note. source: order sas/1620/2009, https://www.boe.es/boe/dias/2009/06/17/pdfs/boe-a-2009-10107.pdf table 2 organization and annual planning m1 m2 m3 m4 m5 m6 m7 m8 m9 m10 m11 m12 r1 (p1) community care, outpatient mental health and primary care support m13 m14 m15 m16 m17 m18 m19 m20 m21 m22 m23 m24 r2 (p2) primary care (p3) addictions (p4) psychosocial rehabilitation and recovery m25 m26 m27 m28 m29 m30 m31 m32 m33 m34 m35 m36 r3 (p4 cont.) (p5) ward, hospitalization, emergencies (p6) clinical health psychology and liaison (p7) m37 m38 m39 m40 m41 m42 m43 m44 m45 m46 m47 m48 r4 (p7 cont.: child and adolescent clinical psychology) (p8) specific training areas (p9) free disposal note. m1, m2, etc. = month 1, month 2, etc.; r1, r2, etc. = 1st year intern resident psychologist (pir), 2nd year pir, etc.; p1, p2, etc. = training program 1, training program 2, etc. (see table 1); cont. = continued. source: order sas/1620/2009, https://www.boe.es/boe/dias/2009/06/17/pdfs/boe-a-2009-10107.pdf training lasts 4 years. the exam consists of a psychology general knowledge test with 225 items (plus 10 reserve items) with a 4-option multiple-choice system. testers have 5 hours to complete the exam. the test is composed of an open list of topics including all the contents of the psychology degree. however, a higher percentage of questions are prado-abril, sánchez-reales, gimeno-peón, & aldaz-armendáriz 5 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.boe.es/boe/dias/2009/06/17/pdfs/boe-a-2009-10107.pdf https://www.boe.es/boe/dias/2009/06/17/pdfs/boe-a-2009-10107.pdf https://www.psychopen.eu/ taken from psychopathology, clinical and health psychology, psychological treatment, psychotherapy, psychological assessment and personality and individual differences. the final score is calculated from a formula whereby 90% of the score is obtained from the exam and 10% from the academic record. it is a very demanding access test since there are thousands of applicants and only 189 estimated vacancies for 2020 (source: ministry of health). only one study has evalu‐ ated the characteristics of the applicants that obtain a placement (carreras & morilla, 2010). using a survey completed by 61 out of the 131 intern resident psychologists that began their training in 2010, authors found that the test preparation phase involved an average of 16.11 months of full-time study, with an average 7 study hours a day and a total amount of 2,881 hours before the exam. this scenario contrasts with the number of vacancies offered at degree level by academic institutions that draws an excessive and ir‐ responsible formative bubble that leaves a structural unemployment of 20,000 non-spe‐ cialist psychologists (sánchez-reales et al., 2017). the need to restrict access at degree level and the development of a sustainable profession as a whole is a national controver‐ sy that exceeds the purposes of this paper, but is outlined in sánchez-reales et al. (2017). regarding the pir specialized training, article 21 (law 44/2003) establishes the proce‐ dure to approve the training programs of the health specialties. the national commis‐ sion of the specialty in clinical psychology (ncscp) elaborated and proposed the cur‐ rent training program in 2009 (tables 1, 2). since the ncscp is an advisory committee, the training program was then ratified by the national council of specialties in health sciences of the ministries of health and education (order sas/1620/2009). consequently, after passing the pir test and choosing one of the nhs vacancies, trainees are enrolled at a hospital teaching unit of psychiatry and clinical psychology. this teaching unit will ensure compliance with the program for 4 years. in addition, trainees sign a full-time contract of 37.5 hours a week. they become full members of staff at the health area to which they are attached. their income is around 15,400-22,400 € be‐ fore tax per year depending on different incentives (rd 1146/2006). their clinical practice is supervised by staff clinical psychologists assuming increasing clinical responsibility and professional autonomy over the 4 years of training. this training system fundamentally provides skills and competences to future clinical psychologists for a performance in clinical and healthcare settings. it basically provides skills and legal competence for clinical assessment, diagnosis and psychological treat‐ ment (order sas/1620/2009). however, as a theoretical-technical program, and in coher‐ ence with the eaclipt task force proposal (2019), the training program goes further and establishes four main thematic areas: (i) co-education and training, with other spe‐ cialists in health sciences (doctors, pharmacists, biologists, chemists), in bioethics and professional deontology, healthcare organization and management, health legislation, and research methods; (ii) general theoretical education in clinical psychology (e.g., clini‐ cal sessions, seminars, specific training in psychotherapy schools); (iii) clinical and clinical psychology in spain 6 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.psychopen.eu/ healthcare contents or different internships (table 1); and (iv) continuing care. therefore, as part of future professional challenges, clinical psychologists are enabled for healthcare policy management and leadership of mental healthcare services. nonetheless, most management posts are occupied nowadays by physicians and psychiatrists. the training program also promotes teaching and research and many residents complete their aca‐ demic phd during their training or shortly after finishing it. as in other european countries, there is a close relationship between training in clini‐ cal psychology and psychotherapy, which requires a more detailed explanation. first, clinical psychology holds a broader scope than psychotherapy. despite the progressive expansion of the integrative approach, psychotherapy continues to be a set of schools and name brands (or acronym-defined treatments) with epistemological, theoretical and technical differences sometimes irreconcilable (paris, 2013). instead, clinical psychology in spain was designed from the very beginning, taking inspiration from the boulder mod‐ el (1949; cited in frank, 1984) in order to promote an atheoretical training that combined scientific knowledge with the delivery of professional service mainly from a public health care stance (ávila espada, 1990). right now, we can perhaps say that pir training is a pluralistic and free-school education system, although subject to the requirements of evidence-based practice (american psychological association [apa], 2006). likewise, in licensed clinical psychologists, although they should follow clinical guidelines, integra‐ tive attitudes prevail as shown in a recent national survey (prado-abril et al., under review). it is important to emphasize that training in clinical psychology lays the groundwork for a clinical psychologist to face clinical practice in spain with a broad view (eaclipt task force on “competences of clinical psychologists”, 2019). future sub-specialization may be required in certain mental health settings. we are aware that our pir training system may seem long and excessive in certain european countries. however, it has been emphasized that excellence is a goal in the nhs (law 14/1986) and this is based on hav‐ ing well trained health specialists. from that viewpoint, some contents that appear in table 1 may be better understood. the specific training areas that clinical psychologists pursue could be sub-specialized into psycho-oncology and palliative care, neuropsycholo‐ gy, psychogeriatrics, sexual and reproductive health, eating disorders, personality disor‐ ders or extend 4 more months in child and adolescent clinical psychology, among other options. the free disposal internship placement reinforces this strategy and it allows for a placement in an international mental health institution or in accredited excellence healthcare settings, while keeping their salary. the most common destinations are the united states, argentina and the united kingdom (uk). anpir society offers scholar‐ ships to the best candidates and a list of some of the centers chosen in recent years can be seen in https://www.anpir.org/becas-anpir/. finally, continuing care is a very impor‐ tant part of the program since it allows a supervised continued clinical activity through‐ out the 4 years of training allowing a broader view of clinical practice that sometimes can prado-abril, sánchez-reales, gimeno-peón, & aldaz-armendáriz 7 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.anpir.org/becas-anpir/ https://www.psychopen.eu/ be limited by short-term specific internships. continuing care is carried out in different ways such as the performance of low and high-intensity psychological treatments in in‐ dividual and/or group formats, both in outpatient mental health centers or primary care, liaison programs (in oncology, neurology…) or even, taking part in emergency guards with their psychiatry co-residents. c o n c l u s i o n s a n d f u t u r e c h a l l e n g e s in the last 26 years, clinical psychology in spain has progressively acquired its own iden‐ tity based on a solid specialized health training that also has a clear interest in contribu‐ ting to the development of high-quality public health services. however, spanish clinical psychology faces some important future challenges. the two main future challenges are improving training and citizens’ access to psy‐ chological treatments within the nhs. concerning training, there are suggestive evi‐ dence-based proposals on how to improve supervision and a more individual-focused training (callahan & watkins, 2018; prado-abril, gimeno-peón, inchausti, & sánchezreales, 2019). once training in evidence-based treatments is established, it is crucial to promote those personal and interpersonal attitudes and skills that have proven to influ‐ ence the outcome of psychological treatments (bennett-levy, 2019; heinonen & nissenlie, 2019). the goal is to get our specialists to be flexible while remaining faithful to wellestablished procedures (norcross & wampold, 2018; truijens, zühlke-van hulzen, & vanheule, 2019) and involved in ce throughout their professional life. the second goal is perhaps somewhat more complicated but inspired by the uk expe‐ rience (clark, 2018). primary care-mental health interface programs and stepped care models should be implemented and developed so as to improve access to well-established psychological treatments. this would allow a better management of common mental health disorders that otherwise do not receive adequate treatment and reducing the men‐ tal disorders burden charge (ruiz-rodríguez et al., 2018). catalonia has pioneered this strategy since 2006, so by 2017 all mental health programs in primary care were available for the entire catalonian territory. the rest of the country is still far behind, but the psi‐ cap project (psicología en atención primaria [psychology in primary care]; e.g., gonzález-blanch et al., 2018; ruiz-rodríguez et al., 2018) is gradually helping to change the mindset of health and policy managers. psicap is a national multicentric randomized controlled trial that pursues testing the effectiveness, cost-effectiveness and cost-utility of a transdiagnostic cognitive-behavioral group therapy versus treatment as usual with common mental health disorders in the primary care settings (cano-vindel et al., 2016). other specific challenges that derive from these two major issues listed above are now going to be summarized. in order to carry out a solid and professional mental health care project, we will not only need better trained professionals, but also a greater number of them and, consequently, more than 141 or 189 pir vacancies per year. similarly, devel‐ clinical psychology in spain 8 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://www.psychopen.eu/ oping child prevention and care requires a greater sub-specialization. the creation and regulation of a child and adolescent clinical psychology specialty is being considered at this moment (source: ministry of health). it will enable clinicians to offer more effective care to children and adolescents. likewise, there is increasing interest in strengthening training in specific areas such as neuropsychology. nevertheless, there is still a lot of re‐ luctance in certain healthcare contexts of the nhs regarding the development and con‐ solidation of clinical psychology, particularly in management or leadership positions. at this point, it should be outlined that the psychiatric reform was an incomplete process due to a counter-reform led by some psychiatrists that gave way, at times to authoritari‐ an, pharmaco-centric biomedical approaches. under these limitations, our attachment to psychiatry services does not make sense anymore. there is now an increasing demand amongst clinical psychologists to create clinical psychology services. it would allow clini‐ cal psychologists to improve service delivery, management and clinical programs based on evidence-based practices without the limitations of a biomedical model that now con‐ trols care policies in mental health in spain, limiting access to proper psychological treat‐ ment. funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: jpa, ssr and agp are members of the board of directors of the spanish national association of clinical psychologists and intern resident psychologists (asociación nacional de psicólogos clínicos y residentes, anpir). acknowledgments: the authors have no support to report. r e f e r e n c e s anpir. 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(1999). deinstitutionalization and psychiatric reform in spain. european archives of psychiatry and clinical neuroscience, 249, 128-135. https://doi.org/10.1007/s004060050077 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. clinical psychology in spain 12 clinical psychology in europe 2019, vol.1(4), article e38158 https://doi.org/10.32872/cpe.v1i4.38158 https://doi.org/10.1002/jclp.22712 https://doi.org/10.1027/1016-9040.13.1.53 https://doi.org/10.1007/s004060050077 https://www.psychopen.eu/ clinical psychology in spain (introduction) a brief history of clinical psychology in spain pir test access, pir training system and psychologist specialized in clinical psychology conclusions and future challenges (additional information) funding competing interests acknowledgments references the (neuro)-science behind resilience: a focus on stress and reward editorial the (neuro)-science behind resilience: a focus on stress and reward chantal martin-soelch 1 [1] ireach lab, unit of clinical and health psychology, department of psychology, university fribourg, fribourg, switzerland. clinical psychology in europe, 2023, vol. 5(1), article e11567, https://doi.org/10.32872/cpe.11567 published (vor): 2023-03-31 corresponding author: chantal martin-soelch, university of fribourg, department of psychology, rue p-a faucigny 2, ch-1700 fribourg. tel: +41 26 300 76 87. e-mail: chantal.martinsoelch@unifr.ch mental disorders represent one of the major causes of disability worldwide, with depres­ sive disorders being the leading causes of burden among mental disorders in all age categories above 14 years old, followed by anxiety disorders (gbd 2019 mental disorders collaborators, 2022). although knowledge concerning their etiology has improved, it is still unclear why one person will develop a mental disorder while another will not when facing adversities. in this context, the identification of resilience mechanisms is crucial. adopting an approach based on mechanisms allows us to have a transdiagnostic and transtheoretical approach and to target specific processes for the development of psychological interventions. indeed, better knowledge of resilience mechanisms allows the development of tar­ geted interventions in at-risk populations. some risk factors for the development of mental disorders have been well identified, such as childhood abuse or in general early adverse childhood experiences (els) (kessler et al., 2010; mandelli et al., 2015). els have received increased attention from research, which led recently to the development of a consortium in the framework of the global traumatic stress collaboration dedicated to the investigation of socio-emotional consequences of els (pfaltz et al., 2022). a further well-investigated risk factor is being the offspring of one or more parents suffering a mental health condition, particularly depression, bipolar disorder or schizophrenia (rasic et al., 2014). resilience can be defined as the capacity of an individual to adapt successfully to highly adverse events and keep a healthy functioning by harnessing resources (southwick et al., 2014). it is most often measured by questionnaires, although these may be limited by issues of internal validity in particular because little is known about the this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.11567&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0003-3859-9023 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ different elements that make up resilience. these questionnaires therefore often focus on one or a set of measures related to well-known protective factors or resources, such as feelings of self-efficacy, self-esteem, sense of mastery, optimism, positive affect, good emotion regulation skills or sense of coherence (southwick et al., 2014). neuroscience has provided new insights in this area and indicates that neurocognitive and neuroaffective factors, such as cognitive flexibility or reactivity to stress or reward may play a role in resilience. these two processesreward and stressare linked to well-defined brain systems that are considered to be crucial for human motivation and adaptation (godoy et al., 2018; schultz, 2000). blunted neural responses to reward have been consistently observed in depressive disorders, and have been hypothesized to underly the symptoms of anhedonia, apathy and loss of interest observed in these conditions (pizzagalli et al., 2009). and a large body of empirical evidence shows the importance of stress in the development of several psychopathological conditions, among others depression (liu & alloy, 2010). recently, it has been postulated that not only the responses to reward or the effect of stress, but rather an interaction between both is involved in the etiology of men­ tal disorders. thus, a high reactivity of the brain to stress and a reduced brain reactivity to reward, also conceptualized as an imbalance between the neural responses to stress and to reward, has been hypothesized to be a vulnerability factor for the development of mental disorders, in particular depressive disorders (admon et al., 2013). this model has been completed with research works showing that not only the neural responses during the presentation of stressful stimuli or rewarding information is important, but also the neural recovery after these events, in particular longer recovery after stress and shorter recovery after reward, might play a role. this has been conceptualized as emotional inertia and brought in relationship with difficulties in emotion regulation (koval et al., 2015). our laboratory, the ireach lab at the department of psychology of the university of fribourg (switzerland), has been particularly interested in the stress-reward interac­ tions and their role in understanding the development of disorders in a transdiagnostic approach based on clinical neuroscience research results. preliminary studies from our group suggest that in children of parents suffering from depression, reactions to rewards are impacted differently than in a control group under acute stress conditions (gaillard et al., 2020; martin-soelch et al., 2020). these results are interesting because our partici­ pants had no clinical symptoms, but they showed different neural activation to reward stimuli and to the effect of stress on their processing. this may suggest a form of latent vulnerability that is not observable at the behavioral level. these results are in line with differences observed in response to rewarding information (without stress) in offspring of depressed parents (mccabe et al., 2012). understanding and integrating the interactions between the reward and stress sys­ tems in a model (see figure 1) can serve as basis for developing and testing psychological prevention and/or treatment interventions that target these mechanisms. on this basis, the (neuro)-science behind resilience: a focus on stress and reward 2 clinical psychology in europe 2023, vol. 5(1), article e11567 https://doi.org/10.32872/cpe.11567 https://www.psychopen.eu/ we developed for instance a multi-modal stress management program that has shown effects in activating resources in general and increasing the feeling of reward in daily life in particular (recabarren et al., 2019). other therapeutic programs have also shown significant effects on reward processing. for instance, a study by dichter et al. (dichter et al., 2009) suggests that behavioral activation restores the brain's reactivity to reward in association with improvement of depressive symptoms in individuals diagnosed with major depressive disorder. furthermore, a recently developed and validated intervention, the mindfulness-oriented recovery enhancement (more) program, which was original­ ly developed for the management of substance use and addiction problems, in particular opioid use in connection with chronic pain management (garland et al., 2022), also seems to show beneficial effects on the brain's responses to reward and to increase positive affect and emotion regulation (garland et al., 2017). this group intervention program combines cognitive-behavioral techniques, mindfulness and meditation methods with savoring training. this 8-weeks training has shown significant beneficial effects on opioid use and improvement in chronic pain symptoms in large clinical trials in the usa (garland et al., 2022). a current study of our group is interested in investigating whether this program can improve pain symptoms as well as affective symptoms of women suffering from fibromyalgia at a clinical level and to investigate as well the neural responses to reward changes and in the functioning of dopamine, a neurotransmitter that has been linked to reward, before and after the intervention (ledermann et al., 2021). figure 1 simplified schematic model of the stress-reward interaction as mediator of the relationship between stress exposure and the development of psychopathological symptoms psychopathological symptomsexposure to stress stress reactivity reward reactivity note. a higher neural reactivity to stress and a lower reactivity to reward are hypothesized to be a vulnerability factor for psychopathology. interventions targeting one or both mechanisms can be used in a preventive manner or as treatment. martin-soelch 3 clinical psychology in europe 2023, vol. 5(1), article e11567 https://doi.org/10.32872/cpe.11567 https://www.psychopen.eu/ what does this mean for psychologists? integrating results and approaches from other disciplines such as neuroscience to understand and identify neural mechanisms that are important for the development of disorders and that are directly associated with psychological mechanisms allows the development of targeted psychological interventions that can be used preventively in groups of individuals at risk of developing psychological disorders, for example in offspring of depressed parents. these interventions can also be used in addition to or in complement to usual psychotherapeutic treatment for individuals currently diagnosed with a mental disorder in order to offer targeted treatment. these mechanism-based interventions enrich the clinical psychologist's range of interventions and allows for a transdiagnostic approach. finally, as their neural correlates are known, it is possible to perform neuroimaging measures of these mechanisms before and after the intervention in randomized controlled trials to show the effect of the psychological interventions not only at a clinical level, but also at a neural level. this approach is therefore a promising avenue for the development of new clinical psychological interventions either for the prevention or the treatment of mental disorders. funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. twitter accounts: @psychologiecli1 r e f e r e n c e s admon, r., lubin, g., rosenblatt, j. d., stern, o., kahn, i., assaf, m., & hendler, t. 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(2014). resilience definitions, theory, and challenges: interdisciplinary perspectives. european journal of psychotraumatology, 5(1), article 25338. https://doi.org/10.3402/ejpt.v5.25338 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. the (neuro)-science behind resilience: a focus on stress and reward 6 clinical psychology in europe 2023, vol. 5(1), article e11567 https://doi.org/10.32872/cpe.11567 https://doi.org/10.3389/fpsyt.2020.563475 https://doi.org/10.1016/j.biopsych.2012.04.034 https://doi.org/10.1159/000523667 https://doi.org/10.1176/appi.ajp.2008.08081201 https://doi.org/10.1093/schbul/sbt114 https://doi.org/10.3389/fpsyt.2019.00088 https://doi.org/10.1038/35044563 https://doi.org/10.3402/ejpt.v5.25338 https://www.psychopen.eu/ prospective mental imagery in depression: impact on reward processing and reward-motivated behaviour scientific update and overview prospective mental imagery in depression: impact on reward processing and reward-motivated behaviour fritz renner 1 , jessica werthmann 1, andreas paetsch 1, hannah e. bär 1, max heise 1, sanne j. e. bruijniks 1 [1] clinical psychology and psychotherapy unit, institute of psychology, university of freiburg, freiburg, germany. clinical psychology in europe, 2021, vol. 3(2), article e3013, https://doi.org/10.32872/cpe.3013 received: 2020-03-30 • accepted: 2021-02-08 • published (vor): 2021-06-18 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: fritz renner, clinical psychology and psychotherapy unit, institute of psychology, university of freiburg, engelbergerstr. 41, 79106 freiburg, germany. e-mail: fritz.renner@psychologie.uni-freiburg.de abstract background: mental imagery has long been part of cognitive behavioural therapies. more recently, a resurgence of interest has emerged for prospective mental imagery, i.e. future-directed imagery-based thought, and its relation to reward processing, motivation and behaviour in the context of depression. method: we conducted a selective review on the role of prospective mental imagery and its impact on reward processing and reward-motivated behaviour in depression. results: based on the current literature, we propose a conceptual mechanistic model of prospective mental imagery. prospective mental imagery of engaging in positive activities can increase reward anticipation and reward motivation, which can transfer to increased engagement in reward-motivated behaviour and more experiences of reward, thereby decreasing depressive symptoms. we suggest directions for future research using multimodal assessments to measure the impact of prospective mental imagery from its basic functioning in the lab to real-world and clinical implementation. conclusion: prospective mental imagery has the potential to improve treatment for depression where the aim is to increase reward-motivated behaviours. future research should investigate how exactly and for whom prospective mental imagery works. keywords prospective mental imagery, depression, reward processing, motivation, behavioural activation this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3013&domain=pdf&date_stamp=2021-06-18 https://orcid.org/0000-0002-1692-449x https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • this review provides a selected update of the literature on prospective mental imagery. • prospective mental imagery might decrease depression via reward processing and reward-motivated behaviours. • suggestions for future research to investigate these hypotheses are provided. according to beck’s cognitive model, individuals with depression hold negative views about the self, others and the future (beck, rush, shaw, & emery, 1979). in addition to the negatively biased content of future thinking in depression, the importance of thought modality, particularly mental representations, has increasingly been recognized as a key target in psychotherapy (arntz, 2020). thinking about events or activities in the future might draw on imagery-based thought, involving a rich perceptual experience in the absence of external sensory input (pearson, naselaris, holmes, & kosslyn, 2015). prospective mental imagery, i.e. future-directed imagery-based thought, has recently gained interest in the context of depression. in this review, we provide a selected update of the recent scientific literature on prospective mental imagery and its impact on reward processing (i.e., anticipation or experience of reward) and reward-motivated behaviour (i.e., behaviour driven by the motivation to attain rewards) in depression. drawing from the wider research in this area, we present a conceptual model linking prospective mental imagery to reward processing and reward-motivated behaviour and discuss future directions for research. for a broader discussion of the nature, function and clinical applications of mental imagery in depression and other mental disorders see e.g. blackwell, 2019; holmes, blackwell, burnett heyes, renner, and raes, 2016; ji, kavanagh, holmes, macleod, and di simplicio, 2019; renner and holmes, 2018. i d e n t i f y i n g c o r e c l i n i c a l f e a t u r e s i n d e p r e s s i o n : r e w a r d p r o c e s s i n g major depressive disorder (mdd) is characterized by low mood and/or the loss of interest in previously rewarding or enjoyable activities as well as a number of other emotional, cognitive and physical symptoms (american psychiatric association, 2013). mdd is a heterogeneous disorder, meaning that two individuals with a diagnosis of mdd may have little or no symptoms in common (strunk & sasso, 2017). this presents a major challenge for research and treatment development in depression (fried, 2015, 2017; olbert, gala, & tupler, 2014). accordingly, recent initiatives have called to focus research on core clinical features rather than psychiatric syndromes in depression and other mental disorders (insel et al., 2010). alterations in reward processing are common in psychopathology (zald & treadway, 2017) and therefore one potential treatment target in this context. in depression, alterations in reward processing might manifest in a reduced prospective mental imagery in depression 2 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ sensitivity to reward, resulting in decreased approach motivation (alloy et al., 2016). def­ icits in reward processing represent a central aspect of anhedonia, defined as “diminished interest or pleasure in almost all activities” (american psychiatric association, 2013). diminished interest and diminished experienced pleasure correspond to two distinct components of reward processing: reward anticipation and reward consummation (gard, germans gard, kring, & john, 2006; treadway & zald, 2011). reward anticipation can be further divided into anticipated reward, i.e. the expectation of how rewarding/pleasant a future activity will be, and anticipatory reward, i.e. the subjective experience of how rewarding/pleasant it is to think about a future activity (baumgartner, pieters, & bagozzi, 2008). reward consummation, on the other hand, refers to rewarding/pleasant feelings experienced while engaging in enjoyable activities (gard, germans gard, kring, & john, 2006). while both components are important, research has suggested that deficits in reward-motivated behaviour are primarily driven by reduced or dysfunctional reward anticipation (bakker et al., 2017; gorka et al., 2014). given that these deficits in reward processing are not adequately addressed by current treatments of depression (treadway & zald, 2011), one way forward in treatment innovation is to develop procedures directly targeting reward anticipation and reward-motivated behaviours. t a r g e t i n g r e w a r d a n t i c i p a t i o n , r e w a r d m o t i v a t i o n a n d r e w a r d m o t i v a t e d b e h a v i o u r s u s i n g p r o s p e c t i v e m e n t a l i m a g e r y by drawing on shared brain structures and functions (dijkstra, bosch, & van gerven, 2019; kosslyn, ganis, & thompson, 2001; pearson et al., 2015), vivid mental imagery can give rise to an “as real” experience and evoke emotional responses at subjective, physio­ logical and neural levels (ji, burnett heyes, macleod, & holmes, 2016). these properties of prospective mental imagery allow us to simulate engagement in behavioural activities and to “pre-experience” future activities, thereby providing “a taste” of different courses of action and their potential (emotional) consequences (moulton & kosslyn, 2009). this makes prospective mental imagery an excellent candidate procedure to target reward anticipation and reward-motivated behaviours. recently, a number of studies have emerged that tested the impact of prospective mental imagery of positive events or activities on reward anticipation and reward-mo­ tivated behaviour. these studies have the common aim of investigating new ways of promoting positive experiences, in line with recent calls for treatment innovation in depression to focus on positive affect systems (dunn, 2012; dunn et al., 2019). studies presented here also fit within the broader literature that highlights the role of expectan­ cies in mental disorders (rief & glombiewski, 2017; rief et al., 2015). in depression, an absence of positive expectancies might manifest as low anticipated reward/pleasure from engaging in otherwise enjoyable activities. renner, werthmann, paetsch et al. 3 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ several studies have investigated the impact of mental imagery on reward antici­ pation. in a case-series, hallford, sharma, and austin (2020) asked participants with depression to rate anticipatory pleasure of future events over a no-treatment baseline phase. participants then switched to an intervention phase in which they completed an episodic future thinking task involving vivid imagery of engaging in enjoyable upcom­ ing activities, focussing on contextual and episodic detail of these events. the authors found large effects of the intervention on anticipatory pleasure. in two experimental studies, hallford, farrell, and lynch (2020) further tested the impact of guided episodic thinking about past or future positive events on anticipated and anticipatory pleasure in a non-clinical sample. participants were instructed to imagine past or future events from a first-person perspective emphasising positive aspects of the events. in general, the authors found support for their hypothesis that guided episodic thinking of positive events (pastand future-oriented) increases anticipated and anticipatory pleasure (com­ pared to baseline ratings). in an earlier study, pictet et al. (2016) tested the effect of an imagery cognitive bias modification (cbm) procedure on depression, anhedonia and anticipatory and consummatory pleasure in individuals with depressive symptoms. they found positive effects of the cbm intervention involving imagery of positive everyday experiences (compared to a closely matched control condition) on anhedonia and antic­ ipatory pleasure as well as a stronger increase in consummatory pleasure (compared to a waitlist control condition). this is in line with earlier findings by blackwell et al. (2015), who found positive effects of an imagery cbm intervention (compared to an active control condition) on the anhedonia item of the beck depression inventory. these studies suggest that imagery-based interventions might have merit in targeting reward-related processes in depression. other studies have focussed on the effects of mental imagery on approach motiva­ tion. for example, linke and wessa (2017) tested the effects of an online mental imagery training, compared to a waitlist control condition, on reward sensitivity and approach tendencies towards positive activities and edibles. during the imagery training, partici­ pants imagined the positive emotions, affirmative thoughts and pleasurable sensations associated with previously selected positive activities every second day over a two-week period. the authors found that the imagery training successfully increased reward sensi­ tivity and faster approach tendencies for activities (linke & wessa, 2017). another study tested the effects of a positive prospective imagery intervention for planned everyday enjoyable and routine activities in a non-clinical sample (renner, murphy, ji, manly, & holmes, 2019). participants first selected and planned activities following the procedures described in behavioural activation treatment for depression (martell, addis, & jacobson, 2001). participants in a motivational imagery condition then vividly imagined engaging in each of their planned activities. participants in a no-imagery control condition plan­ ned the activities, but did not engage in the imagery exercise. the prospective imagery intervention increased anticipated pleasure/reward and motivation to engage in the prospective mental imagery in depression 4 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ activities, compared to the control condition. in two independent experiments, boland, riggs, and anderson (2018) asked non-depressed and dysphoric participants to simulate positive events using vivid mental imagery. they found that event likelihood (i.e., how likely participants thought the event would happen to them in the future) for positive events increased following imagery simulation of the events compared to a neutral imagery control task. taken together, these studies demonstrate that engaging in positive prospective mental imagery of everyday activities has an impact on reward processing and transfers to approach motivation for engaging in the simulated activities. finally, a number of studies have investigated the transfer of the motivating effect of mental imagery interventions to self-reported activity levels outside the lab. one study conducted a secondary analysis of a randomized controlled trial (blackwell et al., 2015) to test the effects of a four-week positive mental imagery intervention on self-reported behavioural activation in individuals with major depressive disorder (renner, ji, pictet, holmes, & blackwell, 2017). participants randomized to the positive imagery condition showed a greater increase in self-reported behavioural activation over the study period, compared to participants randomized to a control condition (renner et al., 2017). in line with these findings, renner et al. (2019; reviewed above) found that positive men­ tal imagery simulations of planned activities was associated with higher completion of activities that participants had previously been putting-off doing. considering all types of activities, mental imagery led to a higher completion compared to a control group receiving activity reminder messages but not to a control group without reminder messages. thus, while these preliminary findings need replication, they provide initial evidence that the positive effects of prospective mental imagery on approach motivation for rewarding activities might transfer to reward-motivated behaviour outside the labo­ ratory. the studies reviewed here suggest that positive prospective mental imagery of activ­ ities can facilitate reward anticipation, reward motivation and reward-motivated behav­ iour. this is clinically relevant given that reward anticipation deficits are not adequately addressed in current treatments of depression (treadway & zald, 2011). drawing from this broader literature, in the following paragraph, we provide a conceptual model de­ scribing how prospective mental imagery could promote the engagement in reward-mo­ tivated behaviour and its clinical potential to impact mood and depressive symptoms. m e n t a l i m a g e r y a s m o t i v a t i o n a l a m p l i f i e r : a c o n c e p t u a l m o d e l figure 1 provides a conceptual model illustrating the expected effects of prospective mental imagery on reward-motivated behaviour: positive prospective mental imagery of activities gives rise to a motivational amplifier effect by facilitating reward anticipation, reward motivation and reward-motivated behaviour. given the power of mental imagery renner, werthmann, paetsch et al. 5 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ to amplify emotions (holmes, geddes, colom, & goodwin, 2008), it has the potential to evoke the anticipation of reward-related emotions by drawing upon prior knowledge and experiences (kavanagh et al., 2005; moulton & kosslyn, 2009; schacter et al., 2008). anticipating the positive emotional consequences of future behaviour, in turn, predicts reward motivation and reward-motivated behaviour (hallford & sharma, 2019; mellers & mcgraw, 2001; sherdell, waugh, & gotlib, 2012; treadway & zald, 2011). this transfer from imagery to behaviour might be further facilitated by a boost in prospective memory for the simulated activity (schacter, benoit, & szpunar, 2017). actual engagement in simulated activities might then lead to a reward experience. the episodic memory of this experience, in turn, affects subsequent imagery simulations of similar future activities (figure 1, see table 1 for key term definitions). figure 1 conceptual model of the motivational amplifier hypothesis note. positive prospective mental imagery of engaging in (everyday) activities (e.g. running) can increase reward anticipation (anticipatory and anticipated reward) and reward motivation, which can transfer to increased engagement in reward-motivated behaviour and reward experience. note that concepts in bold boxes are part of the literature review above. prospective mental imagery in depression 6 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ table 1 definition of key terms used in the conceptual model concept definition prospective mental imagery future-directed imagery-based thought, involving a rich perceptual experience without external sensory input reward processing reward anticipation anticipated reward expectation of how rewarding/pleasant a future activity will be anticipatory reward subjective experience of how rewarding/pleasant it is to think about a future activity reward experience pleasant/rewarding feelings experienced while engaging in the activity reward motivation amount of effort an individual is prepared to expend for reward attainment reward-motivated behaviour behaviour driven by the motivation to attain rewards prospective memory remembering to carry out a planned activity in the future episodic memory memory of personal experiences the conceptual model has clinical potential insofar as it illustrates how positive prospec­ tive mental imagery could be used to promote behavioural activation in depression. the central assumption here is that reduced reward anticipation in depression contributes to a downward-spiral of reduced reward-motivated behaviours due to a loss of interest in previously rewarding activities that reduces the experience of rewards in daily life and, consequently, worsens depressive symptoms such as low mood (figure 2). based on our conceptual model, we hypothesise that positive prospective mental imagery of everyday activities can reverse this process by acting as a motivational amplifier boosting behavioural activation and thereby alleviating depressive symptoms (figure 2). renner, werthmann, paetsch et al. 7 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ figure 2 reversing the downward spiral of depression with prospective mental imagery note. key assumption: reduced reward anticipation leads to a downward spiral of reduced reward-motivated behaviour and less reward experiences, resulting in increased depressive symptoms (left side). key hypothesis: targeting reward anticipation using vivid prospective mental imagery leads to increased reward-motivated behaviour and more reward experiences, resulting in a decrease of depressive symptoms (right side). in summary, the recent literature reviewed above supports the idea that positive prospec­ tive mental imagery of activities can facilitate reward anticipation, reward motivation and reward-motivated behaviour. however, the reviewed studies primarily relied on self-report and more work is needed to investigate how the transfer of imagery to behaviour beyond the laboratory can be facilitated and how prospective mental imagery might benefit clinical practice. f u t u r e d i r e c t i o n s recent literature has emphasised the importance of conducting multimodal research to understand and thereby improve clinical interventions (holmes, craske, & graybiel, 2014). a future endeavour might thus be to extend previous research on the mechanism underlying prospective mental imagery beyond self-report. neuroimaging, for instance, has provided initial evidence for a recruitment of brain regions implicated in reward pro­ cessing, such as the dorsal (caudate nucleus) and ventral striatum (nucleus accumbens), prospective mental imagery in depression 8 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ during prospective mental imagery of positive events (d’argembeau, xue, lu, van der linden, & bechara, 2008; gerlach, spreng, madore, & schacter, 2014). other measures that have been used to evaluate imagery-based manipulations and reward processing include pupil size, attention bias and approach/avoidance tendencies (anderson, laurent, & yantis, 2011; henderson, bradley, & lang, 2018; linke & wessa, 2017; schneider, leuchs, czisch, sämann, & spoormaker, 2018; werthmann, jansen, & roefs, 2016). sim­ ilar approaches could prove useful to further investigate reward processing as a work­ ing mechanism of prospective mental imagery for behavioural activation. ultimately, investigations beyond self-report will help us fine-tune imagery-based interventions and thereby guide treatment innovation for depression. another important question in experimental psychopathology research is how lab­ based findings hold up under everyday circumstances. recent research in the broader field of clinical psychology demonstrated the added value of combining laboratory ex­ periments with ecological momentary assessment (ema; e.g. bakker et al., 2019; moran, culbreth, & barch, 2017; ramirez & miranda, 2014) and of integrating experimental manipulations into daily life (huffziger et al., 2013; huffziger, ebner-priemer, koudela, reinhard, & kuehner, 2012). for example, bakker and colleagues (2019) showed that when neural activity in reward processing regions was lower, assessed in the lab, ema of reward anticipation and activity pleasantness were increasingly dissociated from one another. findings like these can be valuable to refine or develop interventions by identi­ fying treatment targets (e.g. coupling of anticipation and engagement) under well-speci­ fied circumstances (e.g. low neural activity in reward-processing brain regions). these findings are also relevant in the context of earlier findings regarding challenges with the transfer of experimental prospective mental imagery interventions from lab to the real world (renner et al., 2019). integration of ema with lab-based experiments as well as the use of ecological momentary interventions (emi; myin-germeys, klippel, steinhart, & reininghaus, 2016) or manipulations of reward processing through prospective mental imagery in daily life may offer an additional means to facilitate the transfer from lab to real-world behaviour. moreover, individuals may differ in the extent to which they benefit from prospec­ tive mental imagery interventions. studies already pointed to individual variation in processes related to prospective mental imagery, such as anticipatory pleasure (hallford, sharma, & austin, 2020) and the perception of reward (locke & braver, 2008), and sug­ gested promising potential predictors or moderators that should be investigated in future studies. potential moderators include individual differences in generating vivid mental imagery (blackwell et al., 2015; renner et al., 2017, 2019), procrastination (renner et al., 2019) and the number of depressive episodes (blackwell et al., 2015). additionally, when moving towards clinical applications, the question of how individual differences interact with the active ingredients of prospective imagery interventions becomes relevant. for example, initial evidence highlights the importance of simulating rewarding aspects of renner, werthmann, paetsch et al. 9 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ planned activities in non-clinical participants, but it has not yet been investigated if individuals who have difficulties experiencing pleasure/reward from (thinking about) activities (i.e., individuals with anhedonia) benefit from simulating rewarding aspects of planned activities. relatedly, prospective mental imagery interventions developed in the lab might need to be adjusted for clinical groups. for example, individuals with low mood and depression experience more difficulty in generating vivid prospective imagery and experience less spontaneous positive imagery (hallford, barry, et al., 2020; holmes et al., 2016; ji, holmes, macleod, & murphy, 2019; morina, deeprose, pusowski, schmid, & holmes, 2011). individuals with depression might thus benefit from additional training in generating vivid imagery for positive events. imagery based interventions have been used as stand-alone interventions as well as part of regular cbt for depression (renner & holmes, 2018). so far, we have mainly discussed the use of prospective mental imagery to target specific core clinical features in depression. another line of inquiry involves integrating prospective imagery procedures to enhance the effects of established treatments for depression. recent studies have suggested that cbt might be improved by the use of cognitive support strategies that enhance memory for the session content, and subsequently outcome (harvey et al., 2017, 2014). we suggest that prospective mental imagery could potentially work as a cognitive support strategy for cbt skill acquisition. cbt skills have been defined as the ability to re-evaluate the accuracy of one's own automatic beliefs or underlying stable cognitive patterns (a cognitive therapy skill; ct skill) and to engage proactively in pleasurable activities (a behavioral therapy skill; bt skill) (strunk, derubeis, chiu, & alvarez, 2007). in non-clinical settings, mental imagery has been linked to improved skill acquisition in health-related and sport contexts (anton, bean, hammonds, & stefanidis, 2017; dana & gozalzadeh, 2017). in a clinical setting, mental imagery has been indirectly linked to bt skill by demonstrating an impact on self-reported behavioural activation (renner et al., 2017; reviewed above). future studies should investigate how and for whom prospective mental imagery may increase the acquisition of cbt skills. further down the road, for a successful clinical implementation, training sessions in prospective mental imagery could be included as part of a regular behavioural activation treatment protocol (martell et al., 2001) to facilitate engagement in pleasant and rewarding activities. o v e r a l l c o n c l u s i o n in this review, we provided a selected update of the recent scientific literature on pro­ spective mental imagery and its impact on reward processing and reward-motivated behaviour in depression. overall, the studies presented here suggest that prospective mental imagery simulations of activities can increase reward processing related to these activities as well as reward motivation and reward-motivated behaviors. thus, these initial studies suggest that prospective mental imagery is a promising experimental prospective mental imagery in depression 10 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://www.psychopen.eu/ intervention in the context of depression, where the aim is to increase engagement in potentially rewarding activities. future directions for research in this area may focus on multimodal assessments of prospective mental imagery effects to gain a better under­ standing of the processes involved, from basic mechanisms to everyday situations and its clinical applications. funding: all authors are supported by a sofja kovalevskaja award from the alexander von humboldt foundation and the german federal ministry for education and research awarded to fr. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @fritz_renner, @andreaspaetsch r e f e r e n c e s alloy, l. b., olino, t., freed, r. d., & nusslock, r. 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(2011). reconsidering anhedonia in depression: lessons from translational neuroscience. neuroscience and biobehavioral reviews, 35(3), 537-555. https://doi.org/10.1016/j.neubiorev.2010.06.006 werthmann, j., jansen, a., & roefs, a. (2016). make up your mind about food: a healthy mindset attenuates attention for high-calorie food in restrained eaters. appetite, 105, 53-59. https://doi.org/10.1016/j.appet.2016.05.005 zald, d. h., & treadway, m. t. (2017). reward processing, neuroeconomics, and psychopathology. annual review of clinical psychology, 13(1), 471-495. https://doi.org/10.1146/annurev-clinpsy-032816-044957 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. prospective mental imagery in depression 16 clinical psychology in europe 2021, vol. 3(2), article e3013 https://doi.org/10.32872/cpe.3013 https://doi.org/10.1016/j.neuroimage.2018.04.078 https://doi.org/10.1037/a0024945 https://doi.org/10.1037/0022-006x.75.4.523 https://doi.org/10.1016/j.neubiorev.2010.06.006 https://doi.org/10.1016/j.appet.2016.05.005 https://doi.org/10.1146/annurev-clinpsy-032816-044957 https://www.psychopen.eu/ prospective mental imagery in depression (introduction) identifying core clinical features in depression: reward processing targeting reward anticipation, reward motivation and reward-motivated behaviours using prospective mental imagery mental imagery as motivational amplifier: a conceptual model future directions overall conclusion (additional information) funding acknowledgments competing interests twitter accounts references the paths to children’s disordered eating: the implications of bmi, weight-related victimization, body dissatisfaction and parents’ disordered eating research articles the paths to children’s disordered eating: the implications of bmi, weight-related victimization, body dissatisfaction and parents’ disordered eating marilou côté a, maxime legendre a, annie aimé b, marie-christine brault c, jacinthe dion c, catherine bégin a [a] laval university, québec, canada. [b] université du québec en outaouais, st-jérôme, canada. [c] université du québec à chicoutimi, chicoutimi, canada. clinical psychology in europe, 2020, vol. 2(1), article e2689, https://doi.org/10.32872/cpe.v2i1.2689 received: 2019-07-25 • accepted: 2019-11-10 • published (vor): 2020-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: marilou côté, pavillon f-a.-savard, 2325, rue des bibliothèques, local 1116, laval university, quebec (qc), canada, g1v 0a6, phone: +1 418 656-2131. e-mail: marilou.cote.2@ulaval.ca abstract background: being the target of peer victimization is frequent among children categorized as overweight and obese and is thought to play a central role in disordered eating behavior development. in accordance with a previous theoretical model, this cross-sectional study aimed to replicate among children the mediating role of weight-related victimization from peers and body dissatisfaction in the association between body mass index (bmi) and children’s disordered eating attitudes and behaviors (cdeab), while also taking into account the contribution of parents’ disordered eating attitudes and behaviors (pdeab). methods: participants were 874 children aged between 8 and 12 years old who were recruited in elementary schools. height and weight were measured and used to calculate bmi. self-reported questionnaires were used to measure weight-related victimization, body dissatisfaction, cdeab and pdeab. results: for both girls and boys, a path analysis showed no direct effect of bmi on cdeab, but a significant indirect effect was found, indicating that weight-related victimization and body dissatisfaction mediated this relationship. in addition, the indirect effect of weight-related victimization and body dissatisfaction remained significant even when controlling for pdeab. conclusion: while weight itself appears to be insufficient to explain cdeab, weight-related victimization may lead children to see their weight as problematic and develop disordered attitudes and behaviors toward eating. this suggests that weight-related victimization from peers and body dissatisfaction must be taken seriously and that preventive and intervention efforts must be pursued. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2689&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords weight-related victimization, disordered eating behaviors, body dissatisfaction, body mass index, children, cross-sectional study highlights • body weight per se seems insufficient to explain children’s disordered eating attitudes and behaviors (cdeab). • weight-related victimization and body dissatisfaction mediate the association between bmi and cdeab. • parents‘ deab is associated with cdeab. • the tested paths from bmi to cdeab appear to be globally the same for boys and girls. despite decades of efforts to prevent overweight and obesity, its prevalence is on the rise among children in developed and in developing countries (ng et al., 2014). children cate‐ gorized as overweight or obese are at an elevated risk for disordered eating (tanofskykraff et al., 2004). some public health programs designed to prevent overweight actually use weight stigmatization as a tool to sensitize people to the consequences of obesity (e.g., georgia’s strong4life campaign; teegardin, 2012). however, these programs may be counterproductive and instead increase weight-related victimization. in return, experi‐ encing weight-related victimization may contribute to disordered eating among youth who present with overweight or obesity (libbey, story, neumark-sztainer, & boutelle, 2008). although there is existing literature linking weight-related victimization and eating behaviors, no research has examined this association while taking into account parents’ disordered eating, which has been extendedly related to children’s disordered eating (scaglioni, salvioni, & galimberti, 2008). the current study mostly replicates pre‐ vious work by assessing the mediating roles of weight-related victimization from peers and body dissatisfaction in the association between body mass index (bmi) and children’s disordered eating, and extends past reports by controlling for parents’ disordered eating. weight-related victimization includes cognitive and behavioral aspects. the cognitive aspect covers bias and stereotyping based on one’s weight. this leads to the belief that individuals categorized as overweight are lazy, lack self-discipline, have poor willpower, and show defects of intelligence and character. the behavioral aspect of weight-related victimization can materialize in verbal, physical and relational victimization, such as teasing, bullying, pushing and social exclusion (puhl & latner, 2007). some studies demonstrated that children as young as 3 years old may be victimized because of their weight (cramer & steinwert, 1998; rodgers, wertheim, damiano, gregg, & paxton, 2015). therefore, weight-related victimization may start at a very young age. during the school years, weight-related victimization behaviors become frequent and mostly impact over‐ weight children (see puhl & heuer, 2009; puhl & latner, 2007 for a review). for instance, the paths to children’s disordered eating 2 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ many studies have shown that children and adolescents categorized as overweight are at a greater risk of being teased about their weight by school peers, educators, family members and peers of family members compared to their counterparts categorized as normal weight (brixval, rayce, rasmussen, holstein, & due, 2012; hayden-wade et al., 2005; neumark-sztainer et al., 2002). among all weight-related victimization behaviors, teasing has been largely studied, most likely because it is common among youth (hayden-wade et al., 2005). weight-rela‐ ted teasing is associated with various negative psychosocial consequences in children and adolescents, such as loneliness and preference for sedentary-isolative activities, social anxiety, poor quality of life and depression (hayden-wade et al., 2005; juvonen, lessard, schacter, & suchilt, 2017; stevens, herbozo, morrell, schaefer, & thompson, 2017). weight-related teasing also seems to be the starting point for many negative consequences related to eating and weight problems in adolescents. for example, parents, siblings and peer teasing were linked to body dissatisfaction in girls and to drive for muscularity in boys (schaefer & blodgett salafia, 2014). furthermore, weight-related teasing has been linked to the drive for thinness and disordered eating behaviors such as binge-eating, compensatory behaviors, and dietary restraint (cook-cottone et al., 2016; haines, 2006; neumark-sztainer et al., 2002; zuba & warschburger, 2017). a recent longitudinal study noted that weight-related teasing in adolescence predicted resorting to disordered eating behaviors as a coping strategy, which in turn resulted in a higher body mass index (bmi) or into obesity 15 years later (puhl et al., 2017). recently, the effect of weight-related teasing on disordered eating behaviors was validated in a few prospective studies. most of these studies seemed to build their prospective design on a pioneering study by thompson, coovert, richards, and johnson (1995). thompson and colleagues (1995) proposed a path analysis with a sample of girls aged 13-18 years old. in their model, the level of obesity at the baseline influenced weight-related teasing at the baseline, which further influenced body image (weight and appearance dissatisfaction) at the 3-year follow-up. furthermore, body image at the 3-year follow-up influenced disordered eating behaviors such as bulimic behaviors and dietary restraint at the 3-year follow-up. jendrzyca and warschburger (2016) presented a similar comprehensive model of disordered eating behaviors in children. in their prospec‐ tive design, 1,486 children aged 6-11 years old in germany completed height and weight measurements (used for bmi calculation) and questionnaires related to eating, weight and body image (weight-related stigmatization, including weight-related teasing, body dissatisfaction and disordered eating behaviors) twice with a one-year interval. for girls, bmi at the baseline was significantly associated with the baseline weight-related stigma, which predicted body dissatisfaction one year later, which in turn predicted disordered eating behaviors, also at the one-year follow-up. for boys, a different pattern was found. bmi at the baseline was significantly associated with the baseline weight-related stigma, and body dissatisfaction at the one-year follow-up predicted disordered eating behaviors côté, legendre, aimé et al. 3 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ at the one-year follow-up, but baseline weight-related stigma did not predict body dissatisfaction at the one-year follow-up. using a similar model, pryor and colleagues (2016) found that children categorized as overweight and targeted by peers’ victimization between 6 and 12 years old tended to be less satisfied with their bodies (they wanted to be thinner) and to report increased depression and anxiety at 13 years old. thereby, some authors implied that weight-related victimization should be included in a comprehensive model of disordered eating behaviors development (jendrzyca & warschburger, 2016). however, most available studies have only targeted adolescent pop‐ ulations. furthermore, studies tend to report mixed results regarding possible sex specific effects, and parental influences are often overviewed. however, parents’ eating behaviors have a major influence on their children’s eating behaviors, especially at a younger age (scaglioni, et al., 2008; ventura & birch, 2008; wertheim, martin, prior, sanson, & smart, 2002; wertheim, mee, & paxton, 1999). therefore, to better assess (and not overestimate) the influence of weight-related victimization and body dissatisfaction in a comprehensive model of disordered eating behaviors in children categorized as overweight or obese, the influence of parents’ eating behaviors should be considered. the present study aimed to examine the mediating role of 1) weight-related victimiza‐ tion from peers, as perceived by children, and 2) body dissatisfaction in the association between bmi and children’s disordered eating attitudes and behaviors (cdeab) among 8-12 years old boys and girls, controlling for parents’ disordered eating attitudes and behaviors (pdeab). it was expected that a higher bmi would be associated with greater cdeab, mediated by perceived weight-related victimization and body dissatisfaction (serial) for both boys and girls. moreover, it was hypothesized that pdeab would be positively associated with cdeab. m e t h o d participants participants were 874 children aged between 8 and 12 years old and one of their parents. they were recruited from 27 public elementary schools located in two urban areas in the province of quebec, canada. the sample was composed of 44% boys and 56% girls. their mean age was 10.29 (sd = 1.19). among the sample, 1.5% of the children could be classified in the underweight category, 69.3% in the normal weight category, 20.9% in the overweight category and 8.3% in the obese category. regarding weight-based victimiza‐ tion, 24.4% of children reported having been teased about their weight at least once. the participating parents were mostly mothers (86%). their mean age was 39.65 years old (sd = 5.69), and their mean bmi was 26.23 (sd = 5.04). almost all of the children were born in canada (95%) and came from a family where their parents were either married or living in a common-law relationship (83%). on average, these children came from wealthy and the paths to children’s disordered eating 4 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ educated families. nearly a third had an annual family income of $100,000 or more, which was over the average wage (approximately $73,000) in the province of quebec (statistics canada, 2019). furthermore, almost the half of the children had a parent with a university diploma, while about 35% of the population of the province of quebec had achieved an academic degree (crespo, 2018). procedure the children were recruited to participate in a study about body weight, body image and eating and physical activity habits. the study was presented to them in class. interested children were given an envelope containing both parents and children questionnaires, as well as informed consent form. both the children and parents were asked to complete questionnaires at home (approximately 45 minutes for parents and 30 minutes for chil‐ dren). parents were instructed to let their children fill autonomously the questionnaires. children returned the completed questionnaires to their teacher, and were met individ‐ ually at school by a trained research assistant to collect their anthropometric (height and weight) measures. all of the parents gave written informed consent (approved by university’s institutional review board of laval university) prior to their inclusion in the study, and children provided their assent to participate. the children who completed the questionnaires were included in a lottery drawing to win a $100 gift card to a sports shop. measures children’s bmi height and weight were measured individually and out of sight of the children’s peers and only one time as recommended by lohman, roche, and martorell (1988), and trained research assistants used a metric scale and a numeric weighing scale. height was measured to the nearest 0.1 centimeter and weighed to the nearest 0.2 pound. measure‐ ments in pounds were then transformed into kilograms. gender specific bmi-for-age z scores were computed based on the world health organization recommendations (who multicentre growth reference study group, 2006). the children’s bmi was classified into four categories (underweight, normal weight, overweight, or obese) still according to the who recommendations. these categories were used to describe the sample and for the mean comparisons, and bmi z-scores were used as a continuous variable in the path analyses. perceived weight-related victimization by peers perceived weight-related victimization was measured with a question adapted from the children's social experience questionnaire (crick & grotpeter, 1996). the question “how often does another child say negative things about your weight?” was answered on a côté, legendre, aimé et al. 5 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ 5-point likert scale ranging from 1 (never) to 5 (all the time). a higher score indicated a higher level of perceived weight-related victimization by peers. body dissatisfaction body dissatisfaction was evaluated with two questions inspired by collins (1991). one evaluated actual body perception (how would you describe your body? with answers ranging from 1 “far too thin” to 5 “far too big”), while the other evaluated desired body (how would you like your body to be? with answers ranging from 1 “a lot thinner” to 5 “a lot bigger”). we further subtracted the desired body from the actual body perception. the discrepancy between the perceived and the desired body provided an indication of the level of body dissatisfaction, with a negative score reflecting a desire for a thinner body and a positive score reflecting a desire for a larger body. children’s eating attitudes test the children’s version of the eating attitudes test (cheat; maloney, mcguire, & daniels, 1988) was used to measure disordered eating attitudes and behaviors. the cheat is a 26-item self-report questionnaire, with a 6-point likert scale ranging from 1 (never) to 6 (always). the total score was used. a higher score reflects more disordered eating attitudes and behaviors. its reliability and concurrent validity have been demon‐ strated previously (maloney, mcguire, daniels, & specker, 1989; smolak & levine, 1994). the cronbach’s alpha was .79 in the present sample. eating attitudes test the eating attitudes test (eat-26; garner, olmstead, bohr, & garfinkel, 1982) was used to measure parents’ disordered eating attitudes and behaviors. the eat is a 26-item self-report questionnaire which uses a 6-point likert scale ranging from 1 (never) to 6 (always). the total score was used. a higher score reflects more disordered eating attitudes and behaviors. the questionnaire has adequate reliability (koslowsky et al., 1992). the cronbach’s alpha was .87 in the present study. statistical analyses prior to analyses, all variables’ distributions were inspected, and appropriate transforma‐ tions were applied when needed in order to respect the basic assumptions. first, t-test and anova analyses were run to compare the children on the three study dependent variables (weight victimization, body dissatisfaction and cdeab) based on their sex and bmi category. afterward, the proposed model was tested with a path analysis using mplus version 7.0 (muthén & muthén, 2012). path analysis is a statistical method that allows the simultaneous testing of both direct and indirect associations among different variables (kline, 2011). the paths to children’s disordered eating 6 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ in this model, bmi was used as an independent variable with both weight-related victimization and body dissatisfaction as mediators (serial mediation), and cdeab was used as the dependent variable. pdeab was included as a control variable. because standard errors underlying indirect effects (i.e., product terms) are known to be skewed, we instructed mplus to generate 1000 bootstrap samples from the data to create indirect effects with bias-corrected 95% confidence intervals (cis; mackinnon, lockwood, & williams, 2004). indirect effects would only be found to be significant if the cis would not include zero. to determine whether the model provided a good fit for the data, three indices recommended by hu and bentler (1999) were used: the comparative fit index (cfi), the standardized root mean square residual (srmr), and the root mean square error of approximation (rmsea). the determined threshold values indicating a good fit are cfi ≥ .95, srmr ≤ .08, and rmsea ≤ .06 (hu & bentler, 1999). a good fit of the model can also be identified by a nonsignificant χ2 value (tabachnick & fidell, 2001). r e s u l t s mean comparisons the results from t-tests and anovas, as well as means and standard deviations, are presented in table 1. weight-related victimization was similar for boys and girls but significantly differed across weight statuses. children categorized as obese reported more frequent weight-related victimization compared to children categorized as underweight, normal weight and overweight (all p values < .001). children categorized as overweight also reported more victimization than peers categorized as normal weight (p < .001). body dissatisfaction differed between boys and girls, as well as across weight statuses. as expected, girls were significantly more dissatisfied with their body than boys. children categorized as obese were more dissatisfied with their body than children categorized as underweight, normal weight and overweight (all p values < .01). children categorized as overweight were also more dissatisfied than children categorized as normal weight (p < .001). finally, for cdeab, girls reported significantly higher scores than boys. across weight statuses, children categorized as obese reported more disordered eating attitudes and behaviors than children categorized as overweight or normal weight (all p values < .01). côté, legendre, aimé et al. 7 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ table 1 means and standard deviations by sexes and by weight categories variable sex weight category t f girls boys under‐ weight normal over‐ weight obesity sex weight categorym sd m sd m sd m sd m sd m sd weight-related victimization 1.40 0.80 1.36 0.74 1.23 0.60 1.24 0.58 1.53 0.88 2.17 1.19 -0.72 39.50*** body dissatisfaction 0.62 0.95 0.49 0.84 0.75 1.29 0.36 0.74 0.80 0.94 1.64 1.05 -2.17* 59.04*** cdeab 6.44 5.56 5.55 3.98 5.62 4.31 5.52 4.19 6.49 5.50 9.40 7.59 -1.60* 10.20*** note. n = 874 children. cdeab = children’s disordered eating attitudes and behaviors. *p < .05. ***p < .001. path analyses pearson’s correlations between the variables studied are presented in table 2. the pro‐ posed theoretical model was first tested with path analyses separately for both boys and girls. the results showed very similar patterns among boys and girls. therefore, we expected the models to be invariant with regard to sex and we performed multigroup tests. the nonsignificant adjusted difference of the chi-square, χ2(5) = 6.579, p = .254, showed that the model was invariant by sex on all the tested paths except the bmi-body dissatisfaction one. that is, the tested paths were similar for boys and girls, but the path between bmi and body dissatisfaction was slightly different regarding the strength of the association, β = .33 (p < .0001) for girls and β = .18 (p = .003) for boys. since this minor sex difference did not affect the direction nor the signification of the association between bmi and body dissatisfaction, a single model will be presented for girls and boys for the sake of parsimony. table 2 pearson’s correlations between studied variables variable 1 2 3 4 5 1. cdeab – .09** .16** .22** .29** 2. pdeab – .08* .04 .05 3. bmi – .21** .32** 4. weight-related victimization – .31** 5. body dissatisfaction – note. n = 874 children. cdeab = children’s disordered eating attitudes and behaviors. pdeab = parents’ disordered eating attitudes and behaviors. *p < .05. **p < .01. the paths to children’s disordered eating 8 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ the fit indices revealed that the tested model provided a good fit to the data: cfi = .99, srmr = .02, rmsea = .03. the nonsignificant chi-square value also indicated that the data were adequately represented by the model, χ2(3) = 5.59, p = .133. the model with standardized path coefficients is presented in figure 1. the model explained 11% of the variance of the main dependent variable (cdeab; r 2 = .11). figure 1 relationships among studied variables in boys and girls, with standardized coefficients note. n = 874 children. *p < .05. **p < .01. ***p < .001. in this model, bmi did not have a direct effect on cdeab (β = .06; p = .097). rather, three different paths (indirect effects) were statistically significant: 1) bmi was associated to cdeab through weight-related victimization and body dissatisfaction (β = .01, 95% bootstrap ci [.001, .005]; 2) bmi was associated to cdeab through perceived weight-re‐ lated victimization (β = .03, 95% bootstrap ci [.003, .012]; and 3) bmi was associated to cdeab through body dissatisfaction (β = .06, 95% bootstrap ci [.010, .021]. the results of the path analyses further confirmed the relevance of adding the control variable pdeab, since its positive association with cdeab was significant (β = .07; p < .05). d i s c u s s i o n the aim of this study was to mostly replicate previous work (jendrzyca & warschburger, 2016; thompson et al., 1995) by examining the mediating role of weight-related victimi‐ zation from peers as perceived by children aged 8 to 12 years old and body dissatisfaction in the association between bmi and cdeab, and to extend previous studies by taking in‐ to account the contribution of pdeab. overall, the results confirmed our hypotheses and côté, legendre, aimé et al. 9 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ revealed that bmi was associated with disordered eating only through its associations with perceived weight-related victimization and body dissatisfaction. parental disordered eating was also associated with higher disordered eating among children. first, the level of perceived weight-related victimization and body dissatisfaction were significantly different across weight statuses. children categorized as overweight or obese reported more weight-related victimization and body dissatisfaction compared to children categorized as normal weight. this is consistent with what others have previously reported (brennan, lalonde, & bain, 2010; neumark-sztainer et al., 2002; puhl & latner, 2007). the level of perceived weight-related victimization was similar for boys and girls, but girls were significantly more dissatisfied with their body than boys were. this may be because girls, even at this age, present a higher risk of being exposed to media and beauty pressure, resulting in higher preoccupation with their weight and body shape. it could also be that for boys, body dissatisfaction kicks in later or that it may be more about looking fit and muscular than looking thin (barlett, vowels, & saucier, 2008; brennan et al., 2010; dion et al., 2016; thompson & chad, 2000). even though girls reported more body dissatisfaction than boys did, the same trajec‐ tory from bmi to cdeab applied for both sexes, since the model was, globally, statisti‐ cally invariant in regard to sex. considering that bmi had no direct effect on cdeab, weight per se appears to be insufficient to explain the development of disordered eating attitudes and behaviors. most likely, it is the negative experience, mostly interpersonal, associated with being categorized as overweight or obese that may influence children and adolescents to see their weight as problematic. as demonstrated in this study, high bmi was associated with cdeab through the indirect effect of perceived weight-rela‐ ted victimization and body dissatisfaction. furthermore, bmi was also associated with cdeab through the indirect effect of perceived weight-related victimization and body dissatisfaction separately. along with the findings of jendrzyca and warschburger (2016), the present results suggest that weight-related victimization and body dissatisfaction might play a key role in the likelihood of developing disordered eating attitudes and behaviors for children who present as overweight or obesity. this highlights the need to fit in, as children grow older, and the important effect that these relationships with peers have on children. in addition, it may provide a clue about why body dissatisfaction is different between girls and boys. this might be likely because the importance of inter‐ personal experiences may change greatly from childhood to adolescence and differently for girls and boys. however, the cross-sectional design of the present study calls for caution, and additional prospective studies are needed to confirm those hypotheses. the fact that our study took into account the contribution of pdeab was an impor‐ tant strength. while the association between pdeab on cdeab does not need to be proven further (scaglioni et al., 2008; ventura & birch, 2008; wertheim et al., 2002; wertheim et al., 1999), it still has to be considered when predicting cdaeb in order to avoid overestimating the effect that weight-related victimization has on it. had we not the paths to children’s disordered eating 10 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ statistically controlled for pdeab, one could have thought that the association between bmi, weight-related victimization, body dissatisfaction and cdaeb may be explained by parental influences. however, although parents may influence the development of disordered eating in their children as they approach adolescence, these youths may be even more affected by their experiences with peers. as they get older, negative experiences such as weight-related victimization can seriously affect the way children evaluate themselves and push them to try to modify their weight and appearance to like themselves better and better fit in their peer group (vander wal, 2012). another strength of this study was to target elementary school girls and boys. studies that focus on weight-related victimization and body dissatisfaction have previously targeted, for the most part, high school adolescents. it appeared important to replicate the results from adolescents’ studies with younger children since disordered eating attitudes and behaviors can be adopted early and can be especially harmful (goldschmidt, aspen, sinton, et al., 2008). the recruiting process is another important element of this study. to favor a diversified sample, 874 children from 27 public elementary schools were included in our path analysis. finally, it was a great strength to use objective anthropometric measures because parents are likely to misreport their children's weight and height (brault, turcotte, aimé, côté, & bégin, 2015). some limitations of this study should be considered. first, as mentioned earlier, the cross-sectional design does not allow for drawing causal conclusions. however, the paths proposed follow a logical cascade in time that has already been demonstrated in a pro‐ spective design (jendrzyca & warschburger, 2016). second, weight-related victimization from peers and body dissatisfaction were measured with single items. moreover, no specific time frame was given in the question assessing victimization. the use of valida‐ ted questionnaires for our two mediating variables would have significantly enhanced internal validity. since the same measurement limitation applies to the prospective study of jendrzyca and warschburger (2016), future studies may benefit from testing weightbased victimization and body dissatisfaction with complete validated scales. nonetheless, despite the limitation that represents the use of single item measures (i.e., underestima‐ tion of the strength of the tested associations; menzel et al., 2010), the present study successfully detected statistically significant effects between studied variables, which suggests robust associations. another limitation stems from the representativeness of the sample. indeed, higher-educated wealthy families were over represented. since disor‐ dered eating behaviors and body dissatisfaction have been previously found to be higher in high socioeconomic status (ses) children compared to low ses children (adams et al., 2000; o’dea & caputi, 2001), it would be of great interest to replicate our results in a more diversified sample in terms of ses. additionally, it would be of great interest to assess victimization from different points of view, (i.e., reported not only from children but also from teachers and parents) to verify whether it is weight victimization per se which is associated with negative psychological outcomes or feeling victimized. different côté, legendre, aimé et al. 11 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://www.psychopen.eu/ sources of comments should also be studied, since parental comments on weight might be very harmful for young people (neumark-sztainer et al., 2010). conclusion this study adds to the limited data currently available in the field of the early develop‐ ment of disordered eating behaviors (before adolescence). an important contribution of this study was to consider the implication of pdeab in a comprehensive model of eating attitudes and behaviors in children. a model in which weight-related victimization experienced by children was associated with body dissatisfaction and disordered eating attitudes and behaviors was replicated. while weight itself appears to be insufficient to explain disordered eating, interpersonal experiences might be what influence children to see their weight as problematic and adopt disordered attitudes and behaviors toward eat‐ ing. this suggests that weight-related victimization from peers and body dissatisfaction must be taken seriously and that prevention and intervention efforts must 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(2017). the role of weight teasing and weight bias internalization in psychological functioning: a prospective study among school-aged children. european child and adolescent psychiatry, 26(10), 1245-1255. https://doi.org/10.1007/s00787-017-0982-2 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. the paths to children’s disordered eating 16 clinical psychology in europe 2020, vol.2(1), article e2689 https://doi.org/10.32872/cpe.v2i1.2689 https://doi.org/10.1007/bf03404273 https://doi.org/10.1002/1098-108x(199511)18:3<221::aid-eat2260180304>3.0.co;2-d https://doi.org/10.1016/j.ehb.2012.04.011 https://doi.org/10.1186/1479-5868-5-15 https://doi.org/10.1080/10640260214507 https://doi.org/10.1023/a:1018850111450 https://doi.org/10.1007/s00787-017-0982-2 https://www.psychopen.eu/ the paths to children’s disordered eating (introduction) method participants procedure measures results mean comparisons path analyses discussion conclusion (additional information) funding competing interests acknowledgments references only the lonely: a study of loneliness among university students in norway research articles only the lonely: a study of loneliness among university students in norway mari hysing a, keith j. petrie b, tormod bøe a, kari jussie lønning cd, børge sivertsen efg [a] department of psychosocial science, faculty of psychology, university of bergen, bergen, norway. [b] department of psychological medicine, university of auckland, auckland, new zealand. [c] the norwegian medical association, oslo, norway. [d] the student welfare organization of oslo and akershus (sio), oslo, norway. [e] department of health promotion, norwegian institute of public health, bergen, norway. [f ] department of research & innovation, helse-fonna hf, haugesund, norway. [g] department of mental health, norwegian university of science and technology, trondheim, norway. clinical psychology in europe, 2020, vol. 2(1), article e2781, https://doi.org/10.32872/cpe.v2i1.2781 received: 2019-06-10 • accepted: 2020-01-13 • published (vor): 2020-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: mari hysing, department of psychosocial science, faculty of psychology, university of bergen, post box 7807, 5020 bergen, norway; +47 55 58 86 98. e-mail: mari.hysing@uib.no abstract background: loneliness is a major public health concern among college and university students, the evidence is inconsistent regarding whether there is an increasing trend or not. furthermore, knowledge of the demographic determinants for loneliness are limited. the present study assesses recent trends of loneliness from 2014 to 2018, and explores demographic risk indicators of loneliness among students. method: data was drawn from two waves of a national student health survey from 2014 and 2018 for higher education in norway (the shot-study). in 2018, all 162,512 fulltime students in norway were invited to participate and 50,054 students (69.1% women) aged 18-35 years were included (response rate = 30.8%). loneliness was measured by “the three-item loneliness scale” (t-ils) and one item from the hopkins symptom checklist-25 (hscl-25). results: age showed a curvilinear association with loneliness, with the youngest and oldest students reporting the highest level of loneliness across all measures. other significant demographic determinants of loneliness were being female, single and living alone. there was a considerable increase in loneliness from 2014 (16.5%) to 2018 (23.6%, p < .001), and the increase was particularly strong for males, for whom the proportion of feeling “extremely” lonely had more than doubled. conclusion: the high rate of loneliness and the increasing trends indicate the need for preventive interventions in the student population. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2781&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords loneliness, students, young adults, partnership status, student accomodation highlights • loneliness among norwegian university students increased from 2014 to 2018, particularly for males. • students in transitional periods, both the youngest and oldest reported the most loneliness. • being single and living alone were risk factors for loneliness. loneliness reflects the subjective feeling of disconnectedness and not belonging, and is often characterized as “a perceived discrepancy between desired and actual social rela‐ tionships” (portnoy, 1983). loneliness is associated with more health problems (hayley et al., 2017), and has been linked to an increased mortality risk (holt-lunstad, smith, baker, harris, & stephenson, 2015). loneliness has often been thought of as a concern that peaks in older age. however, recent evidence has shown that the developmental trajectory is more u-shaped, with young adults having the highest levels of loneliness (luhmann & hawkley, 2016), followed by a second peak in older age groups. the transition from adolescence to young adulthood makes college and universi‐ ty students a particularly vulnerable group for feelings of loneliness (diehl, jansen, ishchanova, & hilger-kolb, 2018). this may be related to developmental-specific risk factors, such as moving away from home and their local community, and re-establishing new social networks. surprisingly, the epidemiology of loneliness in young people has received scant attention. knowledge of risk indicators and vulnerable subgroups are important in order to promote preventive actions. if loneliness is limited to, or peaks at the actual transition from moving away from home, a decline in loneliness over time should be expected among more senior students, which has been demonstrated in a german university sample (diehl et al., 2018). a recent uk study of 18-year-old twins found that loneliness was equally common across sexes and socioeconomic status (ses) (matthews et al., 2019), whereas others have found both higher (mounts, 2004) and lower (mcwhirter, 1997) levels of loneliness among men. this inconsistency was also confirmed in a recent meta-analysis (mahon, yarcheski, yarcheski, cannella, & hanks, 2006). in the general population, loneliness is more prevalent among adults without partners (beutel et al., 2017), and also students living alone report more loneliness compared to those living in dorms or with a partner/ friend (diehl et al., 2018). still, the literature remains sparse on the issue of identifying risk indicators of loneliness among young adults. it has been suggested that the prevalence of loneliness is increasing, but very few studies have examined this over time (cacioppo, grippo, london, goossens, & cacioppo, loneliness among university students 2 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ 2015). a study of older dutch people showed no change in loneliness from 2005 to 2010, with the exception of a subgroup of individuals with activity limitations, where the trend was increasing (honigh-de vlaming, haveman-nies, groeniger, de groot, & van ’t veer, 2014). a similar stable pattern was observed in a swedish study of an elderly population (dahlberg, agahi, & lennartsson, 2018). in contrast, there was a rising rate of loneliness among danish adolescents from 1991 to 2014, with the largest increase being observed among adolescents from families with high ses (madsen et al., 2019). this study addressed three main questions in a large nationally representative sample of young people: (1) what demographic factors are associated with loneliness in young adult college and university students? (2) how does partnership status offer protection from feelings of loneliness? and (3) has the rate of loneliness changed from 2014 to 2018 in this population? m e t h o d procedure the shot study (students’ health and wellbeing study) is a national student survey for higher education in norway. the main aim of the survey is to monitor students’ health, wellbeing and psychosocial environment. the survey has been carried out three times (2010, 2014 and 2018), and the two most recent waves (2014 and 2018) were used in the present study. the shot2014 study was conducted by the three largest student welfare organizations (sammen [bergen], sit [trondheim] and sio [oslo and akershus]) in collaboration with, and with participation from, the 10 largest student welfare organizations in norway, also targeting full-time norwegian students < 35 years of age. data for the shot2014 study were collected electronically using a web-based platform in the period from 24 february 2014 to 27 march 2014. an invitation email containing a link to an anonymous online questionnaire was sent to 47,514 randomly selected students and stratified by study institutions, faculties, and departments. the overall response rate was 28.5% and included 13,525 students. the shot2018 was initiated by the three largest student welfare organizations (sam‐ men [bergen and surrounding area], sit [trondheim and surrounding area] and sio [oslo and akershus]), representing all student welfare organizations in norway and done as a joint effort between these student welfare organisations and the norwegian institute of public health (niph). data were collected between february 6 and april 5, 2018 and all fulltime norwegian students aged between 18 and 35 years taking higher education (both in norway and abroad) were invited to take part. the survey data were collected electronically through a web-based platform and some institutions allocated time during classes for the students to complete the set of questionnaires. for the shot2018 study, hysing, petrie, bøe et al. 3 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ 162,512 students fulfilled the inclusion criteria, of whom 50,054 (30.8%) students comple‐ ted the online questionnaires (sivertsen, råkil, munkvik, & lønning, 2019). ethics the authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimenta‐ tion and with the helsinki declaration of 1975, as revised in 2008. all procedures in‐ volving human subjects/patients were approved by the regional committee for medical and health research ethics in western norway (no. 2017/1176 [shot2018]). informed consent was obtained electronically after the participants had received a detailed intro‐ duction to the study. approvals for conducting the shot2014 studies were granted by the data protection officer for research at the norwegian centre for research data. instruments demographic information all participants indicated their sex and age. in the current study, age was used both as a continuous and categorical variable, the latter employing the following age categories (18-20 years, 21-22 years, 23-25 years and 26-35 years). participants were also asked about their relationship status (response options: “single”, “girl-/boyfriend”, “cohabitant”, and “married/ registered partner”), as well as their accommodation status (response options: “living alone”, “living with partner”, “living with friends/others in a collective”, and “living with parents”). participants were categorized as an immigrant if either the student or his/her parents were born outside norway. finally, all students indicated if they were living or studying abroad. loneliness loneliness was measured by one item of the depression subscale of the hscl-25 (derogatis, lipman, rickels, uhlenhuth, & covi, 1974) in 2014 and 2018. in the past two weeks, including today, how much have you been bothered by feeling lonely? the response alternatives were “not at all”, “a little”, “quite a bit”, and “extremely”. in shot2018 loneliness was assess using an abbreviated version of the widely used ucla loneliness scale, “the three-item loneliness scale (t-ils)” (hughes, waite, hawkley, & cacioppo, 2004). the t-ils include the following three items, each rate along a 5-point likert scale (“never”, “seldom”, “sometimes”, “often”, and “very often”). for each question below, please indicate how often you have felt that way during the last year: 1) how often do you feel that you lack companionship? 2) how often do you feel left out, and 3) how often do you feel isolated from others? the t-ils has displayed satisfactory reliability and both concurrent and discriminant validity. (hughes et al., 2004) in addition loneliness among university students 4 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ to analysing each of the three t-ils items separately, we also calculated a total score, adding the three items together. the cronbach’s alpha of the t-ils total score was .88. statistics ibm spss version 25 (spss inc., chicago, il, usa) for mac was used for all analyses. chi-square tests and logistic regression analysis were used to examine differences in the three loneliness items across demographical characteristics. analysis of variance (anova) were conducted to examine potential polynomial/curvilinear associations be‐ tween loneliness and age group by entering quadratic terms. we also used the curve estimation command in spss to test both the linear and curvilinear association between age as a continuous variable and overall loneliness. anovas were also used to examine the t-ils total score against the demographic variables. effect sizes (pooled sd) were calculated using the cohen’s d formula (cohen, 1988). pearson’s chi-squared tests were used to test for significant changes in loneliness over time. missing values were handled using listwise deletion. r e s u l t s descriptive characteristics compared to all invited students – 58.1% women (n = 93,267) and 41.9% men (n = 67,558) – the current sample included a larger proportion of women (69.1%) than men (30.9%). the mean age was 23.2 (sd = 3.3). loneliness in shot2018 the response patterns of the three loneliness items are detailed in figure 1. almost one in four students (21% in males and 24% in females) felt that they lacked companionship “often” or “very often”. the corresponding estimates for the items “feeling left out” and “feeling isolated” were slightly lower, with 14%-15% in women and 17-18% in men (see figure 2 for details). one in ten students (10.1%) reporting “often/very often” on all three items (females: 10.6% and males: 8.8%). all sex differences were statistically significant (p < .001). hysing, petrie, bøe et al. 5 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ figure 1 response pattern of the three loneliness items in the t-ils among college/university students in the shot2018 study note. error bars represent 95% confidence intervals. loneliness and age figure 2 shows the prevalence of the three loneliness items across the different age groups. as indicated by the dotted trend lines, there was a significant curvilinear rela‐ tionship (all ps < .001) on all forms of loneliness for both men and women; both the youngest and oldest age-groups reported higher levels of both lacking companionships, feeling left out and feeling isolated (see figure 2 for details). table 1 shows the results from the logistic regression analyses. for example, compared to being 23-25 years old, female students aged between 18 and 20 years had 1.38 higher or, 95% ci [1.29, 1.48], of reporting that they lacked companionship. there were significant sex × age interactions for all three loneliness items (see table 1 for more details). as detailed in table 2, analysing the t-ils total score continuously showed a similar pattern u-shaped, with small cohen’s d effect-sizes. loneliness among university students 6 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ ta b le 1 o dd sr at io s (o r s) o f d em og ra ph ic f ac to rs a ss oc ia te d w it h lo ne li ne ss ( “o ft en ” or “ v er y o ft en ”) a m on g n or w eg ia n u ni ve rs it y st ud en ts d em og ra ph ic f ac to r la ck c om pa n io n sh ip le ft o ut is ol at ed w om en m en w om en m en w om en m en o r 95 % c i o r 95 % c i o r 95 % c i o r 95 % c i o r 95 % c i o r 95 % c i a ge g ro up se x in te ra ct io n: w al d (d f) = 11 .4 1( 3) , p = .0 10 se x in te ra ct io n: w al d (d f) = 29 .7 0( 3) , p < .0 01 se x in te ra ct io n: w al d (d f) = 25 .2 8( 3) , p < .0 01 18 -2 0 ye ar s 1. 38 ** * 1. 29 , 1 .4 8 1. 32 ** * 1. 17 , 1 .4 8 1. 22 ** * 1. 13 , 1 .3 2 1. 05 0. 91 , 1 .2 1 1. 27 ** * 1. 18 , 1 .3 8 1. 15 * 1. 01 , 1 .3 2 21 -2 2 ye ar s 1. 05 0. 98 , 1 .1 2 0. 97 0. 87 , 1 .0 7 1. 02 0. 95 , 1 .1 0 0. 82 ** 0. 73 , 0 .9 3 1. 04 0. 97 , 1 .1 2 0. 81 ** * 0. 72 , 0 .9 1 23 -2 5 ye ar s 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 26 -3 5 ye ar s 1. 07 * 1. 00 , 1 .1 6 1. 24 ** * 1. 11 , 1 .3 8 1. 22 ** * 1. 12 , 1 .3 2 1. 47 ** * 1. 30 , 1 .6 5 1. 21 ** * 1. 11 , 1 .3 2 1. 37 ** * 1. 22 , 1 .5 4 r el at io n sh ip s ta tu s se x in te ra ct io n: w al d (d f) =1 59 .5 8( 3) , p < .0 01 se x in te ra ct io n: w al d (d f) = 88 .4 8( 3) , p < .0 01 se x in te ra ct io n: w al d (d f) = 82 .3 2( 3) , p < .0 01 si ng le 1. 61 ** * 1. 39 , 1 .8 6 2. 85 ** * 2. 14 , 3 .8 1 1. 01 0. 74 , 1 .1 8 1. 59 ** 1. 18 , 2 .1 4 1. 18 * 1. 01 , 1 .3 9 1. 65 ** * 1. 23 , 2 .2 1 bo y/g ir lfr ie nd 1. 27 ** 1. 09 , 1 .4 8 1. 24 0. 92 , 1 .6 8 1. 02 0. 74 , 1 .1 9 0. 90 0. 66 , 1 .2 2 1. 05 0. 90 , 1 .2 4 0. 85 0. 62 , 1 .1 6 c oh ab ita nt 1. 05 0. 90 , 1 .2 2 0. 91 0. 67 , 1 .2 5 1. 10 0. 94 , 1 .2 9 1. 08 0. 79 , 1 .4 8 1. 10 0. 93 , 1 .2 9 0. 94 0. 69 , 1 .2 8 m ar ri ed / re gi st er ed p ar tn er 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 a cc om m od at io n s ta tu s se x in te ra ct io n: w al d (d f) = 86 .7 5( 3) , p < .0 01 se x in te ra ct io n: w al d (d f) = 32 .3 2( 3) , p < .0 01 se x in te ra ct io n: w al d (d f) = 36 .8 6( 3) , p < .0 01 a lo ne 1. 96 ** * 1. 82 , 2 .1 1 3. 85 ** * 3. 37 , 4 .3 9 1. 26 ** * 1. 17 , 1 .3 7 1. 99 ** * 1. 74 , 2 .2 8 1. 50 ** * 1. 39 , 1 .6 2 2. 44 ** * 2. 13 , 2 .8 0 w ith p ar tn er 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 w ith fr ie nd s / o th er s in a c ol le ct iv e 1. 24 ** * 1. 16 , 1 .3 2 2. 08 ** * 1. 85 , 2 .3 5 0. 79 ** * 0. 74 , 0 .8 4 1. 02 0. 90 , 1 .1 5 0. 85 0. 80 , 0 .9 2 1. 15 * 1. 02 , 1 .3 1 w ith p ar en ts 1. 45 ** * 1. 31 , 1 .5 9 2. 74 ** * 2. 33 , 3 .3 4 1. 18 ** 1. 07 , 1 .3 1 1. 57 ** * 1. 32 , 1 .8 8 1. 35 ** * 1. 21 , 1 .4 9 1. 75 ** * 1. 46 , 2 .0 9 im m ig ra ti on s ta tu s se x in te ra ct io n: w al d (d f) = 3. 77 (1 ), p = .0 52 se x in te ra ct io n: w al d (d f) = 0. 16 (1 ), p = .6 88 se x in te ra ct io n: w al d (d f) = 1. 65 (1 ), p = .4 22 n or w eg ia n 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 im m ig ra nt 1. 48 ** * 1. 35 , 1 .6 1 1. 72 ** * 1. 51 , 1 .9 5 1. 45 ** * 1. 32 , 1 .5 9 1. 40 ** * 1. 20 , 1 .6 2 1. 44 ** * 1. 31 , 1 .5 9 1. 55 ** * 1. 34 , 1 .7 9 st ud yi n g ab ro ad se x in te ra ct io n: w al d (d f) = 1. 26 (1 ), p = .2 62 se x in te ra ct io n: w al d (d f) = 6. 14 (1 ), p = .0 13 se x in te ra ct io n: w al d (d f) = 2. 52 (1 ), p = .1 12 n o 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 ye s 1. 19 ** 1. 06 , 1 .3 5 1. 04 0. 84 , 1 .2 8 1. 16 * 1. 02 , 1 .3 3 0. 80 0. 61 , 1 .0 4 1. 16 * 1. 01 , 1 .3 3 0. 92 0. 71 , 1 .1 8 hysing, petrie, bøe et al. 7 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ figure 2 loneliness prevalence (“often”/”very often”) stratified by age-group in male and female students note. the curves show the polynomial/curvilinear trendline (order 2). table 2 demographic factors associated with loneliness (t-ils sum score) among norwegian university students demographic factor women men m sd cohen's da m sd cohen's d age group 18-20 years 7.90 3.11 0.12 7.32 3.10 0.15 21-22 years 7.60 3.00 0.02 6.87 2.93 reference 23-25 years 7.55 2.98 reference 7.07 3.02 0.07 26-35 years 7.66 3.19 0.04 7.50 3.26 0.20 relationship status single 7.78 3.05 0.17 7.62 3.15 0.36 boy-/girlfriend 7.58 3.00 0.10 6.53 2.78 0.01 cohabitant 7.52 3.08 0.08 6.52 2.88 0.01 married / registered partner 7.27 3.07 reference 6.49 3.04 reference accommodation status alone 8.25 3.16 0.25 8.09 3.26 0.52 with partner 7.49 3.07 0.01 6.48 (2.91) reference with friends / others in a collective 7.47 2.92 reference 7.02 2.92 0.18 with parents 7.86 3.22 0.13 7.36 3.30 0.28 immigration status norwegian 7.61 3.03 reference 7.08 3.05 reference immigrant 8.17 3.19 0.14 7.73 3.24 0.05 studying abroad no 7.63 3.05 reference 7.13 3.07 reference yes 8.03 2.99 0.13 7.24 2.84 0.04 acohen’s d effect sizes (pooled sd) were calculated for each demographic variable using the category with the lowest t-ils score (sex specific) as the reference group. loneliness among university students 8 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ when analyzing the association between age as a continuous variable and overall lone‐ liness, similar findings were observed. there was a statistically significant quadratic (curvilinear) association between continuous age and overall loneliness, f(2, 48685) = 12.91, p < .001, but there was no evidence of a significant linear association, f(1, 48686) = 1.48, p = .224). loneliness and relationship status single students reported more often that they lacked companionship compared to stu‐ dents with another relationship status, a tendency that was especially pronounced for single male students, or = 2.85; 95% ci [2.14, 3.81], see table 1 for details. and whereas feeling left out was also more prevalent in single male students, relationship status was not significantly associated with feeling left out in female students. in terms of feeling isolated, single male students reported higher levels of isolation, whereas relationship status was less clearly associated with feeling isolated in female students (see figure 3 for details). there were significant sex × relationship interactions for all three loneliness items (all ps < .001). analyses of the t-ils total score showed a similar pattern (see table 1 for details). figure 3 loneliness prevalence (“often”/”very often”) by relationship status in male and female students note. error bars represent 95% confidence intervals. hysing, petrie, bøe et al. 9 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ loneliness and accommodation status similar to the findings for relationship status, also accommodation status was signifi‐ cantly associated with loneliness. both female and male, but especially male students living alone had the highest loneliness scores across all three items. students living with their parents more often reported lacking companionship, feeling left out and isolated compared with students living with a partner/friends (see figure 4 for details). there were significant sex × accommodation interactions for all three loneliness items (all ps < .001). analyses of the t-ils total score showed a similar pattern (see table 1 for details). figure 4 loneliness prevalence (“often”/”very often”) by accommodation status in male and female students note. error bars represent 95% confidence intervals. loneliness and studying abroad as detailed in table 1, females students living/studing abroad had significantly higher odds of reporting loneliness across all three t-ils items, whereas a similar pattern was not observed for male students. however, a significant sex × studying abroad interaction was only observed for “feeling left out” (see table 1 for details). trend of loneliness from 2014 to 2018 figure 5 shows the prevalence of loneliness across from 2014 to 2018. there was a signif‐ icant overall increase in students reporting feeling lonely (“quite a bit”, or “extremely”) loneliness among university students 10 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ from 2014 (16.5%) to 2018 (23.6%; p < .001). the increase was evident in both men and women, and across both response categories (see figure 5 for details). figure 5 prevalence of loneliness (from the hscl-25) from 2014 to 2018 by sex note. error bars represent 95% confidence intervals. d i s c u s s i o n this large national survey from 2018 of norwegian fulltime students found that feelings of loneliness were common. age showed a curvilinear association with loneliness, with the youngest and oldest students reporting the highest level of loneliness across all indicators of loneliness. other significant demographic determinants of loneliness were being female, single, living alone and studying abroad. there was a considerable increase in loneliness reported by the 2018 cohort compared to the 2014 cohort, and this effect was particular strong for males, for whom the proportion of feeling “extremely” lonely had more than doubled. the findings confirm that loneliness is frequently experienced among college and university students, as indicated by 14-24% of the students responding that they “often” or “very often” lacked companionship, felt left out, or felt isolated. in line with a previous german study (diehl et al., 2018), we found that loneliness peaked among the youngest students (aged between 18-20 years), possibly as a result of the transition to university hysing, petrie, bøe et al. 11 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ life. however, a second peak in loneliness was found among the oldest age group (26-35 years). this may be related to a second transitional period towards the end of the studies, in preparation for moving into full-time work. it may also be that these individuals are establishing new relationships after a transition into work and they identify less with student life and are spending less time in student social activities at this stage. being in a close relationships was associated with less loneliness among the students, comparable to the protective effect of close relationships in the general population (beutel et al., 2017). for students, their living situation is a period-specific buffer against loneliness, with students sharing accommodation reporting less loneliness than those that live alone, a finding which also is in line with a previous german university study (diehl et al., 2018). the complex associations between sex and loneliness may be understood in light of the inconsistencies in sex differences in previous studies (mahon et al., 2006). the general pattern is that female students report more loneliness than men across most categories, especially in the younger age groups, while the difference is attenuated in the oldest student group. some risk factors had differential effects across sexes, including a stronger association between relationship status and loneliness among men, with single men being a noteworthy high-risk group. similarly, living alone was also a stronger risk factor for men than women. overall, it seems that men are more sensitive to the structural factors and relationship status for loneliness than females. this may also indi‐ cate that interventions should be attentive toward sex-specific risks, and it might be that differential interventions are needed. future interventions studies could explore if men show a more beneficial more effect of structural interventions such as organised activites and housing, while women might respond better to strengthening social relationships. women reporting more loneliness than men may also be a result of woman may more easily acknowledging feelings of loneliness, due to less social consequences of lonliness for woman (borys & perlman, 1985). we found a substantial increase in reported loneliness from 2014 to 2018. while there is limited studies reporting on trends, a danish study found a similar pattern from 1991 to 2014 among adolescents (madsen et al., 2019). the effect in that study was strongest for the high ses groups. although we have no information on family ses in the current study, all the included participants are pursuing higher education. two studies of elderly have reported an opposite pattern, with loneliness decreasing over time (honigh-de vlaming et al., 2014; lempinen, junttila, & sourander, 2018), but it might very well be that the trends are different across age groups, and this limits the comparison. the recency of the present study also precludes comparison to others in the same time period. it is uncertain if this is an ongoing trends, but the next planned wave of the shot study in 2022 will give new and valuable information on the longer trajectories of loneliness over time. what the drivers of this increase may be is also uncertain. it may reflect a general increase in mental distress, with recent evidence from the same dataset loneliness among university students 12 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ as the current study showing that both sleep problems and self-harm have increased across the same time period (sivertsen, hysing, et al., 2019; sivertsen, vedaa, et al., 2019). the generalizabilty of the findings to the whole student population should be done with care given the relatively modest response rate for the shot2014 (29%) and shot2018 (31%). in relation to this, the issue of sample comparability is important. as the surveys in 2014 and 2018 included somewhat different welfare organizations and institutions, a recent report using the same datasets, performed detailed sensitivity analyses of the hscl-25, comprising only institutions that were included in both surveys (knapstad et al., 2019). the results from these analyses showed near-identical effect-sizes of the trend data, suggesting that the two samples from 2014 and 2018 are comparable. regarding the representativeness of the sample in comparison to the total student population in norway, the shot2018 study consisted of 69% females, compared to 58% of all those who were invited. as such, this may represent a bias for the overall estimates, which is why we mainly present gender-specific results. in contrast, the age distribution was almost identical between the invited and the participating student, thus supporting the representativeness of the sample (sivertsen, vedaa, et al., 2019). rather, it may be more appropriate to emphasize the relative differences between men and women, as well as different age cohorts and sociodemographic factors found in the current study, as these estimates are less prone to selection bias. the cross-sectional nature of the shot2018-study precludes conclusions on temporal order and causality. for instance, being lonely might reduce the chances for cohabiting, and thus loneliness might be a predictor of accomodation status and not its consequence. the loneliness measure is a three item, psychometrically sound measure, but a more nuanced understanding could have been gained by a more thorough assessment. future studies should investigate risk and protective factors for loneliness over and beyond demographic characteristics. both individual characteristics of the students as well as systemic characteristics of the teaching situation should be investigated to in‐ crease our understanding of what constitutes risks for loneliness in this group to inform preventive interventions. the digital society may be one aspect that could account for the increase in loneliness and should be investigated further (odacı & kalkan, 2010) further, if the trend of increasing loneliness will further strengthen in the coming years or will attenuate should be investigated in the present study as well as other epidemio‐ logical studies of students the findings also have notable implications. the rise in loneliness over a four year period warrants concern, and should be met with preventive actions. the demographic determinants identified in this study could give indications of high risk groups to target, including the transitional periods and those living alone. there might be a need for interventions to target male and female students diffentially. hysing, petrie, bøe et al. 13 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://www.psychopen.eu/ funding: shot 2018 has received funding from the norwegian ministry of education and research (2017) and the norwegian ministry of health and care services (2016). competing interests: the authors have declared that no competing interests exist. acknowledgments: we wish to thank all students participating in the study, as well as the three largest student welfare organizations in norway (sio, sammen, and sit), who initiated and designed the shot study. r e f e r e n c e s beutel, m. e., klein, e. m., brähler, e., reiner, i., jünger, c., michal, m., . . . tibubos, a. n. 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(2019). suicide attempts and non-suicidal self-harm among university students: prevalence study. bjpsych open, 5(2), article e26. https://doi.org/10.1192/bjo.2019.4 hysing, petrie, bøe et al. 15 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://doi.org/10.1177/0898264313518066 https://doi.org/10.1177/0164027504268574 https://doi.org/10.1017/s0033291719003350 https://doi.org/10.1111/jcpp.12807 https://doi.org/10.1037/dev0000117 https://doi.org/10.1093/pubmed/fdy133 https://doi.org/10.1097/00006199-200611000-00009 https://doi.org/10.1017/s0033291718000788 https://doi.org/10.1002/j.1556-6676.1997.tb02362.x https://doi.org/10.1177/0743558403258862 https://doi.org/10.1016/j.compedu.2010.05.006 https://doi.org/10.1192/bjo.2019.4 https://www.psychopen.eu/ sivertsen, b., råkil, h., munkvik, e., & lønning, k. j. (2019). cohort profile: the shot-study, a national health and well-being survey of norwegian university students. bmj open, 9(1), article e025200. https://doi.org/10.1136/bmjopen-2018-025200 sivertsen, b., vedaa, ø., harvey, a. g., glozier, n., pallesen, s., aarø, l. e., . . . hysing, m. (2019). sleep patterns and insomnia in young adults: a national survey of norwegian university students. journal of sleep research, 28(2), article e12790. https://doi.org/10.1111/jsr.12790 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. loneliness among university students 16 clinical psychology in europe 2020, vol.2(1), article e2781 https://doi.org/10.32872/cpe.v2i1.2781 https://doi.org/10.1136/bmjopen-2018-025200 https://doi.org/10.1111/jsr.12790 https://www.psychopen.eu/ loneliness among university students (introduction) method procedure ethics instruments statistics results descriptive characteristics loneliness in shot2018 loneliness and age loneliness and relationship status loneliness and accommodation status loneliness and studying abroad trend of loneliness from 2014 to 2018 discussion (additional information) funding competing interests acknowledgments references integrating metta into cbt: how loving kindness and compassion meditation can enhance cbt for treating anxiety and depression scientific update and overview integrating metta into cbt: how loving kindness and compassion meditation can enhance cbt for treating anxiety and depression simona stefan ab, stefan g. hofmann a [a] boston university, department of psychological and brain sciences, boston, ma, usa. [b] department of clinical psychology and psychotherapy, babes-bolyai university, cluj-napoca, romania. clinical psychology in europe, 2019, vol. 1(3), article e32941, https://doi.org/10.32872/cpe.v1i3.32941 received: 2019-01-08 • accepted: 2019-06-11 • published (vor): 2019-09-20 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: stefan g. hofmann, 900 commonwealth avenue, boston, ma, usa. e-mail: shofmann@bu.edu abstract background: loving kindness meditation and compassion meditation are traditional buddhist practices that have recently been introduced and investigated in psychotherapy with promising results. both meditation practices emphasize metta, a mental state of positive energy and kindness towards oneself and other beings, as opposed to the anger, hostility, or self-loathing that often accompany emotional problems. method: we conducted a qualitative review of the literature to produce an integrative review. results: metta meditation appears to be particularly useful for treating depression and social anxiety, both characterized by low positive affect and negative attitudes and core beliefs about the self. conclusion: metta meditation can aid therapy by promoting more adaptive self-images, social connectedness, and emotional experiences. keywords meditation, cbt, depression, anxiety, loving kindness, compassion this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.32941&domain=pdf&date_stamp=2019-09-20 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • loving kindness and compassion meditation (metta) have been recently introduced in psychotherapy. • metta addresses shame, anger, and hostility, and promotes an accepting attitude towards oneself. • metta meditation increases positive affect. • metta meditation can be particularly useful in social anxiety and depression. l o v i n g k i n d n e s s a n d c o m p a s s i o n m e d i t a t i o n i n p s y c h o t h e r a p y initially derived from buddhist practices, the concept of mindfulness, briefly defined as the non-judgmental, accepting experience of the present, as it unfolds moment by mo‐ ment, has nowadays become ubiquitous in the fields of psychotherapy and mental health, as well as in self-help and popular psychology. psychotherapy interventions, such as mindfulness-based stress reduction (mbsr; [kabat-zinn, 1982] and mindfulness based cognitive therapy (mbst; [segal, williams, & teasdale, 2002] are considered established interventions for conditions such as chronic stress and depression (hofmann, sawyer, witt, & oh, 2010). furthermore, mindfulness has become an integral part of various psy‐ chological interventions, such as acceptance and commitment therapy (act; hayes, 2004) and dialectical behavioral therapy (dbt; linehan et al., 1999). more recently, oth‐ er forms of meditation inspired by buddhist philosophy, especially loving kindness and compassion meditation, have been introduced and investigated in mental health inter‐ ventions (hofmann, grossman, & hinton, 2011; zeng, chiu, wang, oei, & leung, 2015). although the term was originally associated with loving kindness, we will refer to both as metta interventions, as both types of interventions instill a sense of positive energy (metta) directed at oneself and other beings. taking a mindful stance, they further en‐ courage a kinder view on oneself and others, which is central to addressing many emo‐ tional intra and interpersonal problems (e.g., anger, hostility, depression, anxiety). due to the warmth and sense of connection they provide, metta interventions increase positive affect, particularly emotions related to calmness and safety. in this article, we will explore how metta-derived practices can help build a healthier view and a warmer attitude to‐ wards oneself, and how we can combine them with more traditional intervention techni‐ ques, specifically cognitive-behavioral therapy (cbt), when treating depression and so‐ cial anxiety. according to the buddhist tradition, loving kindness (metta) and compassion (karuna) are two of the four brahma viharas, or sublime states, which also include sympathetic joy (mutida; feeling joy when others are joyful) and equanimity (upekkha; tranquility, equi‐ distance, calmness) (hofmann et al., 2011). they are centered on the idea of universal and metta and cbt 2 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ unconditional kindness and interconnection among human beings, as opposed to the harshness and isolation which often accompany the experience of emotional suffering. whereas loving kindness meditation promotes an attitude of warmth and positive energy directed at oneself and all other beings, compassion entails the drive and commitment to alleviate suffering (graser & stangier, 2018). thus, compared to loving kindness, the ex‐ perience of compassion encompasses a warm feeling of sadness. self-compassion (i.e., an attitude of compassion directed towards the self), as defined by (neff, 2003) has emerged as a somewhat separate concept made up of three components: mindfulness (as opposed to over-identifying with one’s own suffering), common humanity (as opposed to isola‐ tion), and self-kindness (a kind attitude towards the self, as opposed to harshness and self-criticism). an alternative conceptualization promoted by gilbert describes compas‐ sion (and self-compassion implicitly) as a positive affect motivational system, with evolu‐ tionary roots and specific neurobiological underpinnings, channeled on soothing and providing care, safety, and empathy (gilbert, 2005; macbeth & gumley, 2012). studies have shown self-compassion to be consistently inversely related to psychopathology measures (e.g., depression, anxiety, stress), pointing to its potential role in preventing negative, dysfunctional emotions (see macbeth & gumley, 2012). in practice, loving kindness meditation (lkm) involves the mental repetition of phra‐ ses directed at others’ and one’s well-being and relief from suffering, in a non-judgmen‐ tal and observing mental stance (e.g., “may you be well”, “may you be happy”, “may we be safe”). as lkm progresses, kindness is directed towards more and more challenging recipients, starting with oneself or a friend, continuing with a neutral person, and ending with the entire universe (hofmann et al., 2011). the purpose is to experience a wish for universal well-being with a kind and tender mindset. compassion meditation is similar to lkm, but encompasses the acknowledgement of suffering (e.g., “this is a moment of suf‐ fering”), recognizing the communality of suffering (e.g., “suffering is a part of life) and committing to a position of kindness to oneself or others (e.g., “may i be kind to myself”), often accompanied by compassionate imagery – imagining a compassionate person, character, or any other entity evoking features of wisdom, empathy, and understanding (gilbert & procter, 2006; neff, 2011). however, there are multiple techniques for deliver‐ ing lkm and compassion meditation (see finlay-jones, 2017 for a review) and many exer‐ cises actually combine the two, generating some conceptual overlap in the field (shonin, van gordon, compare, zangeneh, & griffiths, 2015). so far, previous results have shown that lkm and compassion meditation interven‐ tions are effective in reducing depression, and increasing mindfulness, compassion, and self-compassion (against passive control conditions), as well as positive emotions (against relaxation) (galante, galante, bekkers, & gallacher, 2014). evidence suggests that these meditation interventions are useful for both clinical and healthy populations, in address‐ ing psychological distress, positive and negative affect, the frequency and intensity of positive thoughts and emotions, interpersonal skills, and empathic accuracy (shonin et stefan & hofmann 3 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ al., 2015). a recent review (graser & stangier, 2018) also evidenced that, looking at randomized trials only, compassion-based interventions are effective for psychotic disor‐ ders, depression, eating disorders, and patients with suicide attempts, while loving kind‐ ness interventions are effective in treating chronic pain, and a combination of both is useful for borderline personality disorder. still, there are few randomized trials and even fewer that compared compassion and loving kindness interventions with active control conditions. therefore, it is not certain whether these related strategies bring a unique, unshared contribution to relieving distress or promoting positive affect. also, results are difficult to summarize because of the divergent conceptualizations of metta interven‐ tions; using very similar terminology, studies refer to compassion and/or loving kindness interventions as 1. single sessions consisting of brief exercises (e.g., feldman, greeson, & senville, 2010), 2. several sessions of meditation (e.g., carson et al., 2005; hofmann et al., 2015), 3. specific interventions which include, but are not restricted to compassion/loving kindness meditation, such as compassion-focused therapy (e.g., gilbert & procter, 2006) or cognitively-based compassion training (e.g., mascaro, rilling, tenzin negi, & raison, 2013), or 4. combining these interventions with cbt (e.g., beaumont, galpin, & jenkins, 2012). l o v i n g k i n d n e s s a n d s e l f c o m p a s s i o n i n d e p r e s s i o n a n d s o c i a l a n x i e t y d i s o r d e r negative self-views, self-criticism, and shame in depression and social anxiety conceptually, due to their focus on promoting a kind, accepting view of oneself and oth‐ ers, these interventions particularly resonate with disorders characterized by self-criti‐ cism and shame (gilbert & procter, 2006), anger, and hostility (hofmann et al., 2011). the experience of shame and self-criticism is transdiagnostic, prevalent in disorders such as depression, social anxiety disorder, psychotic disorders, ptsd, eating disorders, and per‐ sonality disorders (gilbert, pehl, & allan, 1994; thompson & waltz, 2008). for instance, in depression, the classical cognitive-behavioral model (beck & alford, 2009) emphasizes the role of negative core beliefs related to oneself (worthlessness/ help‐ lessness, unlovability), which further lead to a strain of negative automatic thoughts sup‐ porting the depressed, negative affect. depressed individuals thus often have a harsh, critical attitude towards themselves, which is difficult to change. in this sense, studies have found that self-coldness (i.e., the reverse of self-compassion, including self-judg‐ ment, isolation, and over-identification) is a strong predictor of depressive symptoms in the general population both cross-sectional and longitudinally, over a period of 1 year (lópez, sanderman, & schroevers, 2018). also, depressed outpatients score lower on selfcompassion as compared to never-depressed participants, even when controlling for de‐ metta and cbt 4 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ pression levels, with symptom-focused rumination and behavioral avoidance mediating the relation between self-compassion and depression (krieger, altenstein, baettig, doerig, & holtforth, 2013). self-compassion also predicts subsequent depressive symp‐ toms in clinical patients, while depression does not predict self-compassion (krieger, berger, & holtforth, 2016), and the relation between self-compassion and depression ap‐ pears to be mediated by emotion regulation skills (diedrich, burger, kirchner, & berking, 2017). additionally, personality traits such as dependency (the tendency to rely exces‐ sively on other people and their approval) and self-criticism are related to depression se‐ verity scores in clinical (luyten et al., 2007) and remitted depressives (mongrain & leather, 2006), and constitute independent predictors (luyten et al., 2007). similarly, socially anxious individuals display low self-esteem, high self-criticism, and dependency, with self-criticism as the strongest predictor of social anxiety symptoms (iancu, bodner, & ben-zion, 2015). also, people with social anxiety disorder show lower levels of self-compassion when compared to healthy controls, and within group, selfcompassion is related to fear of negative and positive evaluation (werner et al., 2012). additionally, shame and shame-proneness (the tendency to experience shame frequently) are particularly important in social anxiety disorder, being associated with social anxiety symptoms even after controlling for levels of depression and guilt (fergus, valentiner, mcgrath, & jencius, 2010). following psychological intervention, changes in social anxi‐ ety symptoms are further associated with decreases in shame proneness (fergus et al., 2010). emotion regulation and negative self-schemas emotions can be regulated intrapersonally (hofmann, sawyer, fang, & asnaani, 2012) or interpersonally (hofmann, 2014; hofmann & doan, 2018). strategies that involve other people are interpersonal emotion regulation and include strategies such as soothing and social modeling (hofmann, carpenter, & curtiss, 2016). these strategies appear to en‐ hance emotions by targeting the social self (hofmann & doan, 2018). an example of an intrapersonal emotion regulation is cognitive reappraisal (e.g., hofmann, 2016), a strategy aimed to cognitively modify one’s perspective as to elicit an alternative emotional re‐ sponse (as conducted in the process of cognitive restructuring). it is usually less effective‐ ly used by currently depressed participants (visted, vøllestad, nielsen, & schanche, 2018). possibly, this is because cognitive reappraisal is demanding on the executive functions, which are sometimes impaired in depression, or because cognitive change is incongruent with the depressive mood and its subsequent negative and ruminative thinking style (gotlib & joormann, 2010). alternative accounts posit that depressive thinking is hard to change because although patients may logically understand that their thinking is distor‐ ted, they cannot embrace kinder, healthier views of themselves if they lack the emotional experience of being cared for. many depressed patients report having been abused, bul‐ lied, or heavily criticized during childhood, and experienced little parental warmth. selfstefan & hofmann 5 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ criticism thus becomes a sort of inner voice, towards which the patient often assumes a submissive position (gilbert, clarke, hempel, miles, & irons, 2004). therefore, in these cases, the motivational system related to soothing and safeness appears to be “malfunc‐ tioning”. usually, the activation of the soothing system (i.e. prompted by affection and safety signals perceived from others or oneself) deactivates defensive emotions (e.g., anxiety) and behaviors, and also turns off behaviors related to goal seeking, achieving, and acquiring, instead eliciting a state of calmness and connectedness. however, with de‐ pressed individuals, this system seems to be suppressed, possibly because its develop‐ ment was impaired at critical times in the past (gilbert, 2005). in other words, depressed people have difficulty soothing themselves because the experience of being cared for is affectively foreign. this is why metta interventions could be particularly useful, since they do not aim to merely restructure negative self-views, but to create an inner experi‐ ence of warmth and peace by promoting a qualitatively different kind of attitude towards oneself. furthermore, self-criticism is highly prevalent in social anxiety disorder com‐ pared to other anxiety disorders, and remains at elevated levels even in people with his‐ tory of social anxiety only (cox, fleet, & stein, 2004). also, people with social anxiety often have high levels of perfectionism and unrealistic social standards (hofmann, 2007), intrusive self-deprecating thoughts, and hostility and paranoia (hofmann & otto, 2018), which combine with poor cognitive and emotion regulation strategies in the face of per‐ ceived threats and challenges, further complicating treatment (flett & hewitt, 2014). cog‐ nitive models of social anxiety disorder also emphasize maladaptive self-beliefs (clark & wells, 1995; farmer, kashdan, & weeks, 2014) as central to symptom development, like high standard self-beliefs, conditional self-beliefs (e.g., “if people see i’m anxious, they’ll think badly of me”), and unconditional beliefs (e.g., “i’m weak”). similarly to depressed patients, individuals with social anxiety disorder also have diminished levels of positive affect due to lack of normative positive biases, unusual processing of positive events in the form of dampening positive affect, and lack of positive self-evaluations, which also contribute to living in a cold, harsh inner world (farmer et al., 2014). efficacy of metta interventions in depression and social anxiety. can we change the inner experience (qualia) in relation to oneself ? compassion-based (metta) interventions have been found to be effective in treating de‐ pression, anxiety, and shame, although the conceptualizations and treatment approaches are diverse (finlay-jones, 2017; kirby, 2017). for instance, compassion-focused therapy (gilbert & procter, 2006) is itself a form of psychotherapy, including the functional analy‐ sis of self-criticism and safety behaviors, explicitly training clients in decentering from their inner self-critical voice, and using experiential techniques such as compassion im‐ agery, compassionate letter writing, or the two-chair technique. compassion-focused therapy has been found to be effective in increasing happiness and mindfulness and de‐ metta and cbt 6 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ creasing worry and emotional suppression in the general population (jazaieri et al., 2014), as well as in schizophrenic, anxious, depressed, and disordered eating populations (see graser & stangier, 2018 and kirby, 2017). another type of compassion intervention, mindfulness-based compassionate living was administered online and was found to be ef‐ fective in reducing depressive and anxiety symptoms in participants with high levels of self-criticism, thus pointing to its potential as a transdiagnostic intervention (krieger et al., 2019). as an emotion regulation strategy, self-compassion is similarly effective as reapprais‐ al and acceptance in reducing depressed mood following a mood induction task in de‐ pressed participants, but the effect seems to be moderated by baseline levels of depres‐ sion, in the sense that self-compassion appears to be more effective than reappraisal for more severely depressed participants (diedrich, grant, hofmann, hiller, & berking, 2014). also, even a short, 7-minute lkm exercise (i.e., imagining two loved ones sending their love to the participants) can increase explicit and implicit positivity towards strang‐ ers and implicit positivity towards the self, as well as positive affect (calm, happy, loving) when compared to a control condition (hutcherson, seppala, & gross, 2008). regarding social anxiety, a recent study (cȃndea & szentágotai-tătar, 2018) examined self-compassion as an emotion regulation strategy (i.e., for people with social anxiety) comparing self-compassion to cognitive reappraisal and waitlist. they found no differen‐ ces at posttest between the groups, although the self-compassion group had significantly lower levels of shame-proneness and fear of negative evaluation at posttest compared to the pretest levels. also, shame-proneness decreased from pre to posttest only in the selfcompassion and cognitive reappraisal groups. similar results had been previously ob‐ tained, showing that self-compassion and cognitive reappraisal as emotion regulation strategies are similarly effective in reducing self-conscious negative emotions (a combi‐ nation of shame, embarrassment, shyness, guilt, and regret), and more effective than re‐ sponsibility reattribution and control condition (arimitsu & hofmann, 2017). all these results suggest that metta interventions can qualitatively change the inner experience of oneself, thus fostering feelings of warmth, acceptance, and peace. positive affect and its role in depression and social anxiety: how metta interventions can help the data previously presented suggest that being overly self-critical and exhibiting an in‐ flexible vision of oneself are at the core of depression and social anxiety disorder. there‐ fore, metta-focused interventions may be particularly beneficial for treating these prob‐ lems. according to the emotion dysregulation model of mood and anxiety disorders (hofmann et al., 2012), apart from the enduring negative affect, both depression and so‐ cial anxiety are characterized by deficiencies in positive affect (brown, 2007), which are less specifically targeted by cbt protocols, potentially with the exception of behavioral activation. increasing positive affect is especially important in depression and social stefan & hofmann 7 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ anxiety since, apart from increasing well-being as proposed by the broaden and build theory (fredrickson, 2001), it enhances behavioral repertoires, promoting approach be‐ haviors to relevant situations (e.g., social situations, pleasant activities, new contexts and challenges), instead of the typical withdrawal and avoidance behaviors. essentially, posi‐ tive emotions extend the behavioral spectrum in reverse to negative emotions, which are associated with more circumscribed responses (e.g., withdrawal associated with sadness). when it comes to loving kindness and compassion specifically, the action tendencies that follow are those of interactional and interpersonal engagement, even if the emotional re‐ sponses may differ between the two (happiness versus compassion), thus pointing to their unique contribution in alleviating depression and social anxiety (hofmann et al., 2011). metta meditation has the potential to increase positive affect, especially since it does not rely on transient, hedonic values, but fosters a deeper sense of kindness and connectedness (hofmann et al., 2011, 2012). in this sense, meta-analytic results show that loving kindness increases the level positive emotions, potentially more so the peaceful and prosocial emotions, to a larger extent compared to compassion interventions (zeng et al., 2015). this is not surprising, given the fact that compassion and self-compassion interventions stem from the experience and acceptance of suffering. also, in a proof-ofconcept study, loving kindness meditation, administered as a 12-session group interven‐ tion, was found to be effective for symptoms of dysthymia and depression, as well as for increasing positive affect (hofmann et al., 2015). including metta interventions into cbt apart from using them as independent interventions, metta interventions can be used adjunctively to cbt protocols in order to increase positive affect levels and to create an appropriate emotional climate for clients to easily accept the cognitive restructuring of negative self-schemas. metta meditation can be time restricted as to accommodate typical cbt sessions, with the advantage of facilitating cognitive restructuring and potentially also increasing the level of positive affect. metta interventions can be delivered as exerci‐ ses in individual and group psychotherapy, practiced in the beginning or at the end of the cbt session, and then also as homework. we can also design interventions which in‐ clude one or two sessions of metta interventions, then maintain the interventions as homework while the protocol proceeds as usual. some authors also designed protocols where compassion-based sessions are introduced at the end of treatment, following the first standard cbt sessions (e.g., asano et al., 2017). however, given that both loving kindness and self-compassion meditation are, like mindfulness, abilities acquired in time, it is essential to practice them continually. nowadays, we can find various types of loving kindness and self-compassion exercises online, which is a useful resource for both pa‐ tients and practitioners. although we believe these interventions can be easily practiced by cbt trained therapists (with no additional credentials), exercising these abilities one‐ self, as well as advanced reading and practical training are important prerequisites. so metta and cbt 8 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ far, few studies have tested the combination of cbt and metta interventions in clinical trials. to date, experimental data has shown that adding a preparatory self-compassion ex‐ ercise prior to a cognitive reappraisal task increases the efficacy of the latter in depressed individuals, thus providing encouraging results (diedrich, hofmann, cuijpers, & berking, 2016). that is, participants who practiced a self-compassion exercise (seeing oneself as from outside with a compassionate mindset) showed afterwards a greater reduction in negative emotions during cognitive reappraisal, following a negative mood induction task. these results point to the usefulness of metta interventions in facilitating cognitive restructuring, thus providing another argument for incorporating them into cbt. similarly, one of our ongoing studies aims to investigate how group cbt plus positive affect training (including mindfulness and loving kindness meditation) fares for people with low positive mood, irrespective of disorder. in this study, the protocol (12 sessions) introduces the concept and practice of mindfulness as an adjunct to forthcoming loving kindness meditation in the first two sessions, while the concept of loving kindness is in‐ troduced and practiced starting with session 3 (approximately 40 minutes). the following group sessions (4-12) begin with a brief 10-minute mindfulness exercise, then classic cbt techniques and exercises (e.g., thought record, cognitive restructuring, behavioral activa‐ tion) are introduced, and followed by metta meditation (10 minutes) and debriefing (10 minutes), each time promoting a more challenging target of loving kindness (e.g., beloved friend, then someone neutral, etc.). participants are also instructed to practice the medita‐ tion exercises at home. other studies have investigated the use of compassion-based interventions (i.e., not only meditation, but also exercises such as letter writing) in combination with cbt. for instance, a single group feasibility study tested the combination of cbt with compassion intervention sessions in depressed participants with good results (asano et al., 2017). the protocol (10 sessions) used standard cbt and, in the last three sessions approached shame and self-criticism, memories of compassion, and compassion letters. combining cbt with compassionate mind training in 12 sessions (combining imagery exercises with other techniques, like letter writing and grounding) was also shown to be effective for people referred to therapy as victims of traumatic incidents, with the cbt plus compas‐ sionate mind training scoring higher on self-compassion post-therapy (beaumont et al., 2012). finally, we have to keep in mind the fact that some barriers may restrict the useful‐ ness of metta interventions. for instance, individuals high on self-criticism often show a fear of compassion and self-compassion, because these states are experienced as unfami‐ liar and sometimes, as a sign of weakness (gilbert, mcewan, matos, & rivis, 2011). also, precisely because metta interventions foster a sense of calm and soothing rather than a more energetic kind of positive affect, they may appeal less to some people who value the latter kind of emotions more (galante et al., 2014). in these cases, introducing other stefan & hofmann 9 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://www.psychopen.eu/ compassion-based techniques besides meditation could be helpful (e.g., two-chair techni‐ que with the critical and the criticized self). c o n c l u s i o n metta interventions have been shown to be effective for a wide range of emotional prob‐ lems, reducing shame and self-criticism, and also increasing positive affect. this allows for conversions into promising interventions especially for disorders characterized by harsh, critical, inflexible self-views and low positive affect, with depressive and social anxiety disorders as the most prevalent. precisely because loving kindness and compas‐ sion are experienced less by these patients, metta interventions appear to be particularly useful; whether they really succeed, however, is still an empirical question (e.g., they may be difficult to practice by these participants again, because they lack these abilities in the first place). more data are needed in clinical populations, as well as for comparisons with active control groups. nonetheless, so far it seems that metta interventions are effective as independent interventions, as well as emotion regulation strategies, and potentially as adjuncts to cbt protocols as well. future research should look into the added benefits of combining loving kindness and compassion interventions with established treatment protocols and address their mechanisms of change. funding: dr. hofmann receives financial support from the alexander von humboldt foundation (as part of the humboldt prize), nih/nccih (r01at007257), nih/nimh (r01mh099021, u01mh108168), and the james s. mcdonnell foundation 21st century science initiative in understanding human cognition – special initiative. he receives compensation for his work as editor from springernature and the association for psychological science, and as an advisor from the palo alto health sciences and for his work as a subject matter expert from john wiley & sons, inc. and silvercloud health, inc. he also receives royalties and payments for his editorial work from various publishers. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. r e f e r e n c e s arimitsu, k., & hofmann, s. g. 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(2015). the effect of lovingkindness meditation on positive emotions: a meta-analytic review. frontiers in psychology, 6, article 1693. https://doi.org/10.3389/fpsyg.2015.01693 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. stefan & hofmann 15 clinical psychology in europe 2019, vol.1(3), article e32941 https://doi.org/10.32872/cpe.v1i3.32941 https://doi.org/10.1007/s12671-014-0368-1 https://doi.org/10.1002/jts.20374 https://doi.org/10.3389/fpsyg.2018.00756 https://doi.org/10.1080/10615806.2011.608842 https://doi.org/10.3389/fpsyg.2015.01693 https://www.psychopen.eu/ metta and cbt loving kindness and compassion meditation in psychotherapy loving kindness and self-compassion in depression and social anxiety disorder negative self-views, self-criticism, and shame in depression and social anxiety emotion regulation and negative self-schemas efficacy of metta interventions in depression and social anxiety. can we change the inner experience (qualia) in relation to oneself? positive affect and its role in depression and social anxiety: how metta interventions can help including metta interventions into cbt conclusion (additional information) funding competing interests acknowledgments references a response to marvin goldfried's article on the immaturity of the psy-professions letter to the editor, commentary a response to marvin goldfried's article on the immaturity of the psy-professions vik nair a [a] nhs greater glasgow and clyde, glasgow, united kingdom. clinical psychology in europe, 2020, vol. 2(2), article e3105, https://doi.org/10.32872/cpe.v2i2.3105 published (vor): 2020-06-30 corresponding author: vik nair, glasgow psychological trauma centre, the anchor, festival business centre, 150 brand street, glasgow, g51 1dh, united kingdom. e-mail: vikas.nair@nhs.net marvin goldfried’s article (goldfried, 2020) critiqued the lack of consensus within the psy-professions, articulating reasons for this, but without mentioning power or interest. i believe the preoccupation with new theories described by goldfried arises from our inability to discard unworkable ideas, despite ample empirical or conceptual grounds for doing so, because of the workings of power. if technology is the ability to understand and manipulate the non-human material world, social power is the ability to influence the behaviour of other humans. social pow‐ er varies according to the identities of the parties involved, while technology does not. disciplines concerned with humans affect and are affected by social power, immediately creating uncertainty. people do not passively accept the effects of new knowledge, but seek to achieve outcomes favourable to their interests by taking control over that knowl‐ edge (“history is written by the victors”). research findings are not determined solely by empirical data, but also through the exercise of ideological power. social dynamics affect what is asked, what answers are acceptable, how data is interpreted and how much attention is paid to conclusions. our profession's immaturity is not for want of empirical data. questions that may have been answerable decades ago persist because the answers have been unacceptable to powerful interests. would we really expect the psychometric industry (enmeshed with clinical psychology because of the power it affords the profession) to accept that there is no evidence to support the existence of g or temporally and contextually stable personality? would the legal systems in our societies suddenly shift from punishment to pragmatism, as proposed by skinner (1973) almost half a century ago, simply because of empirical data refuting free will? is the persistence of psychiatric diagnosis due to its utility or to the power of the psychiatric profession? how many expert witnesses in legal this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.3105&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ cases point out to judges that data obtained through self-report psychometrics is in no way objective? this is not to suggest that change cannot happen, but that social power is as least as important as “truth” in determining how knowledge develops. attempts to increase the maturity of our discipline have to take account of power and interest. funding: the author has no funding to report. competing interests: the author has declared that no competing interests exist. acknowledgments: the author has no support to report. r e f e r e n c e s goldfried, m. r. (2020). the field of psychotherapy: over 100 years old and still an infant science. clinical psychology in europe, 2(1), article e2753. https://doi.org/10.32872/cpe.v2i1.2753 skinner, b. f. (1973). beyond freedom and dignity. new york, ny, usa: bantam books, vintage books. (original work published 1971) clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. letter to the editor 2 clinical psychology in europe 2020, vol.2(2), article e3105 https://doi.org/10.32872/cpe.v2i2.3105 https://doi.org/10.32872/cpe.v2i1.2753 https://www.psychopen.eu/ social impairments in mental disorders: recent developments in studying the mechanisms of interactive behavior scientific update and overview social impairments in mental disorders: recent developments in studying the mechanisms of interactive behavior konrad lehmann a, lara maliske a, anne böckler bc, philipp kanske ac [a] clinical psychology and behavioral neuroscience, faculty of psychology, technische universität dresden, dresden, germany. [b] institute of psychology, julius-maximilians-universität würzburg, würzburg, germany. [c] max planck institute for human cognitive and brain sciences, leipzig, germany. clinical psychology in europe, 2019, vol. 1(2), article e33143, https://doi.org/10.32872/cpe.v1i2.33143 received: 2019-01-16 • accepted: 2019-05-22 • published (vor): 2019-06-28 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: lara maliske, clinical psychology and behavioral neuroscience, faculty of psychology, technische universität dresden, chemnitzer str. 46, 01187 dresden, germany. e-mail: lara.maliske@tu-dresden.de abstract background: most mental disorders are associated with impairments in social functioning. paradigms developed to study social functioning in laboratory settings mostly put participants in a detached observer point of view. however, some phenomena are inherently interactive and studying full-blown reciprocal interactions may be indispensable to understand social deficits in psychopathology. method: we conducted a narrative review on recent developments in the field of experimental clinical psychology and clinical social neuroscience that employs a second-person approach to studying social impairments in autism spectrum disorder (asd), personality disorder, social anxiety disorder (sad), and schizophrenia. results: recent developments in methodological, analytical, and technical approaches, such as dual eye-tracking, mobile eye-tracking, live video-feed, hyperscanning, or motion capture allow for a more ecologically valid assessment of social functioning. in individuals with asd, these methods revealed reduced sensitivity to the presence of a real interaction partner as well as diminished behavioral and neural synchronicity with interaction partners. initial evidence suggests that interactive paradigms might be a powerful tool to reveal reduced interpersonal sensitivity in personality disorders and increased interpersonal sensitivity in individuals with sad. conclusion: a shift towards adapting a second-person account has clearly benefitted research on social interaction in psychopathology. several studies showed profound differences in behavioral and neural measures during actual social interactions, as compared to engaging participants as mere observers. while research using truly interactive paradigms is still in its infancy, it holds great potential for clinical research on social interaction. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.33143&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords social interaction, social cognition, second-person approach, mental disorders, social immersion, ecological validity highlights • we review studies adopting a second-person account of social interaction in clinical psychology. • studies show profound differences between actual social interactions and mere observations. • the full extent of impairments in social functioning unfolds only in complex social interactions. • new methodological developments hold great potential for research on social interaction deficits. most mental disorders are associated with impairments in social functioning. social diffi‐ culties are both diagnostic criteria for several disorders such as autism, schizophrenia, social anxiety disorder, or personality disorders (kennedy & adolphs, 2012; skodol et al., 2002) and also constitute risk factors for developing, sustaining, and exacerbating clinical symptoms (cacioppo, hawkley, & thisted, 2010; fowler, allen, oldham, & frueh, 2013; hawkley & cacioppo, 2010). though social functioning is complex and challenging to assess, several recent methodological advancements may allow to directly study so‐ cial-interactive behavior and its underlying (neural) mechanisms in more ecologically valid ways. the goal of this update article is to delineate these developments and their relevance for understanding mental disorders. deficits in social functioning can be based on impairments in the underlying social affective and cognitive processes (amodio & frith, 2006) that range from basic social at‐ tention and memory to empathy and theory of mind (tom; also termed mentalizing; happé, cook, & bird, 2017; kanske, 2018). while empathy allows access to other minds via directly sharing other persons’ emotional states (de vignemont & singer, 2006), men‐ talizing enables the understanding of others through abstract inference of their thoughts and beliefs (frith & frith, 2005). the typical approach to studying these phenomena in experimental clinical psychology and social neuroscience has been criticized as assessing individual minds as detached observers (fuchs & de jaegher, 2009). paradigms ask partic‐ ipants, for instance, to predict the behavior of cartoon characters, classify emotions of static pictures of eyes, or judge the trustworthiness of face photographs. while these tasks have certainly provided valuable insight into the mechanisms of social functioning, they lack the reciprocal nature of full-blown interactions (bird et al., 2010; dziobek et al., 2008; kanske, böckler, trautwein, & singer, 2015; von dem hagen, stoyanova, rowe, baron-cohen, & calder, 2014; walter et al., 2009). social impairments in mental disorders 2 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ in contrast to this observer account of social cognition, recent developments in philos‐ ophy, experimental psychology, and neuroscience call for a second-person account that en‐ gages participants in real dynamic interactions (e.g., de jaegher, di paolo, & gallagher, 2010; gallagher, 2008; konvalinka & roepstorff, 2012; schilbach et al., 2013). researchers argue that making sense of another person during an embodied and ongoing social inter‐ action occurs implicitly by making use of enactive perception that takes the context of a shared, intersubjective world into account. in real-time social interaction, implicit pro‐ cesses seem to be more relevant than the explicit forms that have been especially empha‐ sized in previous research (schilbach, 2016). accordingly, the full extent of deficient so‐ cial functioning in psychopathology may only manifest in complex social interactions. for instance, autistic individuals report more problems with direct and immediate social interactions than situations involving slow-paced interactions (e.g., email) or social ob‐ servation. recent research has advanced paradigms originating from an observer account of so‐ cial interaction towards implementing interactions (or at least interactive elements) with one or more real other persons. in addition to examining real, reciprocal interaction, au‐ thors suggested that even the potential for reciprocal interaction constitutes an impor‐ tant step forward, as one becomes actively engaged through another person that is expe‐ rienced as active and salient (krach, müller-pinzler, westermann, & paulus, 2013; risko, richardson, & kingstone, 2016) – a process that is also referred to as social immersion. among the novel approaches, research on gaze behavior has taken a leading role. one prominent paradigm makes use of anthropomorphic virtual characters who respond in a contingent way to participants’ eye movements, resulting in reciprocal interaction (wilms et al., 2010). comparably, redcay et al. (2010) developed a paradigm using live video-feed that allows for gaze based face-to-face interaction between an experimenter outside and a participant inside a magnetic resonance imaging (mri) scanner. yet another setup even enables two participants to interact via live video-feed while simultaneously tracking their eye-movements (hessels, cornelissen, hooge, & kemner, 2017). such a du‐ al eye-tracking method has also been implemented in setups wherein two individuals are lying in mri scanners (e.g., saito et al., 2010), enabling the simultaneous acquisition of brain activation of two interacting persons (referred to as hyperscanning). other ap‐ proaches rely less on technical means but establish real live interaction between partici‐ pants with, for instance, free eye contact or structured conversations while measuring the allocation of visual attention or indicators of arousal (e.g., freeth, foulsham, & kingstone, 2013; myllyneva, ranta, & hietanen, 2015). while these paradigms sometimes differ substantially in the way they operationalize social interactions, they can be classi‐ fied along different dimensions, such as complexity of interaction, temporal dynamics, social presence, and embodiment (table 1). lehmann, maliske, böckler, & kanske 3 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ table 1 classification of studies task / study social presence interaction complexity temporal dynamics embodiment disorder measure joint attention (oberwelland et al., 2017; redcay et al., 2013; including dual eye-tracking: bilek et al., 2017; tanabe et al., 2012) yes medium low high medium high visual information autism / borderline personality disorder neural activity & gaze behavior mutual eye-gaze (hessels et al., 2018; myllyneva et al., 2015) yes low high medium high visual information autism / social anxiety disorder gaze behavior listening to short stories (rice & redcay, 2016) yes vs. no (experimental condition) low low medium auditory information autism neural activity listening to short stories (von dem hagen & bright, 2017) yes vs. no (experimental condition) no interaction high visual + auditory information autism gaze behavior live face-to-face interaction (freeth & bugembe, 2019; freeth et al., 2013; hanley et al., 2015; hanley et al., 2014; magrelli et al., 2013; nadig et al., 2010) yes high high very high physically present autism gaze behavior live interaction (fitzpatrick et al., 2017a, 2017b; romero et al., 2018) yes high high very high physically present autism movement kinematics performance task, audience present (chib et al., 2018; müller-pinzler et al., 2015) yes vs. no (experimental condition) no interaction medium high visual information social anxiety disorder neural activity touch anticipation (scalabrini et al., 2017) yes low high medium tactile information narcissistic personality disorder neural activity conversation (takei et al., 2013) yes high high very high physically present schizophrenia neural activity note. the table summarizes how the reviewed studies (clustered by the kind of task) vary on features of social interaction. these features encompass the social presence of the interaction partner or audience in a mutual social situation; the interaction complexity expresses how much information is transferred during the interac‐ tion; the temporal dynamics of the interaction provides information about how quick responses have to be inte‐ grated and reacted upon; and the embodiment of the interaction partner expresses how rich s/he is perceived by the participant. this update article shortly reviews recent laboratory studies that adopt a second-person account of social interaction within clinical experimental psychology and clinical social neuroscience. we want to delineate how novel and ecologically valid measures have hel‐ social impairments in mental disorders 4 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ ped to gain new insight into impairments of social interaction, with a particular focus on studies employing advanced experimental and methodological approaches. this kind of research in the context of mental disorders is still scarce and we will focus on autism spectrum disorders, personality disorders, social anxiety disorder, and schizophrenia. a u t i s m s p e c t r u m d i s o r d e r autism spectrum disorder (asd) is a developmental disorder manifested particularly in persistent patterns of deficient social interactive and communicative behavior (e.g., irreg‐ ular eye contact, behavioral inflexibility in social contexts) (american psychiatric association [apa], 2013). deficits in joint attention are one of the core impairments in asd (dawson, bernier, & ring, 2012). establishing joint attention – for instance, by directing or following anoth‐ er’s gaze to an object – is a simple, but inherently interactive process (redcay, kleiner, & saxe, 2012) that can easily be implemented in truly interactive settings. using a live vid‐ eo-feed, tanabe and colleagues (2012) employed a dual eye-tracking joint attention task in dyads of asd and typically developed (td) participants during mri hyperscanning. asd participants showed reduced accuracy at detecting gaze direction, corresponding with reduced neural activation in the left occipital pole, suggesting altered early visual gaze processing. furthermore, mixed pairs of td and asd participants revealed lower neural synchronization in the right inferior frontal gyrus (ifg) than td-td pairs, which the authors attributed to problems integrating selfand other-oriented attention in asd participants. in another joint attention study using a live video-feed, asd participants did not differ behaviorally from td participants (redcay et al., 2013). however, on the neural level, asd participants (in contrast to td participants) did not show differential activity between social and non-social conditions in the dorsomedial prefrontal cortex (dmpfc) and left posterior superior temporal sulcus (lpsts), which might play a role in mutual engagement with a social partner. similar patterns were observed using virtual interacting avatars (oberwelland et al., 2017). beyond simple joint attention, one study used task-independent dual eye-tracking, in‐ structing participants to look at each other for five minutes (hessels, holleman, cornelissen, hooge, & kemner, 2018). pairs high in autism displayed less two-way eye gaze (i.e., eye contact), but, interestingly, more one-way eye gaze (only one participant looking in the eyes of the other). the interactive nature of this study design could pro‐ vide support for the so-called gaze aversion model (i.e., avoidance of eye contact) over the gaze indifference model (i.e., insensitivity to others’ eyes) (moriuchi, klin, & jones, 2017). directly targeting the role of true interaction, some studies investigated how different degrees of ecological validity differentially influence behavior along autistic traits. rice and redcay (2016) implemented a simulated live interaction between participants in an mri scanner and an experimenter, examining how brain activity is altered depending on lehmann, maliske, böckler, & kanske 5 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ whether participants think speech is addressed to them live versus pre-recorded. increas‐ ing scores in subclinical autism went along with reduced differential dmpfc activation for live compared to pre-recorded speech, presumably reflecting lower perceived liveness of the speaker in high autistic individuals. similarly, von dem hagen and bright (2017) manipulated participants’ belief whether the video of a person telling a story was prerecorded or live. while these different beliefs resulted in modulated attention towards the eye region in low autistic individuals, they did not affect the attention of persons with high autistic traits. using mobile eye-tracking, freeth et al. (2013) involved participants in a structured conversation with an experimenter whose social presence varied (live faceto-face interaction versus pre-recorded video). during the pre-recorded video ‘interac‐ tion’, the amount of time looked at the experimenter correlated negatively with subclini‐ cal autistic traits, whereas there was no such correlation in the face-to-face interaction. these studies suggest that individuals with asd display reduced sensitivity to the cues of online versus offline interaction compared to td individuals. several other studies have used mobile eye-tracking in the context of a more natural social environment. during a semi-structured conversation, children with asd looked less to the face of the experimenter (particularly to the eyes) than children without asd (hanley et al., 2014; magrelli et al., 2013). children were mostly listening in hanley and colleagues’ (2014) study, and this pattern of reduced looking at their interaction partner’s face was not found when children were primarily speaking (nadig, lee, singh, bosshart, & ozonoff, 2010). during a structured face-to-face conversation, adults with asd showed fewer fixations on the eyes and more fixations on the mouth as compared to td adults, however, they showed no alterations in fixation on the face in general (hanley et al., 2015). similarly, freeth and bugembe (2019) found no difference in fixations on the face when the social partner’s gaze was averted. however, when participants were being looked at directly, individuals with asd fixated the face for a shorter time than td indi‐ viduals. these interactive studies have helped to reveal factors that modulate social at‐ tention of autistic individuals, such as conversational phase or gaze direction of the inter‐ locutor. to capture nonverbal interpersonal behavior beyond eye gaze, several recent studies employed videoor device-based motion tracking (e.g., fitzpatrick et al., 2017a; romero et al., 2018). using a motion-tracking device, fitzpatrick and colleagues (2017a) imple‐ mented a battery of imitation and motor synchronization tasks to capture dynamical measures of synchronicity. children with asd showed reduced social synchronization abilities and had difficulties producing consistently timed movements over the course of an interaction. interestingly, synchronization abilities correlated with performance on a false-belief tom task (fitzpatrick et al., 2017b). romero and colleagues (2018) objectively quantified synchronization of whole-body movement from video recordings of live inter‐ actions, showing that complex whole-body synchronicity between children with asd and clinicians was above chance level, and correlated negatively with asd severity, that social impairments in mental disorders 6 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ is, children with higher social-cognitive abilities exhibited more behavioral synchronici‐ ty. such dynamic measures of interpersonal behavior and coordination provide interest‐ ing insights into more complex components of social interaction. in summary, these results underline how asd research benefits from implementing a second-person approach: being addressed by a social partner modulates social attention in response to different contextual factors. depending on the type of paradigm (e.g., joint attention, manipulation of the degree of ecological validity), asd compared to td indi‐ viduals show reduced sensitivity to the presence versus absence of a real-interaction partner, both in neural and in behavioral measures. in addition, asd participants re‐ vealed diminished levels of neural and behavioral synchronicity with td interaction partners. p e r s o n a l i t y d i s o r d e r s personality disorders comprise a number of maladaptive behavioral patterns and cogni‐ tive styles (apa, 2013). based on previous research, we will focus on borderline personal‐ ity disorder (bpd) and narcissistic personality disorder (npd). bpd is characterized by unstable affect and self-image as well as impulsivity, account‐ ing for severely impaired everyday social functioning (apa, 2013). investigating social interactions through a joint attention task, bilek and colleagues (2017) assessed live inter‐ acting dyads in mri hyperscanning. neural coupling at the site of right temporo-parietal junction (rtpj), a core region for mentalizing processes, was lowest in bpd-healthy con‐ trol (hc) dyads, which might be a cause for difficulties in social interactions in everyday life. interestingly, coupling in dyads of remittent bpd and hc was at the level of hc-hc dyads, suggesting a state specificity or reversibility of low neural coupling in bpd. npd is characterized by the need for admiration, a lack of empathy as well as pro‐ nounced self-absorbedness. in subclinical narcissism, scalabrini and colleagues (2017) re‐ ported higher scores on narcissistic grandiosity going along with reduced activation in the right anterior insula (rai) in anticipation of touching a human hand. the rai is a main structure of the so-called salience network that is assumed to switch attention away from internal towards external stimuli, indicating that narcissists might be less respon‐ sive to others and rather remain in self-reflective internal processes. taken together, though studies employing truly interactive tasks are still sparse in personality disorders, initial evidence indicates the power of these paradigms in revealing reduced interpersonal sensitivity in the respective populations. lehmann, maliske, böckler, & kanske 7 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ s o c i a l a n x i e t y d i s o r d e r the diagnostic criteria for social anxiety disorder (sad) include fear in social perform‐ ance situations and the fear of behaving embarrassingly, leading to avoidance of the re‐ spective situations altogether (apa, 2013). experimental settings that use socially immersive environments in order to induce the feeling of being observed by others are particularly suitable to study social evaluative threat and embarrassment in sad populations. in doing so, müller-pinzler and colleagues (2015) applied a value estimation task to investigate neural pathways of em‐ barrassment. participants were led to believe that feedback regarding their performance in the experimental task was shared with three confederates outside the scanner room. when feedback on their performance was made public, participants with higher levels of sad showed heightened visual attention towards their observers’ faces, as well as in‐ creased activation in medial prefrontal cortex (mpfc) and the right fusiform face area, possibly indicating increased attention to others and mentalizing about how oneself is perceived by the audience. similar results were reported for the performance in a motor task under observation (chib, adachi, & o’doherty, 2018). in a behavioral task using dual eye-tracking, pairs of participants were instructed to look at each other for five minutes (hessels et al., 2018; see section on autism above). pairs high in subclinical social anxiety were engaged in more frequent, but shorter oneway eye gaze than low social anxiety pairs. myllyneva et al. (2015) had a person sitting opposite the participant with an lcd screen in between that could be either transparent or opaque. when the switching between transparent and opaque was computer control‐ led, both sad adolescents and controls showed higher arousal to direct gaze than to averted gaze by the other person. however, when participants were forced to initiate the social interaction themselves by controlling when the screen turned transparent/opaque, this difference only remained in individuals with sad. hence, self-initiated interaction reduced direct-gaze related arousal in healthy participants, but not in sad participants. overall, these results corroborate clinical descriptions of sad regarding a higher con‐ cern of one’s public appearance, resulting in increased neural activation of areas associ‐ ated with mentalizing and face processing. the possibility to actively initiate contact with an interaction partner could reveal different arousal patterns in response to direct (versus averted) gaze between sad patients and healthy controls. s c h i z o p h r e n i a schizophrenia (scz) is a mental disorder characterized by profound changes in behavior, communication, and cognition, with symptoms including hallucinations, disorganized speech and behavior, and delusions that greatly impair interpersonal functioning (apa, 2013; tandon et al., 2013). social impairments in mental disorders 8 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ to investigate neural activation in scz during live face-to-face conversation, takei and colleagues (2013) used functional near infrared spectography (fnirs) in a sample of scz patients and controls to investigate neural patterns during live interaction. specifi‐ cally, participants and experimenters spoke for fixed intervals about a previously speci‐ fied topic. scz participants exhibited less appropriate speech, lower production of new topics, and spoke less overall. on a neural level, scz participants showed decreased ac‐ tivity in bilateral temporal lobes and right inferior frontal gyrus, co-varying with nega‐ tive symptoms and disorganization, where the authors suggest a causal role of these brain areas. while the field of scz research is still underrepresented regarding the implementa‐ tion of truly interactive paradigms, these results show an interesting trend that could not have been revealed in other, less interactive tasks. c o n c l u s i o n a shift towards applying a second-person account has clearly benefitted research on so‐ cial interaction in psychopathology, with the case of autism taking a prominent role. sev‐ eral studies showed profound differences in behavioral and neural measures during ac‐ tual social interactions, as compared to engaging participants as mere observers. this pattern suggests that the full extent and the nature of impairments in social functioning unfolds only in complex social interactions. furthermore, many social phenomena are inherently interactive and can therefore only manifest themselves in paradigms implementing real dynamic interactions. the sec‐ ond-person account aims at capturing the underlying mechanisms of these phenomena in their entirety. a few published studies employed hyperscanning with dyads consisting of healthy and psychopathological participants during live interaction, enabling the in‐ vestigation of co-activation patterns and synchronization of brain activity. however, the possibilities to interact while lying in an mri scanner are highly restricted and para‐ digms used in this context are limited in their degree of ecological validity. likewise, the implementation of paradigms employing more complex social interactions introduces new methodological problems, such as complexity of data and reduced experimental con‐ trol. here, economic games offer the chance to study social interactions in a controlled environment but with limited flexibility within the interaction. the use of virtual reality bears potential to regain experimental control as the behavior of a virtual character can be manipulated gradually. usually, this comes at the price of the participants being aware that they interact not with another human but a virtual agent as has been done in experi‐ mental studies addressing autism and psychotic symptoms (e.g., forbes, pan, & hamilton, 2016; veling, pot-kolder, counotte, van os, & van der gaag, 2016). this prob‐ lem could, however, be overcome by applying a cover story making participants believe lehmann, maliske, böckler, & kanske 9 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://www.psychopen.eu/ that they interact with a virtual avatar that is controlled by another human (e.g., wilms et al., 2010). outside the scanner, paradigms with real life face-to-face interaction allow assessing the embodied and implicit nature of interactions. the use of technical means such as mo‐ bile eye-tracking or motion capturing devices as well as advanced analytical methods represent an advancement in objective quantification of social interactions. however, it should be noted that although these advanced methods enhance the ecological validity of social interactions in the laboratory, assessing factors like emotions or the dynamics of interpersonal relations remains challenging. here, field methods and self-report measures are still the means of choice: ecological momentary assessment (ema) – the collection of various types of data via portable technical devices – has the advantage of capturing reallife social interactions while (or shortly after) they are happening. furthermore, they can be complemented with more objective measures such as the electronically activated re‐ corder (ear). here, participants wear a portable audio recorder that periodically records the acoustic environment, allowing for the analysis of, for instance, the words or prosody used during social interaction or the number of interaction partners. in conclusion, paradigms employing a second-person approach to the study of social interactions in mental disorders have yielded promising results. while research using truly interactive paradigms is still in its infancy, it holds great potential for clinical re‐ search on social interaction. funding: pk is supported by german federal ministry of education and research within the asd-net (bmbf fkz 01ee1409a), the german research council (heinz maier-leibnitz prize ka 4412/1-1) and die junge akademie at the berlin-brandenburg academy of sciences and humanities and the german national academy of sciences leopoldina. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. author contributions: the first and second author contributed equally to this work. r e f e r e n c e s american psychiatric association. 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(2010). it’s in your eyesusing gaze-contingent stimuli to create truly interactive paradigms for social cognitive and affective neuroscience. social cognitive and affective neuroscience, 5(1), 98-107. https://doi.org/10.1093/scan/nsq024 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. lehmann, maliske, böckler, & kanske 15 clinical psychology in europe 2019, vol.1(2), article e33143 https://doi.org/10.32872/cpe.v1i2.33143 https://doi.org/10.1093/cercor/bht003 https://doi.org/10.1093/scan/nsn047 https://doi.org/10.1093/scan/nsq024 https://www.psychopen.eu/ social impairments in mental disorders (introduction) autism spectrum disorder personality disorders social anxiety disorder schizophrenia conclusion (additional information) funding competing interests acknowledgments author contributions references fear of happiness predicts concurrent but not prospective depressive symptoms in adolescents research articles fear of happiness predicts concurrent but not prospective depressive symptoms in adolescents merle kock 1,2,3 , eline belmans 1,2 , filip raes 1,2,3 [1] centre for the psychology of learning and experimental psychopathology, ku leuven, leuven, belgium. [2] child & youth institute, ku leuven, leuven, belgium. [3] leuven mindfulness centre, ku leuven, leuven, belgium. clinical psychology in europe, 2023, vol. 5(2), article e10495, https://doi.org/10.32872/cpe.10495 received: 2022-10-18 • accepted: 2023-02-21 • published (vor): 2023-06-29 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: merle kock, tiensestraat 102, box 3712, 3000 leuven, belgium. phone: +32 16 71 02 37. email: merle.kock@kuleuven.be supplementary materials: materials [see index of supplementary materials] abstract background: it is increasingly recognised that the study of responses to positive emotions significantly contributes to our understanding of psychopathology. notably, positive emotions are not necessarily experienced as pleasurable. instead, some believe that experiencing happiness may have negative consequences, referred to as fear of happiness (foh), or they experience a fear of losing control over positive emotions (folc). according to reward devaluation theory, such an association of positivity with negative outcomes will result in positive stimuli being devalued over time, contributing to or maintaining depressive symptoms. the prospective relationship between fears of positivity and depressive symptoms is yet to be examined in adolescents. the present longitudinal study investigated whether foh and folc prospectively predict depressive symptoms. method: 128 adolescents between 16-18 years of age (m = 16.87, sd = 0.80) recruited from two secondary schools in flanders, belgium, completed measures of depressive symptoms (depression anxiety stress scales) including consummatory anhedonia, foh (fear of happiness scale), and folc (affective control scale) in their classroom at baseline and 2-months follow-up. regression analyses were performed to test the association between foh, folc, and depressive symptoms. results: foh concurrently, but not prospectively, predicted depressive symptoms. there was no significant association between foh and consummatory anhedonia. folc was not a significant predictor of depressive symptoms or consummatory anhedonia. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10495&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0001-9429-6321 https://orcid.org/0000-0001-9979-512x https://orcid.org/0000-0003-2770-2806 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: these findings suggest that foh may only be concurrently related to depressive symptoms. considering prior findings in adults, future research should investigate the association of foh with anticipatory anhedonia in adolescents. keywords adolescents, dampening, depression, fear of happiness, positive affect, anhedonia highlights • concurrent and prospective associations between fears of positivity and adolescents’ depressive symptoms were tested. • fear of happiness was concurrently but not prospectively associated with depressive symptoms. • fear of happiness did not predict consummatory anhedonia; anticipatory anhedonia was not assessed. • fear of losing control over positive emotions did not predict depressive symptoms or anhedonia. the ability to regulate emotional experience plays a vital role in development and maintenance of emotional disorders in adolescents (young et al., 2019). research into emotion regulation has to date primarily focused on negative emotions but it is increas­ ingly recognised that studying positive emotions is also of great value. because positive and negative emotions are independent of each other, emotion regulation may function differently in each domain (wood et al., 2003). moreover, deficits in experience and regulation of positive emotions are present across various forms of psychopathology (dillon & pizzagalli, 2010). from a clinical perspective, most psychological treatments are targeting negative emotions and are often ineffective for improving deficits in positive emotion regulation (dunn, 2012). thus, investigating positive emotion regulation may contribute to our understanding of psychopathology, particularly depressive disorders, over and above insights gained through research into negative emotion regulation. defining foh and folc notably, positive emotions are not necessarily experienced as pleasurable. instead, em­ pirical evidence suggests that some individuals are even afraid of positive emotions. one reason may be the belief that experiencing happiness may have negative consequences, referred to as fear of happiness (foh; joshanloo, 2013). individuals may experience foh because they are more afraid of the loss after feelings of happiness have ended than they value experiencing feelings of happiness. other individuals experience foh because they have repeatedly been disappointed when looking forward to pleasurable activities and are afraid of being disappointed again. another reason for fearing positive emotions may be that individuals are afraid of losing control over their positive emotions (folc; foh predicts concurrent depressive symptoms 2 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ williams et al., 1997), for example because they get carried away with their excitement and consequently become careless. generally, deficits in the experience of positive emotions predict a poor prognosis of depression (morris et al., 2009), possibly because positive emotions were found to increase resilience against negative life events (tugade & fredrickson, 2004). however, fear of positive emotions may prevent individuals from savouring positive emotions and using them to cope with adversities. for example, a patient with an agoraphobic mother reported getting excited to go to the beach as a child, which repeatedly ended in her mother experiencing a panic attack, triggering an argument with her father, and creating a terrible atmosphere. as a result, the patient felt she would be better off not looking forward to enjoyable activities because she got to associate positive emotions with negative outcomes (p. gilbert, 2007). according to reward devaluation theory, such a repeated association of positive emotions with either an ultimate negative outcome or simultaneous negative emotions may result in positive stimuli being devalued over time (winer & salem, 2016). positive stimuli are consciously inhibited or avoided because individuals fear that their initially positive experience will result in negative outcomes. ultimately, positivity becomes a signal of negative affect (jordan et al., 2021), which may be reflected in foh. a meta-analysis (winer & salem, 2016) provides evidence for reward devaluation theory by showing that depressed patients are more likely to avoid positive information in a dot probe task compared to anxious patients and healthy controls. moreover, two experimental studies demonstrated that pairing environmental reward with inhibition of rewarding behaviour slowed responses to reward or reduced the reward value (veling et al., 2011; veling & aarts, 2009). notably, inhibition of reward was only visible in participants initially sensitive to the reward, suggesting the initiallyrewarding stimulus was devalued rather than lacked value from the start. because foh is characterised by deficits in the positive affect system, it may be specifically related to anhedonia, a hallmark symptom of depression. anhedonia encom­ passes both deficits in looking forward to pleasurable events (anticipatory anhedonia) and deficits in experiencing pleasure during an enjoyable event (consummatory anhedo­ nia) (gard et al., 2006). since individuals with foh associate happiness with negative consequences, they may lack motivation to approach pleasurable events and may in turn develop anticipatory anhedonia. ultimately, this increase in anticipatory anhedonia may contribute to the development of other symptoms of depression such as sadness and lack of hope because individuals lack motivation to approach reward. this was supported by jordan et al. (2018) who found anticipatory anhedonia to mediate the relationship between fear of positive evaluation, another fear of positivity related to foh, and other depressive symptoms in adults. on the other hand, individuals with foh may also experience consummatory anhedonia when confronted with positive events because they associate positivity with negative outcomes. this may trigger other depressive symptoms such as lack of hope or sadness when they realise that they cannot enjoy positive kock, belmans, & raes 3 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ experiences anymore. for adolescents, who cannot withdraw as easily when caregivers confront them with pleasurable experiences, this may be especially relevant. hence, foh may be associated with and predict anticipatory and consummatory anhedonia, which in turn contributes to other depressive symptoms. previous research found that foh is strongly correlated with depression, anxiety, and stress (p. gilbert et al., 2012). using a slightly different measure of foh, joshanloo et al. (2014) showed that foh predicted lower life satisfaction above a set of recognized predictors at the individual (e.g., autonomy) and cultural level (e.g., wealth). these findings of cross-sectional studies demonstrate that foh is associated with lower wellbeing and psychopathology. there is currently only one study providing evidence for a significant positive prospective link between foh and depressive symptoms in adults (jordan et al., 2021). in contrast to foh, folc reflects losing control over positive emotions and may therefore be more related to bipolar disorder. given folc’s effect on the positive valence system, it may be especially associated with anhedonia. individuals with folc may be unable to look forward to pleasurable events (anticipatory anhedonia) because they anticipate losing control of their emotions, but they may also be unable to enjoy pleasur­ able events in the moment (consummatory anhedonia) because they fear to lose control any moment instead of enjoying the experience. this feeling of lack of control may be especially prominent in adolescents as affective control is reduced during adolescence compared to childhood and adulthood (schweizer et al., 2020). notably, poor affective control is associated with mental health problems. also fear of losing affective control (i.e. folc) has been associated with increased depressive symptoms (yoon et al., 2018). yet, findings are limited by the cross-sectional design of previous studies and folc’s influence on depressive symptoms requires further investigation. importance of assessing an adolescent sample adolescence is a crucial period with regard to mental health because a substantial amount of depressed patients experience their first episode in adolescence (zisook et al., 2007). given the possible role of foh and folc in the development of depressive disorders, it is important to study the associations of foh and folc with depressive symptoms not only in adults, which has been done in prior research, but also in adolescents. understanding which factors contribute to the development of depressive symptoms in adolescence would allow us to counteract the alarming rise of mental disorders among young people (patel et al., 2007). this rise is to be expected considering that adolescents undergo an emotionally challenging period, in which they develop strategies to regulate their emotions more independently. however, research on the use, adaptiveness, and effectiveness of emotion regulation strategies in adolescents is scarce (riediger & klipker, 2014). two experimental studies found that inducing thoughts to downregulate positive emotions (dampening) completely reduced the effects of a positive memory recall in adults while in adolescents the positive memory still positively foh predicts concurrent depressive symptoms 4 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ impacted happiness (dunn et al., 2018; yilmaz et al., 2019). these findings support the idea that appraisal-based emotion regulation strategies like dampening are less potent in adolescents because top-down cognitive control is still developing (skinner & zimmergembeck, 2016). in sum, adolescence is an important period for emotional development. given that emotion regulation strategies, or at least their effects, seem to differ between adults and adolescents it is important to better understand how adolescents respond to emotions in order to counteract the alarming rise in mental disorders. the present study this study aims to investigate whether foh and folc prospectively predict depressive symptoms. 128 adolescents completed self-report questionnaires of depressive symptoms (including consummatory anhedonia), foh, and folc at baseline and 2-months later. based on prior cross-sectional research, we hypothesized that foh and folc would cross-sectionally and prospectively predict depressive symptoms including anhedonia. hypotheses were formulated prior to data analysis. m e t h o d participants our sample was recruited as part of a larger study aiming to test whether negative self-referent processing predicts depressive symptoms in adolescents (belmans et al., 2023). for this larger study, a power analysis in g*power (faul et al., 2007) indicated a required sample of n = 58 participants to reach a power of .80 with α = .05 based on a cross-sectional effect size of cohen’s d = .82 (iijima et al., 2017). the larger study oversampled to account for attrition and because smaller prospective effects were expec­ ted compared to previously observed cross-sectional effects. school classes, rather than individual participants, were recruited from two secondary schools in flanders, belgium, resulting in a total sample of 128 adolescents (60.63% female). adolescents were 16-18 years old (m = 16.87, sd = 0.80) and most were of belgian origin (80%). at follow-up assessment, 11 adolescents (8.7%) did not participate because they were absent from school on the day of assessment. the age group was chosen to ensure that participants understand the computer task in the larger study. sensitivity analyses conducted in g*power revealed that the present study was able to detect a small-to-medium effect (cohen’s f = .28) in concurrent and prospective multiple regression models given n = 128, a power of .80, and α = .05. the study was approved by the social and societal ethics committee at ku leuven (g-2018-01-1090) and all participants provided informed consent in accordance with the declaration of helsinki (world medical association, 2013). kock, belmans, & raes 5 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ measures depression subscale of depressive anxiety stress scales (dass-d) depressive symptoms were assessed with the 7-item dass-d (lovibond & lovibond, 1995). participants indicated on a 4-point scale, from did not apply to me at all to applied to me very much, or most of the time, how they felt during the past week (e.g., i felt down-hearted and blue). one item assesses consummatory anhedonia (i couldn’t seem to get any enjoyment out of the things i did). the total score is calculated as the sum of all item scores. the dutch dass-d has good psychometric properties (de beurs et al., 2001). fear of happiness scale (fohs) to assess fear of happiness, the dutch fohs was used (joshanloo, 2013; nelis et al., n.d.). its 5 items are scored on a 7-point scale ranging from strongly disagree to strongly agree (e.g., i prefer not to be too joyful, because usually joy is followed by sadness). positive affect subscale of affective control scale (acs-pa) folc was assessed with the 13-item acs-pa (raes et al., 2017; williams et al., 1997). on a 7-point scale ranging from very strongly disagree to very strongly agree, participants in­ dicated how they respond to positive affect (e.g., when i feel really happy, i go overboard, so i don’t like getting overly ecstatic). procedure at baseline and 2-months follow-up, participants completed all questionnaires and a computer task that is not part of this study collectively in their classrooms. the duration of follow-up was chosen such that both assessments took place in the same school year to minimise attrition. statistical analyses to test whether foh and folc predicted concurrent and prospective depressive symp­ toms, regression analyses with dass-d scores as criterion variable were performed for cross-sectional and prospective data separately. foh and folc scores were entered as predictors and the dummy-coded variable female was added as covariate. for prospective analyses, dass-d scores at baseline were entered as in a first step, before all other pre­ dictors were entered. since previous studies identified anhedonia as a mediator between fear of positive evaluation and depressive symptoms, we performed post-hoc analyses to test the association between fears of positivity and the single-item measure of consum­ matory anhedonia from the dass-d scale (item 1). using this item as criterion variable, we conducted an additional ordinal logistic regression. predictor variables were the same as in aforementioned analyses except for prospective analyses, in which the baseline foh predicts concurrent depressive symptoms 6 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ consummatory anhedonia score was entered in the first step. z-scores of continuous predictors were added to compute standardised odds ratios as a measure of effect size. collinearity between predictors was assessed by a variance inflation factor (vif) larger than 10. to confirm that the proportional odds assumption was met, the brant test was applied (brant, 1990). additionally, the proportional odds assumption for each predictor was checked using likelihood ratio tests comparing a proportional odds model with a partial proportional odds model for which the proportional odds assumption was relaxed for the respective predictor. benjamini-hochberg adjustment for multiple testing was applied to all p-values ex­ cept those testing a priori hypotheses. we reported partial r 2 as effect size with .02, .13, and .26 indicating small, medium, and large effects, respectively (cohen, 1992). for the ordinal regression analysis, we reported or as effect size with 1.44, 2.48, and 4.27 indicating small, medium, and large effects, respectively (sánchez-meca et al., 2003). missing data was limited. 11 participants were lost to follow-up because they were not present at school on the day of assessment. only their baseline data was included in the analysis. additionally, single items were missing from the dass-d and folc scales for individual participants. in total, there were 0.002% of dass-d items missing at baseline, 0.004% of folc items missing at baseline, and 0.0007% of folc items missing at follow-up. little’s test for mcar demonstrated that missing data at both time points were missing completely at random (little, 1988). missing items were imputed using the mean score of all remaining questionnaire items. analyses were conducted in r (r core team, 2021) using the stats package (version 4.1.1) for linear regression analyses and the vgam package (version 1.1-7) for ordinal regression analyses (yee, 2022). r e s u l t s descriptive statistics and internal consistency means, standard deviations, ranges, and cronbach’s α for all measures are reported in table 1. correlational analyses zero-order pearson correlations revealed significant correlations of depressive symptoms with foh and folc at baseline (table 2). higher levels of depressive symptoms were associated with greater foh and folc. zero-order correlations between predictors at baseline and depressive symptoms at follow-up yielded similar results. kock, belmans, & raes 7 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ table 1 descriptive information for baseline and follow-up measures variable n m sd min max α assessment t1 dass-d 127 4.39 3.98 0 17 .84 foh 127 13.69 6.85 5 35 .89 folc 127 39.38 9.54 15 60 .82 assessment t2 dass-d t2 116 3.92 3.68 0 15 .83 foh t2 116 12.21 6.34 5 28 .89 folc t2 116 37.20 10.33 13 60 .83 note. α = cronbach’s alpha. table 2 pearson correlations between depressive symptoms (dass-d), fear of happiness, and fear of losing control over positive emotions variable 1 2 3 4 5 6 1. dass-d ‒ .45*** .26** .69*** .37*** .27** 2. foh [.30, .58] ‒ .50*** .36*** .69*** .39*** 3. folc [.09, .42] [.35, .62] ‒ .25** .41*** .68*** 4. dass-d t2 [.58, .77] [.19, .51] [.07, .41] ‒ .45*** .34*** 5. foh t2 [.20, .52] [.58, .78] [.25, .55] [.29, .58] ‒ .52*** 6. folc t2 [.09, .43] [.23, .54] [.57, .77] [.17, .49] [.38, .64] ‒ note. pearson correlations with benjamini-hochberg adjustment for multiple testing are reported above the diagonal. 95% confidence intervals are reported below the diagonal. *p < .05. **p < .01. ***p < .001. regression analyses results of regression analyses are displayed in table 3 and will be reported using effect sizes and corresponding confidence intervals (cis). an effect size of zero indicated that the predictor did not significantly impact the outcome. hence, when a ci does not include zero, the effect is considered significant. foh was significantly associated with depressive symptoms at baseline with a medi­ um effect size (partial r 2 = .14, 95% ci [.05, .26]), with greater foh predicting higher levels of depressive symptoms. foh did not significantly predict depressive symptoms at follow-up when controlling for depressive symptoms at baseline, which is reflected in the effect size falling below the cut-off for a small effect (partial r 2 = .004, 95% ci [0, .04]). however, foh significantly predicted depressive symptoms at follow-up with foh predicts concurrent depressive symptoms 8 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ a small-to-medium effect size when baseline depressive symptoms were deleted from the model (partial r 2 = .07, 95% ci [.004, .19]; see appendix a in the supplementary materials). folc was not significantly associated with depressive symptoms at baseline nor at follow-up. the effect size for both concurrent and prospective associations of folc with depressive symptoms fell well below the threshold for a small effect (see ta­ ble 3). an examination of vifs confirmed no violations of multicollinearity (see table 3). table 3 summary of regression analyses for variables predicting depressive symptoms (dass-d) at t1 and t2 variable b (se) b 95% ci β p partial r 2 r 2 vif dv: dass-d t1 constant 0.04 (1.40) [-2.72, 2.81] .97 female 0.21 (0.65) [-1.08, 1.51] .03 .74 .001 [0, .03] 1.01 foh t1 0.25 (0.05) [0.14, 0.35] .43 < .001 .140 [.05, .26] 1.34 folc t1 0.02 (0.04) [-0.06, 0.10] .05 .59 .002 [0, .03] .21 1.33 dv: dass-d t2 step 1 constant 0.90 (0.47) [-0.03, 1.83] .06 female 0.30 (0.52) [-0.73, 1.33] .04 .56 .002 [0, .03] 1.02 dass-d t1 0.66 (0.07) [0.53, 0.80] .68 < .001 .460 [.28, .61] .48 1.02 step 2 constant -0.19 (1.08) [-2.33, 1.95] .86 female 0.25 (0.52) [-0.79, 1.28] .03 .64 .001 [0, .03] 1.04 dass-d t1 0.62 (0.07) [0.48, 0.77] .64 < .001 .340 [.18, .51] 1.20 foh t1 0.04 (0.05) [-0.05, 0.13] .07 .37 .004 [0, .04] 1.49 folc t1 0.02 (0.03) [-0.04, 0.08] .05 .52 .002 [0, .03] .49 1.33 note. 95% percentile bootstrap confidence intervals for partial r 2 are reported in brackets. ordinal logistic regression analyses using the single-item anhedonia score as criterion variable are displayed in table 4 and will be reported using odds ratios (or) and corre­ sponding cis. an or of one indicated that there is no association between predictor and outcome. hence, when a ci does not include one, the effect is considered significant. due to low frequencies of the outcome categories “applied to me to a considerable degree or a good part of time” and “applied to me very much or most of the time” for consum­ matory anhedonia, these two categories were combined to increase statistical power of the overall model. for the model predicting anhedonia at baseline, the proportional odds assumption for folc was violated and a partial proportional odds model was used kock, belmans, & raes 9 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ instead. for all other predictors in both models, the proportional odds assumption was satisfied. table 4 summary of ordinal logistic regression analyses for variables predicting consummatory anhedonia (single item dass-d) at t1 and t2 variable β (se) p or or 95% ci vif dv: anhedonia t1 female 0.38 (0.36) .71 1.46 [0.73, 2.93] 1.01 foh t1 0.47 (0.21) .06 1.61 [1.07, 2.41] 1.34 comparison: (applied to a considerable degree & applied to some degree) vs. did not apply at all folc t1 -0.01 (0.21) .97 0.99 [0.66, 1.49] 1.33 comparison: applied to a considerable degree vs. (applied to some degree & did not apply at all) folc t1 -0.60 (0.30) .29 0.55 [0.31, 0.99] nagelkerke pseudo-r 2 = 0.09 dv: anhedonia t2 female 0.15 (0.39) .71 1.16 [0.54, 2.50] 1.04 anhedonia at t1 [not at all as reference] to some degree 1.11 (0.41) .01 3.02 [1.34, 6.80] 1.03 to a considerable degree 2.01 (0.65) .01 7.46 [2.08, 26.81] fears of positive emotions foh t1 0.44 (0.22) .07 1.56 [1.01, 2.41] 1.37 folc t1 0.22 (0.22) .64 1.24 [0.81, 1.91] 1.33 note. nagelkerke pseudo-r 2 = 0.23. after multiple testing correction, there was a trend towards an association between foh and consummatory anhedonia at baseline (or = 1.61; 95% ci [1.07, 2.41]), meaning that a one unit increase in foh at baseline was associated with a 61% increase in the odds to experience consummatory anhedonia at baseline to some or a considerable degree as compared to not at all. similarly, there was a trend towards an association between foh at baseline and consummatory anhedonia at follow-up when controlling for consummatory anhedonia at baseline (or = 1.56; 95% ci [1.01, 2.41]), meaning that a one unit increase in foh at baseline was associated with a 56% increase in the odds to experience anhedonia at follow-up to some or a considerable degree as compared to not at all. folc was not significantly associated with consummatory anhedonia at baseline nor at follow-up (see table 4). an examination of vifs confirmed no violations of multicollinearity (see table 4). foh predicts concurrent depressive symptoms 10 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ d i s c u s s i o n this study aimed to investigate whether foh and folc concurrently and prospectively predict depressive symptoms in adolescents. results showed that higher levels of foh are related to higher concurrent depressive symptoms but were not predictive of depres­ sive symptoms two months later. folc was not a significant predictor of depressive symptoms or anhedonia at the concurrent or prospective level. importantly, it is unlike­ ly that the lack of significant prospective associations with depressive symptoms was caused by low power. a post-hoc sensitivity analysis revealed that the minimum detecta­ ble effect size in this study was small-to-medium (f 2 = 0.085) given α = .05 and a power of .80. from a clinical perspective, effects that are smaller than this small-to-medium effect are unlikely to make a meaningful impact in clinical practice as small effects can easily be overshadowed by other influencing factors. thus, the current study was sufficiently powered to detect an effect that is clinically meaningful. this suggests that the lack of significant prospective associations is not caused by low power but may be explained by a negligible prospective association between foh, folc, and depressive symptoms in our sample. our findings are in line with prior research on a closely related construct, i.e. damp­ ening (feldman et al., 2008; nelis et al., 2015). dampening is defined as downgrading positive emotions by decreasing intensity and duration of positive mood states (feldman et al., 2008). therefore, dampening can be regarded as a broader concept that partly encompasses the construct of foh because some dampening thoughts include the fearrelated aspect of foh while other dampening thoughts are not related to foh. in alignment with our findings, increased dampening has been consistently associated with higher levels of concurrent depressive symptoms in adults and adolescents (feldman et al., 2008; nelis et al., 2015). however, results on the prospective association between dampening and depressive symptoms are mixed, with some studies reporting that damp­ ening predicts increased depressive symptoms (hudson et al., 2015; raes et al., 2012) and others reporting absence of effects (k. e. gilbert et al., 2013; nelis et al., 2015). notably, there is some evidence that dampening may be specifically predictive of anhedonia (nelis et al., 2018). since anhedonia includes diminished pleasure in positive experiences, it might be more strongly linked to dampening responses compared to general depressive symptoms. similarly, fear of positive evaluation, another type of fear of positivity closely linked to foh, has been shown to affect depressive symptoms via anticipatory anhedonia (jordan et al., 2018). considering the similarities of, and strong correlation between dampening and foh, foh may display similar correlation patterns with anhedonic symptoms compared to general depressive symptoms. in this study, we observed a trend towards a concurrent and prospective association between foh and consummatory anhedonia but no prospective association between foh and general de­ pressive symptoms. moreover, the prospective association between foh and depressive symptoms decreased when the consummatory anhedonia item was excluded from the kock, belmans, & raes 11 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ measure of depressive symptoms (see appendix b in the supplementary materials). however, the size of the association between foh and consummatory anhedonia is rather small and did not pass the multiple testing correction. one possible explanation for this non-significant association of foh with consummatory anhedonia may be the use of a single-item measure. this measure may be problematic because single-item measures are more affected by measurement error as they cannot be compared to corresponding items measuring the same construct, resulting in lower or at least un­ known reliability compared to multi-item scales (allen et al., 2022). moreover, the used single-item measure only captures consummatory but not anticipatory anhedonia. this is important given that jordan et al. (2018) found that anticipatory, but not consummatory, anhedonia mediates the effect of fear of positive evaluation on depressive symptoms. it is possible that foh, like fear of positive evaluation, mainly affects anticipatory and to a lesser extent consummatory anhedonia. future studies should use a more fine-grained measure of anhedonia to differentiate the relationships between foh, anticipatory and consummatory anhedonia, and depressive symptoms. this study was carried out in a non-clinical sample. it is possible that the prospective association between foh and depressive symptoms is only evident in clinical popula­ tions with stronger depressive symptoms at baseline. however, one prior study did not find a prospective association between dampening and depressive symptoms in remitted depressed patients (k. e. gilbert et al., 2013), suggesting that there is no prospective link between dampening and depressive symptoms in clinically-depressed populations. on the other hand, jordan et al. (2018) found an effect of fear of positive evaluation on depressive symptoms via anticipatory anhedonia in a community sample with mild depressive symptoms. future studies should disentangle the relationship between fears of positivity and depressive symptoms in clinical samples. unexpectedly, we did not find any association between folc and depressive symp­ toms. one possible explanation is that the original factor structure of the acs is based on expert opinion and does not provide acceptable fit in factor analyses (melka et al., 2011). however, re-analysing the data with the factor structure derived from exploratory factor analysis did not change the results (see appendix c in the supplementary materials), suggesting that folc has no association with depressive symptoms in adolescents, at least not in our sample. the main limitations of our study were the reliance on self-report measures and the use of the dass as only measure of depressive symptoms. the dass mainly assesses symptoms related to negative emotions and only includes one item measuring consum­ matory anhedonia. moreover, the average scores on the dass-d are quite low in our sample compared to a dutch-speaking clinically depressed sample (de beurs et al., 2001). future studies should investigate the relationship between foh, folc, and depressive symptoms in adolescent samples with more prominent depressive symptoms. another limitation of this study is the failure to measure positive emotions. future studies should foh predicts concurrent depressive symptoms 12 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ specifically assess positive emotions to examine whether the association of foh and depressive symptoms is dependent on the current level of positive emotions. in conclusion, this study shows that foh is concurrently but not prospectively asso­ ciated with depressive symptoms. there was no significant association between foh and the single-item measure of consummatory anhedonia, however, anticipatory anhedonia was not assessed. in light of prior findings on the effect of related fears of positivity on anticipatory anhedonia in adults, future research should investigate the concurrent and prospective association between foh and anticipatory anhedonia in adolescents using a more fine-grained measure of anhedonia. funding: this work was supported by the research foundation – flanders (fwo-vlaanderen) under a red noses grant (g0f5617n) and research grant (g068318n). merle kock was supported by the research foundation – flanders (fwo-vlaanderen) under a red noses grant (g049019n) and is supported under a phd fellowship (11i1622n). eline belmans is supported by the research foundation – flanders (fwo-vlaanderen) under a phd-fellowship (1177820n). acknowledgments: we thank brecht hugaerts, myrthe keiren, and toke laemont for their assistance in collecting the data and liesbeth bogaert for her support in writing the manuscript. competing interests: the authors have declared that no competing interests exist. ethics statement: this study was approved by the social and societal ethics committee at ku leuven (g-2018-01-1090). all participants provided informed consent after being informed about all aspects of the study in accordance with the declaration of helsinki (2013). twitter accounts: @kockmerle, @elinebelmans, @raziraes data availability: the data that support the findings of this study are available on request from the corresponding author. the data are not publicly available due to privacy or ethical restrictions. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • code used for analyses • appendix a: regression analysis for variables predicting depressive symptoms (dass-d) at t2 without controlling for baseline depressive symptoms • appendix b: hierarchical regression analysis for variables predicting depressive symptoms excluding the anhedonia item (dass-d 2) at t2 • appendix c: hierarchical regression analyses for variables predicting depressive symptoms (dass-d) at t2 using the updated factor structure of acs kock, belmans, & raes 13 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://twitter.com/kockmerle https://twitter.com/elinebelmans https://twitter.com/raziraes https://www.psychopen.eu/ index of supplementary materials kock, m., belmans, e., & raes, f. 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(2007). effect of age at onset on the course of major depressive disorder. american journal of psychiatry, 164(10), 1539–1546. https://doi.org/10.1176/appi.ajp.2007.06101757 kock, belmans, & raes 17 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://doi.org/10.1016/j.jesp.2009.04.020 https://doi.org/10.1016/j.appet.2011.02.018 https://doi.org/10.1016/s0005-7967(96)00098-8 https://doi.org/10.1037/bul0000022 https://doi.org/10.1037/0022-3514.85.3.566 https://doi.org/10.1001/jama.2013.281053 https://doi.org/10.1016/j.brat.2019.103476 https://doi.org/10.1016/j.jad.2018.02.009 https://doi.org/10.3390/brainsci9040076 https://doi.org/10.1176/appi.ajp.2007.06101757 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. foh predicts concurrent depressive symptoms 18 clinical psychology in europe 2023, vol. 5(2), article e10495 https://doi.org/10.32872/cpe.10495 https://www.psychopen.eu/ foh predicts concurrent depressive symptoms (introduction) defining foh and folc importance of assessing an adolescent sample the present study method participants measures procedure statistical analyses results descriptive statistics and internal consistency correlational analyses regression analyses discussion (additional information) funding acknowledgments competing interests ethics statement twitter accounts data availability supplementary materials references visual triggers of skin picking episodes: an experimental study in self-reported skin picking disorder and atopic dermatitis research articles visual triggers of skin picking episodes: an experimental study in self-reported skin picking disorder and atopic dermatitis linda marlen mehrmann a, alice urban a, alexander leopold gerlach a [a] institute of clinical psychology and psychotherapy, university of cologne, cologne, germany. clinical psychology in europe, 2020, vol. 2(4), article e2931, https://doi.org/10.32872/cpe.v2i4.2931 received: 2020-03-11 • accepted: 2020-11-03 • published (vor): 2020-12-23 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: linda marlen mehrmann, university of cologne, institute of clinical psychology and psychotherapy, pohligstraße 1, 50969 cologne, germany. phone: 0049-221-470-6854. e-mail: linda.mehrmann@unikoeln.de abstract background: skin picking disorder (spd) is a new diagnosis with limited information available about triggers of picking episodes. itch can be induced via audio-visual stimuli and the effect of contagious itch is stronger for those affected by atopic dermatitis. we examined if picking-related visual stimuli can trigger the urge to pick skin in self-reported spd. we compared itch and the urge to pick in a sample of ad and/or spd-affected to controls without either. method: urge to pick skin and/or scratch when viewing 24 itch-related, picking-related or neutral online pictures was assessed in adult females, who self-report skin-picking (spd-only, n = 147) and/or atopic dermatitis (ad-only, n = 47; ad+spd, n = 46) as well as in skin healthy controls (hc, n = 361). results: all participants reported a stronger urge to pick for picking-related pictures compared to neutral content (f[1, 597] = 533.96, p < .001, ηp2 = .472) and more itch for itch-related pictures compared to neutral stimuli (f[1, 597] = 518.73, p < .001, ηp2 = .465). spd-all (spd-only & ad+spd) reported stronger urges to pick for picking-related vs. other stimuli compared to the adonly and hc group (p < .001, ηp2 = .047). likewise, ad-all (ad-only & ad+spd) reported significantly stronger itching for itch-related vs. other stimuli compared to spd-only and hc (p = .001, ηp2 = .019). conclusions: analog to visual provocation of itch, the urge to pick can be triggered by visual stimuli. treatments for spd and ad may profit from addressing visual stimuli. keywords skin picking, excoriation disorder, body-focused repetitive behaviors, contagious itch, visual stimuli this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.2931&domain=pdf&date_stamp=2020-12-23 https://orcid.org/0000-0001-6794-5349 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • contagious itch can be induced with visual stimuli (videos or static pictures). • this effect is especially strong in individuals self-reporting atopic dermatitis. • the urge to pick can also be induced with visual stimuli (picking-related pictures). • this effect is especially strong in individuals self-reporting skin picking disorder. • treatment for skin picking disorder may profit from addressing visual stimuli. skin picking disorder (spd) has recently been included as official diagnosis in the diag‐ nostic and statistical manual of mental disorders (dsm). dsm-5 characterizes spd as recurrent skin picking resulting in lesions of the skin and repeated attempts to decrease or stop this behavior. additionally, for a diagnosis of skin picking disorder, skin picking must cause clinically significant distress or impairment in important areas of functioning (american psychiatric association, 2013). many people indulge in picking behavior from time to time, however, people with spd feel a strong urge to manipulate their skin and feel unable to resist this urge or to stop (american psychiatric association, 2013). clinical experience suggests that skin picking episodes can be triggered in various different ways (mansueto et al., 1997; neziroglu et al., 2008). however, mostly self-report studies of triggers for skin picking episodes have been published. in a clinical sample emotional triggers such as general anxiety, general stress, interpersonal rejection, a sense of emptiness, and teasing were reported (neziroglu et al., 2008). in terms of visual stimuli, skin imperfections were most commonly mentioned (80%), including pimples, scabs, scars, and mosquito bites. regarding somatosensory triggers, itchiness (40%), the feeling of something being underneath the skin surface (32%), and a “right feeling” sensation (40%) were described. the most common environmental triggers were looking in the mir‐ ror and checking one’s skin (52%; neziroglu et al., 2008). in a german nonclinical sample (bohne et al., 2002; n = 133), students reported cutaneous triggers to be pimples (93.2%), insect bites (63.9%), scabs (57.1%), itching (45.9%), inflammation (34.6%), warts (13.5%), healthy skin (18.0%), moles and scars (9.8%). participants with spd reported the feel (55%) and sight (26.7%) of the skin as the most common triggers to picking behavior (odlaug & grant, 2008). finally, houghton et al. (2018) investigated sensory processing in people affected by body-focused repetitive behaviors (bfrbs; e.g., hairpulling, skin picking, nail biting) via the adult/adolescent sensory profile (brown et al., 2001). participants with clinical bfrbs reported increased sensory sensitivity including visual stimuli compared to subclinical bfrbs and healthy controls. in summary, many of these triggers indicate visual perception of one’s skin (e.g., when looking in the mirror) to be one of various factors within the cycle of urge to pick and picking behavior. visual triggers of skin picking episodes 2 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ one fmri study examined visual symptom provocation in spd (schienle, ubel, & wabnegger, 2018). for pictures with skin irregularities, disgust, tension and urge to pick ratings were significantly higher in the spd-group. however, the same was true regarding disgust and urge to pick for pictures without skin irregularities. furthermore, when looking at skin imperfections, spd-patients showed greater activation in the left insula and in the amygdala with stronger insula-putamen coupling compared to matched controls. these brain regions are linked to visual disgust elicitation, process salience and the affective significance of stimuli. whereas experimental studies examining mechanisms underlying the urge to pick in spd are mostly lacking, some exist for pruritus, especially pruritus associated with atopic dermatitis (ad). ad presents several similarities with spd. ad patients suffer from a cutaneous hyperreactivity to environmental triggers resulting in a chronic inflammatory skin disease (leung, 2013). pruritus is the cardinal symptom of ad provoking the desire to scratch for relief from this unpleasant sensation but leading to skin damage and other negative consequences (mochizuki et al., 2014; ständer & steinhoff, 2002). however, the mechanical stimulation of the skin may provoke inflammation, which again exacerbates itch (itch-scratch-cycle; mochizuki et al., 2017). due to its negative impact on quality of life, most patients measure the severity of their ad by intensity of pruritus rather than visible skin damage (ständer & steinhoff, 2002). against this background, verhoeven et al. (2008) proposed a biopsychosocial model of itch in patients with chronic skin diseases: internal vulnerability factors (e.g., personality) interact with external environmental fac‐ tors (e.g., stressors). meanwhile, cognitive (e.g., illness cognitions), behavioral, and social factors are mediating and/or moderating factors to trigger a skin disease and enhance symptoms of itch. contagious itch (ci) can therefore be a cognitive psychological factor causal in pathological itch (verhoeven et al., 2008). itch sensations can be evoked through mechanical, electrical, thermal and chemical stimulation of free nerve endings in the skin (leknes et al., 2007; murota & katayama, 2017). apart from methods manipulating the skin to induce itch (e.g., histamine and allergen solutions), non-skin-manipulating methods also lead to itch sensations (leknes et al., 2007). for example, itch can be induced with audio-visual stimuli. niemeier, kupfer, and gieler (2000) held two different lectures (“itch lecture”, “relaxation lecture”) for participants with and without self-reported skin disease. self-reported itch sensation after the lecture as well as the number of scratch movements during the “itch lecture” (slides with pictures of fleas, allergic reactions etc.) were significantly higher compared to the “relaxation lecture”. however, there was only a trend with regard to the experience of itching sensations when comparing participants with and without skin conditions. ogden and zoukas (2009) replicated these results with college students without assessing skin conditions using purely visual stimulation (e.g., videos of lice, person scratching head) without audio. in 2011, papoiu et al. investigated whether exposure to visual cues of itch (5-minute video of people scratching their left forearm vs. people sitting idle) mehrmann, urban, & gerlach 3 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ can induce or intensify itch in ad patients and healthy controls. itch intensity increased slightly in healthy volunteers and significantly in ad patients. the latter also scratched more frequently while watching the itch video. schut et al. (2015) identified depression as an additional significant predictor of induced itch. furthermore, agreeableness and public self-consciousness were significant predictors of scratching in ad-patients. palani et al. (2018) asked healthy participants to watch videos picturing a demonstrator scratching in four body regions with and without sound and a control video with neutral content. results showed ci to be body-region dependent, with the craniofacial region being the predominant site for participants to experience itching sensations after watching the video compared to arm, chest, and back. these studies on ci used a lecture or video material to induce itch. lloyd et al. (2013) tested whether static images (i.e., visual cues alone) were able to induce ci. they used neutral (e.g., butterflies or healthy skin) or itch-related pictures (e.g., fleas or skin conditions). healthy participants reported higher itch intensity for itch-related pictures compared to neutral pictures, and scratching frequency when viewing the pictures was significantly higher for itch-related pictures. furthermore, more scratch movements for the “skin response” picture type (e.g., scratching an insect bite) were found. lloyd et al. (2017) tested whether a history of pruritic skin conditions moderates the ci effect when looking at static pictures. itch-related pictures again caused higher self-itch. furthermore, participants with a history of pruritic skin conditions gave higher self-itch ratings when viewing “skin response”-images. in summary, somatosensory perception in the absence of somatosensory stimulation (i.e., ci) can be induced via the presentation of sounds, pictures or videos (schut et al., 2015) and is enhanced in individuals suffering from chronic itch-related skin conditions. in the present study, we test if this type of effect (i.e., ci) can be replicated with other types of stimuli and reactions – specifically, with visual stimuli triggering the urge to pick one’s skin. we investigated whether picking-related visual stimuli compared to other stimuli (itch-related, neutral) trigger the urge to pick in spd-affected compared to persons without spd. comparably, we tested, whether itch-related visual stimuli compared to other stimuli (picking-related, neutral) trigger itch sensations in ad patients compared to participants without ad. our investigation could experimentally present a pathological mechanism previously mainly self-reported as a relevant trigger for skin picking episodes in spd. visual triggers of skin picking episodes 4 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ m e t h o d design in a quasi-experimental study (stimulus type [3] ☓ group [4]), data was collected online with enterprise feedback suite survey. following the guidelines of the german psycho‐ logical society, all participants provided written informed consent prior to participation. procedure the survey was disseminated in several recruitment waves, among others the newsletter of a german self-help group for skin picking and in forums focusing on ad and pruritus. after the initial data collection of sp affected individuals (n = 307; spd: 74%, ad: 4%, hc: 22%, male gender was substantially underrepresented (9.5%). given that it was unlikely that we would be able to recruit a sufficient number of male participants, we thenceforth exclusively targeted female ad-patients and healthy controls in the following recruit‐ ment waves. after an introductory text and informed consent (following the ethical guidelines of the german psychological society, see appendix b5), sociodemographic information was assessed. derived from dsm-5 criteria for spd a three-question (criteria a-c) screening was conducted (kssp, n = 601, α = .86; mehrmann, hunger, & gerlach, 2017). as soon as participants reported feeling impaired due to spd, they were allocated to the spd group. additionally, participants were asked about skin diseases (e.g., ad, psoriasis, lice). when answering positive regarding ad (current symptoms or symptoms in the past three months), they were allocated to the ad-group. materials visual stimuli following a short explanation to german synonyms and difference between picking and scratching (see appendix b4), every participant looked at 24 visual stimuli (500x759 pixel) in random order (see additional information in appendix b1). the stimuli consisted of 24 static images of human skin sourced from google images and one photo specifically taken for this project. similar to the stimulus material used by lloyd et al. (2017) eight pictures represented one of three stimulus types each: (1) picking-related images depict‐ ing pimples, scabs, or loosening skin flakes, (2) itch-related images with skin conditions (e.g., eczema, mosquito bites), and (3) neutral images with pictures of intact, healthy skin. for each stimulus type, two images of four different body parts (head, torso, arm/hand, leg) were included. after looking at each stimulus a minimum time of three seconds the participants could click to the next page and answer four questions on a 5-point likert-type scale (0 = not at all, 4 = very strong): “how itchy do you feel?” (itch-self), “how itchy do you think the person in the picture feels?” (itch-other), “how strong is your urge to pick (not scratch)?” (urge-to-pick-self), “how strong do you think is the mehrmann, urban, & gerlach 5 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ urge to pick (not scratch) of the person in the picture?” (urge-to-pick-other). given that participants were free to look at the pictures as long as they wished, we checked for differences between viewing times. however, there was no main effect of viewing times for stimulus-type, pillai’s trace v = .002, f(2, 596) = .69, ns, ηp2 = .002; no effect for group, f(3, 597) = 1.93, ns, ηp2 = .01 and no interaction effect for stimulus-type ☓ group, pillai’s trace v = .004, f(6, 1194) = .42, ns, ηp2 = .002. questionnaires several questionnaires were used to assess ad and spd as well as general measures of psychopathology. ad or spd specific questionnaires were only presented if participants screened positive for one or both of them. msps-d — the modified skin picking scale, german version (mehrmann et al., 2017), is a translated and adapted version of the skin picking scale by keuthen, wilhelm, et al. (2001; snorrason et al., 2012) and the massachusetts general hospital (mgh) hairpulling scale (keuthen et al., 1995). nine items measure frequency and intensity of picking as well as impairment due to skin picking on a 5-point likert-type scale. scores can range from zero to 36 (n = 515, α = .95). currently, there is no clinical cut-off score for the german version available. msps-d-ad — to use a similar scale to explore the ad-sample, we modified the msps-d by exchanging the words “picking” and “skin picking” with “scratching” and “atopic dermatitis” (n = 105, α = .89). spis-d — the skin picking impact scale by keuthen, deckersbach, et al. (2001) was translated into german (mehrmann et al., 2017). a short version with four items (snorrason et al., 2013) measures psychosocial impairment due to skin picking on a 5point-likert-type scale (n = 515, α = .97). for the original version, keuthen, deckersbach, et al. (2001) propose a score ≥ 7 to determine clinical impairment. spis-d-ad — participants with ad symptoms answered an ad-adapted version (see above) of the spis-d items for psychosocial impairment (n = 105, α = .89). ad-scale — ad-affected answered a three-question scale on feeling itchy and actual scratching during the last two weeks as well as impairment due to ad via a 5-point likert-type scale (stangier, gieler, & ehlers, 2013; n = 105, α = .83). bsi-18 — the german short version of the brief symptom inventory (franke, 2000; spitzer et al., 2011) is a self-report symptom scale assessing levels of psychological distress. eighteen items with a 5-point likert-type scale result in a global severity scale (gsi) ranging between 0 and 72 (n = 598, α [gsi] = .91). visual triggers of skin picking episodes 6 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ sample primary inclusion criteria were consent to study participation, age > 18 years, female gender and completion of the online survey. altogether, 764 out of 1,406 participants met all primary inclusion criteria. 163 participants were excluded during data processing, be‐ cause they reported other skin conditions during the last three months, with symptoms that could be confounded with itch or the urge to pick, e.g. mycosis pedis, parasites. the final data set contained 601 participants. the four groups were represented as followed: n (adonly) = 47 (7.8%), n (spdonly) = 147 (24.5%), n (ad+spd) = 46 (7.7%), n (hc) = 361 (60.0%). post hoc tests showed the adonly-group to be significantly older than the spdonly-group (-5.05, 95%-ci [-9.77, -.34]).there was only a small negative correlation between age and the perception of itch (r = -.11, p = .04), or the urge to pick (r = -.16, p = .003) for the hc-group. see table 1 for questionnaire-scores (see additional information in appendix b2). table 1 descriptive statistics for all questionnaires with univariate analysis questionnaire adonly (n = 47) spdonly (n = 147) ad+spd (n = 46) hc (n = 361) f df1, df2 ηp2m sd m sd m sd m sd age 34.32 13.17 29.27 9.63 29.91 11.27 31.55 10.58 3.30* 3, 597 .016 msps-d – – 20.60 5.48 20.41 5.10 5.38 4.66a 565.01** 2, 509 .689 spis-d – – 10.59 4.19 6.85 4.60 0.74 1.88a 554.53** 2, 509 .685 msps-d-ad 17.21 7.24 – – 21.57 5.56 – – 10.54* 1, 91 .104 spis-d-ad 6.36 4.96 – – 8.41 4.55 – – 4.31* 1, 91 .045 bsi-18 13.81 9.93 18.41 11.64 b 16.26 10.29 8.14 9.41 40.07** 3, 595 .168 note. spdonly = skin picking disorder; adonly = atopic dermatitis; ad+spd = atopic dermatitis and skin picking disorder; hc = healthy control; msps-d = modified skin picking scale, german version; spis-d = skin picking impact scale, german version; msps-d-ad = modified sps-d for ad; spis-d-ad = modified spis-d for ad; bsi-18 = german short version of the brief symptom inventory. an = 319. bn = 145. *p < .05, two-tailed. **p < .001, two-tailed. analysis all participants were allocated to one of four groups (adonly, spdonly, ad+spd, hc). so‐ ciodemographic characteristics and questionnaires were tested using an anova and we used the bonferroni method as provided by spss to adjust for multiple comparisons in the post-hoc tests. in a repeated measures manova, itch-other and urge-to-pick-other ratings were analyzed for stimulus type (itch-related, picking-related, neutral), followed by univariate anovas and planned contrasts. in a repeated measures manova itch-self and urge-to-pick-self ratings were analyzed for stimulus type (3) ☓ group (4) with sepa‐ mehrmann, urban, & gerlach 7 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ rate univariate anovas and planned contrasts (see additional information in appendix b3). when sphericity was violated, the greenhouse–geisser adjustment was used. r e s u l t s manipulation check (urge-to-pick-other and itch-other ratings) a manova revealed a significant effect of urge-to-pick-other and itch-other ratings for stimulus type, pillai’s trace v = .92, f(4, 597) = 1714.56, p < .001, ηp2 = .920, indicating the experience of itch and the urge to pick varied based on picture content. urge-to-pick-other in the univariate anova a significant effect for stimulus type was revealed, f(1.89, 1135.54) = 1027.02, p < .001, ηp2 = .631. urge-to-pick-other ratings were significantly higher for picking-related stimuli (m = 1.64, sd = .77) than for neutral stimuli (m = .27, sd = .37), f(1, 600) =2344.64, p < .001, ηp2 = .796. urge-to-pick-other ratings were also significantly higher for picking-related stimuli than for itch-related stimuli (m = 1.41, sd = .95), f(1, 597) = 11.24, p = .001, ηp2 = .018. itch-other in the univariate anova a significant effect for stimulus type was revealed f(1.97, 1181.05) = 3465.76, p < .001, ηp2 = .852. itch-other ratings were significantly higher for itch-related stimuli (m = 2.34, sd = .67) than for neutral stimuli (m = .31, sd = .38), f(1, 600) = 6543.65, p < .001, ηp2 = .916. itch-other ratings were significantly higher for itch-related stimuli than for picking-related stimuli (m = 1.11, sd = .66), f(1, 597) = 1186.43, p < .001, ηp2 = .665. manova (stimulus type ☓ group; urge-to-pick-self and itchself ratings) the manova revealed a significant main effect for group (pillai’s trace v = .26, f[6, 1194] = 29.41, p < .001, ηp2 = .129), a significant main effect for stimulus type (pillai’s trace v = .53, f[4, 594] = 169.78, p < .001, ηp2 = .533), and a significant interaction effect for stimulus type ☓ group (pillai’s trace v = .25, f[12, 1788] = 13.41, p < .001, ηp2 = .083). urge-to-pick-self ratings univariate follow-up analyses of urge-to-pick-self ratings again found a significant main effect for stimulus type, f(1.96, 1172.76) = 304.54, p < .001, ηp2 = .338, and for group, f(3, 597) = 42.47, p < .001, ηp2 = .176. additionally, there was a significant interaction effect visual triggers of skin picking episodes 8 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ for stimulus type ☓ group, f(5.89, 1172.76) = 24.21, p < .001, ηp2 = .108 (see figure 1; additional tables on urge-to-pick-self and itch-self ratings in appendix a). figure 1 experienced urge to pick (0-4) by group and type of stimulus note. spdonly = skin picking disorder; adonly = atopic dermatitis; ad+spd = atopic dermatitis and skin picking disorder; hc = healthy control. error bars show standard errors. all participants experienced a stronger urge to pick when looking at picking-related compared to neutral stimuli, f(1, 597) = 533.96, p < .001, ηp2 = .472. they also reported a stronger urge to pick when looking at picking-related compared to itch-related stimuli, f(1, 597) = 112.41, p < .001, ηp2 = .158 and when looking at itch-related compared to neutral stimuli, f(1, 597) = 216.11, p < .001, ηp2 = .266. to check whether participants with spd reported a stronger urge to pick for pick‐ ing-related stimuli compared to other stimuli, we compared this difference in spd par‐ ticipants (spdall) with participants without spd (adonly & hc). planned contrast were calculated merging the spdonly and ad+spd group (spdall, n = 193). the difference in urge-to-pick-self ratings for pick-related vs. itch-related and neutral pictures was significantly higher in spdall participants compared to participants without spd (adonly & hc), with a mean difference of 1.59 (se = .29, p = .001, ηp2 = .047). likewise, the difference in urge-to-pick-self ratings for picking-related vs. neutral stimuli as well as for picking-related vs. itch-related stimuli was significantly higher in spdall participants compared to participants without spd (adonly & hc), with a mean difference of 1.11 (se = .18, p < .001, ηp2 = .062) and .48 (se = .16, p = .003, ηp2 = .015). when comparing urge-to-pick-self ratings from participants with spdonly to individuals affected by both mehrmann, urban, & gerlach 9 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ ad and spd, the difference between picking-related vs. itch-related and neutral stimuli is significantly larger for the spdonly group, with a mean difference of 1.28 (se = .22, p < .001, ηp2 = .055). for the group comparison spdonly vs. spd+ad the difference in urge-to-pick-self ratings between picking-related and neutral stimuli as well as between picking-related and itch-related stimuli was significantly higher for spdonly with a mean difference of .62 (se = .13, p < .001, ηp2 = .037) and .66 (se = .12, p < .001, ηp2 = .050). itch-self ratings there was a significant main effect on itch-self ratings for stimulus type, f(1.58, 940.90) = 391.95, p < .001, ηp2 = .396, for group, f(3, 597) = 14.17, p < .001, ηp2 = .066) and a significant interaction effect for stimulus type ☓ group, f(4.73, 940.90) = 8.06, p < .001, ηp2 = .039 (see figure 2). figure 2 experienced itch (0-4) by group and type of stimulus note. spdonly = skin picking disorder; adonly = atopic dermatitis; ad+spd = atopic dermatitis and skin picking disorder; hc = healthy control. error bars show standard errors. all participants experienced stronger itch-sensations when looking at itch-related com‐ pared to neutral stimuli, f(1, 597) = 518.73, p < .001, ηp2 = .465. they also reported stronger itch-sensations when looking at itch-related compared to picking-related stimuli, f(1, 597) = 293.72, p < .001, ηp2 = .330 and when looking at picking-related compared to neutral stimuli, f(1, 597) = 225.76, p < .001, ηp2 = .274. to check whether participants with ad reported greater perception of itch for itchrelated versus other stimuli, we compared this difference in participants with versus visual triggers of skin picking episodes 10 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ without ad. planned contrast were calculated merging the adonly and ad+spd group (adall, n = 93). the difference in itch-self ratings for itch-related vs. picking-related and neutral stimuli was significantly higher in adall compared to without ad participants (spdonly& hc), with a mean difference of 1.09 (se = .32, p = .001, ηp2 = .019). likewise, the difference in itch-self ratings for itch-related vs. neutral stimuli as well as for itch-related vs. picking-related stimuli was significantly higher in adall compared to without ad participants (spdonly & hc), with a mean difference of .48 (se = .20, p = .014, ηp2 = .010) and .61 (se = .15, p < .001, ηp2 = .027). d i s c u s s i o n in the presented study, we investigated whether picking-related visual stimuli trigger the urge to pick in individuals affected by spd compared to persons without spd. correspondingly, we tested, whether itch-related visual stimuli trigger itch sensations in individuals with ad versus without ad. analog to the visual provocation of itch, we demonstrated that the urge to pick can also be triggered by visual stimuli. all participants experienced a stronger urge to pick looking at pictures with picking-related content compared to neutral stimuli. furthermore, individuals with self-reported spdall reported a significantly stronger urge to pick when looking at these stimuli compared to the adand hc-group. interestingly, the spdonly group showed a significantly stronger reaction to picking-related stimuli than the participants with both ad and spd. at the same time, the ad+spd group reported more itch-sensations to itch-related stimuli compared to the adonly group. thus, for the comorbid group the transmission of the urge to pick was less prominent than the transmission of itch-sensations. note that the burden of skin picking as measured by the spis-d was higher in the spdonly group (m = 10.59, sd = 4.19) compared to the comorbid group (m = 6.85, sd = 4.60). on the other hand, the psychosocial impairment due to ad (spis-d-ad) was higher in the comorbid group (m = 8.41, sd = 4.55) compared to the adonly group (m = 6.36, sd = 4.96). the combination of spd with comorbid ad regarding visual symptom provocation clearly requires further investigation. even though we disseminated the survey contacting many ad specific associations, online-groups and forums, it was difficult to acquire a larger ad-sample, which limits the generalizability of our results. this evidence for visual transmission for the urge to pick supports spd affected self-report of different visual cues acting as triggers for picking episodes (bohne et al., 2002; neziroglu et al., 2008; odlaug & grant, 2008). the results of our study document that visual stimuli may trigger specific experiences of somatosensory perception (itch and/or the urge to pick) in the absence of somatosensory stimulation. not surprisingly, we were also able to replicate visual transmission of itch (niemeier et al., 2000; ogden & zoukas, 2009; papoiu et al., 2011) with people reporting to ex‐ perience more itch when looking at itch-related pictures compared to other pictures mehrmann, urban, & gerlach 11 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ (neutral, picking-related pictures). this effect was stronger for ad patients, who reported more self-itch when exposed to itch-associated skin pictures. this is again in line with previous findings on people suffering from a skin condition like ad to be more prone to visual transmission of itch than healthy controls (papoiu et al., 2011; schut et al., 2015). when comparing transmission of itchiness with transmission of the urge to pick, overlapping concepts for the urge to scratch itchy skin vs. the urge to pick may be a problem. in the present sample, picking-related pictures gained significantly higher rat‐ ings for itch experience compared to neutral pictures. by presenting a short explanation including synonyms and an explanation of differences between picking and scratching, we tried to minimize the influence of this possible overlap effect. likewise, stimuli may trigger both sensations at the same time. furthermore, differentiating between the urge to scratch and pick may be even harder for people with both conditions (spd and ad). another limitation is that allocation to one of the four groups was conducted through self-report information and could not be validated by a clinician. there may have been be false-positive allocations to spd and/or ad and conclusions on treatment of the two diagnoses need to be considered carefully. overall, the adonly sample and ad+spd sample were underrepresented. also, the self-reports on itch and urge to pick perception were not compared to behavioral measures such as actual scratching or picking and the urges to itch or scratch elicited were only on an average level. finally, we recruited only female participants. consequently, implementation objectivity, sample representativeness and external validity may be somewhat limited. this is the first study to compare the effects of different visual stimuli as triggers for spd compared to ad and healthy controls. understanding the role of visual triggers for picking and/or itch episodes may help to improve treatment for both ad and spd. in a meta-analytic review looking at efficacy of treatments for spd (schumer, bartley, & bloch, 2016) cognitive behavioral therapy (cbt) and habit reversal training (hrt) were highlighted as efficacious treatments compared to waiting list and pharmacological treatment. cbt/hrt includes assessment of picking behavior, psychoeducation, and strategies to reduce picking (e.g., hrt, relapse prevention). while hrt is a strategy designed for dealing with the overwhelming need to pick, stimulus control can be used to avoid typical trigger situations. within stimulus control treatment, triggers are identified and then changed to reduce picking behavior (e.g., dimming the lights in the bathroom when standing in front of the mirror). this serves to strengthen alternative non-harm‐ ful behaviors. with this strategy individual visual trigger situations can be targeted specifically to prevent formation of an urge to pick (e.g., covering with clothing, limited mirror-time). behavioral therapy for ad includes similar modules to spd treatment. among others, they also include techniques to reduce scratching, like hrt and stimulus control techniques (scholz, 1999). further research on the transmission of itch and the urge to pick should consequently include additional (i.e., behavioral) measures for diagnoses and explore possible gender visual triggers of skin picking episodes 12 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ differences. for example, it would be helpful to check if the urge to pick induced by visual stimuli actually translates into picking episodes, which could be assessed in a laboratory setting. given that most ad patients report tactile triggers for their scratching rather than visual triggers, it may be also interesting to examine the sensation of touch in absence of a tactile stimulus in these two groups. this could be accomplished, by using the somatic signal detection task (ssdt; lloyd et al., 2008). the ssdt allows studying perceptual processes related to physical symptoms by provoking illusory tactile experiences. the number of such illusory tactile experiences may be associated with symptom severity in both ad and spd patients. within this online study, the transmission of itch and the urge to pick and scratch for those effected by spd and/or ad could be elicited using visual stimuli. the transmission of the urge to pick can serve to guide the development and improvement of interven‐ tions developed to treat spd in the future. the present findings help to understand the relevance of visual triggers for itch/scratch and picking behaviors in ad and spd, respectively. looking more closely at visual triggers will aid therapists when attempting to improve treatment components targeting the onset of skin picking episodes (e.g., stimulus control techniques, hrt). funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s american psychiatric association. 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(2008). biopsychosocial mechanisms of chronic itch in patients with skin diseases: a review. acta dermato-venereologica, 88(3), 211-218. https://doi.org/10.2340/00015555-0452 visual triggers of skin picking episodes 16 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://doi.org/10.1016/j.jocrd.2012.03.001 https://doi.org/10.1111/sjop.12057 https://doi.org/10.1055/s-0031-1281602 https://doi.org/10.1034/j.1600-0625.2002.110102.x https://doi.org/10.1007/978-3-642-47631-0 https://doi.org/10.2340/00015555-0452 https://www.psychopen.eu/ a p p e n d i c e s appendix a table a1 urge to pick ratings (self ) sample n stimulus type totalitch-related images picking-related images neutral images m sd m sd m sd m sd spdonly 147 1.14 .95 2.00 .91 .39 .47 1.18 .65 adonly 47 .63 .79 .82 .82 .16 .34 .54 .58 ad+spd 46 1.04 .87 1.25 .97 .26 .38 .85 .64 hc 361 .55 .75 .96 .86 .13 .28 .55 .55 total 601 .74 .85 1.23 .99 .20 .37 – – note. spdonly = skin picking disorder; adonly = atopic dermatitis; ad+spd = atopic dermatitis and skin picking disorder; hc = healthy control. scale ranging from 0 (= not at all) to 4 (= very strong). table a2 itch ratings (self ) sample n stimulus type totalitch-related images picking-related images neutral images m sd m sd m sd m sd sponly 147 1.34 .99 .89 .89 .22 .35 .82 .66 adonly 47 1.38 1.01 .72 .77 .32 .66 .80 .72 ad+spd 46 1.79 1.00 .88 .70 .38 .48 1.02 .63 hc 361 1.01 .96 .49 .58 .14 .28 .55 .55 total 601 1.18 1.00 .63 .72 .19 .36 – – note. spdonly = skin picking disorder; adonly = atopic dermatitis; ad+spd = atopic dermatitis and skin picking disorder; hc = healthy control. scale ranging from 0 (= not at all) to 4 (= very strong). appendix b b1 the 24 pictures applied as visual stimuli in this investigation were selected from a pretest with 48 pictures on a student sample (n = 17) to control for valence and arousal of the pictures: in our pretest, we selected 48 pictures, four pictures of each body-part (head/face, torso/décol‐ leté, hands/arms and legs/feet) for each of the three stimulus-types (itch-related, picking-related and neutral skin). in an online study (n = 17) we asked students to rate valence and arousal for each picture using the five-scale self-assessment manikin (sam, bradley & lang, 1994). out of the four pictures for each body-part category, we choose the two pictures, which had the lowest valence and arousal ratings. the pictures will be provided by the first author upon request. mehrmann, urban, & gerlach 17 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ b2 an analysis with age as covariate showed a significant main effect for age with wilk’s λ = .981, f(2, 595) = 5.86, p = .003, ηp2 = .019. including age as covariate did not relevantly change the results of the main tests as well as the post hoc tests (i.e., all previously significant results remained significant). consequently, we decided not to include age as a covariate in the results presented. b3 initial exploratory analyses revealed a few outliers. however, there was no relevant change in the pattern of results when including vs. excluding outliers. thus, results from the complete data set are reported. the assumption of normality was not met. since the f-test is relatively robust for violation of assumption, especially in samples with more than 40 subjects, the results of the manova were reported (lindman, 1974; tabachnick & fidell, 2013). b4 short explanation to german synonyms and difference between picking and scratching (german version): wichtige vorabinformation skin picking bzw. dermatillomanie = erkrankung, bei der betroffene einen starken drang verspüren ihre haut zu bearbeiten. wird dem drang nachgegangen, wird die haut gezupft, gequetscht, an der haut gepult und geknibbelt, was zu hautschädigungen führen kann. kratzen, welches als reaktion auf einen neurodermitisschub erfolgt, fällt nicht unter skin picking. verwendete synonyme im weiteren verlauf: skin picking, hautzupfen/-quetschen, haut bearbeiten und knibbeln. short explanation to german synonyms and difference between picking and scratching (translated version): important preliminary information skin picking or dermatillomania = disorder, in which affected persons feel a strong urge to manipulate their skin. if a person succumbs to that urge, the skin is plucked, squeezed, nibbled at and skin parts are removed, which can lead to skin damage. scratching, which occurs as a reaction to an episode of neurodermatitis, does not fall under skin picking. used synonyms in the further course: skin picking, skin plucking/squeezing, skin manipulation and nibbling. visual triggers of skin picking episodes 18 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ b5 data collection for the research reported in this study started in december 2016. unfortunately, the local ethics committee responsible for our faculty, at that time, had not yet started to accept research proposals. the first opportunity to apply for ethical review was not possible until may 2018. given that the study was self-funded and no funds were available for outside ethical review, it was decided to follow the procedure commonly used at that time according to the ethical guidelines of the german psychological society. the following procedures were included in the implementation of the study: research participants were provided with adequate and complete information regarding participation, followed by informed consent. specifically, all participants were informed in advance of the type of pictures they were about to see and advised on possible reactions these pictures may elicit (itch, urge to pick, some disgust). furthermore, all participants were advised that participation was voluntary and that participants were free to end participation at any time without having to give any reasons and without having to worry about any negative consequences. furthermore, data was assessed anonymously and participants were advised in this regard. after having received this information, all participants provided informed consent prior to participation in the study. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. mehrmann, urban, & gerlach 19 clinical psychology in europe 2020, vol.2(4), article e2931 https://doi.org/10.32872/cpe.v2i4.2931 https://www.psychopen.eu/ visual triggers of skin picking episodes (introduction) method design materials sample analysis results manipulation check (urge-to-pick-other and itch-other ratings) manova (stimulus type ☓ group; urge-to-pick-self and itch-self ratings) discussion (additional information) funding competing interests acknowledgments references appendices appendix a appendix b revisiting the cognitive model of depression: the role of expectations scientific update and overview revisiting the cognitive model of depression: the role of expectations winfried rief* a, jutta joormann b [a] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. [b] department of psychology, yale university, new haven, ct, usa. clinical psychology in europe, 2019, vol. 1(1), article e32605, https://doi.org/10.32872/cpe.v1i1.32605 received: 2018-12-21 • accepted: 2019-02-18 • published (vor): 2019-03-29 handling editor: cornelia weise, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, gutenbergstraße 18, 35032 marburg, germany. fax: +49 6421 28 28904. e-mail: rief@uni-marburg.de abstract background: the cognitive model of depression was highly stimulating for a better understanding and development of treatment for depression. however, the concept of “cognition” is rather broad and unspecific, and we suggest to focus on the cognitive subset of expectation. method: we conducted a narrative review on the role of expectations, and present an expectationfocused model of explaining why depression tends to persist despite the occurrence of positive events. results: several results from basic neuroscience to effects in clinical interventions indicate that expectations play a special role not only for the understanding of the development of mental disorders and the effects of treatment approaches, but especially for an improved understanding of the persistence of mental disorders. if expectations are a major mechanism of depression, the treatment of depression must maximize the violation of dysfunctional expectations. we also introduce the concept of immunization that describes any cognitive or behavioral strategies to reduce the effect of expectation violation experiences, and hereby contributing to expectation maintenance despite expectation contradicting events. we postulate that the development of immunization strategies could help to better understand the transition from episodic to chronic depression. conclusion: while in early periods of depression development, a focus on expectation change might be sufficient in treatment, the treatment of patients with chronic depression requires addressing these cognitive and behavioral immunization strategies more intensively. further implications for treatment and research are outlined that are derived from this balance between expectation violation and cognitive immunization in depression. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.32605&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords depression, persistence, expectation, expectation violation, cognitive immunization highlights • a focus on “expectations” helps to better understand the maintenance of depression • we offer a model that explains why depression persists even in the presence of positive experiences. • many psychological treatments focus on the violation of negative expectations, but cognitive immunization can hinder treatment success • we suggest strategies on how to improve psychological treatments for depression by maximizing expectation violation, and minimizing cognitive immunization e x p e c t a t i o n s a s s u b s e t s o f c o g n i t i o n s the cognitive model of depression has had tremendous impact on our understanding of cognition as an underlying mechanism of psychopathology and on the development of successful treatment approaches. cognition as a construct, however, is extremely broad, starting from perceptions, automatic thoughts, intermediate beliefs, up to schemas, selfconcepts, existential life goals and more generalized concepts (beck & haigh, 2014). moreover, the cognitive model does not differentiate among cognitions concerning the past, present, and future. in this manuscript, we will focus on the role of expectations. we will argue that expectations play a specific role in our understanding of depression and other forms of psychopathology and we will discuss advantages of an in-depth per‐ spective of this specific construct for understanding and treating depression. the importance of expectations as specific subsets of cognition are obvious in the def‐ inition of this construct. expectations are estimations of the likelihood of future events, and they are triggered by internal or external events (“priors”). expectations are by defi‐ nition cognitions that deal with the future, and impact future well-being. most people have impressive abilities to cope with momentary unpleasant feelings, pain, earache and social rejection, as long as they do not expect these aversive experiences to last forever, or to be frequently repeated in the future. thus, expectations regarding the stability of these experiences may have considerable impact on the emotions they elicit. considering that psychological interventions are not able to change the past, and that addressing is‐ sues of the present is only of relevance if it impacts on the future, one major goal of psy‐ chological interventions should focus on improving the quality of life in the future of pa‐ tients. expectations offer the link between present state and future well-being. revisiting the cognitive model of depression 2 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ other observations support the special role of expectations. placeboand nocebo-re‐ search has shown that a patient´s expectations determine the success of various medical interventions, ranging from antidepressant pills to heart surgery (enck, bingel, schedlowski, & rief, 2013; rief, bingel, schedlowski, & enck, 2011). therefore, expecta‐ tions can be considered the most frequently investigated mechanism of treatment success in health care systems because this mechanism has been shown to play a role in nearly all fields of medicine (schedlowski, enck, rief, & bingel, 2015). a meta-analysis of the association between treatment expectations and treatment outcome for psychological treatments confirmed the special role of patients’ treatment outcome expectations (constantino, arnkoff, glass, ametrano, & smith, 2011), a result that was also found for psychological treatments of mental disorders or chronic pain (cormier, lavigne, choiniere, & rainville, 2016; delgadillo, moreea, & lutz, 2016). expectations predict the transition from acute pain to chronic pain, and the persistence of pain symptoms (gehrt et al., 2015; holm, carroll, cassidy, skillgate, & ahlbom, 2008). modern neuroscience further supports the importance of focusing on predictions/ expectations. whereas former models of the brain mainly considered its function as pas‐ sively waiting for sensory input before processing it, modern models consider the brain a “prediction coding machine”, continuously creating predictions about what will happen next (seth, suzuki, & critchley, 2012). “prediction errors” trigger selective attention, and they are able to stimulate learning processes. thus, the brain`s predictions steer percep‐ tion, attention, and information processing in general. the parallel between the neuro‐ scientific concepts of prediction and prediction error versus the more applied concepts of expectation and expectation violation is obvious (d’astolfo & rief, 2017). of further rele‐ vance is the blunted reward processing in depression (pizzagalli, 2014; wilson et al., 2018), which could help to understand why depressed patients do not update negative ex‐ pectations. the “bayesian brain” offers a computational perspective on mood as creating and updating “priors” over uncertainty (clark, watson, & friston, 2018). finally, expecta‐ tions also offer a link between mind and body: they trigger anticipatory physiological re‐ actions. the anticipation of threat triggers physiological fight-flight-reactions. the antic‐ ipation of pain activates the somatosensory fields that are responsible for pain perception (koyama, mchaffie, laurienti, & coghill, 2005), but also brain functions that are respon‐ sible for pain control (wager, scott, & zubieta, 2007). whereas expectations as mechanisms of treatment success are frequently investiga‐ ted, the specific role of expectations as a mechanism of disorders and in the maintenance of mental problems is a less frequently studied topic. however, expectations can play a special role in improving our understanding of transdiagnostic processes, hereby offering a link to the rdoc-approach (insel, 2014). anxiety disorders and phobias are by defini‐ tion expectation disorders, and also for associated fields such as ocd-associated disor‐ ders, expectations can be considered a core feature contributing to the persistence of rief & joormann 3 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ clinical problems (rief & glombiewski, 2017). however, the role of expectations in de‐ pression is less obvious, and this will be discussed in the next section. t h e c o g n i t i v e m o d e l a n d t h e s p e c i f i c r o l e o f e x p e c t a t i o n s i n d e p r e s s i o n the cognitive model of mental disorders goes back to formulations of ancient greek phi‐ losophers, such as epiktet (born about 50 a.d.). it postulates that negative affective states develop not because of direct external influences (e.g., social rejection), but because of the interpretation of these external and internal events. it was the merit of a.t. beck to translate this approach to improve our understanding of depression. beck’s original for‐ mulation of the cognitive triad in depression can be easily transformed to expectations: negative expectations for outcomes relevant to the self, negative expectations about oth‐ er’s behavior, and finally negative expectations about future events. the cognitive model was supported by various experimental studies, summarized elsewhere (gotlib & joormann, 2010; joormann & quinn, 2014). the standard assessment of dysfunctional attitudes (dysfunctional attitudes scale das; oliver & baumgart, 1985) targets various expectations, but also covers other cogni‐ tions considered to be specific to depression. however, the question arises whether other cognitions have explanatory value for depression beyond the value of depression-specific expectations. to investigate this question, we developed a self-rating scale to assess de‐ pression-specific expectations. using a path analytical approach, we analyzed whether other cognitive aspects of depression explain additional variance, if the role of depres‐ sion-specific expectations was controlled (kube et al., 2018c). in this study, depressionspecific expectations had a clear association with depression, while other cognitions did not significantly add to this association. this confirms the special illness-relevant role of expectations as an important subgroup of cognitions. kube and colleagues (kube, d’astolfo, glombiewski, doering, & rief, 2017) developed a depressive expectations scale that allows to assess situation-specific expectations in major depression. this scale includes 25 items. the depression-specific expectations can be clustered in‐ to four subgroups: expectation of social rejection, expectation of (lack of) social support, expectation of ability to regulate mood, and expectations about the ability to perform cognitive tasks and about the likelihood of professional achievements. the advantage of this scale is that all its specific items can be directly translated into behavioral experi‐ ments, which offer the opportunity to assess expectations in depressed patients, to moti‐ vate them to test them, and to modify expectations after expectation violation experien‐ ces. thus treatment of depression can be reformulated as an intervention to change dys‐ functional expectations, mainly via the exposure to expectation violating situations (see figure 1). revisiting the cognitive model of depression 4 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ while typical cbt approaches also cover some of these strategies, our plea is to better focus on expectation change not only in anxiety treatment (craske, treanor, conway, zbozinek, & vervliet, 2014), but also in depression treatments. one future gain of focus‐ ing on expectation could be the development of more effective and economic interven‐ tions for depression. figure 1. psychological treatment as expectation violation. depression has been also linked to reward expectancy (greenberg et al., 2015). not expecting reward and not expecting positive events is closely associated with depressive states. moreover, it has been postulated that depression is mainly characterized by a lack of positive expectations (instead of increased negative expectations); a concept that was also confirmed using longitudinal designs (horwitz, berona, czyz, yeguez, & king, 2017). t h e r o l e o f c o g n i t i v e i m m u n i z a t i o n i n d e p r e s s i o n if negative expectations are a core part of depression, the crucial question is why these negative expectations persist, even after new positive experiences (“expectation violating situations”). whereas difficult life conditions or critical life events can lead to the devel‐ opment of negative expectations, and thereby contribute to the development of episodes of depression (heim, newport, mletzko, miller, & nemeroff, 2008; mclaughlin et al., 2017; nelson, klumparendt, doebler, & ehring, 2017), the process of persistence of these negative expectations is still poorly understood. even patients with depression experi‐ ence positive life events, positive interactions, successful performances, but most of these events do not lead to a change in negative expectations, and development of positive ex‐ pectations. therefore, we introduced another construct in our depression model that helps to understand the persistence of negative expectations even if positive experiences occur. this concept is “(cognitive) immunization”. it describes all cognitive (and some‐ times also behavioral) processes to invalidate the effect of positive, expectation violating experiences. while we will focus on cognitive immunization processes, behavioral strat‐ egies can also contribute to immunization: avoiding expectation-violating situations, se‐ lective attention and ignoring stimuli that transport the contradicting information are just a few examples. rief & joormann 5 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ these processes can also be observed in psychological interventions. it happens when psychotherapists try to induce positive, disconfirming experiences, but patients continu‐ ously invalidate them. typical invalidation strategies are declaring these experiences as exceptions to the rule (“if someone is friendly with me, this is only the exception to the rule that people dislike me”; “you, as a psychotherapist, are only friendly with me be‐ cause you are getting paid for it”), or invalidation of a positive situation in general (“al‐ though i succeeded in this exam, in other, much more important exams, i will fail”). many psychological interventions aim to violate negative expectations of patients. they can be even optimized in optimizing expectation violation experiences. however, as shown in figure 2, cognitive immunization can contribute to the invalidation of expecta‐ tion violation effects. thus treatment aims should be reformulated to maximize expecta‐ tion violation effects, and to minimize (cognitive) immunization processes. figure 2. expectation violation and cognitive immunization. a s t o c h a s t i c u n d e r s t a n d i n g o f e x p e c t a t i o n c h a n g e the neuroscientific prediction error paradigms have been extended by stochastic ap‐ proaches, and this extension is also helpful to better understand expectation maintenance versus expectation change in depressed patients. if healthy people develop the expecta‐ tion that most people are quite friendly, they interpret a broad variety of the behavior of the person with whom they’re interacting as confirmation of their expectations (see fig‐ ure 3, top). even neutral events (see arrow) confirm the positive expectations about the behavior and intentions of others. this is a potential explanation for the reported opti‐ mism bias of healthy people to memorize neutral events as being positive, and to expect positive outcomes even without any information supporting this expectation (sharot, riccardi, raio, & phelps, 2007). expectations form an interpretation bias towards their confirmation, and this sticking to expectations can be postulated to have an evolutionary meaning, providing stability in humans’ life. moreover, expectation confirmation can be postulated to be a typical automatic process, not requiring much cognitive resources, while the revision of expectations can be more demanding. to really challenge long-held expectations, other highly discrepant and powerful experiences are necessary. in healthy revisiting the cognitive model of depression 6 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ people, this means that only very harsh social rejection or traumatizing events really challenge their positive expectations about future events. figure 3. a stochastic model of expectation maintenance. when developing depression, the curve of expectations appears to move to the more negative part (see figure 3, bottom). most events are interpreted as confirmation of a negative view of the world. even neutral experiences may be considered as confirmation of negative expectations (see arrow). in other words: the very same experience that con‐ firms positive expectations in healthy persons can confirm negative expectations in de‐ pressed patients. again, to change negative expectations of depressed patients, very pow‐ erful, clearly distinguishable positive experiences are necessary. this example highlights why normal experiences and their attribution (e.g. in cognitive work) sometimes do not lead to any changes of negative expectations; effortful cognitive evaluations do not auto‐ rief & joormann 7 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ matically lead to changing automatic processes of confirmations of negative expecta‐ tions. e x p e r i m e n t a l s t u d i e s i n v e s t i g a t i n g e x p e c t a t i o n a n d c o g n i t i v e i m m u n i z a t i o n i n d e p r e s s i o n kube et al. (kube, rief, gollwitzer, & glombiewski, 2018b) investigated the interplay of expectation manifestation and expectation change in depression quite elegantly using an experimental paradigm. participants received a negative performance expectation (“the following test on emotional intelligence is hard to succeed”). afterwards, participants re‐ ceived different tasks on emotional intelligence that are difficult to evaluate which an‐ swers are correct. during the first trials, participants received the feedback that they were not successful, as expected. both healthy controls and depressed patients developed similar negative expectations after these experiences (kube, rief, gollwitzer, gärtner, & glombiewski, 2018a). however, after several failures, performance feedback switched to more frequent positive results (“expectation violation”). in accordance with the depres‐ sion model mentioned above, healthy controls changed their negative expectation to pos‐ itive, while negative expectations of depressed patients persisted despite positive feed‐ back. in a second experiment, the same authors introduced either instructions that suppor‐ ted cognitive immunization strategies (“the following test is not really valid, but just a weak indicator of performance”), while others received strategies aimed to inhibit cogni‐ tive immunization (“this is a really powerful and valid test”). if depressed patients re‐ ceived strategies that inhibited cognitive immunization, the change to positive feedback resulted also in a change of negative expectations to positive expectations (kube et al., 2018a). in other words: if cognitive immunizations are blocked in depressed patients, pa‐ tients can benefit from positive experiences. this offers new foci for treatment planning and prevention of treatment failures in depression. these effects are in line with other studies investigating cognitive adaptation process‐ es in depression. depressed persons have less favorable success expectations, and show a tendency to self-confirmation of negative attitudes (morris, 1997). further evidence comes from a study of everaert and others (everaert, bronstein, cannon, & joormann, 2018) who found that depressed patients do not only have a negative interpretation bias, but also showed a reduced revision of negative interpretations by disconfirmatory posi‐ tive information. liknaitzky and colleagues confirmed that patients with depression have a reduced ability to update interpretations after receiving expectation violating informa‐ tion (liknaitzky, smillie, & allen, 2017). of note, this effect was independent of the direc‐ tion of expectation violations. revisiting the cognitive model of depression 8 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ t r e a t m e n t i m p l i c a t i o n s o f t h e e x p e c t a t i o n m o d e l o f d e p r e s s i o n the implications for psychological treatments can be reduced to two main strategies: am‐ plifying the effect of expectation violations if positive experiences occur, and reducing the effect of cognitive immunization. first experiences with these foci in the work with patients were quite encouraging: patients can easily adapt this expectation model, and understand what is meant by cognitive immunization. after such a psychoeducational period, both typical expectations associated with the depressive disorder, but also cogni‐ tive immunization strategies that occur in everyday experiences when positive events oc‐ cur, can be collected. instead of continuing with cognitive dispute techniques like in cog‐ nitive therapy, patients are informed that humans often maintain negative expectations even if positive experiences occur. therefore, they are encouraged to develop more open‐ ness for experiences that are not in accordance with current expectations. considering the reduced motivation for complex and effortful cognitive processes in many patients with depression, we are working on developing more and more attention-based strat‐ egies that do not require complex cognitive reasoning. patients must be sensitized for the perception of relevant information, before starting with behavioral experiments. what would be the first stimuli indicating that expectations could be wrong? what kind of immunization strategies can be expected by this patient, if expectation violation occurs? what could be possible strategies to avoid the negative ef‐ fect of cognitive immunization? only after such a cognitive preparation period, are be‐ havioral experiments testing negative expectations executed. this strategy can easily be extended with a behavioral component. what kind of pa‐ tient’s behavior would maximize the likelihood of confirmations of negative expectations (e.g., avoiding eye contact although you hope for positive interaction with others; not preparing for an exam because expecting to fail anyway; …). after collecting behavioral patterns that serve to confirm negative expectations, the question can be reversed: what would be behavior patterns that minimize the likelihood of fulfillment of negative ex‐ pectations? not surprisingly, these kinds of behaviors should be shown during subse‐ quent behavioral experiments. table 1 shows a structure of such an expectation focused psychological intervention; further details can be found elsewhere (rief & glombiewski, 2016, 2017). this brief guideline shows that expectation-focused psychotherapy is not a complete‐ ly new approach, but more like an improved focus on most relevant cognitive and behav‐ ioral aspects in depression. while full evaluation trials in depression are lacking, we have positive evidence for expectation-focused approaches from other clinical fields. exposure therapy in anxiety disorders has been reformulated as a therapy to disconfirm negative expectations, and to increase inhibition of avoidance behavior (craske, 2015; craske et al., 2014). in pain disorder, many patients report “fear avoidance” behavior which can be considered as a special expectation pattern of chronic pain. if these patients were treated rief & joormann 9 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ with a highly focused expectation-based exposure intervention, they showed the most impressive improvements even in treatment arms with less treatment sessions than com‐ parative treatments (glombiewski et al., 2018). obviously, the improved focusing in pain patients led to more effective, but also more economic interventions. an expectation-focused approach was also used for a better preparation of patients undergoing heart surgery. pre-operatively, patients received an optimization of expecta‐ tions about how life can continue after successful heart surgery. such an expectation-fo‐ cused intervention was compared to an emotionally-supportive intervention, and to standard medical care. although the expectation-focused intervention was just two ses‐ sions in person, two phone calls (before surgery) and one booster phone call after sur‐ table 1 the steps of expectation-focused psychological interventions why are expectations maintained despite contradicting information? examples of queries and patients' reflections as part of the psychoeducation what are my specific expectations? others don’t like me. how can i check whether my expectations are valid? go to a party and check whether people talk to me. what are signals, perceptions, observations, that would show me that my expectations are disconfirmed? others talk to me; others initiate eye contact what kind of immunization strategies do i typically use in such a situation? thought: “they only look at me because they have negative thoughts about me”; i look away; if somebody talks to me, this is just on account of being polite – s/he has no special interest in me. how can i deal with my immunization strategies? accept negative thoughts, but be open for contradicting experiences; don’t look away results of behavioral test people came and talked to me what are further situations to test my expectations? at work during coffee breaks how should i behave to make my negative expectations come true? avoid eye contact; stand away from others, facial expression of bad mood how should i behave to make my negative expectations not come true? stand closer [...]; search eye contact; don't walk away [...] results of reality checks i was concerned that others don't like me. however, i made it quite difficult for them to show me some sympathy. and i use a lot of “immunization strategies” if positive events occur. revisiting the cognitive model of depression 10 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ gery, patients in this arm showed the lowest disability scores six month after surgery (rief et al., 2017). it is most impressive that such a low dose intervention achieved these striking effects. with more than 120 patients in this trial, it can be postulated that many risk factors and life problems were prevalent in these patients that were not addressed at all during the psychological interventions (e.g., marital conflicts, adverse early life expe‐ riences); however, quality of life improved substantially just by improving expectations. this is a further argument to better focus on crucial mechanisms that maintain mental, behavioral and even physical disorders (holmes et al., 2018). current depression treat‐ ments should be optimized to change dysfunctional expectations according to the princi‐ ples outline above, and these treatments should be subject to further evaluation. i m p l i c a t i o n s f o r r e s e a r c h several hypotheses can be derived from the expectation model of depression that should be a further subject of investigation. first, it is postulated that healthy individuals show more immunization strategies to prevent them from the effects of negative experiences than depressed patients. if healthy individuals are repeatedly exposed to positive events, and subsequently negative experiences occur, we expect them to stick to positive expect‐ ations, and to activate immunization strategies. this is in line with some studies indicat‐ ing that depressed patients are sometimes more “realistic” than healthy individuals, be‐ cause healthy individuals show an optimism bias (sharot, korn, & dolan, 2011). this can be also considered as a resilience mechanism of healthy people (brown, 2012). with the first depressive episodes, the expectation curve is hypothesized to move to a more negative level. this change could be induced by negative experiences that trigger the first depressive episode, but also the depressive episode itself is associated with a change of expectations. if the expectation curve has been moved to the more negative side, this could receive a self-maintaining functionality and is resistant to change. after this move has happened, depressed patients could tend to interpret neutral events as con‐ firmation of their negative expectations, while healthy controls interpret the same neu‐ tral experiences as confirmation of their positive view of the world. again this dynamic can be subject to experimental, cross-sectional and longitudinal studies, to better under‐ stand and confirm ongoing mechanisms. another hypothesis is that only very salient positive information is able to modify negative expectations in depressed patients. this could be studied with experimental de‐ signs to investigate the effects of expectation development, expectation persistence and change to the positive or to the negative direction. the above described expectation model may also be a model to better understand the process of persistence of depressive episodes. we hypothesize that patients with persis‐ tent depression show more immunization strategies than patients with episodic depres‐ sion, in particular to invalidate the effects of positive experiences. this sticking to nega‐ rief & joormann 11 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ tive expectations is further supported by automatic information processes, while expecta‐ tion change is frequently associated with effortful cognitive processes. again, this has implications for treatment planning. the more chronic the depressive state is, the more relevant it might be to address cognitive immunization strategies in patients. to summarize, several hypotheses of the expectation model of depression can be ex‐ tracted that can be subject to further evaluation. it not only invites observational studies, but also more mechanistic research using experimental designs. further paradigms should be developed to establish and modify expectation processes that should have spe‐ cial ecological validity for affective disorders. l i n k i n g t h e e x p e c t a t i o n m o d e l o f d e p r e s s i o n w i t h o t h e r p s y c h o l o g i c a l c o n c e p t s the suggested expectation model of depression focuses on aspects of how negative ex‐ pectations develop, how they contribute to depression-specific symptoms and disability, and why negative expectations are maintained even if contradicting positive events oc‐ cur. such a focus offers various links to other prominent depression concepts, and a few of them will be addressed. neuroscience has shown that the expectation of negative emotions (e.g. pain) acti‐ vates brain areas that are responsible for this emotion, and hereby facilitates the expected perception of the corresponding negative experience (atlas & wager, 2012; keltner et al., 2006; koyama et al., 2005; wager et al., 2004). this implies that the manifestation of ex‐ pectations supports the persistence of negative mood that is associated with the expected negative experience. for the development of expectations, associative learning processes (rheker, winkler, doering, & rief, 2017), observational learning (vögtle, barke, & könerherwig, 2013) or instructional learning can contribute. to overcome negative expectations, powerful expectation-violating positive experien‐ ces are necessary. however, this requires an individual to attend to this new information, to react to its positive content, and to modify and memorize the revised version of ex‐ pectations. for this process, reward sensitivity, a concept that is closely linked to neuro‐ physiological processes in depression, can be crucial (alloy, olino, freed, & nusslock, 2016). blunted reward sensitivity was also found in relatives of depressed patients (liu et al., 2016). the postulated role of reward insensitivity is in line with recent findings that patients with depression show reduced revision of negative interpretations by disconfir‐ matory positive information (everaert, bronstein, cannon, & joormann, 2018). a revision of negative expectations requires a detailed perception and memorization of expectation-violating experiences. however, many patients with depression suffer from unspecific autobiographical memory reports (kim, yoon, & joormann, 2018; sumner, griffith, & mineka, 2010). according to the violex-model of revising expecta‐ tions (rief et al., 2015), a revision of expectations requires a very specific definition of revisiting the cognitive model of depression 12 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ specific expectations a priori, and a clear comparison of expected versus experienced spe‐ cific outcomes. if experiences are memorized only vaguely, their potential power to stim‐ ulate expectation violations is only low. this notion is in accordance with the fact that abstract ruminations lead to more regrets about past decisions than concrete ruminations (dey, joormann, moulds, & newell, 2018). repetitive negative thinking, ruminations and worrying are also major features of de‐ pression (gotlib & joormann, 2010; mcevoy et al., 2018). these strategies can be consid‐ ered as preventing the change of negative expectations, even when positive events occur. therefore, a close link between these cognitive processes and immunization strategies exists. persistent depressive disorder is frequently associated with negative early life experi‐ ences and the development of insecure attachment styles. while negative life events can trigger the establishment of various negative expectations directly, insecure attachment styles can be also reformulated as negative relationship expectations. an association be‐ tween attachment and depression was frequently shown; this association is mediated via social anxieties (manes et al., 2016). social anxieties (like all anxiety disorders) can be mainly understood as expectation disorders. several psychological interventions try to address these relationship expectations, and the active formulation of a “transference hy‐ pothesis” in cbasp is a typical example (mccullough, 2000; mccullough et al., 2011). ob‐ viously, many psychological interventions include explicit or implicit interventions at‐ tempting to change relationship expectations, although an even more focused and explic‐ it work with relationship expectations seems promising. with this subchapter, we wanted to highlight that the expectation model of depres‐ sion is able to integrate other evidence-based approaches of depression research, and it invites to link this concept with others. while these are just a few examples, further con‐ ceptual work is possible and needed. c l o s i n g r e m a r k s while the cognitive model of depression was highly stimulating for a better understand‐ ing, improved conceptualization and development of treatment for depression, we sug‐ gest that it is time to better specify this approach. several results from basic neuroscience regarding effects in clinical interventions indicate that expectations can play a special role not only for the understanding of the development of mental disorders and effects of treatment approaches, but especially for an improved understanding of persistence of mental disorders. therefore, we also introduced the concept of immunization to describe any cognitive or behavioral strategies to reduce the effect of expectation violation experi‐ ences, and hereby contributing to expectation maintenance despite expectation contra‐ dicting events. we postulate that the development of immunization strategies could, in particular, be of relevance for the transition from episodic to chronic depression. while in rief & joormann 13 clinical psychology in europe 2019, vol.1(1), article e32605 https://doi.org/10.32872/cpe.v1i1.32605 https://www.psychopen.eu/ early periods of depression development, a focus on expectation change might be suffi‐ cient in treatment approaches as long as it respects some of the principles mentioned above, the treatment of patients with persistent depressive disorder requires more and more to address these cognitive and behavioral immunization strategies. we understand our manuscript mainly as stimulating further research and using this conceptual framework, instead of presenting a final model. first experimental results confirm its usability, and first clinical experiences encourage this approach as something that is easily explained to patients who found it very helpful. however, the model of the interplay between expectation processes and immunization strategies should be subject to further evaluation. funding: the authors have no funding to report. competing interests: winfried rief is editor-in-chief of clinical psychology in europe but played no editorial role for this particular article. acknowledgments: the authors have no support to report. r e f e r e n c e s alloy, l. b., olino, t., freed, r. d., & nusslock, r. 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[b] green lane paediatric and congenital cardiac services, starship children’s hospital, auckland, new zealand. [c] department of paediatrics child and youth health, university of auckland, auckland, new zealand. clinical psychology in europe, 2019, vol. 1(4), article e38062, https://doi.org/10.32872/cpe.v1i4.38062 received: 2019-07-08 • accepted: 2019-10-28 • published (vor): 2019-12-17 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: elizabeth broadbent, department of psychological medicine, university of auckland, private bag 92019, auckland 1142, new zealand. e-mail: e.broadbent@auckland.ac.nz abstract background: the small number of published studies indicate increased rates of anxiety and depression among patients with cardiac inherited diseases (cid). this study aimed to assess the prevalence of anxiety and depression in a new zealand cid cohort and seek any associations with clinical and psychosocial factors. method: patients on a national cid register were sent a survey; 202 of 563 contactable patients participated (36% response rate). ages ranged from 16 to 83 years (median 53). most had long qt syndrome (43%) or hypertrophic cardiomyopathy (34%). questionnaires collected demographic and psychological variables, including anxiety (gad-7), depression (phq-9), illness perceptions, perceived risk and social support. the registry supplied clinical and genetic characteristics. results: 80 participants (42%) reported features of anxiety and/or depression. 24 (13%) reached clinical levels of depression, a greater proportion than that found in the general population. poorer perceived social support was associated with worse anxiety (p < .001) and depression (p < .001) scores. reporting more physical symptoms (p = .001) (commonly not caused by the cid) was associated with poorer depression scores and greater perceived consequences of the cid was associated with greater anxiety scores (p < .05). neither anxiety nor depression were associated with time since diagnosis, disease severity or type of disease. conclusion: forty percent of the cid population live with some degree of psychopathology but this did not correlate with disease severity, type of disease nor time since diagnosis. correlating factors which may be modifiable include illness perceptions, various physical symptoms and social support. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.38062&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords generalized anxiety, depression, cardiac inherited diseases, long qt syndrome, hypertrophic cardiomyopathy, health psychology highlights • rates of clinical levels of anxiety and depression in this cid sample were 10% and 13% respectively. • anxiety and depression were not associated with disease type, severity or time since diagnosis. • perceived lack of support, consequences, and symptoms were associated with depression and anxiety. • high rates of anxiety and depression in cid’s indicate the need for access to psychological support. cardiac inherited diseases are a group of genetic heart conditions that account for many sudden cardiac deaths in individuals aged 1 to 35 years (bagnall et al., 2016). these condi‐ tions generally fall into two categories, channelopathies, which affect the electrical pro‐ cesses of the heart, e.g. long qt syndrome (lqts); and cardiomyopathies which cause the heart muscle to become dysfunctional and electrically unstable e.g. hypertrophic cardiomyopathy (hcm). the last decade has seen a dramatic rise in the detection of peo‐ ple with cardiac inherited diseases, which is the result of effective international efforts to reduce sudden deaths in young people (bagnall et al., 2016; behr et al., 2008; hofman et al., 2013). however the psychological impact of such detection has been under researched and is only just starting to be explored. the few studies performed to date suggest these individuals are particularly vulnerable to anxiety and depression, with prevalence rates found to be as high as 38% and 21% respectively (ingles, sarina, kasparian, & semsarian, 2013; morgan, o'donoghue, mckenna, & schmidt, 2008; richardson et al., 2018). these rates are considerably higher than the prevalence of anxiety (6 – 9%) and depressive dis‐ orders (5 8%) in general populations (alonso et al., 2004; kessler, chiu, demler, & walters, 2005; wells et al., 2006). however, the rates are in line with clinical levels of anxiety (20-25%) and depression (20-40%) in other cardiac populations (celano & huffman, 2011; moser, 2007). cardiac inherited disease patients have shed some light on why this may be in two qualitative studies (andersen, øyen, bjorvatn, & gjengedal, 2008; subasic, 2013). patients report that they struggle with the uncertainty of the trajectory of their disease; their in‐ creased risk of sudden cardiac arrest; and identifying whether their symptoms are normal or sinister. patients report a physical burden associated with living with these conditions, including symptoms such as extreme fatigue, palpitations and headaches, and side effects from treatment, which can in some instances get in the way of fulfilling roles at home and/or work or engaging with their social network. anxiety and depression in cid 2 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ greater clinical severity and uncertainty of risk may therefore be associated with psy‐ chological outcomes. however, research on other hereditary heart diseases has found that disease severity is not the only predictor of psychological well-being (o’donovan, painter, lowe, robinson, & broadbent, 2016). physical symptoms (including those unrela‐ ted to the heart condition) and illness perceptions also contribute to psychological wellbeing. it is well accepted that anxiety and depression have a negative influence on patient engagement and clinical outcomes (andrássy et al., 2007; dimatteo, lepper, & croghan, 2000; ziegelstein et al., 2000). disengagement is particularly unhelpful with cardiac in‐ herited disease because it could impede the detection and management of the heart con‐ dition in other family members, and nonadherence can be life-threatening. therefore it is imperative to gain a better understanding of the psychological impact of these condi‐ tions. the aim of this study was to assess rates of anxiety and depression in the new zea‐ land cardiac inherited disease population and determine which clinical, demographic and psychological factors were associated with anxiety and depression. this study intention‐ ally focused on factors that may be amenable to amelioration, including illness percep‐ tions and social support, as these factors might help to inform the delivery of psychologi‐ cal interventions for this group (broadbent, ellis, thomas, gamble, & petrie, 2009). m e t h o d s study design and study population the new zealand cardiac inherited diseases register was used to recruit participants (earle et al., 2019). eligible patients had a ‘definitely’ or ‘probably’ affected clinical status and a genetic status of ‘positive’, ‘uninformative testing’ or ‘unclassified variant’. over 15 years of age and proficiency in english were also required. multi-regional ethical appro‐ val was given 9th december 2016 (hdec ethics ref: 16/sth/200) there were 618 individuals who were identified as eligible; invitations were sent to them in may 2017. however, 55 of these eligible patients were non-contactable due to out of date contact details. a total of 202/563 contacted individuals returned questionnaires within three months (36% response rate); 361 patients did not participate ‘non-partici‐ pants’. demographic information for participants is shown in table 1. the questionnaire collected data on anxiety and depression and a number of other psychological and clini‐ cal variables, as follows. o’donovan, skinner, & broadbent 3 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ table 1 demographic and clinical variables of cardiac inherited disease participants characteristic n (%) demographic characteristics age: range (median) 16 83 (53) sex: female 103 (54.2) ethnicity nz european 151 (74.8) māori & pacific 21 (10.4) māori 19 (9.4) samoan 0 (0) cook island maori 1 (0.5) tongan 1 (0.5) other 16 (7.9) chinese 3 (1.5) indian 4 (2.1) other 9 (4.5) clinical characteristics inherited cardiac condition long qt syndrome 86 (42.6) hypertrophic cardiomyopathy 69 (34.2) dilated cardiomyopathy 12 (5.9) brugada 6 (3.0) other 21 (8.5) arvc 5 (2.5) cpvt 6 (3.0) sudden cardiac arrest syndrome 3 (1.5) progressive cardiac conduction disorder 3 (1.5) diagnosis missing 12 (5.8) clinic status definitely affected 145 (71.8) probably affected 42 (21.8) genetic status positive 110 (54.5) testing uninformative 57 (28.2) unclassified variant 20 (9.9) anxiety and depression in cid 4 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ characteristic n (%) proband true 121 (59.9) false 66 (32.7) β-blocker use 131 (64.9) number of years since diagnosis: range (median) 0 – 51 (9) note. participants n = 202. measures depression was assessed using the patient health questionnaire – 9 (phq-9) (kroenke, spitzer, & williams, 2001). this tool has 9 items that measure how often, in the last two weeks, symptoms of depression have occurred. responses are recorded on a 4-point scale from 0 – “not at all” to 3 – “nearly every day”. the phq-9 has been validated against clinical interviews with the following cut-off scores, 5 – 9 ‘mild cases’; 10 – 14 ‘moderate cases’; 15 – 19 ‘moderately severe cases’; and ≥20 ‘severe cases’ (kroenke et al., 2001). anxiety was measured using the generalized anxiety disorder – 7 (gad-7) (spitzer, kroenke, williams, & löwe, 2006). this assessment tool has 7 items and follows the same structure as the phq-9 asking how often symptoms of anxiety have occurred. the gad-7 has been validated against clinical interviews and the following cut-off scores were established, 5 – 9 ‘mild cases’; 10 – 14 ‘moderate cases’; 15 – 21 ‘severe cases’ (spitzer et al., 2006). the brief illness perception questionnaire (brief ipq) (broadbent, petrie, main, & weinman, 2006) assesses an individual’s cognitive and emotional representations of their illness. it contains eight items, with a 0 – 10 response format; assessing people’s experi‐ ence of symptoms (identity); perceptions of personal and treatment control; perceived timeline for the illness, the consequences it has on their life; how concerned they are about it; how much they understand the illness (coherence) and how much it affects them emo‐ tionally (emotional representation). the ninth item measures perceptions around cause and was not used in the analysis of this study. perceptions of risk were measured using questions based on bjorvatn and colleagues’ (2007) risk questions. one item was used in the analysis, which asked participants to re‐ port their perceived chance (0-100%) of experiencing severe symptoms (e.g. cardiac ar‐ rest, sudden cardiac death). the problem list is an assessment tool used to identify sources of distress in oncolo‐ gy patients (holland & bultz, 2007). minor changes were made to the problem list for this study so items were specific to this cardiac population. for example, mouth sores were removed and palpitations were added. it includes practical problems with ‘changes to fi‐ nances’, ‘work or school’ and taking medication; family problems with ‘communicating with extended family’, ‘fulfilling roles within the family’ and ‘planning to have children’; emotional problems such as ‘distress’, ‘isolated/feeling alone’ and ‘worried’; physical o’donovan, skinner, & broadbent 5 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ problems such as ‘blackouts/faints’, ‘breathing’ ‘cold hands and feet’, and ‘fatigue/tired‐ ness’; and spiritual/religious concerns such as ‘loss of purpose’ and ‘why me?’. each item was either scored zero if not identified as a problem or 1 if it was identified as a problem. subtotals for each subscale, and an overall total were then created by the number of problems selected. this tool is a practical way for patients to highlight aspects of their life contributing to their distress levels, so support provisions can be put in place. the stop-d is a five item screener used commonly in cardiac populations (young, ignaszewski, fofonoff, & kaan, 2007; young, nguyen, roth, broadberry, & mackay, 2015). the five items measure depression, anxiety, stress, anger and social support, participants are asked how much they have been bothered by each item over the last two weeks on a 10-point scale 0 – ‘not at all’ to 9 – ‘severely’. in this instance the whole measure was not used; we utilized the social support single item which asked how much participants had been bothered by: ‘not having the social support you feel you need?’ clinical information was extracted from the registry including the type of diagnosis, clinical status (level of certainty of their diagnosis, i.e. definitely affected vs probably af‐ fected), genetic status (genotype positive, unclassified variant or uninformative genetic test) and proband status (proband or cascade family member). participants responded to clinical questions in the questionnaire including, how long since their diagnosis, whether they had been prescribed β-blockers, how many of their family members had a cardiac inherited disease diagnosis and whether any family mem‐ bers had died from the condition. participants also completed demographic questions in‐ cluding age, gender, ethnicity and employment status. statistical analysis missing data were left out of analysis on a case by case basis. of the 202 participants, 20 had either missing ethnicity and beta-blocker data, clinical, genetic or proband status or did not indicate whether a death had occurred within their family. in total, 17 partici‐ pants had missing data for anxiety scores, three participants could have scores imputed as no more than two items were missing. in these cases the mean of the completed five items was used as a replacement for the missing items, leaving 14 participants without an anxiety score. in total 28 were missing for depression, 15 participants had scores imputed as no more than three items were missing, again the mean of the remaining items was used as a replacement, leaving 13 participants without a depression score. of these par‐ ticipants with missing data, 10 did not complete both measures. analyses were conducted on spss version 24 software. non-parametric tests were used due to non-normally dis‐ tributed data and medians were used when reporting findings. spearman correlations were conducted to determine associations between psychological variables and age, anxi‐ ety and depression. mann-whitney tests were performed to assess differences in anxiety and depression between those taking and not taking β-blockers, probands versus family members, and those with a definite versus probable clinical status. comparisons were al‐ anxiety and depression in cid 6 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ so made using the kruskal-wallis test to assess whether anxiety and depression differed between genetic status and a death in the family status. hierarchical multiple regression analysis was performed using the significant variables from the above tests along with age and gender given they are consistently associated with anxiety and depression (baxter, scott, vos, & whiteford, 2013; stordal, mykletun, & dahl, 2003). a total of 160 cases were included in the anxiety regression and 158 for the depression regression. a significance level of .05 was maintained apart from when post-hoc tests were performed during which a bonferroni correction was made. r e s u l t s participants did not differ from non-participants on gender, genetic, proband and clinical status and type of condition; but they did differ based on age (p < .001) and ethnicity (p < .001). those who participated were significantly older (median 53 years) compared to those who did not (median 45 years) and new zealand europeans were over represented in the study compared to other ethnicities (see table 1). means and standard deviations for all the psychological variables are reported in ta‐ ble 2. table 2 means and standard deviations of the psychological variables psychological variable m sd anxiety 3.37 4.28 depression 4.62 4.60 perceived social support 0.87 1.62 perceived risk 32.28 30.50 ip consequence 3.73 2.96 ip timeline 9.60 1.55 ip personal control 4.30 3.27 ip treatment control 4.59 3.35 ip identity 2.92 2.76 ip concern 4.50 3.23 ip coherence 7.17 2.54 ip emotional representation 3.30 3.12 problem list – practical 1.91 2.60 problem list family 0.69 1.09 problem list – emotional 1.62 2.61 problem list – physical 2.26 2.35 problem list spiritual 0.21 0.52 o’donovan, skinner, & broadbent 7 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ depression and anxiety scores ranged from 0 to 21 and 0 to 19 respectively. there were 27/192 (14%) individuals reporting clinical levels of anxiety and/or depression. of these individuals 16 (8%) reported clinical levels of both, 4 (2%) just depression, and 7 (4%) clinical levels of one and mild levels of the other. there were, 53/192 (28%) individuals who reported subclinical (mild) levels of anxiety and/or depression. of these individuals 23 (12%) reported subclinical levels of both, 22 (12%) just mild depression and 8 (4%) just mild anxiety. accordingly, 112/192 (58%) participants fell in the ‘non-clinical range. table 3 displays the proportion of people with at least mild levels of anxiety and depression by type of condition. there was no significant difference in anxiety and depression levels between the two most common conditions lqts and hcm, χ2(1, n = 146) = 3.87, p = .273. levels of anxiety and depression did not differ significantly based on gender or age (table 3). table 3 the proportion of participants with at least mild anxiety and/or depression by the type of cid condition condition n (%) anxiety only depression only anxiety & depression total long qt syndrome 6 (7) 7 (8) 23 (27) 36 (42) hcm 1 (1) 12 (17) 16 (23) 29 (42) dcm 0 (0) 2 (17) 1 (8) 3 (25) arvc 0 (0) 1 (20) 1 (20) 2 (40) cpvt 0 (0) 0 (0) 1 (17) 1 (17) brugada 1 (17) 1 (17) 0 (0) 2 (33) sudden cardiac arrest syndrome 0 (0) 1 (33) 1 (33) 2 (67) missing diagnosis 0 (0) 1 (8) 3 (25) 4 (33) totals 7 (4) 26 (13) 46 (24) 79 (41) anxiety bivariate analyses (table 4) showed that ethnicity was the only demographic variable as‐ sociated with anxiety u = 1919.5, z = -2.28, p < .05. a smaller proportion of new zealand european participants (7.5%) scored above the clinical threshold for anxiety compared to non-new zealand european participants (17%). a kruskal-wallis test on ‘death of a fami‐ ly member due to a cardiac inherited disease’ was found to be significantly related to anxiety h(2) = 6.31, p < .05; however mann whitney post hoc tests using a bonferroni correction did not reach significance between the groups (‘yes’, ‘no’, or ‘i don’t know’). participants on beta-blockers had significantly greater clinical anxiety u = 2952, z = -2.93, p < .01, compared to participants not on beta-blockers (14% vs 3% respectively). clinical, genetic and proband status and channelopathy versus cardiomyopathy were not related anxiety and depression in cid 8 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ to anxiety. there was also no significant correlation between anxiety and time since di‐ agnosis. table 4 bivariate analyses (pearson correlations, mann-whitney and kruskal-wallis tests) of the relationship between psychological, clinical and demographic variables with scores on the anxiety and depression scales phq-9 depression gad-7 anxiety spearman correlations rs p rs p age -.03 .677 -.13 .079 time since diagnosis .01 .939 -.09 .230 percentage of life with diagnosis .00 .963 -.04 .574 problem list – total .69 < .001 .66 < .001 problem list – physical .55 < .001 .44 < .001 problem list – emotional .62 < .001 .71 < .001 problem list – practical .50 < .001 .53 < .001 bipq – consequence .54 < .001 .53 < .001 bipq –timeline .01 .874 .00 .968 bipq – personal control -.21 .004 -.17 .019 bipq – treatment control -.02 .832 -.08 .317 bipq – identity .52 < .001 .40 < .001 bipq – concern .45 < .001 .53 < .001 bipq – understand .01 .892 -.07 .352 bipq – emotional representation .51 < .001 .62 < .001 perceived social support .39 < .001 .48 < .001 risk perceptions for severe symptoms (%) .38 < .001 .40 < .001 mann whitney tests u (z) p u (z) p beta-blockers (prescribed) 3179 (-2.32) .02 2952 (-2.93) .003 parent (not being a) 2585.5 (-1.61) .107 2428.5 (-1.95) .051 gender 3709.5 (-1.04) .297 3850.5 (-0.53) .596 cardiomyopathy vs channelopathy 3923.5 (-0.47) .637 3839.5 (-0.58) .563 proband (true) 2885 (-2.34) .019 3095.5 (-1.72) .085 clinical 2749 (-0.35) .730 2372.5 (-1.44) .150 ethnicity (non-european) 1935 (-2.58) .010 1919.5 (-2.28) .022 kruskal wallis tests h(2) p h(2) p genetic status 0.53 .777 0.09 .958 death of a family member (don’t know vs no) 9.42 .007 6.31 .043 note. z = z score. the psychological variables associated with anxiety in the bivariate analyses (table 4) in‐ cluded the number of physical and practical problems reported, illness perceptions (con‐ sequences; personal control; identity, concern, and emotional representation), percep‐ tions of risk and social support. o’donovan, skinner, & broadbent 9 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ hierarchical multiple regression analysis (table 5) was conducted and significant var‐ iables from the bivariate analyses and age and gender were entered into the model to predict anxiety. table 5 regression analysis to investigate predictors of anxiety in individuals with a cardiac inherited disease steps b se b β 95% ci for b ll ul step 1 (constant) 5.68 1.98 1.78 9.59 age -0.04 0.02 -.18* -0.08 -0.01 gender 0.31 0.64 .04 -0.95 1.57 ethnicity (european vs non-european) 0.90 0.80 .09 -0.68 2.47 prescribed beta-blockers -1.85 0.67 -.21** -3.18 -0.52 deaths within the family yes 0.79 0.70 .10 -0.59 2.18 deaths within the family – don’t know 0.69 0.90 .07 -1.09 2.47 step 2 (constant) 3.18 1.75 -.28 6.64 age -0.03 .02 -.10 -0.06 0.01 gender 0.05 0.52 .01 -0.97 1.07 ethnicity (european vs non-european) 0.08 0.69 .01 -1.29 1.46 prescribed beta-blockers -1.01 0.56 -.12 -2.12 0.11 deaths within the family yes -0.89 0.61 -.11 -2.09 0.31 deaths within the family – don’t know -0.68 0.74 -.06 -2.16 0.79 pl physical symptoms 0.32 0.17 .17 -0.01 0.65 pl – practical problems 0.16 0.15 .10 -0.14 0.46 ip – personal control -0.08 0.08 -.07 -0.23 0.08 ip – consequence 0.33 0.14 .24* 0.05 0.61 ip – identity -0.11 0.15 -.08 -0.39 0.18 ip – concern 0.15 0.11 .12 -0.08 0.37 risk perception – severe symptoms -0.00 0.01 -.03 -0.03 0.02 perceived social support 0.79 0.17 .34*** 0.47 1.12 note. ci = confidence interval; ll = lower limit; ul = upper limit. *p < .05. **p < .01. ***p < .001. all significant brief ipq items were included in the regression except emotional repre‐ sentation due to its conceptual overlap with the outcome variable. ethnicity, age, gender, beta-blocker and death of a family member variables were entered in model 1, and ex‐ plained 9% of the variance in anxiety scores f(6, 153) = 2.65, p = .018. being younger and prescribed beta-blockers (p = .007) were significant independent predictors in model 1. anxiety and depression in cid 10 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ after entering physical (symptom reports) and practical problems, perceptions of person‐ al control, consequences, identity, concern, risk and social support at model 2, the total variance explained by the model as a whole was 46% (r 2 = .46, adjusted r 2 = .41), f(14, 145) = 8.76, p < .001. the variables in model 2 explained an additional 37% of the variance in anxiety, fchange(8, 145) = 12.18, p < .001. in the final model higher perceptions of conse‐ quences (p = .021) and perceptions of poorer social support (p < .001) were significantly associated with greater anxiety. depression ethnicity was the only demographic variable related to depression u = 1935, z = -2.58, p < .05 (table 4). overall, more non-new zealand european participants (16%) reported clinical levels of depression than new zealand european participants (11%). reports of whether a family member had died due to a cardiac inherited disease was significantly related to depression h(2) = 9.42, p < .01. mann whitney post hoc tests us‐ ing a bonferroni correction showed a significant difference between those who had lost a family member and those who reported they had not (13% vs 11% respectively reported clinical levels of depression) u = 1963.5, p = .008; and between those who didn’t know if they had lost a family member and those who reported they had not (16% vs 11% respec‐ tively reported clinical levels of depression) u = 812.5, p = .014. those participants prescribed beta-blockers had significantly greater depression scores than those not prescribed them u = 3179, z = -2.32, p < .05 (16% vs 6% respectively reported clinical levels of depression). probands had significantly greater depression scores compared to family members u = 2885, z = -2.34, p < .05 (14% vs 8% respectively reported clinical levels of depression). clinical and genetic status, channelopathy versus cardiomyopathy, and time since diagnosis were not significantly related to depression. the psychological variables associated with depression in the bivariate analysis (ta‐ ble 4) mirrored the anxiety results. depression scores were significantly related to the number of physical and practical problems participants reported, illness perceptions (consequences, personal control, identity, concern, and emotional representation), per‐ ceptions of risk and social support. a hierarchical multiple regression analysis (table 6) was conducted using significant variables from the bivariate analysis (again, the emotional representation item from the brief ipq was left out due to its conceptual similarity with the outcome variable) and age and gender. ethnicity, age, gender proband status, beta-blocker and death of a family member variables were entered in model 1; they explained 12% of the variance in depres‐ sion scores f(7, 150) = 3.04, p = .005. a death in the family (p = .006) and being a proband (p = .035) were significant variables in model 1. in model 2, physical and practical prob‐ lems, perceptions of personal control, consequences, identity, concern, risk and social support were entered, and the total variance explained by the model as a whole was 50% (r 2 = .50, adjusted r 2 = . 45), f(15, 142) = 9.39, p < .001. the variables in model 2 ex‐ o’donovan, skinner, & broadbent 11 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ plained an additional 38% of the variance in depression, fchange(8, 142) = 13.21, p < .001. in the final model greater reported physical problems (p < .001) and perceptions of poorer social support (p < .001) were significantly associated with greater depression scores. table 6 regression analysis to investigate predictors of depression in individuals with a cardiac inherited disease steps b se b β 95% ci for b ll ul step 1 (constant) 7.21 2.39 2.48 11.94 age -0.03 0.02 -.12 -0.08 0.01 gender 0.00 0.73 .00 -1.45 1.45 ethnicity (european vs non-european) 1.43 0.89 .13 -0.34 3.19 prescribed beta-blockers -1.24 0.78 -.12 -2.78 0.29 deaths within the family yes 2.24 0.80 .24** 0.66 3.82 deaths within the family – don’t know 1.14 1.02 .09 -0.88 3.16 proband status -1.63 0.77 -.17* -3.15 -0.12 step 2 (constant) 4.04 2.13 -0.16 8.25 age -0.02 0.02 -.08 -0.06 0.01 gender -0.54 0.59 -.06 -1.71 0.62 ethnicity (european vs non-european) 0.48 0.78 .04 -1.05 2.01 prescribed beta-blockers -0.35 0.63 -.04 -1.60 0.90 deaths within the family yes 0.42 0.68 .05 -0.92 1.76 deaths within the family – don’t know -0.33 0.83 -.03 -1.96 1.31 proband status -0.77 0.63 -.08 -2.01 0.47 pl physical symptoms 0.72 0.19 .35*** 0.35 1.10 pl – practical problems 0.08 0.16 .04 -0.24 0.40 ip – personal control -0.07 0.09 -.05 -0.24 0.11 ip – consequence 0.29 0.16 .18 -0.02 0.60 ip – identity 0.06 0.16 .04 -0.26 0.38 ip – concern -0.04 0.12 -.03 -0.29 0.20 risk perception – severe symptoms 0.00 0.01 .02 -0.02 0.03 perceived social support 0.75 0.18 .28*** 0.39 1.12 note. ci = confidence interval; ll = lower limit; ul = upper limit. *p < .05. **p < .01. ***p < .001. d i s c u s s i o n this study found an increased prevalence of depression and anxiety in patients with a cardiac inherited disease, which supports findings from the small number of earlier stud‐ anxiety and depression in cid 12 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ ies with this patient population. eighty (42%) participants had features of at least mild depression and/or anxiety. time since diagnosis and milder clinical severity did not di‐ minish the likelihood of either anxiety or depression symptoms. the diagnostic levels of depression and anxiety (13% and 10% respectively) and subclinical levels of depression (24%) in this cardiac inherited disease population were found to be higher than that in general populations (alonso et al., 2004; kessler et al., 2005; wells et al., 2006). treating psychopathology is important not only for patients’ quality of life but evidence suggests even subclinical levels of depression and anxiety can be detrimental for engagement and health outcomes (lewinsohn, solomon, seeley, & zeiss, 2000; roest, martens, de jonge, & denollet, 2010) and can be risk factors for more severe future psychopathology (cuijpers & smit, 2004). this study found that perceptions of social support were associated with both anxiety and depression scores in the hierarchical regression models. perceptions of social support are consistently associated with mental health and wellbeing across many different ill‐ ness groups including cardiac populations (hughes et al., 2004; thoits, 2011). the current study focused on perceived social support, a subjective feeling of being supported, as op‐ posed to received social support, the actual support provided. a perceived lack of support has been found to be a stronger predictor of greater depression than the actual support received, with studies showing a perceived sense of good social support plays a protec‐ tive role in the association between chronic illness and depression (santini, koyanagi, tyrovolas, mason, & haro, 2015). given these heart conditions are hereditary, multiple people within a family can be affected. it would be easy to assume there would be an inbuilt support network for pa‐ tients, and this is likely the case for the majority of study participants who reported hav‐ ing the social support they felt they needed. however this study suggests an important minority of patients feel they do not have the social support they feel they need and this group is doing poorer psychologically. further research is needed to better understand perceptions of social support with this specific patient population. janney (2011) provides some insight in a qualitative study in which lqts patients reported a perceived lack of emotional support from their social networks due to a poor understanding of the condi‐ tion (i.e. the absence of visible symptoms). the number of physical symptoms individuals reported was significantly associated with depression. the association between physical symptoms and depression is also well documented across different conditions, (katon, lin, & kroenke, 2007) and likely related to the limitations physical symptoms can cause. the items most commonly endorsed by participants in this study were fatigue, palpitations, insomnia, shortness of breath with exercise, and dizziness. these are common symptoms, many of which are reported in pri‐ mary care populations, and are highly correlated with anxiety and depression (kroenke et al., 1994). it is therefore important to be aware that patient-reported symptoms may not always be related to their heart condition. indeed, some of these symptoms would o’donovan, skinner, & broadbent 13 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ not generally be caused by a channelopathy at all, and may in fact provide an indication that anxiety and/or depression is present. as the common sense model of illness (csm) indicates (leventhal, meyer, & nerenz, 1980), patients attempt to make sense of their symptoms, even mild ones, and may misat‐ tribute unrelated symptoms (or side effects from medication) to their cardiac condition which will affect the mental model the patient holds for their cardiac inherited disease. although certain patient-reported symptoms may not be of direct clinical relevance to the medical management of the heart condition, it is important they get addressed. further support for the common sense model was provided by this study, in that ill‐ ness perceptions were strongly related to psychological distress. the consequence do‐ main was a significant individual contributor to the regression model for anxiety. this is in line with a meta-analysis that included different health conditions, which found the consequence domain consistently predicted the presence of anxiety (broadbent et al., 2015). other illness perceptions (personal control, identity and concern) and risk percep‐ tions were associated with anxiety and depression as well. illness perceptions represent malleable aspects of a patient’s experience that could be targeted in an intervention (broadbent et al., 2009). longitudinal research is needed to better understand the rela‐ tionship between perceived social support and illness and risk perceptions and anxiety and depression over time. this study found that time since diagnosis (median 9 years) and disease severity were not associated with depression or anxiety. it is intuitive to think that the longer someone has a health condition the better they will become at integrating it into their life and cop‐ ing with its consequences (morgan et al., 2008). however, studies of other cardiac condi‐ tions have shown similar findings (pelletier et al., 2014), indicating even patients with mild disease can be vulnerable. this study also supports research that found the preva‐ lence of anxiety and depression does not differ between the two most common cardiac inherited diseases, long qt syndrome and hypertrophic cardiomyopathy (hamang, eide, rokne, nordin, & øyen, 2011) which is worth investigating further, given the very differ‐ ent disease trajectories these conditions have. hcm is a progressive condition of heart muscle thickening and dysfunction and reminder symptoms such as shortness of breath on exertion are common in advanced disease. lqts is non-progressive, and the only symptoms anticipated are syncope, or cardiac arrest. further research may help to estab‐ lish which features in common are the most important (such as hereditability and risk of sudden death), as well as the dominant findings here which seem to be common to many diseases in general, such as the importance of a good social support infrastructure. although cardiac inherited disease patients are likely to be vulnerable to distress ear‐ ly on (which research shows usually dissipates) (hendriks et al., 2008), living with these conditions day to day may create an on-going vulnerability to anxiety and depression re‐ gardless of severity or how long someone has had the condition. the american heart as‐ sociation and american college of cardiology recommend that there is an integration of anxiety and depression in cid 14 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ psychological screening, assessment and intervention into cardiac care across the life span of patients with a congenital heart disease (warnes et al., 2008). the existing re‐ search would suggest it is time to consider similar recommendations for cardiac inherited disease patients. clinical implications the fact that 14% of patients had clinical levels of psychopathology and 28% had subclini‐ cal levels regardless of clinical severity or time with the condition, suggests that psycho‐ logical support should be made available to this patient population. the finding that noneuropeans had higher psychological morbidity indicates that ethnic minorities, most no‐ tably māori and polynesian peoples in this study, will need specific attention. limitations there are some limitations to this research. although a 36% response rate is in accord‐ ance with postal and web based surveys (shih & fan, 2008), it means this sample may not be representative of the population as a whole. it is difficult to know whether anxiety and depression are therefore underrepresented or overrepresented in this study. when people are choosing to take part in a voluntary survey they balance the interest, value, and personal relevance of it with the cost in time, energy and resources required to com‐ plete it (groves, cialdini, & couper, 1992). it is feasible that individuals suffering from anxiety and depression could come to a decision from either side of that equation. com‐ pounding this issue of sample representativeness is the fact that younger and ethnic mi‐ norities were under-represented and the questionnaire was only provided in english, cre‐ ating a potential bias around english language proficiency. this is also cross-sectional data and no direction of relationship can be determined. conclusion this study found anxiety and depression were more prevalent in the cardiac inherited disease population than in the general population and a perceived lack of social support was significantly associated with both. in addition the presence of more physical symp‐ toms (not necessarily specific to the heart condition) was associated with an increased risk of depression and more severe perceptions of the consequences of the heart condi‐ tion was associated with anxiety. the presence of a mild cardiac phenotype, and having had the condition for a long time do not appear to be protective of poor psychological wellbeing. future research should investigate these associations in a longitudinal study to help inform psychological interventions with this patient population. o’donovan, skinner, & broadbent 15 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ funding: dr. skinner receives salary support from cure kids. claire o’donovan receives a phd scholarship from the university of auckland. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. ethics approval: this study was approved by the health and disability ethics committee new zealand and local area health board: number: 16/sth/200. data availability: data was collected with the ethics requirement that patients’ data is confidential and will not be shared. however any requests for de-identified data should be directed to the corresponding author. r e f e r e n c e s alonso, j., angermeyer, m., bernert, s., bruffaerts, r., brugha, t., bryson, h., . . . vilagut, g. 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(2000). patients with depression are less likely to follow recommendations to reduce cardiac risk during recovery from a myocardial infarction. archives of internal medicine, 160(12), 1818-1823. https://doi.org/10.1001/archinte.160.12.1818 o’donovan, skinner, & broadbent 19 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://doi.org/10.1016/j.jacc.2010.03.034 https://doi.org/10.1016/j.jad.2014.12.049 https://doi.org/10.1177/1525822x08317085 https://doi.org/10.1001/archinte.166.10.1092 https://doi.org/10.1034/j.1600-0447.2003.02056.x https://doi.org/10.1111/jnu.12040 https://doi.org/10.1177/0022146510395592 https://doi.org/10.1016/j.jacc.2008.10.001 https://doi.org/10.1080/j.1440-1614.2006.01903.x https://doi.org/10.1097/01.jcn.0000297383.29250.14 https://doi.org/10.1177/1474515114548649 https://doi.org/10.1001/archinte.160.12.1818 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. anxiety and depression in cid 20 clinical psychology in europe 2019, vol.1(4), article e38062 https://doi.org/10.32872/cpe.v1i4.38062 https://www.psychopen.eu/ anxiety and depression in cid (introduction) methods study design and study population measures statistical analysis results anxiety depression discussion clinical implications limitations conclusion (additional information) funding competing interests acknowledgments ethics approval data availability references developments in psychotraumatology: a conceptual, biological, and cultural update scientific update and overview developments in psychotraumatology: a conceptual, biological, and cultural update andreas maercker a, mareike augsburger a [a] psychopathology and clinical intervention, department of psychology, university of zurich, zurich, switzerland. clinical psychology in europe, 2019, vol. 1(1), article e30294, https://doi.org/10.32872/cpe.v1i1.30294 received: 2018-10-03 • accepted: 2019-03-01 • published (vor): 2019-03-29 handling editor: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: andreas maercker, abstract background: this report discusses recent developments of psychotraumatology mainly related to the recently published icd-11, but also from a societal point of view. methods: the selected aspects of the development of this field will be presented as a scoping review. results: in the first section, the new concept of disorders specifically associated with stress and its relevant diagnostic groups (posttraumatic stress disorder [ptsd], complex ptsd, prolonged grief disorder, and adjustment disorder) are presented, with an emphasis on ptsd. the second section embeds these diagnostic concepts within a broader context. in particular, the concept of psychotraumatology is applied to the impact of adverse childhood experiences. more specifically, recent scientific developments are discussed with respect to biological stress research. in a third section, a global perspective is applied that reflects psychotraumatology as embedded in culturallyspecific concepts. lastly, societal developments are taken into consideration. this section focusses on recent processes of victim acknowledgement and compensation taking place in europe and beyond. examples are provided for how traumatic stress is perceived and processed in society. concepts such as continuous stress and historical trauma are also discussed. conclusion: demands and opportunities of basic research and psychological interventions with a global focus are outlined. keywords psychotraumatology, icd-11, posttraumatic stress disorder (ptsd), adverse childhood experiences, child abuse, acknowledgment of victims, cultural background, survivor status, compensation this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.30294&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • psychotraumatology is an expanding field including both basic research and intervention-related research. • starting points of this new research area are not only potential traumatic events but also adverse childhood experiences. • in a globalized world, cultural and societal factors play an increasingly important role in psychotraumatology. in the early 1980s, the scientific field of psychotraumatology arose with the first descrip‐ tion of posttraumatic stress disorder (ptsd) as a new diagnostic category in dsm-iii (american psychiatric association, 1987). today, this research area has been internation‐ ally recognized and well-accepted despite prevailing critical concerns and controversies (rosen, spitzer, & mchugh, 2008). from its initial description in the 1980s, concepts of psychotraumatology have continuously developed. this is also reflected by the growing number of scientific publications, the founding of thematically relevant journals, as well as increasing public awareness and perception (maercker & augsburger, 2017). in the following sections, recent developments in psychotraumatology will be descri‐ bed. first, we will focus on new diagnostic concepts and changes in stress-related disor‐ ders associated with the launch of icd-11. since icd is a major classification system used in clinical practice in many european countries, we will only briefly refer to alter‐ native concepts as presented in dsm. a more detailed and explicit comparison of icd-11 and dsm-5 extends beyond the scope of this review. second, we will describe recent developments in areas closely related to ptsd, mainly adverse childhood experiences (aces) and their biological impact. we focus on this spe‐ cific topic for two reasons: first, in clinical practice, aces remain an often-neglected area despite their frequent occurrence and large burden. second, technical advancements have resulted in a vast increase in recent years in studies focusing on biological markers asso‐ ciated with aces. in a third section, culturally-specific models of mental disorders will be discussed with a focus on global challenges. and, lastly, aspects of public discourses are considered. the aim of this report is to give a summarized overview of selective topics and con‐ cepts associated with recent developments in the field of psychotraumatology and in light of icd-11. thus, core areas were selected according to the authors’ personal re‐ search foci. developments in psychotraumatology 2 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ n e w c o n c e p t u a l i z a t i o n s o f s t r e s s r e l a t e d d i s o r d e r s i n i c d 1 1 the updated 11th version of the international classification of disorders (icd-11) of the world health organization (who, 2018) brought about a number of significant changes in the conceptualization of stress-related mental disorders. these changes are a marked contrast to the other major classification system, the diagnostic and statistical manual, version 5 (dsm-5), released by the american psychiatric association (apa, 2013). with icd-11, ptsd and two additional stress-related mental disorders can now be adequately diagnosed: a complex form of ptsd and prolonged grief disorder. moreover, a completely new symptom formulation was also grouped in this category, for adjustment disorder oc‐ curring after severe non-traumatic stressors (first, reed, hyman, & saxena, 2015; maercker et al., 2013). some years previously, these changes were discussed for dsm-5. but at this time the committee declared that sufficient evidence was not provided for an empirically valid distinction between ptsd and complex ptsd. as a consequence, the current ptsd diagnosis in dsm-5 also incorporates symptoms that are specified as com‐ plex ptsd in icd-11. in addition, prolonged grief disorder cannot be diagnosed as a “full disorder” in dsm-5, but exists as a provisional diagnostic concept in the appendix (under the term “persistent complex bereavement disorder”). concerning adjustment disorder, the concept has remained largely the same in its transition from dsm-iv to dsm-5. in the following sections, the four diagnoses (ptsd, complex ptsd, prolonged grief disorder, adjustment disorder) will be introduced and discussed. all criteria are based on the online version of the icd-11 (who, 2018). ptsd ptsd manifests itself after exposure to an extremely threatening adverse event or series of events. it is characterized by the following three symptom clusters: 1) re-experiencing of the traumatic event(s). this occurs in the form of vivid intrusive memories, such as flashbacks or nightmares. 2) avoidance of thoughts or reminders of the traumatic event(s) or avoidance of activities, situations, or persons that elicit memories. 3) persis‐ tent perception of heightened current threat, as characterized by an enhanced startle re‐ action or alertness. for a diagnosis of ptsd, all symptom clusters must persist for several weeks and lead to significant impairment in psychosocial functioning (who, 2018). in contrast to both dsm-5 and icd-10, the intrusion criterion of icd-11 is stricter and not only requires aversive memories of the traumatic event(s), but also stronger feelings of vivid re-experiencing. in addition, the definition of hyperarousal focuses on increased perception of threat. icd-11 prevalence rates of ptsd are lower than those for icd-10 and are also reduced in comparison to dsm-5 (brewin et al., 2017). results from the world mental health survey indicate a lifetime prevalence from 3.0-3.4% worldwide (stein et al., 2014). maercker & augsburger 3 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ complex ptsd (cptsd) cptsd can develop after exposure to an extreme and threatening event or a sequence of events, from which escape or flight is difficult or impossible. in order to give a diagnosis of cptsd, individuals first need to fulfill all symptoms of ptsd. in addition, difficulties in three further areas must be reported: 1) severe problems with affect regulation; 2) per‐ ception of oneself as diminished, worthless, or defective; and 3) persistent difficulties in establishing or maintaining relationships and the feeling of being close to others. as with ptsd, all symptoms need to lead to significant impairment in psychosocial functioning (who, 2018). this diagnosis is the successor of icd-10 personality disorder f62.0 (endur‐ ing personality change after catastrophic experience), but with an entirely new conceptu‐ alization. to date, limited information on prevalence rates is available for the us, den‐ mark, and germany. in these countries, the rates range between 0.5-1.0%, across 1-12 months (brewin et al., 2017; maercker, hecker, augsburger, & kliem, 2018). prolonged grief disorder (pgd) pgd can develop after the loss of a loved one. it is marked by a persistent and intense longing for the deceased, accompanied by a strong cognitive attachment. in addition, in‐ tense emotional suffering occurs, such as sadness, feelings of guilt, anger, denial, or diffi‐ culties in accepting the death (who, 2018). it is important to note that all these symp‐ toms can fall within the normal range of grieving. they may only be considered as pathological if they persistently occur over an atypically long period of time, in relation to what is considered as normative in the respective social, cultural, and religious setting. this aspect is important as it allows a broad range of culturally-related variability. for instance, in traditional western or european cultures, symptoms that present within one year of mourning may be perceived as acceptable within this setting. regarding prevalence rates, studies are still lacking with respect to the new icd-11 criteria. a recent meta-analysis on a preliminary concept of pgd reported a prevalence rate of 9.8% following the violent loss of a close person (lundorff, holmgren, zachariae, farver-vestergaard, & o'connor, 2017). in general, lower rates are expected for icd-11 (e.g., kersting, brahler, glaesmer, & wagner, 2011). adjustment disorder adjustment disorder manifests itself as an intense reaction towards a clearly identifiable psychosocial stressor. typically, it occurs within one month following the starting point of the stressor. a main symptom is the cognitive attachment towards the stressor or its consequences. this can be expressed as excessive worrying, persistent burdensome thoughts about the stressor, and constant rumination. for a diagnosis of adjustment dis‐ order, these symptoms must lead to significant impairment in psychosocial functioning. developments in psychotraumatology 4 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ improved functioning should only be possible with considerable effort. over the course of time, a symptom remission can occur within six months (who, 2018). in contrast to both icd-10 and dsm-5, this new concept of adjustment disorder brings significant changes: first, the core symptoms of preoccupation and failure to adapt are now clearly described and must be present for a diagnosis. and second, in the current formulation, the subtypes of adjustment disorder (e.g., depressive or anxious) were omitted, as previ‐ ous studies showed a high degree of overlap between the subtypes (maercker & lorenz, 2018). regarding prevalence rates, a recent study reported a one-year prevalence of 2% in a representative german sample (glaesmer, romppel, brahler, hinz, & maercker, 2015). however, rates are much higher in risk samples. for instance, rates ranged between 13.8-17.2% in a sample of individuals who had experienced involuntary job loss in swit‐ zerland (perkonigg, lorenz, & maercker, 2018). the above four stress-related diagnoses not only emphasize the considerable im‐ provements in clinical utility (maercker et al., 2013), but also reflect the fact that thera‐ peutic interventions for specific disorders have been developed and evaluated in recent years (schnyder & cloitre, 2015). for ptsd, trauma-focused specific psychotherapeutic interventions that incorporate a variant of exposure show the best evidence for treatment efficacy (e.g., narrative exposure therapy, trauma-focused cognitive-behavioral therapy). for complex ptsd, a phase-based intervention was developed and is currently being evaluated (e.g., cloitre, koenen, cohen, & han, 2002). for prolonged grief disorder, differ‐ ent treatment manuals are available (rosner et al., 2014). lastly, adjustment disorder is also benefitting from new interventions on a low-threshold level (maercker, lorenz, perkonigg, & kapfhammer, 2016). a remaining issue is the different conceptualizations of the disorders, specifically ptsd with respect to dsm-5 and icd-11. recent studies point to the fact that different subgroups of patients are being identified depending on the classification system used (e.g., barbano et al., 2019). however, these discrepancies also offer the opportunity for further scientific discourse. e x p a n d i n g t h e c o n c e p t o f p s y c h o t r a u m a t o l o g y today, it is well recognized that traumatic experiences during childhood, such as sexual abuse or physical violence, can have a long-lasting and devastating impact on later life. more recently, less severe types of traumatic experiences, such as verbal abuse, have also gained awareness as a similarly potent form of maltreatment (teicher, samson, polcari, & mcgreenery, 2006). the term adverse childhood experiences (ace) incorporates a much broader range of these exposure types, including emotional or physical neglect, or peer violence. it is evident that some of these maltreatment types extend beyond the definition of a traumatic event, according to the classification of dsm or icd. maercker & augsburger 5 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ consequences of adverse childhood experiences the first systematic investigation of adverse childhood experiences (the so-called ace studies) incorporated a huge sample of 17,300 study participants and were a milestone for later research (anda et al., 2006; dube et al., 2001). for the first time, not only the longterm consequences of exposure to physical or sexual abuse were assessed, but also the impact of a broad range of other experiences, such as emotional abuse, physical or emo‐ tional neglect, and other risk factors in the child’s environment. the ace-studies resul‐ ted in overwhelming evidence for the significant negative impact of these experiences in later life: up to a 3.6-fold increased risk for depressive disorders, 2.4-fold increased risk for anxiety disorders, 2.7-fold increased risk for occurrence of hallucinations, 2.1-fold in‐ crease for sleeping disorders, and 7.2-fold increased risk for alcohol abuse. in addition, risk for somatic complaints was increased by 2.7-fold, and severe obesity showed up to a 1.9-fold increased risk (anda et al., 2006). these ace-studies not only led to the general acknowledgement of the detrimental effects of adverse childhood experiences, but also resulted in the development of standar‐ dized and validated measures to assess aces. today, the childhood trauma question‐ naire is one such questionnaire investigating adverse and traumatic childhood experien‐ ces, and has thus far been used in more than 500 studies (viola et al., 2016). several meta-analyses have provided further evidence and confirmed the risk for the development of mental and somatic diseases and behavioral problems as a result of ad‐ verse experiences (e.g., augsburger, basler, & maercker, in press; hughes et al., 2017; norman et al., 2012). additionally, a meta-review (summarizing previous reviews) on sex‐ ual abuse, demonstrated the devastating impact of sexual abuse on later life, showing an increased risk for a broad range of severe disorders and symptoms (e.g., personality dis‐ orders, eating disorders, psychotic symptoms, sexual dysfunction, and also somatic com‐ plaints, such as pelvic pain or non-epileptic seizures); as well as impairment in social in‐ teractions, and an increased risk for future exposure to sexual violence, but also involve‐ ment in aggressive acts (maniglio, 2009). this last aspect is particularly relevant for the field of pediatric and adolescent psychiatry (anda et al., 2006; augsburger, meyerparlapanis, bambonyé, elbert, & crombach, 2015). however, the sequela of aces also ex‐ pand to geronto-psychiatry, evident in an increased risk for cognitive deficits in older age (burri, maercker, krammer, & simmen-janevska, 2013). modulation of the biological stress response as mentioned above, adverse childhood experiences present an unspecific risk factor for increased vulnerability to later (psycho)pathology. they are assumed to have an impact on biological regulatory mechanisms in the human body. more specifically, exposure to aces may result in a cascade of neuro-endocrine and immunologic alterations that are associated with changes in the brain (nemeroff, 2016; teicher & samson, 2013, 2016). developments in psychotraumatology 6 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ these processes refer to disturbed regulation of the human stress reaction, and the hypo‐ thalamic–pituitary–adrenal axis (hpa axis). accordingly, structural changes are likely to occur in stress-sensitive brain regions with a high density of glucocorticoid receptors, to which the stress hormone cortisol binds (nemeroff, 2016). most evident is an increase in volume of the amygdala, as well as a reduction of the hippocampus, but structural changes in prefrontal regions have also been reported (nemeroff, 2016; teicher & samson, 2016). more recent studies investigating connectivity have demonstrated a strong connection between these brain regions. accordingly, the inhibition of brain re‐ gions, such as the amygdala, that are involved in the processing of fear stimuli, can act in a hyperactive manner. however, different types of adverse experiences can lead to differ‐ ential effects (see norman et al., 2012; teicher & samson, 2016). similarly, brain regions are likely to have sensitive phases during a specific age period, in which they are particu‐ larly vulnerable to the effect of adverse experiences. in addition, there may be a genderspecific component. for instance, the hippocampus of girls appears to be more stress-re‐ sistant than the hippocampus of boys (teicher & samson, 2016). all these aspects can be subsumed under the term “type-and-timing” as they relate to differential effects during specific age periods and for various types of aces (nemeroff, 2016; teicher & samson, 2016). these new developments complement the cumulative ef‐ fects of aces with a dose-response relationship that was reported in the initial acestudies (anda et al., 2006). teicher and samson (2013) even argue in favor of two biologi‐ cally distinct groups of patients with mental disorders that can be differentiated based on their specific neuro-biological alterations: those with exposure to aces and those with‐ out. this assumption has been taken up by other scientists (cf. nemeroff, 2016) and, if proven valid, would result in huge implications for diagnostic procedures as well as the treatment of disorders. whilst findings of altered biological circuits offer a powerful explanation for the longterm impact of aces, many studies rely on cross-sectional data, thus compromising cau‐ sality. however, a limited number of studies also provide evidence from a longitudinal perspective. for instance, trickett, noll, susman, shenk, and putnam (2010) investigated long-term hpa axis activity by assessing cortisol levels in two cohorts of young women with or without exposure to sexual violence, who were followed up from a mean age of 11 until the age of 24. in accordance with previous findings, cortisol levels and trajecto‐ ries between the two cohorts significantly differed. however, the sample size was rather small and potential confounders were not taken into account. epigenetic alterations the field of epigenetics investigates the direct impact of the environment on transcrip‐ tion of the human dna through the process of methylation, without changing the origi‐ nal dna-sequence (marinova et al., 2017; turecki & meaney, 2016). due to its involve‐ ment in the stress reaction, focus is placed on methylation in glucocorticoid receptor maercker & augsburger 7 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ genes (nemeroff, 2016). here, a large number of experimental studies with animals dem‐ onstrate increased methylation to be associated with a lack of maternal care (nemeroff, 2016; turecki & meaney, 2016). regarding humans, similar results have been reported with respect to adverse childhood experiences (nemeroff, 2016). a systematic review in‐ corporating 27 studies with humans supported the assumption of increased methylation, despite different methodological approaches (turecki & meaney, 2016). some researchers argue that alterations in methylation are not specifically induced by aces, but are rather a general effect associated with a broad range of mental disorders. however, previous research has provided evidence that patients with ptsd and addition‐ al exposure to aces showed increased rates of methylation compared to ptsd patients without exposure to aces (pape & binder, 2014). these results are in favor of effects spe‐ cifically induced by aces and support the previously discussed theory of a biologically distinct subtype (cf. teicher & samson, 2016). outlook on aces overall, these findings demonstrate the future potential of research involving biomarkers and epigenetic approaches. epigenetic processes can also aid in the identification of mechanisms involved in the trans-generational transmission of adverse experiences, as indicated by previous studies (yehuda et al., 2016). despite these significant findings, pre‐ mature conclusions should be avoided: many relevant studies did not incorporate poten‐ tial confounding variables, thus weakening causal explanations (nemeroff, 2016). fur‐ thermore, the majority of studies apply cross-sectional research designs, with retrospec‐ tive self-reports of aces (see hughes et al., 2017). regarding type and timing of aces, the heterogeneity of assessments (e.g., different scales, frequency versus severity of events) and restricted sample types further limit generalizability. additionally, epigenetic research itself suffers from methodological constraints: dif‐ ferent extraction methods (e.g., saliva versus serum), as well as non-standardized proce‐ dures for pre-processing, weaken empirical evidence. moreover, the previously men‐ tioned shortcomings in study designs, such as cross-sectional studies and the failure to include mediators, require a cautious interpretation of causality. finally, the implications of these findings for clinical practice remain less clear. nemeroff (2016) highlights two important aspects: first, can these biological alterations be prevented by psychotherapy or pharmacotherapy, if detected early? and second, it needs to be investigated, if these biological alterations are reversible following interven‐ tions. while preliminary studies with animals and also studies with war veterans support this view, evidence is far from conclusive (nemeroff, 2016). in sum, the majority of findings are consistent and provide strong evidence for in‐ creased later vulnerability towards mental disorders, with relative effects for specific types of events. further research is required in order to disentangle potential methodo‐ logical constraints and draw final conclusions. developments in psychotraumatology 8 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ m o d e l i n g o f c u l t u r a l l y s p e c i f i c t r a u m a c o n c e p t s focusing on european, us-american, and australian ptsd researchers (the so-called “global north”), one aspect that is often neglected concerns the cultural background of patients. thus, it is basically assumed that psychological processes and their social impli‐ cations work in a universal manner across all cultures. however, both clinical practice and (cross)-cultural clinical research still have to demonstrate if these assumptions are valid (hinton & good, 2016; maercker, heim, & kirmayer, 2019). this aspect is particu‐ larly relevant, as many patients with ptsd symptoms grow up in cultures other than the “global north”. examples include individuals from war-affected regions (e.g., afghani‐ stan, iraq, syria), those who have experienced political prosecution (e.g., in the case of the rohingya communities in myanmar in 2017), or natural catastrophes (e.g., banda aceh tsunami in 2004). within the context of the migration and refugee movement affecting europe in 2015, many countries began to tailor their psychological and psychotherapeutic interventions towards these groups (silove, ventevogel, & rees, 2017). however, there is still too little work on culturally-specific adaptations. this may lead to an over-simplification, which may account for the fact that many interventions developed in western communities show less efficacy in other samples, as a recent meta-analysis indicated (thompson, vidgen, & roberts, 2018). consequently, an extension of theoretical models is required, to help explain the development and maintenance of ptsd in a culturally-sensitive manner. thus far, the existence of these models is rather limited (bernardi, engelbrecht, & jobson, 2018; hinton, ojserkis, jalal, peou, & hofmann, 2013; maercker & horn, 2013). in our working group, the socio-interpersonal model of ptsd was developed, which explicitly takes cultural aspects into account (maercker & hecker, 2016; maercker & horn, 2013). more specifically, it works on three levels (cf. filipp & aymanns, 2018): 1. the traumatized individual is an interdependent self in relation to other human beings. this stands in contrast to the independent self – a traditional differentiation in cultural psychology. it is indisputable that the self is never completely independent from its social relations, but is always interdependent, also in individualized societies from the global north. this is mainly relevant with respect to exposure to traumatic events and the frequent arising of specific social emotions, such as guilt and shame, but also anger, rage, and thoughts of revenge. all these emotions reflect the interdependency between the self and others. moreover, the individual’s perception and self-labelling of the traumatic event and its sequela (e.g., “i am traumatized”, “i am diagnosed with ptsd”), relates to the interaction with and comparison to other persons. for example, as a result of this comparison, members maercker & augsburger 9 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ from disadvantaged communities frequently argue that their own personal experiences are not relevant as the whole community is suffering. as a consequence, they do not perceive themselves as individuals seeking help (rechsteiner, maercker, & tol, 2019). 2. the maintenance of trauma-related symptoms is embedded in a dialogical or communicative process. to date, research has mainly focused on procedures of service utilization in order to identify person-related internal and external barriers. here, a shift is needed towards the exploration of possibilities for individuals to selfdisclose their traumatic experiences, as well as the investigation of reactions from other persons towards this disclosure (pielmaier & maercker, 2011). as speechlessness and the inability to verbalize what happened is a significant facet of trauma-related disorders, this dialogue between individuals is essential. the tremendous value of relationships between two people or within a community is therefore reflected by the opportunity for individuals to overcome this speechlessness. on a more basic level, other individuals with similar experiences can additionally provide non-verbal support, resulting in feelings of emotional connection. these aspects fit well with the rationale of narrative exposure therapy, which has been successfully applied in diverse international settings (cf., schauer, neuner, & elbert, 2011). 3. from a broader perspective, the societal and cultural context play a significant role in relation to the impact of traumatic experiences. here the model becomes a sociocultural one, referring to cultural value orientation and religious or traditional cultural beliefs. for instance, cross-cultural studies indicate an association between traditional norms in the society (e.g., conformity, obedience, or benevolence) and increased rates of ptsd after exposure to interpersonal violence (maercker et al., 2009). this leads to the essential question, with great relevance for the respective health care system, if the status of a victim or survivor is ascribed to these affected individuals in their respective society. a refusal of this societal acknowledgement of the survivor status can result in feelings of being left alone, and may lead to increased helplessness, embitterment, and fatalism. this may also contribute to a cycle of ongoing violence in fragile regions, perpetuated by inter-generational transmission (elbert, rockstroh, kolassa, schauer, & neuner, 2006). inevitably, these contextual factors require a culturally-sensitive or even culturally-adapted treatment approach for patients from the “global south” (previously termed “non-western countries”) (dickerson et al., 2018; von lersner & kizilhan, 2017; whealin et al., developments in psychotraumatology 10 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ 2017). this cultural adaptation is visible when certain parameters are considered, such as setting, delivery mode, translation, treatment goals, local conceptualizations of disorders, the use of metaphors, and particularities of relationships (bernal & sáez‐santiago, 2006). currently, there are limited studies that consider the treatment of ptsd or complex ptsd, whilst also taking these aspects into account. however, a recent meta-analysis was published concerning e-mental health of common mental disorders and the so-called scalable psychosocial interventions. it demonstrates that treatment efficacy is linearly and positively associated with the number of culturally-adapted parameters (harper shehadeh, heim, chowdhary, maercker, & albanese, 2016). nevertheless, further research is needed, for instance, concerning culturally appropriate metaphors of adverse events (meili, heim, & maercker, 2018). following this socio-interpersonal model of ptsd, trauma-focused interventions also need to incorporate interventions on a group or community level (maercker & hecker, 2016). this corresponds to the who's demand for new theoretically derived, empirically verifiable interventions for the international arena (tol et al., 2011). p u b l i c d i s c u s s i o n s nowadays, the field of psychotraumatology is not only limited to clinical psychology and psychiatry, but extends to the overall society: it is discussed among legal experts, histori‐ ans, anthropologists, politicians, the media, cultural scientists, as well as artists. in the public media, traumatic experiences and its sequela are present on a level similar to de‐ pression and substance abuse. in this section, public aspects of psychotraumatology will be discussed (cf. maercker, 2017, p. 70 et seq.). acknowledgement and compensation of survivors the general public has started to acknowledge the immense damage that traumatic expe‐ riences can cause to individuals’ mental and physical health. this is an important step in order to remedy past failures, for instance, with respect to institutional abuse. in germa‐ ny, austria, and switzerland, round table discussions were initiated and commissioners were implemented for specific topics, in order to collectively process these dark chapters of the past. an example in germany is the round table sexual child abuse in dependent relationships and power relations in private and public institutions and in the family, and the round table residential care in the 50s and 60s. in austria, the position of an independ‐ ent commissioner for victims of the catholic church was implemented in 2010. finally, in switzerland, there is the independent commission of experts on institutional care at the swiss federal parliament. the work of these institutions is based on state-of-the-art sci‐ maercker & augsburger 11 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ entific findings, which also incorporates the recent findings concerning the impact of aces. for instance, an investigation at the university of ulm in germany assessed the current health status of victims of sexual abuse, who were involved in the round table sexual child abuse. they reported a high rate of mental disorders, with 40% depressive disorders, 19% ptsd, and 18% anxiety disorders (spröber et al., 2014). as previously described, it is a political and societal necessity to acknowledge the suf‐ fering of survivor groups that have been previously neglected. however, it is not appro‐ priate to exclusively focus on the high incidence of trauma-related disorders in these groups. it is similarly important to investigate and emphasize results related to resilience, that is, reasons for overcoming traumatic stress. increased public awareness is needed for this second aspect. certainly, this must not imply that financial compensation is only ac‐ cessible for survivors suffering from their traumatic experiences, but must be offered to all survivors. thus, discussions about the criteria that need to be fulfilled in order to gain access to compensation need to continue (maercker & augsburger, 2017). continuous stress and historical aspects of traumatic experiences in the process of re-formulating the icd-11 grouping of disorders specifically associated with stress, a new diagnostic category was discussed: continuous trauma disorder. in many countries and regions, there is no clear onset and end of a traumatic event, but rather a constant and ongoing threat for human life (e.g. somasundaram, 2014). accord‐ ingly, the term “post-traumatic” is not feasible for these regions and the diagnosis of ptsd does not apply, if taken literally. from a biological viewpoint, in these circumstan‐ ces the body is in a state of constant high physiological alertness in order to survive – resulting in impaired body function and significant distress. currently, best-practice sug‐ gestions are available for dealing with these aspects (world health organization, 2016). however, in the relevant icd-11 working group, the incorporation of an entirely new di‐ agnostic concept was rejected, and was instead referred to the areas of emergency psy‐ chology and medicine. related to this is the term “historical trauma”, which describes the experiences of sys‐ tematic violent discrimination, persecution, and extermination of ethnic or religious groups. it is often called “historical” if public acknowledgment is not provided and if an “atonement” is not yet sufficient (kirmayer, gone, & moses, 2014). examples include col‐ lective traumatic experiences of the first nations and african-americans in the us, or the holocaust in europe. more recently, the term has also been used to describe nonman-made mass catastrophes, such as the tsunami in 2004, or the 2011 fukushima nucle‐ ar disaster in japan. some researchers suggest that collective perceptions and pathologi‐ cal alterations in thoughts and behavior emerge following these events, which can be dif‐ ferentiated from symptoms associated with ptsd or similar diagnoses. for instance, somasundaram (2014) reported the following changes, among others, in response to developments in psychotraumatology 12 clinical psychology in europe 2019, vol.1(1), article e30294 https://doi.org/10.32872/cpe.v1i1.30294 https://www.psychopen.eu/ these experiences: general mistrust, suspicion, brutalization, a drop in morals and values, passivity, and negativism. processing of trauma in other public areas perceptions and explanations related to traumatic stress also expand beyond the previ‐ ously discussed aspects and permeate into several other public areas. this is not only re‐ flected by topics such as cultures of memory, and the occurrence of several truth and reconciliation commissions following political violence; but also, art exhibitions featur‐ ing artists that try to process and integrate their biographical experiences and wounds into their artistic work. examples for the latter include the internationally renowned con‐ ceptual artists joseph beuys or marina abramović (see maercker, 2017). not surprisingly, within these settings, the conceptualizations of traumatic stress and psychotraumatology can differ from a scientific point of view. also, in this area, recent developments may not be sustainable. nevertheless, they have the potential to aid and support individuals in overcoming their personal experiences. funding: the authors have no funding to report. competing interests: the first author had previously chaired the work group on “disorders specifically associated with stress” for the icd revision at the world health organization from 2011-2018. however, he did not receive any reimbursement for this work. the views expressed in this article are those of the authors and do not represent the official policies or position of the who. the first author is member of the editorial board of clinical psychology in europe but played no editorial role for this particular 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(2017). kultursensitive psychotherapie [cultural sensitive psychotherapy]. göttingen, germany: hogrefe. whealin, j. m., yoneda, a. c., nelson, d., hilmes, t. s., kawasaki, m. m., & yan, o. h. (2017). a culturally adapted family intervention for rural pacific island veterans with ptsd. psychological services, 14(3), 295-306. https://doi.org/10.1037/ser0000186 world health organization. (2016). problem management plus: individual psychological help for adults impaired by distress in communities exposed to adversity. geneva, switzerland: who. world health organization. (2018). icd-11 for mortality and morbidity statistics. retrieved from https://icd.who.int/browse11/l-m/en yehuda, r., daskalakis, n. p., bierer, l. m., bader, h. n., klengel, t., holsboer, f., & binder, e. b. (2016). holocaust exposure induced intergenerational effects on fkbp5 methylation. biological psychiatry, 80(5), 372-380. https://doi.org/10.1016/j.biopsych.2015.08.005 developments in psychotraumatology 18 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org https://doi.org/10.1176/ajp.2006.163.6.993 https://doi.org/10.1016/j.cpr.2018.06.006 https://doi.org/10.1016/s0140-6736(11)61094-5 https://doi.org/10.1017/s0954579409990332 https://doi.org/10.1016/j.biopsych.2014.11.022 https://doi.org/10.1016/j.chiabu.2015.11.019 https://doi.org/10.1037/ser0000186 https://icd.who.int/browse11/l-m/en https://doi.org/10.1016/j.biopsych.2015.08.005 https://www.leibniz-psychology.org/ https://www.psychopen.eu/ developments in psychotraumatology (introduction) new conceptualizations of stress-related disorders in icd-11 ptsd complex ptsd (cptsd) prolonged grief disorder (pgd) adjustment disorder expanding the concept of psychotraumatology consequences of adverse childhood experiences modulation of the biological stress response epigenetic alterations outlook on aces modeling of culturally-specific trauma concepts public discussions acknowledgement and compensation of survivors continuous stress and historical aspects of traumatic experiences processing of trauma in other public areas (additional information) funding competing interests acknowledgments general note references integrating cognitive behavioral group therapy and psychodrama for social anxiety disorder: an intervention description and an uncontrolled pilot trial research articles integrating cognitive behavioral group therapy and psychodrama for social anxiety disorder: an intervention description and an uncontrolled pilot trial hanieh abeditehrani a, corine dijk a, mahdi sahragard toghchi b, arnoud arntz a [a] department of clinical psychology, university of amsterdam, amsterdam, the netherlands. [b] department of psychology, payame noor university, tehran, iran. clinical psychology in europe, 2020, vol. 2(1), article e2693, https://doi.org/10.32872/cpe.v2i1.2693 received: 2018-11-26 • accepted: 2019-11-16 • published (vor): 2020-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: hanieh abeditehrani, university of amsterdam, department of clinical psychology, po box 15933, 1001 nk amsterdam, the netherlands. e-mail: h.abeditehrani@uva.nl abstract background: cognitive behavioral therapy (cbt) is generally considered to be the most effective psychological treatment for social anxiety disorder (sad). nevertheless, many patients with sad are still symptomatic after treatment. the present pilot study aimed to examine integrating cbt, with a focus on cognitive and behavioral techniques, and psychodrama, which focuses more on experiential techniques into a combined treatment (cbpt) for social anxious patients in a group format. this new intervention for sad is described session-by-session. method: five adult female patients diagnosed with social anxiety disorder participated in a twelve-session cbpt in a group format. pretest and posttest scores of social anxiety, avoidance, spontaneity, cost and probability estimates of negative social events, depression, and quality of life were compared, as were weekly assessments of fear of negative evaluation. results: results demonstrated a significant reduction of the fear of negative evaluation and social anxiety symptoms. it is noteworthy that also the scores of the probability and cost estimates decreased. however, there were no significant differences between pre and post measures in any of other measures. conclusion: the current study suggests that group cbpt might be an effective treatment for sad. however, our sample size was small and this was an uncontrolled study. therefore, it is necessary to test this intervention in a randomized controlled trial with follow-up assessments. keywords integrating therapies, cognitive behavioral therapy, psychodrama, social anxiety disorder, clinical trial this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2693&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • this study describes integrating cognitive behavioral therapy and psychodrama (cbpt). • cbpt significantly reduced fear of negative evaluation and social anxiety. • three of the five patients have a clinically significant change on the lsas after the treatment. • cbpt also changed estimates of social cost and the probability of negative social events. social anxiety disorder (sad) is one of the most common mental disorders, with a 13% lifetime prevalence (kessler, petukhova, sampson, zaslavsky, & wittchen, 2012). recent research shows that the prevalence of sad in iran is approximately 10% (talepasand & nokani, 2010). depression is highly comorbid with sad and more than half of the pa‐ tients report lifetime major depression (brown, campbell, lehman, grisham, & mancill, 2001). sad is associated with increased functional disability, substantial economic inac‐ tivity, and a lower quality of life (patel, knapp, henderson, & baldwin, 2002). therefore, it is important to treat sad effectively. several meta-analyses show that cognitive behavioral therapy (cbt) is the most effective psychotherapy for sad (hofmann & smits, 2008; mayo-wilson et al., 2014). cbt is an eclectic approach based on a combination of techniques from cognitive and behavioral theories (harwood, beutler, & charvat, 2001). cognitive behavioral group therapy (cbgt), as developed by heimberg and becker (1991, 2002) is an efficacious and evidence-based treatment for sad. the effect of cbgt on social anxiety symptoms has been demonstrated in meta-analyses (barkowski et al., 2016; mayo-wilson et al., 2014). cbgt usually consists of cognitive restructuring, exposure and homework assignments (coles, hart, & heimberg, 2005; heimberg & becker, 2002). judgmental biases such as beliefs about the cost and probability of negative social events play an important role in the maintenance of sad (clark & wells, 1995; heimberg, brozovich, & rapee, 2010; hofmann, 2007; morrison & heimberg, 2013). there is an association between cbt treatment and a reduction in probability or cost estimates for individuals with sad (foa, franklin, perry, & herbert, 1996; gregory, peters, abbott, gaston, & rapee, 2015; hofmann, 2004; lucock & salkovskis, 1988; poulton & andrews, 1994). hence, cb(g)t is an effective treatment for sad. however, 25-50% of patients with sad show little or no improvement after treatment (davidson et al., 2004; heimberg et al., 1998; hofmann & bögels, 2006). thus, many patients remain symptomatic after completing treatment, and it is clear that there is room to improve interventions to enhance clinical outcomes for sad. we propose that cbt and psychodrama can be integrated to enhance treatment effects. psychodrama is an action-based method of group psychotherapy, developed integrating cbt and psychodrama 2 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ by jacob levy moreno (moreno, 1946). in psychodrama, patients use role-playing to dramatize their psychological and social problems rather than just talking about them (blatner, 2000). furthermore, psychodrama can enhance the potency of therapeutic alli‐ ance and create a therapeutic bond between group members by letting patients engage in role-playing and the playing of auxiliaries in the other members’ enactment, and by evoking emotions during action (orkibi, azoulay, regev, & snir, 2017). several studies with non-sad samples on the combination of cbt and psychodrama demonstrated that cbt and psychodrama could be integrated (boury, treadwell, & kumar, 2001; hamamci, 2002, 2006; treadwell, kumar, & wright, 2002). there are several reasons why psychodrama techniques can enhance therapy outcome for sad patients as well. first, several acting techniques in psychodrama do not occur in cbgt but might be helpful, because they involve experiential learning (see table 2 for a description of typical psychodrama techniques and their goals for treatment of sad), whereas the focus of traditional cbt is on cognitive and behavioral learning. second, there is increasing evidence that (traumatic) childhood experiences contribute to the development of sad (arrindell, emmelkamp, monsma, & brilman, 1983; blöte, miers, & westenberg, 2015; bruch & heimberg, 1994; kuo, goldin, werner, heimberg, & gross, 2011; simon et al., 2009). psychodrama provides an opportunity to reenact a negative social interaction from the past as if it occurs in the present, but now in the safe setting in which the patient has more control over what is said and done. this might, in turn, change the patient's beliefs, feelings, and attitudes about the traumatized situation (treadwell & kumar, 2002). third, socially anxious people devote effort to control the expression of feelings and suppress their emotions to minimize the chance of making social transgressions and elicit rejection by others (kashdan & steger, 2006). they also report a fear of experiencing emotions and more negative beliefs about the consequences of emotional expression (spokas, luterek, & heimberg, 2009). in psychodrama, a safe environment is created which can help patients to express their inhibited emotions and examine the accuracy of their beliefs about the negative outcomes of this. finally, according to moreno’s theory, anxiety decreases by increasing spontaneity. in cbt-terms, spontaneity can be seen as the opposite of avoidance and inhibition that is central to sad. one of the aims of psychodrama is to increase spontaneity. there is no research to demonstrate that cbt and psychodrama can be integrated in‐ to the treatment of social anxiety disorder. the main aim of this pilot study is to describe the intervention and examine the integrated group cbt-psychodrama protocol (labelled cbpt) to treat social anxious patients and to get a first impression of its effectiveness. we hypothesized that cbt and psychodrama can be successfully integrated and that this integration is effective in improving fear of negative evaluation, the characteristic feature of sad, which was measured by the brief fear of negative evaluation scale (bfne), and social anxiety symptoms, which were measured by the liebowitz social anxiety scale (lsas). furthermore, integrating psychodrama and cbgt might be efficacious for sad abeditehrani, dijk, sahragard toghchi, & arntz 3 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ because they focus on separate mechanisms. psychodrama focuses on increasing sponta‐ neity and decreasing avoidance behavior through role-playing. cbgt, on the other hand, focuses on decreasing cognitive biases associated with sad and decreases avoidance behavior through exposure. the cbpt, therefore, might offer a broader treatment which might also affect depression, an often comorbid disorder with sad, and increase the quality of life in patients suffering from sad. m e t h o d participants six patients with a primary diagnosis of social anxiety disorder were included in this study; all were diagnosed with the structured clinical interview for dsm 4th ed (scidi, farsi version; first, spitzer, gibbon, & williams, 2012). participants were recruited through the media and poster advertisements. one participant dropped out of the study because she found a full-time job before the first session, and was therefore not included in the analysis. all the patients were females, living in tehran. the mean age of the five patients was 36.6 (age range = 21-63; sd = 17.89). three of them were diagnosed with generalized and two of them with specific sad. an iranian ethical committee (reference number ir.umsha.rec.1394.521) approved the protocol on february 27, 2016, and all patients gave their written informed consent prior to their inclusion in the study. this study is a preparatory pilot for an rct that included the cbpt protocol as an arm. the rct was preregistered at a trial register (irct2016032321385n1). inclusion criteria were sad as a primary diagnosis, age between 18 and 65 years, ability to read and understand the questionnaires and the interview. exclusion criteria were comorbid psychotic or bipolar disorder, lifetime history of schizophrenia or bipolar disorder, a high suicidality risk, antisocial or borderline personality disorder, a comorbid diagnosis of substance abuse or dependence. furthermore, unwillingness to stabilize medication for the duration of the study was an exclusion criterion as well. procedures and measures social anxiety was assessed with the clinician-administered version of the lsas (liebowitz, 1987) at pre and posttests by an independent assessor and the brief fear of negative evaluation scale (bfne; rodebaugh et al., 2004; weeks et al., 2005) was completed before the treatment and also after every treatment session (thus in total there were 13 measurements). additionally, the patients were assessed at pre and posttests on the following outcomes: social avoidance with the social avoidance and distress scale (sads; watson & friend, 1969); spontaneity with the personal attitude scale-ii (pas; kellar, treadwell, kumar, & leach, 2002); and cost and probability estimates of negative social events with the outcome probability questionnaire (opq; uren, szabó, integrating cbt and psychodrama 4 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ & lovibond, 2004) and the outcome cost questionnaire (ocq; uren et al., 2004). depres‐ sion was measured with the beck depression inventory (bdi; beck, steer, & brown, 1996), and quality of life was measured with the quality of life inventory (qoli; frisch, cornell, villanueva, & retzlaff, 1992). for the several questionnaires, no persian version existed (e.g., quality of life inven‐ tory, outcome probability questionnaire, outcome cost questionnaire, and personal attitude scale-ii). therefore, these were translated and back-translated to ensure the adequacy of the translation. finally, therapists used a session report form to record the procedures used in the session, such as the name of the protagonist and the auxiliaries, the type of therapeutic techniques that were used (e.g., role reversal, cognitive challenging), and also patients’ feedback on the therapy session. primary outcomes the brief fear of negative evaluation scale (bfne; rodebaugh et al., 2004; weeks et al., 2005), is a self-report measure consisting of 12 items on a 5-point likert scale (1 = strongly disagree, 5 = strongly agree). an example question is: “i am afraid that others will not approve of me”. the bfne has excellent internal consistency (cronbach's alpha > .92) and validity in clinical samples (weeks et al., 2005). the liebowitz social anxiety scale – clinician-administered version (lsas; liebowitz, 1987) is a 24-item interview that assesses fear and avoidance, in social interac‐ tions (e.g., talking with people you don’t know very well) and performance situations (e.g., returning goods to a store). the items are on a 4-point-likert scale (0 = never, 3 = usually). the lsas has shown good test–retest reliability, internal consistency, and convergent and discriminant validity (baker, heinrichs, kim, & hofmann, 2002; fresco et al., 2001; oakman, van ameringen, mancini, & farvolden, 2003; rytwinski et al., 2009). secondary outcomes the social avoidance and distress scale (sads; watson & friend, 1969) is a self-report inventory with 28-item that includes 14 items to assess social avoidance (e.g., i often want to get away from people) and 14 items to assess social anxiety (e.g., i often feel on edge when i am with a group of people). all items are rated as true or false. cronbach's alpha reliability coefficient was .90 and the test-retest reliability was .77 in a study by watson and friend (1969). the personal attitude scale-ii (pas; kellar, treadwell, kumar, & leach, 2002) is a self-report measure of spontaneity. an example item is: “i am at ease when meeting new people”. it has 66 items on a 5-point likert scale (0 = strongly disagree; 4 = strongly agree). cronbach's alpha reliability coefficient of internal consistency was .92 and the test-retest reliability was .86 in a study by kellar et al. (2002). abeditehrani, dijk, sahragard toghchi, & arntz 5 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ the outcome probability questionnaire (opq) and the outcome cost questionnaire (ocq) (uren, szabó, & lovibond, 2004) are two self-report questionnaires consisting of 12 items. the opq assesses an individual’s probability estimate of the occurrence of negative social events (e.g., how likely would be for you at a party, others will notice that you are nervous?). the ocq then asks about the same negative social events but here individuals are asked to indicate how costly it would be if these events were actually to occur (e.g., how distressing would be for you if at a party, others will notice that you are nervous?). both questionnaires have items on a 9-point likert scale (0 = not at all likely/distressing; 8 = extremely likely/distressing). the internal consistency of both instruments is good (cronbach’s alpha ≥ .90) (uren et al., 2004). the beck depression inventory-ii (bdi-ii; beck, steer, & brown, 1996) is a 21-item self-report inventory that measures the severity of symptoms of depression in the previous two weeks (e.g., loss of energy, worthlessness). a good internal consistency (cronbach’s alpha = .92), and test-retest reliability have been shown in several studies (beck, steer, & carbin, 1988; beck et al., 1996). the quality of life inventory (qoli; frisch, cornell, villanueva, & retzlaff, 1992) is a 16-item self-report questionnaire that includes 16 areas that are related to the overall happiness of life (e.g., work, health). the survey asks the participants to describe first the importance (0 = not at all important, 2 = very important) and then satisfaction (+3 = very satisfied, -3 = very dissatisfied) of each area. for each area quality of life is measured by multiplying the importance with the satisfaction which can range from -6 to +6. the internal consistency is high, cronbach’s alpha between α = 0.77 and α = 0.89, and the one month test-retest reliability is between r = 0.80 and r = 0.91 (frisch et al., 1992). intervention the cbpt therapists integrated cognitive restructuring and exposure with psychodrama techniques. the cbpt group underwent 12 weekly sessions each lasting 2.5 hours with five patients and two therapists (one male and one female). the therapists received train‐ ing in the integrated psychodrama and cbt protocol, were trained in and had experience with conducting both psychodrama and cbgt. furthermore, an expert in cbpt had weekly supervision meetings with the therapists to ensure the quality of the treatment. the cbpt treatment consisted of four phases: (1) an initial preparatory interview (2) building group cohesion and introduction of cognitive restructuring (sessions 1 and 2), (3) cbt and psychodrama (sessions 3 through 11), and (4) conclusion (the 12th session). the treatment starts with an individual treatment orientation interview in which group treatment procedures and fear of participation in group sessions are discussed. this interview prepares patients for group sessions and makes them familiar with one of the therapists (heimberg & becker, 2002). session 1 and 2 are devoted to creating a safe atmosphere in which patients can share their feelings and thoughts with other members of a group, and to the building of group cohesiveness. the sessions are based integrating cbt and psychodrama 6 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ on heimberg and becker's (2002) cbgt protocol and are used as basic training in cogni‐ tive restructuring. in the first session, the therapists present cbpt therapy for social anxiety and briefly explain the primary treatment techniques. next, the session focuses on the identification of automatic thoughts. at the end of the session, patients share their individual problems, and goals and homework are assigned, which is a recording of automatic thoughts during the following week. the second session is devoted to developing cognitive restructuring skills of patients and to introduce thinking errors by practicing with the recorded automatic thoughts form. the therapists teach patients how to dispute cognitions and replace negative automatic thoughts with more helpful cognitions. therapists also inform and prepare patients for initiation of the role-playing in the third session. at the end of the session, homework is assigned again, which is to label thinking errors in the identified automatic thoughts and to practice with cognitive restructuring (heimberg & becker, 2002). session 3 to 11 follow the stages of classical psychodrama, which includes warm-up, action, and sharing. before the warm-up stage, the therapists review homework in order to identify automatic thoughts and thinking errors and use socratic questioning to help patients with finding a more rational response. the warm-up stage facilitates a safe, supportive and creative atmosphere at the beginning of every session by doing warm-up techniques to prepare patients for action. during the warm-up stage, the therapists ask patients to do a verbal or non-verbal warm-up practice (weiner & sacks, 1969). for example, patients are encouraged to get up, move around and select someone to meet as if they have never met them before, but to meet them without using words. after this warm-up stage, the individual who will act as the protagonist is identified (see table 1 for a description of typical psychodrama roles). table 1 description of typical psychodrama roles roles description protagonist the main character, the session is focused on his/her problem. auxiliary ego an auxiliary ego is a person that has an important role in the situation chosen by the protagonist in the group and is played by a group member. audience other patients who observe the action are called audience. stage a semi-circle of chairs is put in the room to create a stage so that the protagonist can act in front of the patients. each patient is protagonist at least once during the treatment. the therapist can ask who is ready to work as a volunteer. alternatively, the therapists can select a protagonist abeditehrani, dijk, sahragard toghchi, & arntz 7 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ based on what they observed during the preparation in warm-up stage (e.g., sometimes patients express their performance anxiety in the warm-up stage verbally or non-verbal‐ ly which is appropriate for the selection of the protagonist) or based on information revealed during sharing phase of the previous session (kumar & treadwell, 1986). in the action stage of the therapy sessions, the therapists create a scene with the protagonist, in which an anxiety-provoking situation is acted out. although role-playing can be an element of cbt, the most important difference between psychodrama and cbt is the aim of role-playing and the manner in which it is executed. in cbgt, role-playing focuses on the thinking process and is used as exposure to change irrational thoughts. in psychodrama, role-playing focuses on emotional expression and it is used to evoke and release emotions (fisher, 2007). the role-playing can involve past as well as future situations but also feared situations that did not actually happen (karp & farrall, 2014). the protagonist can select the auxiliary ego (see table 1) from the group members. during the action stage, therapists can use various psychodrama techniques, as described in table 2. however, during this stage therapists use cbt techniques as well. for example, thera‐ pists might shortly stop the scene and use cognitive restructuring to provide alternative thoughts so role-playing can be continued with these alternative thoughts. which psy‐ chodrama technique is used depends on the type of anxiety-provoking situation and is chosen by the therapists with the protagonist’s agreement. for example, role reversal is suitable for social interactions (e.g., talking with strangers, dating, and meeting unfa‐ miliar people), and mirroring is suitable for performing in front of others (e.g., public speaking). double is used to identify automatic thoughts that can be used for cognitive restructuring and is often used in situations in which someone feels observed (e.g., eating or drinking in front of others, writing in public, going to parties, being at the center of attention, and using public toilets). finally, empty chair and soliloquy are suitable for traumatic situations where it is helpful to express suppressed emotions. the last part of each session is sharing or closure. this is a time for patients to discuss the effects the action of the scene had on them and share their feelings and thoughts with the group. the therapists use cognitive restructuring techniques after the action stage to identify automatic thoughts and help patients to correct thinking errors that occurred during role-playing. at the end of each session, the therapists ask patients to provide feedback on therapy session. they also assign exposure in vivo as homework for the protagonist. the other participants not receive homework. the twelfth and last session is again based on heimberg and becker's (2002) proto‐ col and is divided into two parts. the first half is used for practicing with additional exposure, role-playing, and cognitive restructuring. in the second half, the therapists and patients review their development during treatment. that is, they discuss situations that may still be problematic and suggest rational responses can be beneficial in these integrating cbt and psychodrama 8 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ situations. finally, therapists help patients to set goals for situations after the end of the formal treatment (heimberg & becker, 2002). table 2 description of psychodrama techniques and their goals for treatment of sad description techniques goal role reversal two individuals first roleplay a situation. next, the protagonist and the antagonist are asked to change the positions and play the other's role. experiencing the role of the other person results in cognitive change. it helps to correct biased beliefs about how one comes across to others. double a patient of the group plays the protagonist’s inner self and gives a voice to the protagonist’s feelings, thoughts or needs, usually by standing behind the protagonist. the protagonist can accept or reject double’s offers. identify automatic thoughts and express suppressed thoughts and feelings during roleplaying. it helps the protagonist to explore and expose his/her cognitive distortions. empty chair the protagonist can talk to an imaginary person that is represented by an empty chair. express negative as well as positive feelings. mirroring the auxiliary ego plays the role of the protagonist for a short time. the protagonist stands aside and watches an immediate action and see his/her own behavior, body language and interactions with the other as in a mirror. observe themselves through the eyes of the audience works as immediate feedback from the audience (hammond, 2014) to gain a more realistic view from others’ judgment about his/her performance. soliloquy a monologue in which the patients can express their thoughts and feelings to the audience. practice expressing their suppressed thoughts and feelings to the audience to relieve negative beliefs about emotional expression and decrease emotional suppression. statistical analysis in total, there were 10 missing values in the bfne score that were completed each session (6.5 percent). we used a linear mixed model to handle these missing values, which allowed us to still examine if there was an effect of time on the session-by-session bfne scores. the fixed part included an intercept and a linear effect of time (the pretest bfne and the scores after completing each treatment session coded as 0, 1, 2, …, 12), the repeated part an autoregressive arma11 covariance structure. the effect size of the fixed time effect was expressed as r (r = t/√(t 2 + df)). we also estimated the effect size of the pre-post change in terms of cohen’s d which is pre-post change calculated on the basis of the estimated effects of the linear mixed model, divided by the pretest standard deviation (morris, 2008). the pretest and posttest scores of the other outcomes were abeditehrani, dijk, sahragard toghchi, & arntz 9 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ compared with paired sample t-tests (see de winter, 2013, for the validity of the t-test with small samples). pre-post effect sizes were calculated in terms of cohen’s d = mean pre-post change divided by pretest standard deviation (morris, 2008), and hedges’ g (see table 4 note for the formula). hedges’ g is smaller than conventional cohen’s d but has less bias. r e s u l t s primary outcomes a linear mixed model analysis showed that the intervention resulted in a significant reduction of fear of negative evaluation, see table 3. the pre-post effect size estimated from the linear mixed model on the bfne was cohen’s d = 1.16. table 3 linear mixed model estimates [and 95% confidence interval] of fixed effects with bfne as dependent variable parameter b se df t (n) p 95% ci effect size ll ul r cohen’s d (bl) cohen’s d (ml) intercept 37.64 2.46 6.64 15.28 < .001 31.75 43.53 time -0.68 0.22 11.94 -3.16 .008 -1.15 -0.21 .67 1.16 1.32 note. ci = confidence interval; ll = lower limit; ul = upper limit; effect size for the fixed effect r = t/√(t 2 + df). cohen’s d (bl) = |b (time)* 12/sd baseline|. cohen’s d (ml) = |standardized beta (time) * (standardized time at pretest – standardized time at posttest)| (lorah, 2018). figure 1 illustrates that although the mean score of the bfne increased after the second session, it then decreased till the end of the treatment. figure 2 shows the individual bfne scores per assessment and indicates that in 4 of the 5 participants there was a reduction in bfne scores. the dots in the figure show at which session each participant had a protagonist role. in 7 of the 10 instances, there was an immediate reduction in bfne scores after the session. there was also a significant decrease in social anxiety symptoms assessed with the lsas (see table 4). integrating cbt and psychodrama 10 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ figure 1 observed and estimated (by the linear mixed model) mean and standard deviation (sd) of bfne every session by assessment note. there was a significant linear decrease over time in bfne scores. figure 2 individual bfne scores over the period of treatment note. dots show who is a protagonist in the session. abeditehrani, dijk, sahragard toghchi, & arntz 11 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ table 4 pretest and posttest comparison for the cbpt intervention scale pre post t (4) m difference [ci 99%] cohen’s d hedges’ gm sd m sd ll ul p bfne 35.60 7.02 28.40 4.10 2.86 -4.39 18.79 .046 1.03 0.82 lsas 99.40 16.99 58.40 24.81 3.82 -8.44 90.44 .19 2.41 1.93 sads 14.40 5.64 11.80 7.73 1.31 -6.56 11.76 .261 0.46 0.37 pas 133.20 13.88 131.60 17.21 0.20 -34.67 37.87 .849 -0.12 -0.09 opq 56.20 23.18 35.80 16.63 3.22 -8.74 49.54 .032 0.88 0.70 ocq 64.80 23.47 47.00 26.67 5.95 4.03 31.57 .004 0.76 0.61 bdi 19.60 5.86 12.60 8.20 2.03 -8.82 22.82 .111 1.19 0.96 qoli 29.40 21.31 36.00 25.17 -0.88 -41.13 27.93 .429 0.31 0.25 note. observed means (m) and standard deviations (sd) for the pre and post assessment points; results of t-test analyses (t, p-value) and effect sizes cohen’s d and hedges’ g. bfne = brief fear of negative evaluation; lsas = liebowitz social anxiety scale; sads = social avoidance and distress scale; pas = personal attitude scale-ii; opq = social cost and probability by the outcome probability questionnaire; ocq = outcome cost questionnaire; bdi = beck depression inventory; qoli = quality of life inventory. cohen’s d was estimated as d = (mean pre-post change)/(pretest sd). hedges’ g was calculated as follows: g = j*d, with d = cohen’s d; j = (1 – 3/(4*df-1)); df = n-1. the sign of the effect size was chosen so that a positive effect size indicates improvement and negative effect size represents worsening. secondary outcomes there was a significant decrease in outcome probability and outcome cost question‐ naires. however, there was no significant difference in social avoidance, spontaneity, depression, and quality of life after completing treatment. the test statistics, as well as the effect sizes, are presented in table 4. reliable change and clinical significant change to estimate the rates of clinical significant improvement, we computed the reliable change, clinical significant change, and cutoffs as suggested by jacobson and truax (1991) on the primary outcome measures. moreover, because our sample is too small, we used standard error and test-retest values of two iranian studies with large samples for bfne (se bfne 4.49 from tavoli, melyani, bakhtiari, ghaedi, & montazeri, 2009), and lsas1 (se lsas 11.07 from atrifard et al., 2012). reliable change (rc) was calculated as difference between post and pretest divided by standard error of change. an rc rate greater than 1.96, is considered as improvement (jacobson & truax, 1991; see table 5). clinically significant change (csc) consists of reliable change and a posttest score that falls within mean ± two standard deviations of non-anxious sample, which was 39.86 ± 1) this was self-report lsas. integrating cbt and psychodrama 12 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ 2*18.98 for lsas, and 28.7 ± 2*5.9 for bfne, again using data from two larger studies (atrifard et al., 2012; tavoli et al., 2009). as can be seen in table 5, three of the five patients with lsas and two of the five patients with bfne have a clinical significant change after the treatment. table 5 within-participant changes for the cbpt intervention on the primary outcomes participants bfne lsas pre post change rc below c = 30.97 pre post change rc below c = 57.57 1 30 25 5 n y 80 52 28 y y 2 45 35 10 y n 104 86 18 y n 3 35 29 6 n y 83 34 49 y y 4 28 28 0 n y 116 37 79 y y 5 40 25 15 y y 114 83 31 y n note. rc = reliable change; bfne = brief fear of negative evaluation; lsas = liebowitz social anxiety scale (lsas); y = yes; n = no. feedback from patients in the course of the treatment, role reversal and double were the most frequently used techniques in cbpt based on therapists’ post-session reports. after sessions, patients re‐ ported that role reversal was a helpful technique that enables them to expose themselves to anxiety-provoking social situations. they further reported that cognitive restructuring as it was integrated into techniques in the action stage, helped them to understand cbt concepts in a more experiential way. patients also experienced some warm-up techniques (e.g., forming a band by playing their invisible musical instruments) as anxiety-provoking and embarrassing situations, but they finally evaluated them as helpful warm-up techni‐ ques to decrease anxiety. d i s c u s s i o n cbpt balances a focus on cognition and behavior through cbt techniques, and emotion during psychodrama techniques in action. the results from this pilot study supported that integrating cbgt and psychodrama might be considered as a new treatment for patients diagnosed with sad. also, the fact that patients continued the treatment until the last session indicates that cbpt was acceptable for patients. the pilot indicated that the treatment was effective in the core area of sad. social anxiety, as assessed by the lsas, reduced significantly from pre to posttest. the current study showed a high effect size on the lsas (pre-post effect size hedges’ g = 1.93) in comparison to the pre-post effect sizes of other studies using heimberg’s cbgt on the abeditehrani, dijk, sahragard toghchi, & arntz 13 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ lsas (blanco et al., 2010, g = 0.56; bjornsson et al., 2011, g = 0.61; hayes-skelton and lee, 2018, g = 0.82; hedman et al., 2011, g = 0.99; heimberg et al., 1998, g = 0.75). significant improvements were also found on the two cognitive measures of cost and probability estimates of negative outcomes. this suggests that cbpt can change cognitive processing biases to decrease social anxiety in sad. our findings are in line with research that reported changes in probability or cost estimates after cbt, which in turn related to therapeutic changes in social anxiety symptoms (foa et al., 1996; gregory et al., 2015; hofmann, 2004; lucock & salkovskis, 1988). hamamci (2002) also showed that integrating cbt and psychodrama techniques leads to a reduction in cognitive distortions related to interpersonal relationships. it is conceivable that the use of psy‐ chodrama techniques contributed to a decrease in estimated social cost and probability because it helped patients to experience a disconfirmation of their expectations. howev‐ er, because in the current study cbt and psychodrama techniques were integrated, it is not clear how much change results from psychodrama techniques alone. future research should reveal if that cbpt is more effective in decreasing negative beliefs than cbt or psychodrama alone. likewise, fear of negative evaluation also reduced during treatment with a pre-post effect size of hedges’ g = 0.82 on bfne scores, which is in line with the pre-post effect sizes of studies using cbgt in the treatment of sad (bjornsson et al., 2011; heimberg et al., 1998). the decline of fear of negative evaluation was not consistent in the course of treat‐ ment. after the second session, there was an increase in fear. this might be due to the announcement in the second session of the start of in-session exposure and role-playing in the third session. however, the increase was only temporary, and social anxiety decreased significantly till the end of treatment. fear of negative evaluation decreased immediately after 7 of the 10 sessions in which a patient was the protagonist, showing an overall immediate positive effect of being protagonist on social anxiety symptoms in a small sample. why being a protagonist was not always followed by a decrease in bfne is not clear. this might be due to the patients’ attitude toward role-playing or the level of expression of emotions, or other factors. clearly, further work in large clinical trials is required to gain a better understanding of the effects of being the protagonist in social anxious patients. next to social anxiety outcomes there were several other outcomes measures. these showed that there were no significant differences between pre and posttest in avoidance, spontaneity, depression symptoms and quality of life. the lack of significant effects on the measure of spontaneity is rather surprising, given the prominent position spontane‐ ity has in the theory of psychodrama. perhaps the spontaneity measure that we used is not sensitive to change because the items that were used describe spontaneity more as a stable personality trait than a characteristic that can easily be changed during a short cbpt treatment. however, moreno (1953) noted that especially spontaneity can be integrating cbt and psychodrama 14 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://www.psychopen.eu/ enhanced during psychodrama and that it is an important mechanism of clinical change (moreno, 1953). further research is required to examine if the current lack of change in spontaneity is due to the type of measure or if the short integrated cbpt is not suitable to change spontaneity. the lack of significant effects on avoidance, depression, and quality of life might relate to the limited power of this pilot study, as the changes are in the direction of improvement, and are in the range of effect sizes of previous studies, or exceed them. that is, the finding on avoidance, depression, and quality of life are consistent with previous studies: avoidance with a pre-post effect size of hedges’ g = 0.37 on sads scores, while heimberg’s studies using cbgt in the treatment of sad resulted in a pre-post sads effect size of hedges’ g = 0.29 (heimberg et al., 1990), and hedges’ g = 0.17 (heimberg et al., 1998); depression with a pre-post effect size of hedges’ g = 0.96 on bdi scores, which is in line with previous studies using cbgt in the treatment of sad that found pre-post bdi effect sizes of hedges’ g = 0.78 (heimberg et al., 1990), and hedges’ g = 0.82 (koszycki, benger, shlik, & bradwejn, 2007); quality of life with a pre-post effect size of hedges’ g = 0.25 on qoli scores, which is in line with other studies using cbgt in the treatment of sad finding small pre-post qoli effect sizes of hedges’ g = 0.28 (hayes-skelton & lee, 2018), and hedges’ g = 0.44 (koszycki et al., 2007). an important limitation of the present study is that our sample size was small (5 patients) limiting the external validity of the results. besides, this was an uncontrolled study and the internal validity study is limited by the lack of a control group. moreover, the lsas assessors were not blind to the timing of the interviews (before or after treatment). there was no follow-up assessment into also, thus it is unclear whether the results were maintained or whether there were further changes. this is in particular important for outcomes like avoidance, depression, and quality of life that might show a delayed response to treatment. furthermore, integrating psychodrama and cbt in therapeutic practice usually includes 16 sessions (treadwell, dartnell, travaglini, staats, & devinney, 2016). however, the current cbpt protocol consists of twelve sessions to make it comparable to cbgt in future random clinical trials. nevertheless, the effects of cbpt might be larger with 16 sessions. future studies might investigate different lengths of treatment. the results of this pilot are promising, but it is necessary to do research in a randomized controlled trial with follow-up assessments to compare this treatment to cbgt alone and psychodrama alone. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to 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(1969). warm-up and sum-up. group psychotherapy, 22(1-2), 85-102. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. abeditehrani, dijk, sahragard toghchi, & arntz 21 clinical psychology in europe 2020, vol.2(1), article e2693 https://doi.org/10.32872/cpe.v2i1.2693 https://doi.org/10.3200/jgpp.55.2.51-53 https://doi.org/10.3200/jgpp.55.2.55-65 https://doi.org/10.1016/s0887-6185(03)00028-8 https://doi.org/10.1037/h0027806 https://doi.org/10.1037/1040-3590.17.2.179 https://www.psychopen.eu/ integrating cbt and psychodrama (introduction) method participants procedures and measures results primary outcomes secondary outcomes reliable change and clinical significant change feedback from patients discussion (additional information) funding competing interests acknowledgments references evidence-based psychodynamic therapies for the treatment of patients with borderline personality disorder latest developments evidence-based psychodynamic therapies for the treatment of patients with borderline personality disorder svenja taubner a, jana volkert a [a] university hospital heidelberg, university of heidelberg, heidelberg, germany. clinical psychology in europe, 2019, vol. 1(2), article e30639, https://doi.org/10.32872/cpe.v1i2.30639 received: 2018-10-17 • accepted: 2019-05-24 • published (vor): 2019-06-28 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: svenja taubner, university hospital heidelberg, university of heidelberg, institute for psychosocial prevention, bergheimer str. 54, 69115 heidelberg, germany. tel.: 0049(0)6221-56-4700. e-mail: svenja.taubner@med.uni-heidelberg.de abstract background: borderline personality disorder (bpd) is a serious health issue associated with a high burden for the individual and society. among the “big four” of evidence-based treatments for patients with bpd are two psychodynamic therapies that have evolved from classic psychoanalytic treatment with a change of setting and change of focus: transference-focused psychotherapy (tfp) and mentalization-based treatment (mbt). aims: this overview provides a comparison of the two treatments in terms of stance, clinical concepts, costs and key interventions. furthermore, the current literature on the efficacy of both treatments is reviewed. results: while tfp focuses on the content of disintegrated representations of self and other, mbt focuses on the processing of mental states. both treatments diverge in their clinical concepts and interventions for the treatment of bpd. conclusion: although both treatments are regarded as effective in treating bpd, no direct comparison of both treatments has been made so far. future studies are needed to investigate mechanisms of change and derive recommendations for a differential indication. keywords psychodynamic psychotherapy, borderline personality disorder, mentalization-based treatment, transferencefocused psychotherapy, efficacy, clinical concepts this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.30639&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • specialized therapies for bpd have favorable drop-out rates and outcome compared to non-specialized ones. • mbt and tfp have very diverse clinical concepts and interventions for the treatment of bpd. • both, mbt and tfp show efficacy in rcts. • no trial has directly compared mbt and tfp; there is no evidence base for differential indication. the cochrane review (stoffers et al., 2012) on psychological therapies for borderline per‐ sonality disorder (bpd) lists several approaches as ‘probably effective’ in treating bpd. four psychological treatments are described as evidence-based, the “big four”. among those two psychodynamic treatments are listed: mentalization-based therapy (mbt) and transference-focused psychotherapy (tfp). both represent the trend in psychodynamic therapies to develop disorder-specific treatments that can be tested for efficacy in con‐ trast to a classic, more transdiagnostic approach. furthermore, psychodynamic therapies have been developed that deviate from the classic freudian conceptualizations of ad‐ dressing unconscious conflict to improving personality functioning instead. in this paper, we will outline these current developments of psychodynamic treatments among the “big four” for bpd as the most prevalent disorder in clinical settings (torgersen, 2005), due to a lack of trials for other psychodynamic approaches (e.g. dynamic deconstructive psy‐ chotherapy or psychoanalytic interactional method). first, we will summarize the com‐ mon ground of psychodynamic therapies and, secondly, describe the clinical and change theory as well as therapeutic stance and key interventions of the two treatments. in a third step, tfp and mbt will be compared and contrasted with regard to their similari‐ ties and differences. the paper concludes with a summary of the current research find‐ ings on the efficacy of mbt and tfp for bpd and points out future directions for clinical research of these two approaches. differences in efficacy to classic psychodynamic treat‐ ment will be discussed. c o m m o n f e a t u r e s o f p s y c h o d y n a m i c p s y c h o t h e r a p y the term psychodynamic psychotherapy was established to describe therapies following the core psychoanalytic principles but with a lower weekly session rate and using a faceto-face setting instead of the classic freudian couch setting (whitehorn, braceland, lippard, & malamud, 1953). furthermore, psychodynamic psychotherapies establish a treatment focus and limit treatment goals also with regard to symptomatic changes. par‐ psychodynamic treatments for bpd 2 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ allel to the development of psychodynamic psychotherapy, clinical theories were broad‐ ened from seeing symptoms not only as a manifestation of unconscious conflicts but also as impairments in personality functioning and disturbed relationships (opd-2, opd taskforce, 2008). following the demands of evidence-based medicine, disorder-specific treatment manuals were established, e.g. for the treatment of panic disorders (milrod et al., 2007) and depression (lemma, target, & fonagy, 2011). the core ideas of psychody‐ namic therapies remained the following (shedler, 2010): 1. focus on emotions and affect 2. exploration of aspects that patients tend to avoid (e.g. painful and threatening aspects of experience), which is called defense or resistance in psychoanalytic terms 3. identification of recurrent topics or themes with regard to self, other, relationships, etc. 4. discussion of past experiences that help to contextualize current experiences 5. focus on relationships, especially the therapeutic relationship 6. exploration of dreams, phantasies and wishes all of these aspects can also be found in mbt and tfp; however, there is a shift of focus in the treatment of bpd to emphasize the “here-and-now” instead of discussing past events. both treatments work very explicitly with the current therapeutic relationship and the exploration of dreams, phantasies and wishes is not central for the therapeutic process, at least at the beginning of treatment. furthermore, psychodynamic therapies follow the goal to change distorted representations of self, other or relationships in a quite comparable way to cognitive-behavioral therapy (cbt). these can be distinguish‐ ed at the level of intervention: while cbt aims to change patients’ dysfunctional beliefs at a micro level, psychodynamic therapies reach out to change personality aspects e.g. with regard to depression at a macro level (luyten, blatt, & fonagy, 2013). both aim to change the content of representations. however, because a large number of patients do not correspond to a treatment approach focusing on the content of representations, re‐ cently in both therapeutic schools, new therapies have been developed that shift from ad‐ dressing content to the processing of mental states itself (e.g. how we think and interpret instead of what we think). in this paper, we will regard tfp as a primarily content-fo‐ cused treatment, whereas mbt focuses more on the processing of mental states, which can be regarded in line with the third wave therapies in cbt. before comparing these two specific treatment approachestfp and mbt-, we will summarize the core symp‐ toms and burden of bpd. taubner & volkert 3 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ b o r d e r l i n e p e r s o n a l i t y d i s o r d e r bpd is a severe health issue characterized by at least five of the following nine criteria (diagnostic and statistical manual of mental disorders [5th ed.; dsm–5]; american psychiatric association, 2013): a) unstable relationships, b) inappropriate anger, c) frantic effort to avoid abandonment, d) affective instability, e) impulsivity, f) self-harm/suicidali‐ ty, g) dysphoria, h) stress-related paranoid thoughts and i) identity disturbance and disso‐ ciation. point prevalence in community samples ranges from 0.7-3.9% (trull, jahng, tomko, wood, & sher, 2010), lifetime prevalence is around 6% (grant et al., 2008). in a recent meta-analysis with n = 66,914 included individuals from community samples of 9 studies in western countries the prevalence rate was 1.90% (volkert, gablonski, & rabung, 2018). furthermore, bpd is the most common personality disorder in clinical populations, with prevalence rates of around 10% in outpatient and 15-25% in inpatient settings (torgersen, 2005). bpd is often associated with both comorbid axis i and ii disor‐ ders: approx. 85% of bpd patients have a 12-months diagnosis of at least one axis i and 74% for another axis ii disorder (grant et al., 2008). 69-80% of bpd patients engage in sui‐ cidal behavior and 3-10% commit suicide with a 50 fold heightened risk in comparison to the general population (gunderson, weinberg, & choi-kain, 2013; leichsenring, leibing, kruse, new, & leweke, 2011; oldham, 2006). bpd accounts for 2.2% of all disability adjus‐ ted life years (dalys), 1.2% of all dalys (ranking 3rd in mental disorders in women, and 4th in men) and suicide accounts for 1.0-2.8% of all dalys (victorian government department of human services, 2005). the burden of bpd on society in terms of produc‐ tivity losses and other indirect costs is assumed to reach 76.3% of the total costs (olesen, gustavsson, svensson, wittchen, & jönsson, 2012). similarly, direct costs of bdp are con‐ sidered to be higher than in depression or diabetes (wagner et al., 2013), with average per capita costs ranging between 11,000€ and 14,000€ (salvador-carulla et al., 2014) per year. in sum, bpd is a severe treatment condition that comes with a high burden for the indi‐ vidual and society. however, treatment of bpd patients is emotionally challenging for therapists, and therapists often decline treatment with this group of patients; although 50% of therapists agree that a bpd-specific treatment qualification is useful, only 3% have such a qualification (jobst, hörz, birkhofer, martius, & rentrop, 2010). thus, there is a high need of training therapists in bpd-specific treatment approaches. the two ap‐ proaches that will be presented here, mbt (bateman & fonagy, 2016) and tfp (yeomans, clarkin, & kernberg, 2015), offer an additional training on top of a psychodynamic (or other) psychotherapeutic training that was created to treat bpd more effectively. psychodynamic treatments for bpd 4 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ a c o n t e n t f o c u s e d p s y c h o d y n a m i c t r e a t m e n t – t r a n s f e r e n c e f o c u s e d p s y c h o t h e r a p y tfp was developed by frank yeomans, john clarkin, and otto kernberg (yeomans et al., 2015) and is associated with a new conceptual idea of identity formation and personality organization. the aim of treatment is to decrease the symptomatic burden and interper‐ sonal problems in patients with bpd by changing patients’ mental representations of others and self that underlies their behavior (clarkin, cain, & lenzenweger, 2018), to meaningfully improve functioning in the domains of work, studies and profession, and intimate relations (yeomans et al., 2015). clinical concept personality organization is described as comprising three aspects of personality function‐ ing: identity integration, level of defense mechanisms and degree of reality testing. fol‐ lowing kernberg (1967), borderline personality organization is marked by identity diffu‐ sion, low level of defenses but mainly intact reality testing. thereby, identity diffusion is considered central to the clinical understanding of bpd in tfp and is related to a lack of coherence in the individual’s experience and understanding of both self and others. fur‐ thermore, social signals are consistently misunderstood because the inner experience of a bpd patient is dominated by aggressive internalized object relations that are split from idealized ones. thus, identity diffusion is associated with defensive strategies involving dissociation of conscious aspects of conflicting experiences (splitting). the lack of an in‐ tegrated self is also seen as leading to internal distress and emptiness that lead to pa‐ tients’ attempts to relieve distress through impulsive acting out (kernberg, 1967). ker‐ nberg’s etiology follows the idea of object relation theory that early experiences of self and others are organized by splitting, meaning that positive and negative representations of self and other need to be gradually integrated to achieve normal functioning. in bpd, positive and negative representations of self and other remain separated/ disintegrated because negative representations contain traumatic affects that would possibly destroy positive representations. change theory the authors propose that tfp helps patients to establish an increased affect regulation achieved through the growing ability of the patient to psychologically reflect and inte‐ grate thoughts, emotions and behavior and to establish positive relationships with others (kernberg, 2016). this is achieved through a modification of personality structure by linking the dissociated parts of positive and negative representations that are enacted in the therapeutic relationship. the patient’s partial representations are experienced in the therapeutic relationship that mirror splitting in the patient (transference). this can lead to a rapid change in the therapeutic relationship, e.g. an idealization of the therapist fol‐ taubner & volkert 5 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ lowed by a fear of being dominated or threatened, which is outside of the patient’s awareness. the therapist describes these different states of the relationship and links this with the inner experience of the patient. this way an integration of the split off idealized and persecutory segments of experience can take place, i.e. identity diffusion can be re‐ solved. by addressing the different split-off representations of self and other the therapist engages the patient in thinking and reflecting about their emotional responses and be‐ havior and links this, moment by moment, to the experiences in the therapeutic relation‐ ship. this leads to a reflection in the here and now with another person and a growing awareness of how the perception of others is distorted by expectations derived from in‐ ternal representations. within this therapeutic process the patient’s view of current in‐ terpersonal realities becomes more accurate. setting tfp begins with a verbal contract that serves as a framework to discuss risks to a pa‐ tient’s life (suicidality, self-harm, drug abuse) as well as behavior that potentially limits or hinders the continuation of therapy (leaving a job, insurance, moving to another city). furthermore, the contract aims at reducing any gains that the patient would take from their symptoms with regard to negative reinforcements. after having agreed on a com‐ mon contract, two individual sessions weekly are carried out with weekly supervision. the average treatment duration is between two and three years. stance the therapist takes a more active stance in comparison to classic psychoanalytic treat‐ ment by paying more attention to the external reality of the patient (e.g. breaking the contract, antisocial behavior) and selects priority themes that need to be addressed in ev‐ ery session in the material the patient is presenting. the stance is characterized by the “technical neutrality”, focusing on the “here-and-now” as well as balancing between ex‐ ploring and confronting the patient with incompatible views on the one hand and regula‐ tion of arousal on the other hand. technical neutrality describes the general stance of continuously keeping the goal of therapy in mind with an attitude of objective inquiry, to clarify issues without being judgmental. contradictions in the patient’s perception or representations of self and others are observed at three levels: what the patient is saying, how the patient is acting (inside and outside session) as well as the counter-reactions and feelings of the therapist. the latter requires constant monitoring of what belongs to the patient, the therapist and/or their interaction. key interventions while the patient is asked to freely associate and disclose any idea that comes to mind, the therapist listens carefully and uses the three following interventions: clarification, psychodynamic treatments for bpd 6 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ confrontation and interpretation. clarification means to thoroughly explore the patient’s subjective experience with a special focus on contradictions or conflicts as well as affects in his/her perception of self and others. this intervention aims to promote mentalization of internal states (yeomans, levy, & caligor, 2013). confrontations take the therapeutic work to the second level of actively pointing out discrepancies between the three chan‐ nels of communication (verbal, non-verbal and counter-reactions of the therapist) (zerbo, cohen, bielska, & caligor, 2013). finally, interpretations aim to integrate contradictions by offering a hypothesis for a deeper understanding of the different self and other repre‐ sentations that dominate the patient’s thinking and feeling in relationships. in the begin‐ ning and middle parts of the treatment, tfp recommends to avoid so-called genetic inter‐ pretations that link childhood experiences to current states of mind but stay in the hereand-now. time and costs training comprises 34 weekly seminars over a duration of one year including supervi‐ sion. this is followed by 6 months’ home study and supervision. the cost of the training adds up to 3,000€ (tfp institute munich, germany). treatment costs for an individual pa‐ tient may vary from country to country. number, duration and frequency of therapeutic sessions may approximately range from a minimum of 180 hours (two weekly sessions for one year) to a maximum of 405 sessions (three sessions weekly for three years) based on data from trial therapies. a cost effectiveness study revealed average costs for tfp at about 46.000€ and concluded that sf was more cost-effective in comparison to tfp (van asselt et al., 2008). however, there is no time-limitation to tfp according to the manual, which makes cost calculation outside of research difficult. widening scope (disorders and age groups) tfp started to provide an adapted and manualized psychoanalytic treatment for bpd, and there are further adaptions for the treatment of adolescents with borderline features (tfp-adolescence, normandin, ensink, yeomans, & kernberg, 2014; adolescent identity treatment, foelsch et al., 2014) and other personality disorders such as narcissistic per‐ sonality disorder. furthermore, the treatment approach was adapted for implementation in an acute psychiatric setting (zerbo et al., 2013). a p r o c e s s f o c u s e d p s y c h o d y n a m i c t r e a t m e n t – m e n t a l i z a t i o n b a s e d t r e a t m e n t mbt is a manualized treatment protocol developed by anthony bateman and peter fona‐ gy (bateman & fonagy, 2016). the treatment is based on validating the emotional experi‐ ence of patients within a significant therapeutic relationship and promotes several tech‐ taubner & volkert 7 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ niques that directly aim to stabilize or enhance mentalizing (bateman & fonagy, 2016). mentalization is the imaginative ability to interpret human behavior in terms of mental states (fonagy, gergely, jurist, & target, 2002). empirical research has shown that al‐ though social cognition is not necessarily impaired in bpd the construct of understand‐ ing others in emotionally intense relationships is highly impaired in bpd, which may un‐ derlie the core problems of these patients (fonagy, luyten, & strathearn, 2011). by pro‐ moting mentalizing, mbt addresses the interpersonal sensitivity in bpd. clinical concept effective mentalizing is characterized by a genuine curiosity about mental states’ under‐ lying behavior, a flexibility in interpreting self and others as well as the knowledge that mentalizing is inaccurate most of the time and needs communication with others to clari‐ fy intentions more precisely. furthermore, healthy mentalizing enables an individual to actively shift between different poles of mentalizing, e.g. self vs. others, integration of cognition and affect or implicit vs. explicit mentalizing. patients with bpd are often over‐ whelmed by their emotions, make over-quick assumptions and focus on thinking about others with fears of abandonment and rejection. in mbt, the prototypical problems for working with patients with bpd are regarded as a sign of vulnerability in mentalizing that goes along with a high interpersonal sensitivity. an attachment threat leads to a breakdown in mentalizing, which leads to a failure of affect regulation and impulsive be‐ havior. the vulnerability in mentalizing has been conceptualized as three different forms of inadequate mentalizing: teleological mode, psychic equivalence and pseudo-mentaliz‐ ing. teleological thinking overgeneralizes behavior as proof for internal states, whereas psychic equivalence generalizes from internal experience to the external reality. pseudo‐ mentalizing creates mental theories without a connection between internal and external experience. change theory the proposed mechanism of change in mbt is to stabilize mentalizing in certain focus areas to create a psychic buffer between affect and behavior to foster affect regulation, reduce impulsivity and promote functional supportive relationships. this is reached by employing “contrary moves” to create more flexibility in using the different poles of mentalizing. if the patient is stuck in thinking about the self, the therapist will try to shift him or her towards thinking about others. if the patient is too certain about quickly made assumptions, the therapist will try to slow down and question the first assumption, etc. by sharing or disclosing the therapist’s interpersonal experience with the patient from the beginning and throughout the process, the patient can find him/herself in the mind of the therapist and reflect on how the therapist is represented in the mind of the patient. using constant empathic validation of the patient’s affects and working slowly on cur‐ psychodynamic treatments for bpd 8 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ rent experiences with the therapist and other important others; the patient develops epis‐ temic trust and is able to generalize helpful mentalizing experiences with the therapist to other relationships outside of therapy. furthermore, by sharing a written case formula‐ tion, the patient learns about the therapist’s idea of the patient’s mentalizing failures and help him/her to establish more agency and responsibility for his/her behavior with re‐ gard to core symptoms e.g. self-harm, drug abuse. setting mbt was initially developed as an inpatient treatment with a duration of 18 months and evolved to an intensive outpatient program that is now commonly limited to 12 months. mbt sets off with a diagnostic phase. in addition to standard diagnostic assessment, the clinician is assessing mentalizing problems and interpersonal triggers that are associated with the core problem behavior. this is written down in a case formulation that summa‐ rizes the clinician’s current understanding of the patient’s vulnerabilities and mentalizing problems all set in the context of current relationships and behavior. the case formula‐ tion is shared with the patient, serves as a focus for treatment, and is revised approx. ev‐ ery three months. in addition to the case formulation, a crisis plan is developed together with the patient entailing information which the patient finds helpful or hindering dur‐ ing breakdowns for him/herself, professionals and significant others. after the diagnostic phase the patient participates in a psycho-education group that teaches core elements of the treatment including an understanding of the bpd diagnosis. after 12 sessions the group changes its format to a mbt-group therapy focusing on elaborating perspectives from each group member. parallel to the weekly group sessions patients have one weekly individual session. stance several aspects are essential for the mbt stance: being curious and enthusiastic for men‐ tal states, being authentic, empathic and validating as well as most importantly, taking a not-knowing stance. the latter is based on the modesty that no one can read minds and creates a less hierarchical relationship between therapist and patients. the therapist is not the expert for the patient’s mind but rather takes an inquisitive stance to explore to‐ gether with the patient what kind of thinking is helpful or unhelpful to have good rela‐ tionships with others. another focus is related to misunderstanding each other. misun‐ derstanding is considered as an opportunity to learn about perceptions, interpretations and experience. the therapist actively structures the session by focusing on topics related to the case formulation, management of arousal and monitoring the level of mentalizing. taubner & volkert 9 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ key interventions interventions start from the surface and work towards relational mentalizing of the ther‐ apeutic relationship if the current arousal and level of mentalizing allows. during times of high arousal it is recommended to intervene supportively by empathically validating the patient’s subjective experience and addressing non-mentalizing by exploring affects, certainties, quick assumptions, and by challenging pseudo-mentalizing. the techniques are called “stop and stand” or “stop, rewind and explore” that slow down the processing of current experiences. lower levels of arousal allow to start basic mentalizing around the focus of treatment such as triggers of strong affects and effect on behavior and others as well as linking different experiences to patterns of experience. finally, exploring the current affect during the session (affect focus) and the relationship between therapist and patient are seen as crucial change mechanisms as this allows an understanding of inter‐ personal processes in the here-and-now. mbt deviates from classic psychoanalytic inter‐ pretations as this is regarded aversive for bpd patients. thus, within the mbt frame‐ work it is recommended to contextualize affects and patterns of behavior in the hereand-now that should not be interpreted as a mere repetition of past relationships and ex‐ periences. time and costs training comprises 5 days and four supervised cases with at least 24 sessions each and four sessions of supervision per case. supervision and training add up to an overall cost of 1,600€ when following the requirements of the anna-freud-centre in london but may vary country wise. number, duration and frequency of mbt sessions based on one week‐ ly group and one individual session ranges between 90 sessions in twelve months or 120 sessions in 18 months. mbt was originally developed as an inpatient treatment, which is more costly than the outpatient program. however, exact numbers have not been repor‐ ted yet. a recent rct in the netherlands tested the efficacy between mbt outpatient and day-hospital, and reported a superiority in secondary outcomes for the more costly dayhospital treatment (smits et al., 2019). cost-effectiveness data comparing both settings is not available yet. widening scope (disorders and age groups) meanwhile, programs have been developed for adolescents with bpd (mbt-a), parents with bpd (mbt-lighthouse), conduct disorder, antisocial personality disorder, eating disorders, families (mbt-f), children (mbt-c) and hard to reach clients (ambit) (for an overview: bateman & fonagy, 2019). psychodynamic treatments for bpd 10 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ e f f i c a c y o f p d t r e a t m e n t s f o r b p d efficacy of tfp three rcts have demonstrated the efficacy of tfp. the first efficacy trial was conducted by giesen-bloo et al. (2006), with outpatients (n = 88) comparing tfp with schema-fo‐ cused therapy (sft) with 2 weekly sessions over a duration of 3 years. using an inten‐ tion-to-treat approach, statistically and clinically significant improvements were found for both treatments on all measures after 1-, 2-, and 3-year treatment periods. however, sft patients had a lower risk for drop-out (rr = 0.52) and after 3 years of treatment, sur‐ vival analyses demonstrated that significantly more sft patients recovered or showed re‐ liable clinical improvement. robust analysis of covariance (ancova) showed that they also improved more in general psychopathologic dysfunction and showed greater increa‐ ses in quality of life. arntz, stupar-rutenfrans, bloo, van dyck, and spinhoven (2015) reanalyzed the giessen-bloo study and identified the following predictors for drop-out and reduced recovery: initial burden of dissociation, hostility and childhood physical abuse, whereby in-session dissociation (observer-report) was identified as a mediator. another outpatient rct with n = 90 patients was conducted by clarkin, levy, lenzenweger, and kernberg (2007), who compared tfp (two individual weekly sessions) with dbt (weekly individual + group plus telephone consultation) and dynamic suppor‐ tive treatment (dst) (one individual weekly session) over a duration of 12 months. they found significant improvement for all three treatments on a number of outcomes: depres‐ sion, anxiety, global functioning and social adjustment. no differences were found be‐ tween the three different treatments; only tfp had a two times lower risk of drop-out (compare also oud, arntz, hermens, verhoef, & kendall, 2018, for a summary). thereby individual slopes differed with regard to within-patient effects. individual growth curve analysis showed that dbt and tfp had significant change rates compared to dst on sui‐ cidality, whereas tfp and dst had significant change rates compared to dbt on anger and impulsivity. furthermore, only tfp showed significant change rates in aggression (direct and verbal assault) and irritability. doering et al. (2010) investigated the efficacy of a tfp treatment compared to community treatment by experts (ctbe) over one year in n = 104 female patients with bpd. in this trial, tfp showed superiority to ctbe with re‐ gard to reduced drop-out (38.5% v. 67.3%), suicide attempts, borderline symptomatology, increased psychosocial functioning, personality organization and psychiatric inpatient admissions. no differences between the two treatment conditions were observed for de‐ pression, anxiety and general psychopathology. however, self-harming behavior did not change in either group. in a further analysis of the same data by fischer-kern et al. (2015) significant improvements in reflective functioning was also found for the tfp vs. the tau group with a medium between-group effect size (d = 0.45). taubner & volkert 11 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ efficacy of mbt four rcts have investigated the efficacy of mbt in comparison to psychiatric services (bateman & fonagy, 1999), structured clinical services including supportive psychothera‐ py (bateman & fonagy, 2009; jørgensen et al., 2013) and in adolescents with non-suicidal self-injury (nssi), who mainly fulfilled criteria for bpd (rossouw & fonagy, 2012). mbt proved to be superior to tau/ clinical management in nssi, suicide attempts, psychiatric symptoms, and hospitalization (bateman & fonagy, 1999, 2009; rossouw & fonagy, 2012) as well as core bpd symptoms (bales et al., 2012; rossouw & fonagy, 2012). one inde‐ pendent rct confirmed positive effects for mbt in comparison to supportive therapy for general functioning, suggesting that mbt may address core problems in bpd beyond nssi and suicidality (jørgensen et al., 2013). mbt is the only treatment for which superi‐ ority to clinical management was demonstrated in all primary outcome variables as well as achieving significantly higher levels of employment or academic/occupation training eight years after admission (bateman & fonagy, 2008). findings also demonstrate that mbt shows superiority over tau for interpersonal problems and general functioning (stoffers et al., 2012). in sum, mbt has demonstrated reliable improvements for psychiat‐ ric symptoms. a mediator analysis in an adolescent trial demonstrated that two changing variables were partially explaining differences in outcome between control and interven‐ tion group. these variables were changes in mentalizing and attachment avoidance, which were specific to the mbt effects (rossouw & fonagy, 2012). in a recent naturalistic study with a sample of 175 patients with bpd treated in an inpatient setting, changes of mentalizing operationalized with the reflective functioning questionnaire uncertainty scale (rfq) were significantly associated with changes in outcome (r = .89) (de meulemeester, vansteelandt, luyten, & lowyck, 2018). this can be regarded as first evi‐ dence for a proposed specific change mechanism, i.e. changes in mentalizing mediate symptom improvement in bpd. reviews and meta-analyses seven systematic reviews on the general efficacy of psychological therapies for bpd (brazier et al., 2006; cristea et al., 2017; juanmartí & lizeretti, 2017; leichsenring et al., 2011; oud et al., 2018; stoffers et al., 2012) and therapy retention have been conducted, respectively (barnicot, katsakou, marougka, & priebe, 2011). the cochrane review (stoffers et al., 2012) lists several approaches as ‘probably effective’ in treating bpd. among those treatment approaches, mbt is the most frequently investigated after dbt. the authors recommend to conduct future trials with more than one psychological treat‐ ment and to include quality of life and preference measures across different programs. in a recent meta-analysis investigating rcts on psychotherapy efficacy in reducing suicidal attempts and nssi (calati & courtet, 2016), efficacy was established only for mbt compared to dbt, cbt, cognitive therapy and interpersonal psychotherapy. how‐ psychodynamic treatments for bpd 12 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ ever, results were based on the inclusion of only two mbt rcts. in an updated metaanalysis, cristea et al. (2017) with k = 33 studies (n = 2,256 patients) conclude that only dbt and psychodynamic approaches were more effective than control interventions, however risk of bias was a significant moderator and publication bias was persistent par‐ ticularly at follow-up. mclaughlin, barkowski, burlingame, strauss, and rosendahl (2019) investigate in k = 24 rcts with over n = 1,500 patients the efficacy of group psy‐ chotherapy for bpd and find that group psychotherapy has a large effect on the reduc‐ tion of bpd symptoms and a moderate effect on suicidality/ parasuicidal symptoms. while the largest numbers of studies available have investigated dbt, theoretical orien‐ tation of treatment was not a significant moderator for bpd symptoms in this meta-anal‐ ysis. mclaughlin et al. (2019) conclude that dismantling studies, investigating the effect of various treatment components are promising. leichsenring et al. (2011) and the co‐ chrane review (stoffers et al., 2012) criticize the low study quality across bpd trials due to researcher allegiance, attention bias and small samples. they conclude that there is a strong need for confirmatory trials with high study quality and sufficient sample sizes. oud et al. (2018) summarize in their review and meta-analysis rcts on dbt, mbt, tfp and st to compare specialized therapies for bpds with non-specialized treatments. when pooling comparison data from specialized treatments vs. community treatment by experts, they demonstrate that specialized psychodynamic treatments like mbt or tfp are superior to non-specialized psychodynamic treatment with regard to overall bpd se‐ verity and drop-out. with regard to self-injury tfp showed no superiority and with re‐ gard to suicidality both dbt and tfp were no better than community expert therapists. however, these results have to be interpreted cautiously as they are based on three trials only. s i m i l a r i t i e s a n d d i f f e r e n c e s b e t w e e n m b t a n d t f p both treatment approaches are regarded as evidence-based and are gathering further proof in ongoing trials. so far, mechanisms of change have not been empirically estab‐ lished; however, this is, unfortunately, currently the case for all psychotherapies. as no study has directly compared tfp and mbt so far, it is unclear if one is more effective than the other or more suited for bpd and respective subgroups. thus, a differential indi‐ cation for the treatment of patients with bpd cannot be made based on empirical find‐ ings. there is no evidence that allows to choose which psychotherapy may be the most appropriate for which patient profile (fonagy, luyten, & bateman, 2017). aside from bpd, the widening scope of treating other personality disorders reveals recommenda‐ tions for treating patients with internalizing personality disorders with tfp (e.g. narcis‐ sistic pd) (kernberg, 2016) and patients with externalizing personality disorders with mbt (e.g. aspd) (bateman, o'connell, lorenzini, gardner, & fonagy, 2016). taubner & volkert 13 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ tfp and mbt are based on different clinical and theories of change. tfp is more stringently rooted in classic psychoanalytic theory and jargon, while mbt created a new conceptual framework by bridging several theoretical underpinnings from psychoanaly‐ sis, attachment theory and general developmental psychology. differences can also be found with regard to the setting: while tfp deviates from classic psychoanalysis only by not using the couch and reducing the weekly frequency to one to two hours, mbt has integrated psycho-education and group therapy which may create less pressure or inten‐ sity. however, the dyadic therapeutic work itself appears quite similar even though both approaches use different terminology for their interventions. especially, clarification and confrontation in tfp are very close to exploration, clarification and challenge in mbt. furthermore, establishing a contract and crisis plan at the beginning of therapy, working in the here-and-now, using the therapeutic relationship as a training ground and moni‐ toring the therapist’s counter-reaction is required in both therapies. major differences can be found in the general therapeutic stance that each approach is advocating. a tfp therapist is asked to remain in technical neutrality (not taking a stance towards or against any content discussed). on the contrary, the mbt therapist is asked to be enthusiastic and praising for mentalizing as well as disclosing his/her emo‐ tions if this is regarded as helpful to create a mentalizing process. while tfp is deploying a content-focused approach taking an interpretative expressive therapeutic stance, mbt focuses on the process of thinking about mental states based on a supportive therapeutic stance. yet again, there is also a considerable overlap: interestingly, tfp also increases mentalizing (fischer-kern et al., 2015; levy et al., 2006), which may be evidence that the core therapeutic work of clarification and confrontation and maybe also interpretation creates robust mentalizing. as mechanism of change studies in mbt reveal that increas‐ ing reflective thinking is indeed mediating symptomatic improvement in bpd, this could also be interpreted as a common change factor across treatments in bpd (goodman, 2013). hence, it would be worth investigating these specific differences and similarities in process research as well as within non-inferiority trials to test the efficacy. dissemination of mbt and tfp is a major challenge as many psychodynamic thera‐ pists are skeptical towards disorder-specific treatment and variations from a highly indi‐ vidualized and transdiagnostic approach that is typical for psychodynamic therapies (gonzalez-torres, 2018). furthermore, accredited supervisors and trainers are still scarce for both tfp and mbt, and this significantly hinders the international dissemination of training programs. however, considering the substantial burden of these patients, their need for adequate treatment and the substantial evidence supporting the efficacy of these treatments, advancing dissemination of treatment and empirical knowledge seems to be a worthwhile future investigation. psychodynamic treatments for bpd 14 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. r e f e r e n c e s american psychiatric association. 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(2015). transference-focused psychotherapy for borderline personality disorder: a clinical guide. washington, dc, usa: american psychiatric publishing. yeomans, f. e., levy, k. n., & caligor, e. (2013). transference-focused psychotherapy. psychotherapy, 50(3), 449-453. https://doi.org/10.1037/a0033417 zerbo, e., cohen, s., bielska, w., & caligor, e. (2013). transference-focused psychotherapy in the general psychiatry residency: a useful and applicable model for residents in acute clinical settings. psychodynamic psychiatry, 41(1), 163-181. https://doi.org/10.1521/pdps.2013.41.1.163 taubner & volkert 19 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://doi.org/10.1521/pedi.2010.24.4.412 https://doi.org/10.1192/bjp.bp.106.033597 https://doi.org/10.1192/bjp.2018.202 https://doi.org/10.1026/1616-3443/a000227 https://doi.org/10.1037/a0033417 https://doi.org/10.1521/pdps.2013.41.1.163 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. psychodynamic treatments for bpd 20 clinical psychology in europe 2019, vol.1(2), article e30639 https://doi.org/10.32872/cpe.v1i2.30639 https://www.psychopen.eu/ psychodynamic treatments for bpd (introduction) common features of psychodynamic psychotherapy borderline personality disorder a content-focused psychodynamic treatment – transference focused psychotherapy clinical concept change theory setting stance key interventions time and costs widening scope (disorders and age groups) a process-focused psychodynamic treatment – mentalization-based treatment clinical concept change theory setting stance key interventions time and costs widening scope (disorders and age groups) efficacy of pd treatments for bpd efficacy of tfp efficacy of mbt reviews and meta-analyses similarities and differences between mbt and tfp (additional information) funding competing interests acknowledgments references pre-sleep arousal and fear of sleep in trauma-related sleep disturbances: a cluster-analytic approach research articles pre-sleep arousal and fear of sleep in trauma-related sleep disturbances: a cluster-analytic approach gabriela g. werner a, sarah k. danböck ab, stanislav metodiev a, anna e. kunze a [a] department of psychology, lmu munich [study institution], munich, germany. [b] department of psychology, university of salzburg, salzburg, austria. clinical psychology in europe, 2020, vol. 2(2), article e2699, https://doi.org/10.32872/cpe.v2i2.2699 received: 2019-09-27 • accepted: 2019-12-05 • published (vor): 2020-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: gabriela g. werner, department of psychology, lmu munich, leopoldstraße 13, 80802 munich, germany. phone +49 89 2180 5297. fax: +49 89 2180 5288. e-mail: gabriela.werner@psy.lmu.de abstract background: trauma-related sleep disturbances constitute critical symptoms of posttraumatic stress disorder (ptsd), but sleep symptoms often reside even after successful trauma-focused psychotherapy. therefore, currently unattended factors – like fear of sleep (fos) – might play a crucial role in the development and maintenance of residual sleep disturbances. however, it is unclear whether trauma-exposed individuals exhibit different symptomatic profiles of sleep disturbances that could inform individualized therapeutic approaches and eventually enhance treatment efficacy. method: in a large online study, a two-step cluster analysis and a hierarchical cluster analysis using ward’s method were performed to explore subgroups among trauma-exposed individuals (n = 471) in terms of fos, different aspects of trauma-related sleep disturbances (e.g., insomnia symptoms, nightmares, arousal), and ptsd symptoms. these variables were compared between resulting clusters using anovas and scheffé’s post-hoc tests. results: the hierarchical cluster analysis supported 3and 4-cluster solutions. the 3-cluster solution consisted of one “healthy” (n = 199), one “subclinical” (n = 223), and one “clinical” (n = 49) cluster, with overall low, medium, and high symptomatology on all used variables. in the 4-cluster solution, the clinical cluster was further divided into two subgroups (n = 38, n = 11), where one cluster was specifically characterized by elevated somatic pre-sleep arousal and high levels of fos. conclusions: a subgroup of trauma-exposed individuals with ptsd and sleep disturbances suffers from increased pre-sleep arousal and fos, which has been suggested as one possible explanation for residual sleep disturbances. in these patients, fos might be a relevant treatment target. keywords trauma-related sleep disturbances, pre-sleep arousal, insomnia, nightmares, fear of sleep, posttraumatic stress disorder, cluster analysis this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2699&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • fear of sleep is one additional, important aspect of trauma-related sleep disturbances. • trauma-exposed individuals can be clustered based on their sleepand ptsdrelated symptomatology. • one subgroup was specifically characterized by increased fear of sleep and somatic pre-sleep arousal. • fear of sleep might be a relevant treatment target and might provide more specialized treatments with greater response rates. • somatic pre-sleep arousal might reflect the physiological component of fear of sleep. during the last decade, the body of research on sleep disturbances in traumaand stressor-related disorders, particularly posttraumatic stress disorder (ptsd), has rapidly grown. sleep disturbances following traumatic experiences are mostly conceptualized as symptoms of insomnia (e.g., difficulties falling or staying asleep) and recurrent night‐ mares (pace-schott & bottary, 2018), which were previously seen as secondary symptoms of ptsd (spoormaker & montgomery, 2008). this might be due to the fact that these types of sleep disturbances are represented in the formal diagnosis of ptsd (american psychiatric association, 2013). however, recent research has consistently shown that sleep disturbances are more than a mere epiphenomenon, as they appear to constitute a crucial factor in the development and maintenance of ptsd (cox, tuck, & olatunji, 2017; germain, mckeon, & campbell, 2017; sinha, 2016; spoormaker & montgomery, 2008). furthermore, although evidence-based treatment for ptsd (lee et al., 2016; schnurr, 2017) often leads to significant reductions in symptoms of insomnia as well as night‐ mares, in contrast to other ptsd symptoms, sleep disturbances do not usually fully remit (belleville, guay, & marchand, 2011; galovski, monson, bruce, & resick, 2009; gutner, casement, stavitsky gilbert, & resick, 2013; lommen et al., 2016; woodward et al., 2017). sleep-focused treatments, like cognitive behavioral therapy for insomnia (cbt-i) or forms of trauma-related nightmare treatments (e.g., imagery rehearsal therapy, irt; or exposure, relaxation, and rescripting therapy, errt), lead to stronger reductions in sleep disturbances and nightmares respectively (casement & swanson, 2012; ho, chan, & tang, 2016), and additionally moderately reduce ptsd symptoms (davis et al., 2011; davis & wright, 2007; pruiksma, cranston, rhudy, micol, & davis, 2018). however, most studies show that even after sleep-focused treatments, sleep disturbances remain in the clinical range, especially in more severe ptsd samples (nappi, drummond, thorp, & mcquaid, 2010; swanson, favorite, horin, & arnedt, 2009; ulmer, edinger, & calhoun, 2011). this leads to the assumption that other factors, which are currently unattended, seem to play a role in the development and maintenance of trauma-related sleep distur‐ bances. fear of sleep in trauma-related sleep disturbances 2 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ one such factor is fear of sleep (fos), which includes dysfunctional beliefs about one’s perceived safety during sleep, fear of nightmares, and maladaptive behaviors. fos seems to develop due to two main reasons: first, traumatic experiences together with daytime ptsd-symptoms (e.g., intrusive re-experiencing) induce a feeling of loss of control, which can trigger strong feelings of helplessness and reduced trust in other people and in the world (ehlers, hackmann, & michael, 2004). yet sleep is a state where a reduced ability to monitor the environment and giving up control is inevitable (dahl, 1996). therefore, it is plausible that trauma survivors with ptsd might be particularly fearful of this state because they feel extremely vulnerable during sleep. second, due to a fear of re-experiencing the traumatic event during sleep, nightmares might additionally enhance fos (davis, 2009; krakow, tandberg, scriggins, & barey, 1995; neylan et al., 1998). also, related sleep-interfering maladaptive behaviors, such as sleeping with lights on, the use of heavy blankets, exaggerated safety checking before sleeping, or delaying bedtime in order to deal with nightmares or being vulnerable during sleep, can be considered part of fos (pruiksma et al., 2014). as fos is not targeted during traumaor sleep-focused psychotherapy (pigeon & gallegos, 2015), it has recently been suggested as an underlying mechanism of residual sleep disturbances (pruiksma et al., 2014). several empirical findings support correlational links between fos and increased symptoms of insomnia and nightmares, as well as overall ptsd symptomatology (huntley, hall brown, kobayashi, & mellman, 2014; kanady et al., 2018; neylan et al., 1998; pruiksma, cranston, jaffe, & davis, 2011). however, other factors can also influence the maintenance of trauma-related sleep disturbances. for example, traumatic experien‐ ces generally lead to a state of heightened cognitive and somatic arousal – particularly during the pre-sleep period – that might consequently induce sleep disturbances (sinha, 2016). furthermore, the severity of trauma-related insomnia symptoms and nightmares per se might be one important factor for the persistence of sleep disturbances. finally, both difficulty maintaining sleep and nightmares have also been associated with more interrupted, and therefore fragmented, rapid eye movement (rem) sleep, which can in‐ terfere with treatment response via impaired extinction learning (pace-schott, germain, & milad, 2015; riemann et al., 2012). overall, there is a need to investigate these various aspects of trauma-related sleep disturbances in order to provide additional promising treatment targets. fos might be a particularly relevant factor influencing the maintenance of trauma-related sleep distur‐ bances because other factors (e.g., feeling of safety during the day, sleep disturbances, and nightmares in general) are already targeted during traumaor sleep-focused therapy (pigeon & gallegos, 2015). however, the role of fos in individuals with trauma-related sleep disturbances is currently unknown. therefore, we have investigated fos together with symptoms of insomnia, nightmares, pre-sleep arousal, and rem sleep fragmentation in the context of traumatic experiences in a general population sample that included both healthy individuals and individuals with clinically relevant ptsd symptoms. through werner, danböck, metodiev, & kunze 3 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ the use of a cluster-analytic approach, this study aims to explore symptomatic profiles of trauma-exposed individuals on fos, insomnia symptoms, nightmares, pre-sleep arousal, and rem sleep fragmentation, as well as ptsd symptomatology. classifying this hetero‐ geneous group of individuals with traumatic experiences into better-defined subgroups could help to provide more specialized treatments with greater response rates, especially with regard to trauma-related sleep disturbances. m e t h o d sample and procedures overall, 754 individuals (62% female, mean age = 48.69 years; sd = 14.00; range 18– 92) from the german nationwide online panel psyweb (n = 12.317 in 2017; https:// www.uni-muenster.de/psyweb) participated in the study. psyweb is a panel that provides information about psychological topics of common interest and offers possibilities to take part in anonymous psychological tests and studies for registered members from the general population (i.e., panel members). panel members were contacted via e-mail by the panel organization and were invited to take part in an online survey study investigating influencing factors on sleep and sleep problems. we specifically invited all panel members, independent of existing sleep problems or previous traumatic experi‐ ences. study participants did not receive any monetary compensation but were offered automated feedback regarding their sleep quality and depression scores after completion of the survey. participants were included if they were 18 years or older and proficient in the german language, but were excluded from all analysis if they did not give written informed consent. it is worth noting that the data collected in this study was also used to validate the german version of the fear of sleep inventory-short form (fosi-sf; drexl, kunze, & werner, 2019). both projects were preregistered specifying their different research foci and analytic approaches (kunze, drexl, metodiev, & werner, 2017; werner, metodiev, drexl, & kunze, 2017). measures the survey included several measures assessing fos, insomnia symptoms, nightmares, traumatic experiences, ptsd symptoms, and other aspects of trauma-related sleep distur‐ bances, like arousal and a proxy for fragmented rem sleep, with higher scores indicating increased symptomatology. traumatic experiences and ptsd symptoms were measured by the german version of the life events checklist (lec-5, including the extended crite‐ rion a assessment), followed by the ptsd checklist for dsm-5 (pcl; range 0-80; krügergottschalk et al., 2017) if any traumatic experience was indicated by the participant. in the present sample, internal consistency for the pcl was excellent (cronbach’s α = .95). fear of sleep in trauma-related sleep disturbances 4 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.uni-muenster.de/psyweb https://www.uni-muenster.de/psyweb https://www.psychopen.eu/ insomnia severity was measured via the german version of the insomnia severity index (isi; range 0-28; gerber et al., 2016). it assesses difficulties with initiating or maintaining sleep as well as early morning awakenings and related worries, and there is good internal consistency in our sample (α = .84) and a clinical cut-off at 15 for moderate insomnia. furthermore, nightmares were assessed using the german version of the nightmare distress questionnaire (ndq; range 13-65; böckermann, gieselmann, & pietrowsky, 2014) with excellent internal consistency in the present sample (α = .91). additionally, fos was measured via the german version of the fosi-sf (drexl et al., 2019). the fosi-sf contains 13 items (range 0–52) on the fear of being particularly vulnerable during sleep, fear of experiencing nightmares, fear of darkness, and related behaviors, such as sleeping with lights on. the fosi-sf showed good internal consistency in this sample (α = .86). further measures linked to trauma-related sleep disturbances included the german ver‐ sions of the pre-sleep arousal scale (psas; range 15-75; gieselmann, de jong-meyer, & pietrowsky, 2012; somatic arousal [8 items]: α = .80; cognitive arousal [7 items]: α = .92) as well as nocturnal mentations as a proxy for rem sleep fragmentation (nms; range 3-27; wassing et al., 2016); however internal consistency was questionable for this 3-item scale (α = .63). depression and anxiety were assessed for exploratory purposes using the german versions of the depression module of the patient health questionnaire (phq-9; range 0-27; löwe, spitzer, zipfel, & herzog, 2002) and the general anxiety disorder screener (gad-7; range 0–21; löwe et al., 2008). statistical analyses only participants with at least one potentially traumatic experience (according to dsm-5) – and therefore valid values for ptsd symptom severity (pcl) – were further included in the analyses. potentially traumatic experiences were defined on the basis of the lec-5 and the extended criterion a assessment if one of the traumatic events was personally experienced or witnessed (weathers et al., 2013). however, if the indicated index traumatic event for the pcl did not include any of the following criterion a characteristics, the participant was assigned to the no-trauma group and excluded from further analyses. the criterion a characteristics were: danger of life, serious injury, sexu‐ al violence, or – in the case of the death of a close family member – accident or violence. after exclusion, the remaining sample consisted of 471 trauma-exposed individuals (see table 1 for demographic variables of the sample). all analyses were carried out using the statistical package for the social sciences (ibm spss statistics, version 24). cluster analysis is a data-driven approach seeking to identify specific subgroups of individuals within a larger sample on the basis of shared charac‐ teristics. specifically, cluster analyses aim to group individuals that are similar to each other on specified variables into distinct groups. in the present study, cluster analyses were used to explore different symptomatic profiles of trauma-exposed individuals. in order to identify subgroups within our sample, we first performed a non-hierarchical werner, danböck, metodiev, & kunze 5 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ two-step cluster analysis. this type of cluster analysis is advantageous, as it automati‐ cally uses standardized variables and chooses the optimal number of clusters based on schwarz’s bayesian criterion (bic) and the ratio of distance measures (schendera, 2010); in this case the euclidian distance measure was used. the resulting cluster quality was automatically rated based on the silhouette measure for cohesion and separation. for ptsd symptomatology we used the pcl score without items referring to sleep (“pcl-”, i.e., pcl without items 2 and 20) to decrease overlap with other measures assessing sleep-relevant variables. table 1 demographic variables of the trauma-exposed subsample (n = 471) variable age m sd 49.02 13.25 female n % 306 64.97 marital status n % single 101 21.44 in relationship 95 20.17 married 201 42.68 divorced or widowed 74 15.71 education n % middle school degree 55 11.68 high school degree 98 20.81 university degree 268 56.90 vocational education 45 9.55 other 5 1.06 occupation n % student 33 7.00 employed 319 67.73 unemployed 13 2.76 retired 86 18.26 other 20 4.25 past psychotherapeutic treatment n % 225 47.77 as non-hierarchical cluster analyses only detect main clusters, we also conducted a hierarchical cluster analysis, using ward’s method (ward, 1963). this method, which has been broadly used in the social sciences (clatworthy, buick, hankins, weinman, fear of sleep in trauma-related sleep disturbances 6 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ & horne, 2005), seeks to minimize the total within-cluster variance (leading to more homogeneous subgroups) and tends to create approximately equally sized, non-overlap‐ ping clusters (schendera, 2010). using this agglomerative approach, each individual initially represents its own cluster and clusters then progressively merge with others (as a function of their relative distance, i.e., the squared euclidian distance) until one cluster including all cases is formed. the ideal number of clusters was determined by inspection of the resulting dendrogram and agglomeration coefficients, where a large increase between two consecutive cluster solutions indicates an unfavorable combination of two heterogeneous clusters and should therefore be abandoned. if the dendrogram and agglomeration coefficients supported more than one cluster solution, they were all trea‐ ted as final solutions and further examined. differences in clustering variables between the resulting clusters of the final cluster solution were then explored via subsequent analyses of variance (anovas) followed by post-hoc analyses. differences in secondary and demographic variables were investigated for exploratory purposes. r e s u l t s psychometric variables the psychometric characteristics of the sample with regard to variables used in the cluster analyses are given in table 2. ptsd symptomatology is reported both overall (pcl) and without items referring to sleep disturbances (pcl-), as the latter was used for cluster analyses. table 2 psychometric characteristics of the trauma-exposed subsample variable m sd range ptsd symptoms (pcl) 14.60 14.71 0–71 ptsd symptoms without sleep disturbances (pcl-) 13.23 13.57 0–63 insomnia symptoms (isi) 8.63 5.39 0–26 nightmare distress (ndq) 23.10 8.99 13–54 fear of sleep (fosi-sf) 2.07 4.39 0–35 pre-sleep arousal (psas) 27.56 9.70 15–62 somatic pre-sleep arousal (psas, somatic subscale) 12.56 4.51 8–32 cognitive pre-sleep arousal (psas, cognitive subscale) 15.01 6.30 7–33 rem sleep fragmentation (nocturnal mentations) 10.86 5.91 3–27 note. pcl = posttraumatic checklist; pcl= pcl score without items 2 and 20; isi = insomnia severity index; ndq = nightmare distress questionnaire; fosi-sf = fear of sleep inventory-short form; psas = pre-sleep arousal scale. werner, danböck, metodiev, & kunze 7 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ two-step cluster analysis the lowest bic (2067.80) and the largest ratio of distance (1.39) both supported a 2cluster solution, which was automatically chosen. cluster quality was rated as good, based on the silhouette measure for cohesion and separation. cluster 1 was characterized by low values of all variables (“healthy cluster”; n = 418), and cluster 2 was characterized by high values of all variables (“clinical cluster”; n = 53) (see table 3). subsequent t-tests revealed significant differences between the two clusters on all grouping variables, ps ≤ .001. table 3 mean scores of clustering variables in clusters obtained by two-step cluster analysis variable healthy cluster n = 418 clinical cluster n = 53 m sd m sd pcl 11.35 11.01 40.25 15.09 pcl10.28 10.28 36.45 14.07 isi 7.69 4.78 15.98 4.09 ndq 21.18 6.92 38.28 9.10 fosi 1.06 2.00 10.09 8.27 psas-s 11.70 3.53 19.32 5.65 psas-c 13.70 5.16 25.28 4.95 nms 10.22 5.72 15.85 4.93 note. pcl is reported for descriptive purposes, pclwas used as clustering variable. pcl = posttraumatic checklist; pcl= pcl score without items 2 and 20; isi = insomnia severity index; ndq = nightmare distress questionnaire; fosi-sf = fear of sleep inventory-short form; psas-s = pre-sleep arousal scale somatic subscale; psas-c = pre-sleep arousal scale cognitive subscale; nms = nocturnal mentations. hierarchical cluster analysis the dendrogram of the hierarchical cluster analysis using ward’s method and squared euclidian distances showed possible solutions of two, three, and four clusters (see figure s1, supplementary material). there was a smaller increase in agglomeration coefficients between the 4and 3-cluster solutions (155.73) and a larger increase between the 3and 2-cluster solutions (525.09), indicating a stronger increase in the heterogeneity within clusters between the latter solutions (see table s1, supplementary material). therefore, the 2-cluster solution was abandoned and the 3and 4-cluster solutions were further described. the 3-cluster solution revealed two bigger clusters and one smaller cluster (cluster 1: n = 199; cluster 2: n = 223; cluster 3: n = 49). one-way anovas and scheffé’s post-hoc comparisons indicated that all clusters differed significantly from each other regarding all fear of sleep in trauma-related sleep disturbances 8 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ variables (see table 4 for descriptive values and inferential statistics). specifically, cluster 1 was characterized by low levels, cluster 2 by medium levels, and cluster 3 by high levels of all variables. based on these results, and taking the clinical cut-offs for insomnia (isi ≥ 15) and ptsd symptoms (pcl ≥ 33) into consideration, these clusters were named “healthy cluster”, “subclinical cluster”, and “clinical cluster” (see table 4). in line with the two-step cluster analysis, the clinical clusters of both analytic approaches are comparable with respect to cluster size (n = 53 vs. n = 49) and mean scores of all variables. table 4 descriptive values and inferential statistics of the 3-cluster solution variable healthy cluster n = 199 subclinical cluster n = 223 clinical cluster n = 49 statistics m sd m sd m sd f(2, 468) η2 pcl 5.36a 5.15 16.98b 12.31 41.29c 14.16 256.36*** .52 pcl4.84a 4.81 15.39b 11.58 37.45c 13.27 239.18*** .51 isi 4.78a 2.92 10.39b 4.63 16.22c 3.92 210.29*** .47 ndq 16.92a 3.32 25.27b 7.30 38.35c 9.09 260.68*** .53 fosi 0.20a 0.57 2.24b 3.01 8.92c 9.11 115.86*** .33 psas-s 10.06a 2.14 13.09b 3.87 20.27c 4.84 183.94*** .44 psas-c 10.61a 2.71 16.45b 5.25 26.29c 3.42 303.46*** .56 nms 7.23a 4.00 12.90b 5.62 16.29c 5.07 102.60*** .31 note. pcl is reported for descriptive purposes, pclwas used as clustering variable. omnibus tests and η2 of one-way anovas are reported (independent variable: cluster, dependent variables: clustering variables). differ‐ ent subscripts indicate significant differences in scheffé's post-hoc comparisons (p < .001). pcl = posttraumatic checklist; pcl= pcl score without items 2 and 20; isi = insomnia severity index; ndq = nightmare distress questionnaire; fosi-sf = fear of sleep inventory-short form; psas-s = pre-sleep arousal scale somatic subscale; psas-c = pre-sleep arousal scale cognitive subscale; nms = nocturnal mentations. ***p < .001. regarding the 4-cluster solution, the clinical cluster was further divided into two clusters (cluster 3: n = 38; cluster 4: n = 11). one-way anovas and scheffé’s post-hoc compari‐ sons were again used to explore differences between the identified clusters regarding all clustering variables as well as some additional exploratory and demographic variables (see table 5 for descriptive values and inferential statistics). in line with the 3-cluster solution, scheffé’s post-hoc comparisons demonstrated that both clinical clusters were characterized by significantly higher levels of all variables compared to the subclinical cluster and the healthy cluster; only nocturnal mentations did not differ significantly between one of the clinical clusters (cluster 4) and the healthy cluster (cluster 1), mdiff = 0.92, p = .948 (see table 5). however, comparing both clinical clusters, cluster 4 werner, danböck, metodiev, & kunze 9 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ additionally showed significantly increased levels of somatic pre-sleep arousal, mdiff = 3.41, p = .033, as well as much higher levels of fos than cluster 3, mdiff = 18.16, p ≤ .001 (see also figure 1 for cluster group mean z-scores). moreover, the amount of variance in fos that can be explained by clustergroup membership (η2) was much higher in the 4-cluster solution (η2 = .64) than in the 3-cluster solution (η2 = .33), while the amount of explained variance of all other variables did not differ between solutions. therefore, cluster 4 was named “clinical cluster with fos”, while the third cluster remained a more general “clinical cluster”. table 5 descriptive values and inferential statistics of the 4-cluster solution variable healthy cluster n = 199 subclinical cluster n = 223 clinical cluster n = 38 clinical cluster with fos n = 11 statistics m sd m sd m sd m sd f(3, 467) η2 pcl 5.36a 5.15 16.98b 12.31 41.11c 13.84 41.91c 15.90 170.58*** .52 pcl4.84a 4.81 15.39b 11.58 37.21c 13.06 38.27c 14.60 159.19*** .51 isi 4.78a 2.92 10.39b 4.63 16.82c 3.94 14.18c 3.25 142.35*** .48 ndq 16.92a 3.32 25.27b 7.30 38.37c 7.26 38.27c 14.20 173.42*** .53 fosi 0.20a 0.57 2.24b 3.01 4.84c 4.37 23.00d 6.81 278.75*** .64 psas-s 10.06a 2.14 13.09b 3.87 19.5c 4.29 22.91d 5.89 127.60*** .45 psas-c 10.61a 2.71 16.45b 5.24 26.58c 2.97 25.27c 4.67 202.52*** .57 nms 7.23a 4.00 12.90b 5.62 17.00c 5.04 13.82a, c 4.58 69.96*** .31 phq-9 12.66a 2.82 18.05b 4.83 25.11c 4.79 27.45c 5.05 150.43*** .49 gad-7 10.08a 2.27 13.93b 3.82 20.61c 3.51 20.09c 3.78 148.64*** .49 age 51.27a 13.42 48.09a,b 12.82 44.08b 12.55 44.18a,b 14.52 4.64* .03 note. pcl scores are reported for descriptive purposes, pclwas used as clustering variable. omnibus tests and η2 of one-way anovas are reported (independent variable: cluster, dependent variables: clustering variables and secondary variables). different subscripts indicate significant differences in scheffé's post-hoc comparisons (p < .05). pcl = posttraumatic checklist; pcl= pcl score without items 2 and 20; isi = insomnia severity index; ndq = nightmare distress questionnaire; fosi-sf = fear of sleep inventory-short form; psas-s = pre-sleep arousal scale somatic subscale; psas-c = pre-sleep arousal scale cognitive subscale; nms = nocturnal mentations; phq-9 = patient health questionnaire, depression module; gad-7 = general anxiety disorder screener. *p < .05. **p < .01 ***p < .001. fear of sleep in trauma-related sleep disturbances 10 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ figure 1 profile of z-scores (with standard error bars) for clustering variables by cluster group note. pcl scores are reported for descriptive purposes only and were not included in the analysis. pcl = posttraumatic checklist; pcl= pcl score without items 2 and 20; isi = insomnia severity index; ndq = nightmare distress questionnaire; fosi-sf = fear of sleep inventory-short form; psas-s = pre-sleep arousal scale somatic subscale; psas-c = psas cognitive subscale; nms = nocturnal mentations. additionally, one-way anovas and scheffé’s post-hoc comparisons were used to explore differences between the final four clusters regarding secondary and demographic varia‐ bles that were not used as clustering variables (see table 5 for descriptive values and inferential statistics). both clinical clusters were characterized by significantly higher levels of depression and anxiety compared to the subclinical cluster and the healthy clus‐ ter. however, comparing both clinical clusters, no differences in the levels of depression and anxiety were found. considering age, only a difference between the healthy and the clinical cluster was found indicating higher age in the healthy cluster. furthermore, there was a significant association between cluster group membership and gender, χ2(3) = 23.67, p < .001. overall, clusters with higher symptom severity were associated with female gender (healthy cluster: 53.8% women; subclinical cluster: 70.7% women; clinical cluster: 84.2% women; clinical cluster with fos: 90.9% women). werner, danböck, metodiev, & kunze 11 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ d i s c u s s i o n the present study investigated fos together with other factors that might be important for the maintenance of trauma-related sleep disturbances in trauma-exposed individuals (i.e., symptoms of insomnia, nightmares, pre-sleep arousal, rem fragmentation, and ptsd symptoms) by using a data-driven, cluster-analytic approach. identifying different symptomatic profiles in individuals with trauma-related sleep disturbances might help to provide more individualized treatment targets. the main analyses supported a 3-cluster as well as a 4-cluster solution: the 3-cluster solution revealed one healthy, subclinical, and clinical cluster with respective low, medium, and high scores for all variables. in the 4-cluster solution, the clinical cluster was further split into two smaller clusters. both clusters again demonstrated significantly higher levels of all variables compared to the healthy and subclinical clusters. additionally, one of the two clinical clusters was characterized by elevated levels of somatic pre-sleep arousal and considerably higher levels of fos compared to the other clinical cluster. the results suggest that a subgroup of individuals suffering from ptsd is characterized by increased somatic pre-sleep arousal and fos, which might be relevant treatment targets, particularly for these individuals. in general, trauma-exposed individuals differ dramatically with regard to their levels of psychopathology. empirical findings indicate that, on average, around 10% of trau‐ ma-exposed individuals demonstrate residual stress-related symptoms and subsequently develop ptsd (hidalgo & davidson, 2000). in line with these observations, both cluster methods in this study revealed clinical clusters whose size accounted for around 10% of the trauma-exposed sample. in the two-step cluster analysis, the clinical sample consisted of 53 (11.25%) individuals who showed ptsd and insomnia symptoms above the pro‐ posed clinical cut-offs (bovin et al., 2016; gerber et al., 2016). in the hierarchical cluster analysis using ward´s method, the clinical sample consisted of 49 (10.40%) individuals, again with ptsd and insomnia symptoms above the clinical cut-off (3-cluster solution). these findings support the representativeness of our online sample with regard to ptsd symptomatology. furthermore, 47% of the trauma-exposed sample formed a subclinical cluster with significantly higher levels on all variables (i.e., fos, insomnia symptoms, nightmares, pre-sleep arousal, rem sleep fragmentation, and ptsd symptoms) compared to the healthy cluster. in further support of the dimensionality of the constructs meas‐ ured in the present study, this cluster indicated levels of subthreshold insomnia symp‐ toms (gerber et al., 2016) as well as medium levels on all other variables. in the 4-cluster solution, the clinical cluster of the 3-cluster solution was further split into two clusters. while one of these two clusters was very similar to the clinical cluster in the 3-cluster solution (i.e., clinical cluster), the fourth cluster additionally showed significantly higher levels of somatic pre-sleep arousal as well as absolute levels of fos that were nearly 5 times higher than in the clinical cluster (i.e., clinical cluster with fos). this cluster accounted for 22% of the clinical sample and 2% of the overall sample. however, the average scores of fos in this cluster are slightly higher than those fear of sleep in trauma-related sleep disturbances 12 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ observed in other studies with diagnosed ptsd patients, whereas the average fos score in the other clinical cluster is significantly lower (see figure 1). this might indicate that, although the percentage of individuals with clinically-relevant ptsd symptoms is in line with the prevalence of ptsd in the general population, the overall symptom severity, and especially fos, is less pronounced in this online sample, with only a subgroup demonstrating fos values that are rather comparable to those observed in diagnosed clinical samples (kanady et al., 2018; pruiksma et al., 2014; short, allan, stentz, portero, & schmidt, 2018). although a clinical cut-off for the fosi-sf is currently lacking, a detailed assessment of various aspects of sleep disturbances, like fos (including whether the traumatic event took place in a sleep-related context and maladaptive sleep-interfering behaviors), could inform practitioners whether or not sleep and/or fos should also be targeted in treatment. furthermore, preliminary findings on the temporal links between fos and sleep disturbances have shown that increased fos during a baseline period predicted worse daily sleep quality during the following week in ptsd patients (short et al., 2018). in our sample, individuals in the clinical cluster with fos indicated that they experience fos once or twice per week (mean fosi-sf = 1.77), whereas individuals in the clinical cluster indicated that they never experience fos (mean fosi-sf = 0.37; scale 0 = not at all, 1 = a few times per month, 2 = once or twice per week, 3 = several times per week, 4 = every night). it is worth noting that in the fos subgroup, participants overwhelmingly indicated that they experienced the fear of loss of control and being vulnerable during sleep as often as several times per week or nearly every night. al‐ though losing control and feeling vulnerable are cognitive dysfunctional beliefs, they are also a form of anticipatory anxiety that goes along with enhanced arousal (davis, 2009). accordingly, our results show that pre-sleep somatic arousal, conceptualized as various physical sensations during the pre-sleep period (e.g., palpitations, breathlessness, sweating, or muscle tension), was also significantly enhanced in the fos subgroup (see figure 1). somatic pre-sleep arousal might reflect the physiological component that accompanies cognitive dysfunctional beliefs about safety during sleep. in contrast, cog‐ nitive arousal was conceptualized as more general rumination behaviors and worries about sleep disturbances as well as non-sleep-related problems and a feeling of mental activation in this study. cognitive arousal might therefore be more characteristic of individuals suffering only from insomnia, but not in the context of ptsd, where the feeling of safety is more important than the effect of non-restorative sleep (pigeon & gallegos, 2015). overall, enhanced fos might increase sleep disturbances due to increased somatic pre-sleep arousal on the one hand, and, on the other hand, through increased engagement in sleep-interfering maladaptive behaviors. completing this vicious cycle, there is considerable evidence supporting a perpetuating role of sleep disturbances for daytime ptsd symptomatology (short, allan, & schmidt, 2017). werner, danböck, metodiev, & kunze 13 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ trauma-focused treatments aim to differentiate between past experiences and the present situation in order to restructure dysfunctional posttraumatic cognitions with regard to safety and control (könig, resik, karl, & rosner, 2012). however, dysfunctional beliefs about safety during sleep are not part of standardized treatments. consequently, anticipatory anxiety together with somatic pre-sleep arousal and subsequent maladaptive behaviors might contribute to prolonged trauma-related sleep disturbances, even after remission of other ptsd symptoms (belleville et al., 2011). these are only theoretical considerations and research investigating the sensitivity of fos across trauma-focused treatment is yet to be conducted. though current sleep-focused treatments do not explic‐ itly target fos, promising findings have been reported recently. for example, studies using trauma-related nightmare treatments (e.g., errt) have reported reductions in fos from preto post-treatment as well as during the follow-up assessments, together with reductions in overall sleep disturbances and ptsd symptom severity (davis et al., 2011; davis & wright, 2007; pruiksma et al., 2018). it is assumed that these treatments target mastery (“i can deal with/manage the nightmares”), which might increase a more general sense of control (germain et al., 2004). thus, it seems plausible that trauma-related nightmare treatments, such as errt, might also affect fos. other approaches, like cbt-i, have also shown moderate reductions in fos after 8 weekly sessions with 29 individuals with ptsd and clinical insomnia (vs. 16 waitlist controls), although beliefs about the safety of the bed or bedroom were intentionally not targeted (kanady et al., 2018). given that reduced dysfunctional beliefs about sleep have been linked to better sleep in insomnia (morin, blais, & savard, 2002), specifically changing dysfunctional beliefs about one’s safety during sleep and the corresponding maladaptive behaviors (i.e., fos) might reduce trauma-related sleep disturbances. therefore, directly targeting fos in addition to trauma-focused and/ or sleep-focused treatment in individuals with high levels of fos might increase treatment response, especially with regard to trauma-related sleep disturbances. limitations some limitations must be considered when interpreting the current findings. first, al‐ though the lec-5 and specific items regarding the index traumatic experience were used to identify trauma-exposed individuals according to ptsd criterion a as defined in the dsm-5 (weathers et al., 2013), traumatic experiences and ptsd symptomatology were based solely on online self-report measures. second, this is the first study to classify individuals on the basis of fos, insomnia symptoms, nightmares, arousal, a self-report proxy for rem sleep fragmentation, and ptsd symptoms. although meaningful cluster solutions were found, we were not able to validate cluster stability and meaningfulness of cluster membership with an external criterion. therefore, it is essential to replicate and extend the present findings in diagnosed ptsd samples. for this purpose, we are currently collecting data in ptsd patients before trauma-focused treatment with fear of sleep in trauma-related sleep disturbances 14 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ a twofold aim: 1) to investigate whether the results of the current study also hold for clinically diagnosed ptsd samples and 2) to validate the meaningfulness of the identified subgroups by using treatment outcome as an external criterion. third, somatic pre-sleep arousal and sleep difficulties were only measured via self-report. especially in sleep research the use of self-reported versus objectively measured sleep is an often discussed topic. however, the subjective “sleep quality” experience seems to cover aspects that cannot be exhaustively captured via objective indices yet (see krystal & edinger, 2008, for a discussion on this topic). the diagnosis of insomnia disorder is currently only based on subjective complaints (e.g., harvey & spielman, 2011), therefore focusing on subjective indices in clinical studies is a common approach. fourth, the 3-item measure of nocturnal mentations, which was used as a self-report proxy for rem sleep fragmentation, showed low internal consistency and was the only variable that did not consistently differentiate between the healthy, subclinical, and clinical clusters. to increase the validity of this self-report proxy, future research should include physiological measures of arousal and rem sleep fragmentation. finally, medication and substance use as well as other sleep disturbances that might occur in ptsd (e.g., sleep apnea, parasomnias, and disruptive nocturnal behaviors) were not assessed. conclusion in sum, the data-driven, cluster-analytic approach used in this study clearly supports fos as an important characteristic and possible additional treatment target of trauma-re‐ lated sleep disturbances in individuals with ptsd. current standard trauma-focused and/ or sleep-focused treatments seem to only moderately reduce trauma-related sleep disturbances, and residual sleep symptoms often remain. the present data support the proposition that fos might offer an important construct involved in the development and maintenance of sleep disturbances after exposure to a traumatic event, at least in a subgroup of individuals suffering from ptsd. however, research about fos is still in its infancy and additional studies are needed to investigate whether directly targeting fos during treatment – particularly in ptsd subgroups with high fos scores – might enhance treatment efficacy. funding: the second author is supported by the doctoral college “imaging the mind” (fwf; w1233-b). competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors would like to thank margaret tyson and jona meyer for translating the english version of the fosi-sf questionnaire forward and backward, as well as keisuke takano for his statistical support. werner, danböck, metodiev, & kunze 15 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include the dendrogram of the hierarchical cluster analysis as well as the corresponding agglomeration schedule (for access see index of supplementary materials below): index of supplementary materials werner, g. g., danböck, s. k., metodiev, s., & kunze, a. e. 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(2017). effects of psychotherapies for posttraumatic stress disorder on sleep disturbances: results from a randomized clinical trial. behaviour research and therapy, 97, 75-85. https://doi.org/10.1016/j.brat.2017.07.001 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. fear of sleep in trauma-related sleep disturbances 20 clinical psychology in europe 2020, vol.2(2), article e2699 https://doi.org/10.32872/cpe.v2i2.2699 https://doi.org/10.1016/j.smrv.2015.01.008 https://doi.org/10.1016/j.smrv.2007.08.008 https://doi.org/10.1002/jts.20468 https://doi.org/10.5664/jcsm.28042 https://doi.org/10.1080/01621459.1963.10500845 https://doi.org/10.1073/pnas.1522520113 http://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp https://osf.io/vumh6/ https://doi.org/10.1016/j.brat.2017.07.001 https://www.psychopen.eu/ fear of sleep in trauma-related sleep disturbances (introduction) method sample and procedures measures statistical analyses results psychometric variables two-step cluster analysis hierarchical cluster analysis discussion limitations conclusion (additional information) funding competing interests acknowledgments supplementary materials references the field of psychotherapy: over 100 years old and still an infant science editorial the field of psychotherapy: over 100 years old and still an infant science marvin r. goldfried a [a] stony brook university, stony brook, ny, usa. clinical psychology in europe, 2020, vol. 2(1), article e2753, https://doi.org/10.32872/cpe.v2i1.2753 published (vor): 2020-03-31 corresponding author: marvin r. goldfried, department of psychology, stony brook university, psychology b building, stony brook, ny 11794-2500, usa. twitter: @goldfriedmarvin. e-mail: marvin.goldfried@stonybrook.edu keywords clinical trials, therapy alliance, clinical training, practice-research gap, psychotherapy integration, rdoc although the field of psychotherapy has been in existence for well over 100 years, we have not yet reached the point of becoming what sociologists of science have called a “mature” science. sociologists who study the evolution of different scientific enterprises have defined a mature field as one where there is not only the cutting edge–where new contributions are being made–but also an agreed-upon core or consensus. although there is often disagreement among those contributing to the cutting edge of a mature science, there nonetheless remains the agreed-upon core. in the field of psychotherapy, although there are clinicians and researchers who have been working at the cutting edge, what we lack is an agreed-upon core or consensus. in essence, even after more than 100 years, psychotherapy is still considered an infant science. one of my first experiences in recognizing the disjointed nature of psychotherapy occurred when i was in graduate school way back in the 1950s when i was traumatized by paul meehl over diner. as i have described elsewhere: meehl paid a visit to our program, delivered a colloquium, and spent some time with us graduate students. i was fortunate enough to be among a small group of students that went out to dinner with him. this was a rare treat, especially since i had read virtually everything meehl had written, and had enormous respect for his insights on research, practice, and the philosophy of science. indeed, he was my role model. at one point during the evening, someone asked him the question about the extent to which his clinical work was informed by research. without any hesitation, he replied, “not at all.” as someone who was this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2753&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ struggling to adopt the identity of scientist–practitioner, i left this memorable dinner disheartened. i don’t think i ever fully recovered. the challenge of how we could close the gap between research and practice has stayed with me all these years, and because i am attracted to challenges–my experiential colleagues would probably call it “unfinished business”–i have continued to be intrigued with the integration of research and practice. (goldfried, 2015, pp. 1086-1087). one can most assuredly forgive meehl for not making use of research in his clinical work; there was relatively little research on psychotherapy in the 1950s. however, the gap between research and practice continues to exist, even though there is now an extraordinary amount of research on psychotherapy. however, the researchers complain that the clinicians are not making use of their findings, and the clinicians are complain‐ ing that the researchers are not studying issues that are relevant to their therapeutic practices. and although there are many professionals in the field who are trying to close this gap, it nonetheless continues to exist. another most significant factor that prevents the field of psychotherapy from forming a core is that we think in terms of schools of therapy rather than basic processes or principles. that the field of psychotherapy is made up of so many different schools of therapy also means that these views compete with each other. although some therapists maintain that diversity is good, sociologists of science have characterized a field with competing schools of thought as being “immature.” there are several factors that motivate the development of competing schools. rela‐ tively little professional credit goes to those who simply repeat what has already been said in the past. after all, careers are made by making history, not knowing it. in the field of psychotherapy, there are also social, personal, and economic factors that operate as well. however, developing still another new school of therapy is working at the cutting edge, and does nothing to contribute to an agreed-upon core. in essence, the field of psychotherapy has been spinning its wheels by proliferating different approaches to therapy. we seem to be more interested in what is “new” than what is “old.” here again, what is new is at the cutting edge and therefore is more likely to be rewarded. when a new school of therapy is proposed, it often comes with its own set of theoretical jargon (e.g., “observing ego,” “metacognition,” “decentering,” “reflective functioning”). one of the unintended consequences of developing new terms for old phenomenon is that clinical and research contributions on a given topic may disappear by virtue of the fact that the keywords used to search the literature change. thus, to talk about “values” as an important phenomenon in therapeutic intervention can mask earlier work on encourag‐ ing patients to identify and express their needs. thus, a “new wave” of therapy that comes up with new terms for old phenomena may wash away relevant keywords, such as “assertiveness.” editorial 2 clinical psychology in europe 2020, vol.2(1), article e2753 https://doi.org/10.32872/cpe.v2i1.2753 https://www.psychopen.eu/ although i most certainly do not propose that i have the answer to how the field of psychotherapy might move forward, there nonetheless are directions i believe might be pursued (for further details please refer to goldfried, 2019). i have no doubt that one day the field of psychotherapy will develop an agreed-upon core or consensus, using a common language that facilitates communication to all. funding: the author has no funding to report. competing interests: the author has declared that no competing interests exist. acknowledgments: the author has no support to report. r e f e r e n c e s goldfried, m. r. (2015). a professional journey through life. journal of clinical psychology/in session, 71, 1083-1092. https://doi.org/10.1002/jclp.22218 goldfried, m. r. (2019). obtaining consensus in psychotherapy: what holds us back? the american psychologist, 74(4), 484-496. https://doi.org/10.1037/amp0000365 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. goldfried 3 clinical psychology in europe 2020, vol.2(1), article e2753 https://doi.org/10.32872/cpe.v2i1.2753 https://doi.org/10.1002/jclp.22218 https://doi.org/10.1037/amp0000365 https://www.psychopen.eu/ evidence of a media-induced nocebo response following a nationwide antidepressant drug switch research article evidence of a media-induced nocebo response following a nationwide antidepressant drug switch kate mackrill a, greg d. gamble b, debbie j. bean a, tim cundy b, keith j. petrie a [a] department of psychological medicine, university of auckland, auckland, new zealand. [b] department of medicine, university of auckland, auckland, new zealand. clinical psychology in europe, 2019, vol. 1(1), article e29642, https://doi.org/10.32872/cpe.v1i1.29642 received: 2018-09-10 • accepted: 2018-12-05 • published (vor): 2019-03-29 handling editor: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: keith j. petrie, psychological medicine, faculty of medical and health sciences, university of auckland, private bag 92019, auckland, new zealand. e-mail: kj.petrie@auckland.ac.nz abstract background: in 2017, patients on a generic or branded antidepressant venlafaxine were switched to a new generic formulation (enlafax). in february and april 2018, two major nz media outlets ran stories about the new generic being less effective and causing specific side effects. this study aimed to examine the effect of the media coverage on drug side effects reported to the national centre for adverse reactions monitoring (carm) and whether the specific symptoms reported in the media increased compared to side effects not reported in the media. method: we analysed monthly adverse reaction reports for enlafax to carm from october 2017 to june 2018 and compared adverse reports, complaints of decreased therapeutic effect and specific symptom reports before and after the media coverage using an interrupted time series analysis. results: we found the number of side effects and complaints of reduced therapeutic effect increased significantly following the media stories (interruption effect = 41.83, 95% ci [25.25, 58.41], p = .003; interruption effect = 15.49, 95% ci [7.01, 23.98], p = .012, respectively). the specific side effects mentioned in the media coverage, including suicidal thoughts, also increased significantly compared to other side effects not mentioned in the media. conclusions: in the context of a drug switch, media reports of side effects appear to cause a strong nocebo response by increasing both the overall rate of side effect reporting and an increase in the specific side effects mentioned in the media coverage, including reduced drug efficacy and heightened suicidal thoughts. keywords media, nocebo effect, venlafaxine, side effects, generic medicines this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.29642&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • the study provides further evidence that media coverage of side effects can induce a nocebo effect. • this is the first study to look at media coverage of an antidepressant brand switch. • the increase in reported adverse events was higher for those symptoms mentioned in the media reports. switches from branded to generic medicine formulations have become more frequent in recent times as health funders seek to reduce costs. these switches to generic medical and psychotropic medications have from time to time caused an increase in reported ad‐ verse events (desmarais, beauclair, & margolese, 2011; leclerc et al., 2017), and this is likely to be due to negative attitudes towards generic medicines rather than pharmaco‐ logical differences between the branded and generic versions of the medication (colgan et al., 2015). this phenomenon is known as the nocebo effect and research using inert medicines has shown that people report a reduced therapeutic effect and more side effects from a generic-labelled placebo compared to a branded placebo (faasse, martin, grey, gamble, & petrie, 2016). similarly, the process of switching from one placebo tablet to another is as‐ sociated with reports of side effects and reduced drug efficacy (faasse, cundy, gamble, & petrie, 2013). the nocebo effect can also occur in active medications and there is recent evidence that media coverage about drug side effects can create a nocebo response by highlighting negative reactions to a particular medication and prompting an increase in symptom complaints and drug discontinuation (faasse & petrie, 2013). in 2017, 45,000 new zealand patients prescribed the antidepressant venlafaxine were switched to a new funded generic (enlafax xr) from either the branded originator or a different generic version. in february 2018, two major print and online media outlets in new zealand ran stories on patients’ complaints that the new generic was less effective and causing an increase in various symptoms, including heightened suicidal thoughts. a few months later, another media report was released, again discussing patients’ reports of ineffectiveness and side effects from enlafax. based on previous research, we tested two hypotheses: firstly, that media coverage of the complaints following the venlafaxine switch would be associated with an increase in adverse drug reactions reported to the new zealand centre for adverse reactions monitoring (carm); and secondly, that the specific side effects reported in the media would increase compared to other side effects not reported in the coverage. media-induced nocebo response 2 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ m e t h o d newspaper articles on february 28 2018, two leading new zealand media outlets, the new zealand herald (nzme) and stuff (fairfax media), published newspaper and online articles on the venla‐ faxine brand switch. the new zealand herald ran a story titled “patients say generic pharmac-funded version of antidepressant venlafaxine left them depressed, anxious” (henry, 2018), while stuff’s article was titled “anti-depressant swap: sufferers claim ge‐ neric drug is harming their condition” (maude, 2018). these articles described the per‐ sonal experience of two patients when they switched from their original brand efexor to enlafax. the reports stated that the new, cheaper generic version was not as efficacious in managing the patients’ depression and they were also experiencing side effects. the new zealand herald article specifically mentioned that patients were reporting suicidal thoughts, nausea, fatigue, headaches and anxiety. in april, stuff released another online article, which continued on the subject of the previous media coverage. this media report, “fight over pharmac’s switch to generic an‐ ti-depressant brand continues” (steele, 2018), again stated that the new generic was not as effective and noted that various adverse events had been reported specifically head‐ aches, anxiety and suicidal thoughts. of the two websites, stuff is the most viewed with approximately 161,600 unique views per day, while the new zealand herald has 94,800 views (https://www.siteprice.org). neither of these stories suggested patients report side effects to their doctor or to carm. adverse drug reactions a report of all adverse reactions to venlafaxine was obtained from carm through med‐ safe, new zealand’s medicines monitoring agency. the carm database collects adverse reactions to medicines and vaccines, the majority of which are submitted by healthcare professionals. reporting is usually made online and carm reporting forms can be ac‐ cessed on the website https://nzphvc.otago.ac.nz. reports were obtained from october 2017 to july 2018 and included the month the report was received, the patients’ age and gender, and up to five symptoms attributed to the medicine. as the data was anonymous and publicly available, the study did not require ethical approval. measures the number of reports of decreased therapeutic response was calculated for each month. decreased therapeutic response is an adverse reaction category on the carm database equivalent to a reduced efficacy of the medicine. mackrill, gamble, bean et al. 3 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.siteprice.org https://nzphvc.otago.ac.nz https://www.psychopen.eu/ the total number of side effects reported each month was also calculated as was the number of times the five specific side effects mentioned in the new zealand herald arti‐ cle were reported. the side effects were matched to the corresponding adverse reactions in the carm database with headaches, nausea and anxiety being matched exactly. two of the media-mentioned side effects were considered broad enough to cover a range of carm adverse reactions. as such, reports of fatigue, lethargy and tiredness were grou‐ ped under the broader side effect of fatigue, while suicidal thoughts were matched with reports of suicidal tendencies, suicidal ideation and impulses to self-harm. the five most common adverse reactions not mentioned in the media reports were identified from the carm database and used as control symptoms. these were dizziness, drug withdrawal syndrome, irritability, sleep disturbance and a fuzzy head. statistical analyses interrupted time series analyses were conducted to investigate whether the february and april media reports on the venlafaxine brand switch were associated with an increase in the carm reporting of decreased therapeutic response, total number of side effects and the specifically mentioned side effects in the months directly after the media reports compared to the five months before. an autoregressive integrated moving average (ari‐ ma) model with an autoregression term of 1 and moving average term of 1 was used for all analyses. as the three media reports were a one-off interruption to the normal time series, a binary independent variable was created to indicate their presence by month. march and may were given the value of 1 as these were the periods directly after the feb‐ ruary and april media reports and all other months were coded 0. the analysis produces an estimated interruption effect, which is the change in the rate of adverse event report‐ ing from the months coded 0 and 1, and indicates whether this change is significantly different. this is a more conservative analysis as the adverse event reports in march and may are averaged together to calculate the general effect of the three media stories rather than both months being compared separately to the pre-media rate. analyses were con‐ ducted in sas (v9.4 sas institute inc., cary, nc) using the sas proc arima procedure. an alpha level of .05 was considered significant. r e s u l t s in total, there were 100 adverse event reports from october 2017 to july 2018. the aver‐ age age of reporters was 43.7 years old and 70.0% were female. in the five months prior to the first newspaper articles, the average number of adverse event reports to carm was 6.00 (sd = 1.23) per month. in march and may, the two months directly after the release of the articles, the average number of carm reports significantly increased to 25.50 media-induced nocebo response 4 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ (sd = 12.02; interruption effect i.e. difference between the pre-media average and march + may average = 19.45, 95% confidence interval (ci) [10.77, 28.13], p = .005). the newspaper articles also had a significant effect on side effect reporting with the pre-media average of 7.00 reports (sd = 4.18) a month increasing to 49.00 (sd = 26.63) in march and may, see figure 1. similarly, the rate of decreased therapeutic response re‐ porting significantly increased from 4.00 (sd = 2.12) during the previous months to an average of 17.00 (sd = 9.90) over march and may. the interruption effect of the media on side effect reporting = 41.83, 95% ci [25.25, 58.41], p = .003. interruption effect for de‐ creased therapeutic response reports = 15.49, 95% ci [7.01, 23.98], p = .012. figure 1. number of reports of side effects and decreased therapeutic response before and after the media reports. mackrill, gamble, bean et al. 5 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ a further analysis investigated whether the reports to carm of the specific side effects mentioned in the february new zealand herald article increased in march and may com‐ pared to the five previous months. figure 2 shows the rate of reporting for the mediamentioned side effects and table 1 shows the interruption effects and corresponding p values. figure 2. numbers before and after media reports for the specific side effects reported in the media and control symptoms not in media reports. media-induced nocebo response 6 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ prior to the media coverage, suicidal thoughts were reported an average of 0.40 times (sd = 0.55) per month but following the media report this significantly increased to 7.00 (sd = 1.41) across march and may. there were no adverse event reports of nausea before the media coverage, but reporting significantly increased to 2.00 (sd = 1.41) during the post-media months. the average rate of reporting per month of headache was 0.60 (sd = 0.55) before the media focus, which significantly increased to 4.00 (sd = 2.83) reports in march and may. fatigue was reported 0.80 times (sd = 1.10) over the five pre-media months but this did not change significantly after the media coverage (m = 4.00, sd = 4.24). similarly, the reporting of anxiety did not change, going from an average of 0.40 (sd = 0.89) before the media coverage to 1.00 (sd = 1.41) after the focus. the side effects most frequently reported to carm that were not mentioned in the newspaper article were investigated to determine the effect on other adverse events. diz‐ ziness, sleep disturbance, irritability and fuzzy head were all reported an average of 0.20 times (sd = 0.45) per month before the media focus. following the coverage, there was a significant increase in the reporting of dizziness (m = 3.00, sd = 1.41) and sleep disturb‐ ance (m = 1.00, sd = 1.41). there was no change in the post-media rate of reporting for irritability and fuzzy head (both m = 1.00, sd = 1.41). before the media articles, drug withdrawal syndrome was reported an average of 0.40 times (sd = 0.55) a month, which did not change after the media coverage (m = 2.00, sd = 0). table 1 estimated interruption effects of the newspaper articles on carm reports for specifically mentioned side effects and control side effects variable interruption effect 95% ci p side effects mentioned in article suicidal thoughts 6.64 [4.60, 8.68] < .001 nausea 1.95 [0.62, 3.28] .029 fatigue 1.63 [-1.45, 4.71] .339 headache 3.62 [1.05, 6.19] .034 anxiety 0.39 [-2.34, 3.11] .791 side effects not mentioned in article dizziness 2.70 [1.72, 4.60] .002 drug withdrawal syndrome 2.96 [0.53, 5.39] .055 sleep disturbance 0.75 [0.20, 1.30] .036 irritability 0.50 [-0.91, 1.91] .507 fuzzy head 0.88 [-0.30, 2.06] .190 mackrill, gamble, bean et al. 7 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ d i s c u s s i o n main findings this study found that reports by the two largest new zealand media outlets highlighting the side effects and lack of efficacy of a new generic antidepressant were followed by a significant increase in reports to carm of similar side effects. the increase in reported adverse events was largely limited to those mentioned in the media reports. while two of the control symptoms, dizziness and sleep disturbance, did also increase, this was at a lower rate than the symptoms mentioned in the media stories. the results are consistent with a nocebo response driven by the media coverage, whereby patients’ expectations of particular side effects result in an increase in those specific symptoms. a pharmacologi‐ cal explanation for this effect is very unlikely as the side effects highlighted in the media stories and the control side effects were mentioned at a similar rate prior to the media coverage. following the media coverage, it was those symptoms mentioned in the media stories that were mostly affected. a particular concern in the findings is the mirroring of reports of decreased therapeu‐ tic efficacy, which could potentially drive non-persistence with antidepressant therapy. also of public health relevance is the increase in reports of suicidal ideation which is likely due to the highlighting of suicidal thoughts and behaviour by patients discussed in the media stories in february and again in april. comparison with other studies previous studies have shown that information about likely side effects from medication can result in a significant increase in reports of those specific effects. patients who were told about sexual side effects when starting finasteride or beta-blocker medication were significantly more likely to report these symptoms than patients who were not told of these side effects (cocco, 2009; mondaini et al., 2007). similarly, in the context of a clini‐ cal trial, those patients warned of gastrointestinal side effects in one research site were more likely to complain of this as a side effect and withdraw from the study due to these complaints (myers, cairns, & singer, 1987). seeing another person in a media story report side effects from a medication can also increase the expectations of a similar response (faasse & petrie, 2016). in an earlier study by our group, media reporting on a change in the formulation and appearance of thyro‐ xine replacement therapy that led to a dramatic increase in adverse reaction reports (faasse, cundy, & petrie, 2009), found side effect complaints increased significantly after television news stories. the largest increases concerned symptoms mentioned in the me‐ dia reports. this was strongest for the initial coverage and weakened with successive sto‐ ries (faasse, gamble, cundy, & petrie, 2012). this occurred in the current study, as the may adverse event reporting was not as large as in march. research on side effects from media-induced nocebo response 8 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ electromagnetic fields has also shown that alarmist media reports, which emphasise ad‐ verse effects, exacerbate the nocebo effect and lead to greater symptom reporting and a perceived sensitivity to the supposedly harmful substance (verrender, loughran, dalecki, freudenstein, & croft, 2018; witthöft & rubin, 2013). switches to generic medicine provide potential for a nocebo response to be strongly influenced by negative media coverage as non-adherence, patient reports of decreased ef‐ ficacy and increased side effects are more common following switches (boone et al., 2018; weissenfeld, stock, lüngen, & gerber, 2010). a nocebo response induced through media reports can have a detrimental effect. recent work has shown that negative stories in the media about statins have led to an increase in the rate of patients discontinuing statins in the united kingdom (matthews et al., 2016) and this early discontinuation has been linked to an increase in myocardial infarction and death from cardiovascular disease in denmark (nielsen & nordestgaard, 2016). the likely mechanisms of the nocebo response found in this study are social trans‐ mission and the misattribution of common symptoms to the effects of the new medica‐ tion (petrie & rief, 2019). previous research has found that seeing another person report side effects after receiving a treatment increases the likelihood of side effects’ complaints after receiving the same treatment, especially if the observer can empathise with the per‐ son reporting the side effects (faasse, parkes, kearney, & petrie, 2018). studies have also found that individuals with higher levels of psychological distress also report a greater number of physical symptoms (watson & pennebaker, 1989). this is likely to be of more relevance in this group of patients taking an antidepressant and thus allowing more symptoms to be misattributed to the effects of the new generic medicine. while generic switches are now commonplace in new zealand, a recent general population survey found 38% still preferred taking branded medication compared to a generic or no prefer‐ ence (kleinstäuber, mackrill, & petrie, 2018). following a switch to a generic medicine more side effects are reported by patients who are older, female and by those who have been on their previous branded medicine longer (mackrill & petrie, 2018). strengths and limitations while this study drew on adverse reports to a national database, it is likely that the rates are a substantively low estimate of the true effect of the nocebo effect caused by the me‐ dia coverage. studies estimate that reports to a national adverse database represent less than 10% of detected adverse drug reactions (mcgettigan, golden, conroy, arthur, & feely, 1997; smith et al., 1996). it is further likely that many patients would not have sought medical assistance for symptoms due to the perception that there was little that could be done by their gp. the study is limited by the non-experimental design and restricted in outcomes to the specific side effect categories recorded by carm. as such, it is possible that patients may have experienced other side effects that the carm database does not measure. although mackrill, gamble, bean et al. 9 clinical psychology in europe 2019, vol.1(1), article e29642 https://doi.org/10.32872/cpe.v1i1.29642 https://www.psychopen.eu/ patients can make direct reports using online forms this makes up only a small percent‐ age of carm reports. the behavioural outcomes of the adverse event reporting are also unknown. it is not known whether there was an increase in suicidal behaviour following the stories or whether patients stopped venlafaxine or changed to another medication. in conclusion, we found media coverage of reports of a lack of efficacy and side ef‐ fects following a switch to a generic version of venlafaxine were likely responsible for an increase in similar reports to a national centre for adverse drug reactions. of particular concern is how media reports of increases in suicidal thoughts and loss of drug efficacy following a drug switch can be readily converted in similar complaints across the wider community. more research is also required on how such media reports are associated with increases in non-adherence and non-persistence with medication, as well as possible increases in suicidal behaviour. future work may also be needed to develop guidelines for media reporting on generic switches with a view to avoiding these adverse outcomes. funding: the authors have no funding to report. competing interests: km, gg, db, tc declare no conflicts of interest. kp has received research grants in the past from pharmac, the new zealand government’s pharmaceutical management agency. acknowledgments: the authors have no support to report. r e f e r e n c e s boone, n. w., liu, l., romberg-camps, m. j., duijsens, l., houwen, c., van der kuy, p. h. m., . . . van bodegraven, a. a. 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(2013). are media warnings about the adverse health effects of modern life self-fulfilling? an experimental study on idiopathic environmental intolerance attributed to electromagnetic fields (iei-emf). journal of psychosomatic research, 74(3), 206-212. https://doi.org/10.1016/j.jpsychores.2012.12.002 media-induced nocebo response 12 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org https://doi.org/10.1111/j.1743-6109.2007.00563.x https://doi.org/10.1038/clpt.1987.142 https://doi.org/10.1093/eurheartj/ehv641 https://doi.org/10.1146/annurev-psych-010418-102907 https://doi.org/10.1111/j.1365-2125.1996.tb00004.x https://www.stuff.co.nz https://doi.org/10.1016/j.envres.2018.06.032 https://doi.org/10.1037/0033-295x.96.2.234 https://doi.org/10.1016/j.jpsychores.2012.12.002 https://www.leibniz-psychology.org/ https://www.psychopen.eu/ media-induced nocebo response (introduction) method newspaper articles adverse drug reactions measures statistical analyses results discussion main findings comparison with other studies strengths and limitations (additional information) funding competing interests acknowledgments references psychological processes associated with resilience in uk-based unpaid caregivers during the covid-19 pandemic research articles psychological processes associated with resilience in uk-based unpaid caregivers during the covid-19 pandemic emma wilson 1,2,3 , juliana onwumere 1,4 , colette hirsch 1,4 [1] department of psychology, institute of psychiatry, psychology and neuroscience, king’s college london, london, united kingdom. [2] health service and population research, institute of psychiatry, psychology and neuroscience, king’s college london, london, united kingdom. [3] esrc centre for society and mental health, king’s college london, london, united kingdom. [4] south london and maudsley nhs foundation trust, london, united kingdom. clinical psychology in europe, 2022, vol. 4(4), article e10313, https://doi.org/10.32872/cpe.10313 received: 2022-09-17 • accepted: 2022-11-02 • published (vor): 2022-12-22 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: colette hirsch, department of psychology, institute of psychiatry, psychology and neuroscience, king’s college london, de crespigny park, london se5 8af, uk. phone: +44 207 848 0697. e-mail: colette.hirsch@kcl.ac.uk supplementary materials: materials [see index of supplementary materials] abstract background: unpaid caregivers have faced and dealt with additional challenges during the covid-19 pandemic. understanding the psychological processes associated with their resilience is warranted. the objective of this study was to examine the associations between resilience with mental distress, emotion regulation strategies (i.e., reappraisal and suppression) and interpretation bias in adult caregivers. method: participants were living in the uk, aged 18+, and consisted of 182 unpaid caregivers of an adult aged 18+ living with a long-term health condition, and 120 non-caregivers. data were collected in an online study during the first national uk covid-19 lockdown (may and september 2020). hierarchical multiple regression analyses explored whether emotion regulation strategies and interpretation bias explained unique variance in levels of resilience in caregivers whilst controlling for anxiety and depression. results: compared to non-caregivers, caregivers reported higher levels of anxiety, depression, negative interpretation bias and lower levels of resilience. emotion regulation strategies did not differ between groups. within caregivers, greater resilience was associated with lower mood disturbance, a positive interpretation bias, and greater use of cognitive reappraisal and lower use of this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10313&domain=pdf&date_stamp=2022-12-22 https://orcid.org/0000-0003-4413-8338 https://orcid.org/0000-0001-7119-7451 https://orcid.org/0000-0003-3579-2418 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ suppression strategies to regulate emotions. emotion regulation and interpretation bias together predicted an additional 15% of variance in current levels of resilience. conclusion: our findings indicate that psychological mechanisms such as emotion regulation strategies, particularly reappraisal, and interpretation bias are associated with resilience in caregivers. although preliminary, our findings speak to exciting clinical possibilities that could form the target of interventions to improve resilience and lower mental distress in unpaid caregivers. keywords resilience, interpretation bias, emotion regulation, informal carers, unpaid caregivers, covid-19 highlights • negative interpretation bias, alongside use of emotional regulation strategies (i.e., suppression; reappraisal), and their association with resilience was investigated in unpaid caregivers for the first time. • caregivers report lower levels of resilience and higher levels of anxiety and depression compared to non-caregivers during the covid-19 pandemic. • the tendency to interpret information in more positive ways, and to use reappraisal as a way to regulate emotions, were associated with greater resilience in caregivers. • interpretation bias and reappraisal could form the target of future caregiver tailored interventions to improve resilience. data suggests the united kingdom (uk) is facing an increase in negative mental health outcomes due to the impact of the covid-19 pandemic (li & wang, 2020). unpaid caregivers (also called informal carers, herein ‘caregivers’) have been defined as ‘anyone, including children and adults who looks after a family member, partner or friend who needs help because of their illness, frailty, disability, a mental health problem or an addiction and cannot cope without their support’ (nhs england, 2014). pre-pandemic, caregivers represented around 7% of the uk population (department for work and pensions, 2020) and carers uk (2020) has suggested that numbers doubled from 6.5 million to 13.6 million during the covid-19 pandemic. compared to the general popula­ tion and pre-pandemic, caregivers were at greater risk of anxiety and depression and poorer health outcomes (smith et al., 2014). this is observable across different illness groups; for example, when caring for someone with dementia (papadopoulos et al., 2019), cancer (leseure & chongkham-ang, 2015), multiple sclerosis (mckeown et al., 2003), and a mental health condition (young et al., 2019). on 23rd march 2020, the uk government introduced a nationwide lockdown with measures aimed to restrict transmission of the virus and mitigate pressure on the nation­ al health service (nhs). measures included staying at home with few exceptions (e.g., essential purposes), working from home unless designated a ‘key worker’ and always resilience and distress in unpaid caregivers during covid-19 2 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ maintaining social distancing rules. people in at-risk groups were asked to ‘shield’ by remaining indoors. caregivers had to navigate the changes to their own routine and con­ sider their own pre-existing health conditions and life situation (onwumere, 2021; vahia et al., 2020). hence, in a group already at a heightened risk of social isolation (hayes et al., 2015) and lower life satisfaction compared to non-caregivers (naef et al., 2017), distress was exacerbated by social distancing rules and inability to access support from friends and family or formal services in their caring role (baker & clark, 2020; whitley et al., 2021). understanding how the psychological wellbeing of caregivers, relative to their non-caregiver peers, was impacted during the pandemic and the key mechanisms driving their presentations is an important step in informing future targeted interventions. however, these types of investigations have been limited. nevertheless, emerging data suggests reduced psychological wellbeing (e.g., heightened anxiety/depressive symptoms, stress/distress related to caregiving, care burden) among family caregivers (gallagher & wetherell, 2020; muldrew et al., 2022), although the psychological mechanisms driving these mood states remain less researched in the literature. one psychological factor associated with better psychological functioning (i.e., posi­ tive adaptation) is resilience (luthar et al., 2015; seery et al., 2010), commonly defined as the ability to bounce back from adversity (rutter, 1985, 1987; southwick et al., 2015). this psychological process can fluctuate over time and across contexts, so one person may be resilient to certain adversities but not others (egeland et al., 1993; pooley & cohen, 2010). windle and bennett’s (2012) theoretical resilience framework for caregivers also highlights how resilience is influenced by interactions in the environment and draws on social resources. restricted access to important resources in health and social care during periods of lockdown, combined with the threat from the virus to the most vulner­ able, may have impacted caregivers in particular, threatening their capacity to remain resilient. identifying factors that may foster lower levels of distress and higher levels of resilience in caregivers during times of extra stress, such as a pandemic, could help us identify those who are likely to need extra support and better tailor future interventions; particularly when resources are limited (rapado-castro & arango, 2021). resilience is associated with higher quality of life, better regulation of emotions, more positive emotions, and less perceived stress, anxiety and depression (balmer et al., 2014; troy & mauss, 2011). in caregivers, reduced mood disturbance (e.g., lower levels of anxiety and depression) is recorded in those reporting higher levels of resilience (simpson et al., 2015). moreover, systematic review data suggests that higher resilience levels are linked to reductions in the risk of stress and care burden and supports greater role adaptation (palacio gonzález et al., 2020). to determine whether caregiver and non-caregiver populations in the uk differed in levels of resilience during early stages (first 3 months) of a global pandemic, data were collected using a widely used, multidi­ mensional self-report measure of resilience with good psychometric properties (connor & davidson, 2003; pangallo et al., 2015). wilson, onwumere, & hirsch 3 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ given the potential importance of resilience to caregiver wellbeing and outcomes, it would seem important to also identify modifiable psychological mechanisms that can foster resilience, such as emotion regulation approaches (palacio gonzález et al., 2020). common approaches include cognitive reappraisal (occurs before an emotion is experienced; seeking alternative perspectives in situations that may change the emotion­ al response) and suppression (purposively attempting to suppress expressive behaviour while emotionally aroused, such as trying not to display anger or annoyance; gross, 1998; gross, 2014; gross & levenson, 1993). reappraisal is seen as an opportunity to grow in times of adversity by reducing maladaptive appraisals (e.g., self-blame), whereas suppression involves the avoidance of expressing one’s feelings and may lead to negative outcomes (gross & john, 2003; john & gross, 2004). the links between emotional regu­ lation and resilience are yet to be explored despite a hypothesised relevance between two concepts that are arguably connected (kay, 2016). the limited work in this area has suggested that high levels of cognitive reappraisal may serve as a protective factor that fosters resilience after adverse situations (polizzi & lynn, 2021; troy & mauss; 2011), while expressive suppression may have a negative effect on resilience (hong et al., 2018; mouatsou & koutra, 2021). another psychological mechanism that might potentially expand our understanding of resilience in caregivers is interpretation bias, which is the tendency to draw negative conclusions from ambiguous information (hirsch et al., 2016). there is already data to suggest that lower levels of interpretation bias are linked to greater resilience in groups such as women living beyond breast cancer (booth et al., 2022; gordon et al., 2022) and in adolescents (booth et al., 2022). such findings support a cognitive model of psychological resilience (booth et al., 2022), whereby interpretation bias influences levels of resilience and is a key mechanism for maintaining internalising disorders such as mood conditions. moreover, interpretation biases may interfere with certain protective emotion regulation strategies (e.g., reappraisal), impacting the regulation of negative affect (joormann & siemer, 2011). it was therefore anticipated that cognitive reappraisal would be associated with interpretation bias, and suppression associated with more negative interpretation biases of ambiguous situations. given the challenges faced by unpaid caregivers, it is important to explore the relevance to their wellbeing of these potentially modifiable psy­ chological mechanisms and by doing so, potentially inform the development of targeted and care focused support interventions. study aims first, we sought to examine caregivers reports of depression, anxiety and resilience, alongside their levels of negative interpretations and compare these to non-caregiver populations. second, we wanted to assess whether more negative interpretations and suppression of emotions, as well as less use of reappraisal, are associated with, and resilience and distress in unpaid caregivers during covid-19 4 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ help predict, resilience levels in uk caregivers between may to september 2020 of the covid-19 pandemic. hypothesis 1 caregivers compared to non-caregivers will have lower levels of resilience, and higher levels of anxiety and depression. exploratory analysis will see if negative interpretation bias, emotion regulation (reappraisal and suppression) varies between caregivers and non-caregivers. hypothesis 2 within the caregiver population, greater resilience will be associated with lower levels of negative interpretation bias and expressive suppression, and greater use of cognitive reappraisal. hypothesis 3 within the caregiver population, emotion regulation and interpretation bias will contrib­ ute extra and unique variance in levels of resilience in a model which controls for factors known to be associated with resilience – anxiety and depression. m e t h o d participants participants were aged 18+ and living in the uk. we recruited 182 caregivers and 120 non-caregivers. caregivers could participate if they were not in a paid caring role (except for any state benefits/financial support for carers), had been in a caring role for 6 months or more, for someone aged 18+ who has a long-term condition commonly asso­ ciated with caregiving (i.e., dementia, cancer, multiple sclerosis, and any mental health condition). participants were recruited through social media, online message boards, charities (e.g., webpages or newsletters), the join dementia research forum and call for participants. materials and measures demographic questions participants completed several demographic questions regarding age, ethnicity, gender, employment status and relationship status. questions were completed about their experi­ ence of the pandemic, including whether they believed they had had covid-19, were currently self-isolating/quarantining (i.e., not leaving the house or having visitors), and wilson, onwumere, & hirsch 5 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ whether they were a paid keyworker (i.e., paid workers in certain key sectors defined as critical to the covid-19 response; department for education, 2021). caregivers were asked additional questions about the people they provide care for (i.e., number they care for, their relationship to them, their condition). if caregivers selec­ ted more than one medical condition, caregivers were asked to stipulate whether it was the primary condition of the person they care for. for caregivers caring for more than one person, they were asked to respond in relation to the person they currently spent most time caring for. questions covered specific diagnosis, gender, age, employment status of the person cared for, estimated number of hours spent in this caregiving role per week, whether they live together and duration of their caring role. caregivers were also asked if they had people to confide in and if so, how many. see supplementary materials 1 for full list of questions. questionnaire measures connor-davidson resilience scale (cd-risc) — this 25-item questionnaire (connor & davidson, 2003) measures resilience over the past month on a 5-point likert scale (1 = not at all to 5 = true nearly all the time). total scores range from 0 – 100 with higher scores reflecting greater resilience. example item: ‘i tend to bounce back after illness, injury, or other hardships’. the cd-risc has demonstrated high internal consistency in previous studies with caregivers of older adults (α = .94; ong et al., 2018), people with dementia (α = .89; ruisoto et al., 2020), and severe mental illness (α = .93; mulud & mccarthy, 2017). present sample cronbach’s α = .91. generalized anxiety disorder 7 (gad-7) — this 7-item questionnaire (spitzer et al., 2006) measures symptoms of anxiety over the past 2 weeks and asks participants ‘how often have you been bothered by the following problems?’ on a 4-point likert scale (1 = not at all to 4 = never). a sum score is calculated, and scores assigned to the following categories of anxiety: minimal (< 4), mild (5-9), moderate (10-14), severe (15-21). example item: ‘worrying too much about different things’. the gad-7 has been found to have high/good internal reliability in the general population (löwe et al., 2008) and in carers (α = .93; lappalainen et al., 2021). present sample cronbach’s α = .91. patient health questionnaire 9 (phq-9) — this 9-item questionnaire (kroenke & spitzer, 2002) measures symptoms of depression over the past 2 weeks and asks partic­ ipants ‘how often have you been bothered by the following problems?’ on a 4-point likert scale (1 = not at all to 4 = never). the sum of scores indicates the following depression severities: none (<4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). example item: ‘little interest or pleasure in doing things’. the phq-9 has been found to be a valid and reliable measure of depression (kroenke et al., 2001) and resilience and distress in unpaid caregivers during covid-19 6 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ is widely used in caregiver studies (kishita et al., 2020; ping pang et al., 2020). present sample cronbach’s α = .91. emotion regulation questionnaire (erq) — this 10-item questionnaire (gross & john, 2003) measures how individuals use two emotional regulation strategies in daily life: cognitive reappraisal and expressive suppression. the reappraisal scale contains six items (e.g., ‘when i’m faced with a stressful situation, i make myself think about it in a way that helps me stay calm’) and suppression contains four items (e.g., ‘i control my emotions by not expressing them’), using 7-point likert scales (1 = strongly disagree to 7 = strongly agree). the score for each subscale is the mean of the items (range 1 – 7) and the erq has been used in carer populations (α range from .67 to .84; aerts et al., 2019; lamothe et al., 2018). present sample cronbach’s α = .74. interpretation bias task scrambled sentences test (sst) — adapted from wenzlaff and bates (1998, 2000) and used in hirsch et al. (2020); in 20 trials, participants select 5 words from 6 randomly presented words to form a grammatically correct sentence. potential completions are positive or negative interpretations of self-referent statements. the task is completed over five minutes while holding a six-digit string in mind. the digit string has been used previously to add a cognitive load, allowing latent biases to be observed and limit participants from guessing the purpose of the sentence scrambling task, reducing the risk of answers being subject to demand characteristics such as social desirability (krahé et al., 2022; schoth & liossi, 2017). an interpretation bias score is created by dividing the number of grammatically correct positively unscrambled sentences by the number of correct negatively unscrambled sentences. index scores range from 0 to 1, with higher scores denoting a more positive interpretation bias. procedure the survey was hosted on qualtrics with all data collected between may and september 2020, between the middle of the first covid-19 lockdown and the start of the uk home nations gradually reopening. both caregiver and non-caregiver groups completed the same core survey (questionnaires, sst), and caregivers completed additional demo­ graphic questions about the person(s) they care for. the survey took 35 – 50 minutes to complete and participants could enter a prize draw for amazon vouchers: 1 of 20 £10 prizes, 1 of 2 £50 prizes, or 1 of 2 £100 prizes. the study was approved by the king’s college london research ethics committee (approval number: hr-19/20-14617) and participants provided consent and data electronically. wilson, onwumere, & hirsch 7 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ statistical analysis bivariate descriptive statistics were used to describe sample characteristics and summa­ rise scores of study measures. continuous variables were expressed as means (standard deviation, sd). two-tailed t-tests for continuous variables (e.g., age) and chi-squared tests for categorical variables (e.g., gender) were used to test for group differences in sociodemographic factors and study variables (h1). effect sizes were calculated using cohen’s d for t-tests, and phi and cramer’s v for chi-squared tests. associations between study variables in caregivers were quantified using pearson’s correlation coefficient (h2). in the caregiver sample, a hierarchical regression tested the hypothesis that emotion regulation strategies (i.e., reappraisal and suppression) and interpretation bias would contribute significant variance, beyond anxiety and depression, in predicting levels of resilience (h3). anxiety and depression were entered as independent variables in the model’s first step. emotion regulation and interpretation bias were entered into the second step as independent variables. resilience was the outcome variable. statistical significance was set at p < .05. spss versions 26 and 27 were used to conduct all analyses. r e s u l t s see table 1 for participant demographics and table 2 for characteristics of the individuals that caregivers were caring for and their caregiving role. participants were predominant­ ly women and white british, with a higher proportion in the caregiver group. the higher rates of women as caregivers is similar to levels reported in the literature (tur-sinai et al., 2020). other demographic characteristics were well-matched. caregivers most often cared for someone with dementia (66%) and lived with the person they cared for (61%). mental health conditions included depression (n = 8), anxiety (n = 4), psychosis/schizo­ phrenia, (n = 3), ptsd (n = 2), bipolar disorder (n = 2), personality disorder (n = 2), eating disorder (n = 2), ocd (n = 1), other/multiple conditions including autism and learning difficulties (n = 12), not reported (n = 8). several post hoc power analyses were conducted to test for the power of the analyses conducted for each of our hypotheses (e.g., t-test, correlation, multiple regression). ex­ cept for two t-tests with small effect sizes (i.e., erq-r, erq-s; see table 3), the minimum power achieved for all analyses was .82. resilience and distress in unpaid caregivers during covid-19 8 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ table 1 demographic characteristics baseline characteristic caregiver sample (n = 182) non-caregiver sample (n = 120) statistical test, significance value and effect sizen (%) n (%) age – m (sd)a 56.36 (13.48) 53.76 (17.65) t (207.98) = 1.37, p = .172, d = .166 ethnicity non-white british vs. white british, χ2(1) = 7.64, p = .006, φ = -.159 arab – 1 (0.8) bangladeshi 1 (0.5) – black british 3 (1.6) – chinese 1 (0.5) 1 (0.8) indian 3 (1.6) 1 (0.8) pakistani 1 (0.5) – other 1 (0.5) 22 (18.3) white and asian 1 (0.5) 1 (0.8) white and black caribbean 1 (0.5) 1 (0.8) white british 159 (87.4) 90 (75.0) white gypsy or irish traveller 1 (0.5) – white irish 5 (2.7) 3 (2.5) genderb χ2 (1) = 12.19, p = .001, φ = .201 woman 155 (85.2) 82 (68.3) man 26 (14.3) 37 (30.8) employment status χ2 (3) = 1.68, p = .641, v = .075 full-time employment 25 (13.7) 23 (19.2) part-time employment 34 (18.7) 22 (18.3) retired 62 (34.1) 39 (32.5) other 61 (33.5) 36 (30.0) relationship status χ2 (3) = 11.15, p = .011, v = .192 married/ domestic partnership 108 (59.3) 49 (40.8) cohabiting 23 (12.6) 18 (15.0) single 26 (14.3) 31 (25.8) separated, divorced, widowed 25 (13.7) 22 (18.3) covid-19 questions caregiver has had covid-19c 25 (13.7) 19 (15.8) χ2 (1) = 0.96, p = .327, φ = -.063 self-isolating/ in quarantinede 20 (11.0) 18 (15.1) χ2 (2) = 2.59, p =.274, v = .093 considered a ‘key worker’fg 36 (19.8) 22 (18.3) χ2 (1) = .08, p = .781, φ = .016 adeclined to say: n = 1. bother: n = 2. crespondents asked: n = 245. ddeclined to say: n = 1. eby self-isolating/ in quarantine we mean not leaving the house for any reason and avoiding contact with anyone outside the household. fdeclined to say: n = 1. ga ‘key worker’ was defined as someone who worked in: health and social care, education and childcare, key public services, local and national government, food and other necessary goods, public safety and national security, transport, utilities, communication and financial services. phi (φ) and v (v) are measures of effect size for chi-square tests. wilson, onwumere, & hirsch 9 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ table 2 characteristics of the person/people caregivers cared for and the caregiving role characteristics participants (n = 182) number they care for, mean (sd) 1.25 (0.62) primary condition, n (%)a dementia 120 (65.9) multiple sclerosis 8 (4.4) cancer 10 (5.5) mental health condition 44 (24.2) relationship, n (%) spouse/partner 66 (36.3) son/daughter 62 (34.1) parents 34 (18.7) other relative/friend/neighbour 20 (11.0) hours per week in caregiving role, n (%) 0 – 19 60 (33.0) 20 – 49 49 (26.9) 50 – 90 24 (13.2) over 100 49 (26.9) duration of caregiving role, n (%) under 12 months 18 (9.9) 1 – 5 years 75 (41.2) 5 – 10 years 45 (24.7) over 10 years 44 (24.2) live with person cared for, n (%) yes 111 (61.0) no 71 (39.0) has someone to confide in, n (%) 136 (74.7) number of confidents, mean (sd) 3.32 (2.51) aif more than one condition listed, participant asked to provide primary condition of person they care for. do caregivers exhibit lower levels of resilience and higher levels of distress than non-caregivers and is interpretation bias more negative in caregivers? the mean scores for all questionnaires are presented in table 3. in keeping with hy­ pothesis 1, caregivers demonstrated lower levels of resilience, higher levels of anxiety, depression and interpretation bias with small to medium effect sizes (d = 0.36 to 0.74). exploratory analysis found that emotion regulation techniques did not differ significant­ ly between groups. resilience and distress in unpaid caregivers during covid-19 10 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ table 3 scores for questionnaires and interpretation bias measure, by group measures caregiver group (n = 182) non-caregiver group (n = 120) t-test and significance valuem (sd) m (sd) questionnaire resilience (cd-risc) 62.21 (13.86) 66.98 (12.58) t (300) = -3.04, p = .003, d = 0.36 anxiety (gad-7) 6.91 (5.44) 4.03 (4.63) t (281.09)* = 4.92, p < .001, d = 0.57 depression (phq-9) 8.95 (6.60) 4.63 (5.00) t (294.30)* = 6.47, p < .001, d = 0.74 emotion reappraisal (erq-r) 4.44 (1.18) 4.62 (1.03) t (300) = -1.33, p = .183, d = 0.16 emotion suppression (erq-s) 3.77 (1.35) 3.54 (1.23) t (300) = 1.49, p = .137, d = 0.18 interpretation bias (sst) 0.67 (0.24) 0.76 (0.20) t (285.26)* = -3.60, p < .001, d = 0.42 note. cd-risc = connor-davidson resilience scale; gad-7 = generalised anxiety disorder questionnaire; phq-9 = patient health questionnaire; erq-r = emotion regulation questionnaire – reappraisal; erq-r = emotion regulation questionnaire – suppression; sst = scrambled sentences test. *equal variances not assumed. is there an association between resilience, emotion regulation techniques and interpretation bias in caregivers? to examine how resilience may be associated with emotion regulation techniques and more negative interpretations (h2), we conducted pearson’s correlations; see table 4 (non-caregiver sample on request). as expected, caregivers reporting greater resilience had a more positive interpretation bias, and greater use of cognitive reappraisal and lower use of suppression strategies to regulate emotions. furthermore, greater resilience was associated with lower levels of anxiety and depression symptoms. to determine whether emotion regulation and/or interpretation bias helps account for levels of resilience, we conducted a hierarchical multiple regression (see table 5). in step 1, processes known to be covariates of resilience were entered: anxiety and depression. in step 2 emotion regulation via reappraisal, emotion regulation via suppres­ sion and interpretation bias scores were entered into the model. in step 1, the model accounted for 33% of the variance in resilience, f(2, 179) = 44.69, p < .001 (see table 5). when emotion regulation techniques and interpretation bias were added in step 2, an wilson, onwumere, & hirsch 11 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ additional 15% of variance of resilience was explained (adjusted r 2 = .48), f(5, 176) = 33.96, p < .001. furthermore, both interpretation bias (β = .35, p < .001) and cognitive reappraisal (β = .28, p < .001) significantly predicted independent variance in resilience, but not emotion regulation via suppression (β = -.05, p = .385). results did not change when other covariates associated with caregiving were added into the model (i.e., gender, age, ethnicity, time caring per week, duration of caregiving role; see supplementary analyses 2). table 4 correlations between resilience, anxiety, depression, emotion regulation and an interpretation bias measure (sst) in caregiver participants measure 1 2 3 4 5 1. cd-risc 2. gad-7 -.50*** 3. phq-9 -.57*** .80*** 4. erq-r .49*** -.31*** -.31*** 5. erq-s -.21** .23*** .293** -.03 6. sst .64*** -.65*** -.75*** .41*** -.26*** note. n = 182; cd-risc = connor-davidson resilience scale; gad-7 = generalised anxiety disorder question­ naire-7; phq-9 = patient health questionnaire-9; erq-r = emotion regulation questionnaire – reappraisal; erq-s = emotion regulation questionnaire – suppression; sst = scrambled sentences test. **p < .01. ***p < .001. table 5 hierarchical regression analysis testing the influence of our predictors on resilience predictor variable b se β t step one gad-7 -0.33 0.26 -.13 -1.28 phq-9 -0.98 0.21 -.47 -4.59*** step two gad-7 -0.10 0.23 -.04 -0.42 phq-9 -0.37 0.22 -.18 -1.69 erq-r 3.26 0.69 .28 4.71*** erq-s -0.51 0.58 -.05 -0.87 sst 20.35 4.90 .35 4.15*** note. n = 182. b = unstandardized coefficient; se = standard error; β = standardised coefficient; gad-7 = gener­ alised anxiety disorder questionnaire; phq-9 = patient health questionnaire; erq-r = emotion regulation questionnaire – reappraisal; erq-r = emotion regulation questionnaire – suppression; sst = scrambled sentences test. ***p < .001. resilience and distress in unpaid caregivers during covid-19 12 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ d i s c u s s i o n this study aimed to investigate reported levels of resilience and wellbeing in unpaid adult caregivers of a person aged 18+ with a long-term condition (specifically, multiple sclerosis, dementia, any mental health condition, and/or cancer) compared to non-care­ givers during a period of additional stress – the covid-19 pandemic – and what role, if any, potentially modifiable psychological mechanisms (i.e., interpretation bias, emotion regulation via reappraisal and suppression) had on carers’ reported levels of resilience. to the best of our knowledge, this represents the first investigation of its kind. as predicted and in keeping with non-pandemic data, caregivers reported lower lev­ els of resilience and greater levels of depression and anxiety compared to non-caregivers (our control condition). our pattern and direction of findings for these higher levels of caregiver emotional distress and lower resilience support published findings using samples from before (onwumere et al., 2017; smith et al., 2014; windle & bennett, 2012) and during the pandemic (kalb et al., 2021). our study confirmed for the first time that caregivers’ resilience levels were asso­ ciated with greater levels of positive interpretation bias, greater levels of reappraisal emotion regulation techniques and, to a lesser extent, lower levels of suppression. a more positive interpretation bias as well as greater use of cognitive reappraisal accounted for an additional 15% of the variance in resilience scores, with interpretation bias and use of reappraisal to regulate emotions both accounting for independent variance in resilience. to support a more nuanced understanding of these findings, an investigation with a similar sample outside of a global pandemic would be indicated. cognitive reappraisal and expressive suppression are independent constructs within the area of emotion regulation (moore et al., 2008). reappraisal is central to managing one’s emotional reaction to stressful situations, encouraging positive outcomes over time and important for understanding resilience, whereas suppression fails to address the emotion internally (troy & mauss, 2011). although both forms were associated with resilience, the current data found reappraisal, a cognitive construct, more relevant to fos­ tering resilience than suppression, a non-cognitive construct that is focused on changing only the outward expression of emotions (gross, 2014). this supports recent literature, which has found more mixed findings for the relation between expressive suppression and resilience, suggesting that situational factors may influence the longer-term adaptive or maladaptive role of suppression (polizzi & lynn, 2021). as a first step, supporting caregivers with emotional reappraisal techniques may be more beneficial than targeting expressive suppression. our findings on interpretation bias add to a growing body of literature that explores the impact of this cognitive bias in other populations, including adolescents with eat­ ing disorders, individuals with anxiety disorders, pregnant women, parents and their offspring (hirsch et al., 2021; rowlands et al., 2020; subar & rozenman, 2021). all highlight the risk of negative outcomes for negative interpretation biases. importantly, wilson, onwumere, & hirsch 13 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ interpretation bias and reappraisal are known to be modifiable mechanisms that can be targeted in psychological interventions; fostering a more positive interpretation bias or facilitating greater use of reappraisal techniques to regulate emotions could be beneficial in increasing resilience in caregivers. interventions to foster resilience both at an individ­ ual or familial level, and population level, are crucial for managing future pandemics and any longstanding negative impacts from covid-19 (ameis et al., 2020), as well as challenges associated with long-term caregiving in non-pandemic times. it is notable that while resilience is lower in caregivers (62.21) than non-caregivers (66.98), scores are much lower than general populations prior to the covid-19 pandemic (80.4; connor & davidson, 2003). indeed, our caregiver sample have similar levels of resilience to patients commencing a trial for ptsd (62.0; krystal et al., 2014) and psychi­ atric outpatients with a history of recent trauma (64.3; glass et al., 2019), although not as severe as some other ptsd populations (e.g., 49.8 to 55.7; davidson et al., 2006; mcguire et al., 2018). while the mean levels of anxiety and depression reported in caregivers fell within the non-clinical range (i.e., a score of 7 or below for the gad-7 and 9 or below for the phq-9), levels were higher compared to non-caregivers (p < .001, d = 0.57 to 0.84) and 46.2% still reported clinical levels of anxiety and 25.8% reported clinical levels of depression. this remains consistent with current literature (giebel et al., 2021; li et al., 2021) and offers further support of the need to consider the wellbeing of caregivers. the results offer early support for potential therapeutic avenues. cognitive behaviour therapy (cbt), for example, fosters more positive interpretations by reducing maladap­ tive thinking (derubeis et al., 2008) and a greater use of reappraisal to regulate emotion (smits et al., 2012). another approach to increase positive interpretation bias is cognitive bias modification for interpretations (cbm-i); this involves repeated computerised prac­ tice in generating more positive interpretations (menne-lothmann et al., 2014). it is pos­ sible that a caregiver focused cbm-i intervention could be tailored to focus on promot­ ing more positive interpretations of ambiguous and potentially negative situations that caregivers frequently encounter (e.g., uncertainty and ambiguity around implications for changes in symptoms in the person they care for). future qualitative studies could explore the specific caregiver stressors contributing to negative interpretations and its sequalae, compared to those unrelated to caregiving, to see if there is a generalised or situation-specific bias. there are limitations of the current study. firstly, it is cross-sectional, with data collected data within four months near the start of the pandemic. it therefore does not provide information on trajectories of resilience over the longer term during the pandemic, nor provide information on the extent to which interpretation bias predicts later levels of resilience in the caregiver populations. furthermore, we are unable to determine the extent to which general caregiver stress was exacerbated by the pandemic for a given individual in this sample due to lack of pre-pandemic data. while caregiving roles can be held by anyone, irrespective of demography, ethnic minority participants resilience and distress in unpaid caregivers during covid-19 14 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://www.psychopen.eu/ were largely underrepresented in our sample. this is important given that many of the key conditions in this study disproportionately affect some racial and ethnic minority groups, such as dementia, and caregiver experiences may differ across cultures (liu et al., 2021). consequently, the under-representation limits generalisability of findings to the wider population. additionally, our study did not look at the impact of looking after children during the pandemic. managing home-schooling alongside other responsibilities such as work undoubtedly contributed to additional challenges. these have been considered in great depth elsewhere. finally, participants could only be recruited and participate via the internet and therefore less likely to represent the experiences of informal caregivers with no or limited access to the internet, or those with less time to take part due to increase caregiving demands. in 2020, groups less likely to have internet access in the uk included the over 75s (46%), retired individuals (28.9%) and persons who self-assessed as having a disability (18.6%; office for national statistics, 2021). as convenience samples, our groups were also not matched on all demographic variables. specifically, control participants were more frequently european white, men and single, as compared to caregivers. the under representation of particular groups is part of a broader issue in uk health focused surveys (harrison et al., 2020). nevertheless, future studies should aim to better match the control group to the caregiver sample. in summary, caregivers were reporting less resilience and higher levels of anxiety and depression compared to non-caregivers during the covid-19 pandemic. importantly, the tendency to interpret information in more positive ways and to use reappraisal as a way to regulate emotions was associated with greater resilience and could form the target of future caregiver interventions to improve resilience. funding: ch and jo have salary support from national institute for health research (nihr) biomedical research centre at south london and maudsley nhs foundation trust and king’s college london. the views expressed are those of authors and not necessarily those of the nhs, nihr, king’s college london or the department of health. acknowledgments: we are very grateful to everyone who took part in the study. competing interests: colette hirsch is a subject editor of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. twitter accounts: @mindfulem s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): wilson, onwumere, & hirsch 15 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://twitter.com/mindfulem https://www.psychopen.eu/ • supplementary materials 1: additional questions asked to unpaid caregivers • supplementary materials 2: hierarchical regression analysis testing the influence of our predictors on resilience while controlling for additional covariates index of supplementary materials wilson, e., onwumere, j., & hirsch, c. 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(2012). caring relationships: how to promote resilience in challenging times. in m. ungar (ed.), the social ecology of resilience: a handbook of theory and practice (pp. 219-231). springer science + business media. https://doi.org/10.1007/978-1-4614-0586-3_18 young, l., murata, l., mcpherson, c., jacob, j. d., & vandyk, a. d. (2019). exploring the experiences of parent caregivers of adult children with schizophrenia: a systematic review. archives of psychiatric nursing, 33(1), 93–103. https://doi.org/10.1016/j.apnu.2018.08.005 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. wilson, onwumere, & hirsch 23 clinical psychology in europe 2022, vol. 4(4), article e10313 https://doi.org/10.32872/cpe.10313 https://doi.org/10.1007/978-1-4614-0586-3_18 https://doi.org/10.1016/j.apnu.2018.08.005 https://www.psychopen.eu/ resilience and distress in unpaid caregivers during covid-19 (introduction) study aims method participants materials and measures procedure statistical analysis results do caregivers exhibit lower levels of resilience and higher levels of distress than non-caregivers and is interpretation bias more negative in caregivers? is there an association between resilience, emotion regulation techniques and interpretation bias in caregivers? discussion (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references successful aging in individuals from less advantaged, marginalized, and stigmatized backgrounds scientific update and overview successful aging in individuals from less advantaged, marginalized, and stigmatized backgrounds myriam v. thoma ab, shauna l. mc gee ab [a] psychopathology and clinical intervention, institute of psychology, university of zurich, zurich, switzerland. [b] university research priority program “dynamics of healthy aging”, university of zurich, zurich, switzerland. clinical psychology in europe, 2019, vol. 1(3), article 32578, https://doi.org/10.32872/cpe.v1i3.32578 received: 2018-12-20 • accepted: 2019-03-27 • published (vor): 2019-09-20 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: myriam v. thoma, department of psychology, university of zurich, binzmühlestrasse 14/17, 8050 zurich, switzerland. tel.: +41 635 73 06. e-mail: m.thoma@psychologie.uzh.ch abstract background: health and well-being in later life are heavily influenced by behaviors across the life course, which in turn are influenced by a variety of wider contextual, social, economic, and organizational factors. there is considerable potential for inequalities in health-promoting behaviors and health outcomes, arising from poverty, social, and environmental factors. this suggests that individuals from disadvantaged backgrounds and circumstances may have more exposure to (chronic) stressors, coupled with reduced access to resources, and increased susceptibility to risk factors for ill-health and mental disorders in later life. this drastically decreases the likelihood for successful aging in individuals from less advantaged backgrounds. nevertheless, despite these adverse circumstances, some high-risk, disadvantaged individuals have been shown to achieve and maintain good health and well-being into later life. method: this scientific update provides an overview of recently published research with samples that, against expectations, demonstrate successful aging. results: favorable personality traits, cognitive strategies, and a high-level of intrinsic motivation, paired with a supportive social environment, have been found to build a prosperous basis for successful aging and positive health outcomes in later life for individuals living in aversive environmental circumstances. conclusion: for clinical psychologists, the movement towards the investigation of underlying mechanisms of successful aging from a psychological perspective, particularly in disadvantaged individuals, may be a critical step towards understanding the vast heterogeneity in aging. keywords successful aging, disadvantaged backgrounds, marginalization and stigmatization, lgbt, disparities in racial and ethnic minorities this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.32578&domain=pdf&date_stamp=2019-09-20 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • successful aging is possible in disadvantaged individuals. • psychological and social resilience resources may compensate for the impact of disadvantage. • the application of multi-level resilience models can aid future research on successful aging. old age is a life stage characterized by a high degree of diversity between individuals. a growing body of literature has been dedicated to understanding this heterogeneity in ag‐ ing. special focus has been placed on the positive end of the aging spectrum. at the mo‐ ment, there exists no universally-accepted definition for what constitutes this “positive end of the aging spectrum”. the “successful aging” (sa) construct, which is often used in research to examine positive aging research questions, is currently defined and opera‐ tionalized in more than 100 different ways (cosco, prina, perales, stephan, & brayne, 2014). however, despite the current lack of a commonly-accepted definition, experts in the field generally agree that the sa construct should consist of several different dimen‐ sions, including a (mental and physiological) health facet, a (subjective) well-being facet, as well as a social (engagement) facet (kleineidam et al., 2018). nevertheless, despite its broad variety of operationalizations, the sa construct as a whole constitutes a meaning‐ ful and useful construct that can be applied to examine why some individuals are more likely than others to remain predominantly healthy and maintain a high level of physical functionality and social activity even into older age (kleineidam et al., 2018). in this regard, it is particularly useful to examine what factors can be identified in connection with more favorable aging processes and outcomes. previous research on sa has uncovered a range of predictors, including socio-demographic factors and specific be‐ haviors linked to sa. socio-economic status (ses; including income and wealth), educa‐ tion, and health-promoting behaviors (e.g., non-smoking, healthy diet, physical activity), are among the frequently identified predictors for sa (e.g., daskalopoulou et al., 2018; gopinath, kifley, flood, & mitchell, 2018; kok, aartsen, deeg, & huisman, 2016; vauzour et al., 2017; whitley, benzeval, & popham, 2018). other branches of health-related re‐ search can also provide additional evidence for potential risk and protective factors that are essential in predicting sa. for instance, an important line of research on the (longterm) impact of early-life stress suggests that childhood neglect and abuse can increase the risk of future ill health and mental disorders, and may thus diminish the probability of sa (jones, nurius, song, & fleming, 2018; nurius, fleming, & brindle, 2017). in fact, supporting this, a recently published large-scale longitudinal study found a meaningful link between early-life stress and sa trajectories (kok, aartsen, deeg, & huisman, 2017). upon closer examination of the factors that may promote or hinder sa, it appears as if sa may be a rather elitist paradigm, seemingly reserved for more advantaged and al‐ successful aging in disadvantaged individuals 2 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ ready healthy individuals. that is, those who grow up in more functional families, who were provided with the opportunity for a good education, and the necessary access to health-literacy and services, coupled with the essential assets and time required to imple‐ ment health-promoting behaviors. this leaves a rather pessimistic prospect for individu‐ als who grew up and lived in poverty or come from underprivileged educational back‐ grounds; as well as for those who experienced early misfortune in the form of childhood stressful life events, abuse and neglect, or those living with chronic health conditions (e.g., bøe, serlachius, sivertsen, petrie, & hysing, 2018; kok et al., 2017; lê-scherban et al., 2018). are these individuals deprived of the opportunity to age successfully? this scientific update aims to answer this question by providing an overview of the latest research dedicated to the investigation of sa in individuals from less advantaged backgrounds. for this, a list of 'disadvantaged' groups was first compiled and the search was then limited to articles on older adults. a search of the databases was conducted for articles published since 2017. given the wide diversity in how the sa construct is cur‐ rently defined in the scientific literature, the search was not restricted by applying a par‐ ticular sa definition or operationalization. s u c c e s s f u l a g i n g w i t h i n t h e c o n t e x t o f s o c i o e c o n o m i c d i s a d v a n t a g e a n d c h i l d h o o d a d v e r s i t y the research group of kok and colleagues (kok, van nes, deeg, widdershoven, & huisman, 2018) qualitatively examined sa in dutch individuals (n = 11; agerange = 78-93 years) who had a low lifetime socio-economic position (sep). more specifically, the au‐ thors were interested in the identification of resilience factors that protected those indi‐ viduals from the potentially negative impact of chronic socio-economic adversity. several resilience-enhancing factors were identified, including ‘social support’, ‘generativity’, ‘pro-active management’, ‘cognitive restructuring’, ‘enduring’, and ‘surrendering’. con‐ firming, but also expanding the resilience conceptualization for low sep individuals pre‐ viously proposed by chen and miller (2012), the authors concluded that in addition to mental re-evaluation of the disadvantaged background, it also appears to be necessary to have a supportive social environment (which also requires pro-social behaviors) and the will to actively confront the external circumstances in question, i.e., by changing the ad‐ verse environment with one’s own actions (kok et al., 2018). another recent study (scelzo et al., 2018) examined a sample of very old individuals living in rural villages in the southern part of italy (n = 29; agerange = 90-101 years). ru‐ ral areas tend to show health-disparities due to a disproportionate lack of services in medically underserved areas, issues of access to existing services, differences in patient expectations and health-seeking behaviors, as well as the delivery of health care (douthit, kiv, dwolatzky, & biswas, 2015). while not directly assessing sa in this study, thoma & mc gee 3 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ (extreme) longevity can be regarded (and has previously been used) as a proxy to assess (the consequences of) sa (see cosco et al., 2014). the qualitative part of this mixed-meth‐ od study examined themes related to (extreme) longevity. common themes associated with sa were identified, including ‘positivity’, i.e., resilience and an optimistic outlook on life (also including self-efficacy and perseverance); being a ‘controlling’ or ‘strong’ per‐ sonality; being socially active and engaged, i.e., having tight bonds with family members; religious beliefs; as well as being hard working; and having a “love of the land” (p. 33). altogether, the above findings show some parallels to those reported by kok et al. (2018): in addition to the importance of having mental resources, such as the capacity for accept‐ ance/perseverance (facilitated by religious beliefs or particular personality traits), there is also the necessity of actively engaging with or changing the external environment (e.g., by being hard working), which is framed within the context of a functional and close so‐ cial network. another example of sa despite adverse life circumstances can be seen in the case of swiss former indentured child laborers (i.e., former verdingkinder). due to extreme pov‐ erty, death of a parent, divorce, or single motherhood, children were taken away from their parents and placed in foster families (mostly farmers), where they had to work for their living (leuenberger & seglias, 2008). given that, in those times, the foster-care sys‐ tem was still poorly controlled, these children (in most cases forcefully separated from their families of origin) often experienced little to no protection. documented by individ‐ uals who came forward publicly with their experiences, and corroborated by contempo‐ rary witnesses, these biographies are filled with reports of (extreme levels of) childhood abuse and neglect. a qualitative study (höltge, mc gee, maercker, & thoma, 2018a) in‐ vestigated sa in former verdingkinder (n = 12; mage = 71 years; agerange = 59-88). sa was defined as (self-rated) good health, feelings of happiness, balance and/or calmness most of the time, and a high level of satisfaction with (social) life. the factors ‘light-hearted‐ ness’, ‘social-purpose’, and ‘self-enhancement’ were identified as predictors for sa. these individuals, after what they had endured in early-life, took on a positive perspective fol‐ lowing conscious reflection (i.e., a proxy for a resilience resource). while striving to ex‐ perience positive feelings, they nevertheless kept a realistic perspective on life by ac‐ knowledging that negative experiences are part of a normal existence (i.e., cognitive reevaluation). in general, participants could be classified as stress-resilient, a resource that was described to be developed through active coping and by coming to terms with their difficult past. they strongly valued (harmonic) social relationships and had the altruistic desire to help others (i.e., social component). furthermore, they developed a strong moti‐ vation for self-improvement that pushed them to work hard and to continuously engage in further education (i.e., active engagement with external environment). successful aging in disadvantaged individuals 4 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ s u c c e s s f u l a g i n g i n r a c i a l a n d e t h n i c m i n o r i t i e s similar to individuals from disadvantaged backgrounds or adverse childhood circumstan‐ ces, individuals from minority groups often face issues of marginalization and stigma, which can influence their health and well-being into later life. one such example can be seen in racial and ethnic minorities, who, in addition to potentially higher levels of disad‐ vantages and inequalities (zubair & norris, 2015), can also face problems with exclusion and discrimination, which may compound health issues and ultimately hinder sa (ferraro, kemp, & williams, 2017). however, despite these additional stressors, evidence is emerging that some individuals can experience good health into older age. for exam‐ ple, a study of perceived discrimination and psychological well-being in african ameri‐ can older adults (n = 397; agerange = 65-89) found that the characteristic of ‘self-accept‐ ance’, an awareness and acceptance of personal strengths and weaknesses, was shown to buffer the negative effect of discrimination on depressive symptomology, an indicator of psychological well-being (yoon, coburn, & spence, 2019). another study (klokgieters, van tilburg, deeg, & huisman, 2018a) examined the potential buffering effect of various religious activities against the negative impact of disadvantage (e.g., no/low resources) in older turkish and moroccan immigrants (n = 455; agerange = 55-66 years). while a posi‐ tive relationship was found between well-being and private religious activities, there was no indication of a buffering effect for any of the religious activities against the experi‐ enced disadvantage. s u c c e s s f u l a g i n g i n i n d i v i d u a l s l i v i n g w i t h h i v another minority group that has experienced much stigma and discrimination is that of individuals living with the human immunodeficiency virus (hiv). hiv is a chronic ill‐ ness, associated with a higher risk of experiencing psychosocial challenges and physio‐ logical issues. however, with advances in medicine, individuals with hiv are living longer, better lives and research has started focusing on sa and sa-related factors in this population. a qualitative study in individuals with hiv (n = 30; agerange = 50-73) as‐ sessed barriers to and strategies for sa (emlet, harris, furlotte, brennan, & pierpaoli, 2017). results showed that while stigma, prejudice, and discrimination were identified as potential sa barriers, a number of sa-related themes emerged, including resilience com‐ ponents, such as self-care, mastery, and spirituality; social support; and the importance of the environmental context, such as structural support, social networks, and communities. another qualitative study on sa in individuals with hiv (n = 24; agerange = 50-73) identi‐ fied similar themes, emphasizing components over which persons had individual control (solomon et al., 2018). these included staying positive, maintaining social support and connectedness with others, taking responsibility and being self-reliant for one’s well-be‐ ing, and engaging in meaningful activities. these findings indicate that a combination of thoma & mc gee 5 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ individual characteristics, such as control and mastery, and external influences, such as social and structural support, are important in fostering sa in this marginalized popula‐ tion. s u c c e s s f u l a g i n g i n l g b t o l d e r a d u l t s a population that also faces additional barriers to sa, are lesbian, gay, bisexual, and transgender (lgbt) older adults. despite the risks of ill-health and social isolation for lgbt older adults (wright et al., 2017), discrimination is often reported as a barrier to the utilization of health and community services (alencar albuquerque et al., 2016). a large-scale study of n = 2,415 lgbt older adults identified risk and resilience pathways to positive health outcomes in later life (fredriksen-goldsen, kim, bryan, shiu, & emlet, 2017). results showed that marginalization was a risk factor associated with fewer social resources and poorer mental health outcomes. however, resilient pathways were identi‐ fied in which psychological (e.g., positive identity appraisal) and social (e.g., social con‐ nectedness) resources were associated with health-promoting behaviors, which in turn facilitated good physical health into older age. these findings suggest that the interaction of social and psychological factors can help lgbt older adults to maintain good health and foster sa, even within an environmental context of marginalization. the above research suggests that sa is possible for individuals from less advantaged, marginalized, and stigmatized backgrounds. however, as this is a relatively new and emerging topic, the exact mechanisms through which sa is fostered in these disadvan‐ taged populations are not yet known. some theories and models are presented in the next section, which may be applied to help explain the underlying mechanisms of this process of sa. u n d e r l y i n g m e c h a n i s m s o f s u c c e s s f u l a g i n g the ‘steeling effect’ is one theory that may explain positive health in the face of adversi‐ ty (liu, 2015; rutter, 2006, 2012). this theory proposes that previous exposure to adversi‐ ty (e.g., disadvantaged circumstances, discrimination) may have a ‘steeling’ or strength‐ ening effect on individuals, which can increase their resistance to later stress or adversi‐ ty. it further suggests that moderate adversity may be more beneficial than no or high adversity, as it is adequately challenging to facilitate the development of coping skills and the utilization of resources (for a review see höltge, mc gee, maercker, & thoma, 2018b). however, there is a lack of research applying this model in human studies (for one such study see höltge, mc gee, & thoma, 2018), particularly with older adults, and the role of steeling for sa remains poorly understood. furthermore, while some studies have exam‐ ined aspects of adverse circumstances as part of a larger assessment, such as exposure to successful aging in disadvantaged individuals 6 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ social and environmental stress (seery, holman, & silver, 2010), future research is needed to apply this steeling model specifically to individuals from disadvantaged populations. the above literature suggests that a combination of psychological and individual fac‐ tors (e.g., mastery and control, self-efficacy) and external social factors (e.g., social en‐ gagement, connectedness with others) can contribute to resilience and sa in disadvan‐ taged populations. however, it is also important to consider the enabling environmental and context factors, which are particularly important in this specific population due to their adverse backgrounds and circumstances. supporting this is the social ecological model of resilience, which emphasizes the role of environmental factors in health and well-being, and suggests that resilience is facilitated by the interaction between the indi‐ vidual and their environment (ungar, 2012). specifically, this model suggests that the en‐ vironment can facilitate access to resilience-promoting resources; that resilience may dif‐ fer as a result of the complex and changing nature of an individual’s circumstances and the interaction with their personal traits; and that the resilience process is culturally and temporally embedded and is therefore influenced by the cultural norms of the time, which is particularly important for specific cultural groups such as minorities (ungar, 2011). the importance of the individual-environment interaction for the well-being of disadvantaged populations can be seen in the reoccurring finding that environmental and contextual factors, such as social support and social engagement, were significant in sup‐ porting individual resilience and sa (e.g., emlet et al., 2017; kok et al., 2018; scelzo et al., 2018). further support comes from a resilience conceptualization in the field of sociology (schafer, shippee, & ferraro, 2009). schafer and colleagues (2009) argue that in order to actively buffer or overcome disadvantage, several processes must take place: first, an in‐ dividual must become aware (i.e., recognition/subjective evaluation) of one’s undesirable position, adversity, or misfortune. second, the individual must take action (i.e., construc‐ tive adaptation) to counteract or amend the adverse situation and/or to avoid negative consequences. third, to efficaciously face disadvantage, one must activate and apply ade‐ quate and effective resources. these resources may be located within oneself (e.g., iq, re‐ siliency traits) and/or within the socio-economic system, in the form of social relation‐ ships, ses, and economic resources (schafer et al., 2009). as in the social ecological model of resilience, this conceptualization highlights the importance of both individual and so‐ cial-context factors in overcoming disadvantage. the interaction between individual and environment is also reflected in and suppor‐ ted by another model of resilience by liu, reed, and girard (2017). this model proposes that resilience is dynamic and is formed through the interaction of factors across multi‐ ple, interconnected levels. these levels include core resilience, which are inherent, stable characteristics and traits, such as gender, race, and ethnicity; internal resilience, which are learnable and changeable factors, such as active coping, mastery, and self-acceptance; and external resilience, which are contextual and environmental factors, such as social thoma & mc gee 7 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ resources and support. this model could be applied in future research to better under‐ stand the multi-level mechanisms underpinning the processes of resilience and sa. in addition, the construct ‘sense of coherence-revised’ (soc-r) could be examined in conjunction with liu et al.’s (2017) model. this construct may help explain how individu‐ als can utilize these multi-level factors to facilitate resilience and sa, as it is the ability to integrate and balance positive and negative experiences in order to maintain and develop health and well-being following stress or adversity (bachem & maercker, 2016; mc gee, höltge, maercker, & thoma, 2018a, 2018b). it is based on the salutogenic theory, which views health as a continuum, and proposes that soc-r can help individuals to utilize re‐ sources (e.g., personality traits, mastery, social support) appropriate for their current cir‐ cumstances and move them towards good health on this continuum (antonovsky, 1987). in this way, soc-r can positively influence the aging process and foster sa (bachem & maercker, 2016). the above theories and models provide a theoretical basis for future re‐ search to examine the mechanisms and factors associated with resilience and sa, particu‐ larly in populations with disadvantaged backgrounds. it should be emphasized that this article constitutes a short, current update and over‐ view of the latest developments and publications in this particular field. as such, a sys‐ tematic review of the literature was not conducted. this may have resulted in a non-com‐ prehensive or even biased delineation of existing literature and the deduction of oversimplified conclusions. it is possible that additional mechanisms and factors exist, which were not discussed in this short update that links sa to adverse experiences and disad‐ vantaged backgrounds. the association between sa and disadvantage is complex and un‐ derlying mechanisms are still poorly understood. disadvantage can have multiple forms and can also hide behind alleged “advantaged” circumstances. for instance, a large-scale longitudinal study on sa (kok et al., 2017) showed that not only low, but also high sep, was linked to stressful life events (e.g., higher divorce rate). it is also important to note that the potential buffering impact of psychological resources may depend on the partic‐ ular context, such as the cultural background (klokgieters, van tilburg, deeg, & huisman, 2018b). c o n c l u s i o n research on sa is continuously uncovering predictors for more favorable aging process‐ es and outcomes. this scientific update and overview focused on very recent develop‐ ments and trends in this area, examining sa in less advantaged populations. findings from these studies highlight the importance of considering a combination of psychologi‐ cal and individual resilience factors, as well as external social and environmental compo‐ nents. individual, psychological, and social factors can play a compensatory role for indi‐ viduals living with negative environmental influences. for clinical psychologists, the movement towards the investigation of underlying mechanisms of sa from a psychologi‐ successful aging in disadvantaged individuals 8 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://www.psychopen.eu/ cal perspective, particularly in disadvantaged individuals, may be a critical step towards understanding the vast heterogeneity in aging. funding: this work was supported by the swiss government excellence scholarship (eskas-nr. 2016.0109) which funded slmg’s position. competing interests: the authors have declared that no competing interests exist. acknowledgments: during the work on her dissertation, shauna l. mc gee was a pre-doctoral fellow of life (international max planck research school on the life course; 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(2015). perspectives on ageing, later life and ethnicity: ageing research in ethnic minority contexts. ageing & society, 35(5), 897-916. https://doi.org/10.1017/s0144686x14001536 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. successful aging in disadvantaged individuals 12 clinical psychology in europe 2019, vol.1(3), article 32578 https://doi.org/10.32872/cpe.v1i3.32578 https://doi.org/10.1037/a0021344 https://doi.org/10.1177/0956462417721439 https://doi.org/10.1111/j.1939-0025.2010.01067.x https://doi.org/10.1016/j.ypmed.2012.07.021 https://doi.org/10.1016/j.arr.2016.09.010 https://doi.org/10.1177/0898264316665208 https://doi.org/10.1093/fampra/cmx005 https://doi.org/10.1080/13607863.2017.1423034 https://doi.org/10.1017/s0144686x14001536 https://www.psychopen.eu/ successful aging in disadvantaged individuals (introduction) successful aging within the context of socio-economic disadvantage and childhood adversity successful aging in racial and ethnic minorities successful aging in individuals living with hiv successful aging in lgbt older adults underlying mechanisms of successful aging conclusion (additional information) funding competing interests acknowledgments author contributions references efficacy of psychological treatments for patients with schizophrenia and relevant negative symptoms: a meta-analysis systematic reviews and meta-analyses efficacy of psychological treatments for patients with schizophrenia and relevant negative symptoms: a meta-analysis marcel riehle a , mara cristine böhl a, matthias pillny a , tania marie lincoln a [a] clinical psychology and psychotherapy, universität hamburg, hamburg, germany. clinical psychology in europe, 2020, vol. 2(3), article e2899, https://doi.org/10.32872/cpe.v2i3.2899 received: 2020-03-03 • accepted: 2020-09-10 • published (vor): 2020-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: marcel riehle, clinical psychology and psychotherapy, institute for psychology, universität hamburg, von-melle-park 5, 20146 hamburg, germany. twitter: @drriehle, @pb_unihh (faculty account). tel.: (+49) (0)40 42838 6072; fax: (+49) (0)40 42838 6170. e-mail: marcel.riehle@uni-hamburg.de supplementary materials: materials [see index of supplementary materials] abstract background: recent meta-analyses on the efficacy of psychological treatments for the negative symptoms of schizophrenia included mostly trials that had not specifically targeted negative symptoms. to gauge the efficacy of such treatments in the target patient population – namely people with schizophrenia who experience negative symptoms – we conducted a meta-analysis of controlled trials that had established an inclusion criterion for relevant negative symptom severity. method: we conducted a systematic literature search and calculated random-effects meta-analyses for controlled post-treatment effects and for pre-post changes within treatment arms. separate analyses were conducted for different therapeutic approaches. our primary outcome was reduction in negative symptoms; secondary outcomes were amotivation, reduced expression, and functioning. results: twelve studies matched our inclusion criteria, testing cognitive behavioral therapy (cbt) vs. treatment-as-usual (k = 6), cognitive remediation (cr) vs. treatment-as-usual (k = 2), cbt vs. cr (k = 2), and body-oriented psychotherapy (bpt) vs. supportive group counseling and vs. pilates (k = 1 each). accordingly, meta-analyses were performed for cbt vs. treatment-as-usual, cr vs. treatment-as-usual, and cbt vs. cr. cbt and cr both outperformed treatment-as-usual in reducing negative symptoms (cbt: hedges’ g = -0.46; cr: g = -0.59). there was no difference between cbt and cr (g = 0.12). significant pre-post changes were found for cbt, cr, and to a lesser extent for treatment-as-usual, but not for bpt. conclusion: although effects for some approaches are promising, more high-quality trials testing psychological treatments for negative symptoms in their target population are needed to place treatment recommendations on a sufficiently firm foundation. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.2899&domain=pdf&date_stamp=2020-09-30 https://orcid.org/0000-0002-7839-077x https://orcid.org/0000-0003-2395-8433 https://orcid.org/0000-0002-6674-2440 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords schizophrenia and psychosis, negative symptoms, psychotherapy, nonpharmacological treatment, meta-analysis highlights • this meta-analysis assesses the efficacy of psychological treatments for relevant negative symptoms. • cognitive behavioral therapy and cognitive remediation show promising effects reducing symptoms. • interventions show differential effects for the subcomponents amotivation and reduced expression. • the evidence-base is not in line with recommendations made in treatment guidelines. the negative symptoms of schizophrenia, i.e. blunted affect, alogia, anhedonia, asociality, and avolition (marder & galderisi, 2017), are among the best predictors of patients’ social functioning levels (fervaha, foussias, agid, & remington, 2014; galderisi et al., 2014) and accordingly an important treatment target. with respect to psychological treat‐ ments, meta-analyses have reported moderate treatment effects for negative symptoms in response to cognitive behavioral therapy for psychosis (cbtp) (wykes, steel, everitt, & tarrier, 2008), cognitive remediation (cr) (cella, preti, edwards, dow, & wykes, 2017; roder, mueller, & schmidt, 2011), social skills training (sst) (kurtz & mueser, 2008; turner et al., 2018), and mindfulness-based interventions (khoury, lecomte, gaudiano, & paquin, 2013). in the case of cbt, the effect was not significant in a more recent metaanalysis (velthorst et al., 2015). among studies comparing different active psychological interventions to one another, sst seems to be superior to other treatments (turner, van der gaag, karyotaki, & cuijpers, 2014) and is recommended for negative symptoms in two german treatment guidelines (dgppn e.v., 2019; lincoln, pedersen, hahlweg, wiedl, & frantz, 2019). according to the british nice guidelines (nice, 2014), offering arts therapy (including music and body-oriented therapy) should be considered both in acute phases and “to assist in promoting recovery, particularly in people with negative symp‐ toms” (p. 220). nice does not recommend any other approach for negative symptoms. why yet another meta-analysis? besides the mixed conclusions from previous meta-analyses, all of the meta-analyses mentioned share the limitation that almost all included original trials reported on nega‐ tive symptoms as a secondary, not a primary outcome. for example for cbtp, only 3 out of 30 studies (velthorst et al., 2015; wykes et al., 2008) specifically targeted negative symptoms. in the case of cr, cella et al. (2017), p. 43, noted that “negative symptoms have not been considered a primary target for cr”. instead, due to the focus on positive psychological treatments for negative symptoms 2 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ symptoms in most included trials, participants in the trials often had passed some min‐ imum criterion for the presence of positive symptoms. therefore, we cannot rule out that the moderate meta-analytic effects for negative symptoms mentioned above result from primary studies that did not include any patients with relevant1 negative symptoms. this makes it extremely difficult to select appropriate treatments for the patients with schizophrenia, who present with relative negative symptoms, which have been estimated to constitute one (buchanan, 2007) or even two (bobes, arango, garcia-garcia, & rejas, 2010) thirds of the total patient population. to emphasize this point; this is as if we wanted to judge the efficacy of an intervention for auditory hallucinations on the basis of studies that did not make sure that their participants actually had auditory hallucinations before the intervention. more specifically, because previous meta-analyses did not limit their eligibility crite‐ ria to studies that required that their patients present with at least some relevant level of negative symptoms, there are several possible ways by which these meta-analyses may have either overor underestimated the effect size of psychological negative symptom treatments. for instance, floor effects need to be expected if patients without relevant negative symptoms and thus little room for improvement in this domain are included in the studies. this would lead to an underestimation of the effect size. on the other hand, we need to consider the possibility that patients with more severe negative symptoms benefit less from therapy or that the interventions’ effects primarily reflect changes in the so-called “secondary” (carpenter, heinrichs, & wagman, 1988) negative symptoms (e.g., social withdrawal due to paranoia). each of these would lead to an overestimation of the effect size. in fact, at least the latter possibility is likely, given that–much more often than not–positive symptoms were the focus of the primary research that fed into the meta-analyses mentioned above. another problem with this focus of most considered trials is that the interventions analyzed usually targeted positive psychotic symptoms and for this reason were derived from psychological models of those symptoms. given that positive and negative symptoms are usually uncorrelated (e.g., engel, fritzsche, & lincoln, 2014; strauss et al., 2012), it is not scientifically plausible that these interventions should work well for negative symptoms. to overcome these uncertainties, we conducted a meta-analysis of only those con‐ trolled treatment studies that focused specifically on psychological interventions for negative symptoms and that made sure that enrolled patients presented with relevant negative symptoms. as the primary outcome, we estimated the controlled meta-analytic effect size for negative symptoms post treatment. as secondary outcomes, we estimated the controlled meta-analytic effect size for each of the two negative symptom dimen‐ 1) because there are no unified criteria to demarcate the presence from the absence of negative symptoms, we use the concept of „relevant negative symptoms“ throughout this paper as an umbrella term for the different ways that have been put forward to describe negative symptoms that can be considered in need of treatment (see for instance table 1 in this paper or the differing criteria used in buchanan, 2007 and bobes et al., 2010). riehle, böhl, pillny, & lincoln 3 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ sions, motivational and expressive negative symptoms (blanchard & cohen, 2006), as well as for level of functioning. as a secondary analysis, we estimated the meta-analytic pre-post changes within treatment arms for each outcome. m e t h o d eligibility criteria we defined six eligibility criteria in accordance with the picos criteria. first, we inclu‐ ded only studies that exclusively enrolled adult patients with a diagnosis of schizophre‐ nia spectrum disorder according to dsm or equivalent icd diagnoses. second, studies were eligible only when they had established any minimum inclusion criterion of neg‐ ative symptom severity (i.e. relevant negative symptoms). third, studies were eligible when they tested a psychological intervention, defined as manual-based non-invasive non-pharmacological talkor exercise-based intervention and when this intervention specifically targeted negative symptoms. fourth, all eligible studies had to include either a wait-list condition (e.g., treatment-as-usual, tau) or an alternative active intervention as a comparator. fifth, eligible studies needed to report outcomes on at least one of the following validated negative symptom assessments: brief negative symptom scale (bnss; kirkpatrick et al., 2011), clinical assessment interview for negative symptoms (cains; horan, kring, gur, reise, & blanchard, 2011), negative symptom assessment (nsa; alphs, summerfelt, lann, & muller, 1989), positive and negative syndrome scale (panss; kay, fiszbein, & opler, 1987), scale for the assessment of negative symptoms (sans; andreasen, 1989). sixth, eligible studies had to be designed as controlled trials (ct) or randomized controlled trials (rct). finally, studies were only eligible if they reported on original data (i.e. no secondary analyses) and were published in a peer-re‐ viewed journal in english or german language. literature search we searched the databases of medline(r) and psycinfo on august 24, 2020, using the following search term: (negative symptoms) and (schizophrenia or psychosis) and (treatment or intervention or therapy or psychotherapy or training or remediation). we also consulted reference lists of several systematic reviews and meta-analyses (cella et al., 2017; devoe, peterson, & addington, 2018; khoury et al., 2013; kurtz & mueser, 2008; lutgens, gariepy, & malla, 2017; roder et al., 2011; turner et al., 2014; velthorst et al., 2015; wykes et al., 2008). m.c.b. screened titles and abstracts of all studies in the search pool for non-eligibility and read full texts of all potentially eligible studies. m.c.b. made final decisions on eligible studies and resolved any uncertainties with m.r. a hierarchical decision structure was used to code the reason for exclusion of a study after reading the full-text: a) not retrievable, b) not a treatment study, c) secondary analysis, d) psychological treatments for negative symptoms 4 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ no ct or rct, e) included patients outside the diagnostic spectrum, f) did not report on a validated negative symptom assessment, g) no inclusion criterion for relevant negative symptoms, h) data reported insufficiently for meta-analysis. in the case of insufficient data, we contacted the study’s corresponding author up to four times to request data. data extraction we developed a coding protocol based on the cochrane handbook (higgins & deeks, 2008). the full item list can be requested from the first author. for our primary outcome, negative symptoms, we extracted per availability the post treatment negative symptom scores (m and sd) for the experimental and control group, respectively, or the between-group effect size estimate reported post treatment. post-treatment scores were defined as the first assessment after the termination of the in‐ tervention. if studies reported on more than one validated negative symptom assessment, we used the data from the one assessment labelled as primary outcome in the study. for all outcomes post treatment, results from intent-to-treat analyses (e.g., last observation carried forward) were prioritized over completer analyses. for the secondary outcomes, motivational negative symptoms, expressive negative symptoms, and level of functioning, we extracted per availability post treatment scores (m and sd) or the between-group effect size estimate reported post treatment. we defined the following as potential measures of motivational negative symptoms: bnss scales anhedonia, asociality, and avolition, cains scale motivation and anticipation of pleasure, sans scales avolition-apathy and anhedonia-asociality, and panss items n2 and n4 (fervaha et al., 2014; jang et al., 2016). we defined the following as potential measures of expressive negative symptoms: bnss scales blunted affect and alogia, cains scale expressive reduction, sans scales affective flattening and alogia, and panss items n1, n3, n6, and g7 (fervaha et al., 2014; jang et al., 2016). we defined measures of level of functioning as assessments of patients’ functionality in one or more of the following areas: family, friendship and partnership, vocation, or recreation. for our secondary analysis on pre-post changes, we also extracted pre-treatment scores (m and sd) on negative symptoms, motivational negative symptoms, expressive negative symptoms, and level of functioning or pre-post within-group effect size esti‐ mates. pre-treatment scores were defined as the last assessment before the start of the intervention. effect size computation at the levels of the individual studies we computed hedges’ g as the mean difference between groups (experimental minus control group) divided by the pooled standard deviation (cohen’s d) multiplied with a correction term (borenstein, 2009; hedges & olkin, 1985). the variance of g was calcu‐ riehle, böhl, pillny, & lincoln 5 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ lated according to borenstein, hedges, higgins, and rothstein (2009) (for the complete formulae see the supplementary materials). for pre-post within group comparisons we calculated g and its variance using the formulae for pre-post changes provided in borenstein et al. (2009) (see supplementary materials for complete formulae). these formulae account for the pre-post correlation of the repeated measure (cf. mcgaw & glass, 1980) that we estimated at r = .50 based on the pre-post correlations of studies included in this meta-analysis (see supplementary mate‐ rials) and in line with recommendations in the literature (lincoln, suttner, & nestoriuc, 2008; smith, glass, & miller, 1980). in cases in which several subscales needed to be integrated into one measure, we estimated d for each subscale, and computed a study-wise mean d, and subsequently g, and estimated its variance based on an integration of the variances of the subscales and their inter-correlations (borenstein et al., 2009). if such correlations could not be obtained from the studies themselves, they were estimated from relevant literature (for details see supplementary materials). we interpreted g ≥ 0.2 as a small effect, g ≥ 0.5 as a moderate effect, and g ≥ 0.8 as a large effect (cohen, 1992). effect size integration we integrated the effect sizes using random-effects models accounting for potential heterogeneity between studies. the effect sizes of single studies were weighted by their inverse variance (shadish & haddock, 2009). variance among studies was estimated according to dersimonian and laird (1986). we assessed heterogeneity between studies with the qand i 2-statistics (higgins, thompson, deeks, & altman, 2003; shadish & haddock, 2009). in accordance with higgins et al. (2003), we defined heterogeneity as‐ sessed with i 2 as low (25%), moderate (50%), and high (75%). all analyses were conducted with the package metafor (viechtbauer, 2010) in rstudio version 1.1.453. all significance tests were performed on an α-level of .05. because we were interested in comparing the efficacy of different psychological treatments for negative symptoms, we calculated separate meta-analyses for each psy‐ chological treatment approach identified in our search. based on a recent literature review (riehle, pillny, & lincoln, 2017), we expected to find studies for the following approaches: cbt, sst, cr, and body-oriented psychotherapy (bpt). we also planned to analyze studies comparing an intervention to tau separately from studies comparing an intervention to an active control condition or an alternative treatment. we integrated effect sizes, when two or more studies were found that could be integrated. psychological treatments for negative symptoms 6 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ risk of bias analyses risk of bias for individual studies was assessed with seven criteria that were based on the cochrane risk of bias tool (higgins, altman, & sterne, 2008). the seven criteria were evaluated on a dichotomous true (high quality)/false (low quality) scale and were: a) use of randomization for group allocation, b) use of an intent-to-treat analysis to account for dropouts, c) assessment of treatment fidelity, d) assessors blinded to group allocation, e) non-selective reporting of outcomes, f) matching of experimental and control group, g) exclusion of patients with high levels of positive psychotic symptoms (cf. savill, banks, khanom, & priebe, 2015). to account for potential publication bias influencing the meta-analysis, we inspected funnel plots (effect sizes plotted against their standard errors) for asymmetry (borenstein et al., 2009; sterne, egger, & moher, 2008) and conducted trim-and-fill analyses (duval & tweedie, 2000). r e s u l t s study selection the flow-chart in figure 1 illustrates the study selection process. we identified k = 12 studies fulfilling our inclusion criteria. of the twelve studies, k = 6 tested cbt vs. tau (bailer, takats, & westermeier, 2001; choi, jaekal, & lee, 2016; favrod et al., 2019; grant, 2012; pos et al., 2019; velligan et al., 2015), k = 2 tested cbt vs. cr (klingberg et al., 2011; penadés et al., 2006), k = 2 tested cr vs. tau (li et al., 2019; mueller, khalesi, benzing, castiglione, & roder, 2017), k = 1 tested bpt vs. group supportive counselling (röhricht & priebe, 2006), k = 1 tested bpt vs. pilates (priebe, savill, wykes, bentall, lauber, et al., 2016a; priebe, savill, wykes, bentall, reininghaus, et al., 2016b). accordingly, we calculated meta-analyses for the comparisons of cbt vs. tau, cr vs. tau, and cbt vs. cr. for the meta-analysis of pre-post changes in negative symptoms within the study groups, we integrated data from all samples included in the twelve studies that received comparable forms of treatment: cbt (k = 8), cr (k = 4), bpt (k = 2), tau (k = 8). data was not available for all outcomes in all studies and tables s3 and s4 in the supplementary materials show in detail which studies were included in which analyses. the study characteristics are shown in table 1. as can be seen, every study used a unique criterion to establish a minimum level of negative symptom severity. riehle, böhl, pillny, & lincoln 7 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ figure 1 flow chart of the literature selection process psychological treatments for negative symptoms 8 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ ta b le 1 c ha ra ct er is ti cs o f st ud ie s in cl ud ed i n th e m et aa na ly si s, s or te d by c om pa ri so n c om pa ri so n / r ef er en ce c ou n tr y of or ig in n a e g b / c g c d ro pou ts e g b / c g c m al e se x e g b / c g c t re at m en t du ra ti on in w ee k s p ri m ar y ou tc om e m ea su re m ot ./e xp . n e s m ea su re le ve l o f fu n ct io n in g n e s in cl us io n cr it er io n c b t v s. t a u ba ile r et a l., 2 00 1 g er 20 / 19 13 % / 21 % 54 % / 58 % 12 sa n s sa n s d a sm ≥ 2 on a ny s a n s sc al e or d a sm g lo ba l c ho i e t a l., 2 01 6 ko r 22 / 19 4% / 21 % 52 % / 50 % 10 pa n ss -n bn ss > 3 on a t l ea st 2 p a n ss n it em s fa vr od e t a l., 2 01 9 c h e 40 / 40 8% / 0% 53 % / 70 % 8 sa n s sa n s ≥ 2 on s a n s ap at hy / an he do ni a g ra nt e t a l., 2 01 2 u sa 31 / 29 10 % / 10 % 68 % / 66 % 72 sa n s sa n s g a f ≥ 4 on a t l ea st 1 o r ≥ 3 on 2 s a n s sc al es po s et a l., 2 01 9 n ed 49 / 50 18 % / 20 % 76 % / 86 % 10 bn ss bn ss g a f pa n ss n 2 or n 4 ≥ 3 or bn ss a so ci al ity it em s ≥ 2 ve lli ga n et a l., 2 01 5 u sa 17 / 22 35 % / 12 % 65 % / 68 % 36 n sa c a in s > 3 on a t l ea st 2 n sa sy m pt om d om ai ns c r v s. t a u li e t a l., 2 01 9 c h i 16 / 15 6% / 27 % 53 % / 72 % 4 pa n ss -n sa n s pa n ss -n a t l ea st 6 po in ts > p a n ss -p m ue lle r et a l., 2 01 7 c h e 28 / 33 14 % / 6% 76 % / 79 % 15 pa n ss -n pa n ss it em s n 1, n 4, n 6 g a f > 3 on p a n ss n 1, n 4, an d/ or n 6 riehle, böhl, pillny, & lincoln 9 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ c om pa ri so n / r ef er en ce c ou n tr y of or ig in n a e g b / c g c d ro pou ts e g b / c g c m al e se x e g b / c g c t re at m en t du ra ti on in w ee k s p ri m ar y ou tc om e m ea su re m ot ./e xp . n e s m ea su re le ve l o f fu n ct io n in g n e s in cl us io n cr it er io n c b t v s. c r k lin gb er g et a l., 2 01 1 g er 99 / 99 9% / 20 % 59 % / 53 % 36 pa n ss -m n s sa n s g a f > 10 o n pa n ss -m n s su m s co re pe na dé s et a l., 2 00 6 es p 20 / 20 15 % / 20 % 55 % / 60 % 16 pa n ss -n ls p pa n ss -n > p a n ss po si tiv e sc al e b p t v s. p il at es pr ie be e t a l., 2 01 6b g br 13 1 / 1 23 2% / 4% 50 % / 48 % 10 pa n ss -n c a in s m a n sa ≥ 18 o n pa n ss -n b p t v s. g sc rö hr ic ht & p ri eb e, 2 00 6 g br 24 / 19 4% / 9% 74 % / 74 % 10 pa n ss -n pa n ss it em s n 1, n 6 m a n sa ≥ 20 o n pa n ss -n a nd /o r ≥ 6 on p a n ss n 1, n 2, o r n 6 n ot e. eg = e xp er im en ta l g ro up ; c g = c on tr ol g ro up ; n es = n eg at iv e sy m pt om s; c bt = c og ni tiv e be ha vi or al t he ra py ; t a u = t re at m en tas -u su al ; c r = c og ni tiv e re m ed ia tio n; b pt = b od yor ie nt ed p sy ch ot he ra py ; g sc = g ro up s up po rt iv e c ou ns el lin g; s a n s = sc al e fo r th e a ss es sm en t o f n eg at iv e sy m pt om s; d a sm = d is ab ili ty a ss es sm en t s ch ed ul e; p a n ss -n /m n s = po si tiv e an d n eg at iv e sy nd ro m e sc al e n eg at iv e sc al e/ m od ifi ed n eg at iv e fa ct or (n 1, n 2, n 3, n 4, n 6, g 7, g 16 ); bn ss = b ri ef n eg at iv e sy m pt om s ca le ; n sa = n eg at iv e sy m pt om a ss es sm en t; c a in s = c lin ic al a ss es sm en t i nt er vi ew fo r n eg at iv e sy m pt om s; g a f = g lo ba l a ss es sm en t o f f un ct io ni ng ; l sp = l ife s ki lls p ro fil e; m a n sa = m an ch es te r sh or t a ss es sm en t o f q ua lit y of l ife . a n c or re sp on ds to n um be r of p ar tic ip an ts a va ila bl e fo r a m et aan al ys is o n th e pr im ar y ou tc om e m ea su re . b c bt fo r c bt v s. c r. c c r fo r c bt v s. c r. psychological treatments for negative symptoms 10 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ controlled post-treatment effects figure 2 contains the forest plots for the comparisons of cbt vs. tau, cr vs. tau and cbt vs. cr on controlled effect sizes for a global measure of negative symptoms. cbt vs. tau as can be seen in figure 2, there was a moderate and significant treatment effect favoring cbt over tau for our primary outcome, negative symptoms post treatment. heterogeneity across the four studies was moderate. regarding secondary outcomes, for motivational negative symptoms, there was a moderate significant post treatment effect favoring cbt over tau k = 6, n = 347, g = -0.50, 95% ci [-0.77, -0.22] (heterogeneity: q = 8.04, p = .154, i 2 = 37.8%). for expressive negative symptoms, there was no difference between cbt and tau, k = 5, n = 248, g = -0.05, 95% ci [-0.30, 0.20] (heterogeneity: q = 4.29, p = .369, i 2 = 6.70%). for level of functioning, there was a moderate but non-significant and highly heterogeneous effect favoring cbt over tau, k = 3, n = 198, g = 0.56, 95% ci [-0.11, 1.23] (heterogeneity: q = 9.95, p = .007, i 2 = 79.9%). cr vs. tau as also can be seen in figure 2, there was a moderate and significant treatment effect favoring cr over tau for our primary outcome, negative symptoms post treatment. no heterogeneity was noted across the two studies. regarding secondary outcomes, for motivational negative symptoms, there was a small but non-significant post treatment effect favoring cr over tau k = 2, n = 87, g = -0.23, 95% ci [-0.64, 0.19] (heterogeneity: q = 0.80, p = .371, i 2 = 0.0%). for expressive negative symptoms, there was a moderate and significant effect favoring cr over tau, k = 2, n = 87, g = -0.53, 95% ci [-0.93, -0.12] (heterogeneity: q = 0.30, p = .584, i 2 = 0.0%). for level of functioning, only one study reported sufficient data (mueller et al., 2017), so that no effect size integration was performed. cbt vs. cr as shown in figure 2, there was no significant difference between cbt and cr for negative symptoms post treatment and the heterogeneity measure indicated uniformity of the two studies’ effects. regarding the secondary outcomes, for level of functioning, there was a small but non-significant post treatment effect favoring cr over cbt, k = 2, n = 238, g = 0.31, 95% ci [-0.71, 1.34] with high heterogeneity, q = 8.47, p = .004, i 2 = 88.2%. for motivational and expressive negative symptoms, only one of the two studies reported sufficient data (klingberg et al., 2011), so that no effect size integration was performed. riehle, böhl, pillny, & lincoln 11 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ figure 2 forest plot of the random effects meta-analyses for the controlled treatment effects of cbt vs. tau, cr vs. tau, and cbt vs. cr in reducing relevant negative symptoms pre-post within group changes the meta-analytic results for the pre-post within group changes are detailed in table 2. for our primary outcome, global negative symptoms, significant moderate effects were noted for cbt and cr. the moderate effect of bpt was non-significant and highly heterogeneous. a small significant effect emerged for tau. for our secondary outcome motivational negative symptoms, cbt and cr showed moderate significant effects accompanied by high heterogeneity. tau showed a small significant effect. for bpt there was insufficient data. for expressive negative symptoms, cr showed a significant moderate effect. a small significant effect emerged for cbt. there was also a moderate effect of bpt on expres‐ sive negative symptoms, which was, however, non-significant due to high heterogeneity. we did not find an effect of tau. for level of functioning, small to moderate significant effects emerged for cbt, cr, and tau, all with moderate heterogeneity, whereas there was no effect of bpt. psychological treatments for negative symptoms 12 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ table 2 results of the random-effects meta-analyses on pre-post changes within treatment arms for primary and secondary outcomes, sorted by type of intervention intervention k n g 95% ci q i2 global negative symptoms cbt 7 286 -0.50*** -0.66, -0.35 8.54 29.7% cr 4 162 -0.60*** -0.86, -0.35 5.33 43.7% bpt 2 154 -0.62† -1.36, 0.11 7.93** 87.4% tau 7 194 -0.20* -0.38, -0.03 8.74 31.3% motivational negative symptoms cbt 7 289 -0.58*** -0.90, -0.26 36.92*** 83.8% cr 3 142 -0.59* -1.11, -0.07 11.69** 82.9% bpt tau 8 220 -0.26** -0.45, -0.06 14.09* 50.3% expressive negative symptoms cbt 5 209 -0.24** -0.41, -0.08 5.43 26.4% cr 3 142 -0.48*** -0.64, -0.32 0.86 0.0% bpt 2 154 -0.57 -1.41, 0.23 10.38** 90.4% tau 6 144 -0.10 -0.26, 0.06 4.59 0.0% level of functioning cbt 5 238 0.61*** 0.30, 0.92 17.37** 77.0% cr 3 147 0.40*** 0.10, 0.70 4.63† 56.8% bpt 2 152 0.10 -0.07, 0.25 0.23 0.0% tau 3 112 0.41* 0.08, 0.74 5.61† 64.3% note. cbt = cognitive behavioral therapy; cr = cognitive remediation; bpt = body-oriented psychotherapy; tau = treatment-as-usual. †p < .10. *p < .05. **p < .01. ***p < .001. risk of bias analyses publication bias inspection of the funnel plots (cf. supplementary materials) for the three comparisons of cbt vs. tau, cr vs. tau, and cbt vs. cr and trim-and-fill analyses suggested the following: no studies were estimated to be missing for cbt vs. tau and cr vs. tau. for cbt vs. cr, one study was estimated to be missing; the corrected effect, k = 3, g = 0.12, 95% ci [-0.12, 0.36], did not change the interpretation that there was no difference between the two interventions. risk of bias in individual studies and sensitivity analyses the results of the quality assessment of individual studies are shown in table 3. riehle, böhl, pillny, & lincoln 13 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ table 3 results of the quality assessment of included studies, sorted by comparison comparison/ reference random‐ ization intent-totreat analysis assessment of treatment fidelity blinded assessors nonselective outcome report matching groups high levels of positive symptoms excluded cbt vs. tau bailer et al., 2001 + + -/+ choi et al., 2016 + + + + favrod et al., 2019 + + -/+ + + + grant et al., 2012 + + + + + + pos et al., 2019 + + + + + + -/+ velligan et al., 2015 + + + + + + cr vs. tau li et al., 2019 + + +/+ mueller et al., 2017 + + + + + cbt vs. cr klingberg et al., 2011 + + + + + + + penadés et al., 2006 + + + + + -/+ bpt vs. pilates priebe et al., 2016b + + + + + + bpt vs. gsc röhricht & priebe, 2006 + + + + + + note. cbt = cognitive behavioral therapy; tau = treatment-as-usual; cr = cognitive remediation; bpt = body-oriented psychotherapy; gsc = group supportive counselling; + = criterion fulfilled; = criterion not fulfilled; -/+ = unclear; criterion probably fulfilled. as can be seen there, the overall study quality was high. non-selective reporting of results was implemented in all studies included in the meta-analysis and all investigated at least largely matching experimental and control groups. about half of the studies included a criterion to confine positive symptom severity in addition to their negative symptom inclusion criterion. three studies did not randomize their participants to the treatment arms (i.e., bailer et al., 2001; choi et al., 2016; li et al., 2019). as can be seen in figure 2, these three studies contributed the three largest controlled effect sizes. this could be due to patient prefer‐ ences playing a role in group allocation (e.g., in li et al., 2019). also, these three studies on average fulfilled two quality criteria less than the rcts. for this reason, we performed sensitivity analyses for all effects including only rcts. because for cr vs. tau there was only a single rct and because both cbt vs. cr and both bpt studies were rcts, sensitivity analyses of controlled post treatment effects were performed exclusively for cbt vs. tau. for the primary outcome, global negative symptoms, there remained a small marginally significant effect favoring cbt over tau k = 4, n = 278, g = -0.24, psychological treatments for negative symptoms 14 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ 95% ci [-0.47, 0.004] (heterogeneity: q = 0.56, p = .905, i 2 = 0.0%). regarding secondary outcomes, for motivational negative symptoms, there remained a small significant effect favoring cbt over tau k = 4, n = 278, g = -0.35, 95% ci [-0.58, -0.11] (heterogeneity: q = 1.93, p = .586, i 2 = 0.0%). for expressive negative symptoms, there was no difference between cbt and tau, k = 3, n = 179, g = 0.10, 95% ci [-0.18, 0.38] (heterogeneity: q = 0.65, p = .723, i 2 = 0.00%). finally, for level of functioning, there remained a small but non-significant effect favoring cbt over tau, k = 2, n = 159, g = 0.26, 95% ci [-0.27, 0.78] (heterogeneity: q = 2.61, p = .106, i 2 = 61.7%). results of the sensitivity analyses for the pre-post effects for cbt, cr, and tau can be found in table s5 in the supplementary materials. d i s c u s s i o n different national treatment guidelines have recommended different psychological thera‐ pies to treat the negative symptoms of schizophrenia (e.g., dgppn e.v., 2019; lincoln et al., 2019; nice, 2014). the purpose of such recommendations is to inform clinicians about which treatments to offer to their patients who experience these symptoms (i.e. the target population of the treatment). for this reason, it is important to base the recommendations on research that can answer the question whether a given treatment reduces negative symptoms in the target patient population. here, we conducted the first systematic literature search and meta-analysis of controlled trials of psychological treatments that had employed an inclusion criterion for negative symptom severity. our search identified twelve controlled studies matching our inclusion criteria. these twelve studies targeted cognitive behavioral therapy (cbt), cognitive remediation (cr), and body-oriented psychotherapy (bpt). by integrating findings of studies that investi‐ gated comparable forms of treatments (e.g., all trials testing cbt vs. treatment-as-usual, tau), we were able to calculate meta-analyses on the controlled treatment effects for the comparisons of cbt vs. tau, cr vs. tau, and cbt vs. cr, respectively. we found that cbt reduced negative symptoms more than tau with a small to mod‐ erate effect size (g = -0.46). this effect was larger than in other recent meta-analyses on the efficacy of cbt on negative symptoms (i.e. -0.09 to -0.16, velthorst et al., 2015; -0.34, lutgens et al., 2017). however, our sensitivity analysis including only rcts suggested that the effect size could be only half as big (g = -0.24) in more rigorous trials. this confirms what has already been observed for cbt in psychosis more generally, namely that effect sizes tend to be smaller in more rigorous trials (jauhar et al., 2014; wykes et al., 2008). having this caveat in mind, further high-quality rcts on the efficacy of cbt for negative symptoms in the target patient population are needed to confirm (or disconfirm) the effect found in this meta-analysis. we also found cr to reduce negative symptoms more than tau with a moderate effect size (g = -0.59). again, this effect size is considerably larger than the ones found in riehle, böhl, pillny, & lincoln 15 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ previous meta-analyses (i.e., cella et al., 2017; es = -0.30 to -0.40). however, this effect is based on only two studies, of which one (li et al., 2019) did not randomize patients to the treatment arms and even based their treatment allocation on patients’ preferences. the only rct that compared cr to tau in patients with relevant negative symptoms found a moderate effect favoring cr (mueller et al., 2017). the similar effect sizes for cbt vs. tau (-0.46) and cr vs. tau (-0.59) along with the finding of no significant difference between cbt and cr suggest that cbt and cr may be similarly efficacious. as no alternative psychological treatments have been investigated for this target population compared to cbt and cr, at present we can only conclude that adding a specific psychological treatment for negative symptoms (in this case cbt or cr) to standard care reduces relevant negative symptoms more than standard care alone. nevertheless, the findings from our secondary outcome analyses suggest at least some degree of specificity of treatment effects for cbt and cr. for example, cbt but not cr was efficacious in reducing amotivation. in contrast, cr but not cbt had an effect on reduced expression. moreover, as will be discussed below, bpt could be specifically efficacious to improve reduced expression but might not have an effect on amotivation. even though these findings are certainly tentative, they highlight that there may be treatments that are specifically efficacious for the different subcomponents of negative symptoms. therefore, future research should account for the distinction of the negative symptom subcomponents more explicitly and make these subcomponents the primary outcomes. two of the more recent studies in our meta-analysis already adopted this approach (favrod et al., 2019; pos et al., 2019). an important question then is, whether our findings accord with published treatment guidelines. for example, based on previous rcts and meta-analyses in schizophrenia samples (e.g., granholm, holden, link, & mcquaid, 2014; kurtz & mueser, 2008; turner et al., 2018, 2014), the german treatment guidelines (dgppn e.v., 2019; lincoln et al., 2019) recommend social skills training (sst) for negative symptoms. as we did not identify any study that tested sst in the target group, we argue that there is little evi‐ dence to support this recommendation. therefore, methodologically rigorous tests of sst in patients with relevant negative symptoms are needed. in this regard, it is promising that we found one registered rct testing cognitive behavioral social skills training in people with relevant negative symptoms (twamley, granholm, & clinicaltrials.gov, 2014). the case of bpt, as for example recommended in the british nice guidelines (nice, 2014) is more complex. in our synthesis, we did not find clear evidence that bpt re‐ duces negative symptoms. one important reason is that the large and methodologically rigorous bpt trial that we included and which was published after the last update of the nice guidelines (priebe et al., 2016b) mostly did not show significant results. nevertheless, in line with other trials on bpt (martin, koch, hirjak, & fuchs, 2016; psychological treatments for negative symptoms 16 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ röhricht & priebe, 2006), the priebe et al. (2016b) study found a significant effect for the reduction of expressive negative symptoms that did not show up in our meta-analysis for methodological reasons (i.e. the effect in priebe et al. (2016b) only showed up as a time by group interaction). in the light of very limited treatment options for the expressive subcomponents of negative symptoms, bpt should be further explored as one potentially specific approach for this aspect of negative symptoms. another result of our meta-analysis is that we found a small albeit significant effect for tau on global negative symptoms from pre to post treatment (k = 7, g = -0.20). this somewhat confirms a recent meta-analysis by savill et al. (2015), who showed that negative symptoms decline over time in tau conditions with a less than small, yet significant, effect (k = 15, es = -0.15). together, these findings suggest that current routine care has a negligible impact on relevant negative symptoms. several strengths and limitations need mentioning. due to space restrictions, we have provided a detailed discussion of these issues in the supplementary materials. the limitations discussed include the heterogeneity across primary studies regarding negative symptom assessments and the negative symptom inclusion criteria. we also address the potential lack of fit between interventions and current etiological models of negative symptoms. finally, we address strengths and limitations that arise from our strict inclusion criterion that primary studies needed to have employed an entry criterion for negative symptom severity. this includes a discussion of power issues due to the small number of primary studies. we also address how our study relates to the issue of “pseudo-specificity” in research on negative symptom treatments (cf., fusar-poli et al., 2015). having these caveats in mind, this meta-analysis indicates that routine care has a negligible effect on negative symptoms, whereas there is some evidence for the efficacy of cbt and cr. however, the effects were instable (especially for cbt) and the effect sizes leave room for improvement. additionally, some approaches may be more promis‐ ing to reduce motivational negative symptoms (cbt) and some more promising to reduce expressive negative symptoms (cr, bpt). therefore, research efforts should be held up for the targeted and symptom-specific psychological approaches to reduce negative symptoms in order to place treatment recommendations on a firmer foundation. funding: this research did not receive any specific grant from funding agencies in the public, commercial, or notfor-profit sectors. competing interests: tml is first author of german treatment manuals for cbtp. all other authors declare that they have no conflict of interest. acknowledgments: we thank paul grant, dawn i. velligan, and rafael penadés for providing additional data and information necessary for the analyses. riehle, böhl, pillny, & lincoln 17 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary material contains formulae used for the calculation of effect sizes, additional results, and an in-depth discussion of strengths and limitations (for access see index of supplemen‐ tary materials below). index of supplementary materials riehle, m., böhl, m. c., pillny, m., & lincoln, t. m. 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(2008). cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. schizophrenia bulletin, 34(3), 523-537. https://doi.org/10.1093/schbul/sbm114 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. riehle, böhl, pillny, & lincoln 23 clinical psychology in europe 2020, vol.2(3), article e2899 https://doi.org/10.32872/cpe.v2i3.2899 https://doi.org/10.1017/s0033291714001147 https://doi.org/10.18637/jss.v036.i03 https://doi.org/10.1093/schbul/sbm114 https://www.psychopen.eu/ psychological treatments for negative symptoms (introduction) why yet another meta-analysis? method eligibility criteria literature search data extraction effect size computation at the levels of the individual studies effect size integration risk of bias analyses results study selection controlled post-treatment effects pre-post within group changes risk of bias analyses discussion (additional information) funding competing interests acknowledgments supplementary materials references embracing computational approaches can stimulate clinical psychology research editorial embracing computational approaches can stimulate clinical psychology research omer van den bergh a, nadine lehnen b [a] health psychology, university of leuven, leuven, belgium. [b] department of psychosomatic medicine and psychotherapy, technical university of munich, munich, germany. clinical psychology in europe, 2019, vol. 1(3), article e39237, https://doi.org/10.32872/cpe.v1i3.39237 published (vor): 2019-09-20 corresponding author: omer van den bergh, university of leuven, health psychology, tiensestraat 102, 3000 leuven, belgium. e-mail: omer.vandenbergh@kuleuven.be clinical psychology is predominantly a “verbal” science: we derive most clinically useful information from what people say and talking is a critical means in the preferred unit of intervention: person-to-person interaction. psychologists often tend to believe that num‐ bers are a poor means of capturing and representing what goes on in the individual’s mind and sometimes consider attempts to do so as naïve, if not offensive, to the essence of human nature and existence. one of the arguments advanced cites “complexity”: the human mind is simply too rich and complex to reduce it to numbers. interestingly, com‐ plexity in other sciences and clinical specialties is often cited as one of the main reasons to use computing and to develop mathematical models and apply simulations. should clinical psychology consider going down this path? as a scientific endeavor, clinical psychology is (and should be) rooted in empirical da‐ ta and validated theoretical models that allow prediction. indeed, in a broad sense, both diagnostic and therapeutic steps (implicitly) involve a probabilistic prediction about fu‐ ture behavior. one way to validate models is to carry out experiments. however, reality in experiments is artificially reduced and controlled in order to test the effect of one or only a small set of independent (manipulated) variables on some variable of interest. the benefit is that they allow us to detect causal relationships and develop heuristics to un‐ derstand behavior. this is why experiments should be simple: our human mind can hard‐ ly grasp a 2-way interaction, let alone a 3or 4-way interaction1. however, since multiple higher order interactions and recursive effects (effects feed back on causes) are the rule in life, experiments do not allow us to predict actual behavior in a real context. 1) courtesy for this statement to my old professor of statistics, ovdb this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.39237&domain=pdf&date_stamp=2019-09-20 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ this is no different to natural sciences: just like experimentally investigating the rela‐ tionship between pressure, temperature and volume of a gas is important to eventually understand weather systems, the equations generated in experiments will not enable us to predict the weather across the next few days. the latter implies more complicated computational models with deterministic and stochastic variables in which lab-based equations act as building blocks that are fed with initial data and that are continuously updated as new information unfolds. eventually, our human mind may not be able to fully grasp all the higher-order interactions, but nevertheless we may become quite good at predicting the weather. computational science as an interdisciplinary field develops concepts, methods and tools to mathematically model and analyze complex problems and systems. it is, by itself, rather content-free. computational approaches have been successfully used in neuro‐ sciences for a long time (sejnowski, koch, & churchland, 1988; huys, maia, & frank, 2016) and have been promoted in psychiatry (friston, stephan, montague, & dolan, 2014; petzschner, 2017) and psychosomatics (petzschner, weber, gard, & stephan, 2017). com‐ putational approaches are advocated, for example, to bridge the gap between neural pat‐ tern activity and behavioral data (stephan & mathys, 2014), to improve (data-driven) phe‐ notyping of patients (patzelt, hartley, & gershman, 2018), and to develop, test and im‐ prove theoretical explanatory models through simulation (lehnen et al., submitted). a re‐ cent first attempt at the latter approach, combining mathematical formulization of an ex‐ isting explanatory model with experiments, has proven useful to deepen our understand‐ ing of the complex mechanisms underlying persistent physical symptoms (lehnen, schröder, henningsen, glasauer, & ramaioli, 2019). how relevant is this for clinical psychology in practice? several important new devel‐ opments will probably force us to go in this direction. first, ecological momentary assess‐ ments will undoubtedly become increasingly standard to measure self-reported variables of cognitive and affective processes and social interactions while they are occurring. sec‐ ond, it will increasingly become standard to concurrently collect psychophysiological and behavioral data through unobtrusive body sensors. both sources of information in real life will generate large multilevel sets of data per person in multiple conditions. since clinical psychology is primarily concerned with care for an individual patient in a partic‐ ular context, this is exactly the kind of data that is relevant for personalized care. individ‐ ualized functions comprising deterministic and stochastic variables that model observa‐ tions registered across multiple occasions in multiple relevant contexts actually represent a theory of an individual that may act as an empirically based tool to expect/predict (and understand) behavior. in addition, such functions can be used to assess step by step change over time in a therapeutic process. aggregation of single-case data may enable us to generalize and develop data-driven models and theories and/or to test and refine exist‐ ing theoretical models. such an approach, which has already been successfully applied in other clinical specialties (for a recent example see glasauer, dieterich, & brandt, 2018), editorial 2 clinical psychology in europe 2019, vol.1(3), article e39237 https://doi.org/10.32872/cpe.v1i3.39237 https://www.psychopen.eu/ turns the current situation upside down: rather than using heuristics that are based on experiments to intuitively predict/understand behavior of an individual patients in a par‐ ticular context, the reverse sequence might result in quite different models that, for ex‐ ample, attribute much more weight to contextual variables. obviously, this may require clinical psychologists to be trained in a completely different way, as well as may require much more interdisciplinary collaboration. r e f e r e n c e s friston, k. j., stephan, k. e., montague, r., & dolan, r. j. (2014). computational psychiatry: the brain as a phantastic organ. lancet psychiatry, 1(2), 148-158. https://doi.org/10.1016/s2215-0366(14)70275-5 glasauer, s., dieterich, m., & brandt, t. (2018). neuronal network-based mathematical modeling of perceived verticality in acute unilateral vestibular lesions: from nerve to thalamus and cortex. journal of neurology, 265(suppl 1), 101-112. https://doi.org/10.1007/s00415-018-8909-5 huys, q. j., maia, t. v., & frank, m. j. (2016). computational psychiatry as a bridge from neuroscience to clinical applications. nature neuroscience, 19(3), 404-413. https://doi.org/10.1038/nn.4238 lehnen, n., radziej, k., weigel, a., von känel, r., glasauer, s., pitron, v., … henningsen, p. on behalf of the euronet-soma group (submitted). computational-experimental psychosomatics for a better understanding of persistent somatic symptoms. manuscript submitted for publication. lehnen, n., schröder, l., henningsen, p., glasauer, s., & ramaioli, c. (2019). deficient head motor control in functional dizziness: experimental evidence of central sensory-motor dysfunction in persistent physical symptoms. progress in brain research, 249, 385-400. https://doi.org/10.1016/bs.pbr.2019.02.006 patzelt, e. h., hartley, c. a., & gershman, s. j. (2018). computational phenotyping: using models to understand individual differences in personality, development, and mental illness. personality neuroscience, 1, article e18. https://doi.org/10.1017/pen.2018.14 petzschner, f. h. (2017). stochastic dynamic models for computational psychiatry and computational neurology. biological psychiatry: cognitive neuroscience and neuroimaging, 2(3), 214-215. https://doi.org/10.1016/j.bpsc.2017.03.003 petzschner, f. h., weber, l. a., gard, t., & stephan, k. e. (2017). computational psychosomatics and computational psychiatry: toward a joint framework for differential diagnosis. biological psychiatry, 82(6), 421-430. https://doi.org/10.1016/j.biopsych.2017.05.012 sejnowski, t. j., koch, c., & churchland, p. s. (1988). computational neuroscience. science, 241(4871), 1299-306. https://doi.org/10.1126/science.3045969 stephan, k. e., & mathys, c. (2014). computational approaches to psychiatry. current opinion in neurobiology, 25, 85-92. https://doi.org/10.1016/j.conb.2013.12.007 van den bergh & lehnen 3 clinical psychology in europe 2019, vol.1(3), article e39237 https://doi.org/10.32872/cpe.v1i3.39237 https://doi.org/10.1016/s2215-0366(14)70275-5 https://doi.org/10.1007/s00415-018-8909-5 https://doi.org/10.1038/nn.4238 https://doi.org/10.1016/bs.pbr.2019.02.006 https://doi.org/10.1017/pen.2018.14 https://doi.org/10.1016/j.bpsc.2017.03.003 https://doi.org/10.1016/j.biopsych.2017.05.012 https://doi.org/10.1126/science.3045969 https://doi.org/10.1016/j.conb.2013.12.007 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. editorial 4 clinical psychology in europe 2019, vol.1(3), article e39237 https://doi.org/10.32872/cpe.v1i3.39237 https://www.psychopen.eu/ the icd-11 diagnoses in the mental health field – an innovative mixture editorial the icd-11 diagnoses in the mental health field – an innovative mixture andreas maercker 1 [1] department of psychology, division of psychopathology and clinical intervention, university of zurich, zurich, switzerland. clinical psychology in europe, 2022, vol. 4(special issue), article e10647, https://doi.org/10.32872/cpe.10647 published (vor): 2022-12-15 corresponding author: andreas maercker, university of zurich, division of psychopathology and clinical intervention, department of psychology; binzmühlestrasse 14/17, 8050 zürich, switzerland. e-mail: maercker@psychologie.uzh.ch related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si the development of icd-11 in the mental health field has been innovative in several ways. perhaps most notable is that it has become equally relevant to clinicians and re­ searchers. before discussing these two aspects in more detail, it should be mentioned that the processes by which the icd-11 was created were also innovative and, moreover, that clinical psychologists and psychiatrists were equally involved at several crucial points in the icd-11 development. this began with dr. geoffrey reed, a us clinical and medical psychologist, as the responsible who senior project officer for new developments in the mental health field and who set important impulses at all stages of the process (e.g., reed, 2010). from the beginning, the lebanese psychologist brigitte khoury and the mexican psy­ chologist maria elena medina-mora served on the international advisory group for this field. both have published on important milestones and outcomes of regional meetings (khoury et al., 2011; medina-mora et al., 2019). furthermore, the author of this editorial, in his capacity as a psychologist, was one of the working group leaders of the icd-11 development (maercker et al., 2013). this new way of composing decision-making bodies represented an important step in the development of the international mental and be­ havioral disorder classification. this was further supported by the inclusion of clinicians and researchers from the fields of clinical social work and psychiatric nursing sciences in the committees. thus, the whole icd-11 development relied on a very multidisciplinary process. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10647&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0001-6925-3266 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ what, then, were the innovations for clinicians worldwide? from the very start, the aim was that “clinical usability” should be the focus of development (first et al., 2015). the rationale for this was that global applicability should be ensured both in countries with few and with ample health system resources. the intention was to avoid creating complex and costly diagnostic algorithms that would be unrealistic for the time and human resources available in some regions of the world. regarding clinical usability, the arguments were also based on the limited memory capacity for information elements known from general psychology, which typically does not allow for an overly complex diagnostic decision process without the loss of information. here, experts distinguished their approach from highly complex diagnostic algorithms in the dsm (diagnostic and statistical manual of mental disorders), which, for example, had different minimum numbers of required symptoms for several symptom groups. in addition, the dsm in its various versions contained lists of symptoms and criteria that grew longer and were almost unmanageable in each new version (dsm-iii, dsm-iii-r, dsm-iv, dsm-iv-tr). therefore, the international advisory group made a preliminary decision to follow a prototype approach to disorder definitions. this meant that a few symptoms define the core of a diagnosis (core symptoms or essential features), with a number of other associated symptoms (accessory symptoms or additional clinical features), which must not all be present to assign a diagnosis. the international advisory group also made the decision to omit subtypes from the diagnoses as much as possible, which was later widely adopted in the icd-11 development. further means of increasing clinical usability was the introduction of new sections in the definition texts: e.g., boundary with normality, developmental presentations, culture-related features, sexand/or gender-related features, boundaries with other disorders and conditions (differential diagnosis). these helpful new sections of icd-11 are discussed in most of the articles in this special issue. these sections are, in fact, included as standard in the central internet publication of icd-11 as so-called clinical descriptions and diagnostic recommendations (cddr) and, as with all material from the who, are also available free of charge. how about the scientific innovations? it is impossible to list all innovations in the present context. in terms of methodology, innovations were based on the serious consideration of and alignment with the customer orientation. customers of a classifi­ cation system include the global clinicians or practitioners, as well as the patients or clients in the health care system – both of these groups were involved throughout the entire process. furthermore, survey studies were conducted with the world associations of psychologists and psychiatrists to ask about previous diagnostic habits, as well as missing, problematic, and stigmatizing diagnoses (robles et al., 2014). the results of these studies were implemented whenever possible. for example, 12% of these studies (of over 3200 clinicians from 13 countries across six continents) indicated a need for a diagnosis that went beyond "classic" ptsd to include more complex trauma sequelae. the icd-11 diagnoses in the mental health field – an innovative mixture 2 clinical psychology in europe 2022, vol. 4(special issue), article e10647 https://doi.org/10.32872/cpe.10647 https://www.psychopen.eu/ this finding informed the development of the diagnosis of complex ptsd that now exists in icd-11 (see the paper in this special issue). moreover, the patients or people affected by the disorders were also involved in the feedback process of the icd-11 development (hackmann et al., 2019). for the subsequent steps of icd-11 finalization, the global clinical practice network (https://gcp.network) handled the involvement of global clinicians and practitioners. this network operates in nine world languages (including six european languages) and comprises approximately 10,000 people to date (operating in collaboration with columbia university, new york). beta versions of the new diagnostic proposals were submitted to this network in 2015, and for more recent surveys, the revised diagnoses were also submitted for further review. it is noteworthy to mention that one can also enroll in online continuing education courses in this network. it is impossible to provide an overview of the various innovations and their details here, as they are too extensive for an overview. this special edition of clinical psycholo­ gy in europe (cpe) is very pleased to present five very different topic areas: the autism spectrum disorder (which belongs to the neurodevelopmental disorders), the disorders specifically associated with stress (a separate subchapter), the personality disorders (also a separate subchapter), the disorders of substance use (with the emphasis here on alcohol use and a smaller focus on addictive behaviors), as well as chronic pain (a separate, overarching subchapter). it is very fortunate that our journal clinical psychology in europe is addressing the topic of icd-11 diagnoses, and as mentioned earlier, that many other regions of the world have already highlighted it as an area of particular prominence and innovation. it is interesting to note that the majority of international research activities on the individ­ ual disorders of icd-11 come from outside the united states, with european research activities playing a prominent role. not incidentally, these activities merge closely with who-sponsored programs on culturally appropriate interventions for global application (heim & kohrt, 2019; heim et al., 2021). however, in recent years, there has also been an incipient trend of an increasing number of us studies being devoted to icd-11 (e.g., cloitre et al., 2019). cpe will certainly continue to have a focus on contributions related to this global classification system, which is equally useful for both clinicians and researchers. funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. maercker 3 clinical psychology in europe 2022, vol. 4(special issue), article e10647 https://doi.org/10.32872/cpe.10647 https://www.psychopen.eu/ r e f e r e n c e s cloitre, m., hyland, p., bisson, j. i., brewin, c. r., roberts, n. p., karatzias, t., & shevlin, m. 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(2014). problematic, absent and stigmatizing diagnoses in current mental disorders classifications: the icd-11 diagnoses in the mental health field – an innovative mixture 4 clinical psychology in europe 2022, vol. 4(special issue), article e10647 https://doi.org/10.32872/cpe.10647 https://doi.org/10.1002/jts.22454 https://doi.org/10.1002/wps.20189 https://doi.org/10.1016/s2215-0366(19)30093-8 https://doi.org/10.32872/cpe.v1i4.37679 https://doi.org/10.32872/cpe.6351 https://doi.org/10.1002/wps.20057 https://doi.org/10.1016/j.ijchp.2018.09.003 https://doi.org/10.1037/a0021701 https://www.psychopen.eu/ results from the who-wpa and who-iupsys global surveys. international journal of clinical and health psychology, 14(3), 165–177. https://doi.org/10.1016/j.ijchp.2014.03.003 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. maercker 5 clinical psychology in europe 2022, vol. 4(special issue), article e10647 https://doi.org/10.32872/cpe.10647 https://doi.org/10.1016/j.ijchp.2014.03.003 https://www.psychopen.eu/ the effect of television and print news stories on the nocebo responding following a generic medication switch research articles the effect of television and print news stories on the nocebo responding following a generic medication switch kate mackrill a, greg d. gamble b, keith j. petrie a [a] department of psychological medicine, university of auckland, auckland, new zealand. [b] department of medicine, university of auckland, auckland, new zealand. clinical psychology in europe, 2020, vol. 2(2), article e2623, https://doi.org/10.32872/cpe.v2i2.2623 received: 2019-12-31 • accepted: 2020-02-16 • published (vor): 2020-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: keith j. petrie, psychological medicine, faculty of medical and health sciences, university of auckland, private bag 92019, auckland, new zealand. e-mail: kj.petrie@auckland.ac.nz abstract background: following a nationwide switch to a generic antidepressant, a series of negative media stories publicised the experiences of some patients having side effects following the switch. this occurred first in print media and five months later it occurred again in television news. in this study we examined the effect of television news stories compared to print stories on adverse drug reaction reporting. we also examined the change in reporting rate of specific side effects mentioned in the tv news bulletins. method: using an interrupted time series analysis of data from a national adverse reactions database, we compared the number of adverse reaction reports after the print and television coverage and the changes in reporting rate of side effects mentioned and not mentioned in tv news stories. results: we found a significant increase in adverse reaction reports following tv news items that discussed patients’ reports of side effects following the medication switch (interruption effect = 73.25, p = .046). the reporting rate of symptoms mentioned in the tv news bulletins also increased, in particular suicidal thoughts (interruption effect = 23.60, p = .031). the effect of tv stories on adverse reaction reports was 211% greater than the print articles. conclusions: television stories have a much stronger effect than print media on nocebo responding and specific symptoms mentioned in the bulletins have a direct influence on the type of side effects subsequently reported. media guidelines should be developed to reduce the negative public health effects of media coverage following medication switches. keywords nocebo effect, television media, print media, side effects, medication switch, generic medicine this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2623&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • this study shows that television news items have a considerably greater effect on the rate of adverse reaction reporting than print media. • the specific side effects mentioned in the television coverage, especially suicidal thoughts, showed an increase in reporting. • this study provides further evidence that media coverage of side effects can induce a nocebo effect and have negative effects on public health. negative media stories about medication can increase public anxiety and lead to a reduc‐ tion in the use of the drug highlighted in the news story. studies have shown that media coverage of the negative effects of statin medication is linked to the early discontinuation of the drug by patients in the united kingdom (matthews et al., 2016), australia (schaffer, buckley, dobbins, banks, & pearson, 2015) and france (saib et al., 2013) and led to a subsequent increase in the rates of heart attacks and cardiac deaths in denmark (nielsen & nordestgaard, 2016). while drops in rates of antidepressant dispensing have also been reported in the united states after widespread media coverage linking antidepressant medication to a possible increase in the risk of suicidal behaviour in young people (yu et al., 2014). negative news coverage can also lead to an increase in the rate of adverse reactions reported to medication due to the nocebo effect (petrie & rief, 2019). this typically occurs following publicity about a particular drug’s side effects, which increases the reporting of the specific side effects mentioned in the story, due to common symptoms being misattributed to the effect of the medicine (tan et al., 2014). an increase in the rate of adverse drug reaction reports was shown in new zealand following television news stories reporting that patients were experiencing problems after the appearance of a common thyroid replacement medication had changed due to a shift in manufacturing plant (faasse et al., 2009; faasse et al., 2012). a large increase in the adverse drug reac‐ tions reports to statins was also documented following a dutch television programme on the benefits and risks of statins (van hunsel et al., 2009). it seems likely that television may have a stronger effect on the nocebo response than print media, although this has not been formally investigated. despite the increased role of the internet and a drop in the number of young people watching, television still reaches a larger audience than other forms of news media (gollust et al., 2019). television news is also seen as having an important role in surveillance, by informing the public what health risks to be vigilant of and concerned about (brosius & kepplinger, 1990). television news stories about health risks also typically make more use of individual case studies and individual narratives as a key part of the story, which can play an important role in social modelling of side effects (faasse & petrie, 2016), as well as causing an overestimation of the likelihood of a health problem occurring (gollust et al., 2019). effect of television news stories 2 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ a recent nationwide switch from a branded to generic antidepressant medicine in new zealand in 2017 provided us with the opportunity to investigate the impact of newspaper stories on the nocebo effect. in this previous study we examined how news‐ paper stories published in february and april 2018 influenced side effect reporting up to july 2018 (mackrill et al., 2019). we found the number of side effects, particularly those mentioned in the stories, and complaints of reduced dug efficacy increased immediately after the newspaper stories before returning to baseline levels. however, later in the year after our paper was submitted, the medicine switch received more media attention, this time from television news. four tv news stories were broadcast from september 2 to no‐ vember 30 and discussed patients’ negative reactions following the generic venlafaxine switch. the television news coverage of the same generic switch allowed us to quantify the relative impact of newspaper and television media on the nocebo response. based on previous research we hypothesised that television news would have a larger impact. we also investigated the hypothesis that the specific side effects mentioned in the television news reports would increase adverse reaction reports to the national centre for adverse reactions monitoring (carm), compared to previously equivalently reported side effects not mentioned in the television bulletins. m e t h o d media coverage newspaper articles in february and april 2018, two of new zealand’s largest print media outlets published three newspaper and online articles discussing a small group of patients’ adverse reac‐ tions to the new generic version of the antidepressant venlafaxine (see table 1). the pre‐ vious year, 45,000 patients prescribed either the branded originator or a generic version of venlafaxine were switched to another generic, enlafax. this compulsory nationwide switch had been initiated by pharmac – the new zealand government’s pharmaceutical agency. the articles described patients’ concerns that enlafax was less effective and was causing side effects such as suicidal thoughts, nausea and headaches (see mackrill et al., 2019 for further details of the newspaper reports). mackrill, gamble, & petrie 3 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ ta b le 1 n ew z ea la nd p ri nt a nd t el ev is io n m ed ia c ov er ag e of t he v en la fa xi ne b ra nd c ha ng e d at e n ew s ou tl et it em t it le u r l p ri n t m ed ia fe br ua ry 2 8 20 18 n ew z ea la nd h er al d pa tie nt s sa y ge ne ri c ph ar m ac -f un de d ve rs io n of an tid ep re ss an t v en la fa xi ne le ft th em d ep re ss ed , an xi ou s ht tp s: // w w w .n zh er al d. co .n z/ nz /n ew s/ ar tic le .c fm ?c _i d= 1& ob je ct id =1 20 02 91 8 fe br ua ry 2 8 20 18 st uf f.c o. nz a nt i-d ep re ss an t s w ap : s uf fe re rs c la im g en er ic d ru g is ha rm in g th ei r co nd iti on ht tp s: // w w w .st uf f.c o. nz /n at io na l/h ea lth /1 01 62 83 17 /a nt id ep re ss an tsw ap -s uf fe re rs -c la im ge ne ri cdr ug -is -h ar m in gth ei rco nd iti on a pr il 27 2 01 8 st uf f.c o. nz fi gh t o ve r ph ar m ac 's sw itc h to g en er ic a nt i-d ep re ss an t br an d co nt in ue s ht tp s: // w w w .st uf f.c o. nz /n at io na l/h ea lth /9 93 88 64 5/ fig ht -o ve rph ar m ac ssw itc hto ge ne ri can tid ep re ss an tbr an dco nt in ue s te le vi si on m ed ia se pt em be r 2 20 18 o ne n ew s g ro w in g nu m be r of p at ie nt s qu es tio ni ng p ha rm ac 's de ci si on to fu nd a d iff er en t b ra nd o f a nt i-d ep re ss an t ht tp s: // w w w .tv nz .c o. nz /o ne -n ew s/ ne w -z ea la nd /g ro w in gnu m be rpa tie nt squ es tio ni ng ph ar m ac sde ci si on -f un ddi ffe re nt -b ra nd -a nt i-d ep re ss an t se pt em be r 26 2 01 8 o ne n ew s pa tie nt s re po rt in g lif eth re at en in g si de e ffe ct s fr om ne w a nt id ep re ss an t ht tp s: // w w w .tv nz .c o. nz /o ne -n ew s/ ne w -z ea la nd /p at ie nt sre po rt in glif eth re at en in gsi de ef fe ct sne w -a nt id ep re ss an t o ct ob er 2 0 20 18 o ne n ew s m en ta l h ea lth s pe ci al is ts q ue st io n ne w an tid ep re ss an t's e ffe ct iv en es s ht tp s: // w w w .tv nz .c o. nz /o ne -n ew s/ ne w -z ea la nd /m en ta l-h ea lth -s pe ci al is ts -q ue st io nne w an tid ep re ss an ts -e ffe ct iv en es s? au to =5 85 11 84 16 90 01 n ov em be r 30 2 01 8 o ne n ew s pa tie nt s cl ai m d is cr im in at io n af te r m ed sa fe w ar ns ab ou t j oi nt s up pl em en t b ut n ot a nt id ep re ss an t ht tp s: // w w w .tv nz .c o. nz /o ne -n ew s/ ne w -z ea la nd /p at ie nt scl ai m -d is cr im in at io naf te rm ed sa fe -w ar ns -jo in tsu pp le m en tbu tno tan tid ep re ss an t? au to =5 97 34 39 90 10 01 effect of television news stories 4 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12002918 https://www.stuff.co.nz/national/health/101628317/antidepressant-swap-sufferers-claim-generic-drug-is-harming-their-condition https://www.stuff.co.nz/national/health/101628317/antidepressant-swap-sufferers-claim-generic-drug-is-harming-their-condition https://www.stuff.co.nz/national/health/99388645/fight-over-pharmacs-switch-to-generic-antidepressant-brand-continues https://www.stuff.co.nz/national/health/99388645/fight-over-pharmacs-switch-to-generic-antidepressant-brand-continues https://www.tvnz.co.nz/one-news/new-zealand/growing-number-patients-questioning-pharmacs-decision-fund-different-brand-anti-depressant https://www.tvnz.co.nz/one-news/new-zealand/growing-number-patients-questioning-pharmacs-decision-fund-different-brand-anti-depressant https://www.tvnz.co.nz/one-news/new-zealand/patients-reporting-life-threatening-side-effects-new-antidepressant https://www.tvnz.co.nz/one-news/new-zealand/patients-reporting-life-threatening-side-effects-new-antidepressant https://www.tvnz.co.nz/one-news/new-zealand/mental-health-specialists-question-new-antidepressants-effectiveness?auto=5851184169001 https://www.tvnz.co.nz/one-news/new-zealand/mental-health-specialists-question-new-antidepressants-effectiveness?auto=5851184169001 https://www.tvnz.co.nz/one-news/new-zealand/patients-claim-discrimination-after-medsafe-warns-joint-supplement-but-not-antidepressant?auto=5973439901001 https://www.tvnz.co.nz/one-news/new-zealand/patients-claim-discrimination-after-medsafe-warns-joint-supplement-but-not-antidepressant?auto=5973439901001 https://www.psychopen.eu/ television news items five months after the print coverage, the venlafaxine brand change featured in a series of primetime news items on one news, new zealand’s largest television news broadcaster. the first item aired on september 2 and discussed the increasing number of patients questioning pharmac’s decision to fund a generic version of venlafaxine. three patients were interviewed and stated that enlafax had serious side effects, including increased suicidal ideation. while it is estimated that 2.4 of 4.8 million new zealanders watch television each day (thinktv, 2018), ratingpoint, a television viewership database by analytics company nielsen, shows that one news had an estimated audience of 679,500 viewers on september 2. later that month on september 26, another news item stated that more than 200 peo‐ ple had reported adverse reactions from the new generic some of which were considered life threatening. the side effects specifically mentioned were thoughts of self-harm and suicide, nightmares and feeling depressed. a general practitioner was interviewed for the item and stated that the side effects were linked to enlafax and called for patients’ previous medication to remain available as an alternative to the generic. this news bulletin received slightly fewer views at 577,100. on october 20, one news broadcast a third item on the venlafaxine brand change. this media report included interviews with patients as well as two mental health special‐ ists who questioned the effectiveness of the generic enlafax. patients reported feeling disorientated, having a foggy brain and experiencing brain zaps. in a statement, pharmac and medsafe (new zealand’s medicine’s safety authority) stood by the decision to change the funded brand of venlafaxine, emphasising that the medications are pharmaceutically identical. this item received 395,000 views, the lowest of the four items. the last media report on november 30 discussed patients’ claims of discrimination, as the new zealand government’s ministry of health had released two public health warnings about an over-the-counter supplement but had not issued a warning about ven‐ lafaxine, despite patient complaints. this item received 540,600 views and no side effects were mentioned. all four one news items were aired early in the nightly news bulletin between 6pm to 6:15pm. in 2018, one news had the highest ratings of all programmes in new zealand and was the most watched news programme (nielsen, 2018). outcome measures number of adverse reaction reports the primary variable of interest to this study was the number of adverse reaction reports submitted to carm each month. both healthcare professionals and patients can submit a report describing a suspected adverse reaction from a medicine or vaccine directly to carm. adverse reaction data was collected from october 2017 to march 2019 which mackrill, gamble, & petrie 5 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ covered a four-month period before the print articles (february 28 – april 27) to four months after the tv bulletins (september 2 – november 30). total side effects and decreased therapeutic response the total number of side effects reported each month was calculated by summing each patient’s side effect reports excluding decreased therapeutic response, which was calcula‐ ted separately. specific side effects we calculated the reporting rate for suicidal thoughts, foggy brain and brain zaps that were mentioned in the television news items. the carm side effects categories of suici‐ dal ideation, suicidal tendency, suicidal attempt, thoughts of self-harm, and intentional self-injury were summed and recoded as suicidal thoughts. both foggy brain and brain zaps mentioned in the television items do not have specific terms in the carm database. we used reports of fuzzy head and electrical shock sensations as the closest coded categories. we compared the side effects that were mentioned in the television coverage with three control side effects that were not mentioned in television bulletins but were reported at similar rates prior to the media coverage. these control side effects were dizziness, drug withdrawal syndrome and irritability. statistical analyses three analyses were conducted to investigate the study hypotheses. an interrupted time series analysis was conducted to determine whether the television news items were associated with an increase in carm reports, total side effects, reports of decreased therapeutic response, and the specific side effects of suicidal thoughts, foggy brain, brain zaps, dizziness, drug withdrawal syndrome and irritability. an automated integrated moving average model (arima [1,0,1]) was used. to indicate the presence of the televi‐ sion media in the model, an independent binary variable was created with the months september to december 2018 coded 1 and the five baseline pre-media months coded 0. this analysis produces an estimated interruption effect (the change in rate between the months coded 0 and 1) and indicates whether this is a significant change. in addition to this analysis, the number of adverse reaction reports was modelled using general linear modelling (glimmix) assuming a poisson distribution to test for differences in the total number of reports in discrete time periods: 5 pre-media baseline months, 3 months during the print media stories, the next 3 months (a pre-tv, no media period), 4 months during which television media reports appeared, and an additional post-tv 3 months. these time periods were pragmatically determined: initiated by the start of each type of media report and ending when reports had returned to the pre-me‐ dia reporting baseline. tukey’s hsd test was used to protect the overall 5% significance level after pairwise post hoc comparison of time periods. effect of television news stories 6 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ to examine the effect of print versus television media on adverse reporting, a poisson events test was conducted comparing total number of reports between pairs of months, specifically the peak month of reporting during the print media period and the peak during the tv media period. percentage change was used to describe the effect of the print and television media on number of carm reports. analyses were conducted in sas (v9.4 sas institute inc., cary, nc) and alpha level of .05 was considered significant for all analyses. r e s u l t s number of adverse reaction reports from august 2018 to march 2019 there were 341 adverse reaction reports to carm, with 317 of these occurring during the four-month period when the television items aired. the average age of reporters was 44.3 years old and 79.1% were female. these demographic proportions are similar to the total population of people taking venlafaxine in new zealand, the median age range being 40-49 years and 64.5% identifying as female (mackrill & petrie, 2018). the first aim of this study was to examine the impact of the television coverage on adverse event reporting and compare this with what was observed following the print media. there were significant differences between time periods in the number of adverse reaction reports (glimmix p < .001). in the five months before any print or television media (october 2017 to february 2018), there was an average of 6.00 (sd = 1.23) adverse reaction reports to carm per month. however, in the four months where the television coverage occurred, carm reports significantly increased to an average of 79.25 (sd = 60.26) reports per month (interruption effect [ie] = 73.25, p = .046). comparing the average effect of print versus television media, carm reports following the television coverage were 210.8% greater than those that followed the print (mean number of reports = 25.50, sd = 12.02), which was a significant difference (glimmix p = .004) as shown in figure 1. a poisson events test showed that the peak month of adverse reaction reporting during the television coverage was 408.8% greater than the peak during the print media period (p < .001). mackrill, gamble, & petrie 7 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ figure 1 the effect of television compared to print media stories on total number of adverse reaction reports to the centre for adverse reactions monitoring following a switch to generic venlafaxine note. the number of adverse reaction reports during pre-media baseline was not significantly different to the reporting rate pre (glimmix p = .220) or post (glimmix p = .120) the television coverage. total number of side effects and decreased therapeutic response reports individual carm reports submitted from august 2018 to march 2019 listed an average of 2.88 side effects attributed to enlafax. the rate of side effect reporting significantly changed from baseline to post-television. the total number of side effects reported to carm significantly increased from an average of 7.00 reports (sd = 4.18) per month before any media coverage to 235.75 (sd = 184.77) following the television items (ie = 228.75, p = .042). reports of ‘decreased therapeutic response’ increased from 4.00 (sd = 2.12) before the media to 52.25 (sd = 39.35) after the television, however this was not a statistically significant change (p = .064). specific side effects reports we investigated the change in reporting of rate of three side effects that were mentioned in the television coverage (figure 2). the generalised mixed model and interrupted time series analyses both showed a significant increase in reports of suicidal thoughts from an average of 0.40 (sd = 0.55) in the five months before any media coverage to 24.00 (sd = 16.66) following the television (glimmix p = .029; ie = 23.60, p = .031). the reporting rate of foggy brain did not show a statistically significant increase in the number of effect of television news stories 8 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ reports in each time period (glimmix p = .160; ie = 8.13, p = .160), however there was an increasing trend with reports going from 0.20 (sd = 0.40) before the media coverage to 8.33 (sd = 9.74) after the television item aired in october. while there were no reports of brain zaps during the pre-media period, the rate increased to an average of 7.00 (sd = 8.52) but this was not significantly different to baseline (glimmix p = .150; ie = 7.00, p = .098). figure 2 number of reports of side effects mentioned in the television news reports on the venlafaxine switch compared to side effects that were not mentioned finally, we examined whether there was a change in the reporting rate of three side effects that were not mentioned in the media (figure 2). reports of dizziness increased from an average of 0.20 (sd = 0.40) over the five baseline months to 7.00 (sd = 6.40) following the television coverage, which has a statistically significant interruption effect (ie = 6.80, p = .024), however, the general linear model was not statistically significant (glimmix p = .110). the reporting rate of drug withdrawal syndrome did not significant‐ ly change from 0.40 (sd = 0.49) to 4.25 (sd = 2.86) after the television media (glimmix mackrill, gamble, & petrie 9 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ p = .470; ie = 3.85, p = .180). similarly, reports of irritability did not significantly change from 0.20 (sd = 0.40) to 4.75 (sd = 3.27) (glimmix p = .011; ie = 4.55, p = .240). d i s c u s s i o n main findings this study found a significant increase in the number of adverse reaction reports fol‐ lowing a switch to a generic formulation of venlafaxine, which corresponded to the broadcast of four television news items that discussed this medication change. in line with our hypothesis, we found the effect of tv stories on adverse reaction reports to carm was significantly higher than print media, causing an approximately 200% greater rise in adverse reaction reports than the publication of the print articles earlier that year. television news also had a 400% greater peak in reported adverse reports compared to print media, indicating a much stronger nocebo response. there was also partial support for the hypothesis that the specific symptoms mentioned in the tv coverage would be reflected in subsequent side effect reporting. there was an increase in the reporting of side effects mentioned in the television items, especially suicidal thoughts, and although this was generally larger than the symptoms that were not mentioned, it could be that tv coverage causes a greater awareness of side effects in general, rather than being restricted to those specifically mentioned in the bulletins. looking at the reasons why tv has a much stronger effect than print media, it seems unlikely that this is due to the use of expert opinion or difference in the amount of cover‐ age (3 print versus 4 tv stories). a more likely explanation is that television contains a stronger and more impactful modelling element by including real patient stories and experiences that can be easily identified with by viewers (faasse, grey, jordan, garland, & petrie, 2015; faasse & petrie, 2016). comparison with other studies the results are consistent with data in the medical area showing intense negative media coverage on statins was followed by an increase in patients stopping the drug (matthews et al., 2016; schaffer et al., 2015). the results also align with previous work on tv news stories. for example, the thyroxine drug scare produced an increase in both symptom reporting and the specific symptoms mentioned in bulletins, increasing adverse reaction reports by 1,866% following the first television news story (faasse et al., 2012). the current study showed an even larger increase in adverse reaction reports after the first television news bulletin of 4,283%. more widely, the data are consistent with the powerful social modelling effects of tv in the context of suicidal behaviour (hawton & williams, 2002), mass shootings (meindl & ivy, 2017) and the transmission of acute stress following terrorist attacks (holman et al., 2014). the unique contribution of this paper is effect of television news stories 10 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ to quantify the relative impact of television compared to print media and to demonstrate how much more impact tv has in the context of a health scare. it may be that the nature of the population taking venlafaxine could have influenced the strength of the nocebo response. the indications for the drug are for depressive and anxiety disorders and the nocebo effect has been shown to occur more frequently in patients being treated for psychological conditions (weissenfeld et al., 2010). individuals taking venlafaxine may have been more reactive to negative stories, increasing their overall concerns about the medication. it is likely that the increased nocebo response apparent following media coverage arose from an overall increase in anxiety, increased expectations of side effects and greater personal monitoring of the side effects specifical‐ ly mentioned in these bulletins (crichton et al., 2014; faasse & petrie, 2016; petrie, mossmorris, grey, & shaw, 2004; petrie & rief, 2019). of particular concern in such situations is the media transmission of suicidal thoughts, which seem to be easily converted into increased rates of suicidal ideation following both print and television media stories and possibly greater rates of suicidal behaviour, although this has yet to be determined in this situation. strengths and limitations the study is limited by reliance on reporting to the national centre and is likely to be a low estimate of the true rate of nocebo response following the media stories as many patients would not have reported symptoms to carm or to a health professional. it is also likely that many doctors may not have taken the time to file a report. previous studies estimate that reports to a national database are less than 10% of adverse drug reactions (mcgettigan et al., 1997). as the reports to carm are de-identified we are unable to examine other personal characteristics that may be associated with increased or decreased nocebo responding. however, people who are older, female and with lower medicine efficacy beliefs have been shown to report more side effects following a generic medicine switch (mackrill & petrie, 2018). it should be also noted that the current study only had access to adverse reaction reports per month. this makes it more difficult to separate out media effects from background noise compared to a finer grain of measure‐ ment such as weekly reports. in conclusion, we believe this is the first study to compare the effect of both print and television media on medication adverse event reporting. we found television news stories have around a 200% stronger effect on nocebo responding than print media and cause an immediate increase in overall adverse reaction responding as well as influenc‐ ing the type of symptoms reported following the coverage. television news coverage can easily increase overall anxiety about a medication and cause individuals to focus on their symptoms as possible side effects. the transmission of symptoms of suicidal ideation is of special concern as there is good evidence of a strong modelling effect on suicidal behaviour from media stories (hawton & williams, 2002). we believe the data indicate mackrill, gamble, & petrie 11 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://www.psychopen.eu/ that media guidelines should be developed to reduce the possible harm from stories that focus on dramatic negative effects reported by individual patients to include information from a wider range of professionals and agencies as well as including information about the nocebo response. funding: the authors have no funding to report. competing interests: km & gg declare no conflicts of interest. kp has received research grants in the past from pharmac, the new zealand government’s pharmaceutical management agency. acknowledgments: the authors have no support to report. r e f e r e n c e s brosius, h.-b., & kepplinger, h. m. 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(2015). the crux of the matter: did the abc’s catalyst program change statin use in australia? the medical journal of australia, 202, 591-595. https://doi.org/10.5694/mja15.00103 tan, k., petrie, k. j., faasse, k., bollard, m., & grey, a. (2014). unhelpful advice on adverse drug reactions. bmj, 349, article g5019. https://doi.org/10.1136/bmj.g5019 thinktv. (2018). fast facts – new zealand tv viewing. retrieved from https://thinktv.co.nz/research/fast-facts-nz/ van hunsel, f., passier, a., & van grootheest, k. (2009). comparing patients and health professionals’ adr reports after media attention: the broadcast of a dutch television programme about the benefits and risks of statins as an example. british journal of clinical pharmacology, 67, 558-564. https://doi.org/10.1111/j.1365-2125.2009.03400.x mackrill, gamble, & petrie 13 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://doi.org/10.32872/cpe.v1i1.29642 https://doi.org/10.1136/bmjopen-2018-023667 https://doi.org/10.1136/bmj.i3283 https://doi.org/10.1046/j.1365-2125.1997.00616.x https://doi.org/10.2105/ajph.2016.303611 https://doi.org/10.1093/eurheartj/ehv641 https://doi.org/10.1348/135910704322778759 https://doi.org/10.1146/annurev-psych-010418-102907 https://doi.org/10.1016/j.acvd.2013.06.053 https://doi.org/10.5694/mja15.00103 https://doi.org/10.1136/bmj.g5019 https://thinktv.co.nz/research/fast-facts-nz/ https://doi.org/10.1111/j.1365-2125.2009.03400.x https://www.psychopen.eu/ weissenfeld, j., stock, s., lüngen, m., & gerber, a. (2010). the nocebo effect: a reason for patients’ non-adherence to generic substitution? die pharmazie, 65, 451-456. https://doi.org/10.1691/ph.2010.9749 yu, c. y., lakoma, m. d., madden, j. m., rusinak, d., penfold, r. b., simon, g., . . . soumerai, s. b. (2014). changes in antidepressant use by young people and suicidal behaviour after fda warnings and media coverage: quasi experimental study. bmj, 348, article g3596. https://doi.org/10.1136/bmj.g3596 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. effect of television news stories 14 clinical psychology in europe 2020, vol.2(2), article e2623 https://doi.org/10.32872/cpe.v2i2.2623 https://doi.org/10.1691/ph.2010.9749 https://doi.org/10.1136/bmj.g3596 https://www.psychopen.eu/ effect of television news stories (introduction) method media coverage outcome measures statistical analyses results number of adverse reaction reports total number of side effects and decreased therapeutic response reports specific side effects reports discussion main findings comparison with other studies strengths and limitations (additional information) competing interests funding acknowledgments references reduction of pathological skin-picking via expressive writing: a randomized controlled trial research articles reduction of pathological skin-picking via expressive writing: a randomized controlled trial carina schlintl 1 , anne schienle 1 [1] clinical psychology, university of graz, biotechmed, graz, austria. clinical psychology in europe, 2023, vol. 5(2), article e11215, https://doi.org/10.32872/cpe.11215 received: 2023-01-24 • accepted: 2023-04-11 • published (vor): 2023-06-29 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: anne schienle, clinical psychology, university of graz, universitätsplatz 2/iii, a-8010, graz, austria. phone: +43 (0)316 380 – 5086. e-mail: anne.schienle@uni-graz.at supplementary materials: materials, preregistration [see index of supplementary materials] abstract background: expressive writing (ew: a personal form of writing about emotional distress, without regard to writing conventions) can improve physical and mental health. the present study investigated whether ew can reduce pathological skin-picking. in addition, the effects of two modalities of writing were contrasted with each other: computer vs. paper/pencil. method: a total of 132 females with self-reported pathological skin-picking participated in a twoweek intervention. they either carried out six ew sessions or wrote about six abstract paintings (control condition), using either paper/pencil or a computer. before and after each session, participants rated their affective state and the urge to pick their skin via a smartphone application. questionnaires for assessing skin-picking severity were completed before and after the two-week intervention. results: the urge for skin-picking decreased directly after a writing session. the reduction was more pronounced in participants of the ew group, who also experienced reduced tension and increased feelings of relief at the end of a writing session. ew also reduced the severity of focused skin-picking after the two-week intervention. the writing modality had no differential effect on skin-picking symptoms. conclusions: this study identified beneficial effects of ew on pathological skin-picking. a future study could investigate ew as a potential tool in the context of (online) psychotherapy for skinpicking disorder. keywords skin-picking, expressive writing, app-assisted approach, tension, relief this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.11215&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0002-2285-0650 https://orcid.org/0000-0003-2173-6626 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • expressive writing (ew) reduces pathological skin-picking. • ew reduces the urge for skin-picking. • ew increases feelings of relief. • the beneficial effects of ew are associated with trait anxiety. skin-picking is a common behavior in the general population. while occasional manipu­ lation of the skin in the form of picking at scabs, bumps, or the cuticles around finger­ nails can be considered normal and generally as not having any negative consequences, more frequent and intense skin-picking can lead to somatic problems (skin lesions, infections, scars) and impaired socio-emotional functioning. in this case, excessive skinpicking has developed into a mental disorder, labeled as skin-picking disorder (spd; american psychiatric association, 2013). research suggests that (benign as well as pathological) skin-picking often occurs in reaction to the experiencing of negative affective states (e.g., anger, anxiety). it usually provides short-term relief of tension and elicits positive feelings (bohne et al., 2002). indeed, many people who pick their skin report that they find it soothing, satisfying, and/or rewarding (gallinat et al., 2021; schienle & wabnegger, 2020). thus, skin-picking can be seen to serve emotion regulation, which can be functional (as in occasional skin-picking), or dysfunctional (as in spd). several studies have shown associations between excessive skin-picking and difficul­ ties in emotion regulation (prochwicz et al., 2018; schienle et al., 2018; snorrason et al., 2010). for example, snorrason et al. (2010) demonstrated that difficulties in emotion regulation (e.g., difficulties engaging in goal-directed behavior under distress), as well as increased emotional reactivity, predicted pathological skin-picking. a study by schienle et al. (2018) also found strong associations between excessive skin-picking and emotion dysregulation. more specifically, the severity of focused skin-picking (i.e., skin-picking performed with full awareness, in contrast to automatic skin-picking) was predicted by difficulties in controlling impulsive behaviors, self-disgust (the tendency to feel disgusted by one's behavior), and disgust proneness (the tendency to experience disgust towards potential transmitters of disease). further, prochwicz et al. (2018) investigated a non-clin­ ical sample (university students) and also found an association between a strategy for emotion regulation and skin-picking severity. it was shown in that study that those who used cognitive reappraisal more often (i.e., re-evaluation of emotion-eliciting situations/ cognitive distancing) reported a lower skin-picking severity. the studies mentioned above suggest that excessive skin-picking might be used as an alternative strategy for controlling one’s negative emotions when other effective strategies are not at hand. along this line of reasoning, the emotion regulation model of spd (e.g., snorrason et al., 2010) holds that skin-picking is an emotion regulation reduction of pathological skin-picking via expressive writing 2 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ strategy used by people who have difficulties in applying more adaptive strategies. based on these findings, it would appear important to offer alternative methods for emotion regulation to those who pick their skin excessively. one possible approach is expressive writing (ew). ew can be described as personal and emotional writing without regard to form or writing conventions (e.g., spelling, punctuation, grammar). ew was first introduced by pennebaker and beall (1986) who asked students to write about their thoughts and feelings associated with a stressful/traumatic or neutral event. the protocol in that inves­ tigation included four writing sessions, each lasting 15 minutes. it was found that ew fostered favorable physical and mental health-related outcomes: a reduction of visits to the university health center during a 6-month follow-up period and improved well-being. further, two meta-analyses support the notion that ew about upsetting experiences produces improvements in mood as well as in indicators of quality of life (pavlacic et al., 2019; reinhold et al., 2018). the mechanisms underlying the positive effects of ew are still under investigation. pennebaker et al. (1990) have suggested that the process of ew can help one to better understand a distressing event that has taken place (gaining insight), and further, that ew can promote better problem-solving. ew has also been suggested to support disin­ hibition (catharsis), self-regulation, social integration, and acceptance of the negative experience (frattaroli, 2006; pavlacic et al., 2019). finally, other authors have emphasized the role of exposure in ew (frattaroli, 2006). participants subject to ew interventions repeatedly confront themselves with thoughts and feelings regarding an upsetting event. similarities can be drawn between this approach and exposure (or flooding) therapy, which promotes habituation, extinction, and cognitive restructuring. based on meta-ana­ lytical findings, frattaroli (2006) concluded that exposure theory has received the most empirical support for explaining ew effects. in the case of excessive skin-picking, it is very likely that ew possesses an additional positive component: the mechanical requirements of writing (either by hand or by com­ puter) make skin-picking difficult to perform at the same time. thus, ew incorporates a form of ‘stimulus control’ (by reducing the opportunity to perform skin-picking), which has been identified as a successful psychological treatment strategy for skin-picking disorder (snorrason et al., 2017). further, the process of writing – holding the pen and performing up and down movements – is somewhat similar to the physical movements involved in skin-picking. along these lines, patients with spd have reported that draw­ ing (e.g., pencil sketches) can be a replacement behavior for skin-picking (atkin, 2017). thus, it is assumed that the process of writing in ew, particularly in the paper/pencil form, may contribute to its effectiveness in reducing skin-picking. the present study investigated whether a two-week intervention with ew (including six writing sessions) could reduce pathological skin-picking. short-term effects of ew (e.g., changes in the urge to pick one’s skin directly after a writing session), as well schlintl & schienle 3 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ as mid-term effects (e.g., changes in self-reported skin-picking severity), were assessed. further, the effects of two modalities of writing on the urge for skin-picking were contrasted with each other: computer vs. paper/pencil. the following hypothesis had been preregistered: expressive writing (particularly paper/pencil writing) reduces skinpicking behavior. in addition, an exploratory regression analysis was carried out to identify variables (e.g., number of completed writing sessions, trait anxiety) that were associated with the effectiveness of expressive writing (in terms of reduction in the urge for skin-picking). m e t h o d participants participants with self-reported pathological skin-picking were invited to participate in a study on the effects of different writing interventions (this was carried out via postings on social media, and self-help groups for skin-picking disorder). the invitation included a link to an online survey that checked that participants met inclusion/exclusion crite­ ria. inclusion criteria were female sex, because of a higher prevalence of skin-picking behavior in the female population (apa, 2013), and scores ≥ 7 on the skin picking scale-revised (sps_r, gallinat et al., 2016). exclusion criteria included an existing diag­ nosis of a psychotic disorder, substance dependence, posttraumatic stress disorder, or depression with severe symptoms. furthermore, participants who reported skin diseases were excluded. a total of 308 participants were eligible; of them, 158 could be contacted and agreed to participate in the study. twenty-six participants (16%) dropped out of the study during the intervention. data from 132 participants were included in the analyses (see supplementary figure 1: consort flow diagram). 34% of the females participated in self-help groups during the course of the study. the participants were randomly allocated to one of four groups: (a) expressive writing (paper/pencil), (b) expressive writing (computer), (c) picture description (pa­ per/pencil), (d) picture description (computer). the four groups did not differ in the number of participants, mean age, years of education, and reported symptom severity of skin-picking as assessed by the skin picking scale (sps_r; gallinat et al., 2016) and the milwaukee inventory for the dimensions of adult skin-picking (midas; walther et al., 2009; m = 22.36, sd = 4.56). moreover, participants did not differ in trait anxiety and trait depression according to the state-trait anxiety and depression inventory (stadi; laux et al., 2013). for group characteristics see table 1. reduction of pathological skin-picking via expressive writing 4 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ table 1 group characteristics (means, standard deviations, f/chi-square statistics) characteristic expressive writing (paper/ pencil) expressive writing (computer) picture description (paper/pencil) picture description (computer) statistics m (sd) m (sd) m (sd) m (sd) mean age (years) 28.21 (8.13) 27.71 (10.69) 30.29 (11.80) 27.50 (6.98) f(3,128) = .61, p = .608, ηp2 = .014 years of education 14.09 (2.14) 13.68 (2.17) 13.68 (2.26) 14.03 (2.16) f(3,128) = .34, p = .796, ηp2 = .008 sps_r 14.58 (4.15) 14.58 (3.78) 14.11 (4.13) 14.47 (4.04) f(3,128) = .11, p = .954, ηp2 = .003 midas (focused) 22.88 (4.97) 22.55 (3.84) 21.50 (5.28) 22.70 (3.81) f(3,128) = .661, p = .578, ηp2 = .015 stadi_depression 20.70 (5.75) 21.45 (6.07) 21.58 (6.04) 22.00 (5.87) f(3,128) = .268, p = .849, ηp2 = .006 stadi_anxiety 23.97 (5.55) 23.55 (5.41) 23.74 (6.32) 25.20 (5.19) f(3,128) = .530, p = .662, ηp2 = .012 n n n n number of participants 33 31 38 30 χ2(3) = 1.15, p = .765 dropout rate 9 3 8 6 χ2(3) = 2.23, p = .527 note. sps_r = skin picking scale revised; midas (focused) = subscale focused picking of the milwaukee inventory for the dimensions of adult skin picking; stadi_depression = subscale trait depression of the state trait anxiety and depression inventory; stadi_anxiety = subscale trait anxiety of the state trait anxiety and depression inventory. all participants provided written informed consent before participating. this study was preregistered on the german register for clinical studies (drks00029224; 2022/06/07) and approved by the ethics committee of the university (gz. 39/79/63 ex 2021/22). questionnaires before and after the two-week intervention participants filled out the following ques­ tionnaires via online surveys: a. german version of the skin picking scale-revised (gallinat et al., 2016), which assesses symptom severity and impairment due to skin-picking during the last week. the eight items (e.g., how strong was your urge to pick your skin?) are answered on schlintl & schienle 5 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ 5-point scales (0 = no urge; 4 = very strong urge). an overall score (total sps_r; cronbach’s alpha = .81) was computed that reflects the severity of skin-picking. a score of 7 represents the clinical cut-off (gallinat et al., 2016). b. the milwaukee inventory for the dimensions of adult skin-picking (midas; walther et al., 2009) is a self-report questionnaire with two subscales: automatic skin-picking (cronbach’s α = 0.62; e.g., i don't notice that i have picked my skin until after it's happened.) and focused skin-picking (cronbach’s α = 0.75; e.g. i experience an extreme urge to pick before i pick). the six items of each subscale are judged on 5-point likert scales (1 = not at all; 5 = very much). due to the low cronbach’s α of the automatic skin-picking subscale, no further analyses were performed with this subscale. c. the trait version of the state-trait anxiety and depression inventory (stadi; laux et al., 2013) has two subscales: depression (α = .913) and anxiety (α = .866), with ten items each (e.g., depression: “i am sad”; anxiety: “i worry that something might happen”) that are scored on a four-point likert scale ranging from 1 (not at all) to 4 (very much). app-assisted interventions all participants of the four intervention groups were asked to set aside at least 10 minutes for each writing session in a quiet place without disturbance. in total, six writing sessions had to be completed within a two-week period (with a maximum of one writing session per day). the participants had the option to write more than six times during the two weeks if they felt to do so. before and after each writing session, the participants rated their affective state (pleasantness, tension, relief, urge to pick the skin) via a smartphone app on 100-point likert scales (0 = i do not feel good, tense, relieved, no urge to pick my skin; 100 = i feel good, tense, relieved, a strong urge to pick my skin). the rating interval (pre vs. post-writing) was set to 10 minutes (it was not possible to provide the app ratings earlier). the group-specific instructions for the writing sessions were as follows: a. expressive writing: expressive writing is an intervention in which people spend a few minutes writing about specific, personally relevant topics over several days. let your thoughts and feelings wander freely while writing. expressive writing has been studied since the 1980s and offers a beneficial way to engage with one's emotions and manage them. write for at least 10 minutes about a topic that is currently on your mind. explore your thoughts and emotions openly that you perceive while writing. spelling, syntax, or grammar are irrelevant. it is desirable to get into a flow of writing. choose a time of the day that suits you best and find a quiet place where you will not be disturbed (e.g., put your mobile phone in flight mode). reduction of pathological skin-picking via expressive writing 6 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ b. picture description: a picture description is a visual representation translated into language. it is meant to be a reproduction of what is seen in the picture. for example, image descriptions enable visually impaired people to find access to pictorial representations such as paintings or photographs. the detailed descriptions train analytical and structural thinking, which are important skills for problemsolving and finding new solutions. choose a time of the day that suits you best and find a quiet place where you will not be disturbed (e.g., put your mobile phone in flight mode). describe for at least 10 minutes one of the abstract pictures that you have received from us. write about the appearance of the image as factually and neutrally as possible, as if you were describing it to a visually impaired person. half of the participants were asked to use paper and pencil to complete the task, while the other half of the participants were assigned to the computer-writing groups. the written texts remained with the participants; the experimenters had no access to the texts. procedure after the first online survey (checking of inclusion/exclusion criteria), eligible partici­ pants were scheduled for a personal meeting where they were randomly allocated to one of four interventions: (a) expressive writing (paper/pencil), (b) expressive writing (computer), (c) picture description (paper/pencil), (d) picture description (computer). all participants received further information about the study, including instructions for using the smartphone app. after participants completed the two-week writing interven­ tion, they were asked to fill out a second online survey (questionnaires). moreover, participants were asked to count the words written in each session. we consider the number of written words as a proxy for the time spent writing. further, we chose this measure to detect potential noncompliance (e.g., refusal to engage in writing). the procedure is depicted in figure 1. statistical analysis self-reports assessed via the smartphone app: mixed-model analyses of variance (anovas) were conducted to compare the two interventions (expressive writing (ew) vs picture description (pd)) and the two writing modalities (paper pencil (pp) vs computer (c)), before vs after a writing session (factor: time). this was done for the dependent measures: urge to pick one’s skin, feelings of tension, relief, and pleasantness. the ratings were averaged across the number of writing sessions during the two weeks. moreover, word count (number of written words) was compared between the inter­ ventions via an anova. schlintl & schienle 7 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ questionnaires: mixed-model analyses of variance (anovas) were computed to com­ pare the questionnaire scores (sps-r; midas; stadi_depression, stadi_anxiety) be­ tween interventions and time (before and after the two-week intervention). exploratory regression analyses: to identify variables (number of completed writing sessions, word count, trait anxiety, trait depression) that are associated with the effec­ tiveness of expressive writing (reduction in the urge to pick one’s skin before vs. after a writing session), a multiple linear regression analysis was conducted. the model was assessed for multicollinearity (all variance inflation factors (vifs) < 1.5; tolerance > 0.7) and residual distribution (cook’s distance < 0.3, durbin watson > 1.5 and < 2.5). all analyses were conducted with spss version 28. figure 1 procedure note. sps-r: skin-picking scale (revised); midas (milwaukee inventrory of the dimensions of adult skinpicking); stadi: subscales trait anxiety/ depression of the state trait anxiety and depression inventory. reduction of pathological skin-picking via expressive writing 8 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ r e s u l t s self-reports assessed via the smartphone app number of completed writing sessions on average, participants completed four writing sessions (range: 1-12). the number of sessions did not differ between the intervention groups, mewpp = 3.88, sd = 2.71; mewc = 4.55, sd = 2.49, mpdpp = 3.76, sd = 2.39, mpdc = 2.97, sd = 2.54; f(3,128) = 2.003, p = .117, ηp2 = .045. word count the anova that was carried out revealed that the four intervention groups differed in the number of written words per writing session, f(3,128) = 14.36, p < .001, ηp2 = .252. tukey post-hoc comparisons (see supplementary table s1) showed that the ewc group had the highest word count (m = 316, sd = 154), followed by the ewpp group (m = 210, sd = 84), the pdc group (m = 205, sd = 135), and the pdpp group (m = 142, sd = 51). urge to pick one’s skin the anova revealed a significant main effect of time, f(1,128) = 50.64, p < .001, ηp2 = .283, and a significant interaction time x intervention, f(1,128) = 8.75, p = .004, ηp2 = .064. all other effects were non-significant (all p > .05; see supplementary table s2). after a session of expressive writing, participants reported a reduced urge to pick their skin compared to before the session, t(63) = 7.02, p < .001. after a session of picture description, the urge to pick was less intense compared to before the pd session, t(67) = 3.12, p = .003; figure 2. the reduction in the urge to pick was more pronounced in the expressive writing groups (mdiff = -15.19, sd = 17.30) than in the picture description groups (mdiff = -6.43, sd = 16.97; t(130) = 2.94, p = .004). relief the anova revealed a significant main effect of time, f(1,128) = 10.07, p = .002, ηp2 = .073, and a significant interaction time x intervention, f(1,128) = 9.83, p = .002, ηp2 = .071. post hoc comparisons showed that participants felt more relieved after expressive writing than before, t(63) = 4.02; p < .001. in the picture description groups, the participants did not significantly differ in their ratings for relief before and after a writing session, t(67) = .04; p = .979; figure 2. all other effects were non-significant (all p > .005; also see supplementary table s2). schlintl & schienle 9 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ tension the anova revealed a significant main effect of time, f(1,128) = 29.95, p < .001, ηp2 = .190, and a significant interaction time x intervention, f(1,128) = 4.52, p = .036, ηp2 = .034. post hoc comparisons showed that after both expressive writing, t(63) = 5.23; p < .001, and picture description, t(67) = 2.52; p = .014, participants reported reduced feelings of tension compared to before writing. the reduction of tension was more pronounced in the expressive writing groups, mdiff = -12.60, sd = 19.28, than in the picture description groups, mdiff = -5.61, sd = 18.35; t(130) = 2.14, p = .035. for means and standard deviations see figure 2. all other effects were non-significant (all p > .005; also see supplementary table s2). pleasantness the anova revealed a significant interaction effect time x intervention, f(1,128) = 7.88, p = .006, ηp2 = .058. all other effects were non-significant (all p > .005, see supplementary table s2). post hoc comparisons revealed that participants in the picture description groups felt more pleasant than participants in the expressive writing groups figure 2 means and standard deviations for the app-data note. ewpp = expressive writing paper/pencil; ewc = expressive writing computer; pdpp = picture description paper pencil; pdc = picture description computer; ew = expressive writing; pd = picture description. reduction of pathological skin-picking via expressive writing 10 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ before the session t(130) = 2.31; p = .023. after the session, the groups did not differ in valence ratings, t(130) = .12; p = .905. in the picture description groups, participants felt more unpleasant after the writing than before, t(67) = 2.56; p = .013. in the expressive writing group, participants did not significantly differ in their pleasantness ratings before and after the session, t(63) = 1.41; p = .165. for means and standard deviations see figure 2. questionnaire data skin picking scale (revised) the anova revealed a significant main effect of time, f(1,128) = 28.53, p < .001, ηp2 = .182. after the two-week intervention, participants scored lower on the sps-r (m = 12.89, sd = 4.72) than before (m = 14.42, sd = 4.00) independent of intervention and writing modality. all other effects were non-significant (all p < .005; see supplementary table s3). milwaukee inventory for the dimensions of adult skin-picking (focused) the anova revealed a significant main effect of time, f(1,128) = 5.56, p = .020, ηp2 = .042, and an interaction effect time x intervention, f(1,128) = 7.46, p = .007, ηp2 = .055. post hoc comparisons showed that participants of the expressive writing groups scored lower on the focused picking scale of the midas after the intervention (m = 21.47, sd = 4.65) than before, m = 22.72, sd = 4.42; t(63) = 4.04, p < .001. in contrast, participants of the picture description groups did not differ in their scores before (m = 22.03, sd = 4.69) and after the two-week intervention, m = 22.10, sd = 4.46; t(67) = .20; p = .842. all other effects were non-significant (all p > .05; see supplementary table s3). state-trait anxiety depression inventory the anova revealed no significant effects for trait anxiety and trait depression (all p > .05; see supplementary table s3). regression analysis the regression equation for the dependent variable ‘reduction in the urge to pick one’s skin’ (before minus after a session of ew) with the predictors number of writing ses­ sions, word count, depression, and anxiety, was significant, r 2 = .17; f(4,63) = 2.98, p = .026. trait anxiety was a significant positive predictor. participants with a higher level of trait anxiety showed a greater reduction in the urge to pick their skin due to expressive writing (for statistics see table 2). schlintl & schienle 11 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ table 2 results of the multiple linear regression analysis for the association between “reduction in the urge to pick” (before minus after a writing session) and “number of writing sessions,” “wordcount”, “stadi_anxiety” and “stadi_depression” variable b se b β t p 95.0% ci b r srll ul (constant) -13.973 10.913 -1.280 .205 -35.810 7.864 wordcount .005 .016 .036 .303 .763 -.026 .036 .014 .039 frequency -.751 .800 -.113 -.939 .352 -2.352 .850 -.106 -.121 stadi_anxiety 1.091 .461 .344 2.368 .021 .169 2.014 .390 .295 stadi_depression .244 .431 .083 .567 .573 -.618 1.106 .263 .074 note. se b = standard error of b; 95% ci b = 95% confidence interval for b; r = bivariate correlation, and sr = partial correlation; wordcount = average number of written words per writing session; frequency = number of writing sessions; stadi_anxiety = subscale trait anxiety of the state trait anxiety and depression inventory; stadi_depression = subscale depression of the state trait anxiety and depression inventory. d i s c u s s i o n this study investigated the effects of expressive writing (using an app-assisted approach) on excessive skin-picking behavior. each participant was asked to complete six writing sessions over two weeks that either focused on emotional experiences with personal rele­ vance (expressive writing), or the description of abstract paintings (control condition). the main findings of this study were that expressive writing (ew) produced posi­ tive short-term and mid-term effects on skin-picking behavior. directly after a writing session, the two ew groups (computer, paper/pencil) reported a reduced urge to pick their skin. interestingly, the control groups also expressed less of an urge to manipulate their skin after describing a painting. this latter finding implies the positive effects of distraction on skin-picking behavior. this is in line with clinical recommendations which suggest, for example, distracting one’s hands with stress balls, fidgets, or tangle toys to reduce skin-picking (e.g., snorrason, goetz, & lee, 2017). similarly, cognitive-behavioral therapy for skin-picking disorder typically includes stimulus control techniques as well as habit reversal training: this involves those affected being taught to engage in harm­ less motor behaviors (like clenching one’s fists), which in turn prevent skin-picking (e.g., snorrason, goetz, & lee 2017). importantly, the effects of ew on skin-picking go beyond distraction and motor control. in the present study, ew was associated with a more pronounced reduction in the urge to pick one’s skin than picture description (a reduction of -15 vs. -6 points on a scale ranging from 0 to 100). moreover, only ew was associated with the reduction of focused skin-picking as indexed by the midas. whereas the control groups showed no change, the ew groups showed an average reduction of one point in their midas scores. reduction of pathological skin-picking via expressive writing 12 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ thus, ew and picture description exhibited differential effects on skin-picking symptoms (with small to moderate effect sizes). ew also demonstrated immediate effects on participants’ affective states. directly after a writing session, participants in the ew groups reported a greater reduction of tension than those in the control groups. in addition to this, those in the ew groups also experienced increased feelings of relief (this positive emotion occurs as a response to a threat that has abated or disappeared). previous findings have suggested that ew exerts its effects through habituation, and/or through the (re)structuring of anxious feelings (sabo-mordechay et al., 2019; pennebaker & chung, 2011; perry & ward-smith, 2018). in this sense, the findings of the present study imply that ew may have assisted participants in reducing their emotional distress, which in turn reduced the need for skin-picking (i.e., the emotional distress may have no longer been pronounced enough to trigger skin-picking). this interpretation is also in line with exposure theory: when pa­ tients repeatedly confront themselves with negative feelings, this repetition and exposure can eventually lead to extinction of those feelings and associated thoughts (see frattaroli, 2006). an exploratory analysis was carried out which attempted to identify variables associ­ ated with the effectiveness of ew. this regression analysis showed that the number of writing sessions completed and the number of words written during a session did not contribute significantly to the positive effects of ew. in the present study, participants completed on average four writing sessions; this was below the six sessions they were originally instructed to carry out. nonetheless, this amount of writing was sufficient to reduce skin-picking behavior. this finding is also in line with recommendations based on a meta-analysis by frattaroli (2006) who investigated optimal conditions for ew effects; these conditions included completing a minimum of only three writing sessions. thus, the average of four writing sessions carried out in the current study can be seen as sufficient to produce positive results. a further finding of the current study was that there was a general trend toward more words being written on the computer compared to handwriting. this appears to reflect different writing speeds for each modality. an unexpected finding was that the writing modality had no differential effect on the reduction of skin-picking symptoms. we had assumed that the process of writing (performing up and down movements) would be similar to the physical movements involved in skin-picking, and could there­ fore be an efficient replacement behavior. the null findings of the current study, howev­ er, are in line with results reported in the meta-analysis by frattaroli (2006). in that study, it was concluded that the mode of disclosure did not moderate ew outcomes; studies using handwritten disclosure did not produce larger effects than studies using typed disclosure. the present investigation also showed that high levels of reported trait anxiety were associated with more positive effects of ew (in terms of a greater reduction in the urge schlintl & schienle 13 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ to pick one’s skin). anxiety has been shown to be a typical elicitor of skin-picking episodes (e.g., yeo & lee, 2017). further, patients with skin-picking disorder report elevated trait anxiety and show elevated rates of comorbid anxiety disorders (schienle et al., 2022). other studies have demonstrated that ew is effective at reducing anxiety and associated problems (e.g., test anxiety; see park et al., 2014; robertson et al., 2021; shen et al., 2018). for example, park et al. (2014) showed that highly math-anxious individuals performed significantly worse on a math test than individuals with low anxiety. notably, a subsequent ew intervention significantly reduced the group difference in test scores. the authors of that study proposed that the ew might have enabled participants to more effectively identify and differentiate their emotional experience, which may have led to the use of better emotion regulation strategies. further, the use of specific words in the ew task related to anxiety, cause, and insight, was positively related to math performance (also see shen et al., 2018). thus, confrontation with anxious feelings, as well as cognitive restructuring, appear to be important components involved in the positive effects of ew on anxiety and related problems; both components are elements of exposure therapy, which is a highly effective method for reducing symptoms of anxiety and other negative emotions (e.g., hollon & beck, 1994; margraf & schneider, 1990; ruhmland & margraf, 2001). in the current study, while trait anxiety was not found to be reduced on average after the ew intervention, trait anxiety was however identified as a moderator for the effects of ew on the urge to perform skin-picking (i.e., participants high in trait anxiety were found to benefit more from ew). considering this, in future ew studies that focus on excessive skin-picking, text analyses could be implemented to further elucidate anxiety-associated mechanisms of ew in the context of this dysfunc­ tional behavior. further, additional trait variables associated with affective processing in the context of pathological skin-picking (e.g., disgust propensity, difficulties in emotion regulation) should be investigated (schienle et al., 2018). it is important to mention the potential limitations of the present study. first, we only studied females. therefore, the results cannot be generalized to males or other groups. second, some of the participants took part in self-help groups during the study; this could have biased results. however, none of the participants received any other form of psychological treatment during the course of the study. third, observed changes in skin-picking behavior were based on the self-reports of participants. in future studies, objective measures could be introduced (e.g., photos of affected skin before and after the ew intervention). finally, participants received a brief intervention lasting only two weeks. the implementation of ew as an additional component in a (longer-lasting) psychotherapy would very likely enhance its effectiveness. further, this type of psycho­ therapy would not have to be based on conventional face-to-face interactions but could be provided via online counseling. the present study underlines how technologies such as app-assisted interventions can be used to promote beneficial effects for reducing psy­ chological symptoms, in this case, pathological skin-picking. such e-therapy approaches reduction of pathological skin-picking via expressive writing 14 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ might also enhance the effectiveness of ew interventions, since larger effects of ew have been obtained when participants have disclosed at home vs. in other (non-private) settings (frattaroli, 2006). conclusion this study revealed positive immediate effects of ew on skin-picking, including a re­ duced urge for skin-picking and increased feelings of relief. mid-term effects of ew on skin-picking were also found, relating to a reduction in focused skin-picking (according to self-reports). the beneficial effects of ew were independent of the writing modality (paper/pencil vs. computer) and were also found to be associated with trait anxiety. funding: the authors have no funding to report. acknowledgments: we would like to thank hannah fink and carla danczewitz for their help in conducting this study. competing interests: the author(s) declared no potential conflicts of interest concerning the research, authorship, and/or publication of this article. ethics statement: all procedures performed in studies involving human participants were in accordance with the ethical standards of the university of graz and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. informed consent was obtained from all individual participants included in the study. the study was approved by the ethics committee of the university of graz (gz. 39/79/63 ex 2021/22). data availability: the raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): 1. the pre-registration protocol for the study. 2. follow-up tests (tukey post-hoc comparisons) for the analysis of variance (anova) that compared the four interventions (expressive writing: paper/pencil; expressive writing: computer; picture description: paper/pencil; picture description: computer) concerning word count (number of written words during a session) are provided in the supplementary table s1. 3. f-statistics (f, df, p, part η2) for the mixed-model analyses of variance (anovas) to compare the two interventions (expressive writing (ew) vs picture description (pd)) and the two writing modalities (paper pencil (pp) vs computer (c)), before vs after a writing session schlintl & schienle 15 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://www.psychopen.eu/ (factor: time) concerning the app ratings (urge to pick one’s skin, feelings of tension, relief, and pleasantness) are provided in supplementary table s2. 4. f-statistics (f, df, p, part η2) for the mixed-model analyses of variance (anovas) to compare the questionnaire scores (sps-r; midas; stadi_depression, stadi_anxiety) between interventions and time (before and after the two-week intervention) are provided in supplementary table s3. 5. supplementary figure s1 depicts the consort flow diagram. index of supplementary materials schlintl, c., & schienle, a. 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(2017). the relationship between adolescents’ academic stress, impulsivity, anxiety, and skin picking behavior. asian journal of psychiatry, 28, 111–114. https://doi.org/10.1016/j.ajp.2017.03.039 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. reduction of pathological skin-picking via expressive writing 18 clinical psychology in europe 2023, vol. 5(2), article e11215 https://doi.org/10.32872/cpe.11215 https://doi.org/10.1016/j.jocrd.2017.10.006 https://doi.org/10.1371/journal.pone.0191779 https://doi.org/10.1002/9781118890233.ch56 https://doi.org/10.1016/j.jbtep.2010.01.009 https://doi.org/10.1016/j.jbtep.2008.07.002 https://doi.org/10.1016/j.ajp.2017.03.039 https://www.psychopen.eu/ reduction of pathological skin-picking via expressive writing (introduction) method participants questionnaires app-assisted interventions procedure statistical analysis results self-reports assessed via the smartphone app questionnaire data regression analysis discussion conclusion (additional information) funding acknowledgments competing interests ethics statement data availability supplementary materials references one single question is not sufficient to identify individuals with electromagnetic hypersensitivity research article one single question is not sufficient to identify individuals with electromagnetic hypersensitivity renáta szemerszky a, zsuzsanna dömötör a, ferenc köteles a [a] institute of health promotion and sport sciences, elte eötvös loránd university, budapest, hungary. clinical psychology in europe, 2019, vol. 1(4), article e35668, https://doi.org/10.32872/cpe.v1i4.35668 received: 2019-04-23 • accepted: 2019-09-04 • published (vor): 2019-12-17 handling editor: omer van den bergh, university of leuven, leuven, belgium corresponding author: ferenc köteles, institute of health promotion and sport sciences, eötvös loránd university, budapest, bogdánfy ödön u. 10., h-1117 hungary. e-mail: koteles.ferenc@ppk.elte.hu abstract background: idiopathic environmental intolerance attributed to electromagnetic fields (iei-emf) is a self-reported condition where non-specific symptoms are attributed to weak non-ionizing electromagnetic fields. despite its expanding prevalence, there is no generally accepted diagnostic procedure or definition to identify patients with this condition, thus studies usually apply only one question as inclusion criterion. the aim of our study was to demonstrate the heterogeneity of a self-reported iei-emf group and to identify further self-report questions that could be applied as inclusion criteria. method: cross-sectional on-line survey study was carried out with 473 participants (76.3% women; age: 35.03 ± 13.24 yrs). self-diagnosed iei-emf (as assessed with a yes-or-no question), frequency of emf-related symptom and severity of the condition were assessed, as well as somatic symptom distress (patient health questionnaire somatic symptom severity scale, phq-15). results: 72 (15.2%) individuals labelled themselves as iei-emf, however only 61% of them remained in the iei-emf group after the use of three inclusion criteria instead of one. 21% of the individuals labelling themselves as iei-emf reported neither symptoms nor any negative impact on their daily life. conclusion: a minimum of two questions appear to be necessary as inclusion criteria for iei-emf in empirical research. instead of the widely used yes-or-no question on accepting the iei-emf label, occurrence of symptoms attributed to emf on a regular basis and at least a slight negative impact on daily life are required. keywords electrohypersensitivity, symptoms, assessment, idiopathic environmental intolerance attributed to electromagnetic fields, iei-emf this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.35668&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • electromagnetic hypersensitivity (iei-emf) is often assessed by one yes-or-no self-report question. • this practice is inappropriate from a conceptual and methodological point of view. • at least two questions, assessing frequency of symptoms and their impact, are needed. according to the definition of the world health organization, the term idiopathic envi‐ ronmental intolerance attributed to electromagnetic fields (iei-emf; formerly electro‐ magnetic hypersensitivity) refers to “symptoms that are experienced in proximity to, or during the use of, electrical equipment, and that result in varying degrees of discomfort or ill health in the individual and that an individual attributes to activation of electrical equip‐ ment” (who, 2004, p. 2). originally, iei was defined along the following criteria: (1) an acquired disorder with multiple recurrent symptoms (2) that could be associated with di‐ verse environmental factors tolerated by the majority of the population, and (3) cannot be explained by any other known disorder (medical or psychological) (lessof, 1997; staudenmayer, 2006). concerning iei-emf, however, some of the aforementioned criteria are unrealistic and practically irrelevant. first (criterion 1), why does one want and how can one distin‐ guish between acquired and inherited conditions in the modern era when the importance of epigenetics and environment-gene interactions is well described, and empirical find‐ ings concerning genetic factors (e.g. gene polimorphisms) behind environmental illnesses are accumulating (berg et al., 2010; caccamo et al., 2013; cui et al., 2013; de luca et al., 2015, 2014; mckeown-eyssen et al., 2004; schnakenberg et al., 2007)? moreover, what is the difference between individuals with acquired and (partly) inherited iei-emf from a therapeutic point of view? second (criterion 3), although it is well documented that ieiemf is often accompanied by co-morbid psychiatric disorders (e.g. depression, anxiety disorder) (frick et al., 2005; landgrebe et al., 2008; meg tseng, lin, & cheng, 2011; österberg, persson, karlson, eek, & ørbæk, 2007; rubin, cleare, & wessely, 2008) partici‐ pants with such comorbid disorder(s) are usually excluded from the investigations (baliatsas, van kamp, lebret, & rubin, 2012a). this practice leads to excessive sample loss, and, most importantly, sampling bias. third, as in other areas of medicine, diagnoses based on exclusionary definitions should be avoided. finally, certain salient aspects of the condition (most importantly, chronicity; m. witthöft, personal communication) are not included. the prevalence of iei-emf shows a considerable variability (between 1.5-20%) (eltiti et al., 2007; hillert, berglind, arnetz, & bellander, 2002; huang, cheng, & guo, 2018; infas, 2006; mohler et al., 2010; schreier, huss, & röösli, 2006; ulmer & bruse, 2006).this assessing iei-emf 2 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ variability could be partly explained by the lack of generally accepted medical diagnostic procedure or definition. in fact, more than half of the empirical studies on iei-emf ap‐ plied only participants’ self-report about their emf-hypersensitivity often assessed us‐ ing a simple yes-or-no question as inclusion criterion (baliatsas et al., 2012b). because of the striking similarities between ieis and medically unexplained symp‐ toms or functional somatic syndromes, many authors suggest that ieis should be man‐ aged as a sub-category of somatoform disorders, where symptoms are attributed to a spe‐ cific environmental factor (bailer, witthöft, paul, bayerl, & rist, 2005; henningsen & priebe, 2003; wiesmüller, ebel, hornberg, kwan, & friel, 2003). keeping in mind that ieiemf is officially often recognized as a functional impairment (johansson, 2015), and that the who definition considers the existence of symptoms and a negative impact on per‐ ceived health also essential to the condition, the use of further questions should be war‐ ranted from a theoretical point of view. in addition, an overly inclusive criterion can-hin‐ der not only the exploration of the aetiology and the treatment of iei-emf patients, but also raises difficulties for the integration of results gained up to the present (baliatsas et al., 2012a). the primary goal of the study reported here was the demonstration of heterogeneity within the category of self-reported iei-emf. we also attempted to identify self-report questions (items) that are necessary as inclusion criteria. m e t h o d participants a non-representative hungarian community sample was used. participants (n = 473; 76.3% women; age: 35.03 ± 13.24) were recruited through various groups in the social me‐ dia that are thematically not connected to environmental intolerances. the study was ap‐ proved by the research ethics board of the university. participants received no reward for their participation; all signed an on-line informed consent form before completing the questionnaire on-line. questionnaires and questions the questions and the questionnaire were part of a larger study that investigated the connection between environment and health. self-diagnosis of iei-emf (iei-emf) was assessed with a single yes-or-no question (“many people experience unpleasant symptoms (e.g. headache, nausea, concentration prob‐ lems, palpitation, etc.) when staying in the vicinity of electromagnetic fields (e.g. near elec‐ tric devices, computers, electric power lines, or during mobile phone calls). this phenomenon is called electromagnetic hypersensitivity or electrosensitivity. do you consider yourself to be szemerszky, dömötör, & köteles 3 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ electrosensitive?”) (dömötör, doering, & köteles, 2016; köteles et al., 2013; szemerszky, gubányi, árvai, dömötör, & köteles, 2015). severity of the condition (impact) was assessed with the following question: “on the whole to what extent do emf-related symptoms affect your everyday life?” (0 = no impact at all, 1 = some impact, 2 = medium impact, 3 = high impact) (dömötör et al., 2016; dömötör, szemerszky, & köteles, 2019). frequency of emf-related symptoms (symptoms) was assessed with the following question: “how often do you experience symptoms in the proximity of electric devices?” (0 = never, 1 = it happened once, 2 = rarely, 3 = often, 4 = every time) (dömötör et al., 2019). the existence of somatic symptoms, regardless of their origin and assumed cause, were assessed with patient health questionnaire somatic symptom severity scale (phq-15) (kroenke, spitzer, & williams, 2002) which measures the prevalence and severi‐ ty of 15 common symptoms in a 3-point likert-scale from 0 (“not bothered at all”) to 2 (“bothered a lot”). higher scores refer to higher prevalence of disturbing symptoms in the past 4 weeks. scores of 5, 10, and 15 represent cut-off points for low, medium and high somatic symptom severity, respectively (kroenke et al., 2002). in clinical practice, phq-15 is often used to measure somatization tendency. the cronbach’s alpha coefficient of the scale in the present study was 0.80. statistical analysis statistical analysis was carried out with the spss v20 software. according to the results of shapiro-wilk tests, phq-15 scores showed a significant deviation from normal distri‐ bution, thus non-parametric methods were used throughout the analysis. groups with and without iei-emf were compared using mann-whitney-u-tests and chi-square tests (for gender ratio). r e s u l t s overall, 15.2% of the individuals (72 participants) labelled themselves as being hypersen‐ sitive to emf (iei-emf item). descriptive statistics and the results of group-level compari‐ sons are presented in table 1. mann-whitney-u-tests indicated a significant difference between the self-reported iei-emf and non-iei-emf group in phq-15 score, frequency of iei-emf related symp‐ toms, and impact of emf-related symptoms on everyday life. the iei-emf group was characterized by higher values in all cases, and it approached but did not reach the phq-15 cut-off point for medium symptom severity. there was no significant difference between the two groups with respect to gender ratio and age. assessing iei-emf 4 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ table 1 descriptive statistics of the measured variables (mean ± standard deviation) variable iei-emf (n = 72) non-iei-emf (n = 401) between-group comparison statistic p age 36.0 ± 13.54 34.86 ± 13.20 m-w u = 13579.50 > .05 gender ratio (women) 82% 75% χ2 = 1.49 > .05 somatic symptoms (phq-15) 9.17 ± 4.67 7.37 ± 4.47 m-w u = 10916.50 .001 impact on daily life 0.74 ± 0.69 0.1 ± 0.33 m-w u = 6894.50 < .001 frequency of symptoms 2.0 ± 1.08 0.4 ± 0.78 m-w u = 4328.50 .001 note. iei-emf = idiopathic environmental intolerance attributed to electromagnetic fields; phq-15 = patient health questionnaire; m-w u = mann-whitney u. if we apply another inclusion criterion, i.e., the rare (but already regular) occurrence of symptoms (symptoms > 1), altogether 25.37% of the 473 participants (120 individuals) re‐ ported that they had experienced symptoms attributed to electromagnetic field exposure at least occasionally. of these 120 individuals, however, only 47.5% (57 individuals) con‐ sidered themselves electrohypersensitive, whereas 63 did not. both groups’ phq-15 score was below the cut-off point (iei-emf: 9.30 ± 4.40; non-iei-emf: 8.54 ± 4.84), and showed no significant difference (mann-whitney u = 1586.00, p = .269). similarly, considering a minimal impact of the condition on everyday functioning (impact > 0), it turns out that 82 individuals of the 473 participants (17.34%) belong to this category. interestingly, only 53.7% (44 individuals) diagnosed themselves as iei-emf, while the remaining 38 did not use this label. in both groups, the phq-15 score exceeds the medium cut-off point (iei-emf: 10.02 ± 4.65; non-iei-emf: 10.13 ± 4.88), but they did not differ from each other (mann-whitney u = 831.50, p = .967). taken together, only 44 of the 72 individuals (61.1%) with self-reported iei-emf had symptoms attributed to electromagnetic devices at least rarely and suffered from the con‐ dition at least slightly. surprisingly, there were 15 individuals (20.8%) who had neither symptoms nor a negative impact on their everyday functioning but still considered them‐ selves iei-emf. in the non-iei-emf group, 25 individuals (6.2%) were characterized by both criteria (for details, see figure 1). within those, who reported symptoms and also an impact on daily life (69 individuals), the iei-emf group’s phq-15 score was slightly above the cut-off point (10.02 ± 4.65), while the non-iei-emf group scored a bit lower (9.76 ± 4.94). still, the difference between the two was not significant (mann-whitney u = 523.00, p = .735). finally, average phq-15 score of the group defined by symptoms and impact regardless of the iei-emf label was close to the threshold of 10 (9.93 ± 4.72). szemerszky, dömötör, & köteles 5 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ figure 1. the number of individuals (and their percentage of total) in the iei-emf and control group after applying additional inclusion criteria beyond self-reported electrohypersensitivity. d i s c u s s i o n our results demonstrate that the use of one single yes-or-no question as inclusion criteri‐ on for self-reported iei-emf is not an acceptable practice. although the iei-emf group selected by this single question shows a higher average somatization tendency than the non-iei-emf group, this tendency is still under the accepted threshold of medium im‐ pact. beyond the widely applied yes-or-no question, the use of at least two additional ques‐ tions appears to be necessary for a more precise definition of the condition and the sam‐ ple. after the use of three inclusion criteria instead of one, only 61% of the individuals of the original iei-emf group remained there. the two additional criteria, i.e., experiencing symptoms attributed to emf on a regular basis and symptoms impacting everyday func‐ tioning, are in accordance with the who definition of the condition. moreover, this more strictly (still rather inclusively) defined group shows a score that indicates a non-negligi‐ ble somatization tendency. this latter finding is in line with the conceptualization of iei as a sub-category of functional somatic syndromes (frick, rehm, & eichhammer, 2002). in fact, self-diagnosis (i.e. the acceptance of the iei-emf label) is not part of the who definition thus the use of the yes-or-no question can be questioned. in our sample, 69 in‐ dividuals of the 473 (14.6%) belong to the iei-emf group as defined by the symptoms and impact question. somatization tendency of this group practically reached the threshold of medium severity, and applying the iei-emf label did not elevate this score substantially. in other words, using the criteria of symptoms and impact appears to be practically suffi‐ cient as well as in line with the definition of the condition. assessing iei-emf 6 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ beyond practical issues, the present findings demonstrate that individuals with selfdiagnosed iei-emf does not represent a homogeneous group. it is particularly striking that 21% of the individuals labelling themselves as iei-emf experience neither symptoms nor any negative impact on their daily life. this finding can be explained by two ap‐ proaches. first, stories about harmful effects of modern technologies are abundant in mass media and impact not only people’s worrying tendency (bräscher, raymaekers, van den bergh, & witthöft, 2017; petrie et al., 2001; witthöft et al., 2018), but also their auto‐ matic self-perception and self-categorization. second, as in the case of complementary and alternative medicine (astin, 1998), philosophical congruence might be a motive for those characterized by an experiential-intuitive thinking style to accept the iei-emf la‐ bel, even in the absence of symptoms. the most important limitation of the present study is that our sample was not repre‐ sentative of the population, therefore the results are not generalizable. additionally, the applied sampling method (online assessment) has well-known limitations. finally, identi‐ fication of people suffering from iei-emf based only self-report questions without any external criterion or assessment could be equivocal. in summary, a minimum of two questions appear to be sufficient as inclusion criteria for iei-emf in empirical research. instead of the widely used yes-or-no question on ac‐ cepting the iei-emf label, regular occurence of symptoms attributed to emf and at least a slight negative impact on daily life are required. funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: this research was supported by the hungarian national scientific research fund (k 124132), the jános bolyai research scholarship of the hungarian academy of sciences (for r. szemerszky) and by the únkp-17-3 new national excellence program of the ministry of human capacities (for zs. dömötör). r e f e r e n c e s astin, j. a. 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(2018). on the origin of worries about modern health hazards: experimental evidence for a conjoint influence of media reports and personality traits. psychology & health, 33(3), 361-380. https://doi.org/10.1080/08870446.2017.1357814 assessing iei-emf 10 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://doi.org/10.1667/rr2153.1 https://doi.org/10.1177/0960327107070575 https://doi.org/10.1016/s0022-3999(01)00219-7 https://doi.org/10.1016/j.jpsychores.2007.05.006 https://doi.org/10.1186/1476-069x-6-6 https://doi.org/10.1007/s00038-006-5061-2 https://doi.org/10.1007/s12529-015-9477-z http://www.emf-forschungsprogramm.de https://doi.org/10.1016/s0306-9877(03)00185-3 https://doi.org/10.1080/08870446.2017.1357814 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. szemerszky, dömötör, & köteles 11 clinical psychology in europe 2019, vol.1(4), article e35668 https://doi.org/10.32872/cpe.v1i4.35668 https://www.psychopen.eu/ assessing iei-emf (introduction) method participants questionnaires and questions statistical analysis results discussion (additional information) funding competing interests acknowledgments references psychoneuroendocrinology and clinical psychology scientific update and overview psychoneuroendocrinology and clinical psychology susanne fischer a, ulrike ehlert a [a] institute of psychology, clinical psychology and psychotherapy, university of zurich, zurich, switzerland. clinical psychology in europe, 2019, vol. 1(2), article 33030, https://doi.org/10.32872/cpe.v1i2.33030 received: 2019-01-11 • accepted: 2019-03-01 • published (vor): 2019-06-28 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: susanne fischer, university of zurich, institute of psychology, clinical psychology and psychotherapy, binzmuehlestrasse 14 / box 26, 8050 zurich, switzerland. e-mail: s.fischer@psychologie.uzh.ch abstract background: hormones impact on cognition, emotions, and behaviour. given that mental disorders are defined by abnormalities in these very same domains, clinical psychologists may benefit from learning more about alterations in endocrine systems, how they can contribute to symptoms commonly experienced by patients, and how such knowledge may be put to use in clinical practice. method: the aim of the present scientific update was to provide a brief overview of endocrine research relevant to the aetiology, diagnostics, and treatment of mental disorders, including some of the latest studies in this area. results: hormones appear to be intrinsic to the development and maintenance of mental disorders. oxytocin is involved in social cognition and behaviour and as such may be relevant to mental disorders characterised by social deficits (e.g., autism spectrum disorder and schizophrenia). stress and sex steroids exert demonstrable effects on mood and cognition. in patients with depression and anxiety disorders, initial attempts to lower/enhance such hormones have thus been undertaken within conventional therapies in order to improve outcomes. finally, hunger and satiety hormones may be involved in the vicious circle of dysfunctional eating behaviours and weight loss/gain in anorexia or bulimia nervosa. conclusion: three conclusions can be drawn from this review: first, endocrine research should be considered when patients and clinicians are developing multidimensional illness models together. second, endocrine markers can complement conventional assessments to provide a more comprehensive account of a patient’s current state. third, endocrine testing may guide treatment choices and inform the development of novel treatments. keywords anxiety, cognition, depression, hormones, mental disorders, mood, psychological therapy this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.33030&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • hormones are intrinsic to the development and maintenance of mental disorders • endocrine research should be incorporated into multidimensional illness models • endocrine markers can complement conventional diagnostic assessments • endocrine testing may guide treatment choices and inform the development of new treatments psychoneuroendocrinology is an interdisciplinary research area dedicated to the interac‐ tion between the mind, brain, and hormonal system (wolf & saucier, 2013). stress and lifestyle behaviours (e.g., diet, physical activity) are the most frequently studied psycho‐ logical factors exerting shortand long-term effects on hormones. conversely, a number of hormones are known to impact on psychological domains, such as cognition, emotions, and behaviour. among these are hormones involved in social interaction (e.g., oxytocin), stress hormones (e.g., noradrenaline and cortisol), sex hormones (e.g., testosterone, oes‐ tradiol, and progesterone), and hormones involved in hunger and satiety (e.g., ghrelin, leptin, or insulin). given that mental disorders are characterised by abnormalities in cog‐ nition, emotions, and behaviour, clinical psychologists may benefit from learning more about alterations in endocrine systems, how they may contribute to symptoms common‐ ly experienced by patients, and how such knowledge may be put to use in clinical prac‐ tice. the aim of the present scientific update was therefore to provide a brief overview of endocrine research relevant to the aetiology, diagnostics, and psychopharmacological and psychotherapeutic treatment of mental disorders, including some of the latest studies in this area. findings will be presented separately for each of the aforementioned domains and summarised in the final part of the manuscript alongside recommendations for clini‐ cal applications. h o w h o r m o n e s a f f e c t s o c i a l i n t e r a c t i o n the most prominent hormone regulating social interaction is oxytocin (meyerlindenberg, domes, kirsch, & heinrichs, 2011). although oxytocin is available in the pe‐ riphery (e.g., in reproductive organs), its central origin is in the hypothalamus, and oxy‐ tocin receptors are widely expressed in numerous areas of the brain, including the frontal cortex, amygdala, and olfactory nucleus. oxytocin has demonstrable effects on social cognition and behaviour, such as enhanc‐ ing theory of mind, emotional recognition, empathy, social exploration, and attachment psychoneuroendocrinology and clinical psychology 2 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ (see also ditzen et al., 2009; heinrichs, baumgartner, kirschbaum, & ehlert, 2003). as such, it has attracted the interest of researchers studying mental disorders characterised by social deficits, including autism spectrum disorders and schizophrenia. there is now evidence to suggest that oxytocin may be an aetiological factor in autism spectrum disor‐ der, since several polymorphisms within the gene encoding its receptor (oxtr) have been found to be risk-inducing (kranz et al., 2016; loparo & waldman, 2015). on the oth‐ er hand, peripheral levels of oxytocin are often found to be unaltered in the same patients as well as in patients with psychotic disorders (rutigliano et al., 2016). these null-find‐ ings need to be interpreted with caution, however, since the bioavailability of oxytocin in blood, urine, or saliva does not necessarily reflect its centrally circulating levels (valstad et al., 2017), which are of greater importance considering the clinical features of these ill‐ nesses. importantly, central levels are only quantifiable in humans via access to the cere‐ brospinal fluid by means of lumbar puncture. thus, although it is unlikely that oxytocin levels will be used as a diagnostic illness marker in the near future, their potential role in the pathophysiology of disorders characterised by social deficits can be incorporated into psychoeducation delivered to patients and their next of kin. another line of research has examined the effects of intranasally administered oxyto‐ cin in patients with autism spectrum disorder and schizophrenia (keech, crowe, & hocking, 2018), with findings of small but significant improvements in theory of mind (but not in emotion recognition or empathy). in other words, patients receiving exoge‐ nous oxytocin showed an increased ability to attribute mental states to others, thus pro‐ viding ex juvantibus evidence for an involvement of the oxytocin system in the patho‐ physiology of these disorders. importantly, numerous open questions need to be an‐ swered before oxytocin can be considered as an adjunct treatment for autism spectrum disorder or schizophrenia, including its precise mechanisms of action in the brain, its long-term efficacy, and potential adverse effects (e.g., increased irritability). interestingly, more recent research has explored the role of endogenous oxytocin as a modulator of treatment outcomes. a pilot study was able to demonstrate that the lower depressed patients’ pre-treatment oxytocin levels, the lower their degree of change in a self-report measure of depression over the course of psychological therapy (jobst et al., 2018). this finding aligns well with another study in patients with depressive disorders, which showed that oxytocin levels fluctuated during therapy sessions, and in parallel with subtle changes in the therapeutic alliance (i.e., ruptures; zilcha-mano, porat, dolev, & shamay-tsoory, 2018). together, these studies suggest that oxytocin levels may also be a useful prognostic tool as well as a means to monitor treatment progress. fischer & ehlert 3 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ h o w h o r m o n e s a f f e c t c o g n i t i o n , m o o d , a n d s e x u a l f u n c t i o n up to now, the largest share of clinical neuroendocrine research has been dedicated to the stress hormones noradrenaline and cortisol. the catecholamine noradrenaline (na) is available in the brain and in several other body tissues (fischer & nater, 2015). its central origin is the locus coeruleus, with αand β-adrenergic receptors expressed in numerous other brain areas, such as the cortex, thalamus, hippocampus, amygdala, and hypothala‐ mus. in the periphery, na, together with adrenaline, is the main end product of the sym‐ pathetic nervous system, and its receptors are present in all major organs and cells of the immune system. noradrenaline has effects on multiple domains of psychological functioning, includ‐ ing cognition, affect, arousal, and pain perception. it is thus unsurprising that 1) cogni‐ tive symptoms (e.g., deficits in working memory), as experienced, for instance, by pa‐ tients with depressive disorders (maletic, eramo, gwin, offord, & duffy, 2017), 2) anxiety and hyperarousal, representing key clinical features of panic disorder and post-traumatic stress disorder (bandelow et al., 2017), and 3) bodily symptoms such as fatigue and pain, which feature prominently in somatic symptom disorders (nater, fischer, & ehlert, 2011), are all paralleled by altered na functioning. notably, findings are highly complex; de‐ pending on the tissue (i.e., different areas within the brain, blood), both elevated and attenuated concentrations of na are observed, sometimes within the same patient co‐ hort. drugs targeting the na system (e.g., venlafaxine) constitute effective antidepressants and anxiolytics (e.g., bandelow et al., 2014; dgppn et al., 2015), thus adding further evi‐ dence to the assumption that the na system is instrumental in the pathophysiology of depressive and anxiety disorders. clinicians administering such drugs are advised to ex‐ plain the role of na to patients before initiating treatment. by contrast, in somatic symp‐ tom disorders and in physical diseases, it is mainly the peripheral actions of na (e.g., its effects on the musculoskeletal or cardiovascular system) which are critical. interestingly, in patients undergoing coronary artery bypass graft surgery, it was recently shown that preoperative psychological interventions led to significantly lower (i.e., more adaptive) levels of adrenaline after surgery when compared to standard medical care (salzmann et al., 2017). this finding highlights the value of catecholamines as markers of therapeutic efficacy. notably, na activity can also be determined non-invasively, namely via salivary alpha-amylase, an enzyme involved in the digestion of starch, thus facilitating its use in clinical practice (nater & rohleder, 2009). the glucocorticoid cortisol, the other major stress hormone, is the end point of the hypothalamic-pituitary-adrenal (hpa) axis (ehlert, 2011). although cortisol is synthe‐ sised in the adrenal cortex, both central (e.g., the hippocampus) and peripheral tissues (e.g., lymphocytes) are densely populated by mineralocorticoid and glucocorticoid recep‐ psychoneuroendocrinology and clinical psychology 4 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ tors. apart from the gluconeogenetic and anti-inflammatory effects of cortisol, one of its main effects lies in influencing cognition. akin to the findings on na, cortisol concentrations have been found to be abnormal in a number of patients presenting with cognitive problems (e.g., difficulty concentrat‐ ing), as is the case in affective disorders (belvederi murri et al., 2016; stetler & miller, 2011). moreover, abnormal cortisol concentrations have been demonstrated in patients with post-traumatic stress disorder, where they may contribute to re-experiencing of trauma via constant retrieval of the fear memory (morris, compas, & garber, 2012), and in somatic symptom disorders, where they may contribute to bodily complaints (tak et al., 2011). interestingly, while patients with affective disorders are characterised by com‐ parably elevated levels of cortisol (i.e., hypercortisolism), patients with posttraumatic stress disorder or somatic symptom disorders mostly exhibit diminished levels (i.e., hy‐ pocortisolism; ehlert, gaab, & heinrichs, 2001; heim, ehlert, & hellhammer, 2000). these differences may be attributable to different genetic predispositions and/or different amounts of stress experienced during the lifespan (ehlert, 2013). together, these findings underline the potential of cortisol for improving differential diagnostics. these findings have been extended by clinical studies, where a similar dichotomy ap‐ pears to prevail. in depression, the current state of research suggests that the higher a pa‐ tient’s pre-treatment cortisol levels, the lower their chances of responding to psychologi‐ cal therapy (fischer, strawbridge, herane vives, & cleare, 2017). in addition, initial at‐ tempts to improve memory performance in these patients have been undertaken using agents which act on glucocorticoid receptors (e.g., mifepristone) or influence cortisol synthesis (e.g., ketoconazole; soria et al., 2018). in anxiety disorders, the pattern seems to be reversed, insofar as lower cortisol levels predict worse treatment outcomes (fischer & cleare, 2017), although importantly, this only appears to be true for stimulated cortisol as measured during exposure sessions. this has been interpreted as an implication that a certain amount of cortisol is a prerequisite for patients to form an extinction memory, which is one of the key mechanisms underlying successful treatment for fear-related ill‐ nesses. more recent research suggests that this knowledge may be utilised to optimise ex‐ posure-based psychological therapy for anxiety disorders. for instance, meuret et al. (2016) were able to demonstrate that early-day exposure sessions (i.e., when endogenous cortisol levels are highest) led to greater clinical improvement in patients with panic dis‐ order and agoraphobia when compared to sessions held later on during the day. sex hormones, such as testosterone, oestradiol, and progesterone, are end products of the hypothalamic-pituitary-gonadal (hpg) axis (melcangi, giatti, & garcia-segura, 2016). they are mainly produced in the testes in men and in the ovaries in women, and their key function is to orchestrate reproduction and sexual functioning. however, sex steroids also act as neurosteroids (e.g., fostering neurogenesis and differentiation) in various parts of the brain, such as the hippocampus and prefrontal cortex. fischer & ehlert 5 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ in terms of mental disorders, the bulk of research to date has studied the role of sex steroids in sexual dysfunctions. testosterone, for instance, is lowered in men with erec‐ tile disorder (isidori et al., 2014), and hormonal (replacement) therapy has been proven to be useful in enhancing erectile function in hypogonadal men (corona et al., 2017; elliott et al., 2017) and sexual function in post-menopausal women (elraiyah et al., 2014). how‐ ever, long-term follow-up studies are scarce and potential adverse effects of exogenous testosterone (e.g., acne) need to be carefully weighed against the benefits. similarly, oes‐ trogens and combined oestrogen/progestogen treatments appear to enhance sexual func‐ tion in some post-menopausal women (nastri et al., 2013), but again, side effects need to be considered. these findings are important for any clinical psychologist advising pa‐ tients with sexual dysfunctions in terms of adjunct treatments. a burgeoning literature also demonstrates the involvement of sex hormones in other mental disorders, which is attributable to the aforementioned central expression of ste‐ roid receptors. in schizophrenia, it was shown that oestradiol and selective oestradiol re‐ ceptor modulators (e.g., raloxifene) can enhance memory and executive functions (soria et al., 2018). in addition, recent research suggests that sex steroids may exert positive ef‐ fects on mood. for instance, longer lifetime exposure to endogenous and exogenous oes‐ tradiol was found to be linked to fewer depressive symptoms during the menopausal transition (marsh et al., 2017), whereas greater fluctuations in endogenous oestradiol during the menopausal transition predicted more depressive symptoms in women report‐ ing high amounts of stress (gordon, rubinow, eisenlohr-moul, leserman, & girdler, 2016). these findings not only contribute to a more profound understanding of the symp‐ toms pertaining to psychotic and mood disorders, but may ultimately be put to use in or‐ der to guide (sex-oriented) treatment choices. h o w h o r m o n e s a f f e c t h u n g e r a n d s a t i e t y a number of hormones regulating hunger and satiety, such as ghrelin, leptin, or insulin, have been related to different mental disorders (drobnjak & ehlert, 2011). whereas the orexigenic hormone ghrelin is produced in the stomach, the anorexic hormones leptin and insulin are produced in adipose tissue and in the pancreas, respectively. all three hormones are capable of crossing the blood-brain barrier and thus directly influence en‐ ergy homoeostasis by acting on the hypothalamus. ghrelin, leptin, and insulin have, for the most part, been objects of research into eat‐ ing disorders. for instance, enhanced baseline ghrelin levels were reported in patients with eating disorders (prince, brooks, stahl, & treasure, 2009), likely as a consequence of restrained eating. importantly, elevated levels of ghrelin may in turn facilitate other dys‐ functional behaviours, such as hoarding food in anorexia nervosa or binge eating in buli‐ mia nervosa or binge eating disorder. furthermore, patients with anorexia nervosa have been found to present with increased insulin sensitivity, whereas patients with bulimia psychoneuroendocrinology and clinical psychology 6 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ nervosa or binge eating disorder exhibit decreased insulin sensitivity (ilyas et al., 2018). similar to ghrelin, these findings have been interpreted as being the result of dietary re‐ striction and weight loss/weight gain, respectively, while at the same time further contri‐ buting to dysfunctional eating patterns by affecting appetite regulation in the brain (i.e., diminishing/enhancing appetite). this is important knowledge when trying to make sense of the vicious circles that perpetuate eating disorders. evidence is now also accumulating that hunger and satiety hormones are abnormal in other mental disorders, mainly those presenting with metabolic symptoms and/or comor‐ bid metabolic diseases (e.g., diabetes mellitus). findings include elevated levels of leptin and insulin resistance in patients with psychotic disorders (greenhalgh et al., 2017; pillinger et al., 2017; stubbs, wang, vancampfort, & miller, 2016) and depressive disorders (kan et al., 2013). notably, these seem to be independent of bmi and intake of antipsy‐ chotic medication (which are known to have several metabolic side effects). this suggests that these hormonal abnormalities are not a mere consequence of lifestyle behaviours as‐ sociated with suffering from a chronic illness, but may be antecedents of highly debilitat‐ ing ancillary symptoms pertaining to psychotic and depressive disorders. importantly, recent studies support the notion that endogenous ghrelin and leptin may also influence treatment outcomes: whereas increases in ghrelin predicted non-re‐ sponses to treatment with lithium-augmented antidepressants in patients with depres‐ sion (ricken et al., 2017), leptin was positively linked to increases in bmi (ricken et al., 2016). in terms of ghrelin, the observed increases in non-responders could be interpreted as being secondary to reduced appetite, a core symptom of severe depression. in terms of leptin, synergistic actions with lithium on the serotonergic system could have resulted in an attenuation of leptin’s anorexic effect, but more research is warranted to investigate the intricate interplay between the two systems. these findings are important to consider by clinicians prescribing psychoactive drugs, and will hopefully allow the adjusting of treatments to the needs of the individual patient in the future. s u m m a r y a n d i n t e g r a t i o n it is evident from this brief overview that hormones are intrinsic to both the development and maintenance of mental disorders, and there are several conceivable ways in which this knowledge may be useful to clinical psychology. first, neuroendocrine research should find its way into clinical practice when clinicians and patients are developing multidimensional illness models together, such as at the beginning of psychological ther‐ apy. this is important given that mental disorders are still stigmatised by a large propor‐ tion of the general population due to lay concepts about their origins (e.g., depressive dis‐ orders being seen as a lack of willpower). second, endocrine markers may be used to aid the (differential) diagnostics of mental disorders. this is important in light of the fact that not all aspects of mental health are accessible by means of introspection, let alone by in‐ fischer & ehlert 7 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://www.psychopen.eu/ dividuals who suffer from deficits in detecting and reporting signs of psychological dis‐ tress (e.g., those scoring high on alexithymia). similarly, hormones may be used to assess treatment outcomes above and beyond self-report symptom measures or clinical rating scales. these ideas align well with the us national institute of mental health (nimh) re‐ search domain criteria (rdoc), which aim to provide more precise characterisations of a patient by integrating biological and psychological research (e.g., insel et al., 2010). to this end, a matrix combining five psychological domains (social processes, arousal/regu‐ lation, negative valence, positive valence, and cognition) with different units of analysis (genes, molecules, cells, neural circuits, physiology, behaviour, self-reported information, and paradigms) has been proposed. this allows for a particular state of mental illness to be described by deficits in different psychological domains, which map on to specific bio‐ logical substrates (e.g., neuroendocrine abnormalities). third, the results of neuroendo‐ crine testing may guide treatment choices, that is, they may support clinicians in finding out what is likely to work for whom and why. this resonates well with the central tenet of precision psychiatry, which advocates the tailoring of treatments to the needs of the individual patient by integrating data from multiple levels of information (e.g., biological, personality, and behavioural measures). on a related note, alternative or additional treat‐ ments for mental disorders may be developed that are based on a more in-depth account of patients’ pathophysiology (e.g., hormonal substitution as an augmentation to psycho‐ logical therapy). in the foreseeable future, clinical psychology is likely to benefit from a number of emerging trends in psychoneuroendocrinological research. elucidating the genetic and epigenetic underpinnings of endocrine functioning will be crucial to fully comprehend its role in mental disorders. as both the distribution and sensitivity of endocrine receptors are governed by genetic variation as well as by the individual’s epigenetic make-up (e.g., dna methylation), this could ultimately enable the identification of patients who run the risk of developing mental illnesses. similarly, learning more about the cross-talk between different endocrine systems and between endocrine and other bodily systems (e.g., cen‐ tral monoaminergic systems) should allow for a more accurate description of how, pre‐ cisely, endocrine disturbances contribute to the onset of mental disorders – and provide more precise targets for additional or alternative treatment options. finally, the advent of novel methodologies to assess hormones in a reliable, non-invasive manner (e.g., finger‐ nail cortisol) holds the promise to translate neuroendocrine knowledge into clinical prac‐ tice – and hopefully to the benefit of patients and clinical psychologists alike. funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. psychoneuroendocrinology and clinical 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(2013). psychoneuroendocrinology. in m. d. gellman & j. r. turner (eds.), encyclopedia of behavioral medicine. new york, ny, usa: springer. https://doi.org/10.1007/978-1-4419-1005-9 zilcha-mano, s., porat, y., dolev, t., & shamay-tsoory, s. (2018). oxytocin as a neurobiological marker of ruptures in the working alliance. psychotherapy and psychosomatics, 87(2), 126-127. https://doi.org/10.1159/000487190 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. fischer & ehlert 13 clinical psychology in europe 2019, vol.1(2), article 33030 https://doi.org/10.32872/cpe.v1i2.33030 https://doi.org/10.1016/j.neubiorev.2017.04.017 https://doi.org/10.1007/978-1-4419-1005-9 https://doi.org/10.1159/000487190 https://www.psychopen.eu/ psychoneuroendocrinology and clinical psychology (introduction) how hormones affect social interaction how hormones affect cognition, mood, and sexual function how hormones affect hunger and satiety summary and integration (additional information) funding competing interests acknowledgments references competences of clinical psychologists politics and education competences of clinical psychologists eaclipt task force on “competences of clinical psychologists” clinical psychology in europe, 2019, vol. 1(2), article e35551, https://doi.org/10.32872/cpe.v1i2.35551 received: 2019-04-18 • accepted: 2019-06-07 • published (vor): 2019-06-28 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: winfried rief, ph.d., professor of clinical psychology and psychotherapy, university of marburg, marburg, germany. e-mail: rief@uni-marburg.de abstract background: politicians, societies, stakeholders, health care systems, patients, their relatives, their employers, and the general population need to know what they can expect from clinical psychologists. even more, for our self-definition as a professional group, we should share a common understanding of the competence profile that characterises our qualifications. this understanding of the competence profile of clinical psychology leads directly to the content that should be taught in university curricula and postgraduate trainings for clinical psychology. the following discussion paper attempts to offer a general european framework for defining the competence profile of clinical psychologists. method: a group of european specialists developed this discussion paper under the umbrella of the european association of clinical psychology and psychological treatment (eaclipt). representatives with different treatment orientations, of basic science and clinical applications, and from east to western european countries, were part of the group. results: we present a list of competences that should be acquired during regular studies of psychology with a clinical specialisation. additionally, further competences should be acquired either during studying, or during postgraduate trainings. conclusion: clinical psychologists are experts in mental and behavioural disorders, their underlying psychological, social and neurobiological processes, corresponding assessments/ diagnostic tools, and evidence-based psychological treatments. while we provide a list with all competences of clinical psychologists, we do not consider this proposal as a final list of criteria, but rather as a living discussion paper that could be updated regularly. therefore, we invite our colleagues to contribute to this discussion, and to submit comments via email to the corresponding author. keywords competences, clinical psychology, psychotherapy, mental disorders this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.35551&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • people need to know what they can expect from clinical psychologists. • we present a list of competences that clinical psychologists acquire during their training. • this list of competences was developed by colleagues representing different treatment orientations, different european countries, and basic versus clinical scientists. • this competence list can represent a basis for optimising education and training programmes for clinical psychologists, and for informing the public. competence lists are increasingly important for the self-definition of a profession, for the planning of study and training curricula, and for the public view on a professional field. politicians, societies, stakeholders, health care systems, patients, their relatives, their em‐ ployers, and the general population need to know what they can expect from clinical psychologists. for our self-definition as a professional group, we should share a common understanding of the competence profile that characterises our qualifications. this un‐ derstanding of the competence profile of clinical psychology leads directly to the content that should be taught in university curricula and postgraduate training for clinical psy‐ chology. therefore, competence lists can be considered as an interactive aspect of the progress of a profession: first, they are developed based on current understanding, reality, experiences, and concepts, but vice versa, the list of competences can be used to develop and improve existing training curricula to better focus on an optimised education of these necessary competences. this interaction is outlined in figure 1. figure 1. how competence profiles, current practice and education inform each other. competences of clinical psychologists 2 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ h o w c o m p e t e n c e p r o f i l e s s t i m u l a t e t h e p r o g r e s s o f a p r o f e s s i o n many activities exist to develop and improve competence lists for clinical psychologists and psychotherapists. however, many of them are limited to specific nations (bartolo, 2005) or to specific psychotherapeutic orientations (sburlati, schniering, lyneham, & rapee, 2011). in the context of the iapt programme in uk, the university college of london developed competence frameworks for specific treatment modalities and their supervision (roth & pilling, 2008). they also provided competence profiles for different clinical groups, and clinical contexts (ucl.ac.uk/core/). these kinds of competence lists serve to quality assurance, but also to ethical evaluations (lane, 2011). some attempts used qualitative methods to approach the field (nodop & strauß, 2014), and differentiated scientific-conceptual competences, personal, and interpersonal competences. compe‐ tence lists also play a role in the development of national legal regulations for psycholo‐ gists and psychotherapists (willutzki, fydrich, & strauß, 2015). the aim of this article was to develop and present a european framework of compe‐ tence profiles for clinical psychologists that should be valid for all evidence-based treat‐ ment orientations in all european countries. therefore, we used the framework of the european association of clinical psychology and psychological treatment (eaclipt) to establish a work group representing different european countries and their national spe‐ cialties, different treatment orientations, the broad range from basic to applied science, but also further aspects of diversity. the proposal was further evaluated and approved by the eaclipt board members. here we present the first version of the european compe‐ tence list of clinical psychologists. c o m p e t e n c e s o f c l i n i c a l p s y c h o l o g i s t s clinical psychologists are experts in mental and behavioural disorders, the continuum from mental health to disease, psychological and psychobiological mechanisms of mental and behavioural disorders and physical diseases, epidemiological and health economic relevance of mental and behavioural disorders, vulnerability and resilience factors of psy‐ chological health, and evidence-based treatments for mental disorders and psychological factors of physical diseases. clinical psychologists are engaged in diagnosing, treating and scientifically investigating mental and behavioural disorders and psychological fac‐ tors of physical diseases within a bio-psycho-social and developmental framework. they plan, conduct, and evaluate activities to promote mental and behavioural health on a sci‐ entific basis in prevention, treatment and rehabilitation. they do not only apply current scientific knowledge, but they are also able to work with new complex problems and pro‐ fessional challenges, in a permanently changing environment. they have the competence eaclipt task force on “competences of clinical psychologists” 3 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ to support the scientifically-driven progress of the field, and to permanently integrate the latest scientific findings into their work. list of competences more detailed competences of clinical psychologists are: a) general psychological processes in health and disease clinical psychologists are experts in identifying and describing psychological, psychosocial, psychobiological and neuroscientific aspects of normal and abnormal human behaviour and experiences, hereby considering the whole life span. they have expertise in analysing the role of cognitive processes such as perception, learning, memory, language, of emotional and motivational processes, in developmental psychology and developmental psychopathology of the whole life span, of the biological basis of human experiences and behaviour, individual differences and dimensions of personality, and they can identify the social and cultural influences on normal and abnormal behaviour and experiences. they are familiar with scientifically sound models to better understand normal and abnormal behaviour, and can apply them to understand and treat psychological problems across life span. b) mental and behavioural disorders and psychological processes in physical disorders clinical psychologists are experts in informing the public, political stakeholders, institutions, affected people and their relatives about psychological problems and mental disorders, their varying appearances, and how to classify them. they can also identify psychological and psychosocial aspects of physical diseases. they are able to detect, diagnose, classify and describe mental disorders and psychological processes of physical diseases, using observational techniques, self-rating scales, expert ratings and other evaluated assessment tools. clinical psychologists reflect on cultural, societal and historical relativism in diagnosing mental and behavioural disorders and continually contribute to the development of international classification systems. c) psychological diagnostics clinical psychologists are able to develop, evaluate, employ, analyse, and report results of diagnostic tools to improve the objectivity, reliability and validity of diagnosing psychological, psychosocial and neurobiological aspects of mental and behavioural disorders and psychological mechanisms relevant in physical diseases. in their diagnostic work, they consider the continuum between healthy and clinically relevant processes, ageand socioeconomically relevant aspects, and other environmental and cultural determinants of psychological well-being and dysfunctional processes. they employ best-evidence self-rating scales, scientifically evaluated interview techniques, and other assessment tools, both for clinical competences of clinical psychologists 4 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ purposes, but also to assess personality characteristics, performance profiles, deficits, skills, and resources. d) intervention: general aspects clinical psychologists know about the different evidence-based psychological interventions, their historical development and current evidence-based evaluation. they can critically think about different treatments and can inform the public about scientifically based treatment guidelines and typical treatment characteristics, hereby considering disorder-, personand sociocultural-relevant aspect. they use scientifically-based interventions to enhance resources of the patients and clients to improve psychological well-being, and to reduce vulnerability and risk factors for psychological problems and mental and behavioural disorders. clinical psychologists can inform patients, their relatives, public institutions, stakeholders and others about the potential and risks of psychological treatments, based on a current critical scientific evaluation of them. e) prevention, rehabilitation: general academic expertise clinical psychologists are able to inform about prevention and rehabilitation programmes, their scientific evidence, and their potential use for society and specific target groups. they can develop, apply and evaluate such programmes. clinical psychologists can promote mental and behavioural health and develop mental health literacy in various settings. f ) scientific methodology clinical psychologists can use qualitative and quantitative approaches to investigate psychological, psychobiological and psychosocial processes and clinical applications to better understand normal and abnormal behaviour and experiences. they are able to plan, conduct and analyse the results of studies using modern criteria for scientific evaluations and advanced statistical modelling. in particular, clinical psychologists are able to plan, conduct, analyse, report and explain clinical trials and their results, to evaluate psychological interventions according to modern scientific standards. they are also able to understand and use methods and results from developmental, cognitive and experimental psychology, or from any other field related to scientific psychology important for the understanding of the aetiology, maintenance and treatment of mental and behavioural disorders. they know methods and central elements of psychotherapy and psychological intervention research, and how to incorporate that knowledge into their clinical practice. they actively take part in psychological intervention and psychotherapy research by developing research questions, designs and treating patients in clinical trials. g) ethical and legal aspects clinical psychologists consider and respect current ethical standards and legal regulations for their professional work. clinical psychologists are sensible regarding cultural diversity and respect it in their work with clients. eaclipt task force on “competences of clinical psychologists” 5 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ depending on national regulations, the following skills are either acquired dur‐ ing university studies, or during postgraduate trainings often connected to the term psychotherapy: h) skills for psychological interventions: meta-competences • clinical psychologists are able to provide psychological interventions that follow treatment aims and a treatment plan, based on current scientific knowledge about mental and behavioural disorders and interventions. major competences to provide interventions have been acquired according to current standards of learning how to practise these interventions. • clinical psychologists are able to motivate patients to engage in psychological interventions, and to foster and maintain a good alliance with their clients/ patients, their relatives and significant others. they can explain the intervention rationale to patients, other health care specialists, and further involved people. • clinical psychologists have the competence for perspective taking, empathy and mentalisation. they have professional skills to identify the diversity of verbal and nonverbal communication signals of others. they have professional competences to communicate with others, based on a broad variety of acquired communication skills, even during difficult communication sequences, or with patients with difficult communication patterns. they can verbally address emotional, cognitive, behavioural and interactive aspects of the patient’s/client’s behaviour. • clinical psychologists have an advanced ability to regulate their own emotions and behaviour, and to reflect their own emotions, cognitions, and behaviour during professional encounters. they can reflect the consequences of past learning and socialisation processes on current behaviour and experiences, not only in others, but also in themselves. they can cope with professional stressful situations, but are able to relax and plan their life according to an adequate work-life-balance. • clinical psychologists are able to evaluate on-going interventions of themselves or of others, to detect unfavourable or unexpected events, and to react adequately in the event of occurring risks (e.g., suicidality). they are able to address treatment problems (e.g. adherence problems of patients) and problems of the therapeutic relationship accordingly. they are able to use the patient’s/client’s feedback to adapt intervention processes. • when confronted with new problematic professional situations, they have concepts about how to develop new problem-solving strategies, based on a profound framework theory how to plan interventions. • clinical psychologists are able to end interventions in a planned manner, to plan for long-term maintenance of treatment gains, and to reduce the risk of relapse after the intervention. competences of clinical psychologists 6 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ • clinical psychologists aim to continuously improve their professional abilities. they are able to learn from their own and other experiences, from supervision and intervision, and to transfer current scientific knowledge to clinical practice and to integrate recommendations of others (e.g. supervisors) in their clinical work. • clinical psychologists are able to communicate with other health-professionals, and to coordinate their diagnostic and intervention plans with other experts involved in the overall treatment plan. i) skills for psychological interventions: disorder-, person-, and contextspecific diagnostics and interventions following recommendations of official scientifically based guidelines, clinical psychologists can select evidence-based diagnostic tools and evidence-based psychological interventions for specific mental and behavioural disorders and psychological aspects of physical diseases. for treatment planning, they consider the different severity degrees and courses of mental and behavioural disorders, the comorbidity profiles, further associated problems, the patient’s and setting’s resources, as well as cultural aspects. j) skills for psychological interventions: prevention, rehabilitation clinical psychologists are able to prepare, conduct, and evaluate clinical prevention and rehabilitation programmes according to current scientific standards. they have public relation skills to present programmes and persuasive skills to promote the relevance of the programmes to significant stakeholders. k) skills for psychological interventions: setting-specific interventions, modern technologies clinical psychologists are able to provide professional, scientifically based work with individuals, with couples, with families, and in groups. they can provide expert knowledge and they have the ability to work in complex systems (e.g., hospitals, occupational health services, political institutions). they are aware of options to increase effectivity, reachability, and benefit-cost-ratios for providing clinical psychological interventions also by using modern technologies. l) skills for psychological interventions: documentation, evaluation clinical psychologists continuously document and evaluate their work. they consider aspects of quality insurance. c o n c l u s i o n we provide a first list with the characterising competences of clinical psychologists that aims to cover the needs of all european nations, but also of representatives of different specialisations and orientations of clinical psychology. however, we do not consider this proposal as an exhaustive list of criteria, but as a living discussion paper that could be eaclipt task force on “competences of clinical psychologists” 7 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ updated regularly. therefore, we invite our colleagues to contribute to this discussion, and to submit comments via email to the corresponding author. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. author note: members of the eaclipt task force on “competences of clinical psychologists” and the eaclipt board which has approved this proposal are: gerhard andersson, natasa jokic begic, claudi bockting, roman cieslak, celine douilliez, thomas ehring, philipp kanske, andreas maercker, agnieszka popiel, winfried rief, chantal martin soelch, svenja taubner. r e f e r e n c e s bartolo, p. a. (2005). regulating the psychology profession in malta. european psychologist, 10(1), 76-77. https://doi.org/10.1027/1016-9040.10.1.76 lane, d. (2011). ethics and professional standards in supervision. in t. bachkirova, p. jackson, & d. clutternuck (eds.), coaching and mentoring supervision: theory and practice (pp. 99–104). maidenhead, united kingdom: open university press. nodop, s., & strauß, b. (2014). kompetenzbereiche in der psychotherapeutischen ausbildung. zeitschrift für klinische psychologie und psychotherapie, 43(3), 171-179. https://doi.org/10.1026/1616-3443/a000272 roth, a. d., & pilling, s. (2008). a competence framework for the supervision of psychological therapies. retrieved august, 18, 2011 from www.ucl.ac.uk/core/. sburlati, e. s., schniering, c. a., lyneham, h. j., & rapee, r. m. (2011). a model of therapist competencies for the empirically supported cognitive behavioral treatment of child and adolescent anxiety and depressive disorders. clinical child and family psychology review, 14(1), 89-109. https://doi.org/10.1007/s10567-011-0083-6 willutzki, u., fydrich, t., & strauß, b. (2015). aktuelle entwicklungen in der psychotherapieausbildung und der ausbildungsforschung. psychotherapeut, 60(5), 353-364. https://doi.org/10.1007/s00278-015-0048-1 competences of clinical psychologists 8 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://doi.org/10.1027/1016-9040.10.1.76 https://doi.org/10.1026/1616-3443/a000272 https://doi.org/10.1007/s10567-011-0083-6 https://doi.org/10.1007/s00278-015-0048-1 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. eaclipt task force on “competences of clinical psychologists” 9 clinical psychology in europe 2019, vol.1(2), article e35551 https://doi.org/10.32872/cpe.v1i2.35551 https://www.psychopen.eu/ competences of clinical psychologists (introduction) how competence profiles stimulate the progress of a profession competences of clinical psychologists list of competences conclusion (additional information) funding competing interests acknowledgments author note references evaluating a programme for intercultural competence in psychotherapist training: a pilot study research article evaluating a programme for intercultural competence in psychotherapist training: a pilot study ulrike von lersner a, kirsten baschin a, nora hauptmann a [a] department of psychology, humboldt university of berlin, berlin, germany. clinical psychology in europe, 2019, vol. 1(3), article e29159, https://doi.org/10.32872/cpe.v1i3.29159 received: 2018-08-21 • accepted: 2019-06-07 • published (vor): 2019-09-20 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: ulrike von lersner, department of psychology, humboldt-universität zu berlin, rudower chaussee 18, 12489 berlin, germany. e-mail: ulrike.von.lersner@hu-berlin.de abstract background: great cultural diversity among clients poses considerable challenges to mental health service providers. therefore, staff in the mental health sector needs to be adequately trained. to date, however, there is little empirical evidence regarding such training. the present pilot study evaluates the effect of a standardised training programme to improve the intercultural competence of therapists. method: intercultural competence and therapeutic relationship were measured three times (pre, post and follow-up) in n = 29 psychotherapists. a control group of n = 48 therapists was included at pre-test to control for covariables. results: the data show a significant increase in intercultural competence as well as an improvement in the therapeutic relationship. interestingly, this positive outcome extends to nonimmigrant clients. conclusion: the results confirm the assumption that culture is not limited to ethnic or national background but includes other dimensions such as age, gender and socioeconomic status which shape illness beliefs and expectations in the psychotherapeutic context. therefore, intercultural competence can be considered a general therapeutic skill that can be taught in short interventions like the one developed in this study. keywords evaluation, intercultural competence, diversity, psychotherapy, migration, awareness this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.29159&domain=pdf&date_stamp=2019-09-20 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • mental health services and practitioners need to be able to respond appropriately to increasing cultural diversity. • intercultural competence in psychotherapy can be enhanced by special training programmes. • these training programmes should focus on three components: intercultural knowledge, cultural awareness and culture-specific therapeutic skills. as a consequence of continuously increasing global mobility, as well as war and environ‐ mental migration, cultural diversity in western societies is growing rapidly. these pro‐ cesses are generating a degree of cultural diversity that requires mental health service administrators and practitioners to be able to respond appropriately. yet, in mental health services a considerably smaller percentage of immigrants is be‐ ing treated now than would be expected considering their overall population share. this has been explained by some as a product of lower service use by clients with a migration background (chen & rizzo, 2010; claassen, ascoli, berhe, & priebe, 2005; koch, hartkamp, siefen, & schouler-ocak, 2008; lindert et al., 2008; machleidt, behrens, ziegenbein, & calliess, 2007; ta et al., 2015). previous studies have also shown that insti‐ tutional barriers can hamper service uptake, including problems of language and other means of communication (claassen et al., 2005; kirmayer et al., 2011; yeo, 2004), per‐ ceived or expected discrimination, and structural and financial barriers (chen & rizzo, 2010; kirmayer et al., 2011). moreover, surveys of psychotherapists have shown a high degree of insecurity and helplessness in intercultural contexts, which can lead to a great‐ er likelihood of rejecting them as patients or to higher dropout rates (de haan, boon, de jong, & vermeiren, 2018; von lersner, 2015; wohlfart, hodzic, & özbek, 2006). the status quo, outlined above, suggests that an intercultural opening up of the men‐ tal health sector is urgently needed (kirmayer et al., 2011; machleidt et al., 2007), imply‐ ing an adaptation of institutional and organisational structures to the needs of immigrant clients. meanwhile, benish, quintana, and wampold (2011) in their meta-analysis have suggested that intercultural therapies have better outcomes when therapists include pa‐ tients’ culturally shaped explanatory models in treatment. furthermore, therapists should be better prepared for this group of clients through their professional training, in order to reduce insecurities and improve treatment outcomes in the long run (aggarwal, cedeño, guarnaccia, kleinman, & lewis-fernández, 2016; kirmayer, 2012; von lersner, baschin, wormeck, & mösko, 2016). evaluation of a program for intercultural competence 2 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ intercultural competence training even though intercultural competence appears to be of high relevance in clinical settings, evaluations of intercultural training in the psychotherapeutic context are unfortunately still very rare (kulik & roberson, 2008; mösko, baschin, längst, & von lersner, 2012). to our knowledge, there has been no such training evaluation in german-speaking areas. in the present study, we evaluated an intercultural training programme for therapists aimed at improving intercultural competence and therapeutic relationship. thus, we evaluated cognitive, skill-based and affective learning, as well as possible improvements in the therapeutic relationship, as components of behavioural change that should emerge after training. since the training programme was being conducted for the first time, our evaluation has the character of a pilot study. before discussing the intercultural training, the concept of culture as it is used in the present study needs to be defined. according to geertz (1973, p. 83), culture describes ‘a system of inherited conceptions expressed in symbolic forms by means of which men communicate, perpetuate, and develop their knowledge about, and attitudes toward, life’. thus, it can be said to refer to a set of values and norms shared by a group of people independently of their national or ethnic backgrounds. meanwhile, in its current usage, the term intercultural competence stands for a wide range of definitions associated with numerous practical implications (steinhäuser, martin, von lersner, & auckenthaler, 2014). however, a widely used concept in clinical settings is the one formulated by sue and sue (1990), which includes the following three dimensions: • awareness: exploration of and reflection on one’s own cultural embeddedness as well as its influence on perceptions of clients and the formation of the therapeutic relationship. • knowledge: knowledge of the cultural background of the client and possible implications for his or her worldview. • skills: the development of culturally sensitive intervention strategies and techniques. these three components, which can be said to constitute the basis of effective treatment in intercultural settings, represent a goal that is unlikely to be achieved in a one-off train‐ ing session; rather, it requires an active, ongoing process that practitioners have to go through over a longer period of time (guzder & rousseau, 2013). the model developed by sue and sue (1990) has also become the basis of national guidelines on intercultural competence in various countries and organisations, such as the multicultural guidelines of the american psychological association (2003, 2008) and the guidelines for training in cultural psychiatry (kirmayer et al., 2012). they have also been applied in a european strategy paper on intercultural competence in the mental health sector (bennegadi, 2009) and in the german guidelines for the training of intercul‐ tural competence of psychotherapists (von lersner et al., 2016). von lersner, baschin, & hauptmann 3 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ intercultural competence training can be carried out in multiple ways and can be quite heterogeneous with regard to target groups, duration, methods used and content, to name only a few dimensions. the majority of intercultural training evaluation studies in the health sector have been conducted with nursing staff and doctors as well as universi‐ ty students as subjects (delgado et al., 2013; khanna, cheyney, & engle, 2009). four systematic reviews, covering 69 studies from 1980 through to 2010, have ana‐ lysed the effectiveness of intercultural training for nursing staff and medical doctors mainly in the us (beach et al., 2005; chipps, simpson, & brysiewicz, 2008; lie, lee-rey, gomez, bereknyei, & braddock, 2011; price et al., 2005). beach et al. (2005) reported very good evidence of increased cultural knowledge among doctors and nursing staff as a re‐ sult of such training, a result that was replicated by chipps et al.’s (2008) study focusing on staff in rehabilitation centres. there is also good evidence from these studies that awareness and skills (see sue & sue, 1990) can change and improve through such train‐ ing. an evaluation of training programmes by kulik and roberson (2008) also reported large benefits in intercultural awareness and knowledge across target groups and train‐ ing settings, but little improvements on the skills dimension. regarding the quality of training schemes, both lie et al. (2011) and price and colleagues (2005) suggest that the quality of the evaluation studies examined was only low to moderate: most of them failed to control for confounding variables and effect sizes varied between zero and moderate. thus, in contrast to the large number of training schemes available, there is a conspicu‐ ous lack of transparently documented and published studies on their effectiveness. one concept that is widely used in intercultural competence training—and in the training programme evaluated in our study too—is the diversity approach. according to this perspective, there are six diversity dimensions that can influence perceptions of commonality and difference and are likely to lead to forms of discrimination: age; gender; sociocultural background, including migration history and skin colour; handicaps and skills; sexual orientation; and religion (van keuk, ghaderi, joksimovic, & david, 2011). diversity training can focus on one or more of these dimensions, implying that cultural background is only one possible dimension. participants should learn to be aware of the different types of diversity among their clients and how to deal with them in a positive way. a meta-analysis of the effectiveness of diversity training by kalinoski et al. (2013) found significant effects on knowledge and skills but none on attitudes and awareness. their analysis of training methods and structural factors suggested that training sessions lasting 12−16 hours and applying active training methods such as role play, discussion or critical incident technique had the greatest effectiveness, with training spread over multi‐ ple sessions being more effective than one-session programmes. effective training should have a positive impact on the cultural competence of the therapist as well as improving the therapeutic process, wherein the therapeutic relation‐ ship is of special interest. norcross (2010, p. 113) defines the client–therapist relationship as ‘the feelings and attitudes that therapist and client have toward one another and how evaluation of a program for intercultural competence 4 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ these are expressed’. meanwhile, khanna and colleagues (2009) describe the therapeutic relationship within the intercultural therapeutic process as an important predictor of compliance and outcomes. therefore, the present pilot study focuses on this aspect as well. with regard to efficiency, it is also relevant to evaluate whether rather short inter‐ ventions, such as the one developed for the present study, can initiate such positive change. from the start, we assumed that our programme would have a positive impact on the intercultural competence of participants, and that these effects would be quantifiable across our three points of measurement—before, immediately after and three months af‐ ter participation—of the programme. we further hypothesised that having to consider in‐ tercultural issues during the programme would affect the therapeutic relationship in a beneficial way. as such an impact would probably only unfold with time (guzder & rousseau, 2013; kulik & roberson, 2008), we assumed that the effects would be most ob‐ servable during the follow-up analysis. further, as another goal of the pilot study was to assess whether the training programme could serve groups of therapists with different levels of experience, we included therapists in training as well as experienced therapists and analysed the effects of the training on them separately. we assumed that participants would benefit from the training regardless of their level of therapeutic experience; that is, that therapists in training would benefit from the programme in a comparable manner to that of experienced therapists. m e t h o d study design data were collected in berlin as part of a project conducted in the department of psycho‐ therapy and somatopsychology at humboldt university of berlin, in collaboration with the department of medical psychology of university medical centre hamburg-eppen‐ dorf, from october 2013 until march 2014. the project was funded by the european inte‐ gration fund (eif) and ethical approval for the study was given by the ethical review board of the department of psychology at humboldt. the conceptual underpinnings of the training programme evaluated in this study were based on the guidelines for inter-/transcultural competence training of psychothera‐ pists, which were developed during a previous project by our workgroup (von lersner et al., 2016). data were acquired before (pre-), immediately after (post-) and three months after (follow-up) the training programme. participants were recruited through mailing lists of educational institutions for clini‐ cal psychologists and psychological associations in berlin. we included five institutes for cognitive behavioural therapy as well as five for psychoanalysis and depth psychology. von lersner, baschin, & hauptmann 5 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ the main inclusion criterion for participation in the training programme was having had professional training in psychotherapy for adult clients. therapists who were still in training had to have passed on to the practical stage and be treating clients under super‐ vision. a control group that did not participate in the programme was polled online dur‐ ing the pre-measurement phase. participation in both groups was voluntary, based on in‐ formed consent and without any incentives or remuneration. unfortunately, as we re‐ cruited participants through mailing lists, we were not able to track a reliable response rate. figure 1 illustrates the flow of participants in the course of the study. figure 1. flow of participants. evaluation of a program for intercultural competence 6 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ implementation of the training programme before implementation of the training programme, a pilot training session was carried out with psychology students. subsequent adjustments were made for the final training manual which would guide the training programme analysed here. the intervention took place in berlin and consisted of two consecutive days of train‐ ing—16.5 hours in total. three weeks later, an additional, one-day refresher session was carried out consisting of six units of 45 minutes each (4.5 hours total). experienced thera‐ pists and therapists in training received separate training circuits, which were run by ex‐ perienced intercultural trainers from the project team. programme content the learning objectives defined in the aforementioned guidelines for intercultural compe‐ tence (von lersner et al., 2016) formed the basis of the content of the training programme. as recommended by hager, patry, and brezing (2000), an outline of the training pro‐ gramme was discussed by an expert panel (consisting of the project team and four expe‐ rienced intercultural trainers from the university medical centre hamburg-eppendorf and the transcultural centre in stockholm), and subsequent adaptations incorporated in‐ to the final version by the project team. table 1 provides a brief overview of the different aspects of intercultural competence covered by individual modules of the programme. in terms of the didactic methods employed, input lectures, self-reflective exercises, critical incident technique, plenary discussions and role play were included. table 1 overview of the training modules module content culture e.g. definition of culture in the personal and therapeutic context, transcultural competence, ethnocentrism, diversity migration e.g. information on facts and figures on migration pathways, stressors & resources, political framework experiencing cultural foreignness in everyday life e.g. personal experiences of cultural foreignness, stereotypes & prejudices, individual norms and values, discrimination working with cultural brokers and interpreters e.g. the meaning of language in the therapeutic process, language barriers, rules for the inclusion of interpreters in the therapeutic setting von lersner, baschin, & hauptmann 7 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ module content psychometric testing & classification of mental disorders e.g. opportunities and limitations of culture-sensitive testing, epidemiology of mental disorders in different cultural settings, culture-specific symptom presentation, cultural concepts of distress in dsm-5 exploration and anamnesis e.g. cultural formulation interview, culture-specific explanatory models of mental illness experiencing cultural foreignness in the clinical setting e.g. critical incidents booster session (three weeks later) e.g. supervision, clarification of outstanding questions, identification of ‘cultural pitfalls’ (auernheimer, 2002) on the basis of own examples measures sociodemographic data basic variables regarding the sociodemographic background of participants—gender, age, migration background, therapeutic approach and first language—were recorded. further, information regarding prior experience of intercultural competence training as well as level of personal interest in the topic was collected. personality traits in order to assess the influence of the personality trait of openness, the survey also inclu‐ ded the short version of the big five inventory (bfi-10; rammstedt & john, 2005), which measures the big five personality dimensions using just two items for each of them. rammstedt (2007) reports satisfactory values for the test’s quality criteria, and the items on openness exhibit moderate values for retest reliability (rtt = .62). intercultural competence the intercultural competence of participants was measured via the widely used four-di‐ mension multicultural counseling inventory (mci; sodowsky, taffe, gutkin, & wise, 1994). the mci is based on the three dimensions of intercultural competence formulated by sue and sue (2012)—knowledge, awareness and skills—but also seeks to capture an ad‐ ditional, fourth dimension: the multicultural therapeutic relationship. this four-factor structure allows single scores to be calculated for each of the dimensions as well as an overall sum score for intercultural competence. the 40 items of the mci comprise state‐ ments about counselling and therapy in intercultural settings. participants are asked to respond on a five-point likert scale, ranging from 1 = ‘very inaccurate’ to 5 = ‘very accu‐ rate’. for the present study, the mci was translated into german via the back-translation evaluation of a program for intercultural competence 8 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ method (brislin, 1970) and adapted linguistically from counselling to therapeutic settings. the mci meets the requirements for questionnaires in terms of reliability (.71 ≤ α ≤ .90) as well as validity. in our sample, it had a cronbach’s alpha α = .88 at t1, α = .88 at t3 and α = .89 at t4, which represent good values. cronbach’s alphas for the subscales were as follows: αrelationship = .68, αawareness = .78, αknowledge = .85 and αskills = .79 at t1; αrelationship = .63, αawareness = .80, αknowledge = .80 and αskills = .76 at t3; and, αrelationship = .67, αawareness = .82, αknowledge = .79 and αskills = .84 at t4. therapeutic relationship in addition to the multicultural therapeutic relationship dimension of the mci, a closer examination of the therapeutic relationship was achieved using the german version of the scale to assess the therapeutic relationship in community mental health care, clinician version (star-c; mcguire-snieckus, mccabe, catty, hansson, & priebe, 2007). the self-report star-c questionnaire consists of 12 items that seek to evaluate the quali‐ ty of the therapeutic relationship from the perspective of the therapist. it consists of three factors: 1) positive collaboration, 2) positive clinician input and 3) emotional diffi‐ culties. participants rated the therapeutic relationship separately for their clients with and without a migration background. retest reliability of the german version is r = .54, which is satisfactory (gairing, jäger, ketteler, rössler, & theodoridou, 2011). in our sam‐ ple, cronbach´s alphas were as follows: αstar_german clients = .67 and αstar_immigrant clients = .42 at t1; αstar_german clients = .64 and αstar_immigrant clients = .45 at t3; and, αstar_german clients = .64 and αstar_immigrant clients = .62 at t4 which reflect moderate to poor values. figure 2 gives an overview of the research design and the measures used at different sections of the study. evaluation at t1 and t4 was carried out online, whereas at t2 and t3 data was collected in a paper and pencil format. figure 2. overview of the research design. note. ig = intervention group. cg = control group. von lersner, baschin, & hauptmann 9 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ statistical analysis data analysis was carried out using spss (version 22.0). in order to compare characteris‐ tics of the intervention and the control group, between-subject descriptive variables were compared using independent-sample t-tests or wilcoxon rank-sum tests for continuous data and chi-square analysis for categorical data. within-subject descriptive variables were compared using either paired-sample t-tests or wilcoxon signed-rank tests, depend‐ ing on data level. internal consistency of the star-c, bfi and mci variables and therefore the reliabili‐ ty of the measures used in this study was examined by calculating cronbach’s alpha for the pre-, postand follow-up total scores. in order to control for possible selection bias for the variables of prior intercultural competence (mci pre) and prior knowledge, as well as proportion of immigrant clients, personal interest and openness, univariate anovas were carried out. post-hoc tests us‐ ing bonferroni correction allowed us to localise the effects. further, to calculate the influence of the training programme on intercultural compe‐ tence the friedman test was used. for localisation of the effects over time, wilcoxon signed-rank tests were applied to non-parametric data and t-tests to parametric data. meanwhile, interaction between time and status of participants (trainee vs. experienced therapist) was examined in a manova with repeated measures. throughout the whole study, effect size is reported as cohen’s d, r and ω. an alpha of .05 was used to define statistical significance in all analyses, and power analysis was carried out using g*power (faul, erdfelder, lang, & buchner, 2007). r e s u l t s sample characteristics at t1 the intervention group consisted of 35 participants. table 2 shows demographic characteristics of this group in comparison to the control group. statistical analysis showed significant differences between the groups in terms of age and therapy method with the control group being younger and containing a larger percentage of cbt thera‐ pists. evaluation of a program for intercultural competence 10 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ table 2 demographic variables of training group and control group at t1 intervention group (n = 35) control group (n = 48) demographic variables n % n % p gender .55 female 31 88.6 42 88.0 male 4 11.4 6 12.0 age .01 21 – 30 years 8 22.9 18 37.5 31 – 40 years 10 28.6 23 47.9 41 – 50 years 9 25.7 5 10.4 51 – 60 years 5 14.3 2 4.2 > 61 years 3 8.6 0 0.0 therapy method < .001 cbt 18 51.4 45 93.8 psychoanalysis 14 40.0 3 6.3 no information 3 8.6 previous intercultural training .34 yes 3 8.6 8 16.7 no 32 91.4 40 83.3 proportion of immigrant clients in daily practice .70 < 10% 14 40.0 19 39.6 10 – 30% 13 37.1 19 39.6 30 – 60% 4 11.4 7 14.6 60 – 90% 2 5.7 2 4.2 > 90% 2 5.7 1 2.1 immigrant background .35 yes 14 40.0 14 29.2 no 21 60.0 34 70.8 note. cbt = cognitive behavioural therapy. *p ≤ .05. **p ≤ .01. the whole training programme and evaluation was completed by n = 24 participants, 33% of whom were between 31 and 40 years old and 82% female; 58% were trained (or still in training) in cbt; and 13% had previously participated in intercultural training programmes lasting on average six hours. regarding prior experience of immigrant cli‐ ents, a quarter of participants reported that immigrants made up about 30% of their clien‐ tele, whereas the remaining participants treated significantly fewer. furthermore, 38% of von lersner, baschin, & hauptmann 11 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ participants had a migration background themselves, meaning that either they them‐ selves or one of their parents had immigrated to germany (federal statistics office, 2016). prerequisites and verification of selection bias the verification of differences between the intervention and control groups before train‐ ing revealed no significant differences in terms of intercultural competence before train‐ ing (mci-pre), t(68.53) = -1.35, p = .183, proportion of immigrant clients, h = 2.739, p = .434, χ2(4) =3.01, p = .556, or openness (w = 726.5, p = .361). however, there were significant differences between the intervention group and control group regarding inter‐ est (w = 1509.5, p < .001) and prior intercultural knowledge (w = 261, p < .001). within groups, i.e. between trainees and therapists, no significant differences in mean values were detected. intercultural competence table 3 shows the development of intercultural competence over time by presenting the results of the four subscales as well as the total score for the mci. table 3 intercultural competence on the mci over the course of the training sub-scale of the mci pre post follow-up prepost prepostt1 t3 t4 follow-up follow-up m sd m sd m sd d d d skills 3.80 0.51 3.75 0.51 3.93 0.40 -.10 .28** .39* awareness 3.09 0.86 3.32 0.67 3.33 0.74 .35* .30* .01 therapeutic relationship 3.39 0.46 3.38 0.47 3.54 0.31 -.02 .38 .40** knowledge 3.22 0.58 3.51 0.50 3.64 0.48 .54* .79** .27 total score 3.41 0.46 3.52 0.30 3.62 0.33 .28* .53** .32* *p ≤ .05. **p ≤ .01. the data indicate a significant effect of time as a variable across both groups (experi‐ enced therapists and therapists in training, χ2(2, n = 24) = 17.70, p < .01, ω = .86). the wilcoxon signed-rank test revealed significant changes between all three measurement times (pre to post: z = -3.29, p < .01, φ =.67, 1 β = .43; postto follow-up: z = -2.29, p < .001, φ =.47, 1 β =.44; pre to follow-up: z = -4.00, p < .01, φ =.82, 1 β =.79). significant changes on the dimensions of awareness and knowledge occurred immediately after training, whereas values for skills and therapeutic relationship increased significantly at follow-up. the status of trainees had no influence on training outcomes, meaning that evaluation of a program for intercultural competence 12 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ experienced therapists and therapists in training benefitted from the training programme to the same degree, f(2, 44) = 2.23, p = .12, η2 = .09. the therapeutic relationship, as seen from the perspective of the therapist, was inves‐ tigated in further detail using star-c. thus, participants were asked at t1, t3 and t4 to rate their therapeutic relationships with their non-immigrant and immigrant clients, sep‐ arately. statistical analysis revealed significant improvement in the therapeutic relationship with non-immigrant clients from t1 to t3, t(28) = -1.73, p = .047, and a clear trend toward significant change from t1 to t4, t(24) = -1.47, p = .076, and t3 to t4, t(22) = -0.43, p = .334. yet, in contrast, no significant changes were observed with immigrant clients, t1 to t3: t(28) = -0.58, p = .284, t1 to t4: t(24)= -1.40, p = .086, and t3 to t4 t(22) = -0.82, p = .210 (see table 4). table 4 therapeutic relationship over the course of the training measured with star-c therapeutic relationship pre post follow-up prepost prepostt1 t3 t4 follow up follow up m sd m sd m sd d d d non-immigrant clients 3.40 .39 3.47 .26 3.52 .25 .21 .37 .20 immigrant clients 3.35 .30 3.37 .25 3.46 .30 .07 .37 .33 d i s c u s s i o n in this pilot study we evaluated an intercultural training programme for psychothera‐ pists, focusing particularly on changes over time in the intercultural competence of par‐ ticipants as well as the therapeutic relationship from the perspective of the therapist. in order to control for a possible selection bias among participants a control group was in‐ cluded at t1 and we measured variables such as interest in intercultural issues prior to training and prior knowledge and experience of immigrant clients, as well as work expe‐ rience. international evaluation studies point to a general effectiveness of intercultural com‐ petency training (benish et al., 2011; betancourt & green, 2010; kalinoski et al., 2013; kulik & roberson, 2008), and our first evaluation of one such training programme in ger‐ many follows these studies in its overall assessment. even though intercultural compe‐ tence training programmes for therapists existed prior to our study, no systematic evalu‐ ation had been carried out with this target group. applying our approach, intercultural competence as measured with the mci in‐ creased significantly. this was the case for the total score as well as the separate scores for each of the four dimensions of the inventory. von lersner, baschin, & hauptmann 13 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ our training programme also had an immediate effect on the dimensions of aware‐ ness and knowledge, as described by beach et al. (2005). in the domain of awareness, this implies, for example, reflecting on one’s own prejudices and examining stereotypes so as to develop better awareness of and openness to cultural diversity, and learning about the interplay between one’s own attitudes towards immigrant clients and the therapeutic process. meanwhile, increases in the domain of knowledge imply being better informed about the diversity of cultural groups, differences in cultural concepts of distress and styles of communication, and the use of cultural brokers in therapy. it may also include greater understanding of the socio-political contexts in which intercultural therapy takes place. these are areas of improved intercultural competence that can be absorbed rather quickly and immediately. in contrast, effects on the dimensions of skills and the therapeutic relationship, again as measured by the mci, only became evident at the three-month follow-up. as already presumed by kulik and roberson (2008), it seems that such changes only become preva‐ lent with direct interaction with clients; thus, these aspects can only be reliably evaluated after participants have returned to work rather than immediately after participation in the programme. campinha-bacote (2002) and guzder and rousseau (2013) describe the development of intercultural competence as an ongoing process in which trainees are constantly chal‐ lenged to be aware of and question their own cultural imprints, thereby becoming able to take their clients’ different cultural backgrounds into account in therapy. but critical analysis of one’s own values and norms, and the acquiring of new skills, are comprehen‐ sive and long-term developmental processes that do not happen overnight. interestingly, though, the results of the present study indicate that this process can be successfully ini‐ tiated through training programmes like the one presented here. our comparison of the study group and the control group revealed that groups did not differ in terms of intercultural competence before training, proportion of immigrant clients or openness but did differ in terms of interest and prior intercultural knowledge. we cautiously take this to assume that selection bias can thus be excluded, and that by and large training outcomes can be attributed solely to the training programme. at the same time, we have to consider that the sample of this pilot study was too small to carry out reliable regression analyses and to safely rule out a selection bias. this shortcoming could be addressed in future research by larger samples and the inclusion of a control group across all times of measurement. one reason for the positive outcome of the programme could be the teaching meth‐ ods used. according to kalinoski et al. (2013), emotion-focused techniques such as critical incident technique, self-reflective units or active sessions can be more effective in inter‐ cultural training than simply imparting theoretical knowledge. the training programme that we developed, implemented and evaluated here includes a high proportion of emo‐ tion-activating methods throughout. in each module, a brief introduction is followed by evaluation of a program for intercultural competence 14 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ exercises in which participants can try out a new approach, discuss case vignettes or re‐ flect upon their own perspective. kalinoski et al. (2013) also demonstrated that training sessions distributed over two or more points in time tend to be more effective compared with longer, one-off interventions. as our training programme consisted of core or pri‐ mary training sessions spread over two days and an additional refresher session three weeks later, this could also account for the positive outcomes observed. besides effective training methods and structure, an additional success factor could be the greater specific‐ ity of the target group we selected compared with those participating in previous train‐ ing programmes, given that the programme was specifically both developed for and eval‐ uated by psychotherapists. as we have mentioned, there was no significant difference in programme outcomes between experienced therapists and therapists in training, suggesting that the pro‐ gramme is appropriate for all therapists regardless of level of experience. this is impor‐ tant for the practical applicability of the programme, as one can either use one pro‐ gramme for all therapists or develop separate curricula for participants of different expe‐ rience levels. the data suggest that the level of therapeutic experience is not important and thus that the training programme could be applied in postgraduate training as well as in trainings at a later point in therapists’ careers. this finding is in line with the guidelines for intercultural training (kirmayer et al., 2012, von lersner et al., 2016), which are based on the same assumption and define quality criteria for intercultural training across all groups of therapists. therapeutic relationship to assess the impact of the programme on the therapeutic process, we examined the per‐ ceived therapeutic relationship from the perspective of the participants over the course of the training. however, our study generated unexpected findings. overall, from the per‐ spective of the therapist, it seems that the therapeutic relationship benefits significantly from additional training. this was evident from the star-c post measurement as well as the relevant sub-domain of the mci at follow-up. yet, when participants were asked to rate the therapeutic relationship for non-immigrant and immigrant clients separately, significant improvement was observable for non-immigrant clients only. at first sight this would appear to be an unexpected outcome, given that the training programme fo‐ cused on intercultural issues with the intention that immigrants should particularly ben‐ efit from it. two possible reasons for this counter-intuitive effect are considered here. first, if we recall the definition of culture on which our training programme is based, this effect should not be so surprising. according to geertz (1973), culture consists of a set of values and norms shared by a group of people independently of their regional origin, a perspec‐ tive that is also linked to the concept of diversity introduced earlier in this paper. thus, during the training sessions regional origin and migration status were only two of nu‐ von lersner, baschin, & hauptmann 15 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ merous dimensions associated with culture and diversity. the results found here would seem to confirm this perspective: the quality of the therapeutic relationship improved for the majority of clients irrespective of their immigrant status, suggesting that factors such as openness, greater sensitivity towards clients’ socio-cultural background and better awareness of one’s own cultural norms and expectations can be beneficial to all clients. secondly, our sample size was rather small at t1 and had decreased further by the time of the follow-up, with the remaining therapists treating a rather small number of immigrants—at or below 30% of their clients—in their daily practice. thus, it may be due to the small size of this reference group that improvements in the therapeutic relation‐ ship between these immigrant clients and their therapists were simply not readily appa‐ rent. at the same time, our statistical results clearly point to a positive trend regarding the effect of the training on the therapeutic relationship. this appears to have been con‐ firmed when we used the mci—on which only the therapeutic relationship with immi‐ grant clients was rated—which reported significant improvement. nonetheless, we feel that, as a consequence of this pilot study, the evaluation should be repeated with a larger sample and more reliable measures in the future. internal consistencies of star-c scales were unsatisfactory and might have had a negative effect on the outcome values. consid‐ eration should also be given to modifying the training programme’s units on migrationrelated issues, so as to increase the likelihood that the therapeutic relationship with im‐ migrant clients benefits in the same way as that with non-immigrant clients did. further‐ more, in order to achieve robust positive training outcomes, guzder and rousseau (2013) recommended ongoing supervision following training. this could support participants in terms of strengthening their newly acquired skills and dealing with any uncertainties arising in the process, both of which may have a long-term, positive impact on the thera‐ peutic relationship. limitations and implications in addition to its positive outcomes, the study also has a number of limitations. because of the small sample size, some statistical trends may have been imperceptible that may have been significant with a larger dataset. also, effect sizes were relatively small. an‐ other result of the small sample size is that our findings cannot be confidently general‐ ised to all therapists. thus, further studies with larger sample sizes are urgently needed to underpin the effects found in this study. in the meantime, in view of the lack of studies in this field internationally, as well as in germany, our pilot data provide important infor‐ mation and empirical insights. the statistical values of the star-c were also unsatisfactory, potentially reducing the explanatory power of our findings on the therapeutic relationship. this limitation should be addressed in future research. nevertheless, significant effects of the programme were established in spite of the poor statistical values of the star-c and the small sample size. evaluation of a program for intercultural competence 16 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychopen.eu/ hence, necessary further studies with larger samples are currently being carried out by our team. in line with kulik and roberson (2008), we believe that in future research it would be interesting to evaluate the impact of single training units or specific interventions. in ad‐ dition, shorter versions of the programme could be evaluated to increase the applicability of the approach in time-strapped clinical settings. turning to methodological issues, we feel that in the intercultural therapy context it is difficult using questionnaires to meas‐ ure awareness or attitudes as they may manifest instead at the behavioural level. hence, it might be useful to examine video recordings of therapy sessions—with real or simula‐ ted clients, before and after training intervention—to examine the behavioural level more directly. other indicators of behavioural change resulting from the training might be cli‐ ent satisfaction with treatment, duration of treatment, percentage of immigrant clients and immigrant-client drop-out rates. it would also appear to be necessary to evaluate cli‐ ent perspectives on the therapeutic relationship, especially those of immigrants. c o n c l u s i o n s we conclude from this first evaluation of our intercultural training programme that it of‐ fers an effective intervention in terms of enabling psychotherapists to be more culturally sensitive towards clients from migration backgrounds. such effects were demonstrable to our satisfaction, even with our small sample. we suggest that this training programme— which is actually a rather brief intervention—could lead to significant improvements in therapeutic practice in crucial ways. funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. r e f e r e n c e s aggarwal, n. k., cedeño, k., guarnaccia, p., kleinman, a., & lewis-fernández, r. 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(2011). transkulturelle kompetenz in klinischen und sozialen arbeitsfeldern. stuttgart, germany: kohlhammer. von lersner, u. (2015, january). kultursensibel aber wie? leitlinien für trainings transkultureller kompetenzen von psychotherapeuten und implikationen für die praxis. paper presented at the berliner psychiatrietage, berlin, germany. von lersner, u., baschin, k., wormeck, i., & mösko, m. (2016). kultursensibel, aber wie? leitlinien für trainings inter-/ transkulturelle kompetenzen in der aus-, fortund weiterbildung von psychotherapeut_innen. abschlusspublikation des projektes. retrieved from https://www.psychologie.hu-berlin.de/prof/the/leitlinien/view wohlfart, e., hodzic, s., & özbek, t. (2006). transkulturelles denken und transkulturelle praxis in der psychiatrie und psychotherapie. in e. wohlfart & m. zaumseil (eds.), transkulturelle psychiatrie & interkulturelle psychotherapie. interdisziplinäre theorie und praxis (pp. 142−168). heidelberg, germany: springer. yeo, s. (2004). language barriers and access to care. annual review nursery research, 22(1), 59-73. https://doi.org/10.1891/0739-6686.22.1.59 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. von lersner, baschin, & hauptmann 21 clinical psychology in europe 2019, vol.1(3), article e29159 https://doi.org/10.32872/cpe.v1i3.29159 https://www.psychologie.hu-berlin.de/prof/the/leitlinien/view https://doi.org/10.1891/0739-6686.22.1.59 https://www.psychopen.eu/ evaluation of a program for intercultural competence (introduction) intercultural competence training method study design implementation of the training programme programme content measures statistical analysis results sample characteristics prerequisites and verification of selection bias intercultural competence discussion therapeutic relationship limitations and implications conclusions (additional information) funding competing interests acknowledgments references the heterogeneity of national regulations in clinical psychology and psychological treatment in europe politics and education the heterogeneity of national regulations in clinical psychology and psychological treatment in europe where are we coming from, where are we now, and where are we going? anton-rupert laireiter ab, cornelia weise c [a] institute of applied psychology: health, development, enhancement and intervention, faculty of psychology, university of vienna, vienna, austria. [b] division of psychotherapy and clinical gerontopsychology, department of psychology, university of salzburg, salzburg, austria. [c] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2019, vol. 1(1), article e34406, https://doi.org/10.32872/cpe.v1i1.34406 received: 2019-02-17 • accepted: 2019-03-09 • published (vor): 2019-03-29 handling editor: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: anton-rupert laireiter, faculty of psychology, liebiggasse 5, 1010 vienna, austria. tel.: +43 (0)1 4277-47233; mobil: +43 (0)664 432 3018. e-mail: anton-rupert.laireiter@univie.ac.at abstract background: the bologna process was initiated to harmonize study processes and contents throughout europe in order to facilitate communication and cross-border study exchange. however, when it comes to postgraduate education and practical work in clinical psychology, no such harmonization exists there is still significant heterogeneity between european countries. method: to initiate the section politics and education, we analysed the current situation in europe with regard to national regulations on education, training and practice in clinical psychology and psychological treatment and give a brief summary on the status quo. results: there are extensive differences across europe regarding governmental and national regulations for psychologists in general, and clinical psychologists in particular. whereas some countries have very detailed regulations including a description of reserved activities for clinical psychologists, others leave the profession widely unregulated. when it comes to psychological treatment, some countries define it as an independent activity allowed to be applied by different professions, others clearly restrict access to the profession of psychotherapists. conclusion: a great diversity in national regulations and practical issues related to clinical psychology and psychological treatment exists across europe. our results underline the importance of the politics and education section in the journal clinical psychology in europe in order to strengthen the development of an international perspective on clinical psychology. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.34406&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords clinical psychology, psychological treatment, education, national regulations, europe highlights • national regulations for clinical psychologists differ significantly between european countries. • structure and contents of postgraduate training in clinical psychology vary widely across europe. • in some countries, treatment is reserved to psychologists, in others it's open for further professions. • the politics and education section shall foster understanding, communication and cooperation. the section "politics and education" has been included in clinical psychology in europe (cpe) to inform our readers about national regulations for training and practice in clini‐ cal psychology and psychological treatment. to describe the current political and educa‐ tional situation of clinical psychology in europe, the bologna process is an important starting point: as an intergovernmental cooperation of 48 european countries, the bolo‐ gna process aims to improve the internationalization of higher education throughout eu‐ rope. its aim is to not only harmonize study processes and, in part, study contents across europe, but also to facilitate an easier comparison of qualifications in order to facilitate exchange and cross-cultural communication. however, postgraduate education and prac‐ tical work in various health professions have been unaffected by the bologna process (baeten, 2017). this is of particular importance for clinical psychology, which is still a rather young and emerging profession. currently, legal regulations for clinical psycholo‐ gists (e.g. requirements for the admission to postgraduate training, structure and con‐ tents of postgraduate training, or prerequisites for work permission as a health care pro‐ vider in a clinical practice) vary substantially throughout europe (european commission [ec], 2016; hokkanen et al., 2019). accordingly, clinical psychology in europe is charac‐ terized by diversification rather than by convergence and agreement. even neighboring countries, such as the nordic countries or german-speaking ones, which in some cases cooperate very closely at university level, differ significantly in postgraduate education and their respective professional status (ec, 2016; karayianni, 2018; kryspin-exner, kothgassner, & felnhofer, 2017). further substantial differences can be found in the rela‐ tionship and differentiation between clinical psychology and psychological treatment (van broeck & lietaer, 2008). although the pan-european heterogeneity in clinical psychology is obvious, details about conditions in various countries are not well known. this applies both to countries and their bilateral communication, but also for multinational initiatives or the superordi‐ national regulations in clinical psychology 2 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://www.psychopen.eu/ nate administration (e.g. the european union, eu) (ec, 2016). even professionals are of‐ ten unaware of the regulations in their respective countries, not to mention the differen‐ ces between countries. as a european journal of clinical psychology, it is an essential goal of cpe to shed light on this important issue. the following article introduces this section of the journal and starts with an over‐ view of different structures of governmental regulations for clinical psychology in eu‐ rope. in addition, we specify the tasks and objectives of this section and goals for possible contributions. we aim not only to provide information on differences between countries, but also to present strengths and limitations of various national regulations, and to pro‐ vide examples that could be helpful for countries who are currently in the process of es‐ tablishing national regulations for clinical psychology. finally, knowledge about the het‐ erogeneity of national regulations in clinical psychology is also essential for investigators of european projects including psychological treatments. s t a r t i n g p o i n t s : c l i n i c a l p s y c h o l o g y i n a c a d e m i a a n d c l i n i c a l p r a c t i c e clinical psychology has different roots and traditions in europe (routh, 2014). whereas more psychodynamically oriented approaches have been developed in central europe and influenced the german-speaking and romano-phone countries, the empirically ori‐ ented anglo-american tradition has had a substantial impact on the current state of clin‐ ical psychology in europe (routh, 2014). although the understanding of clinical psychol‐ ogy as an empirical science with a strong neuro-scientific component has prevailed in academia in almost all european countries, the transfer of this conception into clinical practice varies widely (cheshire & pilgrim, 2004; plante, 2011). however, basic psycho‐ logical and neuroscientific theories and empirical findings should be applied with the goal of improving the understanding as well as the classification, prevention and treat‐ ment of mental disorders and relevant psychological aspects of medical conditions. in‐ stead, applied clinical psychology has been strongly influenced by the strong identifica‐ tion of psychologists, associations, and sometimes even societies with a specific approach to psychotherapy (e.g. psychodynamic, cognitive-behavioral, humanistic, or systemic ap‐ proaches; plante, 2011). it should be noted that this runs contrary to the primary goal of an academic profession: practical work should not be based on selected belief systems, but on scientific evidence relevant to its field, along with clinical expertise. g o v e r n m e n t a l r e g u l a t i o n s f o r p s y c h o l o g i s t s according to the eu, more than 6,000 professions are subject to state or supranational (eu) regulations, 42% of which are in the health and social care sector (baeten, 2017). the laireiter & weise 3 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://www.psychopen.eu/ professions of psychology and clinical psychology are, in most european countries, regu‐ lated by the relevant member state, but are not subject to supranational eu regulations (ec, 2016). this adds to the understanding of the diversity of clinical psychology throughout europe. europe-wide analyses of the professional state of psychology and clinical psychology in the 28 euand four of the non-eu states (i.e. iceland, liechten‐ stein, norway and switzerland) revealed the following picture (ec, 2016; hokkanen et al., 2019): only five states (15.6%) had no legal or state regulation of any kind for psychol‐ ogy in general or health care in particular (ec, 2016, pp. 8ff.). hokkanen et al. (2019) ana‐ lyzed a slightly different sample and found state regulations in 25 out of 29 examined countries (86%). countries without any general psychology regulations are bulgaria, ger‐ many, and the three baltic states, with germany having regulations for psychological psychotherapists and child/adolescent psychotherapists, and bulgaria stipulating mini‐ mal educational requirements for working as a psychologist in health care facilities. in 17 of the above mentioned 32 countries, there are regulations for the profession "psycholo‐ gists" in general, some of which also include clinical-psychological activities. twelve states have specific regulations for "clinical psychologists" and nine for "psychologists in health care" (health psychology). in 11 of these countries, there are separate regulations for other specialized psychologists and activities in various fields, for example forensic, counseling, school, traffic, occupational, or neuropsychologists (for further details see ec, 2016). in addition, some states have specific regulations for the treatment of children and adolescents (e.g. czech republic, hungary, lithuania and the united kingdom [uk]). this brief overview clearly demonstrates how diversely the profession is regulated throughout europe. s p e c i f i c r e g u l a t i o n s f o r c l i n i c a l p s y c h o l o g i s t s as reported above, 12 european countries have specific regulations for clinical psycholo‐ gists, including austria, cyprus, the czech republic, hungary, iceland, ireland, malta, the netherlands, slovakia, slovenia, spain, and the uk (ec, 2016). still, clinical psychologists are trained very differently; they have a differing range of reserved activities and work in diverse areas (e.g. public health care services vs. private sector). in some countries, clini‐ cal psychology is narrowly defined as a singular profession (e.g. austria, hungary and czech republic) whereas in others it is conceptualized as a clinically focused specializa‐ tion of health psychology (e.g. malta, netherlands, spain and the uk). in general, there is no consistent distinction between health psychology and clinical psychology: in some states, both professions are separated by their range of activities (e.g. prevention and health promotion vs. treatment and rehabilitation in cyprus or the uk), in others by the severity of the mental disorder (e.g. health psychology for mild cases, and clinical psy‐ chology for severe cases in the czech republic or the netherlands). similarly, there are differing understandings of clinical psychology, clinical psychological treatment, and national regulations in clinical psychology 4 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://www.psychopen.eu/ psychotherapy: in some countries, psychotherapy is a sub-specialization of clinical-psy‐ chology and thereby reserved for clinical psychologists (e.g. slovakia, hungary), in oth‐ ers, psychotherapy is a distinct profession with separate regulations and may also be open to holders of qualifications from related fields (e.g. medicine or pedagogy). as men‐ tioned above, in some states clinical psychology is affiliated to other specialties, e.g. for‐ ensic psychology (malta, cyprus and the uk), neuropsychology (netherlands and hun‐ gary), or counseling psychology (ireland, malta, slovakia, czech republic, uk and cy‐ prus) (see ec, 2016) which implies a specific appearance of clinical psychological work in these countries. differences across europe are also evidenced by whether the title "clinical psycholo‐ gist" is protected by a specific (psychology) law, or if the profession and its activities are only generally mentioned in another law, e.g. a health law. the former is the case in about 50% of european countries (hokkanen et al., 2019), the latter in about one third (e.g. denmark, ireland and spain). in some countries, both a title protection and a refer‐ ence in specific health acts can be found (e.g. iceland and lithuania). further differences pertain to the reservation of activities for clinical psychologists: according to the ec overview (ec, 2016, p. 19 ff.), two states have pure title protection without any reserved activities (netherlands and the uk), three others have reserved activities without title protection (ireland, slovakia and cyprus), and seven have both (iceland, malta, austria, slovenia, spain, czech republic and hungary). and finally, the core competencies of clinical psychologists in europe are defined to a differing degree. competencies include in most european countries clinical-psychological diagnostics and assessment and psychological treatment. additionally, clinical psycholo‐ gists in various countries are enabled to carry out activities such as counseling, crisis in‐ tervention, education and training, as well as research and evaluation. in some countries these competencies are very clearly defined (e.g. austria), in many others they are vague‐ ly specified and are difficult to separate from activities of other professions in the health care system (ec, 2016). e d u c a t i o n a n d t r a i n i n g i n c l i n i c a l p s y c h o l o g y the situation of education and training for clinical psychologists is an important topic for the profession, and also for this journal. and again, there are tremendous differences between various european states regarding the structure, extent, and contents of train‐ ing. in the majority of european countries, training in clinical psychology requires uni‐ versity studies (bachelor and master) followed by postgraduate training. only in a few countries is training in clinical psychology already included during graduate studies (e.g. norway). postgraduate training varies between two to 12 years (ec, 2016) and contains a broad range of subjects, e.g. training in diagnostics and (clinical) psychological testing, training in counseling, specific treatment methods and crisis intervention as well as laireiter & weise 5 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://www.psychopen.eu/ training in research methods and evaluation. in most curricula, specific obligatory cour‐ ses are integrated into internships or trainee programs and are accompanied by continu‐ ous supervision. moreover, in some countries the training is accompanied by personal and professional self-reflection (e.g. austria), and is completed by a state examination (e.g. austria or spain) (ec, 2016). the most comprehensive training in clinical psycholo‐ gy can be found in the czech republic, hungary, the netherlands, slovenia, and spain (ec, 2016), where it is usually based on training in health psychology. austria has the shortest training of between 1.5 and 2 years. d i f f e r e n t i a t i o n b e t w e e n c l i n i c a l p s y c h o l o g y a n d p s y c h o l o g i c a l t r e a t m e n t significant differences between the european countries can also be found in the relation‐ ship between clinical psychology and psychological treatment (bptk, 2011; ec, 2016; van broeck & lietaer, 2008). of the 28 eu states, 13 separately regulate the profession of psy‐ chotherapists via governmental law (austria, belgium, finland, france, germany, hun‐ gary, italy, lithuania, luxembourg, the netherlands, romania, slovakia and sweden), a further three states regulate psychotherapists in a health-related law (croatia, latvia and malta), and bulgaria regulates the educational requirements for psychotherapists (mas‐ ter's degree in psychology). ireland and cyprus are planning to issue laws for psychologi‐ cal treatment and two non-eu countries (liechtenstein and switzerland) already have them. however, the regulations of the different countries are very heterogeneous and dif‐ fer significantly regarding their understanding of psychological treatment in general, cri‐ teria for theoretical and practical training, as well as the number of approved methods (van broeck & lietaer, 2008). in austria, finland and sweden, psychotherapy is defined as an independent occupa‐ tion that can be learnt and practiced by different professions (almost 40 in austria, eight to ten in finland and sweden). in most other countries, access to the profession of psy‐ chotherapists is restricted, mostly to psychologists and physicians/psychiatrists (e.g. france, italy, liechtenstein, switzerland, slovakia and hungary). in belgium, germany and the netherlands, pedagogues (general, clinical, or social pedagogues for children and adolescents) are additionally admitted to practice psychological treatment. accordingly, in most european countries, non-medical psychological treatment is reserved to psychol‐ ogists; in hungary, psychotherapy is a reserved activity for clinical psychologists, an ap‐ proach which is also planned in ireland (ec, 2016). in most countries, only the titles "psychotherapy" and "psychotherapist" are protec‐ ted, but not the activity itself. hence psychological treatment can also be carried out by other professions (e.g. physicians, clinical psychologists, and clinical pedagogues) in the context of their respective professional activities, although it is not permitted to be called national regulations in clinical psychology 6 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://www.psychopen.eu/ "psychotherapy". in some countries, further specific activities (e.g. family therapy) are re‐ served for psychotherapists, (e.g. germany, hungary, italy, slovakia, and switzerland). there is also a great difference in the number of psychotherapeutic methods ap‐ proved for training and practice. the numbers vary between four (finland) and 23 (aus‐ tria), with five to seven approved methods in the majority of countries. the generally ac‐ cepted methods are cognitive behavioral therapy (incl. 3rd wave methods), psychoanaly‐ sis, psychodynamically-oriented approaches (e.g. analytic psychotherapy following c.g. jung, or individual psychology according to a. adler), client centered psychotherapy ac‐ cording to rogers, systemic (family) therapy, gestalt therapy following perls, existential psychotherapies (e.g. according to frankl). occasionally, hypnosis, integrative, or femi‐ nist therapies are also accepted (bptk, 2011). c o n c l u s i o n a n d c o n s e q u e n c e s in conclusion, we find a great diversity in regulations of clinical and health-related psy‐ chology and psychological treatment as well as in the relation of clinical psychology and psychological treatment on all levels of analysis. psychological treatment is, in a few countries, reserved exclusively for clinical psychologists, whereas in others it can also be applied by other psychologists and/or other professions. in most cases, however, clinical psychology and psychological treatment are two independent professional fields. in ger‐ many, for example, clinical psychology represents an academic-scientific subject and (psychological) psychotherapy is its application in practice (kryspin-exner et al., 2017). the great diversity and heterogeneity demonstrated in this overview underlines the im‐ portance of the goal of cpe's section "politics and education": accomplishing transparen‐ cy and clarity about the political and educational situation regarding clinical psychology and psychological treatment in europe. this will be a necessary precondition for improv‐ ing communication between different countries and different professions, for improving the field of clinical psychology as a whole, as well as for being able to coordinate europe‐ an or multinational initiatives regarding research, structural changes, and psychological treatment. tasks and objectives of the "politics and education" section it is the aim of the journal clinical psychology in europe and its various sections to devel‐ op and strengthen an international perspective on clinical psychology and psychological treatment (https://cpe.psychopen.eu/about#aimsandscope). accordingly, for the section "politics and education", the main purpose is to publish articles dealing with various as‐ pects of the political and legal situation and recent developments in europe regarding training in clinical psychology and clinical psychological practice. the primary goal is to increase knowledge about different regulations and training modalities in europe in or‐ laireiter & weise 7 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://cpe.psychopen.eu/about#aimsandscope https://www.psychopen.eu/ der to foster understanding, communication and cooperation between professionals in the field of clinical psychology. a central topic of european integration is promoting mobility and exchange of pro‐ fessions, which also applies for clinical psychology. on the one hand, clinical psycholo‐ gists planning to move to another eu country or a country outside the eu should be kept fully informed about regulations as well as opportunities to perform their job in the re‐ spective country. on the other hand, comprehensive information is important for crossnational initiatives (e.g. on education and training in clinical psychology and psychologi‐ cal treatment), scientific projects, and the promotion of evidence-based practical applica‐ tions of clinical psychology. it is, however, not planned to compile a legal encyclopedia in this section. rather, papers should deal with the topics of interest in an introductory manner, provide an overview, and refer to further readings. papers to be submitted to this section manuscripts submitted to this section should address one of the following topics: (1) legal regulations on education, training, and practice in clinical psychology and psychological treatment in health care; (2) specific aspects related to politics and education, e.g. prereq‐ uisites for, and contents of, training in various psychological treatments, or the relation‐ ship between clinical psychology and psychological treatment in a certain country; (3) commentaries on university studies (e.g. master's or doctorate level), european harmoni‐ zation, or pan-european regulations (e.g. by the european federation of psychologists' associations or other organizations) are also welcome. the focus of the papers should be on clinical psychology, or on psychological treatment as an area of the application of clinical psychology. all contributions will be reviewed by the editors and must meet the requirements of the journal (for details please see https://cpe.psychopen.eu/about#author-guidelines). manuscripts should not exceed a maximum of 2,500 words (excluding references, author description and cover page). papers can be submitted to the journal at any time. howev‐ er, one of the editors should be contacted beforehand to agree upon the planned topic. in addition, the editors will actively invite experts to submit manuscripts on various topics of interest. funding: the authors have no funding to report. competing interests: arl is section editor of the politics and education section but played no editorial role for this particular paper. cw is managing editor of clinical psychology in europe (cpe) but played no editorial role for this particular paper. the current paper was peer-reviewed by winfried rief, who is editor-in-chief of cpe. acknowledgments: the authors have no support to report. national regulations in clinical psychology 8 clinical psychology in europe 2019, vol.1(1), article e34406 https://doi.org/10.32872/cpe.v1i1.34406 https://cpe.psychopen.eu/about#author-guidelines https://www.psychopen.eu/ r e f e r e n c e s baeten, r. (2017). was the exclusion of health care from the services directive a pyrrhic victory? a proportionality test on regulation of health professions (ose paper series, opinion paper no. 18, european social observatory). retrieved from http://www.ose.be/files/publication/osepaperseries/baeten_2017_opinionpaper18.pdf bundespsychotherapeutenkammer (bptk). (2011). psychotherapy in europe – disease management strategies for depression: national concepts of psychotherapeutic care. retrieved from https://www.bptk.de/fileadmin/user_upload/themen/pt_in_europa/ 20110223_nationalconcepts-of-psychoth-care.pdf cheshire, k., & pilgrim, d. (2004). a short introduction to clinical psychology. london, united kingdom: sage. european commission (ec). (2016). mutual evaluation of regulated professions – overview of the regulatory framework in the health services sector – psychologists and related professions (report grow/e5). retrieved from https://ec.europa.eu/docsroom/documents/16683?locale=en hokkanen, l., lettner, s., barbosa, f., constantinou, m., harper, l., kasten, e., . . . hessen, e. (2019). training models and status of clinical neuropsychologists in europe: results of a survey on 30 countries. the clinical neuropsychologist, 33(1), 32-56. https://doi.org/10.1080/13854046.2018.1484169 karayianni, e. (2018). a european perspective on regulating psychology: a review of the european commission’s mutual evaluation of regulated professions. psichologija, 58, 125-134. https://doi.org/10.15388/psichol.2018.7 kryspin-exner, i., kothgassner, o. d., & felnhofer, a. (2017). central europe. in s. g. hofmann (ed.), international perspectives on psychotherapy (pp. 87–106). cham, switzerland: springer. https://doi.org/https://doi.org/10.1007/978-3-319-56194-3 plante, t. (2011). contemporary clinical psychology (3rd ed.). hoboken, nj, usa: john wiley & sons. routh, d. k. (2014). a history of clinical psychology. in d. barlow (ed.), the oxford handbook of clinical psychology (2nd ed., pp. 23–33). new york, ny, usa: oxford university press. https://doi.org/https://doi.org/10.1093/oxfordhb/9780195366884.001.0001 van broeck, n., & lietaer, g. (2008). psychology and psychotherapy in health care: a review of legal regulations in 17 european countries. european psychologist, 13(1), 53-63. https://doi.org/10.1027/1016-9040.13.1.53 laireiter & weise 9 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org http://www.ose.be/files/publication/osepaperseries/baeten_2017_opinionpaper18.pdf https://www.bptk.de/fileadmin/user_upload/themen/pt_in_europa/20110223_nationalconcepts-of-psychoth-care.pdf https://www.bptk.de/fileadmin/user_upload/themen/pt_in_europa/20110223_nationalconcepts-of-psychoth-care.pdf https://ec.europa.eu/docsroom/documents/16683?locale=en https://doi.org/10.1080/13854046.2018.1484169 https://doi.org/10.15388/psichol.2018.7 https://doi.org/https://doi.org/10.1007/978-3-319-56194-3 https://doi.org/https://doi.org/10.1093/oxfordhb/9780195366884.001.0001 https://doi.org/10.1027/1016-9040.13.1.53 https://www.leibniz-psychology.org/ https://www.psychopen.eu/ national regulations in clinical psychology (introduction) starting points: clinical psychology in academia and clinical practice governmental regulations for psychologists specific regulations for clinical psychologists education and training in clinical psychology differentiation between clinical psychology and psychological treatment conclusion and consequences tasks and objectives of the "politics and education" section papers to be submitted to this section (additional information) funding competing interests acknowledgments references the future of virtual reality therapy for phobias: beyond simple exposures editorial the future of virtual reality therapy for phobias: beyond simple exposures alexander miloff a , philip lindner ab , per carlbring a [a] department of psychology, stockholm university, stockholm, sweden. [b] centre for psychiatry research, department of clinical neuroscience, karolinska institutet & stockholm health care services, stockholm county, stockholm, sweden. clinical psychology in europe, 2020, vol. 2(2), article e2913, https://doi.org/10.32872/cpe.v2i2.2913 published (vor): 2020-06-30 corresponding author: per carlbring, department of psychology, stockholm university, 106 91 stockholm, sweden. e-mail: per@carlbring.se inelegant as they may look to the outsider, the white boxy samsung gear vr goggles with a smartphone strapped to the front, have the power to change lives. in the last few years our research team at stockholm university have used the device to treat nearly 100 spider phobic patients with virtual reality exposure therapy (vret) using the itsy application, developed alongside vr-startup mimerse (miloff et al., 2016). the real tears patients shed may be indication enough that the animated spiders and computer-gener‐ ated world are helping them face their deepest fears. however, evidence shows large reductions in self-reported fear and avoidance around live spiders. in fact, the positive behavior change is very nearly as powerful as the gold-standard treatment for spider phobia that ends with handling a 3-centimeter spider with their hands (miloff et al., 2019). the boundary for how we perceive real and artificial may not be as large as we think. today, the biggest tech companies are still pouring enormous resources into making virtual a reality. facebook purchased oculus, shipped the rift, the mobile go and now quest, google had the daydream-standard and is now moving onto augmented-reality, sony the playstation vr and even apple is said to be working on a device. still, there is a feeling in this industry that it isn’t really clear what virtual reality is good for. there are entertaining games available sure, mostly shooters and rhythm games. there is the extremely enjoyable feeling of awe to be dropped into a virtual world somewhere, flying in a fighter jet or swimming with divers. new ways of storytelling are certainly possible and are being created. however, there is the persistent feeling that something is missing. the technology is just too powerful for the limited experiences we’ve developed so far. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2913&domain=pdf&date_stamp=2020-06-30 https://orcid.org/0000-0002-9125-8060 https://orcid.org/0000-0002-3061-501x https://orcid.org/0000-0002-2172-8813 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ to understand what is possible, it may be best to look at the way our reality generating system functions and work backwards. our eyes, ears, taste and touch are geared towards favoring certain information over others (bayle et al., 2009; erlich et al., 2013; öhman & mineka, 2001). sudden movement in the corner of our eye evokes a fear response, as does the sound of a potentially violent individual above the din of a crowd, or the unexpected irritation of a wriggling bug on our skin. see a certain shape walk by and lust towards an attractive mate might cause butterflies in the stomach. the most common use of virtual reality in clinical treatments is for phobias and similar to face-to-face treatment is almost always seen through the lens of stimulus-emotion pairs and exposure therapy (turner & casey, 2014). with virtual reality, however, we might be able to explore not only working to modify basic emotions using simple stimuli but higher order functions of the mind using complex simulations as well. for millions of years we sat on the savannah around open fires. the rustling and movement in tall grasses at the far edge of the camp may be just the wind but our minds see a leaping lion ready to disembowel us. gifted with large brains capable of complex pattern recognition and learning, we’ve developed immense capabilities of prediction. for want of a better word, this is the power of imagination and at its most vivid. we see in our mind’s eye a disaster before we experience it. we feel ourselves drowning before we ever get on the boat. we feel the wind on our face and the sensation of hitting the ground before we ever step onto the airplane. in the right frame of mind, we may have even pictured the previous two sentences in our imagination as we read them. although this capacity is one of the ways we define ourselves as human, it’s also responsible for great suffering, catastrophic fears, debilitating anxiety; its moderation actually one of the ways we define treatment success in specific phobia, i.e., no longer believing your catastrophic fears (davis et al., 2012). we are just at the beginning of exploring the many uses of vr and its practical application to clinical psychology. tremendous progress has been made at importing what we know from traditional formats for psychological treatments (e.g., exposure ther‐ apy), but new and more innovative leaps in understanding and technique are possible. the capacity of imagination is something we take for granted and generalized solutions for dealing with its problematic aspects limited. virtual reality offers a nearly limitless world in which to create, restricted only by development costs and again, the more useful aspects of our imagination. the industry driving development of the technology is searching for the killer app that could convince new users to jump in, and clinical applications that converge with the gaming industry and storytelling might offer such an opportunity. whether such generalized solutions are possible is uncertain, however what is certain is that the future of clinical treatment and virtual reality is more than just simple exposures. editorial 2 clinical psychology in europe 2020, vol.2(2), article e2913 https://doi.org/10.32872/cpe.v2i2.2913 https://www.psychopen.eu/ funding: the authors have no funding to report. competing interests: author pl has consulted for mimerse but holds no financial stake in the company. no potential conflict of interest was reported by am or pc. acknowledgments: the authors have no support to report. r e f e r e n c e s bayle, d. j., henaff, m.-a., & krolak-salmon, p. (2009). unconsciously perceived fear in peripheral vision alerts the limbic system: a meg study. plos one, 4(12), article e8207. https://doi.org/10.1371/journal.pone.0008207 davis, t. e., ollendick, t. h., & öst, l.-g. (eds.). (2012). intensive one-session treatment of specific phobias. new york, ny, usa: springer. erlich, n., lipp, o. v., & slaughter, v. (2013). of hissing snakes and angry voices: human infants are differentially responsive to evolutionary fear-relevant sounds. developmental science, 16(6), 894-904. https://doi.org/10.1111/desc.12091 miloff, a., lindner, p., dafgård, p., deak, s., garke, m., hamilton, w., . . . carlbring, p. (2019). automated virtual reality exposure therapy for spider phobia vs. in-vivo one-session treatment: a randomized non-inferiority trial. behaviour research and therapy, 118, 130-140. https://doi.org/10.1016/j.brat.2019.04.004 miloff, a., lindner, p., hamilton, w., reuterskiöld, l., andersson, g., & carlbring, p. (2016). singlesession gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. trials, 17(1), article 60. https://doi.org/10.1186/s13063-016-1171-1 öhman, a., & mineka, s. (2001). fears, phobias, and preparedness: toward an evolved module of fear and fear learning. psychological review, 108(3), 483-522. https://doi.org/10.1037/0033-295x.108.3.483 turner, w. a., & casey, l. m. (2014). outcomes associated with virtual reality in psychological interventions: where are we now? clinical psychology review, 34(8), 634-644. https://doi.org/10.1016/j.cpr.2014.10.003 miloff, lindner, & carlbring 3 clinical psychology in europe 2020, vol.2(2), article e2913 https://doi.org/10.32872/cpe.v2i2.2913 https://doi.org/10.1371/journal.pone.0008207 https://doi.org/10.1111/desc.12091 https://doi.org/10.1016/j.brat.2019.04.004 https://doi.org/10.1186/s13063-016-1171-1 https://doi.org/10.1037/0033-295x.108.3.483 https://doi.org/10.1016/j.cpr.2014.10.003 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. editorial 4 clinical psychology in europe 2020, vol.2(2), article e2913 https://doi.org/10.32872/cpe.v2i2.2913 https://www.psychopen.eu/ no1likesu! – a pilot study on an ecologically valid and highly standardised experimental paradigm to investigate social rejection expectations and their modification research articles no1likesu! – a pilot study on an ecologically valid and highly standardised experimental paradigm to investigate social rejection expectations and their modification lisa d’astolfo a +, lukas kirchner a +, winfried rief a [a] department of clinical psychology and psychotherapy, philipps-university of marburg, marburg, germany. +these authors contributed equally to this work. clinical psychology in europe, 2020, vol. 2(2), article e2997, https://doi.org/10.32872/cpe.v2i2.2997 received: 2019-07-11 • accepted: 2020-04-22 • published (vor): 2020-06-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: lukas kirchner, philipps-university of marburg, department of clinical psychology and psychotherapy, gutenbergstraße 18, d-35032 marburg, germany. tel: +49 (0)6421 2824076. fax: +49 (0)6421 282-8904. e-mail: lukas.kirchner@uni-marburg.de abstract background: dysfunctional expectations have been suggested as core features in the development and maintenance of mental disorders. thus, preventing development and promoting modification of dysfunctional expectations through intervention might improve clinical treatment. while there are well-established experimental procedures to investigate the acquisition and modification of dysfunctional performance expectations in major depression, paradigms for investigating other important types of dysfunctional expectations (e.g. social rejection expectations) are currently lacking. we introduce an innovative associative learning paradigm, which can be used to investigate the development, maintenance, and modification of social rejection expectations. method: a pilot sample of 28 healthy participants experienced manipulated social feedback after answering personal questions in supposed webcam conferences. while participants repeatedly received social rejection feedback in a first phase, differential feedback was given in a second phase (social rejection vs. social appreciation). in a third phase, explicit social feedback was omitted. results: participants developed social rejection expectations in the first phase. for the second phase, we found an interaction effect of experimental condition; i.e. participants adjusted their expectations according to the differential social feedback. in the third phase, learned social expectations remained stable in accordance to the social feedback in the second phase. conclusion: results indicate that the paradigm can be used to investigate the development, maintenance, and modification of social rejection expectations in healthy participants. this offers broad applications to explore the differential acquisition and modification of social rejection this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2997&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ expectations in healthy vs. clinical samples. further, the paradigm might be used to investigate therapeutic strategies to facilitate expectation change. keywords violex-model, expectation violation, expectation persistence, expectation modification, dysfunctional expectations, social rejection, no1likesu! highlights • this paradigm can be used to induce and modify social rejection expectations. • this allows to investigate differences in expectation acquisition, maintenance, and modification between clinical vs. healthy samples. • further, this paradigm enables research on interventions promoting expectation modification. recent developments in clinical psychology propose dysfunctional expectations (i.e. fu‐ ture-directed ‘if-x-then-y’-predictions, rief et al., 2015, p. 380) as an important factor in the development of mental disorders and as a promising target in clinical treatment (e.g. greenberg, constantino, & bruce, 2006; rief & glombiewski, 2017; rief et al., 2015). dysfunctional expectations have been shown to play a crucial role in mental health as they negatively impact future behaviour (e.g. excessive avoidance, krypotos, 2015), aggravate subjective suffering (e.g. pain perception, jepma, koban, van doorn, jones, & wager, 2018), and elicit potentially maladaptive anticipatory reactions (e.g. negative mood, davidson, marshall, tomarken, & henriques, 2000). further, dysfunctional expectations have been shown to impede important clinical outcomes (e.g. treatment success, constantino, vîslă, coyne, & boswell, 2018). as george a. kelly put it early in his theory of personal constructs: ‘a person’s processes are psychologically channelised by the ways in which he anticipates events’ (kelly, 1977, pp. 358-359). thus, preventing acquisition and promoting modification of dysfunctional expectations through intervention might improve clinical treatment (craske, treanor, conway, zbozinek, & vervliet, 2014; rief & glombiewski, 2016; rief & joormann, 2019). however, acquisition, maintenance, and modification of dysfunctional expectations is still little understood (rief & joormann, 2019). while there are promising theoret‐ ical approaches (kube, rief, & glombiewski, 2017; kube, schwarting, rozenkrantz, glombiewski, & rief, 2020) and well established experimental procedures concerning this issue with regard to dysfunctional performance expectations in major depression (kube, rief, gollwitzer, & glombiewski, 2018), experimental paradigms are lacking when it comes to other types of dysfunctional expectations (see liebke et al., 2018, for a laudable exception). since especially (dysfunctional) expectations of social rejection (e.g. ‘when i open myself to others, they will refuse me!”) have serious implications for mental health (e.g. no1likesu! – a social learning paradigm 2 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ bianchi, schonfeld, & laurent, 2015; gao, assink, cipriani, & lin, 2017) and the course of various mental disorders (e.g. bungert et al., 2015; de panfilis, riva, preti, cabrino, & marchesi, 2015; kimbrel, 2008; slavich, o’donovan, epel, & kemeny, 2010), ecologically valid experimental procedures are strongly needed for further investigation. the aim of the current study was to develop an experimental social rejection expect‐ ation paradigm (no1likesu!), which can be used to investigate the acquisition, mainte‐ nance and modification of social rejection expectations within a highly standardised and ecologically valid procedure. in contrast to existing paradigms on social exclusion (for an overview, see riva & eck, 2016), no1likesu! was especially designed to mimic key pro‐ cesses proposed by a recently published theoretical model on expectation development, maintenance, and modification – the so called ‘violex-model’ by rief and colleagues (2015). this model proposes that when entering concrete situations, individuals form situa‐ tion-specific predictions about these situations (drawn from more generalised expecta‐ tions) which become either (a) confirmed or (b) disconfirmed by experience. while repea‐ ted expectation confirmations should stabilise or reinforce the original situation-specific prediction (or respectively, the underlying generalised expectation), repeated expectation ‘violations’ should entail its modification (gollwitzer, thorwart, & meissner, 2018; rief et al., 2015). following the predications of the model, we hypothesise that (1) repeatedly expos‐ ing healthy individuals to situation-specific experiences of social rejection will increase levels of social rejection expectations over time. consistent with the violex-model, we further hypothesise that (2) repeatedly exposing healthy individuals with increased levels of social rejection expectations to situation-specific experiences of social rejection (‘stabilisation’) vs. appreciation (‘modification’) will lead to differential changes (i.e. to an increase vs. stabilisation) in social rejection expectation levels over time. m e t h o d no1likesu! is an ecologically valid and highly standardised associative learning para‐ digm created to model the development, maintenance, and modification of social rejec‐ tion expectations. like the o-cam paradigm (godwin et al., 2014; goodacre & zadro, 2010), it relies on a cover story leading participants to believe that they are going to interact with real human beings via webcam. participants in no1likesu! are told that they are going to participate in a study investigating ‘how people socialise with and affect each other in virtual environments’. participants pass multiple supposed ‘web‐ cam-conferences’ (actually, realistic looking video stimuli) on a computer in which they answer personal questions to different ‘listeners’ (actually, pre-recorded and instructed confederates). afterwards, they receive written social feedback on their self-presentation d’astolfo, kirchner, & rief 3 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ (actually, manipulated feedback that induces experiences of social rejection vs. social appreciation). the local ethics committee (reference number 2018-36k) approved the study. all par‐ ticipants gave written informed consent before they started the experiment. this study was part of a parent study, which additionally investigates interventions for promoting the modification of dysfunctional expectations. in the present work, we focus on the effects of the paradigm on the development, maintenance, and modification of social rejection expectations in healthy participants. participants we recruited participants via e-mail lists, flyers, and the research participation system of our university. inclusion criteria were: (a) a minimum age of 18 years, (b) sufficient german language skills, (c) no severe visual impairment, (d) no serious physical illness, (e) no current psychological stress, (f) not in psychotherapeutic treatment, and (g) a sum score in beck’s depression inventory ii (bdi-ii; kühner, bürger, keller, & hautzinger, 2007) ≤ 13, indicating no to minimal depressive symptoms. until now, a pilot sample of 31 healthy participants could be included in the study, which provides sufficient power to investigate our hypotheses (huta, 2014). as men‐ tioned above, recruitment based on a priori power analyses continues as we test no1like‐ su! within an ongoing study addressing further research questions we do not fully report here (preregistered at ‘aspredicted’: https://aspredicted.org/g544c.pdf). since recruitment is currently faltering for the parent study, we would like to publish our pilot results on the paradigm contrary to preregistration in order to make them accessible to the research community. three participants had to be excluded due to technical problems with the experimental software. the final pilot dataset consisted of 28 healthy participants (82.10% female, mage = 23.39 years, sd = 6.51, range of age = 19–51 years). table 1 shows the demographic data of the sample. participants received credit points as compensation for their participation. alterna‐ tively, they got the chance to win gift vouchers for different online shops. procedure testing sessions started with participants reading the study information and signing informed consent (see figure 1 for an overview of the study design). afterwards, they completed paper-pencil pre-questionnaires. research assistants checked age as well as bdi-ii cut-off scores. participants who failed the inclusion criteria received partial compensation and were fully debriefed. participants who met the inclusion criteria received study information incorporating the cover story. to allay concerns about the authenticity of the webcam conference, participants were told that their listeners (who were announced as ‘students from an experimental intern‐ no1likesu! – a social learning paradigm 4 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://aspredicted.org/g544c.pdf https://www.psychopen.eu/ ship at the university’) were instructed ‘not to talk’ during conferences for ‘methodologi‐ cal reasons’. afterwards, research assistants started the paradigm on the computer and left the experimental room. the participants were fully randomised into two independent experimental conditions (group ‘stabilisation’ vs. group ‘modification’) and followed instructions presented on the computer screen, which guided through the paradigm. to model key processes of the ‘violex-model’, no1likesu! encompasses multiple trials (30) which are divided into three different experimental phases (acquisition phase, stabilisation vs. modification phase, test phase, see figure 1). figure 1 study design these phases are structurally based on fear conditioning paradigms (lissek et al., 2005; lonsdorf et al., 2017). during the acquisition and stabilisation phase, participants repeatedly form associations between introducing themselves to strangers (conditioned stimulus, cs) and being socially rejected (unconditioned stimulus, us) resulting into d’astolfo, kirchner, & rief 5 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ situation-specific social rejection expectations (conditioned response, cr). during modi‐ fication, opposing associations (cs-us’ [being socially appreciated]) are formed resulting into expectations of social appreciation. in order to enhance stability of expectations and ecological validity, no1likesu! provides partial reinforcement (70%) within these phases. to explore the stability of the social expectations learned within the experimental para‐ digm, no1likesu! ends with a test phase which did not provide written social feedback (retention test). after completing the paradigm, research assistants entered the experimental room and provided paper-pencil post-questionnaires to check for suspiciousness about the cover story and emotional distress due to participation. participants were then fully de‐ briefed about the true purposes of the study and the deceptions within the experimental manipulation. testing sessions lasted between 1.0 and 1.5 hours. measures note that we applied additional questionnaires to address further research questions in the parent study, which we do not describe here. situation-specific social expectations we assed situation-specific social expectations using a one-item 7-point bipolar likert scale (social expectation rating: ‘please indicate to what extent you expect your next listener to be interested or disinterested in you!’) ranging from -3 (maximal disinterest) to +3 (maximal interest) before each trial. thus, lower values indicate higher social rejection expectations. situation-specific social experience to examine how participants actually perceived a passed webcam conference, we used a one-item 7-point bipolar likert scale (social experience rating: ‘please indicate to what extent you experienced interest or disinterest from your last listener!’) ranging from -3 (maximal disinterest) to +3 (maximal interest) after each trial. thus, lower values indicate higher social rejection experiences. pre-questionnaires depressive symptoms — we assessed depressive symptoms using the beck depression inventory ii (bdi-ii; kühner et al., 2007 prior to running no1likesu!). participants responded to the 21 items on a 4-point scale ranging from 0 to 3. the sum score of the 21 items ranges between 0 and 63, whereby higher values indicate more depressive symptoms. no1likesu! – a social learning paradigm 6 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ socio-demographics — we used a brief self-report questionnaire in order to assess demographic variables like sex, age, nationality, relationship status, educational level, employment status, and living situation. post-questionnaires emotional distress due to participation — we assessed emotional distress due to participation by asking whether participants felt impaired due to the experimental procedures (‘do you feel impaired due to our investigation?’). further, we applied a one-item 5-point bipolar likert scale (‘please indicate to what extent you feel positive or negative in this moment!’) ranging from -2 (very negative) to +2 (very positive) to assess emotional distress. higher values indicate lower emotional distress due to participation. suspiciousness — in order to assess the credibility of the cover story, the video stimuli and the experimental manipulation, we asked participants whether 1) they knew any of their ‘webcam partners’, 2) what they believed was the aim and purpose of the study, and 3) how they experienced the experimental procedure. responses were rated on a 3-point likert scale ranging from 0 ("not suspicious at all") to 2 ("doubted the authenticity of the webcam conferences"). apparatus and stimuli participants were seated in front of a computer with an external microphone and a webcam connected to the computer. the paradigm, including instructions, video stimuli, and social feedback, was presented on the computer screen. participants used a mouse to interact with the computer. video stimuli were pre-recorded with 30 volunteers (15 male, 15 female, age: 25 – 35). volunteers were instructed to express nonverbal cues of either social rejection or social appreciation (see figure 2). we produced two sequences of each volunteer resulting into 30 sequences of social rejection and 30 sequences of social appreciation (50 seconds each). the nonverbal feedback during each trial was matched with the written feedback. the personal and self-related questions were adapted from various dating websites in order to promote positive self-disclosure (see appendix a in the supplementary materials). the video stimuli as well as the personal questions were presented fully randomised during experimental procedure in accordance with the partial reinforcement. for each participant, video stimuli and personal questions were never repeated twice. d’astolfo, kirchner, & rief 7 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ figure 2 video stimuli (left: social appreciation, right: social rejection) trial sequence figure 3 gives an overview of the trial sequence. each trial started with a situation-spe‐ cific social expectation rating. afterwards, participants received a personal, self-related question (e.g. ‘what are your hobbies?’) on the screen ostensibly asked by the ‘next liste‐ ner’ in order to pre-set the content of the next conference. following preparation time depicted by a countdown (20 seconds), participants received a short connection-signal on the screen (5 seconds) before the supposed ‘webcam conference’ started by showing a pre-recorded video stimulus. to ensure the authenticity of the conferences, participants were instructed to actively end conferences when they finished their self-presentation. after each conference, participants gave a situation-specific social experience rating before receiving written social feedback (e.g. ‘your last listener found you rather uninter‐ esting and would not like to get in touch with you again.’). this trial sequence was repeated (10 times) within each of the three experimental phases. however, written feedback was omitted in the last phase. no1likesu! – a social learning paradigm 8 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ figure 3 trial sequence statistical analyses before conducting the analyses, we checked for outliers to exclude influential data points. for each expectation rating, we calculated the mahalanobis distance which we checked against a χ2-cut-off of α = .001. we found no influential data points. all analyses were computed using r studio (r studio team, 2015) for r (r development core team, 2008). we used lme4 (bates, mächler, bolker, & walker, 2015), nlme (kuznetsova, brockhoff, & christensen, 2017), blme (chung, rabe-hesketh, dorie, gelman, & liu, 2013), and lmertest (kuznetsova et al., 2017) to perform a hierarchical mixed effects analysis of the relationship between social expectations, measuring time and experimental condition. since the times at which expectations were measured are separable into the three phases, we defined a contrast matrix for time, which accounted for the nested data structure. we used the contrast matrix for time as a level-1-fixed effect, and group as a level-3-fixed effect (including the interaction term). as random effect, we implemented intercepts for participants (level 2). we checked homoscedastic‐ ity and normality via the residual plots, which always showed expected patterns. we obtained p-values by likelihood ratio tests, testing the model with the additional level effect against the model without the additional level effect. subsequently, we analysed the phases individually to estimate effect sizes for each phase effect. we used linear models to investigate the relationship between social ex‐ pectations and group affiliation. we entered group as fixed effect. we inspected the residual plot to check homoscedasticity and normality. again, all plots showed patterns as expected. for all analyses, we applied sum contrasts to calculate intercepts and slopes. d’astolfo, kirchner, & rief 9 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ r e s u l t s sample characteristics participants were predominantly young (mage = 23.39, sd = 6.51), female (82.14%) and well-educated (100% general qualification for university entrance). the mean bdi-ii sum score was 4.54 (sd = 3.26), indicating that no participant exceeded the clinical threshold of depressive symptoms (kühner et al., 2007). table 1 gives an overview of the sample characteristics. there were no significant differences between the experimental conditions in any of the assessed variables. table 1 sample characteristics variable stabilisation (n = 14) modification (n = 14) difference between experimental conditions age in years, m (sd) 21.79 (3.02) 25.00 (8.57) t (26) = 1.32, p = .20 sex, n (%) χ2 = 2.19, p = .14 male 4 (28.57) 1 (7.14) female 10 (71.43) 13 (92.86) nationality, n (%) χ2 = 0.37, p = .54 german 13 (92.86) 12 (85.71) other 1 (7.14) 2 (14.29) romantic relationship, n (%) χ2 = 1.29, p = .26 yes 5 (35.71) 8 (57.14) no 9 (64.29) 6 (42.86) living situation, n (%)a χ2 = 0.01, p = .94 living alone 2 (14.29) 2 (15.38) living with others 12 (85.71) 11 (84.62) educational level, n (%) χ2 = 1.71, p = .19 university degree 2 (14.29) 5 (35.71) no university degree 12 (85.71) 9 (64.29) employment status, n (%) χ2 = 1.47, p = .23 employed 6 (42.86) 3 (21.43) not employed 8 (57.14) 11 (78.57) bdi-ii sum-score, m (sd) 4.86 (3.44) 4.21 (3.17) t (26) = 0.52, p = .61 mser before first trial, m (sd) 3.86 (1.29) 4.21 (1.12 t (26) = 0.78, p = .44 emotional distress after participation, m (sd) 3.21 (0.70) 3.57 (0.65) t (26) = 1.40, p = .17 note. bdi-ii = beck depression inventory ii; mser = mean social expectation rating. aone missing data point. manipulation check for the nonverbal social feedback we investigated whether the nonverbal social feedback (rejection vs. appreciation) dis‐ played in the videos affected the situation-specific social experience ratings of the sup‐ posed webcam conferences. participants provided these ratings after each conference and before receiving written social feedback. no1likesu! – a social learning paradigm 10 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ first, we performed a mixed anova using a linear model of the mean social expe‐ rience ratings as a function of group (between factor) and time (within factor) using greenhouse-geisser correction. we found a significant interaction of group and time (f(1, 33) = 5.09, p = .023) as well as a significant main effect for group (f(1, 26) = 4.68, p = .040), and time (f(1, 33) = 6.80, p = .009). next, we performed post-hoc analyses and pairwise comparisons to further analyse the significant interaction effect. the bonferroni adjusted p-values suggest that the main effect of group was signifi‐ cant during modification vs. stabilisation phase (f(1, 26) = 11.33, p = .006) but not during acquisition phase (f(1, 26) = 2.46, p = .387), and test phase (f(1, 26) = 0.64, p = 1.000). pairwise comparisons showed that the mean social experience rating between group ‘stabilisation’ and group ‘modification’ differed only during modification vs. stabilisation phase (p = .002) when differential nonverbal social feedback was applied (70% social rejection feedback in group ‘stabilisation’ vs. 70% social appreciation feedback in group ‘modification’). as expected, group ‘modification’ (m = 3.53, sd = 0.64) showed higher social experience ratings than group ‘stabilisation’ (m = 2.77, sd = 0.55), indicating more perceived social appreciation. regarding the main effect of time, the bonferroni adjusted p-values suggested signif‐ icant differences for group ‘modification’(f(1, 16) = 8.26, p = .014), but not for group ‘stabilisation’ (f(1,16) = 4.56, p = .080). pairwise comparisons revealed differences in mean social experience rating within group ‘modification’ between acquisition phase (m = 3.07, sd = 0.72) and modification vs. stabilisation phase (m = 3.53, sd = 0.64) as well as between modification vs. stabilisation phase and test phase (m = 3.27, sd = 0.58) with modification phase having the highest social experience ratings reflecting the highest nonverbal social appreciation feedback of 70%. we found no significant differences in social experience ratings between acquisition and test phase. these results indicate that the participants experienced the nonverbal social feedback as intended. main analyses first, we included all experimental phases in one statistical model and investigated changes in social expectation ratings across the course of the experiment. therefore, we performed a multilevel mixed effect multinomial linear regression on the social expecta‐ tion ratings as a function of group and time (i.e. the contrast matrix of individual social expectation ratings nested in each phase). time therefore consists of three variables each representing an experimental phase (acquisition phase, modification vs. stabilisation phase, test phase). unless otherwise stated, we used the standard bound optimisation by quadratic approximation (bobyqa) optimisation for the models. we calculated the linear regression of the social expectation ratings as a function of time (level 1). we then subsequently added the next-level effects until arriving at the full model including time (level 1), random intercept for participant (level 2), and group with interaction d’astolfo, kirchner, & rief 11 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ term for time (level 3). we compared mixed-effects models using likelihood ratio tests. here, we will describe the results of the level-3-model, the results for the level-1and level-2-models can be found in the supplementary material. figure 4 shows the course of the mean social expectation ratings across all phases of the experiment. figure 4 mean social expectation rating across all experimental phases as a function of experimental condition note. error bars indicate ± 1 se. the level-3-model revealed no significant group x acquisition phase interaction (β = -.00, t = -0.05, p = .585) but a trend for the group x test phase interaction (β = -.02, t = -1.96, p = .050) as well as a significant interaction for group x modification vs. stabilisation phase (β = .02, t = 2.12, p = .034) in accordance with our hypotheses. also, we found a main effect for group (β = .15, t = 2.00, p = .046), acquisition phase (β = -.06, t = -3.61, p < .001), and test phase (β = .04, t = 2.40, p = .016), but not for modification vs. stabilisation phase (β = -.00, t = -0.5, p = .572). in other words, there were no signifi‐ cant group differences in social expectation ratings during acquisition phase but during stabilisation vs. modification phase and test phase (retention test), whereby participants in group ‘stabilisation’ showed higher social rejection ratings than participants in group ‘modification’. also, social rejection ratings significantly increased during acquisition phase and slightly decreased during test phase for both groups. the non-significant main no1likesu! – a social learning paradigm 12 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ effect for stabilisation vs. modification phase can be explained with the opposing effect of the groups on social expectation ratings due to the inverted reinforcement rates. table 2 shows the model comparisons for the hierarchical linear regression. the models were sequentially tested against the previous models. table 2 analysis of variance for the hierarchical linear regression models model aic χ2 χdf p level 2 (random effect for participant) 2249.7 – – – level 3 (fixed effect for group) 2243.8 13.87 4 .007 note. aic = akaike information criterion. individual phases next, we used manova tests to investigate the effect of group on the social expectation ratings for each phase individually to investigate the effect sizes of the changes. hypothesis 1: main effect of acquisition phase we constructed a linear model of the social expectation ratings (as outcome matrix for ratings 1 to 10) as a function of group and baseline social expectation rating (with interaction term) to exclude differential learning for the groups and to account for inter-individual influences of baseline ratings on expectation rating during acquisition. we calculated a type-ii-manova using pillai’s test statistic for the linear model. as expected, we found no significant interaction between group and baseline social expect‐ ation rating, f(1,15) = 1.41, p = .264, and no significant main effect for group, f(1,15) = 0.85, p = .593, but a main effect of the baseline social expectation rating, f(1,15) = 3.53, p = .013. overall, the linear model accounted for 21% of variance (r 2 = .21), which constitutes a medium effect (ellis, 2010). hypothesis 2: main effect of group in stabilisation vs. modification phase following the significant interaction of group x stabilisation vs. modification phase in the main analyses, we constructed a linear model of the social expectation ratings (as outcome matrix for ratings 11 to 20) predicted by experimental condition to further investigate the main effect of group. the type-ii-manova revealed a marginally signif‐ icant main effect for group (f(1,17) = 2.38, p = .055). the model explained 19% of the variance (r 2 = .19) constituting a medium effect (ellis, 2010). d’astolfo, kirchner, & rief 13 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ exploratory analysis: stability of the social expectation ratings to test whether the social expectation ratings would remain consistent during test phase, we analysed a linear model of the social expectation ratings (outcome matrix for ratings 21 to 30) as a function of group. as expected, the type-ii-manova did not reveal a significant main effect for group, f(1,17) = 0.88, p = .568. for test phase, the linear model accounted for 7% of the variance (r 2 = .07) which constitutes a small effect (ellis, 2010). suspiciousness of the cover story additionally, we analysed suspiciousness of the cover story. seven participants reported doubts about the authenticity of the webcam conferences, six reported that they felt something ‘was off’ while 15 participants found nothing wrong with the webcam con‐ ferences. further, three participants knew some of their ‘webcam partners’. however, a sensitivity analysis excluding all suspicious participants did not reveal significant differences in the result patterns. therefore, we based our results on the whole sample. d i s c u s s i o n while social rejection expectations play a crucial role in mental health, experimental re‐ search on the processes of how these expectations develop, maintain, and change is cur‐ rently lacking. our study addresses this gap by providing an ecologically valid and highly standardised experimental paradigm to investigate the acquisition, maintenance, and modification of situation-specific social rejection expectations in healthy samples. results indicate, that this paradigm can be used to successfully induce (hypothesis 1) as well as differentially change (hypothesis 2) situation-specific social rejection expectations in healthy participants as a function of social feedback (social rejection vs. social apprecia‐ tion). altogether these results are consistent with the predictions drawn from the ‘vio‐ lex-model’, which assumes modification of expectations after experiencing disconfirming results (e.g. positive social feedback after negative social feedback) as well as stabilisation of expectations after experiencing confirming results (e.g. rief et al., 2015). further, our results are in line with previous research on expectation development, maintenance, and modification in healthy participants. for example, liebke et al. (2018) showed that healthy participants increase (respectively reduce) expectations of social acceptance as a function of social feedback (acceptance vs. rejection). kube, rief, gollwitzer, and glombiewski (2018) as well as kube, kirchner, rief, gärtner, and glombiewski (2019) provided similar results concerning the modification of performance-related expectations as a function of performance-related feedback. kube, rief, gollwitzer, and glombiewski (2018) showed that healthy participants modify dysfunctional task-specific performance expectations in face of positive performance feedback. consistently, kube, kirchner, rief, gärtner, and glombiewski (2019) found that healthy as well as depressed participants no1likesu! – a social learning paradigm 14 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ update dysfunctional task-specific performance expectations in accordance to positive vs. negative feedback. moreover, our results resemble basic result patterns found in fear conditioning para‐ digms concerning the acquisition and modification of fear (lissek et al., 2005): repeatedly pairing self-presentation with social rejection led to higher social rejection expectation (i.e. higher ‘contingency awareness’, lonsdorf et al., 2017, pp. 268-269) while social rejection expectations decreased in turn when social rejection feedback was omitted. however, comparability is limited here, since social expectations formed in the real world might interfere with social expectations formed within no1likesu! (which is different from most typical fear conditioning procedures). concerning our test phase, results indi‐ cate no ‘return’ or ‘renewal’ of social rejection expectations which is normally a common phenomenon in classical fear conditioning ('return of fear', lonsdorf et al., 2017, p. 260). the stability of the associations learned within stabilisation vs. modification phase might be due to partial reinforcement during this phase as occasional reinforcement seem to attenuate return of fear in human fear conditioning (craske et al., 2014; culver, stevens, fanselow, & craske, 2018). limitations despite incorporating naturalistic stimuli, no1likesu! does not provide dynamic social interactions. while the pre-scripted video stimuli ensure standardised experimental ma‐ nipulation, these stimuli do not adapt to individual expressions of participants, threaten‐ ing its external validity. moreover, the paradigm only focuses on one specific social situation, i.e. self-disclosure in front of a stranger. thus, investigating the generalisation of social rejection expectations to other social situations might be difficult within this paradigm. additionally, a substantial amount of our participants seemed to be suspicious about the ‘webcam conferences’ and the social feedback we provided within no1likesu!. while this issue could be solved at the expense of standardisation (for example by using real time interactions with confederates), problems with suspiciousness should not be overestimated within the actual procedure. firstly, post-hoc questionnaires about the ‘aims and purposes’ of a study demand for suspiciousness by construction and therefore potentially overestimate actual suspiciousness of individuals during participa‐ tion. secondly, research on social exclusion shows that experiences of social exclusion stay impactful even if participants know that social feedback is simulated (e.g. zadro, williams, & richardson, 2004). further, we measured situation-specific social expectation only via self-report on a one-item scale. while expectations are usually assessed via self-report, more advanced self-report measures as well as multimodal indicators of social rejection expectation (e.g. avoidance behaviour) would improve validity of social rejection expectation assessment. further, while we incorporated general suggestions on fear conditioning paradigms, there are no clear instructions on how to set certain parameters in associative learning d’astolfo, kirchner, & rief 15 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ procedures (e.g. reinforcement rate or trial number). thus, changing these parameters might also influence the effects of the paradigm. also, while we focused on contingency learning of outcome expectations, we did not include valence ratings for social rejection and social appreciation. meta-analyses clearly show negative valence for social rejection (gao et al., 2017), however, individual valence ratings might influence contingency learning. outcome valence and outcome expectations might be coded differently in human brains (von borries et al., 2013). while many brain areas associated with contingency learning seem independent of valence, some brain areas are suggested to be more strongly activated when processing positively evaluated stimuli (bischoff-grethe et al., 2009). finally, while we incorporated the concept of ‘expectation violation’ (rief et al., 2015) in our paradigm, it could be argued that we did not provide real extinction training in our study as typically applied in fear conditioning (lonsdorf et al., 2017). since social rejection feedback was not only omitted but replaced by social appreciation feedback, we rather provided a ‘counterconditioning’ (de jong, vorage, & van den hout, 2000) approach in group ‘modification’. future directions no1likesu! provides options for broad applications to investigate the acquisition, main‐ tenance, and modification of social rejection expectations within a highly standardised and ecologically valid experimental procedure. it is adaptable to various research at‐ tempts. future research should use no1likesu! to identify differences in the develop‐ ment, maintenance, and modification of social rejection expectations between healthy and clinical samples (with special regards to patients with borderline personality disor‐ der, social anxiety or depression). to test whether clinical samples show to be differ‐ entially more sensitive to social rejection experiences during acquisition than healthy controls and show to be less responsive to social appreciation experiences during modifi‐ cation, has important implications for etiological considerations and clinical treatment. on the one hand, this could call for the development of expectation-focused etiologi‐ cal models (with special emphasise on dysfunctional social rejection expectations as connecting link) like kube, siebers, et al. (2018) as well as rief and joormann (2019) proposed for major depression. on the other hand, these results would stress the need for carefully designed expectation-focused psychological interventions specifically tar‐ geting dysfunctional social rejection expectations through contradictory experiences like kube, glombiewski, and rief (2019) elaborated for people with depressive symptoms. further, this would extend former findings on the ‘violex-model’ and clarify whether expectations of social rejection should be especially targeted in clinical practice. in order to develop proper interventions, researchers should apply no1likesu! to investigate whether different interventions on informational processing (e.g. verbalisation, function‐ al attention management) improve the modification of social rejection expectations in no1likesu! – a social learning paradigm 16 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ face of expectation violations. here, it would also be of interest to investigate behavioural changes in participants (healthy participants as well as clinical samples) following social appreciation vs. social rejection feedback. this could provide further insight in behaviou‐ ral expressions of social rejection expectations, which might also consolidate or even reinforce social rejection expectations. from an ethical point of view, screening for and treatment of emotional distress produced by the paradigm should be enhanced when investigating clinical samples but also healthy controls. researchers should provide extended debriefing and emotional af‐ tercare by trained psychotherapists in order to prevent clinical subjects from transferring negative social experiences from the paradigm to their real life. further, they should integrate phases of repeated positive social experiences at the end of their experiments by default in order to compensate for negative social experiences. conclusion no1likesu! is an ecologically valid and highly standardised experimental paradigm to investigate the development, maintenance, and modification of social rejection expecta‐ tions. participants pass multiple short ‘webcam-conferences’ (video stimuli) in which they answer personal questions to different ‘listeners’ (confederates). afterwards, they receive manipulated social feedback on their self-presentation. our results suggest that researcher can use no1likesu! to induce and alter social rejection expectations in healthy participants. future research should focus on differences in the acquisition, maintenance, and modification of social rejection expectations between healthy and clinical samples. additionally, incorporating interventions on expectation violation pro‐ cessing might improve the modification of social rejection expectations with implications for clinical treatment. funding: the authors have no funding to report. competing interests: winfried rief is editor-in-chief of clinical psychology in europe but played no editorial role for this particular article. apart from that, the authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. acknowledgments: we thank rené herbstreit for providing technical support with programming the paradigm. s u p p l e m e n t a r y m a t e r i a l s the supplementary material contains an overview of the 30 questions used in the no1likesu! paradigm (appendix a). questions were adapted from various dating websites to promote positive self-disclosure. appendix b provides the results of the level-1and level-2-mixed effects models d’astolfo, kirchner, & rief 17 clinical psychology in europe 2020, vol.2(2), article e2997 https://doi.org/10.32872/cpe.v2i2.2997 https://www.psychopen.eu/ within the multilevel mixed effect multinomial linear regression (for access, see index of supple‐ mentary materials below): index of supplementary materials d’astolfo, l., kirchner, l., & rief, w. 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[b] department of clinical, neuro and developmental psychology, vrije universiteit, amsterdam, the netherlands. [c] department of research and innovation, ggz in geest/amsterdam university medical center, vu university medical center, amsterdam, the netherlands. [d] the hebrew university of jerusalem, mount scopus, jerusalem, israel. [e] mindspot clinic, macquarie university, sydney, australia. [f ] ecentreclinic, department of psychology, macquarie university, sydney, australia. clinical psychology in europe, 2020, vol. 2(3), article e3941, https://doi.org/10.32872/cpe.v2i3.3941 published (vor): 2020-09-30 corresponding author: gerhard andersson, department of behavioural sciences and learning, linköping university, se-581 83 linköping, sweden. tel: ++46 13 28 587 40. fax: ++46 13 28 21 45. e-mail: gerhard.andersson@liu.se the consequences of the covid-19 pandemic are moving targets, making it hard to estimate the societal burden in terms of not only physical but also mental health (holmes et al., 2020). it is clear that mental health problems will increase as a consequence of the pandemic. however, the specific problems across countries will reflect their response to the pandemic with mental health problems including the effects of social isolation (physical distancing), loss followed by disrupted grief ceremonies, loss or disruption to vocational, economic or educational opportunities, fear of a second outbreak of cov‐ id-19 and future post-corona mental health consequences (holmes et al., 2020). recent studies indicate that service demands for psychiatric assessments and interventions have increased (titov et al., 2020), while at the same time in person psychiatric visits for mild to moderate conditions have been advised against. there are many new challenges and possibilities raised by the pandemic. it is likely that we will see new problems and new groups of clients not seen before. mental health problems among health care workers is one example, and loneliness or relationship distress caused by social distancing is another example. a third example could be coping with loss: death of loved ones with little opportunity for social support, loss of employ‐ ment and monetary loss, and loss or disruption to education. to our knowledge, with the this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.3941&domain=pdf&date_stamp=2020-09-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ possible exception of problem-solving therapy and interpersonal psychotherapy focused on bereavement and role change, few psychological treatment studies have targeted financial concerns and mental health problems in association with such changes. the lesson for researchers is to document and adapt according to the new situation. provision of evidence-based psychological treatments that not only are cost-effective but also safe to deliver from a pandemic perspective would have relied solely on tele‐ phone contacts before the advent of modern information technology (wind, rijkeboer, andersson, & riper, 2020). since the late 1990s, a wide range of evidence-based internet interventions have been developed for a range of psychiatric diagnoses (for example major depression, anxiety and substance use disorders), and also psychological problems like loneliness, insomnia and stress (andersson, titov, dear, rozental, & carlbring, 2019). internet interventions often include instructions on how to perform tasks in real life. for example, exposure to feared social situations are performed in real life, and virtual reality and attention training may be used to augment or facilitate real life activities (miloff, lindner, & carlbring, 2020). this leads to one immediate challenge in the era of covid-19: homework assignments must be adapted to the current regulations and restrictions in each jurisdiction. real-time video conferencing is a further alternative to deliver evidence-based psychological treatments (varker, brand, ward, terhaag, & phelps, 2019). however, it is important to note that few studies have evaluated this treatment format and that it is more costly than internet interventions that involve minor therapist input. in spite of the many advantages of internet interventions there are additional limita‐ tions that are specifically relevant in view of the pandemic: first, internet interventions are rarely used for clients with severe mental health problems (e.g., psychosis and acute suicidal intent) and therefore cannot be a total solution in providing remote access to mental health care. second, with the covid-19 pandemic there has been an increase in the use of video consultations. while it is likely that video therapy works as well as face-to-face therapy, this has not been tested in empirical studies to the same extent as internet interventions in the form of guided self-help (varker et al., 2019). third, although a decreasing proportion of the population continue to experience the digital di‐ vide, still far from all people in the world have access to reliable internet. now, a majority have access, but it is still the case that there are groups who are not able to use comput‐ ers or smartphones, including frail, older persons, persons with intellectual disabilities, or those socio-economically disadvantaged. as a fourth limitation we raise the risk of not performing proper diagnostic assessments as is standard practice in most clinical settings (e.g., primary care and also some clinics providing internet interventions), where patients are screened for general health. in other words, internet interventions benefit from a well-functioning health care in order to maintain not only good quality treatment but also ethical standards when referral is needed. for example, if a cardiac problem is editorial 2 clinical psychology in europe 2020, vol.2(3), article e3941 https://doi.org/10.32872/cpe.v2i3.3941 https://www.psychopen.eu/ suspected in a telephone interview it may be more difficult to refer the client to regular health care. despite these limitations, internet interventions research has the advantage that treatments can be adapted rapidly and tested more quickly than is the case in regular psychotherapy research (and also medical research). there are several previous examples of this with treatments being developed for problems like loneliness, procrastination and perfectionism, but also adapting treatments for different age groups (e.g., adolescents, adults and older adults). furthermore, one striking advantage of internet interventions is translation and cultural adaption of interventions that would be very hard to deliver using a translator or expensive when training therapists in new settings (andersson et al., 2019). there are now studies on internet treatments in many languages including arabic, mandarin, and hebrew just to give a few examples. given the limited resources in many places and the risk of even worse economic circumstances, there is need and opportunity to develop and test interventions that are accessible regardless of where the person resides. of course, it is crucial that the medico-legal and clinical aspects are carefully managed, but this is a likely development in the future. in conclusion, the current covid-19 pandemic situation does not allow us to wait. internet-delivered psychological interventions should be offered and in particular evi‐ dence-based internet interventions that allow privacy and can be adapted for different problems and languages. specific interventions for psychological problems related to covid-19 should be developed. this could help reduce the societal burden caused by the pandemic. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s andersson, g., titov, n., dear, b. f., rozental, a., & carlbring, p. (2019). internet-delivered psychological treatments: from innovation to implementation. world psychiatry, 18, 20-28. https://doi.org/10.1002/wps.20610 holmes, e. a., o’connor, r. c., perry, v. h., tracey, i., wessely, s., arseneault, l., . . . bullmore, e. (2020). multidisciplinary research priorities for the covid-19 pandemic: a call for action for mental health science. the lancet: psychiatry, 7, 547-560. https://doi.org/10.1016/s2215-0366(20)30168-1 andersson, berg, riper et al. 3 clinical psychology in europe 2020, vol.2(3), article e3941 https://doi.org/10.32872/cpe.v2i3.3941 https://doi.org/10.1002/wps.20610 https://doi.org/10.1016/s2215-0366(20)30168-1 https://www.psychopen.eu/ miloff, a., lindner, p., & carlbring, p. (2020). the future of virtual reality therapy for phobias: beyond simple exposures. clinical psychology in europe, 2(2), article e2913. https://doi.org/10.32872/cpe.v2i2.2913 titov, n., staples, l., kayrouz, r., cross, s., karin, e., ryan, k., . . . nielssen, o. (2020). rapid report: early demand, profiles and concerns of mental health users during the coronavirus (covid-19) pandemic. internet interventions, 21, article 100327. https://doi.org/10.1016/j.invent.2020.100327 varker, t., brand, r. m., ward, j., terhaag, s., & phelps, a. (2019). efficacy of synchronous telepsychology interventions for people with anxiety, depression, posttraumatic stress disorder, and adjustment disorder: a rapid evidence assessment. psychological services, 16, 621-635. https://doi.org/10.1037/ser0000239 wind, t. r., rijkeboer, m., andersson, g., & riper, h. (2020). the covid-19 pandemic: the ‘black swan’ for mental health care and a turning point for e-health. internet interventions, 20, article 100317. https://doi.org/10.1016/j.invent.2020.100317 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. editorial 4 clinical psychology in europe 2020, vol.2(3), article e3941 https://doi.org/10.32872/cpe.v2i3.3941 https://doi.org/10.32872/cpe.v2i2.2913 https://doi.org/10.1016/j.invent.2020.100327 https://doi.org/10.1037/ser0000239 https://doi.org/10.1016/j.invent.2020.100317 https://www.psychopen.eu/ how strongly connected are positive affect and physical exercise? results from a large general population study of young adults research articles how strongly connected are positive affect and physical exercise? results from a large general population study of young adults sarah d. pressman a, keith j. petrie b, børge sivertsen cde [a] department of psychological science, university of california irvine, irvine, ca, usa. [b] department of psychological medicine, university of auckland, auckland, new zealand. [c] department of health promotion, norwegian institute of public health, bergen, norway. [d] department of research & innovation, helse-fonna hf, haugesund, norway. [e] department of mental health, norwegian university of science and technology, trondheim, norway. clinical psychology in europe, 2020, vol. 2(4), article e3103, https://doi.org/10.32872/cpe.v2i4.3103 received: 2020-04-16 • accepted: 2020-11-13 • published (vor): 2020-12-23 handling editor: omer van den bergh, university of leuven, leuven, belgium corresponding author: sarah d. pressman, department of psychological science, university of california, irvine, ca 92697, usa. e-mail: pressman@uci.edu abstract background: previous research has shown a link between low positive affect (pa) and numerous physical and psychological well-being outcomes but, recent research has raised the possibility that this relationship may be driven by physical activity. thus, we were interested in exploring the paexercise connection by examining this relationship across differing levels of body mass and athleticism. we also looked at whether the item “active” that is used in many pa assessments was responsible for this effect. method: participants were part of the norwegian shot2018 national survey of 50,054 young adults (mean age = 23.2, 68.9% women), who completed electronic surveys about their exercise levels (duration, frequency and intensity) and affect. results: there was a clear and strong dose-response association between current state pa and the duration, frequency and intensity of exercise. for example, duration, magnitude, and slope effects were strongly driven by regular exercisers who had more than a 20-fold greater likelihood of being in the highest pa deciles compared to the least frequent exercisers. these dose-response connections replicated across both healthy and overweight bmis, as well as in elite athletes. removing the word “active” from the pa measure substantially reduced the size of this association, although the dose-response relationship remained. conclusion: the observed strong connections have critical implications for health researchers and clinicians, and point to a need to carefully consider what types of activities are most strongly tied to well-being. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.3103&domain=pdf&date_stamp=2020-12-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords positive affect, exercise, physical exercise, vigor, well-being highlights • there is a strong dose-response connection between exercise and positive emotion. • this pattern persists across a range of body types and athlete characteristics. • overlap between adjectives in affect and self-reported activity scales partially but not fully explains the connection. • past work showing benefits of happiness on health may be partially or primarily driven by activity, not emotion. it has long been established in both research and in common public knowledge that exercise can lead to greater positive affect (pa; arent, landers, & etnier, 2000; elavsky et al., 2005) as well as a reduction in negative affect (na; e.g., depression) (berger & owen, 1983; ströhle, 2009). while perhaps less recognised, it is also true that people high in pa engage in more physical exercise, as well as other positive health behaviors (boehm et al., 2018; cohen & pressman, 2006) indicating potentially bidirectional and strongly interconnected associations between these two variables (pasco et al., 2011). recent work even indicates the value of positive psychology interventions for increasing physical exercise in the context of illness and stress (huffman, millstein, et al., 2020). with the common goal of improving well-being in patient samples, it is critical that we more fully explore this question so as to better inform the value of positive psychology interventions in clinical populations. understanding the nature of this association becomes even more critical given the burgeoning literature connecting pa to better physical health across a wide range of domains (chida & steptoe, 2008; diener & chan, 2011; pressman, jenkins, & moskowitz, 2019). this includes longitudinal studies showing that pa predicts later health outcomes such as longevity (danner, snowdon, & friesen, 2001; pressman & cohen, 2012; willroth, ong, graham, & mroczek, 2020), infectious illness (cohen, alper, doyle, treanor, & turner, 2006; cohen, doyle, turner, alper, & skoner, 2003), heart disease (boehm & kubzansky, 2012), hiv severity (moskowitz, 2003) and other morbidities, even after accounting for critical covariates such as baseline health, medication use, negative affect, and other relevant factors. these types of studies, as well as recent positive psychology interventions showing improvements in later self-reported health (kushlev et al., 2020) and mental health outcomes in diseased samples (see review by pressman, jenkins, & moskowitz, 2019) point to the interesting possibility that pa can cause better health. this work has helped foster a new field of “positive health” research (seligman, 2008) as well as a burgeoning area of research trying to improve health via positive psychology positive affect and physical exercise 2 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ interventions (e.g., huffman et al., 2011; moskowitz et al., 2017, 2012). however, as discussed recently (pressman & cross, 2018), this literature becomes potentially less compelling and the focus on positive psychology interventions for health promotion less useful, if the reason that the pa-health association is largely due to the overlap between positive affect and physical exercise or fitness. that is, is pa correlated with better health primarily because happy people are also more physically active, and therefore healthier people? recent evidence confirming the causal effects of positive psychological interventions on increased exercise and general activity points to this possibility (e.g., huffman, feig, et al., 2019). this problem is compounded by the fact that when utilizing self-report scales, there can be a large overlap between physical health self-reports and pa self-reports. for example, many popular affect measures rely on adjectives like “active” and “energetic” to tap positive affect (mcnair, lorr, & droppleman, 1971; watson, clark, & tellegen, 1988). while these items do tap feelings of vitality important to the conceptualization of pa, critically, they also tap physical fitness and perceived health, as evidenced by frequently used self-reported health scales that use these types of items (kind, brooks, & rabin, 2005; mcnair et al., 1971). that is, if we take the word “active” (an item from the posi‐ tive and negative affect schedule [panas]; watson, clark, & tellegen, 1988) literally, then someone feeling active may also be more (physically) active. assessments do not distinguish between psychological versus physical forms of these vigorous feelings. this is problematic because to the extent that these measures represent the same underlying construct, it may be that feelings of happiness and joy are not predicting future health, but rather that it is health predicting health. we examined this issue recently in a large sample of over 5000 older adults (petrie et al., 2018). consistent with past pa-mortality research (chida, hamer, wardle, & steptoe, 2008), lower pa was associated with nearly double the mortality risk over a 16-year follow-up as compared to those with the highest pa. however, when unpacking the subtypes of pa responsible for this effect, we found that the association was primarily driven by the active item of the panas. this effect remained after accounting for the effects of the remaining panas items, demographics, and other important covariates. thus, it was not the more emotionally laden and less activity/arousal based items driving longevity but the panas activity item. while we did control for exercise in analyses as well, a limitation was that physical activity was assessed by only a single 3-point item asking about weekly level of exercise which did not allow us to look more closely at the nature of the pa (or felt activity) and exercise connection. this minimalist approach to assessing physical activity is echoed across the pa-health literature, including in studies showing that it is the high and not low energy compo‐ nents of pa most tied to reduced mortality (no activity control) (pressman & cohen, 2012) and decreased susceptibility to catching the common cold (included a simple measure of days exercised multiplied by effort) (cohen et al., 2003). this practice is also pressman, petrie, & sivertsen 3 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ common in studies on the connections between general pa and longevity where studies use single yes/no item regarding vigorous activity (steptoe & wardle, 2011) or no activity assessment (danner, snowdon, & friesen, 2001). unfortunately, it is also the case that many studies focused on physical activity do minimal assessments of pa, relying, for example on assessments of only one type of pa (e.g., vigor) or instead infer pa and wellbeing because of a drop in mental health problems like depression or anxiety symptoms (berger & motl, 2000; penedo & dahn, 2005; schinke, stambulova, si, & moore, 2017). thus, clearly there is a need to examine the association between these related varia‐ bles in more detail where pa can be compared to a range of activity markers across a large number of individuals. furthermore, given the concern about high pa simply being a marker of healthy fitness, this should be tested in those both high and low in fitness. this will enable a deeper understanding of the degree of connection association between fitness and high arousal pa, and more clarity about past research linking pa to health and mortality. to examine the extent to which pa and physical activity are overlapping constructs, we used data from the shot2018 study, a sample of over 50,000 norwegian young adults. we hypothesized that pa would be strongly associated with all measures of self-reported physical exercise including exercise frequency, intensity and duration. in addition, we consider several previously unexplored avenues. we capitalized on the survey questions that distinguished young people who self-identified as elite athletes. this allowed us to examine whether top athletes had significantly greater odds of also having higher pa, as well as whether the opposite would be true in individuals with high body mass index. the large size of the sample also enabled an examination of whether the pa-physical exercise connections holds between men and women and within each of the frequency, intensity and duration of exercise dimensions. finally, based on its importance in our past work, we explored to what extent the associations found in the above analyses changed when the word “active” was removed from the panas pa measure and the size of the association of feeling “active” with these exercise measures. m e t h o d participants the shot study (an acronym for the norwegian name: studentenes helseog triv‐ selsundersøkelse [students’ health and wellbeing study]) is a national student survey for higher education in norway. details of the study have been published elsewhere (sivertsen, råkil, munkvik, & lønning, 2019). so far, three health surveys of the student population in norway have been completed (2010, 2014, and 2018). both the size and scope of the shot studies have expanded over time, and now include detailed informa‐ tion on both mental and physical health, quality of life, and health-related behaviours. positive affect and physical exercise 4 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ the shot2018 study was a joint effort between the three largest student welfare organizations in norway and the norwegian institute of public health (niph). the study was conducted between february 6th and april 5th, 2018, on all full-time norwegian stu‐ dents taking higher education (both in norway and abroad). the collection of the health survey was in close collaboration with all the student welfare organizations in norway. students were told that participation was completely voluntary, and that there were no penalties for not filling out the survey. eight percent of the sample were immigrants, defined as either the student or his/her parents being born outside of norway. the study protocol was approved by the regional committee for medical and health research ethics of western norway (no. 2017/1176/rek vest), whose directives are based on the declaration of helsinki. written electronic consent was obtained from all subjects included in this study. measures the positive and negative affect schedule (panas) the panas (watson et al., 1988) is a 20-item questionnaire which comprises two sub‐ scales, one that measures positive affect (pa) and the other which measures negative affect (na). the pa scale of interest here includes the terms interested, alert, enthusias‐ tic, excited, proud, inspired, strong, active, and attentive. participants are instructed to rate to what extent they experience each emotion right now, rated on a 5-point scale from “very slightly or not at all” (coded as 1) to “extremely” (coded as 5). a sum score is calculated with higher scores representing greater pa. for the purpose of the present study, the sum scores were divided into both tertiles and deciles separately for men and women. the cronbach’s alpha for the pa subscale in the current study was 0.91. the na subscale was not included in the shot study1. physical exercise the students were first presented with the following brief definition of physical exercise: “with physical exercise, we mean that you, for example, go for a walk, go skiing, swim or take part in a sport.” physical exercise was assessed using three sets of questions, assessing the average number of times exercising each week, and the average intensity and average hours each time: 1) “how frequently do you exercise?” (never, less than once a week, once a week, 2–3 times per week, almost every day); 2) “if you do such exercise as frequently as once or more times a week: how hard do you push yourself? (i 1) na was not the focus of the paper given our past work showing that it does not alter pa-health associations (petrie et al., 2018), extensive work on the independence of pa and na in the panas (watson et al., 1988), existing work on this sample examining na and mental health (grasdalsmoen, eriksen, lønning, & sivertsen, 2020), and the fact that the questions here target the potential overlap specific to panas pa (not na) and physical activity measurements. pressman, petrie, & sivertsen 5 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ take it easy without breaking into a sweat or losing my breath, i push myself so hard that i lose my breath and break into a sweat, i push myself to near-exhaustion); and 3) “how long does each session last?” (less than 15 minutes, 15–29 minutes, 30 minutes to 1 hour, more than 1 hour”. detailed results of college students’ exercise in the shot studies have been published elsewhere (grasdalsmoen, eriksen, lønning, & sivertsen, 2019). this 3-item questionnaire has previously been used in the large population-based nord-trøndelag health study (the hunt studies). previous validation studies (kurtze, rangul, hustvedt, & flanders, 2008) have demonstrated moderate-to-strong correlations between the questionnaire responses, and direct measurement of vo2max (r = 0.48), (an objective indicator of cardiorespiratory fitness) during maximal work on a treadmill, with actireg (r = 0.39), an instrument that measures pa and energy expenditure (ee), and with the international physical activity questionnaire (ipaq; r = 0.55). respondents were also asked if they considered themselves to be a “top athlete” (yes/no), and if so, how many hours per week they trained (drop-down menu: 0 to 40 hours). statistical analyses ibm spss statistics 25 for mac (spss inc., chicago, il) was used for all analyses. multino‐ mial logistic regression models were computed to assess the association between levels of physical exercise (independent variable; lowest level of the three physical exercise variables being the reference category) and deciles of pa (dependent variable; first decile being the reference category). being similar to binary logistic regression, multinomial regression is used when the dependent variable is nominal with more than two levels. results are presented as odds-ratios (ors) with 95% confidence intervals (95% cis). there was very little missing data on the pa items, with missing responses ranging from n = 167 (1.1%) to n = 1092 (2.6%), and hence techniques involving multiple imputations were not considered, and missing values were handled using listwise deletion. r e s u l t s descriptive statistics in terms of frequency of physical exercise, 24% of the sample reported being physically active “every day”, while 47% responded exercising “2-3 times per week”. moreover, 16%, 12% and 4% reported training “once a week”, “less than once a week”, or “never”, respectively. regarding the students’ reports of their average physical exercise intensity, 11% of the sample responded “i push myself to near-exhaustion”, while 71% reported “i push myself so hard that i lose my breath and break into a sweat” and 18% responded “i take it easy without breaking into a sweat or losing my breath”. on the item assessing the duration of each episode of physical exercise, 37% reported an average duration of positive affect and physical exercise 6 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ “more than 1 hour”, compared to 52%, 10% and 2% reporting “30 minutes to 1 hour”, “15–29 minutes”, and “less than 15 minutes”, respectively. the response distribution of the 10 pa items for both men and women are presented in figure 1. as shown, the proportion of students responding feeling “attentive” either quite a bit or extremely was 51%, followed by “determined” (48%) and “interested” (47%). in contrast, only 17% of the sample responded feeling “excited” quite a bit or extremely. there were only marginal sex differences in terms of the response distribution of pa items. figure 1 distribution of positive affect items in men and women in the shot2018 study women men women men women men women men women men women men women men women men women men women men e xc it ed a le rt p ro ud in sp ir ed e n th u si as ti c a ct iv e st ro ng in te re st ed d et er m in ed a tt en ti ve very slightly or not at all a little moderately quite a bit extremely 21 % 19 % 12 % 6 % 15 % 12 % 13 % 9 % 12 % 10 % 14 % 10 % 12 % 9 % 6 % 5 % 8 % 7 % 6 % 4 % 25 % 26 % 23 % 17 % 22 % 20 % 22 % 19 % 19 % 18 % 21 % 19 % 19 % 17 % 16 % 12 % 16 % 16 % 14 % 13 % 38 % 38 % 39 % 38 % 32 % 32 % 32 % 32 % 34 % 34 % 27 % 27 % 28 % 29 % 32 % 29 % 28 % 30 % 29 % 30 % 15 % 15 % 23 % 34 % 27 % 30 % 28 % 33 % 30 % 32 % 29 % 32 % 33 % 35 % 39 % 45 % 36 % 36 % 40 % 41 % 2 % 2 % 2 % 5 % 4 % 6 % 5 % 7 % 5 % 7 % 8 % 12 % 9 % 10 % 6 % 9 % 12 % 12 % 11 % 12 % 0 % 10 % 20 % 30 % 40 % 50 % 60 % 70 % 80 % 90 % 100 % note. sorted by proportion of students reporting each item “quite a bit” or “extremely”. is positive affect associated with physical exercise? the physical exercise characteristics according to sex-specific tertiles on the pa-scale are presented in table 1. low pa scores were more prevalent among those with lower exercise levels. these trends were present in a dose-response manner, and evident across all four physical exercise items (see table 1 for details). pressman, petrie, & sivertsen 7 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ ta b le 1 a ge g ro up a nd p hy si ca l e xe rc is e c ha ra ct er is ti cs b y p os it iv e a ff ec t (p a ) te rt il e st ra ti fi ed b y se x in t he s h ot 20 18 s tu dy , n or w ay , 2 01 8 g ro up c h ar ac te ri st ic s w om en m en pa l ow er t er ti le pa m id dl e te rt il e pa u pp er t er ti le pa l ow er t er ti le pa m id dl e te rt il e pa u pp er t er ti le a ge g ro up 18 -2 0 ye ar s 36 .0 % 34 .8 % 29 .2 % 36 .5 % 32 .8 % 30 .7 % 21 -2 2 ye ar s 33 .5 % 34 .7 % 31 .8 % 31 .7 % 34 .0 % 34 .3 % 23 -2 5 ye ar s 33 .7 % 34 .0 % 32 .3 % 33 .8 % 31 .8 % 34 .3 % 26 -2 8 ye ar s 35 .6 % 32 .2 % 32 .2 % 39 .0 % 30 .4 % 30 .6 % 29 -3 5 ye ar s 30 .3 % 32 .7 % 37 .0 % 38 .8 % 31 .9 % 29 .3 % p h ys ic al e xe rc is e (f re qu en cy ) n ev er 59 .5 % 27 .2 % 13 .3 % 62 .5 % 24 .4 % 13 .1 % le ss th an o nc e a w ee k 47 .1 % 34 .2 % 18 .8 % 51 .6 % 28 .2 % 20 .1 % o nc e a w ee k 39 .9 % 35 .3 % 24 .8 % 40 .2 % 35 .7 % 24 .0 % 2– 3 tim es p er w ee k 31 .1 % 35 .5 % 33 .5 % 31 .6 % 34 .5 % 34 .0 % a lm os t e ve ry d ay 24 .6 % 31 .4 % 44 .1 % 22 .0 % 31 .3 % 46 .8 % p h ys ic al e xe rc is e (i n te n si ty ) i t ak e it ea sy w ith ou t b re ak in g in to a sw ea t o r lo si ng m y br ea th 43 .5 % 34 .6 % 21 .9 % 48 .0 % 29 .7 % 22 .3 % i p us h m ys el f s o ha rd th at i lo se m y br ea th a nd b re ak in to a s w ea t 31 .0 % 34 .7 % 34 .3 % 31 .4 % 34 .1 % 34 .5 % i p us h m ys el f t o ne ar -e xh au st io n 27 .0 % 31 .0 % 42 .1 % 27 .4 % 30 .4 % 42 .2 % p h ys ic al e xe rc is e (d ur at io n ) le ss th an 1 5 m in ut es 55 .0 % 29 .0 % 16 .0 % 58 .5 % 25 .4 % 16 .2 % 15 –2 9 m in ut es 43 .5 % 34 .8 % 21 .7 % 42 .8 % 31 .7 % 25 .5 % 30 m in ut es to 1 h ou r 33 .4 % 34 .3 % 32 .3 % 35 .5 % 33 .5 % 30 .9 % m or e th an 1 h ou r 27 .9 % 34 .5 % 37 .6 % 28 .2 % 32 .8 % 39 .0 % to p at h le te ye s 18 .8 % 26 .9 % 54 .3 % 15 .6 % 23 .0 % 61 .3 % n o 24 .9 % 31 .6 % 43 .5 % 22 .2 % 31 .8 % 46 .0 % n ot e. a ll p < .0 01 . p v al ue s re fe r to th e re su lts fr om th e ch i-s qu ar ed te st s. positive affect and physical exercise 8 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ figure 2 displays the results from the multinomial regression analysis examining the predictive effect of each physical exercise item on the level of pa, operationalized by deciles on the pa-subscale. as shown, there was a strong dose-response relationship between frequency of physical exercise and pa level. although the associations were significant across all response categories of physical exercise (compared to “never”), the odds-ratios were especially strong among students reporting to train multiple times per week. similarly, the effect sizes gradually increased parallel to elevating pa deciles. for example, students training every day had more than 20-fold increased odds of having a pa-score above the 90th percentile (compared to the lowest decile). the correlations between the total pa score and exercise frequency for men and women were r = 0.28 and r = 0.23, respectively (both ps < .001). a similar pattern was observed for the item assessing the intensity and duration of physical exercise and pa level. as displayed in figure 3, the harder the exercise, the higher the odds-ratio between physical exercise and pa. similar to the frequency item, there was a clear dose-response association for both men and women. the duration of the physical exercise (figure 4) was also associated with pa level in a similar manner: the longer the exercise, the stronger the association with high levels of pa. for example, both men and women reporting an average duration of exercise of more than one hour had between six to eight times increased odds of scoring in the top decile of the pa-subscale. figure 2 odd-ratios of frequency of physical exercise associated with deciles of the positive affect (pa) subscale of panas stratified by sex in the shot2018 study 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 almost every day 2-3 x/wk 1 x/wk < 1 x/wk almost every day 2-3 x/wk 1 x/wk < 1 x/wk nemnemow o d d sra ti o outcome: positive affect deciles: how frequently do you exercise? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th note. reference category: never. error bars represent 95% confidence intervals. pressman, petrie, & sivertsen 9 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ figure 3 odd-ratios of intensity of physical exercise associated with deciles of the positive affect subscale of panas stratified by sex 0 1 2 3 4 5 6 7 8 9 i push myself to near-exhaustion i push myself so hard that i lose my breath and break into a sweat i push myself to near-exhaustion i push myself so hard that i lose my breath and break into a sweat nemnemow o d d sra ti o outcome: positive affect deciles: how hard do you push yourself? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th note. reference category: i take it easy without breaking into a sweat or losing my breath. error bars represent 95% confidence intervals. figure 4 odd-ratios of duration of physical exercise associated with deciles of the positive affect subscale of panas stratified by sex 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 more than 1 hour 30 minutes to 1 hour 15–29 minutes more than 1 hour 30 minutes to 1 hour 15–29 minutes nemnemow o d d sra ti o outcome: positive affect deciles: how long does each session last? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th note. reference category: “less than 15 minutes”. error bars represent 95% confidence intervals. positive affect and physical exercise 10 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ what is the relationship between exercise and positive affect in top athletes? finally, students considering themselves to be a top athlete had significantly higher odds of also having a high level of pa. as shown in figure 5, the associations were also here in a dose-response manner, although the associations were particularly strong for the top two deciles of the pa-subscale (above the 80th percentile). these patterns were similar for both men and women, and there were no significant sex interactions for any of the analysis. figure 5 odd-ratios of being a top athlete associated with deciles of the positive affect subscale of panas stratified by sex 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 etelhtapotetelhtapot nemnemow o d d sra ti o outcome: positive affect deciles: do you consider yourself to be a top athlete? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th note. reference group: those not indicating that they are a top athlete. error bars represent 95% confidence intervals. is this graded association true in both lean and overweight/ obese participants? as shown in figure 6, across healthy weight and obese/overweight categories, the associ‐ ation persists and is seen to be nearly identical across the two bmi groups at different levels of exercise. pressman, petrie, & sivertsen 11 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ figure 6 the association between exercise frequency and decile of panas positive affect for normal and overweight/ obese participants 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 almost every day 2-3 x/wk 1 x/wk < 1 x/wk almost every day 2-3 x/wk 1 x/wk < 1 x/wk overweight/obesenormal weight o d d sra ti o outcome: positive affect deciles: normal weight versus overweight/obese: exercise frequency 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th what happens when the word active is separated from the panas? removing the adjective “active” from the panas cut the association between pa and ex‐ ercise frequency a great deal. as shown in figure 7, when considering exercise frequency, while the graded association remained robust and in the same pattern, some associations dropped by 50%. for example, the odds for daily exercisers of being in the highest pa decile went from approximately 18x to 9x (figure 7, panel 1). the degree of change in odds was less severe at lower levels of exercise. while not as dramatic a change, but in the same direction, the odds of being in the top decile for those who push themselves the hardest during exercise dropped from a 4.8 to a 3.8 (figure 7, panel 2). on the flip side this pattern was present in other activity outcomes, although not to the same degree. for example, in the duration of exercise outcome, there was no observable change from removing “active” from the 15-29 minute of exercise at a time subset (figure 7, panel 3). positive affect and physical exercise 12 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ figure 7 panel 1 0 2 4 6 8 10 12 14 16 18 20 22 24 26 almost every day 2-3 x/wk 1 x/wk < 1 x/wk (ref) almost every day 2-3 x/wk 1 x/wk < 1 x/wk (ref) )evitcatuohtiw(ap)evitcahtiw(ap o dd sra ti o outcome: positive affect deciles how frequently do you exercise? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th figure 7 panel 2 0 1 2 3 4 5 6 i push myself to near-exhaustion i push myself so hard that i lose my breath and break into a sweat i push myself to near-exhaustion i push myself so hard that i lose my breath and break into a sweat )evitcatuohtiw(ap)evitcahtiw(ap o dd sra ti o outcome: positive affect deciles: how hard do you push yourself? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th pressman, petrie, & sivertsen 13 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ figure 7 panel 3 0 1 2 3 4 5 6 7 8 9 10 11 more than 1 hour 30 minutes to 1 hour 15–29 minutes more than 1 hour 30 minutes to 1 hour 15–29 minutes )evitcatuohtiw(ap)evitcahtiw(ap o d ds -r at io outcome: positive affect deciles: how long does each session last? 1st (ref) 2nd 3rd 4th 5th 6th 7th 8th 9th 10th note. (panels 1, 2, 3). odd-ratios of frequency, intensity and duration of physical exercise (versus lowest categories displayed in figure 2, figure 3, and figure 4) associated with deciles of the positive affect (pa) subscale of panas organized by full scale (left) and the panas minus the word “active” (right). error bars represent 95% confidence intervals. d i s c u s s i o n overall, this study replicates past findings indicating a strong association between pa and exercise in a large general population study of over 50,000 norwegian young adults, but it also adds a great deal of new information. first, we show for the first time a surprisingly clear and strong dose-response relationship between pa and physical exercise across all three self-reported assessments (i.e., duration, frequency, intensity). the magnitude and slope of the dose-response relationships were particularly driven by those participants who exercise regularly. for example, those training every day had a more than 20-fold increased odds of being in the top 10% of pa scores (versus those not exercising regularly), albeit with large confidence intervals. similarly, when indexing other measures of self-reported exercise, those reporting more than 1 hour per session had between six to eight times increased odds of scoring in the top decile of the pa-sub‐ scale. also, those who considered themselves to be elite athletes were overrepresented in the top 80th percentile of pa with approximately five to six times the odds of being in positive affect and physical exercise 14 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ these top groups versus non elite athletes. importantly, these effects were seen across all levels of body mass index indicating that this is not simply about physical fitness, but perhaps more about actual activity. relevant to this interpretation, removing the word active from the panas made a large difference in the size of the pa association with exercise, in some cases, cutting the linkage size by 50% in the highest and most consistent exercisers, but having less of a dramatic effect in the less active individuals. all together, these results indicate that high pa, as assessed by the panas, is in fact picking up on activity to a large extent, especially when assessing regular exercisers. that is, the majority of the most positive people are regular exercisers, and in some cases, elite athletes. the robust effect of removing the activity item from the panas highlights further this issue, that is, that the highest people in pa are the most active people, partially because, the panas measures activity. people who say they are feeling active, are by in large actually more active. clearly qualitative work is needed to explore what people are evaluating in their lives and emotions when they answer these panas pa items, as well as work tying objective fitness (e.g., as measured by v02max) to panas active and other pa items. we must also ask the more critical question of how these results impacts our interpre‐ tation of the literature connecting pa to better health? the findings clearly cast some doubt on health studies utilizing the panas pa or similarly active measures of pa (e.g., vigor), especially among results that don’t account for the effects of physical activity in some way. that said, even if they did, given the typically limited fitness measures used in some studies, more work is probably needed to ensure that it is not simply the most physically fit, active, and healthy people driving these findings or some other related third variable (e.g., cardiovascular health, mitochondrial function) (fuchs, 2015; picard, 2011; stevens, 2009). the study also raises questions about whether pa intervention studies in ill populations are in fact increasing the correct factors for health promotion since much of this work is based on past found associations between active pa and health. the current study points to the possibility that exercise may be a more important or sufficient target in some populations (a popular intervention in some diseased or high risk populations) (ornish et al., 1998; ryan, cassidy, noorduyn, & o’connell, 2017; theou et al., 2011; e.g., van der wardt et al., 2020) as opposed to focusing on emotion in interventions. in future research exploring the relationship between pa and health we recommend researchers consider taking extra effort to separate the effects of pa from physical activ‐ ity when exploring health outcomes. this might be done by utilizing objective fitness indicators such as vo2max, accelerometers, extensive exercise and activity self-reports, in addition to covarying perceived health which is likely to relate strongly to fitness. it is only with these deeper and more objective approaches that we will begin to understand when feelings of positivity are promoting health versus activity levels (i.e., healthiness) promoting health. pressman, petrie, & sivertsen 15 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ this study has both strengths and weaknesses. while it is well powered and has an array of physical exercise assessments, it is limited by its cross-sectional design and reliance on self-report. generalization is also limited to young, healthy, and primarily caucasian samples. given the high self-reported exercise levels of this sample, it would be interesting to also contrast these levels against objective activity assessments as well as to look at less active and older samples. in addition, the use of a state (current) affect scale was weaker than that of a trait (long lasting) affect scale, although the two are known to be highly correlated (diener & emmons, 1984). it should also be noted that some of the 95% confidence intervals were quite large, especially for the top deciles of the pa scale. this should be kept in mind when interpreting the results. finally, we could have opted to remove other active/high arousal affect items, such as the word “strong”, from the panas to examine the resulting change in association with exercise. we chose “active” due to its more regular use in affect and health assessments as well as due to past results revealing that it was clearly the most tied to health (specifically, all-cause mortality with a hazard ratio of ~1.9). the association of the word “strong”, for example, was comparable to many other pa items (hr ~ 1.4 which was similar to panas adjectives like interested and attentive) (petrie et al., 2018). overall, this study shows strongly that exercise and positive emotions are closely intertwined, especially for the healthiest and most fit individuals. future work should examine how the same effects are found with objective measures of activity and fitness, and should also further examine the implications for physical health outcomes. that is, when examining pa and health connections, to what extent do these change if we focus on pa measures that do not tap energy, felt vigor, and activity? what happens when we take great efforts to account for activity and fitness? from this data, we might infer that this would not have major implications for sedentary samples, however, for samples that include active individuals, effects may change drastically. it is essential that those of us interested in pa and health start measuring exercise well and that we take the possible different interpretations of high activity/arousal pa effects into account. the extent that we discover that activity levels underlie a large amount of previously observed pa health benefits, it may be the case that activity interventions (with or without pa) may be a more fruitful approach to improving health. positive affect and physical exercise 16 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ funding: shot2018 has received funding from the norwegian ministry of education and research (2017), and the norwegian ministry of health and care services (2016). competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors wish to thank all students participating in the study, as well as the three largest student welfare associations in norway (sio, sammen and sit) who initiated and designed the shot study. author note: twitter handles for authors: @sarahpressman @keithpetrie @borgesivertsen r e f e r e n c e s arent, s. m., landers, d. m., & etnier, j. l. 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(2020). being happy and becoming happier as independent predictors of physical health and mortality. psychosomatic medicine, 82(7), 650-657. https://doi.org/10.1097/psy.0000000000000832 positive affect and physical exercise 20 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://doi.org/10.1002/14651858.cd011660.pub2 https://doi.org/10.1080/1612197x.2017.1295557 https://doi.org/10.1111/j.1464-0597.2008.00351.x https://doi.org/10.1136/bmjopen-2018-025200 https://doi.org/10.1073/pnas.1110892108 https://doi.org/10.2471/blt.09.070565 https://doi.org/10.1007/s00702-008-0092-x https://doi.org/10.4061/2011/569194 https://doi.org/10.1080/13607863.2019.1590308 https://doi.org/10.1037/0022-3514.54.6.1063 https://doi.org/10.1097/psy.0000000000000832 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. pressman, petrie, & sivertsen 21 clinical psychology in europe 2020, vol.2(4), article e3103 https://doi.org/10.32872/cpe.v2i4.3103 https://www.psychopen.eu/ positive affect and physical exercise (introduction) method participants measures statistical analyses results descriptive statistics is positive affect associated with physical exercise? what is the relationship between exercise and positive affect in top athletes? is this graded association true in both lean and overweight/obese participants? what happens when the word active is separated from the panas? discussion (additional information) funding competing interests acknowledgments author note references repetitive negative thinking and interpretation bias in pregnancy research articles repetitive negative thinking and interpretation bias in pregnancy colette r. hirsch a § , frances meeten b §, calum gordon a, jill m. newby cd, debra bick e, michelle l. moulds c [a] institute of psychiatry, psychology and neuroscience, king’s college london, london, united kingdom. [b] school of psychology, university of sussex, sussex, united kingdom. [c] school of psychology, university of new south wales, sydney, australia. [d] black dog institute, hospital road randwick, new south wales, sydney, australia. [e] warwick clinical trials unit, university of warwick, coventry, united kingdom. §these authors contributed equally to this work. clinical psychology in europe, 2020, vol. 2(4), article e3615, https://doi.org/10.32872/cpe.v2i4.3615 received: 2020-04-26 • accepted: 2020-11-01 • published (vor): 2020-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: colette r. hirsch, department of psychology, institute of psychiatry, psychology and neuroscience, king’s college london, de crespigny park, london se5 8af, uk. phone: +44 207 848 0697. e-mail: colette.hirsch@kcl.ac.uk supplementary materials: materials [see index of supplementary materials] abstract background: repetitive negative thinking (rnt; e.g., worry about the future, rumination about the past) and the tendency to interpret ambiguous information in negative ways (interpretation bias) are cognitive processes that play a maintaining role in anxiety and depression, and recent evidence has demonstrated that interpretation bias maintains rnt. in the context of perinatal mental health, rnt has received minimal research attention (despite the fact that it predicts later anxiety and depression), and interpretation bias remains unstudied (despite evidence that it maintains depression and anxiety which are common in this period). method: we investigated the relationship between rnt, interpretation bias and psychopathology (depression, anxiety) in a pregnant sample (n = 133). we also recruited an age-matched sample of non-pregnant women (n = 104), to examine whether interpretation bias associated with rnt emerges for ambiguous stimuli regardless of its current personal relevance (i.e., pregnancy or nonpregnancy-related). results: as predicted, for pregnant women, negative interpretation bias, rnt, depression and anxiety were all positively associated. interpretation bias was evident to the same degree for material that was salient (pregnancy-related) and non-salient (general), and pregnant and nonpregnant women did not differ. rnt was associated with interpretation bias for all stimuli and across the full sample. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.3615&domain=pdf&date_stamp=2020-12-23 https://orcid.org/0000-0003-3579-2418 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: our findings highlight the need to further investigate the impact of interpretation bias in pregnant women, and test the effectiveness of interventions which promote positive interpretations in reducing rnt in the perinatal period. keywords perinatal mental health, repetitive thinking, worry, interpretation bias, pregnancy highlights • a tendency to make negative interpretations was investigated in pregnant women for the first time. • negative interpretation bias was associated with repetitive negative thinking. • interpretation bias extended to pregnancy related information for pregnant and non-pregnant women. • reducing negative interpretation bias in pregnant women could be useful. repetitive negative thinking (rnt) plays a role in the onset and maintenance of depres‐ sion (nolen-hoeksema et al., 2008), and is transdiagnostic such that it is evident in a range of disorders, including anxiety (ehring & watkins, 2008). rnt refers to thinking that is negative, perseverative and difficult to control, whether about the past (rumina‐ tion) or future (worry) (samtani & moulds, 2017). perinatal depression and anxiety are common. one in four pregnant women report mental health problems (howard et al., 2018), the most common being anxiety and depression, and they commonly persist into early motherhood. given the role of rnt in predicting and maintaining both anxiety and depression, it is surprising that rnt in the perinatal period has only recently received research attention (e.g., dejong et al., 2016; moulds et al., 2018; newby et al., 2019). consistent with the broader rnt literature, there is growing evidence that antenatal rnt predicts perinatal mental health problems. schmidt et al. (2016) reported that rnt in the first trimester predicted depression and anxiety in the third trimester (schmidt et al., 2016), and that rnt interacts with other factors (e.g., level of social functioning; o’mahen et al., 2010; perfectionism; egan et al., 2017) to predict postnatal depression. in another longitudinal study, rnt in late pregnancy (i.e., third trimester) predicted change in depression symptoms from the third trimester to 8 weeks postpartum, an association that was not moderated by initial levels of depression (barnum et al., 2013). building on correlational findings, there is experimental evidence that rnt maintains postnatal difficulties. in a sample of new mothers, rnt impaired problem-solving ability and reduced confidence in problem-solving capacity (o’mahen et al., 2015). similarly, in women with postpartum gad, rnt reduced responsivity to infants – suggesting a key role for rnt in mother-infant bonding (stein et al., 2012). taken together, these findings highlight that rnt plays a key detrimental role in the perinatal context. repetitive negative thinking and interpretation bias in pregnancy 2 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ interpretation bias – the tendency to draw negative conclusions from ambiguous information is a transdiagnostic cognitive process evident across emotional disorders (hirsch et al., 2016). interpretation bias often focuses on an individual’s core clinical concern. for example, individuals with panic disorder (stopa & clark, 2000) and social anxiety disorder (amin et al., 1998) demonstrated a more negative interpretation bias for ambiguously threatening information which was central to their clinical problem (i.e., panic and socially-related material, respectively) relative to both individuals with other forms of anxiety, and non-clinical control participants. this content specificity is also evident in children who experience higher levels of anxiety specific to particular fears (e.g. social anxiety, separation anxiety, fear of spiders; mobach et al., 2019). relatedly, everaert et al. (2017) hypothesized that the personal relevance of material may be key to observing interpretation bias, such that the material has to relevant the person them‐ selves in order to be processed in a biased manner. interpretation bias is associated with different forms of rnt (krahé et al., 2019) across the population, and individuals with gad and depression demonstrate particular‐ ly high levels of this bias. there is evidence that targeting (i.e., reducing) a negative interpretation bias has the downstream effect of reducing rnt. for example, training individuals with gad to interpret ambiguous information as benign (rather than nega‐ tive) reduced worry frequency (hayes et al., 2010). in addition, there is evidence that training in generating positive interpretations leads to reduced rnt and anxiety in individuals with high levels of rnt (hirsch, krahé, whyte, bridge, et al., 2020), as well as those with clinical anxiety and/or depression (hirsch et al., 2018; hirsch, krahé, whyte, krzyzanowski, et al., 2020). moreover, improvements in worry, rumination, anxiety and depression are mediated by decreases in interpretation bias, consistent with it being the mechanism of change (hirsch, krahé, whyte, krzyzanowski, et al., 2020). to date, no research has investigated interpretation bias in the perinatal context. it is therefore unknown whether women in the perinatal period have a tendency to draw negative conclusions when presented with ambiguity and if such a bias does exist whether it is associated with levels of depression and anxiety, as well as rnt. further, if such a bias is indeed present, it will be both theoretically and clinically informative to establish whether this mechanism also applies to pregnancy-related ambiguous stimuli (e.g., the outcome of a foetal scan) which would be particularly salient and personally relevant for pregnant but not non-pregnant women. this speaks to a wider conceptual question regarding the nature of interpretation bias underlying rnt: is it a general mechanism that applies to any ambiguity, whether or not it is personally relevant and salient? in order to answer this question, we recruited a sample of matched non-pregnant women and examined whether this general bias also operates for ambiguous material that is not likely to be personally relevant (i.e., is pregnancy-related). that is, if interpre‐ tation bias that is associated with rnt is reduced by lack of current personal relevance, pregnancy-related material would elicit a weaker bias in non-pregnant women with high hirsch, meeten, gordon et al. 3 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ levels of rnt compared to pregnant women with high levels of rnt. alternatively, if such an interpretation bias operates on ambiguously threatening material irrespective of current personal relevance, we would predict an association between rnt and this bias regardless of pregnancy status or personal relevance of the material (i.e., pregnancy-rela‐ ted versus general ambiguity). in sum, extant findings confirm that interpretation bias and rnt are interrelated, and there is emerging evidence that rnt is a key cognitive process in the context of perinatal mental health. however, it remains unknown whether negative interpretation bias is associated with depression and anxiety in the perinatal period. furthermore, the possibility that rnt is correlated with interpretation bias in this period has not been examined to date. accordingly, our first goal was to investigate associations between interpretation bias, rnt (as a trait tendency, as well as specific types of rnt including depressive rumination and worry), as well as symptoms of psychopathology (anxiety, depression) in a community sample of pregnant women. we hypothesised significant positive relationships between rnt, interpretation bias, depression and anxiety symp‐ toms. second, we were interested in whether interpretation bias associated with rnt emerges for ambiguous stimuli regardless of its current personal relevance. we recruited a sample of age-matched women who were not pregnant, and thus for whom pregnan‐ cy-related materials were not likely to be personally relevant. we then examined the association between levels of rnt and interpretation bias for pregnancy-related and general (non-pregnancy-related) materials in samples of both pregnant and non-pregnant women. this enabled us to establish whether interpretation bias underlying rnt oper‐ ates on all ambiguously threatening material, irrespective of personal relevance. m e t h o d participants we recruited 140 pregnant and 107 non-pregnant female participants who were 25-40 years of age, fluent in english and based in the uk. pregnant participants were eligible to take part if they were at least 16 weeks gestation, and had not previously experienced a stillbirth. non-pregnant participants were eligible if they were not currently trying to fall pregnant, and had not experienced a stillbirth in the past. participants were recruited through social media, online message boards, and the king’s college london research circular. the final sample was comprised of 133 pregnant and 104 non-pregnant women1. see table 1 for participant demographics. 1) nine participants were removed from analysis with a score on the recognition test comprehension questions 2.5 standard deviations below the group mean. an additional participant was removed from analysis for having repetitive negative thinking and interpretation bias in pregnancy 4 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ table 1 demographic characteristics baseline characteristic pregnant sample (n = 133) non-pregnant sample (n = 104) statistical test and significance value m sd m sd t (235) = 5.04, p < .001 age 32.64 3.68 30.12 4.0 nationality % n % n % χ2 (2) = 15.94, p < .001 british 123 92.5 77 74.0 other european 4 3.0 16 15.4 world 6 4.5 11 10.6 highest level of education n % n % χ2 (4) = 4.61, p = .33 secondary 26 19.5 13 12.5 bachelor 52 39.1 37 35.6 master 33 24.8 37 35.6 doctoral 7 5.3 7 6.7 other 15 11.3 10 9.6 marital status n % n % single, never married 2 1.5 24 23.1 χ2 (3) = 56.63, p < .001 in a relationship 30 22.6 46 44.2 married /domestic partnership 100 75.2 31 29.8 separated, divorced, widowed 1 0.8 3 2.9 number of children n % n % χ2 (3) = 24.63, p < .001 none 46 34.6 66 63.5 one 65 48.9 19 18.3 two 16 12.0 14 13.5 three or more 6 4.5 5 4.8 english as a native language 123 92.5 84 80.8 χ2 (1) = 7.24, p = .007 materials and measures demographic questions participants completed a number of demographic questions regarding age, nationality, level of education, relationship status, number of children and english fluency. partici‐ pants were also asked whether they were currently pregnant, and if they responded yes, asked to indicate number of weeks gestation, and whether they had previously experienced a stillbirth. interpretation measures scrambled sentences test (sst) — this task was employed by hirsch et al. (2018) and hirsch, krahé, whyte, bridge, et al. (2020), adapted from wenzlaff and bates (1998, no grammatically correct sentences in the scrambled sentences test. seven pregnant and three non-pregnant partici‐ pants were removed from analysis. hirsch, meeten, gordon et al. 5 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ 2000). participants unscramble six words presented in a random order into a grammati‐ cally correct sentence of either positive or negative valence. participants were given 20 sentences, equally divided between worry themes and depressive rumination themes, and asked to unscramble as many as possible in five minutes whilst holding a six-digit number in mind (which increased cognitive load; see wenzlaff & bates, 1998, 2000)2. an index of interpretation bias was created by dividing the number of grammatically correct positively unscrambled sentences by the total number of grammatically correct unscrambled sentences. index scores range from 0 to 1, higher scores denote a more positive interpretation bias. the sst had good internal consistency α = .86, which is comparable to that reported in a recent validation paper where two sst lists of worry and depression items were examined with α = .77 and α = .92 respectively (krahé et al. 2020). recognition test (rt) — this test was based on that used by mathews and mackintosh (2000). materials included items related to two themes – pregnancy related and general (non-pregnancy) related. general materials were drawn from worry and rumination recognition test materials used by hirsch, krahé, whyte, & bridge, et al. (2020), while the pregnancy materials were developed for the current study from interviews with four pregnant women3. the rt has two phases: in the first, participants read 21 ambiguous scenarios and answered a comprehension question after each scenario. in the second section, after all scenarios had been read, participants were presented with the title of each scenario, followed by four statements presented in a random order. participants rated how similar each statement was to the scenario they read on a 4-item likert scale from 1 (very different in meaning) to 4 (very similar in meaning). two of these statements resolved the previously read ambiguous scenario in either a positive or negative way, consistent with the story (targets). the remaining two statements were positively and negatively valenced, but were not realistic interpretations of the story (foils; included as filler items). twenty-one scenarios were equally split between worry and rumination themes, and themes relating to pregnancy. worry and rumination items were a subset of those used by hirsch, krahé, whyte, bridge, et al. (2020). an interpretation bias index was created for each participant by subtracting mean ratings for negative targets from mean ratings for positive targets, with a higher score denoting a more positive interpretation bias. pregnancy interpretation bias index (7 items), general interpretation bias index (14 items) and total interpretation bias index (including both pregnancy and general items) were computed. split half reliability was high, spearman-brown coefficient for negative targets and positive targets respectively was .83 and .85. 2) see appendix a in the supplementary materials for sample items. 3) see appendix b in the supplementary materials for sample items. repetitive negative thinking and interpretation bias in pregnancy 6 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ questionnaire measures repetitive thinking questionnaire (rtq-t [trait]) — the 10-item rtq-t (trait) (mcevoy, thibodeau, & asmundson, 2014) measures trait repetitive negative thinking. participants rate the extent to which each item (e.g., ‘i have thoughts or images about all my shortcomings, failings, faults, mistakes’) is true for them when they are distressed or upset. the rtq possesses good internal consistency, convergent and divergent validity (mahoney, mcevoy, & moulds, 2012). present sample cronbach’s α = .92. penn state worry questionnaire (pswq) — the 16-item pswq (meyer, miller, metzger, & borkovec, 1990) measures worry (example item: ‘my worries overwhelm me’). participants rate the extent to which each item is typical of their experience. the pswq has good test-retest reliability (meyer et al., 1990) and good convergent and discriminant validity (brown, antony, & barlow, 1992). present sample cronbach’s α = .83. ruminative response scale (rrs) — depressive rumination was assessed using the 22-item measure rrs (nolen-hoeksema & morrow, 1991). participants rate the extent to which they engage in a range of responses when they feel sad, down or depressed (e.g., ‘think about how alone you feel’). the rrs has good internal consistency (treynor, gonzalez, & nolen-hoeksema, 2003) and test-retest reliability (just & alloy, 1997). present sample cronbach’s α = .94. generalized anxiety disorder 7-item scale (gad-7) — the 7-item gad-7 (spitzer et al., 2006) questionnaire measures anxiety symptoms over the past 2 weeks (example item: ‘feeling nervous, anxious, or on edge?). the gad-7 is a reliable and valid measure of anxiety in the general population (löwe et al., 2008). present sample cronbach’s α = .92. patient health questionnaire 9 — the 9-item phq-9 (kroenke & spitzer, 2002) meas‐ ures depression symptoms in the previous 2 weeks. the phq-9 is a reliable and valid measure of depression severity (kroenke, spitzer, & williams, 2001). present sample cronbach’s α = .88. perinatal anxiety screening scale — pregnant participants completed the 31-item pass (somerville et al., 2014), which measures anxiety in antenatal and postpartum women. participants indicate how often they experience each item (e.g., ‘fear that harm will come to the baby’) in the past month. the pass has good reliability and validity (somerville et al., 2014). present sample cronbach’s α = .95. edinburgh postnatal depression scale (epds) — the 10-item epds (cox, holden, & sagovsky, 1987) was used to assess depression symptoms in pregnant participants. it possesses a high level of test-retest reliability (kernot, olds, lewis, & maher, 2015), hirsch, meeten, gordon et al. 7 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ and good validity (gibson, mckenzie-mcharg, shakespeare, price, & gray, 2009). present sample cronbach’s α = .89. procedure the survey was hosted on the qualtrics platform. participants were asked to complete the survey in one sitting, at a time they could be free from distractions. both groups of participants completed the same core survey (questionnaires, sst, rt), pregnant participants completed two additional pregnancy-specific questionnaires (pass, epds). the survey took 35-40 minutes to complete. upon completion participants received a £5 amazon voucher. the study was approved by the king’s college london research ethics committee (approval number: hr-17/18-5735). participants provided consent elec‐ tronically. r e s u l t s mean questionnaire scores by group are presented in table 2. table 2 descriptive statistics for questionnaires and bias measures by group measures pregnant group (n = 133) non-pregnant group (n = 104) t-test and significance valuem sd m sd questionnaire rtq 29.78 9.53 30.14 9.44 t (235) = 0.29, p = .77 gad7 7.04 5.32 6.84 6.22 t (202.894)a = 0.26, p = .79 phq9 8.09 5.66 7.56 6.41 t (206.795)a = 0.67, p = .51 pswq 52.16 14.02 53.57 14.90 t (235) = 0.75, p = .46 rrs 45.61 13.24 51.53 14.60 t (235) = 3.27, p = .001 pass 30.23 18.25 – – epds 9.26 5.77 – – interpretation bias measures rt pregnancy items 0.42 0.78 0.36 0.77 t (235) = 0.57, p = .57 rt general items 0.68 0.66 0.60 .73 t (235) = 0.85, p = .39 rt all items 0.59 0.65 0.52 0.68 t (235) = 0.82, p = .42 sst 0.72 0.20 0.69 0.23 t (235) = 1.17, p = .24 note. pswq = penn state worry questionnaire; rrs = ruminative response scale; rtq = repetitive thinking questionnaire; gad7 = generalised anxiety disorder questionnaire; phq9 = patient health questionnaire; pass = perinatal anxiety screening scale; epds = edinburgh postnatal depression scale; rt = recognition test; sst = scrambled sentences test. aequal variances not assumed. repetitive negative thinking and interpretation bias in pregnancy 8 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ mean scores on questionnaire measures (rtq, gad7, phq9, pswq) did not differ be‐ tween groups (ps > .05), except on the rrs, where the non-pregnant group reported significantly higher levels of rumination, t(235) = 3.27, p = .001, r = .21. is there an association between interpretation bias and repetitive negative thinking, and anxiety and depression in a sample of pregnant women? to examine whether levels of rnt, worry and rumination were associated with a more negative interpretation bias in pregnant women, we examined correlations between the rnt measures and the behavioural measures of interpretation bias (sst, rt pregnancy items, rt general items, and all rt items collapsed)4 (see table 3 for correlations by group). trait repetitive thinking (measured by the rtq) was significantly negatively correlated with sst index (r = -.61, p < .001). anxiety (measured by the gad7; r = -.63, p < .001), worry (measured by the pswq; r = -.67, p < .001), depression (measured by the phq9; r = -.62, p < .001), and depressive rumination (measured by the rrs; r = -.72, p < .001) were also significantly negatively correlated with the sst. table 3 correlations between rnt and interpretation bias measures (rt, sst) in pregnant and non-pregnant participants questionnaires rt index sst indexpregnancy items worry items all items pregnant group rtq -.24** -.25** -.27** -.61** gad7 -.14 -.24** -.22* -.63** phq9 -.24** -.29** -.30** -.62** pswq -.16 -.24** -.23** -.67** rrs -.09 -.21* -.18* -.72** non-pregnant group rtq -.18 -.22* -.22* -.56** gad7 -.12 -.12 -.13 -.61** phq9 -.15 -.18 -.18 -.68** pswq -.23* -.24* -.26** -.64** rrs -.25* -.21* -.24* -.66** note. rtq = repetitive thinking questionnaire; gad7 = generalised anxiety disorder questionnaire; phq9 = patient health questionnaire; pswq = penn state worry questionnaire; rrs = ruminative response scale; rt = recognition test; sst = scrambled sentences test. *p < .05. **p < .01. 4) in the pregnant sample, the two interpretation bias measures, the rt (all items) and the sst were significantly correlated (r = .33, p < .001). hirsch, meeten, gordon et al. 9 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ for the recognition test (rt), trait repetitive thinking (rtq) was significantly negatively correlated with rt index (all items) (r = -.27, p = .002). anxiety (r = -.22, p = .01) and worry (r = -.23, p = .008), depression (r = -.30, p = .001), and depressive rumination (r = -.18, p = .04) were also significantly negatively correlated with rt. to investigate bias specificity, we calculated the rt index for general and pregnancy-related items separate‐ ly and examined correlations between both of these indices and self-report measures. the rt index for general items was significantly negatively correlated with rnt (r = -.25, p = .003), anxiety (r = -.24, p = .005), worry (r = -.24, p = .005), depression (r = -.29, p = .001), and depressive rumination (r = .21, p = .02). for the rt index comprised of pregnancy items, there was a significant negative correlation between rnt (r = -.24, p = .006) and depression (r = -.24, p = .006). no other associations were significant. does interpretation bias associated with rnt emerge for ambiguous stimuli regardless of its current personal relevance? to examine whether interpretation bias associated with rnt emerges for ambiguous stimuli regardless of its current personal relevance, we examined interpretation bias for pregnancy-related and general stimuli in samples of pregnant and non-pregnant women. we conducted a 2 group (pregnant vs. non-pregnant) x 2 rt material type (pregnancy-related vs. general) mixed model ancova with repeated measures on the second factor and interpretation bias as the dependent variable. to examine whether trait rnt was associated with interpretative bias irrespective of group, rtq-trait scores were included as a covariate. there was no significant main effect of group, f(1, 234) = 0.52, p = .47, ηp2 = .002. there was no significant main effect of material type, f(1, 234) = 3.60, p = .06, ηp2 = 0.02, however this effect approached significance, but with a small effect size. examination of the means suggested that regardless of group (pregnant vs. non-pregnant), when rtq was included in the model as a covariate, the rt positivity index was higher for general items (m = 0.64, se = 0.04) than for pregnancy-related items (m = 0.40, se = 0.05). there was no interaction of group and material type, f(1, 234) = 0.06, p = .81, ηp2 < .001. trait repetitive negative thinking (rtq) was a significant covariate, indicating that trait rnt had a significant relationship with positivity index ratings (as measured by the rt) regardless of group or material type, f(1, 234) = 14.92, p < .001, ηp2 = .065. 5) we re-ran the ancova with rrs ratings included in the model as a covariate alongside rnt. the effects remain as described above and the rrs was not a significant covariate in the model (p = .36). however, we interpret this result with caution given significant group differences on rrs scores between the two groups at baseline (field, 2009). repetitive negative thinking and interpretation bias in pregnancy 10 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ d i s c u s s i o n we sought to establish whether there are associations between negative interpretation bias, rnt and symptoms of depression and anxiety in the perinatal period. furthermore, if an interpretation bias is present, we sought to examine whether pregnant and nonpregnant women exhibit similar levels of interpretation bias for both general (likely to be personally salient for both groups) and pregnancy-related (likely to be only salient for pregnant but not pregnant women) ambiguous stimuli. clarifying this would speak to the question of whether interpretation bias is lower for non-personally relevant information. in pregnant women, we found negative associations between two behavioural measures of interpretation bias, rnt, and psychopathology symptoms; that is, the more negative one’s interpretation bias, the higher their levels of rnt and symptoms of depression and anxiety. regarding personal relevance, pregnant and non-pregnant women did not differ in their negative interpretation bias, irrespective of material type (pregnancy-related or general). rather, trait rnt predicted interpretation bias regardless of pregnancy status or personal relevance of material focus. it is noteworthy that mean scores on the self-report measures were relatively high in the current sample. importantly, however, (with the exception of the rrs), the pregnant and non-pregnant groups were nonetheless matched. thus, whilst our findings emerged in the context of high levels of psychopathology and rnt for a community sample, the fact that our groups were comparable nonetheless renders our between-group com‐ parisons meaningful. that said, we acknowledge that the pregnant participants reported significantly lower levels of depressive rumination relative to their non-pregnant coun‐ terparts. our findings are theoretically informative, demonstrating that a bias to negatively interpret ambiguous stimuli also extends to women in the perinatal period, and that this bias is associated with psychological symptoms and rnt. moreover, the bias is not influenced by personal relevance such that it was elicited by both pregnancy-related and general non-pregnancy-related material for women irrespective of pregnancy status. this suggests that the tendency to generate negative interpretations for those with higher levels of rnt may be applied to whatever ambiguity an individual encounters; the negative interpretation then has the potential to trigger further negative thoughts which may encompass other ambiguity and as such trigger new bouts of rnt which can then be perpetuated via further negative interpretations (hirsch & mathews, 2012; hirsch et al., 2016). furthermore, if these findings are replicated in those suffering from generalised anxiety disorder, it may help explain how these individuals end up worrying about so many new topics as soon as they encounter them, given that negative interpretations will trigger and maintain worry about a wide range of topics. these results also have implications for the prevention of perinatal depression and/or anxiety, and suggest the potential clinical utility of offering interventions which effec‐ tively reduce cognitive biases, including cognitive behavioural therapy (cbt) and antide‐ hirsch, meeten, gordon et al. 11 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ pressant medication. in addition, the findings suggest the potential utility of offering cbm-i targeting interpretation bias to vulnerable pregnant women (i.e., those with a history of psychopathology) in order to reduce rnt and associated psychological symp‐ toms in the antenatal period. given the generalised (i.e., rather than pregnancy-specific) nature of interpretation bias observed in our sample, such preventive interventions could utilise cbm-i materials employed in our previous work (e.g., hirsch et al., 2018; hirsch, krahé, whyte, bridge, et al., 2020) to train pregnant women to generate positive interpre‐ tations, without the need for adaptation. however, if multi-session cbm-i training is undertaken, ensuring personal relevance of materials is likely to increase engagement and prevent attrition. in addition to potentially reducing rnt and psychological distress, given evidence that rnt predicts postnatal depression (e.g., egan et al., 2017; o’mahen et al., 2010) and predicts increases in depression from the last trimester of pregnancy to 28 weeks postpartum (barnum et al., 2013), a further possibility that awaits testing in future research is that reducing antenatal rnt may prove effective in reducing the likelihood of suffering from postnatal depression and anxiety. the study has some limitations. first, we cannot rule out the possibility that some participants in the non-pregnant group were trying to conceive, had recently miscarried, or were unknowingly pregnant at the time of participation. whilst possible, given our large sample, we reason that the number of such participants is likely to be a very small proportion of the sample, and as such, do not expect that they would influence our findings. second, framing the pregnancy-related scenarios in the first-person (common practice in the interpretation literature) may have inadvertently resulted in them being processed as personally relevant/salient by non-pregnant participants, despite the lack of relevance of the content (i.e., pregnancy) to their real day-to-day lives. future studies which include self-relevant, non-self-relevant (presented in the first person) and nonself-relevant (referring to other) scenarios are needed to clarify this issue (see wisco & nolen-hoeksema, 2010, for this distinction). third, although our pregnant and non-preg‐ nant samples were matched on levels of trait rnt and worry, groups differed on levels of self-reported rumination. furthermore, mean levels of worry were higher than those reported in the general population, with a community sample of adults scoring 42.67 on the pswq (startup & erickson, 2006), compared to 52.78 in the current sample. thus, we acknowledge that our sample may not be representative of the general population. critically, however, this difference does not prevent us from answering our key research question. fourth, whilst we checked that non-pregnant participants were not currently trying to fall pregnant, it is possible that for some of them, pregnancy may have in fact been personally relevant (e.g., if a close family member was pregnant). however, if this were the case it is likely that it only applied to a sub-group of the non-pregnant sample, and as such is unlikely to account for the current findings. in any case, such limitations are balanced by notable strengths; for example, we con‐ ducted ppi with pregnant women to ensure that our pregnancy-related materials were repetitive negative thinking and interpretation bias in pregnancy 12 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ relevant to the concerns of pregnant women, and thus maximise the ecological validity of the results. furthermore, our findings are broadly replicated across two measures of interpretation bias, and demonstrate associations with different forms of repetitive negative thinking, as well as anxiety and depressed mood in pregnant women. an interesting direction for future research in this area would be to investigate the possibility that pregnancy – a period characterised by uncertainty and ambiguous information for many women exacerbates interpretation biases which were present prior to falling pregnant. for example, prospectively examining a sample of women of child-bearing age and re-assessing them during pregnancy would establish whether pre-existing biases are amplified during pregnancy, as well as shed light on the extent to which interpretation biases potentially interact with other cognitive processes (e.g., the tendency to attend to threat), as well as with life events more broadly. in sum, this study is the first to investigate the interrelationship of negative interpre‐ tation bias, rnt, depression and anxiety in the perinatal period, and found positive associations between all of these variables. for pregnant women, interpretation bias was evident to the same degree for both material that was likely to be salient (pregnan‐ cy-related) and material that was general, and did not differ from that of non-pregnant women. our finding that trait rnt is associated with interpretation bias for all ambigu‐ ous material, and across the full sample, underscores the need for novel interventions to target negative interpretations and reduce rnt in those at risk of developing clinical disorders characterised by unhelpful rnt. given the wider impact of perinatal mental health problems on children, partners and the unborn child, we consider pregnant wom‐ en a priority for rnt-focused preventive interventions. funding: ch receives salary support from the national institute for health research (nihr), mental health biomedical research centre at south london and maudsley nhs foundation trust and king’s college london. competing interests: the authors have declared that no competing interests exist. acknowledgments: we are very grateful to the pregnant women who helped us develop the pregnancy related materials, as well as those who took part in the study. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • appendix a: example of materials in scrambled sentences test • appendix b: example of a pregnancy specific materials in the recognition test hirsch, meeten, gordon et al. 13 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://www.psychopen.eu/ index of supplementary materials hirsch, c. r., meeten, f., gordon, c., newby, j. m., bick, d., & moulds, m. l. 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(2010). interpretation bias and depressive symptoms: the role of self-relevance. behaviour research and therapy, 48, 1113-1122. https://doi.org/10.1016/j.brat.2010.08.004 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. hirsch, meeten, gordon et al. 17 clinical psychology in europe 2020, vol.2(4), article e3615 https://doi.org/10.32872/cpe.v2i4.3615 https://doi.org/10.1001/archinte.166.10.1092 https://doi.org/10.1037/a0026847 https://doi.org/10.1016/s0005-7967(99)00043-1 https://doi.org/10.1023/a:1023910315561 https://doi.org/10.1037/0022-3514.75.6.1559 https://doi.org/10.1177/0146167200262003 https://doi.org/10.1016/j.brat.2010.08.004 https://www.psychopen.eu/ repetitive negative thinking and interpretation bias in pregnancy (introduction) method participants materials and measures procedure results is there an association between interpretation bias and repetitive negative thinking, and anxiety and depression in a sample of pregnant women? does interpretation bias associated with rnt emerge for ambiguous stimuli regardless of its current personal relevance? discussion (additional information) funding competing interests acknowledgments supplementary materials references long-term stability of benefits of cognitive behavioral therapy for obsessive compulsive disorder depends on symptom remission during treatment research articles long-term stability of benefits of cognitive behavioral therapy for obsessive compulsive disorder depends on symptom remission during treatment björn elsner a, frieder wolfsberger a, jessica srp a, antonia windsheimer a, laura becker a, tanja jacobi a, norbert kathmann a, benedikt reuter a [a] department of psychology, humboldt-universität zu berlin, berlin, germany. clinical psychology in europe, 2020, vol. 2(1), article e2785, https://doi.org/10.32872/cpe.v2i1.2785 received: 2019-09-03 • accepted: 2020-02-04 • published (vor): 2020-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: björn elsner, humboldt-universität zu berlin, rudower chaussee 18, 12489 berlin, germany, tel.: 0049 30 2093-9338. e-mail: bjoern.elsner@hu-berlin.de abstract background: cognitive behavioral therapy (cbt) is an effective treatment for obsessivecompulsive disorder (ocd) and may afford stable long-term improvements. it is not clear, however, how stability or symptom recurrence can be predicted at the time of termination of cbt. method: in a 1-year follow-up intention-to-treat study with 120 ocd patients receiving individual cbt at a university outpatient unit, we investigated the predictive value of international consensus criteria for response only (y-bocs score reduction by at least 35%) and remission status (y-bocs score ≤ 12). secondly, we applied receiver-operating characteristic (roc) curves in order to find an optimal cut-off score to classify for deterioration and for sustained gains. results: response only at post-treatment increased the likelihood of deterioration at follow-up compared to remission at an odds ratio of 8.8. moreover, roc curves indicated that a posttreatment score of ≥ 13 differentiated optimally between patients with and without symptom deterioration at follow-up assessment. the optimal cut-off score to classify for any sustained gains (response, remission, or both) at follow-up relative to baseline was 12. importantly, previous findings of generally high long-term symptom stability after treatment in ocd could be replicated. conclusion: the findings highlight the clinical importance of reaching remission during cbt, and suggest that a recently published expert consensus for defining remission has high utility. keywords obsessive-compulsive disorder, y-bocs, cut-off score, expert consensus, follow-up this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2785&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • a 1-year follow-up study with ocd patients having received a cbt trial was conducted. • achieving a y-bocs score ≤ 12 at termination of treatment decreases the risk of future deterioration. • the study supports a rationale to treat ocd patients until reaching remission status. • the study confirms the criterion for remission in ocd recently published as an expert consensus. cognitive behavioral therapy (cbt) is an effective treatment for obsessive-compulsive disorder (ocd). its efficacy in randomized-controlled trials (rct; olatunji, davis, powers, & smits, 2013; öst, havnen, hansen, & kvale, 2015) and its effectiveness in routine clinical practice (hans & hiller, 2013) have been confirmed in meta-analyses. according to follow-up data, treatment gains are largely maintained after treatment, but in randomized controlled trials, slight increases of average symptom scores from post-treatment to follow-up are observed at group level (olatunji et al., 2013; öst et al., 2015). however, follow-up data from routine care are still rare, especially for individual outpatient therapy (cabedo, carrió, & belloch, 2018; hans & hiller, 2013; hansen, kvale, hagen, havnen, & öst, 2019). the yale-brown obsessive-compulsive scale (y-bocs) interview (goodman et al., 1989a; goodman et al., 1989b) has been established as the "gold standard" to measure ocd symptom severity, and is commonly used as a primary outcome measure (öst et al., 2015). effect sizes based on y-bocs group mean scores are therefore useful for com‐ parisons between studies and interventions, and allow observing within-group changes. however, group mean scores do not reflect individual improvement (hiller, schindler, andor, & rist, 2011; jacobson, follette, & revenstorf, 1984), which is especially important in research on routine clinical practice. in order to address this issue, jacobson and truax (1991) proposed a definition of clinically significant improvement by combining statistically significant changes in individual symptoms (reliable change index, rci) with subclinical symptom levels. this makes it possible to determine individual response (without remission), remission, and deterioration. since clinically significant change de‐ pends on the reliability of the measure and the variance in the relevant population, cut-off scores for remission varied between 7 and 16 across published studies (öst et al., 2015). subsequently, mataix-cols et al. (2016) published an international expert consensus on change assessment in ocd, in which treatment response was defined as a reduction in y-bocs scores by at least 35% and an improvement score of 1 (“very much improved”) or 2 (“much improved”) on the clinical global impression scale (cgi, guy, 1976). for remission, a y-bocs score of < 13 and cgi severity ratings of 1 (“normal, long-term stability of cbt benefits in ocd 2 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ not at all ill”) or 2 (“borderline mentally ill”) must be achieved. these criteria have been adopted in recent research (hansen et al., 2019) and may prove influential for future clinical decisions in ocd treatment. yet, it remains unclear whether these consensus criteria have clinical utility and are able to predict individual long-term stability. prediction of post-treatment response and remission on the basis of pre-treatment y-bocs scores has been investigated by means of signal detection analyses (farris, mclean, van meter, simpson, & foa, 2013). criteria evaluation for predicting outcome at follow-up, however, is missing. prospective studies on depressive disorder and social phobia suggest that incomplete remission at post-treatment predicts relapse at follow-up (judd et al., 1998; paykel et al., 1995; van ameringen et al., 2003). in line with these results, two studies with ocd patients have shown that “partial remission” compared to “full remission” at the end of treatment predicts relapse during follow-up periods of one to five years (braga, cordioli, niederauer, & manfro, 2005; braga, manfro, niederauer, & cordioli, 2010; eisen et al., 2013). one of these studies (eisen et al., 2013), however, did not use y-bocs scores for the evaluation of clinical status. in the other, full remission required a y-bocs score of < 8 (braga et al., 2005; braga et al., 2010), which is much stricter than the consensus y-bocs cut-off score for remission (≤ 12). it is therefore unclear whether the protective effect of “full remission” can also be found when apply‐ ing the less strictly defined remission criterion. prediction of long-term stability is of major importance for clinical practice, because under routine conditions the criterion for terminating individual psychotherapy is often not specified in advance. treatment may be continued until a “good enough level” (gel) is achieved (barkham et al., 2006; falkenström, josefsson, berggren, & holmqvist, 2016), which is often defined subjectively by patient and therapist. clinical decisions, however, should also be informed by empir‐ ical research. in addition to testing the predictive value of categorical variables such as remission or response, it is also worthwhile to determine the exact post-treatment y-bocs scores that separate patients with stable treatment gains from those with loss of gains in the follow-up period, or patients with long-term improvements in relation to pre-treatment levels from those without such improvements. if good prediction is possible on the basis of a single, widely-used and easy-to-apply instrument, the cut-off scores can inform clinical decisions on whether to terminate or to continue cbt. in the present study, we conducted a 1-year follow-up assessment in a relatively large sample of ocd patients, who had received individual cbt under routine conditions of the german health care system. our main goals were: 1.) testing whether patients achieving the consensus y-bocs cut-off score for remission at post-treatment are less likely to experience significant symptom increase at follow-up compared to unremitted responders, 2.) determining a post-treatment y-bocs cut-off score that differentiates optimally between patients who deteriorate from post-treatment to follow-up and those whose initial improvement remains stable, and 3.) determining a post-treatment y-bocs cut-off score that predicts for any sustained gains (response, remission, or both) at elsner, wolfsberger, srp et al. 3 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ follow-up. a secondary aim was to provide further data for evaluations of average and individual symptom changes from preand post-treatment to follow-up in a treatment setting typical for routine care in many countries. m e t h o d participants study participants had terminated individual cognitive behavioral therapy (cbt) at a uni‐ versity outpatient unit (hochschulambulanz für psychotherapie und psychodiagnostik der humboldt-universität zu berlin) between december 2013 and may 2017. referrals to the outpatient unit were made according to routine clinical care procedures. patients who prematurely discontinued cbt (non-completers) were not excluded and the last observation was carried forward to estimate post-treatment scores (interim-assessments were done every 20 sessions). general study inclusion criteria were: primary diagnosis of ocd, age between 18 and 70 years, and a minimum pre-treatment y-bocs total score of 16. due to general admission policies of the outpatient unit, patients with comorbid psychotic disorders, borderline personality disorder, or substance dependency (life time) were not referred. three patients were excluded from analysis due to missing y-bocs-data at both preand post-treatment. during the study period, a total of 207 patients fulfilled the inclusion criteria and were contacted by telephone for follow-up assessments. among these, 51 (24.6%) patients could not be reached and 36 (17.4%) declined to participate. 120 patients participated in the phone interview (58.0% of the total sample), and 96 of them completed additional online questionnaires (46.4% of the total sample). participants (n = 120, 75 female, 104 therapy completers) and non-participants (n = 87, 49 female, 70 therapy completers) in the follow-up interview did not differ significantly in terms of gender (p = .392), therapy completer status (p = .252), or other demographic and clinical variables (see table 1). for both participants and non-participants, the most common comorbid mental disorders were present or remitted depressive disorders and anxiety disorders. twenty-four patients of the total sample suffered from personality disorders (see table 2). 73 patients took psychotropic medications at admission (35.3%), 55 at post-treatment (26.6%); the most common medications were selective serotonin reuptake inhibitors (ssris) and other antidepressants. the study protocol was approved by the local review board of humboldt-universität zu berlin (protocol number 2016-33) and met the ethical standards of the revised declaration of helsinki. all participants provided written informed consent. long-term stability of cbt benefits in ocd 4 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ table 1 demographic and clinical variables of participants and non-participants in follow-up assessments variable participants assessment tfu non-participants assessment tfu t-test for independent samples n m (sd) n m (sd) df t p age 120 32.3 (9.5) 87 31.5 (9.9) 181.0 0.59 .558 age of symptom onset 109 17.1 (8.8) 81 17.1 (7.6) 183.2 0.02 .986 age of disorder onset 110 23.1 (9.6) 78 22.4 (8.5) 117.3 0.58 .558 duration of therapy (hours) 119 41.0 (17.6) 87 42.3 (20.7) 167.4 -0.45 .653 socio-economic status 112 9.6 (3.7) 79 9.2 (4.2) 154.2 0.77 .443 gaf tpre 118 55.8 (10.1) 86 53.3 (11.2) 171.0 1.66 .099 y-bocs tpre 120 23.3 (4.6) 87 24.4 (4.7) 182.0 -1.74 .083 y-bocs tpost 120 11.9 (7.3) 87 13.7 (7.7) 178.8 -1.69 .092 oci-r tpre 118 27.1 (13.0) 87 29.4 (12.4) 190.1 -1.31 .193 oci-r tpost 120 14.4 (12.0) 85 17.7 (13.5) 167.2 -1.78 .078 bdi-ii tpre 119 18.9 (11.2) 87 20.4 (10.8) 188.8 -0.97 .336 bdi-ii tpost 120 9.8 (8.7) 84 10.9 (11.3) 148.6 -0.78 .438 bsi-gsi tpre 119 0.98 (0.5) 87 1.01 (0.6) 178.0 -0.37 .712 bsi-gsi tpost 120 0.60 (0.5) 85 0.70 (0.6) 163.2 -1.17 .245 note. gaf = global assessment of functioning; y-bocs = yale-brown obsessive-compulsive scale interview score; oci-r = obsessive compulsive inventory revised; bdi-ii = beck depression inventory ii; bsi-gsi = global severity index of the brief symptom inventory; pre = pre-treatment; post = post-treatment; fu = 1-year follow-up. table 2 most common comorbid mental disorders and medication status at tpre and tpost. condition participants assessment tfu non-participants assessment tfu n % n % ≥ 1 comorbid mental disorder 76 63.3 51 58.6 present depressive disorder 40 33.3 29 33.3 remitted depressive disorder 28 23.3 20 23.0 any anxiety disorder 41 34.2 15 17.2 personality disorder 12 10.0 12 13.8 psychotropic medications tpre 45 37.5 28 32.2 psychotropic medications tpost 35 29.2 20 23.0 note. pre = pre-treatment; post = post-treatment; fu = 1-year follow-up. elsner, wolfsberger, srp et al. 5 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ treatment cbt was administered by nineteen licensed psychotherapists, who had completed at least three years of training in cbt. treatments were bound to the general conditions for psychotherapy in the public german health care system. the legal framework allowed up to 66.7 hours (80 units of 50 minutes each) per treatment. therapists were instruc‐ ted to apply cbt including exposure and response prevention (erp) according to the national guideline for evidence-based treatment (hohagen, wahl-kordon, lotz-rambaldi, & muche-borowski, 2014). adherence was not formally controlled and treatment was not manualized, but therapists received weekly supervision by one of four experienced cbt therapists. therapy sessions usually lasted 50 minutes and took place once or twice weekly, yet therapists were free to adjust session length when implementing exposure and to reduce session frequency at the end of treatment. treatment was terminated by consensus of patient and therapist based on clinical criteria. patients who abandoned treatment without the approval of their therapist were classified as non-completers. assessment one-year follow-up status of patients (tfu) was assessed by telephone-based interviews and internet-based self-report questionnaires. analyses also included data from routine assessments at admission (tpre) and termination of therapy (tpost), and for non-completers, from interim-assessments. telephone interviews were conducted by trained master level psychology students, who were supervised by an experienced psychotherapist (b.r.). interviews included the german version of the y-bocs interview to assess ocd symptom severity (goodman et al., 1989a; goodman et al., 1989b; hand & büttner-westphal, 1991). internet-based assessments included the obsessive compulsive inventory revised (oci-r, foa et al., 2002) as a secondary outcome measure of ocd symptoms, the beck depression invento‐ ry ii (bdi-ii, beck, steer, & brown, 1996) to measure current depression, and the brief symptom inventory (bsi, derogatis & melisaratos, 1983) to assess general psychological distress using its global severity index. routine assessments at admission (tpre) included the german version of the struc‐ tured clinical interviews for dsm-iv mental disorders and personality disorders (scid-i, scid-ii, first, gibbon, spitzer, williams, & benjamin, 1997; first, spitzer, gibbon, & williams, 1995), and a socio-economic status scale (lampert & kroll, 2009). in order to assess symptom course, y-bocs interview, oci-r, bdi-ii, bsi, the clinical global impression scale (cgi, guy, 1976) and the global assessment of functioning (gaf, jones, thornicroft, coffey, & dunn, 1995) were administered before the first and after the final therapy session. interim assessments were conducted every 20 sessions and used to estimate post-treatment data for non-completers without post-treatment assessments (n = 10; last-observation-carried-forward method). interim assessments were also used long-term stability of cbt benefits in ocd 6 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ to estimate post-treatment scores for four therapy completers with missing data. all clinical interviews at admission and post-treatment were conducted by trained clinical psychologists. data analysis we analyzed data using r version 1.0.44. participants and non-participants were com‐ pared using independent two sample t-tests (two-sided). fisher’s exact test was applied to compare nominal data. effect sizes were calculated using cohen’s d with pooled standard deviations. changes over time were compared with paired t-tests (two-sided). we used the expert consensus criteria (mataix-cols et al., 2016) for y-bocs scores to define remission (total score ≤ 12), response (reduction ≥ 35%), and non-response (reduction < 35%), but did not apply the cgi improvement scale (see also hansen et al., 2019). we used the reliable change index (rci, jacobson et al., 1984) to define statistically meaningful deterioration (e.g. bablas, yap, cunnington, swieca, & greenwood, 2016; han, geffen, browning, kenardy, & geffen, 2011; kraus, castonguay, boswell, nordberg, & hayes, 2011). to calculate the rci, an internal consistency of α = .79 (moritz et al., 2002) was used as the reliability of the y-bocs. stability was defined as the absence of significant deterioration. logistic regression analysis was used to contrast response with‐ out remission (response only) and remission at post-treatment to predict deterioration at follow-up. as we were interested in stability after initial improvement, patients with no response during treatment were not considered in this analysis. additionally, we ap‐ plied receiver-operating characteristic (roc) curves using r package optimalcutpoints (lópez-ratón, rodríguez-álvarez, cadarso-suárez, & gude-sampedro, 2014) in order to find the best post-treatment y-bocs score classifying for deterioration versus stability at follow-up. roc curves were also used to find the optimal post-treatment cut-off score classifying for sustained gains (response, remission, or both; n = 77) at follow-up. the score that reached a maximum youden index (j = sensitivity + specificity 1; youden, 1950) was considered as optimal cut-off. r e s u l t s average symptom change on group level, the y-bocs score decreased significantly from pre-treatment to posttreatment, t(119) = 17.23, p < .001, with a mean reduction of 11.4 points and a large effect size of cohen’s d = 1.87 (figure 1a, table 3). symptom severity was also significantly reduced from pre-treatment to one-year follow-up, t(119) = 13.75, p < .001, d = 1.46. the increase of the mean y-bocs score from post-treatment to follow-up was small, but close to significance, t(119) = -1.79; p = .076, d = -0.12 (see figure 1a). elsner, wolfsberger, srp et al. 7 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ figure 1 average and individual symptom change note. a) mean y-bocs total scores at pre-treatment (tpre), post-treatment (tpost) and follow-up (tfu). b) individual remission, response only and non-response at post-treatment (according to the expert consensus) and significant deterioration (according to reliable change index) from post-treatment to follow-up. error bars indicate standard deviations. ***p < .001. similarly, secondary outcome parameters showed significant reductions from pre-treat‐ ment to post-treatment (oci-r: t(234) = 7.82; p < .001, d = 1.01; bdi-ii: t(222.99) = 7.03; p < .001, d = 0.91 and bsi-gsi: t(236.01) = 5.62; p < .001, d = 0.73), and from pre-treatment to follow-up (oci-r: t(208.32) = 8.40, p < .001, d = 1.14; bdi-ii: t(196.88) = 4.15; p < .001, d = 0.57; and bsi-gsi: t(207.95) = 5.21; p < .001, d = 0.71). no significant change from post-treatment to follow-up was observed for oci-r, t(205.13) = 0.83, p = .409, d = 0.11; for bdi-ii, t(168.30) = -1.71, p = .089, d = -0.24; and for bsi-gsi, t(204.06) = -0.12, p = .903, d = -0.02; (see table 3). long-term stability of cbt benefits in ocd 8 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ table 3 mean differences and effect sizes from pre-treatment and post-treatment to follow-up measure nfu mfu (sd) mpost (sd) dpost-fu mpre (sd) dpre-fu y-bocs 120 12.9 (9.0) 11.9 (7.3) -0.12 23.3 (4.6) 1.46 oci-r 94 13.1 (11.3) 14.4 (12.0) 0.11 27.1 (13.0) 1.14 bdi-ii 96 12.3 (12.0) 9.8 (8.7) -0.24 18.9 (11.2) 0.57 bsi-gsi 96 0.61 (0.5) 0.60 (0.5) -0.02 0.98 (0.5) 0.71 note. y-bocs = yale-brown obsessive-compulsive scale interview score; oci-r = obsessive compulsive inventory revised; bdi-ii = beck depression inventory ii; bsi-gsi = global severity index of the brief symptom inventory; pre = pre-treatment; post = post-treatment; fu = 1-year follow-up. individual improvement the course of symptoms from pre-treatment to post-treatment and follow-up was het‐ erogeneous across patients (figure 1b). table 4 displays the numbers of patients with non-response, response without remission (response only), and remission at post-treat‐ ment and follow-up. adopting the rci for deterioration, table 5 shows the numbers of participants with y-bocs score stability and deterioration at follow-up broken down by their outcome category at post-treatment. the relationship between outcome category (remission, response only, non-response) at post-treatment and stability at follow-up is illustrated in figure 1b. table 4 number of non-responders, responders without remission and remitters for post-treatment and follow-up outcome category at tpost outcome category at 1-year follow-up (tfu) no response response only remission σpost no response 27 3 7 37 (30.8%) response only 8 4 2 14 (11.7%) remission 8 9 52 69 (57.5%) σfu 43 (35.8%) 16 (13.3%) 61 (50.8%) 120 (100%) note. response only = response without remission; post = post-treatment; fu = 1-year follow-up. elsner, wolfsberger, srp et al. 9 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ table 5 change during follow-up: number of stable and deteriorated participants at follow-up broken down by their outcome category at post-treatment outcome category at tpost change during 1-year follow-up (tfu) stability deterioration σpost no response 34 3 37 (30.8%) response only 10 4 14 (11,7%) remission 66 3 69 (57.5%) σfu 110 (91.7%) 10 (8.3%) 120 (100%) note. response only = response without remission; post = post-treatment; fu = 1-year follow-up. prediction of long-term outcomes compared to remission, response only significantly predicted deterioration at follow-up (b = 2.17, se = 0.84, χ2(1) = 6.58, p = .010, odds ratio (or) = 8.8, ci = 1.71 50.65, wald χ2 = 6.77, p = .009). nagelkerke's r-squared of this model was .174 (hosmer-lemeshow r2 = .137, cox-snell r2 = .076). the inclusion of y-bocs scores at pre-treatment as predictor did not improve the model significantly, b = 0.13 (se = 0.11), p = .235. initial y-bocs scores did not predict deterioration, or = 1.1 (ci = 0.92 1.44, wald χ2 = 1.41, p = .245). cut-off scores the y-bocs score at post-treatment that best predicted significant deterioration versus stability was 13 (sensitivity = .70; specificity = .60), indicating that participants with a score higher than or equal to 13 were more likely deteriorated at follow-up (see figure 2a). interestingly, the optimal cut-off score predicting sustained gains (relative to baseline) was 12 (sensitivity = .83; specificity = .78), suggesting that a y-bocs score of 12 or less at the time of treatment termination predicts sustained benefits at one year follow-up (see figure 2b). long-term stability of cbt benefits in ocd 10 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ figure 2 cut-off points on the y-bocs note. receiver-operating characteristic (roc) curves with optimal cut-off points on the y-bocs at post-treatment to classify a) for deterioration (vs. stability) at follow-up and b) for sustained gains (response, remission, or both) at follow-up. auc = area under the roc curve. medication and subsequent outpatient therapy sixty-seven patients were free of psychotropic medications from post-treatment to fol‐ low-up. twenty patients discontinued medications after post-treatment, but seven of them were again medicated at follow-up. thirty patients were medicated continuously from post-treatment to follow-up. for three patients, data about medication at follow-up was missing. most common were ssris (n = 33). a significant association between medication status (no medication, discontinued, discontinued and medicated again, con‐ tinuously medicated) and outcome category at follow-up was observed (p = .015), with higher remission rates for medication-free patients and discontinuers (61.2% and 69.2%) than for continuously medicated patients (26.7%). no significant association could be observed for medication status and deterioration (p = .402) at follow-up assessment. eighteen patients sought additional outpatient therapy of more than five sessions after post-treatment. subsequent therapy was neither correlated with outcome category at post-treatment (p = .067), nor at follow-up assessment (p = .086), but at both assess‐ ment points, patients without remission sought additional therapy more frequently than remitters on a trend level. elsner, wolfsberger, srp et al. 11 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ d i s c u s s i o n the present study aimed to examine whether remission status and symptom levels at post-treatment are predictive for long-term stability of improvements after cognitive be‐ havioral therapy for ocd. in addition, we intended to evaluate the general effectiveness of individual cognitive behavioral therapy in a sample of 120 patients by conducting a follow-up assessment one year after termination of treatment in routine clinical practice. applying the recently published y-bocs consensus criteria (mataix-cols et al., 2016) to classify patients as non-responders, responders, or remitters showed that response only at post-treatment was associated with a significantly higher likelihood for deteriora‐ tion. among the patients who benefited from cbt, those who achieved remission by the end of treatment had a considerably higher chance of maintaining initial improvement. given the fact that stability and deterioration were defined by absence or presence of reliable changes (rci), the criterion variable was not confounded with the consensus criteria. while similar findings have been shown in previous studies, these applied different remission criteria (braga et al., 2005; braga et al., 2010; eisen et al., 2013). to our knowledge, the present findings are the first to show the predictive value of the consensually recommended y-bocs cut-off score, and thus confirm its validity in terms of long-term stability. considering that different cut-off scores have proven to predict long-term stability, we sought to determine a y-bocs score at post-treatment that best predicts deterioration versus stability one year later. receiver-operating characteristic (roc) curves pointed to a cut-off point of ≥ 13 for classifying for future deterioration. as stability until follow-up may not be sufficient to assume long-term improvement, we finally determined a cut-off score to classify for sustained benefits at follow-up relative to pre-treatment. the result‐ ing cut-off score of ≤ 12 implies that patients with a y-bocs score of twelve or lower at post-treatment are likely to show long-term therapy benefits compared to patients with higher scores. notably, the identified critical symptom levels are almost identical to the proposed expert consensus cut-off score for remission. these findings highlight the utility of a y-bocs cut-off score of ≤ 12 for defining remission status at post-treatment and add to previous evidence that subthreshold symp‐ tom severity protects patients with mental disorders from later deterioration (braga et al., 2005; braga et al., 2010; judd et al., 1998; paykel et al., 1995; van ameringen et al., 2003). the results have implications for both etiological models and clinical practice. differ‐ ent etiological models (kalanthroff, abramovitch, steinman, abramowitz, & simpson, 2016; robbins, gillan, smith, de wit, & ersche, 2012; salkovskis, 1999) emphasize that compulsions contribute to the maintenance or worsening of symptoms. a reduction of symptom severity below a critical threshold may therefore weaken these dynamics. in clinical practice, the question of how to proceed if patients achieve response but not remission during the scheduled duration of psychotherapy is central. ethical considera‐ tions may support continuation of treatment until remission is achieved. however, while long-term stability of cbt benefits in ocd 12 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ there is research on treatment of non-responders to pharmacological therapy (albert et al., 2018; denys, van megen, van der wee, & westenberg, 2004; pallanti, hollander, & goodman, 2004), there is little data on the treatment of patients who failed to reach remission status during cbt. as we observed large effect sizes for pre-post (d = 1.87) and pre-fu (d = 1.46) periods, we were able to confirm previous findings of long-term effectiveness of indi‐ vidual outpatient cbt in ocd (cabedo et al., 2018; hans & hiller, 2013; hansen et al., 2019). although our results suggest that reduced symptom levels are maintained from post-treatment to follow-up, we did observe a slight, non-significant increase in symptoms. recurrence of ocd symptoms after treatment termination has been found in previous follow-up studies (anderson & rees, 2007; barrett, healy-farrell, & march, 2004; bolton & perrin, 2008), yet not consistently (rufer et al., 2005). the slight increase in the present study may be explained by inferior long-term symptom stability of the small group of patients that achieved response without remission: while most patients who remitted (75.4%) or did not respond (73.0%) at post-treatment remained in the same outcome category at follow-up, only 28.6% of responders remained in this category one year later. very few patients with response (without remission) at post-treatment achieve remission one year later (14.3%), which illustrates again that response only at post-treatment indicates insufficient treatment. one limitation of the present study stems from the treatment setting under routine conditions. particularly, treatment did not follow a specific manual and therapy adher‐ ence was not controlled. the mean duration of therapy was longer than in most rcts. note, however, that “high intensity interventions” with more than 30 therapist-hours per patient have been found to yield superior effect sizes for treatment outcome compared to low and medium intensity (national collaborating centre for mental health, 2006). in the present study, the relatively long duration results from individual treatment planning, consideration of comorbid disorders, and termination of treatment on the basis of a consensual decision of patient and therapist. the duration is comparable to the average duration of outpatient psychotherapy in the public health care system in germany (lutz, wittmann, böhnke, rubel, & steffanowski, 2012). thus, our data derive from treatment conditions that are typical for the german and similar health care systems and may provide high ecological validity. sample size constitutes another limitation, as, at post-treatment, we observed only 14 patients in the category of response without remission, and only ten participants with deterioration at follow-up. although, considering the large number of remitted patients that indicates an overall very successful treatment, larger sample sizes would increase the statistical power of predictions of critical subgroups. future follow-up studies should also address life events, other therapies, and medications that may influence symptom stability. furthermore, longer follow-up intervals might enable us to make conclusions about predictors of long-term treatment benefits. elsner, wolfsberger, srp et al. 13 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://www.psychopen.eu/ in summary, the present results suggest that the symptom level reached when termi‐ nating treatment is critical for the future course of illness. a post-treatment y-bocs score < 13 optimally predicts higher individual likelihood for stability one year later. this cut-off almost perfectly fits with the expert consensus criterion for remission of ocd. thus, such a remission criterion may be a useful instrument in aiding decision making in routine clinical practice, in particular for terminating or continuing treatment. funding: this research did not receive any specific grant from funding agencies in the public, commercial, or notfor-profit sectors. competing interests: the authors have declared that no competing interests exist. acknowledgments: we thank katharina schwaiger for language editing. r e f e r e n c e s albert, u., marazziti, d., di salvo, g., solia, f., rosso, g., & maina, g. 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(1950). index for rating diagnostic tests. cancer, 3(1), 32-35. https://doi.org/10.1002/1097-0142(1950)3:1<32::aid-cncr2820030106>3.0.co;2-3 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. long-term stability of cbt benefits in ocd 18 clinical psychology in europe 2020, vol.2(1), article e2785 https://doi.org/10.32872/cpe.v2i1.2785 https://doi.org/10.1007/s00406-004-0544-8 https://doi.org/10.1016/s0005-7967(99)00049-2 https://doi.org/10.1017/s1092852900006933 https://doi.org/10.1002/1097-0142(1950)3:1<32::aid-cncr2820030106>3.0.co;2-3 https://www.psychopen.eu/ long-term stability of cbt benefits in ocd (introduction) method participants treatment assessment data analysis results average symptom change individual improvement prediction of long-term outcomes cut-off scores medication and subsequent outpatient therapy discussion (additional information) funding competing interests acknowledgments references the 12-month course of icd-11 adjustment disorder in the context of involuntary job loss research articles the 12-month course of icd-11 adjustment disorder in the context of involuntary job loss louisa lorenz a , andreas maercker a , rahel bachem a [a] department of psychology, university of zurich, zurich, switzerland. clinical psychology in europe, 2020, vol. 2(3), article e3027, https://doi.org/10.32872/cpe.v2i3.3027 received: 2019-05-10 • accepted: 2020-07-18 • published (vor): 2020-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: louisa lorenz, department of psychology, university of zurich, binzmuehlestrasse 14/17, ch-8050 zurich, switzerland. tel.: +41 44 635 74 57. e-mail: l.lorenz@psychologie.uzh.ch supplementary materials: materials [see index of supplementary materials] abstract background: after its redefinition in icd-11, adjustment disorder (ajd) comprises two core symptom clusters of preoccupations and failure to adapt to the stressor. only a few studies investigate the course of ajd over time and the definition of six months until the remission of the disorder is based on little to no empirical evidence. the aim of the present study was to investigate the course of ajd symptoms and symptom clusters over time and to longitudinally evaluate predictors of ajd symptom severity. method: a selective sample of the zurich adjustment disorder study, n = 105 individuals who experienced involuntary job loss and reported either high or low symptom severity at first assessment (t1), were assessed m = 3.4 (sd = 2.1) months after the last day at work, and followed up six (t2) and twelve months (t3) later. they completed a fully structured diagnostic interview for ajd and self-report questionnaires. results: the prevalence of ajd was 21.9% at t1, 6.7% at t2, and dropped to 2.9% at t3. all individual symptoms and symptom clusters showed declines in prevalence rates across the three assessments. a hierarchical regression analysis of symptoms at t3 revealed that more symptoms at the first assessment (β = 0.32, p = .002) and the number of new life events between the first assessment and t3 (β = 0.29, p = .004) significantly predicted the number of ajd symptoms at t3. conclusion: although prevalence rates of ajd declined over time, a significant proportion of individuals still experienced ajd symptoms after six months. future research should focus on the specific mechanisms underlying the course of ajd. keywords adjustment disorder, icd-11, job loss, prevalence, disorders specifically associated with stress this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.3027&domain=pdf&date_stamp=2020-09-30 https://orcid.org/0000-0001-8639-5661 https://orcid.org/0000-0001-6925-3266 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • symptoms of icd-11 adjustment disorder were highly prevalent among individuals who experienced involuntary job loss up to nine months previously. • in 30% of the adjustment disorder cases the symptoms persisted beyond the 6month remission threshold defined in the diagnostic manuals. • subsequent life events might complicate recovery from adjustment disorder. • mechanisms underlying symptom improvement or exacerbation need to be further studied. the new description of adjustment disorder (ajd) in the international classification of diseases, 11th version (icd-11) includes the presence of (a) one or a series of psychoso‐ cial stressor(s); of (b) preoccupation with the stressor(s); of (c) failure to adapt to the stressor(s); and of (d) significant impairment in personal, family, social, educational, oc‐ cupational or other important areas in functioning (world health organisation [who], 2018). in contrast, the diagnostic and statistical manual of mental disorders, 5th version (dsm-5) does not define specific symptoms and the diagnosis of ajd is not applicable in the presence of any other mental disorder (american psychiatric association [apa], 2013). the usage of ajd based primarily on an exclusion criterion in dsm-5 and earlier icd-versions has resulted in its usage as a diagnostic rest category with subsyndromal character (bachem & casey, 2018; baumeister & kufner, 2009). another difference be‐ tween the current manuals is that the dsm-5 distinguishes subtypes of ajd, such as depressed mood, anxiety, disturbance of conduct and mixed subtypes (apa, 2013), where‐ as the icd-11 does not. the diagnostic manuals state that the symptoms usually emerge within one (icd-11) and three (dsm-5) months after the onset of the stressor and that they typically resolve within 6 months, unless the stressor persists for a longer duration (who, 2018). this makes ajd a disorder with an essential benign outcome and spontaneous remission by definition. a few studies that investigated readmission rates for ajd cases in clinical settings support this concept (jäger, burger, becker, & frasch, 2012; jones, yates, & zhou, 2002). however, ajd is also associated with an elevated risk for concurrent or subsequent mental disorders and for suicidality (casey & doherty, 2012; gradus et al., 2010; o’donnell et al., 2016) and the definition of the 6-months’ period is still based on little to no empirical evidence. in injury survivors, 16% of the participants still met the diagnostic criteria of dsm-5 ajd after twelve months post-injury (o’donnell et al., 2016). in a representative sample from germany, a significant proportion of individuals who reported ajd symptoms (72%) indicated that the symptoms were present for six to twen‐ ty-four months (maercker et al., 2012). finally, a study assessing ajd symptoms several years after organ transplantations found that the time since the medical procedure was 12-month course of icd-11 adjustment disorder 2 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ unrelated to ajd symptom severity (bachem, baumann, & köllner, 2019). to the best of our knowledge, these are the only studies that specifically focused on the course of ajd over time based on a recent definition of the disorder, all of them putting the six months’ period in question. the zurich adjustment disorder study (zads) investigates the validity of the new icd-11 definition of ajd in a sample of individuals who involuntarily lost their job and explores predictors of ajd development over time. previous analyses revealed that the prevalence of ajd in this high-risk sample was 15.5% when applying the full icd-11 diagnostic criteria to a structured diagnostic interview schedule (perkonigg, lorenz, & maercker, 2018). based on questionnaire results, the prevalence of a tentative ajd diagnosis was 25.6% at approximately three months after the last day at work (lorenz, perkonigg, & maercker, 2018b), and 18.2% six months later (lorenz, makowski, & maercker, 2019). demographic factors such as higher age, female gender or low household budget as well as characteristics of the stress experience such as first job loss, a job that required “brainwork”, a job with high responsibility, and a larger number of job applications written to get a new position correlated with higher symptom severity and/or higher odds for a diagnosis of ajd (perkonigg et al., 2018). established intrapersonal resources that support coping with adversity such as high self-efficacy and sense of coherence were similarly related to fewer symptoms of ajd (perkonigg et al., 2018). finally, the socio-in‐ terpersonal framework model for stress-response syndromes (maercker & horn, 2013) suggests that different levels of social contexts play a crucial role in the recovery after stress experiences. these contexts include social affects (e.g., shame, anger, loneliness), interactions in close relationships (e.g., social support, empathy) or societal and cultural factors (e.g. social acknowledgement). in accordance with the model, lower self-efficacy, stronger feelings of loneliness, higher dysfunctional disclosure, less perceived social support, and more negative social interactions were identified as correlates of higher symptom severity (lorenz, perkonigg, & maercker, 2018b). the aim of the present paper is to expand upon previous findings of the zads and other longitudinal investigations. first, we aimed to report on the development of ajd symptoms and icd-11 core symptom clusters in the context of involuntary job loss across three assessments. based on the current disorder model and previous research, we expected that the prevalence rates of symptoms and symptom clusters would be high ini‐ tially and that they would decline after six and twelve months. second, several potential predictors of ajd development were explored. we hypothesized that ajd-related features (initial ajd symptoms, life events experienced), socio-demographic factors (gender, age, household income), and psychosocial factors relevant for stress-response syndromes (e.g., personal beliefs, interpersonal resources) would be associated with long-term outcome. lorenz, maercker, & bachem 3 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ m e t h o d participants and procedure the data for the present analysis stem from the zads investigating the new proposal for adjustment disorder in icd-11 in a sample of individuals who experienced involuntary job loss (perkonigg et al., 2018). the ethics committee of the university of zurich approved the study in june 2015 and all participants gave written informed consent. the study included all participants who were assessed at three time points with a fully structured clinical diagnostic interview for ajd. the first assessment took place up to nine months after the last day at work (t1), followed by a six-months (t2) and a twelve-months (t3) follow-up assessment. the participants were recruited through local employment offices, newspaper articles, and mailing lists in the greater zurich area. participants were excluded if they did not speak german fluently, were unable to give written informed consent, or suffered from a severe mental illness. the latter criterion led to the exclusion of one individual who was assumed to experience a psychotic episode. all participants were invited to participate in the first and second assessment of the study. since a comparison of extreme groups was planned for the original study, only a sub-sample was invited to the third assessment. inclusion in the sub-sample was determined after completion of t2. in the symptomatic group, we invited individuals who (a) met the criteria for an ajd at t1 or a subclinical ajd (either only preoccupation or only failure to adapt) at t1 and who (b) identified the same worst event at t1 and t2. in the non-symptomatic group, we invited individuals who reported a maximum of one symptom of ajd at t1 and at t2. of the 330 individuals that participated in the first assessment, 294 took part in the second assessment. of these individuals, 78 met the criteria for the symptomatic group and could be assessed a third time; 27 individuals met the criteria for the non-symptomatic group and could be assessed a third time. this led to a total sample size of n = 105 for the present analysis. the participant flow is shown in figure 1. table 1 displays a summary of the demographic characteristics of the sample. t1 was conducted m = 3.4 (sd = 2.1) months after the last day at work (mdn = 3.2). the interval between t1 and t3 was m = 12.3 (sd = 0.8) months. at t3, 17.1% (n = 18) of the participants had started a new job since t2, 48.6% (n = 51) of the sample continued the new job they had started between t1 and t2, 30.5% (n = 32) were still unemployed, and 1.9% (n = 2) experienced a new job loss. 12-month course of icd-11 adjustment disorder 4 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ figure 1 participant flow of the zurich adjustment disorder study note. t1 = first assessment; t2 = second assessment; t3 = third assessment. lorenz, maercker, & bachem 5 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ table 1 demographic characteristics of the sample (n = 105) variable m sd n % age at t1 46.3 10.0 gender male 56 53.3 female 49 46.7 marital status at t1 married 38 36.2 separated / divorced 21 20.0 never married 45 42.9 registered partnership 1 1.0 children at t1 0.9 1.1 vocational qualification on-the-job-training 3 2.9 formal apprenticeship 39 37.1 university / university of applied sciences 56 53.3 phd 3 2.9 no qualification 2 1.9 missing 2 1.9 measures adjustment disorder module for composite international diagnostic interview (ajd-cidi) adjustment disorder was assessed with a new module of the composite international diagnostic interview (cidi) that specifically focuses on ajd after icd-11 and dsm-5 (ajd-cidi) (perkonigg, strehle, et al., in press). in the beginning, the ajd-cidi assesses stressors (e.g. family conflict, financial problems, illness of a loved one) that occurred during the 12 months prior to the interview and event-specific characteristics (e.g. time of onset, duration). at the end of this first part, the participants were asked which of the events they experienced as the most distressing. the second part of the interview asks for a range of symptoms occurring in response to this event following the icd-11 and the dsm-5 definition. the 25 symptoms represent the areas of preoccupation with the stressor and failure to adapt to the stressor, as well as accessory symptoms of avoidance, depression, anxiety and impulsivity. the third part of the module assesses information about onset, recency of symptoms and functional impairment (perkonigg, strehle, et al., in press). we used a modified follow-up version of the ajd module for t2. in this version, the first part asks for new life events and the most distressing event from the previous 12-month course of icd-11 adjustment disorder 6 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ interview is coded. the participant then indicated the currently most distressing event out of the new and the old events. then, the second and third part of the ajd-cidi were applied with regard to the event coded at t1. at t3, the symptomatic group was interviewed with a version that asked specifically for symptoms in response to the event they talked about at t1 and t2. the diagnosis of ajd according to icd-11 (who, 2018) was made if the following criteria were met: a) occurrence of a significant life event; b) presence of at least one symptom of preoccupation (recurrent involuntary thoughts about the event, and constant worries related to the event); c) presence of at least two failure to adapt symptoms (con‐ centration problems, difficulties at work/daily activities, loss of interest in work, social network or leisure activities, sleep problems, and loss of self-confidence); d) frequency of symptoms at least 10-15 times per month or clinical relevance of symptoms (impair‐ ment at least “moderate” or contact with a health professional about the symptoms); e) exclusion of cases who presented with a current depressive episode and of cases who presented with a current generalized anxiety disorder as defined by the cidi. scales for predictor variables the general self-efficacy scale (gse; schwarzer & jerusalem, 1999) was used for the assessment of self-efficacy. the 10-item scale has a 4-point likert scale response-format (1, not correct – 4, absolutely correct). the total score is obtained by summing up all indi‐ vidual items and higher scores indicate higher self-efficacy. the psychometric properties of the gse were satisfactory in earlier validation studies with internal consistencies of .80 – .90 (hinz, schumacher, albani, schmid, & brähler, 2006; schwarzer & jerusalem, 1999). the internal consistency in the present study was α = .88. we measured sense of coherence using the sense of coherence scale – revised (soc-r; bachem & maercker, 2018). the scale, consisting of 13 items, measures manageability, reflection, and balance. the response-format is a 5-point likert scale (1, not at all, 5, completely). all items are summed up to build a total score of the soc-r, with one reco‐ ded item. higher scores indicate a higher sense of coherence. earlier validation studies reported satisfactory psychometric properties for the soc-r with internal consistencies of α = .75 – .81 (bachem & maercker, 2018; mc gee, höltge, maercker, & thoma, 2018). the internal consistency in the present study was α = .71. a composite score of two single items from other scales was used to measure feelings of loneliness (lorenz, perkonigg, & maercker, 2018b). we used one item from the brief symptom inventory – 18 (spitzer et al., 2011) and one item of the social functioning questionnaire (tyrer et al., 2005). the item formulations were ‘how strong did you experience feelings of loneliness during the past 7 days?’ and ‘i feel lonely and isolated from other people’. the response-format was a 5-point likert scale (0, not at all – 4, very strong) and a 4-point likert scale (0, almost all the time – 3, not at all), respectively. the lorenz, maercker, & bachem 7 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ latter item was recoded before building a sum score with the first item of the scale. the correlation between the two items in the present study was α = .70. the disclosure of trauma questionnaire (dtq) was used in an abbreviated form (pielmaier & maercker, 2011) to measure dysfunctional disclosure. the scale, consisting of 12 items with a 6-point likert scale (0, not at all – 5, absolutely) response-format, measures the urge to talk, the reluctance to talk, and emotional reactions while disclos‐ ing. the individual items are summed up to build a total score; higher scores indicate higher dysfunctional disclosure. previous studies found satisfying psychometric proper‐ ties for the dtq (müller, beauducel, raschka, & maercker, 2000; müller & maercker, 2006). the internal consistency of the abbreviated form was α = .75 in previous studies (pielmaier & maercker, 2011) and α = .81 in the present study. we used the social support questionnaire, short form (fsozu-k; fydrich, sommer, tydecks, & brähler, 2009) to measure perceived social support. the 14 items are an‐ swered on a 5-point likert scale (1, don’t agree, 5, agree). the mean of all answered items is used to build the total score and higher scores indicate higher perceived social support. the psychometric properties in the validation of the fsozu-k were satisfactory with an internal consistency of α = .94 (fydrich et al., 2009). the internal consistency in the present study was α = .93. a subset of items of the daily hassles scale (perkonigg & wittchen, 1998) was used to measure negative social interactions (lorenz, perkonigg, & maercker, 2018b). six items measured negative interactions with the partner, children, parents, siblings, friends, or neighbours during the last two weeks. the original 4-point likert scale response-format of the items (1, often – 4, never) was reverse coded, so that a higher mean score indicates more negative social interactions. the internal consistency was α = .68 in a previous study (lorenz, perkonigg, & maercker, 2018b) and α = .73 in the present study. the social acknowledgement questionnaire (saq; maercker & müller, 2004) measured perceived acknowledgement of the difficult situation of the individual by the social environment. the 16 items, answered on a 4-point likert scale (0, not at all – 3, complete‐ ly), measure general disapproval, disapproval by family or friends, and recognition as a victim. following the authors of the scale, the total score was built by summing up items 3, 9, and 11 through 16, and subtracting items 1, 2, 4 through 8, and 10. a higher score indicates more social acknowledgement. the validation study of the questionnaire reported satisfactory psychometric properties with an internal consistency of α = .86 (maercker & müller, 2004). the internal consistency in the present study was α = .73. statistical analysis data were analysed using spss version 23. the highest number of missing values was found for social acknowledgement (13%), all other variables had less than 3% missing val‐ ues and data were missing completely at random. pairwise case deletion was used in the analyses. the prevalence of icd-11 ajd was computed with and without consideration 12-month course of icd-11 adjustment disorder 8 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ of the exclusion criterion. to investigate predictive factors, we performed a hierarchical regression analysis with the number of symptoms at t3 as outcome. we decided to include all symptoms that were measured by the ajd-cidi to increase the variance of the outcome variable and because there is still uncertainty about the best conceptualisation of ajd (lorenz, hyland, perkonigg, & maercker, 2018). the analysis included three steps. in the first step, we included the number of symptoms at t1, the total number of life events reported at t1, and the total number of new life events reported between t1 and t3 as predictors. the second step included socio-demographic characteristics (gender, age, household income < 4000 swiss francs) and the third step included psychosocial variables (general self-efficacy, loneliness, dysfunctional disclosure, perceived social support, nega‐ tive social interactions, social acknowledgement). in the second and third step, we inclu‐ ded predictor variables that were found to be associated with initial symptom severity and 6-months outcomes in previous publications from this sample (lorenz, hyland, et al., 2018; lorenz, perkonigg, & maercker, 2018a, 2018b; perkonigg et al., 2018). the final model was selected based on the significance of the f-statistics. no multicollinearity was found based on the vif measure (ranged between 1.030 and 1.078). r e s u l t s descriptives the total amount of symptoms as measured by the ajd-cidi was m = 7.1 (sd = 5.5; mdn = 7.0, range = 0-19) at t1, m = 4.3 (sd = 5.0; mdn = 2.0, range = 0-20) at t2, and m = 2.1 (sd = 2.8; mdn = 1.0, range = 0-13) at t3. the total number of life events reported at t1 was m = 2.3 (sd = 1.2, range = 1-7) and the total number of new life events experienced between t1 and t3 was m = 1.0 (sd = 1.3, range = 0-7). the majority of participants (74.3%) indicated the job loss, financial problems or problems with authorities as their worst event at t1, followed by family matters (22.9%; family conflicts/separation/illness or death of family member). the descriptive statistics for the predictor variables and the correlation coefficients between the main predictor variables can be found in the supplementary material. prevalence of ajd symptoms the prevalence rates of the individual symptoms as measured by the ajd-cidi are displayed in figure 2. for the majority of symptoms, the prevalence was highest at t1 and lowest at t3. the symptoms measuring preoccupation with the stressor, sleep disturbances (as part of failure to adapt), and feeling low and sad (as part of depressive symptoms) were the most prevalent at t1 with over 40% of the individuals reporting each of them. at t2, repetitive thoughts, feeling low and sad, and feeling discouraged and hopeless for the future (depressive symptom) were the most prevalent symptoms lorenz, maercker, & bachem 9 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ (each over 30%). the most prevalent symptoms at t3 were repetitive thoughts, rumination about the event, and avoiding situations or individuals that could remind of the event (avoidance symptom) with roughly a 20% prevalence each. figure 2 prevalence (%) of individual symptoms that may occur in icd-11 adjustment disorder across the three assessments note. pre = preoccupation; fta = failure to adapt; avo = avoidance; dep = depression; anx = anxiety; imp = impulsivity. *items used for diagnostic algorithm for adjustment disorder. prevalence of ajd symptom groups table 2 displays the prevalence of the diagnostic criteria across the three assessments. criterion a was met by every participant since the presence of a stressor was an inclu‐ sion criterion of the study. the prevalence rates of preoccupation (criterion b), failure to adapt (criterion c), and impairment in social functioning (criterion d) were highest for the first assessment and declined over time. the prevalence rate of exclusive disorders (criterion e) remained stable across the three assessments. approximately every fifth individual met the full diagnostic criteria at t1 (21.9%). this prevalence declined to 6.7% at t2, and to 2.9% at t3. the majority of individuals reported no ajd across all assessments (n = 80; 76.2%). most of the other participants met the diagnostic guidelines only at t1 (n = 16, 15.2%) or only at t1 and t2 (n = 5, 4.8%). one individual (1.0%) received an ajd diagnosis at all three assessments. 12-month course of icd-11 adjustment disorder 10 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ table 2 prevalence of adjustment disorder criteria across the three assessments adjustment disorder criterion t1 t2 t3 n % n % n % criterion a: event 105 100.0 105 100.0 105 100.0 criterion b: preoccupation 63 60.0 32 30.5 15 14.3 criterion c: failure to adapt 44 41.9 18 17.1 10 9.5 criterion d: impairment 82 78.1 67 63.8 40 38.1 criterion e: exclusive disorders 10 9.5 10 9.5 9 8.6 icd-11 adjustment disorder without exclusion criterion 29 27.6 12 11.4 4 3.8 icd-11 adjustment disorder with exclusion criterion 23 21.9 7 6.7 3 2.9 note. t1 = first assessment; t2 = second assessment; t3 = third assessment. prediction of ajd symptoms at t3 table 3 displays the results of the hierarchical regression analysis for the total number of ajd-cidi symptoms at t3. the first step included the number of ajd-cidi symptoms at t1, the number of life events reported at t1, and the number of new live events experienced between t1 and t3 as predictors. this model was significant, f(3, 86) = 7.648, p < .001. the second model, which included socio-demographic characteristics, and the third model, which included psycho-social variables, did not significantly increase the fit of the model. thus, the model only including adjustment disorder related characteristics (model 1) was interpreted. a higher number of ajd-cidi symptoms at t1 and a higher number of life events experienced between t1 and t3 were associated with a higher number of ajd-cidi symptoms at t3. the model explained 18% of the variance in the outcome (adjusted r 2 = .183). table 3 hierarchical regression results (standardized β coefficients) for the total number of ajd-cidi symptoms at the third assessment (n = 105) predictor model 1 2 3 number of ajd-cidi symptoms at t1 0.316** 0.365*** 0.278* number of life events at t1 0.060 0.083 0.088 number of new life events between t1 and t3 0.291** 0.286** 0.292** gender -0.235* -0.205 age (t1) 0.046 0.007 household income < 4000 sfr (t1) 0.000 -0.001 general self-efficacy (t1) -0.079 lorenz, maercker, & bachem 11 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ predictor model 1 2 3 sense of coherence (t1) -0.029 loneliness (t1) 0.164 dysfunctional disclosure (t1) -0.032 perceived social support (t1) 0.078 negative social interactions (t1) 0.069 social acknowledgement (t2) -0.035 f 7.648*** 2.130 0.518 r 2 .211 .267 .300 adjusted r 2 .183 .214 .181 δr 2 .056 .033 note. gender: 1 = male; 2 = female; household income < 4000 sfr (0 = no; 1 = yes). *p < .05. **p < .01. ***p < .001. d i s c u s s i o n the aim of the present analysis was to investigate the course of adjustment disorder in the context of involuntary job loss over the course of twelve months. it was the first investigation of prevalence rates according to icd-11 with a new structured diagnostic interview in a high-risk sample. we found an ajd prevalence rate of 21.9% at the first assessment. previous studies using icd-10 or dsm-iv criteria found prevalence rates ranging between 6.9% and 38% in high risk populations (e.g., mitchell et al., 2017; rundell, 2006), between 3% and 12% in medical settings (e.g., fernández et al., 2012; yaseen, 2017), and between 11% and 17% in psychiatric settings (bruffaerts, sabbe, & demyttenaere, 2004; shear et al., 2000). based on a self-report questionnaire, studies investigating the new icd-11 approach reported varying prevalence rates between 21% and 61% in high-risk populations (e.g., dannemann et al., 2010; dobricki, komproe, de jong, & maercker, 2010). however, they refer to a tentative diagnosis and did not apply the icd-11 exclusion criterion. the prevalence rate in this sample, consisting of extreme groups with high or low ajd symptoms at previous assessments, dropped to 3% at the third assessment, which is only slightly higher than prevalence rates found in general population-based samples (e.g., ayuso-mateos et al., 2001; glaesmer, romppel, braehler, hinz, & maercker, 2015). at the same time, the prevalence rate was lower than the twelve-months prevalence rate found in the o’donnell et al. (2016) study investigating the dsm-5 model in a post-injury sample. this could be either an effect of the different diagnostic guidelines applied (icd-11 or dsm-5) or an effect of the stressor (job loss vs. injuries). future studies should aim at a direct comparison between icd-11 and dsm-5 diagnostic guidelines. 12-month course of icd-11 adjustment disorder 12 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ as expected, there was a decline in ajd symptoms over time. this generally supports the assumption of a favourable outcome of ajd. however, a substantial proportion (seven of the twenty-three cases) with an ajd at the first assessment still met the diagnostic criteria for an ajd six months later. this represents 30% of the ajd cases that show a longer duration of the disorder than the conditional six-month threshold in icd-11 and dsm-5. it could be argued that the life event ‘job loss’, which was rated to be the worst event by the majority of the sample, or its consequences is often not resolved within the time period of six months the icd-11 mentions as “typical” for a resolution. this argument is supported by the high number of new or subsequent life events in the present sample, which might complicate recovery. it emphasizes the difficulty of apply‐ ing time period features like six months in stress-related disorders and implies to use this feature only after a thorough substantive examination and a flexible interpretation of the abovementioned period. the second aim of this study was to investigate factors that predict ajd symptoms after twelve months. the hierarchical approach allowed us to examine whether only ajd-related characteristics explain long-term outcome or whether socio-demographic factors and psychosocial processes add explanatory power over the course of twelve months. the results indicate that higher initial symptomatology and more life stressors following the event significantly predicted higher symptomatology twelve months later and that ajd-related characteristics might be a sufficient explanation for symptom se‐ verity over the course of twelve months, supporting the concept of a stress-response syndrome. however, the selection of potential risk and protective factors was limited, and future studies should include other relevant predictors since the model was only able to explain 18% of the variation in symptom severity after twelve months. we included socio-demographic and psychosocial predictors that were associated with initial symptom severity in earlier studies (e.g., lorenz, perkonigg, & maercker, 2018b; perkonigg et al., 2018). although these predictors were not longitudinally asso‐ ciated with ajd symptoms, they were associated with initial symptom severity. since initial symptom severity was one of the strongest predictors of long-term outcome, the effect of the socio-demographic and psychosocial predictors on t3 ajd symptoms could be indirect, via symptoms at t1. hence, future studies could focus on a possible mediation effect of initial symptom severity on the association between socio-demographic and psychosocial predictors and long-term outcome. if this mediation was true, it could be reasonable to target these factors to achieve a better long-term outcome. this assumption finds support in two recent self-help intervention studies for ajd. these interventions aimed at enhancing resilience for example by improving problem-solving skills or mo‐ bilizing social support and showed medium to large effect sizes for the reduction of ajd related symptomatology over time (bachem & maercker, 2016; eimontas, rimsaite, gegieckaite, zelviene, & kazlauskas, 2018). alternative explanations for the result that especially the number of life events predicted symptom severity at t3 could be memory lorenz, maercker, & bachem 13 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ effects or attention deficits. the ajd-cidi stressor list also covers psychosocial stress of minor intensity, such as troubles with neighbours or giving up a hobby. individuals who are worse off could be particularly sensitive to these minor stressors while better adjusted individuals may find it unnecessary to report these events. the analyses for ajd symptoms were based on all symptoms that may occur in ajd rather than only the icd-11 core symptom cluster of preoccupation and failure to adapt because of the differences between the major diagnostic classification systems. while the icd-11 defines specific core symptoms (who, 2018), the dsm-5 kept the previous defini‐ tion that is not based on specific criteria but on the exclusion of other mental disorders (apa, 2013). these dissimilarities are a result of the lack of research around ajd and of a lack of agreement on the main characteristics of the disorder, and they might result in differences in access to treatment. across the three assessments, different symptoms of preoccupation with the stressor were among the most prevalent symptoms, supporting the inclusion of this symptom group in the diagnostic guidelines in icd-11. symptoms that reflect depressive reactions were also commonly present, suggesting that it might be reasonable to include mood alterations in the ajd definition as it is the case in dsm-5. these results could be a first evidence for the validity of both approaches and further revisions of the guidelines might include features of both definitions. future research should not only focus on the most prevalent symptoms but also try to identify symptoms that are associated with high functional impairment or that show high discriminatory power. the use of the new icd-11 diagnostic guidelines and a fully structured clinical diagnostic interview make this study unique. still, it has several limitations. first, the data stems from a particular high-risk sample, which limits the generalizability to all ajd cases. second, the sample for this study was based on specific selection criteria. we specifically defined a symptomatic and a non-symptomatic group to increase variance in the data. moreover, we lifted inclusion criterion b) for the non-symptomatic group in order to be able to investigate incidence rates for adjustment disorder. this specific methodology complicated interpretation of prevalence findings at t3. furthermore, the recruitment was based on self-selection since we did not apply a systematic or stratified recruitment strategy. these methodological concerns restrict the generalizability of the results to the whole population of unemployed individuals. third, we did only control for the presence of a depressive episode and/or generalised anxiety disorder and not the full list of exclusive disorders as recommended by icd-11. future studies should consider the full range of clinically meaningful exclusions. fourth, the interval between assessments was chosen at six months to investigate the proposal of the diagnostic guidelines for ajd. research that includes shorter intervals between assessments could shed further light into the dynamics of the disorder. last, the number of predictors in the hierarchical regression could have limited the power of the analysis considering the sample size. this could have masked some predictive effects and future studies should increase the sample 12-month course of icd-11 adjustment disorder 14 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ size. in addition, loneliness was assessed with two items from different scales rather than with an established questionnaire. adjustment disorder has been a diagnostic category that received little attention in research despite a frequent use in clinical practice (evans et al., 2013; reed, correia, esparza, saxena, & maj, 2011). the relatively high prevalence of ajd in this study, the methodological concerns raised by our findings, and the aforementioned issues of disor‐ der definition again stress the importance of a systematic inclusion of ajd in research in order to understand maladaptive responses to life stress better, especially since ajd is associated with a higher risk for the development of severe psychopathology and suicidality (e.g., casey & doherty, 2012; o’donnell et al., 2016). this study furthermore showed that even though ajd symptomatology shows a favourable course over time, it can also persist beyond the six-month threshold as proposed by icd-11 and dsm-5. further research is needed to understand the mechanisms underlying the disorder and determining the long-term outcome of ajd. moreover, future studies comparing preva‐ lence rates between icd-11 and dsm-5 may deepen our understanding of maladjustment to stressful life events. funding: this research was funded by a grant of the swiss national science foundation (#100019_159436) and financial support by the jacobs foundation. competing interests: the authors have declared that no competing interests exist. acknowledgments: this work is part of the zurich adjustment disorder study (2014-2018). we thank co-pi dr. axel perkonigg, all respondents of the study for their participation and lisa makowski, bsc., for her work regarding data collection and data processing. we acknowledge the office of economy and labour zurich for cooperation on respondents’ recruitment and dr. beesdo-baum, dr. wittchen and dipl. math. jens strehle (tu dresden) for collaboration on the ajd-cidi module. ethics approval: the authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the helsinki declaration of 1964 and its later amendments. all persons gave their written informed consent prior to their inclusion in the study. data availability: data from this study are not publicly available as informed consent and ethical approval for public data sharing were not obtained from participants. the data are readily available upon request by qualified scientists. any enquiries regarding data accessibility can be addressed to the first author. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the descriptive statistics of the main measures of the study and the correlations between study variables (for access see index of supplementary materials below). lorenz, maercker, & bachem 15 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ index of supplementary materials lorenz, l., maercker, a., & bachem, r. 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(2017). adjustment disorder: prevalence, sociodemographic risk factors, and its subtypes in outpatient psychiatry clinic. asian journal of psychiatry, 28, 82-85. https://doi.org/10.1016/j.ajp.2017.03.012 lorenz, maercker, & bachem 19 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://doi.org/10.3402/ejpt.v2i0.8749 https://doi.org/10.1002/j.2051-5545.2011.tb00034.x https://doi.org/10.1016/j.genhosppsych.2006.04.006 https://doi.org/10.1176/appi.ajp.157.4.581 https://doi.org/10.1055/s-0031-1281602 https://doi.org/10.1177/0020764005057391 https://icd.who.int/browse11/l-m/en https://doi.org/10.1016/j.ajp.2017.03.012 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. 12-month course of icd-11 adjustment disorder 20 clinical psychology in europe 2020, vol.2(3), article e3027 https://doi.org/10.32872/cpe.v2i3.3027 https://www.psychopen.eu/ 12-month course of icd-11 adjustment disorder (introduction) method participants and procedure measures statistical analysis results descriptives prevalence of ajd symptoms prevalence of ajd symptom groups prediction of ajd symptoms at t3 discussion (additional information) funding competing interests acknowledgments ethics approval data availability supplementary materials references post-event processing after embarrassing situations: comparing experience sampling data of depressed and socially anxious individuals research articles post-event processing after embarrassing situations: comparing experience sampling data of depressed and socially anxious individuals jasmin čolić a , anna latysheva a, tyler r. bassett a, christian imboden b, klaus bader c, martin hatzinger d, thorsten mikoteit de, andrea hans meyer f, roselind lieb f, andrew t. gloster g §, jürgen hoyer a § [a] institute of clinical psychology and psychotherapy, technische universität dresden, dresden, germany. [b] private clinic wyss, muenchenbuchsee, switzerland. [c] centre for psychosomatics and psychotherapy, psychiatric hospital, university of basel, basel, switzerland. [d] psychiatric services solothurn, solothurn, switzerland. [e] centre for affective, stress and sleep disorders, psychiatric hospital, university of basel, basel, switzerland. [f ] division of clinical psychology and epidemiology, department of psychology, university of basel, basel, switzerland. [g] division of clinical psychology and intervention science, department of psychology, university of basel, basel, switzerland. §these authors contributed equally to this work. clinical psychology in europe, 2020, vol. 2(4), article e2867, https://doi.org/10.32872/cpe.v2i4.2867 received: 2020-02-25 • accepted: 2020-11-01 • published (vor): 2020-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: jasmin čolić, technische universität dresden, institute of clinical psychology and psychotherapy, hohe str. 53, d-01187 dresden (germany). phone: +49 176 80834539. e-mail: jasmin.colic@tudresden.de supplementary materials: materials [see index of supplementary materials] abstract background: post-event processing (pep) after social interactions (sis) contributes to the persistence of social phobia (sp). this study investigated whether pep as a transdiagnostic process also occurs in major depressive disorder (mdd) and controls. we also tested to what extent pep was explained by trait levels of social anxiety (sa) or depression. method: for seven days, a total of n = 165 patients (n = 47 sp, n = 118 mdd) and n = 119 controls completed five surveys per day on their smartphones. event-based experience sampling was used. pep was assessed following subjective embarrassment in sis with two reliable items from the postevent processing questionnaire. data were analysed via multilevel regression analyses. results: individuals with sp or mdd experienced more embarrassing sis than controls and, accordingly, more pep. the relative frequency of pep after embarrassing sis was equally high in all groups (86-96%). the groups did not differ regarding the amount of time pep was experienced. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.2867&domain=pdf&date_stamp=2020-12-23 https://orcid.org/0000-0001-8504-9898 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ after controlling trait depression, embarrassment occurred more frequently only in sp compared to controls. when controlling trait sa, between-group differences in indications of embarrassment, and consequently in pep, dissipated. conclusions: pep could be interpreted as a common coping strategy among all individuals, while more frequent embarrassment might be specific for clinical groups. embarrassment was primarily driven by sa. the alleviation of sa could lead to the reduction of embarrassment and, further, of pep. on this basis, a model describing pep in mdd is proposed, while current models of pep in sp are complemented. keywords post-event processing, social anxiety, depression, transdiagnostic processes, embarrassment, experience sampling highlights • individuals with social phobia or major depression experienced more embarrassing social interactions than healthy controls and, accordingly, more post-event processing. • the frequency of post-event rumination within embarrassing interactions was high in all groups (86-96%). • after controlling trait levels of social anxiety, between-group differences in the number of embarrassing situations, and consequently in post-event processing, dissipated. • when controlling trait levels of depression, post-event rumination was higher in social phobia compared to healthy controls and major depression. background social phobia (sp, or social anxiety disorder) is characterised by fear of acting in a way that could cause embarrassment or rejection from others in one or more social situations (apa, 2013). sp is highly persistent and usually has a chronic and stable course (beesdo‐baum et al., 2012; fehm, beesdo, et al., 2008). one of the key processes that contributes to its persistence is post-event processing (pep; brozovich & heimberg, 2008; clark & wells, 1995; hofmann, 2007; rapee & heimberg, 1997). pep refers to ruminative thinking that centres on one’s self-perception and anxious feelings following a social event (abbott & rapee, 2004; clark & wells, 1995). it is highly associated with in-situation anxiety and with avoidance of future social situations (dannahy & stopa, 2007; hofmann, 2007; mellings & alden, 2000; rachman et al., 2000). during pep, the affected individual mentally reviews a previous event in detail, while pondering over thoughts indicative of the belief that he or she was evaluated negatively (abbott & rapee, 2004). this leads to the event being recalled as more negative than it actually was (hofmann, 2007). accordingly, pep serves as a chain link in a vicious cycle in which recollections of past “failures” lead to anticipatory anxiety and to predictions post-event processing in social phobia, major depressive disorder and controls 2 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ of negative evaluation in subsequent social events (mellings & alden, 2000), thus increas‐ ing the probability to avoid such events completely (rachman et al., 2000). therefore, interventions designed to minimise pep were included in prominent treatment protocols for sp (e.g. rapee & heimberg, 1997). because individuals with sp predominantly fear scrutiny by others, social situations in which said persons felt embarrassed or humiliated could bear particular risk for heightened social anxiety (sa) and pep. in social interactions (si), embarrassment usually results from unwanted exposure of a topic or motive that a person would rather keep hidden or concealed from others (crozier, 2001). to avoid such exposure, individuals with sp maintain high self-focused attention, while scanning their environment for impending negative evaluation. they usually detect such signs rapidly, deeming their behaviour as embarrassing (bögels & mansell, 2004; rapee & heimberg, 1997). both negative evalua‐ tion by others (makkar & grisham, 2011) and negative self-evaluation (chen et al., 2013; perini et al., 2006) have been shown to significantly predict pep. thus, embarrassment, as a catalyst for perceived negative evaluation, might significantly contribute to pep. patterns of ruminative thinking such as pep, are however symptomatic for many mental disorders (mcevoy et al., 2010). this is due to shared cognitive and behaviou‐ ral processes underlying a wide range of clinical conditions (ehring & watkins, 2008; harvey et al., 2004). hence, it remains unclear whether pep is specific to only sp. another disorder to which ruminative thinking has a robust and consistent relation‐ ship is major depressive disorder (mdd; mor & winquist, 2002; nolen-hoeksema et al., 2008). in mdd, rumination is defined as a response style that consists of repetitive and negative thinking about causes and implications of depressive symptoms (nolenhoeksema, 1991; nolen-hoeksema et al., 2008). rumination is associated with dysphoric mood in mdd (nolen-hoeksema, 2000; nolen-hoeksema & morrow, 1993), and is predic‐ tive of the onset and duration of future depressive episodes (nolen-hoeksema, 2000; nolen-hoeksema et al., 1993). rumination exacerbates and maintains depression by in‐ terfering with effective problem solving and with instrumental behaviour (lyubomirsky & nolen-hoeksema, 1993, 1995; nolen-hoeksema et al., 2008; pyszczynski & greenberg, 1987). unlike pep in sp though, rumination in mdd is not bound to specific social events, but rather presents a more general, trans-situational style of thinking (mcevoy et al., 2010). also, it revolves around depressive symptoms and themes of loss (nolenhoeksema et al., 2008), while pep in sp is related to social anxiety and thoughts of negative evaluation (kocovski & rector, 2007). however, as patients with mdd exhibit pronounced interpersonal problems as well (e.g. garrison et al., 2012; pemberton & fuller tyszkiewicz, 2016), this opens the possibility that they, just like socially anxious individuals, would also engage in pep after social events. in interpersonal encounters, depressed individuals were shown to be inhibited, reas‐ surance seeking, and less socially skillful (allen & badcock, 2003; l. h. brown et al., 2011; hames et al., 2013; joiner et al., 1999). this leads others to behave towards them in a čolić, latysheva, bassett et al. 3 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ more detached manner during the interaction or to avoid them completely (gotlib et al., 2004; segrin, 2000). rejection by others can lead to feelings of loneliness and heightened dysphoric mood, which ultimately can lead to rumination (hames et al., 2013; heinrich & gullone, 2006). individuals with mdd also have the propensity to process interpersonal reactions in a negative manner, even if they were not inherently harmful (bistricky et al., 2016; joiner et al., 1999). as embarrassing sis are often accompanied by a certain reaction from others, like an evaluative gaze (robbins & parlavecchio, 2006), they could as well be potentially detrimental for individuals with mdd. behaviours like that could be highly ambiguous and be appraised as negative evaluation (gotlib et al., 2004; joiner et al., 1999; trew & alden, 2009). perceived negative evaluation can trigger depressive feelings and successive rumination in individuals with mdd, especially when it is linked to people close to the individual (like family members or partners; anderson et al., 1999; garrison et al., 2012). hence, it can be assumed that feelings of embarrassment in sis, once they are triggered, can produce ruminative thinking in depressed individuals. one major methodological problem of the studies cited is recall bias, which refers to systematic errors during the retrieval of autobiographical episodes (shiffman et al., 2008). recall bias is especially accentuated in individuals prone to ruminative thinking (williams et al., 2007), like individuals diagnosed with sp or mdd. these individuals tend to resort to overgeneral memory (conway & pleydell-pearce, 2000) and tend to have difficulties recalling specific episodes. as a result, research methodologies that limit recall bias are needed. experience sampling method (esm) as a data collection strategy that is anchored in daily life has proven to bypass these limitations (fahrenberg et al., 2007). while pep in sp has successfully been investigated in everyday life (badra et al., 2017; helbig-lang et al., 2016), no study to date has used esm to explore whether pep is a transdiagnostic phenomenon occurring in mdd as well. the findings could advance the understanding of the genesis, the predecessors and the clinical specificity of pep, and shine light on its natural occurrence in everyday life. it would provide insights into social behaviour of individuals with mdd and the transdiagnostic character of pep as well, which could contribute to the development and enhancement of appropriate treatment strategies. on this basis, we explored the frequency and duration of pep after embarrassing sis in patients with sp and mdd, as well as controls without sp or mdd. we derived two main hypotheses. the first hypothesis (h1) concerned between-group differences in fre‐ quency and duration of pep. because pep is primarily linked to sa and social situations (fehm et al., 2007), and because of the higher importance of embarrassment in sp, we hypothesized that the frequency and duration of pep would be significantly higher in sp compared to mdd. due to symptoms of sa or depression being elevated in both mdd and sp, however, we also hypothesized that the frequency and duration of pep would be significantly higher in both clinical groups (sp and mdd) compared to controls. the post-event processing in social phobia, major depressive disorder and controls 4 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ second hypothesis (h2) concerned the contribution of trait sa and trait depression to indications of embarrassment and to pep. due to the previously exemplified relation of dysphoric feelings to interpersonal rejection (e.g. gotlib et al., 2004) we expected that pep in mdd would be primarily driven by trait levels of depression, while pep in sp would be facilitated by trait sa. to test this hypothesis, we analysed between-group differences while partialling out trait sa or trait depression. we expected that after controlling trait depression, pep would remain elevated in sp compared to controls. on the other hand, when controlling trait sa, we expected that pep would remain significantly higher in mdd compared to controls. lastly, in our third hypothesis (h3) we explored if there are differences in embarrassment and pep between the comorbid sp/mdd group and the sp group without mdd as comorbidity, and the mdd group without sp as a comorbid diagnosis. because of elevated levels of both depression and sa, we predicted that pep would be significantly higher in the comorbid group compared to the non-comorbid groups. we tested all our hypotheses in an esm framework to minimise recall bias and to enhance ecological validity. m e t h o d study design the study was part of a larger project about daily symptom fluctuations in mdd and sp (gloster et al., 2017). data collection was conducted at two research centers, one in switzerland and one in germany. financing was provided by the swiss national science foundation. the study protocol was approved by the ethics committee of the university of basel (approval # ekbb 236/12). participants recruitment and selection criteria participant recruitment and data collection occurred between may 2014 and august 2016 (gloster et al., 2017). patients with sp and mdd were recruited through the outpatient clinics of the research centres, through local practitioners and through internet advertise‐ ments. if the recruited individuals were 18-65 years old, met diagnostic criteria for sp or mdd according to the diagnostic and statistical manual of mental disorders (4th ed., text rev., dsm-iv-tr; apa, 2000), and did not meet any of the exclusion criteria, they were invited to participate in the study. the diagnostic assessments were conducted with the structured clinical interview for dsm-iv axis i disorders (scid-i; first et al., 1997). the exclusion criteria were: current suicidal tendencies, current substance abuse and physical disabilities that prohibited proper use of a smartphone (e.g. an inability to see text on the screen or hear the smartphone’s signal; gloster et al., 2017). the inability to understand german was exclusionary. the controls were recruited through internet advertisements. čolić, latysheva, bassett et al. 5 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ if, according to the scid-i, they did not meet criteria for sp or mdd and were 18-65 years old, while not meeting any exclusion criteria, they were eligible for inclusion. sample size calculation the outpatient clinics, from which the patients were recruited, see an estimated 110 sp and 520 mdd patients per year. thus, the sample size calculation of the overall project (gloster et al., 2017), in which the present study was embedded, was grounded on the assumption that the maximum number of patients with sp that could feasibly be recruited within the study time period would be n = 48. assuming a dropout rate of 5%, this led to an expected number of 45 sp patients to complete the study. this number was used for the power analysis which assumed alpha = .05, power = .8, and a two-sided test for group comparisons on the between-subjects level. based on a medium effect size (d = 0.5), and 45 subjects in the sp group, the sample size necessary to achieve .8 power is 111 subjects in each of the other groups (mdd & controls). assuming a 5% dropout rate, 117 subjects would need to be recruited in each of these two groups. given that we conducted multilevel analyses on the within-subjects level, which usually requires a smaller number of subjects to reach a certain degree of statistical power than the between-subjects level (bellemare et al., 2016; charness et al., 2012), we considered this sample size sufficient for the test of our hypothesis. final sample a total of n = 290 participants were initially included, but n = 6 of them did not complete at least 50% of the esm time points. as an a priori decision (gloster et al., 2017), these participants were removed from the dataset. the final sample size consisted of n = 284 (n = 119 controls; n = 118 with mdd; n = 47 with sp). in the sp group, n = 15 (31.9%) had co-morbid mdd, while n = 29 (24.6%) patients with mdd had co-morbid sp. in controls, n = 9 subjects fulfilled criteria for a clinical diagnosis. the sociodemographic and clinical characteristics of the sample, as well as prevalent diagnoses among controls are presented in table 1. post-event processing in social phobia, major depressive disorder and controls 6 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ table 1 sociodemographic and clinical characteristics of the sample (n = 284) characteristics controls (n = 119) mdd (n = 118) sp (n = 47) age (m, sd) 32.2 (12) 32.7 (12) 28.3 (7.8) female (%) 67.2 66.1 66.0 education (years) (%) 8-10 12.0 21.1 9.3 11-13 53.0 51.4 67.4 14+ 35.0 27.5 23.3 living arrangement (%) alone 30.3 22.9 21.3 family/partner 49.6 60.2 55.3 other 20.2 16.9 23.4 employed (%) 57.1 52.5 38.3 number of diagnoses (%) 0 90.8a 0.0 0.0 1 6.7 45.8 44.7 2 1.7 29.7 27.7 3+ 0.8 24.6 27.7 in therapy (%) 14.3 58.5 46.8 note. controls = control group; mdd = major depressive disorder; sp = social phobia. afollowing diagnoses were prevalent in controls: specific phobia (n = 3), panic disorder (n = 2), anxiety disorder, unspecified (n = 1), obsessive-compulsive disorder (n = 2), agoraphobia with panic disorder (n = 1). measures post-event processing pep was measured with two items from the post-event processing questionnaire (pepq; rachman et al., 2000; german version: fehm, hoyer, et al., 2008): 1. “do you still think about the embarrassing moment from the interaction?”; and 2. “do you have difficulties to forget the embarrassing moment?”. the items were rated on a scale from 0 = not at all to 100 = 100% of the time since the interaction (50 = 50% of the time). the anchors of the scale were changed to percentages because the “percentage of time” approach is preferable to asking for durations, when symptoms lack a clear beginning or end (schimmack et al., 2000). these items were chosen because of their high factor loadings on the first factor (fehm, hoyer, et al., 2008). the german version of the pep-q had an internal consistency of α =.72 in the original translation of the pep-q and α = .90 in the extended version (see fehm, hoyer, et al., 2008). čolić, latysheva, bassett et al. 7 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ sis participants were asked about the number of sis (“since the last inquiry, how many social interactions did you have?”) and the number of meaningful sis (“since the last inquiry, how many of your social interactions were meaningful for you?”) since the last inquiry. they could indicate their answers on a scale from 0 = none to 6 = more than five (1 = one si, 2 = two sis, etc.). if they indicated having at least one meaningful si, they were asked to report about one si that was the most meaningful for them (from then on questions began with “regarding the most meaningful si…”). they were then asked whether they behaved in an embarrassing manner during that si (“regarding the most meaningful si, did you, in your own opinion, in some way behave in an embarrassing manner?”). only if they indicated doing something embarrassing, were they asked about the degree of pep (for survey structure see figure 1). figure 1 survey structure social interaction anxiety scale (sias) the sias is an inventory developed to assess anxiety in sis (mattick & clarke, 1998). it consists of 20 items that depict multiple socially anxious behaviours. the items are rated on a five-point scale. the german version of the sias (stangier et al., 1999) showed high internal consistency (α = .89-.94) across sp and mdd, as well as high test-retest reliability (r = .92) across various samples. post-event processing in social phobia, major depressive disorder and controls 8 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ beck depression inventory ii (bdi-ii) the bdi-ii (beck et al., 1996) is the most widely used measure of depression. it consists of 21 items depicting various dimensions of depression. the german version (hautzinger et al., 2006) that was used in the present study showed sound psychometric properties, exhibiting a high internal consistency (cronbach’s α = .92-.93) and a high test-retest reliability (r = .93). procedure in the overall study project, data were collected over two weeks with observations in seven-day intervals (gloster et al., 2017). time 1 occurred on the first day, time 2 on the eight day and time 3 on the 15th day of the study. the esm took place between time 2 and time 3. both the sias and bdi-ii were assessed as traits at time point 2 before giving out the smartphones (for the complete study design see gloster et al., 2017). participants received a smartphone and were instructed in its use. they were shown how to operate the smartphone, how to recognize the signal tone and how to initiate a survey after a signal. the esm took place for seven days. every day participants completed five surveys on the smartphone screen at fixed times, every three hours, meaning that participants could have completed a maximum of 35 (i.e. 7 x 5) surveys (gloster et al., 2017). prior to receiving the smartphone, participants could decide whether the first survey of the day would be at 10 a.m. or at 11 a.m. the survey would then start on all of the following days at that chosen time. statistical analysis data were analysed with stata statistical software version 14.2. (statacorp, 2015). for the analysis of between-group differences in sis, in indications of embarrassment and in the relative frequency of pep (h1, frequency; exploratory analysis), random effects logistic regression analyses were conducted (rabe-hesketh & skrondal, 2012). for these purposes, both pep variables were recoded. if participants indicated having pep in both items, the answer was coded with 1, and in the opposite case with 0. also, the items assessing the number of overall and meaningful sis were dichotomized (0 = 0, ≥ 1 = 1). to analyse the contributions of trait-social anxiety (sa) and trait-depression to pep (h2), the sias and bdi-ii scores were mean-centred and added as level-2 variables in the previous regression analysis. additionally, we estimated via multilevel mixed effects linear regression analysis (h1, duration) whether groups differed regarding time spent thinking about the event (pep, item 1) and regarding time spent having difficulties to forget the event (pep, item 2). in all estimations, the variable indicating group-affiliation was dummy coded (controls = 0, mdd = 1, sp = 2) and used in the regression analysis as predictor. for comparisons of two groups, the group coded with the lower number was čolić, latysheva, bassett et al. 9 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ used as the reference group (controls in the case of controls vs. mdd and controls vs. sp; mdd in the case of mdd vs. sp). the mentioned analyses were conducted also for comparisons between the “pure” sp (without mdd, coded as 0) and mdd group (without sp, coded as 1) and the comorbid group (mixed sp/mdd; h3). the intercept was specified as random. except for the linear regression analysis, odds ratios with corresponding 95% confidence intervals were calculated as the resulting measures. in all analyses, the p-value was set to .05. r e s u l t s overall, the participants completed 91.8% of the ema-assessments. there were no be‐ tween-group differences in the response rate (see supplemental materials). sis and embarrassment the controls differed from mdd and sp regarding the number of overall sis, while there was no difference between mdd and sp. there were no between-group differences in the number of meaningful sis (see table 2). for a more detailed overview of results see villanueva et al. (2020). the relative frequencies of embarrassing situations within the re‐ ported meaningful interactions were significantly higher in mdd and sp in comparison to controls, while there were no differences between mdd and sp. also, we explored between-group differences in instances of repeated embarrassment on the same day. these were higher in mdd and in sp compared to controls, while mdd and sp did not differ (see table 2). pep after embarrassing sis (h1) frequency when considering only the interactions in which participants felt embarrassed, partici‐ pants indicated thinking repetitively about the interaction (pep item 1) in 95.68% of embarrassing sis (controls: 96.67%; mdd: 96.07%; sp: 94.62%). difficulties to forget the event (pep item 2) were reported in 94.02% of embarrassing sis (controls: 86.67%; mdd: 93.82%; sp: 96.77%). there were neither differences between the groups in the relative frequency of repetitive thoughts (pep, item 1: controls vs. mdd, or = 0.85, p = .888, 95% ci [0.09, 7.70]; controls vs. sp, or = 0.58, p = .646, 95% ci [0.06, 5.69]; mdd vs. sp, or = 0.69, p = .567, 95% ci [0.19, 2.47]), nor in the relative frequency of difficulties to forget the event (pep, item 2: controls vs. mdd, or = 4.57, p = .170, 95% ci [0.52, 40.16], controls vs. sp, or = 7.45, p = .123, 95% ci [0.58, 96.11], mdd vs. sp, or = 1.62, p = .651, 95% ci [0.20, 13.50]). due to elevated indications of embarrassment in sp and mdd compared to controls, it follows that pep would also be higher in the clinical groups. post-event processing in social phobia, major depressive disorder and controls 10 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ to account for imprecisions during the answer selection on the visual analogue scale (e.g. mistakenly marking a low number instead of a 0), we repeated the analyses while recoding the pep variables as 0 when pep ≤ 5% and when pep ≤ 10%. however, no between-group differences were found. results are available upon request. duration the reported duration of pep is presented in table 3. there were no between-group differences. controlling for social anxiety and depression (h2) embarrassment in sis when trait sa was controlled, no differences between mdd and controls were found in indications of embarrassment. when trait depression was controlled, sis were interpreted as embarrassing significantly more in sp compared to controls. the results are shown in table 2. pep after embarrassing sis the between-group differences in the frequency and duration of pep remained non-sig‐ nificant even after controlling for levels of sa and depression of the individual. the results are presented in the supplemental materials. day-level embarrassment and pep we calculated day level embarrassment and pep in the groups and we explored be‐ tween-group differences. controls differed significantly from mdd and from sp in each embarrassment and pep (both variables), while there were no differences between mdd and sp (see table 4). čolić, latysheva, bassett et al. 11 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ ta b le 2 b et w ee ng ro up d if fe re nc es i n r el at iv e fr eq ue nc ie s of i nd ic at io ns o f o ve ra ll s is , o f m ea ni ng fu l s is a nd o f e m ba rr as sm en t w it hi n r ep or te d in qu ir ie s (n = 2 84 ) v ar ia bl e c on tr ol s m d d sp c on tr ol s vs . m d d c on tr ol s vs . s p m d d v s. s p rf (% ) rf (% ) rf (% ) o r p* 95 % c i o r p 95 % c i o r p 95 % c i a ny s ia 80 .4 74 .0 72 .6 0. 63 .0 06 [0 .4 5, 0 .8 7] 0. 57 .0 10 [0 .3 7, 0 .8 7] 0. 90 .6 25 [0 .5 8, 1 .3 8] a ny m ea ni ng fu l s ib 84 .9 85 .3 85 .2 1. 01 .6 82 [0 .7 3, 1 .3 8] 1. 09 .6 82 [0 .7 2, 1 .6 7] 1. 09 .7 02 [0 .7 1, 1 .6 6] in di ca tio ns o f e m ba rr as sm en tc 2. 14 8. 96 11 .7 3 4. 78 < .0 01 [2 .5 5, 8 .9 6] 6. 93 < .0 01 [3 .3 5, 1 4. 35 ] 1. 45 .2 13 [0 .8 1, 2 .6 0] re pe at ed e m ba rr as sm en td 3. 33 14 .0 4 12 .9 0 2. 80 .0 05 [1 .0 4, 5 .9 1] 2. 76 .0 06 [1 .0 5, 6 .2 0] 0. 21 .8 36 [1. 25 , 1 .5 4] d iff er en ce s in in di ca tio ns o f e m ba rr as sm en t w hi le c on tr ol lin g fo r tr ai t s oc ia l a nx ie ty 1. 86 .0 85 [0 .9 2, 3 .7 6] – – tr ai t d ep re ss io n – 3. 76 .0 01 [1 .7 7, 7 .9 8] – n ot e. c on tr ol s = c on tr ol s ub je ct s; m d d = m aj or d ep re ss iv e di so rd er ; s p = so ci al p ho bi a; r f ( % ) = re la tiv e pe rc en ta ge s. a f re qu en ci es a re re la tiv e to th e to ta l s um o f s oc ia l i nt er ac tio ns : 9 10 5 (d en om in at or s: c on tr ol s = 38 68 , m d d = 3 74 7, s p = 14 90 ). b f re qu en ci es a re re la tiv e to th e to ta l s um o f m ea ni ng fu l s oc ia l i nt er ac tio ns : 6 96 5 (d en om in at or s: c on tr ol s = 31 11 , m d d = 2 77 2, s p = 10 82 ). c f re qu en ci es a re re la tiv e to th e to ta l s um o f r ep or ts a bo ut th e m os t m ea ni ng fu l s oc ia l i nt er ac tio n: 4 18 3 (d en om in at or s: c on tr ol s = 79 3, m d d = 1 98 6, s p = 14 04 ). d f re qu en ci es a re re la tiv e to th e to ta l s um o f i nd ic at io ns o f e m ba rr as sm en t: 30 1 (d en om in at or s: c on tr ol s = 30 , m d d = 1 78 , s p = 93 ). *s ig ni fic an t d iff er en ce s ar e bo ld . ta b le 3 b et w ee ng ro up d if fe re nc es i n th e d ur at io n of t im e sp en t e ng ag in g in p os te ve nt p ro ce ss in g (n = 2 84 ) v ar ia bl e c on tr ol s m d d sp c on tr ol s vs . m d d c on tr ol s vs . s p m d d v s. s p m (s e) m (s e) m (s e) z p 95 % c i z p 95 % c i z p 95 % c i pe p, it em 1 35 .5 0 (5 .4 7) 43 .5 7 (2 .6 0) 40 .0 5 (3 .7 5) 1. 33 .1 82 [3. 79 , 1 9. 94 ] 0. 69 .4 93 [8. 45 , 1 7. 56 ] -0 .7 7 .4 40 [12 .4 8, 5 .4 3] pe p, it em 2 32 .1 0 (5 .7 2) 43 .6 8 (2 .7 8) 40 .7 2 (4 .0 5) 1. 82 .0 69 [0. 88 , 2 4. 06 ] 1. 23 .2 19 [5. 12 , 2 2. 37 ] -0 .6 0 .5 46 [12 .5 9, 6 .6 7] n ot e. pe p, it em 1 = t im e sp en t t hi nk in g re pe tit iv el y ab ou t t he e m ba rr as si ng e ve nt ; p ep , i te m 2 = t im e sp en t h av in g di ffi cu lti es to fo rg et th e em ba rr as si ng e ve nt ; c on tr ol s = c on tr ol g ro up ; m d d = m aj or d ep re ss iv e di so rd er ; s p = so ci al p ho bi a. post-event processing in social phobia, major depressive disorder and controls 12 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ ta b le 4 b et w ee ng ro up d if fe re nc es i n d ay l ev el s of e m ba rr as sm en t an d p os te ve nt p ro ce ss in g (n = 2 84 ) v ar ia bl e c on tr ol s m d d sp c on tr ol s vs . m d d c on tr ol s vs . s p m d d v s. s p m (s d ) m (s d ) m (s d ) z p 95 % c i z p 95 % c i z p 95 % c i em ba rr as sm en t 0. 03 (0 .2 0) 0. 21 (0 .5 5) 0. 29 (0 .6 0) 5. 16 < .0 01 [0 .1 1, 0 .2 5] 5. 30 < .0 01 [0 .1 6, 0 .3 4] 1. 41 .1 6 [0. 03 , 0 .1 5] pe p1 0. 03 (0 .1 9) 0. 20 (0 .5 4) 0. 27 (0 .5 9) 5. 09 < .0 01 [0 .1 1, 0 .2 4] 5. 06 < .0 01 [0 .1 4, 0 .3 2] 1. 21 .2 2 [0. 03 , 0 .1 4] pe p2 0. 03 (0 .1 8) 0. 20 (0 .5 4) 0. 28 (0 .5 8) 5. 10 < .0 01 [0 .1 1, 0 .2 4] 5. 29 < .0 01 [0 .1 5, 0 .3 3] 1. 44 .1 5 [0. 02 , 0 .1 5] n ot e. pe p, it em 1 = t im e sp en t t hi nk in g re pe tit iv el y ab ou t t he e m ba rr as si ng e ve nt ; p ep , i te m 2 = t im e sp en t h av in g di ffi cu lti es to fo rg et th e em ba rr as si ng e ve nt ; c on tr ol s = c on tr ol g ro up ; m d d = m aj or d ep re ss iv e di so rd er ; s p = so ci al p ho bi a. čolić, latysheva, bassett et al. 13 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ we also explored associations between embarrassment and both pep variables on the day level. both variables significantly predicted embarrassment: repetitive thoughts, β = 0.58, p < .001, 95% ci [0.56, 0.60]; difficulties to forget the event, β = 0.43, p < .001, 95% ci [0.42, 0.45]. controlling for co-morbidities between mdd and sp (h3) to investigate the contribution of co-morbidity, we divided the groups into patients with mdd and no sp as a co-morbid diagnosis (= mdd/nosp), patients with sp and no mdd as a co-morbid diagnosis (= sp/nomdd) and patients with mixed mdd and sp (= mixed/mdd/sp). we then analysed differences between these groups in indications of embarrassment as well as in the duration and frequency of both pep items. no between-group differences were found regarding any of these variables. results are presented in the supplemental materials. d i s c u s s i o n the findings highlight the high incidence of pep in individuals with sp and mdd, as well as controls, whenever a situation is perceived as embarrassing. the comprehensive nature of pep and its close ties to embarrassment are best reflected in its consistently high rates across all groups. at least 86% of all participants, irrespective of their diagnos‐ tic status, reported pep following an embarrassing si. the groups differed regarding neither its relative frequency nor its duration. these findings must be interpreted with caution, as we do not know the specific content of those repetitive thoughts in clinical groups and controls. while the clinical groups may have reinforced their dysfunctional cognitions, the controls might have focused more on coping with the embarrassing moment. however, while repetitive thinking about a recent embarrassing event seems to be common to all individuals, the more frequent indications of the event as being embarrassing in the first place might be specific for sp and mdd. thus, we can argue that the repetitive thoughts or difficulties to forget the embarrassing moment are not unusual, but rather the contextual processes preceding and laying foundation for their emergence, like the higher occurrence of subjective embarrassment. this was evident in the repeated embarrassment and the day-levels of embarrassment as well. one explanation may be that individuals with sp and mdd engage in misappraisals of the situation. such misappraisals are driven by high sa, characteristic not just for socially anxious but depressed individuals as well (e.g. t. a. brown et al., 2001), as between-group differences in indications of embarrassment dissipated after holding sa constant. this is in line with existing research of self-perception and cognitive biases related to sa. individuals with elevated levels of sa scrutinise their behaviour and un‐ derestimate how well they appear to others (mansell & clark, 1999). they are especially post-event processing in social phobia, major depressive disorder and controls 14 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ sensitive to threat cues and are more likely to interpret ambiguous reactions as evidence of negative social evaluation (heinrichs & hofmann, 2001; stopa & clark, 2000). an alternate explanation is that individuals with sp or mdd actually behave in more embarrassing ways due to a potential lack of social competence or due to the use of open or covert safety behaviours and concerns about their appearance (e.g. moscovitch et al., 2013). empirical data make this explanation, however, less probable as individuals with high social anxiety tend to be more biased in their evaluation of their own performance than in their social competence per se (alden & wallace, 1995; stopa & clark, 2000). accordingly, we can assume that heightened sa contributes to an event more likely to be perceived as embarrassing by the individual. however, once feelings of embar‐ rassment are activated, they can produce subsequent ruminative patterns irrespective of the diagnostic status. when trait sa is low, the indications of embarrassment, and consequently pep, are reduced to non-clinical levels. nonetheless, because of the high‐ er occurrence of repeated embarrassment and day-level embarrassment in the clinical groups, day-level pep was also significantly increased compared to controls. we can draw on these findings to propose a model of pep in mdd and to complement previous research on the formation of pep in sp. considering our analyses, in mdd both depressive and socially anxious states func‐ tion as catalysts for pep, but only symptoms of sa are a prerequisite to experience pep. hence, the following cycle can be proposed: heightened levels of sa in mdd might lead to more social events being interpreted as embarrassing. once embarrassment is experienced, the ongoing ruminations in depressed individuals, which are more general and encompass various areas of life (mcevoy et al., 2010; nolen-hoeksema et al., 2008), might include social encounters as a subject matter too, so that pep arises. on the other hand, if sa is low in mdd, it can be argued that social events might drop out as a possible content of ruminations, thus reducing the frequency of pep. however, it is not clear from our data what the content of these ruminations was, because only the frequency and duration of pep was assessed. while the quantity of pep might have been the same, just as with sis in previous research (baddeley et al., 2013; nezlek et al., 2000), the “quality” (i.e. content, affectivity) might have differed. according to previous research, it is reasonable to assume that in mdd the content consists of interpersonal rejection and accompanying beliefs of being less valuable (dill & anderson, 1999; gotlib et al., 2004; segrin, 2000). to explore this possibility, additional research investigating the cognitive content of pep in mdd is needed. in relation to sp, our results imply that sa and the heightened probability of pep are mediated through feelings of embarrassment. this is consistent with previous findings that negative self-perception mediates the relationship between sa and pep (perini et al., 2006). the present study expands those findings to other diagnoses, as well as to healthy individuals. on this basis, we can argue that sa is a marker that facilitates negative self-perception, which then enhances feelings of embarrassment and ultimately pep. čolić, latysheva, bassett et al. 15 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ a treatment approach for pep could comprise interventions correcting for maladap‐ tive interpretations that act as its precursor. thus, by minimising the (mis-) perceptions of embarrassment during sis, it can be argued that the probability of subsequent pep might significantly be reduced. another strategy would be meta-cognitive therapeutic interventions correcting for the subsequent ruminations (wells, 2009). also, we found that patients with mdd or sp indicated less frequently having had any si since the last inquiry than controls. this might reflect the social difficulties of the clinical groups (e.g. l. h. brown et al., 2011; chen et al., 2013). however, the groups did not differ in indications of meaningful sis. this could reflect the importance of social values compared to other values for patients with mdd and sp. patients tend to exhibit value-consistent behavior in social life areas, which could lead them into sis that are meaningful to them (wersebe et al., 2017). limitations and outlook the question remains whether the contents of those ruminations were maladaptive as well, since we only inquired if repetitive thinking occurred and if individuals had difficul‐ ties forgetting the events. it is possible that the controls focused on coping with the event and reframing the embarrassing moment in a positive way, while the clinical groups focused on negative evaluation or self-worthlessness. to discriminate between controls and clinical groups, as well as between specific cognitive biases in sp and mdd, future research should include additional items exploring the content of ruminative thoughts. an additional limitation is the use of only two items to measure pep, which makes our assessment highly specific. future studies should include a questionnaire that encom‐ passes multiple dimensions of pep and ideally a cut-off score for clinically significant severity of pep. that would allow us to explore whether the incidence rates of pep remain equally high in controls as in the clinical groups. it could as well be possible that the current pep measure is not sensible enough to detect differences between clinical groups and controls. even though we assessed the duration of pep as well and did not find differences between groups, an option in future research could be the inclusion of multiple pep measures. also, the nested structure of the survey allowed for explorations of pep only within the most meaningful si in which also feelings of embarrassment were experienced. this is due to the study being embedded within a large research project that explores a variety of transdiagnostic phenomena with multiple measures and across multiple disor‐ ders (gloster et al., 2017). while this strategy provides an abundance of insights across multiple domains, some questions regarding pep remain open. most notably, it remains unclear how often pep occurs across other sis (vs. the most meaningful) during the day. future esm studies constructed specifically for the investigation of pep should explore these research questions. post-event processing in social phobia, major depressive disorder and controls 16 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://www.psychopen.eu/ lastly, as the present study put the importance of embarrassment forward, it would be intriguing to explore further emotion and thought patterns following embarrassing sis. since this goes beyond the scope of the present article, it should be also a matter of future esm studies. conclusions the main conclusions of the study were that patients with sp and mdd had equal dura‐ tions and frequencies of pep as controls, but more frequent indications of embarrassment in meaningful sis than controls. the indications of embarrassment were primarily driven by trait social anxiety. the limitations notwithstanding, the investigation clearly demonstrated that sa and embarrassment (as a potential mediator) can be considered important psychological mechanisms behind pep in sp and in mdd. by implementing esm, responses are ecolog‐ ically valid and less biased than in questionnaire or laboratory research. funding: this work was supported by the swiss national science foundation [grant/award number: 100014_149524/1 and pp00p1_163716/1], awarded to andrew t. gloster. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. author note: prof. dr. a. gloster and prof. dr. j. hoyer planned and conducted this study in close collaboration and function as shared senior authors. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following sections (for access see index of supplementa‐ ry materials below): • section x1 = between-group differences in the occurrence of post-event processing after embarrassing social interactions after controlling for social anxiety and depression • section x2 = differences in embarrassment, and the frequency and duration of post-event processing between the exclusive sp and mdd groups and the comorbid sp/mdd group • section x3 = differences in completed ema-assessments index of supplementary materials čolić, j., latysheva, a., bassett, t. r., imboden, c., bader, k., hatzinger, m., . . . hoyer, j. 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(2007). autobiographical memory specificity and emotional disorder. psychological bulletin, 133(1), 122-148. https://doi.org/10.1037/0033-2909.133.1.122 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. čolić, latysheva, bassett et al. 23 clinical psychology in europe 2020, vol.2(4), article e2867 https://doi.org/10.32872/cpe.v2i4.2867 https://doi.org/10.1007/s41347-019-00121-x https://doi.org/10.1016/j.jcbs.2016.11.005 https://doi.org/10.1037/0033-2909.133.1.122 https://www.psychopen.eu/ post-event processing in social phobia, major depressive disorder and controls (introduction) background method study design participants measures procedure statistical analysis results sis and embarrassment pep after embarrassing sis (h1) controlling for social anxiety and depression (h2) controlling for co-morbidities between mdd and sp (h3) discussion limitations and outlook conclusions (additional information) funding competing interests acknowledgments author note supplementary materials references change processes in cognitive therapy for social anxiety disorder delivered in routine clinical practice research articles change processes in cognitive therapy for social anxiety disorder delivered in routine clinical practice graham r. thew abc, anke ehlers acde, nick grey def, jennifer wild ac, emma warnock-parkes acde, rachelle l. dawson a, david m. clark acde [a] department of experimental psychology, university of oxford, oxford, united kingdom. [b] oxford university hospitals nhs foundation trust, oxford, united kingdom. [c] oxford health nhs foundation trust, oxford, united kingdom. [d] institute of psychiatry, psychology and neuroscience, king’s college london, london, united kingdom. [e] national institute for health research mental health biomedical research centre, south london and maudsley nhs foundation trust, london, united kingdom. [f ] sussex partnership nhs foundation trust, worthing, united kingdom. clinical psychology in europe, 2020, vol. 2(2), article e2947, https://doi.org/10.32872/cpe.v2i2.2947 received: 2020-03-15 • accepted: 2020-05-05 • published (vor): 2020-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: graham r. thew, oxford centre for anxiety disorders and trauma, department of experimental psychology, university of oxford, the old rectory, paradise square, oxford ox1 1tw, uk. e-mail: graham.thew@psy.ox.ac.uk abstract background: most studies examining processes of change in psychological therapy for social anxiety disorder (sad) have analysed data from randomised controlled trials in research settings. method: to assess whether these findings are representative of routine clinical practice, we analysed audit data from two samples of patients who received cognitive therapy for sad (total n = 271). three process variables (self-focused attention, negative social cognitions, and depressed mood) were examined using multilevel structural equation models. results: significant indirect effects were observed for all three variables in both samples, with negative social cognitions showing the strongest percent mediation effect. ‘reversed’ relationships, where social anxiety predicted subsequent process variable scores, were also supported. conclusion: the findings suggest the processes of change in this treatment may be similar between research trials and routine care. keywords social anxiety, cognitive therapy, change processes, structural equation model, mediation this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2947&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • the three process variables examined showed significant indirect effects on subsequent social anxiety. • there was evidence of a bidirectional relationship between process and outcome. • results are consistent with the theoretical model underpinning the treatment. • the change processes of this treatment in routine practice may be similar to those found in research trials. there is good evidence for the efficacy of psychological therapies in the treatment of mental health problems. however, there is a less clear understanding of the exact pro‐ cesses through which they operate. further research on mechanisms of clinical improve‐ ment has been highlighted as a significant need in clinical psychology (emmelkamp et al., 2014; holmes et al., 2018; kazdin, 2007). if we can determine which process variables are involved in producing clinical improvement, it may be possible to adapt therapies to place more emphasis on these, and to implement techniques that target them earlier in therapy, so as to increase the efficacy and efficiency of treatment. in social anxiety disorder (sad), there is a small but growing body of literature exploring process-outcome relationships in psychological therapy. the choice of process variables to be assessed is generally derived from theoretical accounts of sad, such as the cognitive model of clark and wells (1995), and the cognitive-behavioural model of rapee and heimberg (see hope, heimberg, & turk, 2006; rapee & heimberg, 1997). the clark and wells model specifies several anxiety-maintaining factors that are potential predictors of clinical change. these include negative social anxiety-related cognitions, avoidance and safety behaviours, and self-focused, evaluative attention. the rapee and heimberg model also highlights hypervigilance, avoidance and attentional bias towards perceived threat as potential mechanisms of anxiety maintenance. besides anxiety-main‐ taining factors, other variables such as working alliance, or measures of the degree of compliance with clinical techniques, could be examined. five studies, mostly focusing on cognitive-behavioural interventions (boden et al., 2012; calamaras, tully, tone, price, & anderson, 2015; goldin et al., 2014; gregory, wong, marker, & peters, 2018; hoffart, borge, sexton, clark, & wampold, 2012), have shown evidence that changes in negative cognitions and threat appraisals were as‐ sociated with improvements in social anxiety, while two studies (mörtberg, hoffart, boecking, & clark, 2015; niles et al., 2014) did not find evidence of an association be‐ tween changing negative cognitions and outcome. evidence of changes in self-focused at‐ tention being associated with clinical improvement was found in the study by mörtberg et al. (2015), and in both individual and group cognitive therapy (ct) in a study by hedman et al. (2013). two studies showed support for avoidance of social situations as change processes in ct for social anxiety 2 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ a predictor of outcome (aderka, mclean, huppert, davidson, & foa, 2013; hedman et al., 2013), and the study of participants’ use of exposure and thought records (hawley, rector, & laposa, 2016) also supported a predictive relationship for these factors. in contrast, the two studies analysing working alliance either did not find a mediation relationship (calamaras et al., 2015) or found that the alliance-outcome relationship was itself mediated by cognitive factors (hoffart et al., 2012). the one study investigating physiological anxiety symptoms did not find evidence of a predictive association with outcome (aderka et al., 2013), while the one study examining depression found a weak effect (moscovitch, hofmann, suvak, & in-albon, 2005). although it is promising that mediation and other predictive effects in treatments for sad are starting to emerge, there is a lack of consistency across the studies to date regarding which process variables, and which treatments, are examined. it is rare for two studies to examine the same process variables within the same treatment. in addition, the participant samples analysed in the studies are almost all drawn from randomised controlled trials (rcts), meaning there is a lack of research using data from routine clinical practice. datasets from such settings typically include a larger number of thera‐ pists, some therapists who are less experienced, and fewer participant selection criteria relative to rcts. in the same way that effectiveness studies in routine clinical settings complement efficacy studies, in that they can test whether findings from controlled research settings apply in routine practice (gunter & whittal, 2010; kettlewell, 2004; weisz, ng, & bearman, 2014), it can be argued that for a predictor to be considered reliable, it should operate similarly regardless of setting. it is therefore important to examine process-outcome effects within data from routine clinical practice. the present study therefore aimed to explore change processes during cognitive therapy for social anxiety disorder (ct-sad) based on the clark and wells (1995) model delivered in routine clinical practice, using data from an audit of clinical outcomes from a specialist national health service (nhs) anxiety clinic in london. to be consis‐ tent with previous literature, negative social cognitions and self-focused attention were examined as process variables, and were measured in the same way as in previous studies (e.g. hedman et al., 2013; mörtberg et al., 2015). these variables have a strong theoretical basis given their key roles within the clark and wells (1995) model. in addition, depressed mood, which is not a component of the cognitive model of sad, was investigated as an additional process variable to examine the specificity of any effects found using the other two theoretically-derived factors (see preacher, 2015). there is, however, a plausible rationale for changes in depressed mood being associated with improvements in social anxiety, in that a reduction in depressed mood over time may be accompanied by greater hopefulness and optimism about treatment and the future, leading to subsequent improvement in social anxiety outcomes. thew, ehlers, grey et al. 3 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ m e t h o d participants data were drawn from an audit of clinical outcomes of psychological therapy for sad, which examined consecutive referrals to the centre for anxiety disorders and trauma, a uk nhs specialist clinic in london. the service receives referrals from general prac‐ titioners and community mental health teams. assessments were completed between may 2001 and august 2010. all assessments were conducted by a trained clinician and included the structured clinical interview for dsm-iv (scid-iv; first, spitzer, gibbon, & williams, 2002) to determine primary and comorbid diagnoses. the personality disorder screener questions of the scid-ii (first, gibbon, spitzer, williams, & benjamin, 1997) were also given, with further assessment undertaken as clinically indicated. all partici‐ pants met dsm-iv criteria for sad, with sad being judged to be the main problem by the assessing clinician. exclusion criteria were current psychosis, or dependence on alcohol or substances. across the audit period, 317 people were treated with ct-sad. three of these people were re-referred during the audit period and received a second course of treatment; only their first course of treatment was included in the analysis. files of seven people who received treatment were not available for data entry. to be included in the present studies, participants were required to have attended at least five treatment sessions and completed the weekly questionnaires on at least five occasions. this ensured a sufficient number of measurement points per participant to permit analysis of process variables over time. as 23 participants attended fewer than five sessions, and 13 completed insuffi‐ cient questionnaire data for analysis, the final sample size for the analysis of standard ct-sad was 271. these participants completed an average of 12.3 sessions (sd = 2.9). six participants (2%) had more than 18 sessions and the greatest number of sessions attended was 26. treatment extended over an average of 204.3 days (sd = 103.7). there were 69 partici‐ pants who received their treatment as part of research trials running at the time. some of the outcome measures used by the clinic were changed in september 2008 when the clinic joined the improving access to psychological therapies (iapt) programme (see clark, 2018). participants treated before (sample 1; n = 185) and after (sample 2; n = 86) this change in outcome measures were analysed separately. demo‐ graphic and clinical characteristics of both samples are shown in table 1. the audit was approved by the local ethics committee. change processes in ct for social anxiety 4 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ table 1 demographic and clinical characteristics participant variable sample 1 (n = 185) sample 2 (n = 86) total (n = 271) % female 48 52 49 mean age (sd) 32.2 (8.6) 33.2 (9.5) 32.5 (8.9) marital status n (%) married 19 (10.3) 22 (25.6) 41 (15.1) cohabiting 28 (15.1) 8 (9.3) 36 (13.3) widowed 1 (0.5) 0 1 (0.4) divorced 3 (1.6) 0 3 (1.1) separated 5 (2.7) 3 (3.5) 8 (3.0) single/never married 120 (64.9) 45 (52.3) 165 (60.9) not given 9 (4.9) 8 (9.3) 17 (6.3) ethnicity n (%) black 11 (5.9) 8 (9.3) 19 (7.0) caucasian 140 (75.7) 37 (43.0) 177 (65.3) indian 2 (1.1) 2 (2.3) 4 (1.5) pacific asian 1 (0.5) 0 1 (0.4) other 6 (3.2) 0 6 (2.2) not given 25 (13.5) 39 (45.3) 64 (23.6) highest qualification n (%) doctoral degree 7 (3.8) 2 (2.3) 9 (3.3) masters degree 18 (9.7) 11 (12.8) 29 (10.7) professional qualification 15 (8.1) 5 (5.8) 20 (7.4) bachelors degree 71 (38.4) 27 (31.4) 98 (36.2) a levels 31 (16.8) 12 (14.0) 43 (15.9) gcses 23 (12.4) 9 (10.5) 32 (11.8) none 12 (6.5) 3 (3.5) 15 (5.5) other 7 (3.8) 3 (3.5) 10 (3.7) not given 1 (0.5) 14 (16.3) 15 (5.5) employment status n (%) unemployed 33 (17.8) 11 (12.8) 44 (16.2) full time 103 (55.7) 52 (60.5) 155 (57.2) part time 20 (10.8) 6 (7.0) 26 (9.6) self-employed 4 (2.2) 5 (5.8) 9 (3.3) sick leave 3 (1.6) 1 (1.2) 4 (1.5) retired 0 2 (2.3) 2 (0.7) student 17 (9.2) 2 (2.3) 19 (7.0) homemaker 2 (1.1) 1 (1.2) 3 (1.1) freelance 0 1 (1.2) 1 (0.4) thew, ehlers, grey et al. 5 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ participant variable sample 1 (n = 185) sample 2 (n = 86) total (n = 271) compassionate leave 0 1 (1.2) 1(0.4) not given 3 (1.6) 4 (4.7) 7 (2.6) mean age of sad onset in years (sd) 19.3 (8.4) 19.1 (7.1) 19.3 (8.0) mean duration of sad in years at assessment (sd) 12.9 (9.5) 13.9 (10.8) 13.2 (9.9) % prescribed psychotropic medication 30 25 29 treatment all participants received individual ct-sad as described in clark et al. (2006). manuals, videos of workshops, and other therapist support materials are available at https://oxca‐ datresources.com (oxford centre for anxiety disorders and trauma, 2019). the standard structure of treatment used in rcts comprises 14 weekly sessions, followed by up to three booster sessions at monthly intervals. for the present participants treated in rou‐ tine clinical practice, this structure was followed in most cases, but for some, adjustments in the number and spacing of sessions were made due to clinical need. end of treatment outcomes were taken from the last attended session. therapists therapists were mental health professionals with a range of professional backgrounds including clinical psychology, counselling psychology, nursing and/or specialist cbt training. some of the therapists were on training placements within the service (trainee clinical psychologists, trainee high intensity therapists, and specialist psychiatry regis‐ trars). a total of 22 therapists treated the participants in sample 1, and 36 therapists for the participants in sample 2. the number of participants seen by each therapist ranged from 1 to 24. session-by-session measures self-focused attention this was measured using the mean score of the two self-focused attention items in the social phobia weekly summary scale (spwss; clark, 1995, available at https://oxcadatre‐ sources.com) where people provide a rating of their self-focused attention in general, and in situations they found difficult, over the past week. the full six-item scale also elicits ratings of avoidance, anticipatory worry, and post-event rumination over the previous week, along with an overall rating of social anxiety. all items are rated on 0-8 likert scales, with total scores ranging between 0 and 48. the spwss has been shown to be sensitive to treatment effects and has good internal consistency (clark et al., 2006; clark et al., 2003). cronbach’s alpha in the present sample for the two self-focused attention items was .75 at baseline and .89 at end of treatment. change processes in ct for social anxiety 6 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://oxcadatresources.com https://oxcadatresources.com https://oxcadatresources.com https://oxcadatresources.com https://www.psychopen.eu/ negative social cognitions the social cognitions questionnaire (scq; oxford centre for anxiety disorders and trauma, 2019; wells, stopa, & clark, 1993) was used, which presents 22 negative social cognitions, each of which is rated for both the frequency with which it occurred in the last week when the respondent was anxious (rated from 1 = “thought never occurs” to 5 = “thought always occurs when i am nervous”), and the degree to which they believe the thought to be true when it occurs (rated from 0 = “i do not believe this thought”, to 100 = “i am completely convinced this thought is true”). mean scores are calculated for frequency (range 1-5) and belief (range 0-100) with higher scores indicating more negative social cognition. cronbach’s alpha in the present sample was .90 (baseline) and .96 (end of treatment) for the frequency subscale and .91 (baseline) and .97 (end of treatment) for the belief subscale. for the present studies the frequency and belief subscales were standardised and averaged to produce a single composite z score. depressed mood for sample 1, depressed mood was measured using the beck depression inventory (bdi; beck & steer, 1993). cronbach’s alpha in the present sample was .91 at baseline and .94 at end of treatment. for sample 2, depressed mood was measured using the patient health questionnaire – 9-item version (phq; kroenke, spitzer, & williams, 2001). cronbach’s alpha in the present sample was .88 at baseline and .92 at end of treatment. social anxiety for sample 1, social anxiety was measured using the social phobia weekly summary scale (clark et al., 2003; oxford centre for anxiety disorders and trauma, 2019), minus the two attention items. a total social anxiety severity score was computed from the items: overall rating of social anxiety, avoidance, anticipatory worry, and post-event rumination. cronbach’s alpha for the baseline and end of treatment scores were .74 and .91 respectively. for sample 2, social anxiety was measured using the social phobia inventory (spin; connor et al., 2000), a 17-item scale listing a range of sad-related problems, incorporating fear, avoidance, and physical symptoms. cronbach’s alpha for the baseline and end of treatment scores were .90 and .93 respectively. analysis a series of multilevel structural equation models (msem) were computed (see preacher, zhang, & zyphur, 2011; preacher, zyphur, & zhang, 2010) based on the analytic strategy of mörtberg et al. (2015), with total scores at each session (level 1) nested within participants (level 2). therapist was not included as a third level given the limited number of therapists1, and the variability in the number of participants seen by each therapist. for two-level models, data simulations have shown that sample sizes of 50 and thew, ehlers, grey et al. 7 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ above produce unbiased parameter estimates under a range of conditions (hox, maas, & brinkhuis, 2010). the number of elapsed days in treatment was used as the independent variable, and severity of social anxiety as the dependent variable (see figure 1). three process variables were assessed: 1) self-focused attention, 2) negative social cognitions; and 3) depressed mood. all variables were measured at level 1 following the mediation procedure described by bauer et al. (2006). to incorporate temporal precedence of the process variable (media‐ tor), lagged scores were used, where social anxiety scores at any given assessment point (time j) were regressed on the scores on the process variable at the previous assessment point (time j-1). social anxiety scores from the first week of therapy were therefore not included in the analysis due to the absence of prior scores on the process variable. social 1) maas and hox (2005) suggest group sizes over 50 at the higher level of multilevel models are most appropriate to avoid biased estimates. figure 1 simplified path diagram of multilevel structural equation model (msem) to test the indirect effect of time on scores on the social phobia inventory (spin) via one of three process variables note. filled circles indicate paths specified as random, and raised arrows indicate residuals. change processes in ct for social anxiety 8 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ anxiety data from all other available sessions were included, as the model incorporated time gaps between assessment points. models used robust maximum likelihood estima‐ tion (mlr). path a (regression of the process variable on the independent variable) and path c’ (regression of the dependent variable on the independent variable, in the presence of the process variable) were allowed to vary across participants and were therefore estimated as random, while path b (regression of the dependent variable on the process variable) was modelled as a fixed effect. this was done both to limit model complexity, and because the extent of between-subject variability in this relationship was not of primary interest in this study. to prevent the conflation of withinand between-sub‐ jects variance, independent and process variables were disaggregated into withinand between-level components via group mean centering. the participant (group) mean-cen‐ tered scores, and the participant mean scores across all timepoints therefore represented the within and between components of these variables, respectively, and were entered into the model separately (see hoffart, borge, & clark, 2016; preacher et al., 2010). this approach therefore permits the examination of within-subjects effects, controlling for between-subjects effects. to further examine the direction of the mediated effect, a series of models were computed which were identical to the models described above apart from the process and outcome variables, which were swapped. these therefore examined the ‘reversed’ relationship, using social anxiety at time j-1 as the potential mediator, and self-focused attention, negative social cognitions, or depressed mood at time j as the dependent variable. percent mediation (pm) of outcome by the process variable was calculated as an indicator of the strength of any indirect effects following the procedures described in kenny et al. (2003) and moscovitch et al. (2005); pm = 100 × [((ab + c’ + σab) c’) / (ab + c’ + σab)], where a, b, and c’ represent the respective path coefficients, and σab is the covariance between a and b. however, as path b was specified as fixed, and the covariance between a random and fixed path equals zero, the formula simplifies to pm = 100 × (ab / ab + c’), and the indirect effect to a × b (see mörtberg et al., 2015). analyses were performed using mplus version 7.0 (muthén & muthén, 1998-2015) and r version 3.4.3 (r core team, 2017) using the r package ‘mplusautomation’ (hallquist & wiley, 2018). inspection of the intraclass correlation coefficients for each model indicated sufficient between-subject variance to justify multilevel analysis (icc = .43 – .68). alongside p-values, confidence intervals of parameter estimates were reviewed to assess statistical significance. thew, ehlers, grey et al. 9 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ r e s u l t s baseline and end of treatment means and standard deviations for samples 1 and 2 are shown in table 2. significant decreases were observed across treatment on all of the measures assessed. table 2 baseline and end of treatment mean scores for samples 1 and 2 measure baseline m (sd) end of treatment m (sd) test statistic pre-post dcohen [95% ci] sample 1 (n = 185) spwss (4-item) 21.07 (5.04) 9.41 (7.18) t(183) = 22.23, p < .001 1.88 [1.63, 2.12] sfa 5.30 (1.48) 2.52 (1.75) t(176) = 18.59, p < .001 1.72 [1.47, 1.96] scq-c 1.38 (1.22) -0.91 (1.36) t(182) = 22.77, p < .001 1.77 [1.53, 2.01] bdi 18.32 (11.03) 7.94 (10.07) t(184) = 14.68, p < .001 0.98 [0.77, 1.20] sample 2 (n = 86) spin 41.52 (12.72) 21.71 (15.67) t(70) = 12.35, p < .001 1.39 [1.04, 1.74] sfa 4.82 (1.80) 2.92 (1.83) t(82) = 9.21, p < .001 1.05 [0.73, 1.37] scq-c 1.42 (1.29) -0.74 (1.34) t(77) = 15.34, p < .001 1.64 [1.29, 2.00] phq 11.17 (6.85) 5.21 (6.17) t(83) = 9.59, p < .001 0.91 [0.60, 1.23] note. baseline (pre) scores are taken from the initial assessment, or the session 1 score in cases where no assessment score was available. end of treatment (post) scores used the last available score. t statistics represent paired t-tests comparing baseline and end of treatment scores. spwss = social phobia weekly summary scale; sfa = self-focused attention; scq-c = social cognitions questionnaire – composite z score; bdi = beck depression inventory. spin = social phobia inventory; phq = patient health questionnaire. dcohen calculated using the pooled standard deviation as the denominator, calculated as sqrt((sd 2initial + sd 2post) / 2) (van etten & taylor, 1998). confidence intervals for dcohen were calculated using the hedges and olkin formula (see lee, 2016). cohen (1988) suggested that broadly, effect sizes of 0.2, 0.5, and 0.8 indicated small, medium, and large effects, respectively. sample 1 results of the msem models are shown in table 3. significant indirect effect estimates were observed for all three of the process variables assessed, indicating that self-focused attention, negative social cognitions, and depressed mood all mediated the effect of time on social anxiety. the significant and negative path a coefficients highlighted that as time in therapy increased, scores on the process variables decreased, with the significant, positive path b coefficients indicating that these lower scores predicted lower social anxiety at the following assessment. inspection of the percent mediation values indicated that negative social cognitions showed the strongest indirect effect. the reversed models, which swapped the social anxiety and process variables but re‐ tained the time-lag component, were also significant for the three process variables change processes in ct for social anxiety 10 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ assessed. these findings suggest that lower social anxiety scores were associated with subsequent reduced self-focused attention, reduced negative social cognitions, and im‐ proved mood at the following assessment. the percent mediation values for these models were similar across the three variables examined. table 3 model results for sample 1: unstandardised path coefficients, random slope variances, and indirect effect estimates parameter self-focused attention negative social cognitions depressed mood estimate se p pm estimate se p pm estimate se p pm a -0.013 0.001 < .001 -0.011 0.001 < .001 -0.035 0.003 < .001 b 0.821 0.100 < .001 1.922 0.162 < .001 0.162 0.034 < .001 c’ -0.039 0.002 < .001 -0.029 0.002 < .001 -0.044 0.003 < .001 vara < 0.001 < 0.001 < .001 < 0.001 < 0.001 < .001 0.001 < 0.001 < .001 varc’ 0.001 < 0.001 < .001 < 0.001 < 0.001 < .001 0.001 < 0.001 < .001 indirect effect ab -0.010 0.001 < .001 21 -0.021 0.002 < .001 42 -0.006 0.001 < .001 11 models reversing process variable and outcome a -0.053 0.003 < .001 -0.053 0.03 < .001 -0.053 0.003 < .001 b 0.096 0.008 < .001 0.073 0.005 < .001 0.159 0.030 < .001 c’ -0.006 0.001 < .001 -0.005 < 0.001 < .001 -0.022 0.003 < .001 vara 0.001 < 0.001 < .001 0.001 < 0.001 < .001 0.001 < 0.001 < .001 varc’ (see notes) (see notes) 0.001 < 0.001 < .001 indirect effect ab -0.005 0.001 < .001 46 -0.004 < 0.001 < .001 43 -0.008 0.002 < .001 28 note. n = 185. path a represents the effect of time on the process variable. path b represents the effect of the process variable on social anxiety score at the subsequent assessment (with time held constant). path c’ represents the effect of time on social anxiety score controlling for the effect of the process variable. path ab represents the indirect, or mediated, effect. the ‘reversed’ models swap the process and outcome variables. se = standard error, pm = percent mediation (i.e. the percentage of the total effect of time on outcome score that is accounted for by the mediated path ab), var = variance. due to lack of model convergence when the c’ path was specified as random, the reversed models for self-focused attention and negative social cognitions were run using a fixed c’ path therefore no variance is given. sample 2 results of the msem models for sample 2 are shown in table 4. these models also showed significant indirect effect estimates for all three of the process variables assessed (self-focused attention, negative social cognitions, and depressed mood), indicating that these variables mediated the effect of time on social anxiety as measured by the spin. the percent mediation values again indicated that negative social cognitions showed the strongest effect, though the strength of the indirect effect for self-focused attention was weaker in sample 2 compared to sample 1. the reversed models were significant for the three process variables assessed, with similar percent mediation values across the three thew, ehlers, grey et al. 11 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ variables, as was observed in sample 1. overall, the consistency of model results between the two samples was high, suggesting the sample 1 findings were replicated in sample 2. table 4 model results for sample 2: unstandardised path coefficients, random slope variances, and indirect effect estimates parameter self-focused attention negative social cognitions depressed mood estimate se p pm estimate se p pm estimate se p pm a -0.016 0.001 < .001 -0.016 0.001 < .001 -0.036 0.005 < .001 b 0.796 0.250 .001 3.199 0.448 < .001 0.428 0.123 < .001 c’ -0.128 0.011 < .001 -0.092 0.010 < .001 -0.127 0.011 < .001 vara < 0.001 < 0.001 < .001 < 0.001 < 0.001 < .001 0.001 < 0.001 < .001 varc’ 0.007 0.001 < .001 0.005 0.001 < .001 0.007 0.001 < .001 indirect effect ab -0.013 0.004 .003 9 -0.050 0.008 < .001 35 -0.015 0.005 .002 11 models reversing process variable and outcome a -0.158 0.012 < .001 -0.158 0.012 < .001 -0.159 0.012 < .001 b 0.030 0.007 < .001 0.040 0.005 < .001 0.078 0.021 < .001 c’ -0.010 0.002 < .001 -0.007 0.001 < .001 -0.021 0.005 < .001 vara 0.010 0.002 < .001 0.010 0.002 < .001 0.010 0.002 < .001 varc’ < 0.001 < 0.001 < .001 (see notes) 0.001 < 0.001 .001 indirect effect ab -0.005 0.001 < .001 32 -0.006 0.001 < .001 47 -0.012 0.004 .001 37 note. n = 86. path a represents the effect of time on the process variable. path b represents the effect of the process variable on social anxiety score at the subsequent assessment (with time held constant). path c’ represents the effect of time on social anxiety score controlling for the effect of the process variable. path ab represents the indirect, or mediated, effect. the ‘reversed’ models swap the process and outcome variables. se = standard error, pm = percent mediation (i.e. the percentage of the total effect of time on outcome score that is accounted for by the mediated path ab), var = variance. due to lack of model convergence when the c’ path was specified as random, the reversed model for negative social cognitions was run using a fixed c’ path therefore no variance is given. d i s c u s s i o n this study aimed to examine whether self-focused attention, negative social cognitions, and depressed mood were associated with clinical improvement in ct-sad delivered in a routine clinic setting. negative social cognitions were supported as a mediator of clinical improvement in samples 1 and 2, showing the strongest percent mediation values of the three process variables assessed. the results therefore support the clark and wells (1995) model that underpins the treatment, and suggest that one of the reasons why people experience less social anxiety as they progress through treatment is that they are experiencing fewer and less-convincing negative thoughts about social situations. these findings are in line with a number of other studies investigating cognitions as a possible change processes in ct for social anxiety 12 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ process variable driving improvements in social anxiety (boden et al., 2012; calamaras et al., 2015; goldin et al., 2014; gregory et al., 2018; hoffart et al., 2012). self-focused attention was supported as a mediator of clinical improvement in both samples 1 and 2, suggesting that successfully shifting towards a more external focus of attention is one reason for the reduction in social anxiety as time in therapy increases. these findings are consistent with the three existing studies of self-focused attention (hedman et al., 2013; hoffart et al., 2016; mörtberg et al., 2015), all of which used the same treatment protocol and found process-outcome effects within rct datasets using analytic approaches similar to the present study. however, the results from both of the present samples indicated a weaker effect for self-focused attention compared to cogni‐ tions. this may indicate a distinction between the rct context and routine practice, for example in how the self-focus aspects of treatment were implemented. the clinical methods to address self-focused attention were further refined during the audit period, so it is likely that not all participants completed an ‘attention training’ session or had this consistently emphasised during treatment. in contrast, participants in the hoffart et al. (2016), hedman et al. (2013), and mörtberg et al. (2015) studies all completed a specific attention training session, and were supported to practise externally focused attention throughout therapy. it is possible that the lesser emphasis on targeting self-focused attention in the present samples, especially in comparison to targeting cognitions, may help to explain the differences observed in the strength of these effects. depressed mood showed significant mediation across samples 1 and 2, though the percent mediation values indicated a weaker relationship compared to negative social cognitions. the weaker and less consistent effects observed for this variable, which is not part of the theoretical model underpinning ct-sad, therefore lend some support to the specificity of the effects found for the theoretically-derived process variables. it is notable that for both samples 1 and 2, significant ‘reversed’ effects were observed across the three process variables, with similar or greater percent mediation values than in the forward models. this may indicate a cyclical relationship between process and outcome, where changes in negative cognitions and self-focused attention lead to subsequent reductions in social anxiety, and in addition, reductions in social anxiety have a beneficial effect in reducing negative social beliefs and perhaps reducing the perceived need to monitor and focus on yourself in social situations. strengths and limitations from a methodological perspective, the use of an additional process variable that is not part of the theoretical model being tested, and statistical methods such as msem to account for repeated-measures data and the betweenand within-person variance were strengths of the present work and should be considered for future studies in this area. reversed models are also not implemented consistently and are therefore recommended. while the division of the data into two samples was necessary given the different thew, ehlers, grey et al. 13 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ outcome measures used, it provided a helpful opportunity to assess whether the sample 1 results would replicate, and the similarity of the results between samples affords increased confidence in the findings. the self-focused attention models may be limited by the use of a two-item mean score to measure this construct. while this measure has been used previously (hoffart et al., 2016; mörtberg et al., 2015) future research could usefully develop more nuanced tools to monitor change in this variable over time. it remains possible that other process variables not assessed in the present studies could show strong associations with outcome; for example the use of safety behaviours would be hypothesised as a mediator based on the clark and wells (1995) model, but could not be examined here given this was not measured weekly. it is noted also that the present models only examine consecutive timepoints (usually weekly measures), so do not assess process-outcome effects on broader levels, for example delayed or cumulative effects of changes in process variables. conclusion overall, the present study found that in routine clinical practice, three process variables (negative social cognitions, self-focused attention, and depressed mood) were associated with subsequent social anxiety outcomes in ct-sad, with negative social cognitions showing the strongest and most consistent effect. the findings are therefore in line with the clark and wells (1995) model that underpins the treatment, and are consistent with rct-based research findings examining cognitive-behavioural therapies for sad. further work examining associations between process variables and clinical outcomes within datasets from routine clinical practice is recommended. change processes in ct for social anxiety 14 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ funding: the study was supported by the wellcome trust [102176 (grt); 069777 and 200796 (ae & dmc)], the nihr oxford biomedical research centre (grt), the oxford health nihr biomedical research centre (grt, ae), nihr senior investigator awards (ae, dmc), and the nihr mental health biomedical research centre at south london and maudsley nhs foundation trust and king’s college london. the views expressed are those of the authors and not necessarily those of the nhs, the nihr or the department of health. the funding sources had no involvement in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors wish to thank the clients and therapists of the centre for anxiety disorders and trauma. we would like to thank kelly archer, georgina bremner, lauren canvin, siobhan commins, laura franklin, ruth morgan, hannah murray, jennifer readings, anna sandall, elizabeth woodward and yvette yeboah for their help with data collection and entry, margaret dakin, sue helen, and julie twomey for administrative support, magdalena janecka for statistical advice, and milan wiedemann for comments on an earlier version of the manuscript. author contributions: grt and dmc developed the data analysis concept. dmc and ae designed the data collection protocol and with ng, jw, and ewp supervised treatment and data collection. rd collated, entered, and cleaned the data. grt performed the analyses and drafted the paper, under supervision from ae and dmc who provided critical revisions. all authors reviewed and approved the final version of the paper for submission. r e f e r e n c e s aderka, i. m., mclean, c. p., huppert, j. d., davidson, j. r., & foa, e. b. 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(1993). the social cognitions questionnaire. unpublished manuscript, university of oxford, oxford, united kingdom. change processes in ct for social anxiety 18 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://doi.org/10.1017/s1352465813000738 https://doi.org/10.1037/0022-006x.73.5.945 https://doi.org/10.1016/j.beth.2014.04.006 https://oxcadatresources.com http://www.webcitation.org/76nrqtxmt https://doi.org/10.1146/annurev-psych-010814-015258 https://doi.org/10.1080/10705511.2011.557329 https://doi.org/10.1037/a0020141 https://doi.org/10.1016/s0005-7967(97)00022-3 https://www.r-project.org/ https://doi.org/10.1002/(sici)1099-0879(199809)5:3<126::aid-cpp153>3.0.co;2-h https://doi.org/10.1177/2167702613501307 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. thew, ehlers, grey et al. 19 clinical psychology in europe 2020, vol.2(2), article e2947 https://doi.org/10.32872/cpe.v2i2.2947 https://www.psychopen.eu/ change processes in ct for social anxiety (introduction) method participants treatment therapists session-by-session measures analysis results sample 1 sample 2 discussion strengths and limitations conclusion (additional information) funding competing interests acknowledgments author contributions references there are no short-term longitudinal associations among interoceptive accuracy, external body orientation, and body image dissatisfaction research articles there are no short-term longitudinal associations among interoceptive accuracy, external body orientation, and body image dissatisfaction raechel e. drew ab, eszter ferentzi cd, benedek t. tihanyi cd, ferenc köteles d [a] institute of psychology, elte eötvös loránd university, budapest, hungary. [b] centre for infant cognition, department of psychology, university of british columbia, vancouver, canada. [c] doctoral school of psychology, elte eötvös loránd university, budapest, hungary. [d] institute of health promotion and sport sciences, elte eötvös loránd university, budapest, hungary. clinical psychology in europe, 2020, vol. 2(2), article e2701, https://doi.org/10.32872/cpe.v2i2.2701 received: 2019-04-16 • accepted: 2020-01-11 • published (vor): 2020-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: ferenc köteles, institute of health promotion and sport sciences, elte eötvös loránd university, 1117-budapest, bogdánfy ödön u. 10, budapest, hungary. e-mail: koteles.ferenc@ppk.elte.hu abstract background: objectification theory assumes that individuals with low level of interoceptive accuracy may develop an external orientation for information concerning their body. past research has found associations between interoceptive accuracy and body image concerns. we aimed to explore temporal relationships between the tendency to monitor one's body from a third-party perspective, body image dissatisfaction, and interoceptive accuracy. method: in a short longitudinal research, 38 hungarian and 59 norwegian university students completed the schandry heartbeat tracking task and filled out baseline and follow-up questionnaires assessing private body consciousness, body surveillance, and body image dissatisfaction 8 weeks apart. results: interoceptive accuracy and indicators of external body orientation did not predict body image dissatisfaction after controlling for gender, nationality, and body image dissatisfaction at baseline. similarly, body surveillance was not predicted by baseline levels of interoceptive accuracy and body image dissatisfaction. conclusion: contrary to the tenets of objectification theory, body image dissatisfaction and body surveillance are not predicted by interoceptive accuracy over a short period of time among young individuals. keywords interoceptive accuracy, body image, self objectification, body surveillance, public body consciousness, body image dissatisfaction this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2701&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • past research suggests that an individual's ability to detect their own internal signals may have important implications for body monitoring and body image. • we did not find the expected temporal associations among interoceptive accuracy and body image-related variables. • culture and gender were predictors of body image dissatisfaction, an important consideration when designing interventions targeting body image concerns. interoception, the perception of sensations originating from within the body, is related to many aspects of daily functioning, including subjective emotional experience, decision making, and our sense of self (craig, 2002; damasio, 1999; tsakiris, 2017). in the insular cortex, interoceptive and exteroceptive information converge, are processed and integra‐ ted, and provide us with a sense of the physiological status of our entire body, or a feeling of embodiment (craig, 2015; herbert & pollatos, 2012; tsakiris, 2017). interocep‐ tive accuracy (iac) is the dimension of interoception that specifically describes accurately detecting one’s own bodily signals (ceunen, van diest, & vlaeyen, 2013; garfinkel, seth, barrett, suzuki, & critchley, 2015). it is typically measured via behavioral test, as opposed to self-report. individuals with low levels of iac seem to have more difficulties maintain‐ ing a healthy body image and may be more likely to experience body dissatisfaction and eating disorders (badoud & tsakiris, 2017; cash & deagle, 1997; herbert & pollatos, 2012; pollatos et al., 2008), although this is not always the case (pollatos & georgiou, 2016). body image as a concept refers to the mental representation of one's own body, but is multifaceted in that it includes perceptual, affective, and cognitive components (badoud & tsakiris, 2017; cash & pruzinsky, 1990, 2002; gaudio & quattrocchi, 2012; tiggemann & lynch, 2001). past research has approached body image concerns from several different perspectives (i.e., body image dissatisfaction, internalized thin ideals); thus, body image has been widely used as an umbrella term for several related constructs (badoud & tsakiris, 2017). in light of an absence of a clear definition, badoud and tsakiris (2017, p. 7) have defined body image very simply as “the conscious, predominantly visual, mental representation of one’s own body and of our perceptual, cognitive and affective attitudes towards it”. it is considered the product of a complex aggregation of bottom up and top down information signals originating from within and outside of the body (craig, 2015; eshkevari, rieger, longo, haggard, & treasure, 2012; suzuki, garfinkel, critchley, & seth, 2013). it is proposed that the balance between processing of interoceptive and exteroceptive cues is central to the stability and health of our body image (badoud & tsakiris, 2017; tsakiris, 2017). predictive coding models suggest that individuals who do not perceive interoceptive signals accurately may learn to rely more on external cues when assessing the body's status due to the imprecision of predictions (i.e., top-down interoceptive accuracy and body image dissatisfaction 2 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ representations) based on prior inaccuracies (ainley, apps, fotopoulou, & tsakiris, 2016). in line with this idea, tsakiris and colleagues (2011) found that individuals with low iac were more likely to assume ownership of a false body part, highlighting the level of disembodiment and body image distortion that can occur when accurate perception of internal signals is dampened. objectification theory (fredrickson & roberts, 1997) in‐ dicates that when the psychological experience of the body (i.e., embodiment) is predom‐ inantly informed by external sources of information, there will be greater exposure to negative cultural cues (i.e., unattainable beauty ideals, objectifying media imagery). this, in turn, contributes to discrepancies between the idealized body image and perceived actual appearance of the body, through further internalization of ideals and making salient any existing discrepancies (mckinley & hyde, 1996). furthermore, discrepancies between the perceived self and an internalised ideal self (i.e., evaluation), plus a high level of importance placed on matching that ideal (i.e., investment) can produce body image dissatisfaction (cash, 2012; cash & pruzinsky, 2002). concerning healthy young individuals, women with attenuated iac exhibit higher levels of body image dissatisfac‐ tion (emanuelsen, drew, & köteles, 2015). similarly, duschek and colleagues (2015) found that individuals with greater iac had a more positive body image. self objectification is the acculturated tendency to view one's own body as an object, to evaluate it based on appearance rather than functionality, and to experience oneself from a third-party perspective (ainley & tsakiris, 2013; calogero, tantleff-dunn, & thompson, 2010; fredrickson & roberts, 1997). habitual self-monitoring, an integral aspect of self objectification, is referred to in the literature as body surveillance (calogero et al., 2010; grippo & hill, 2008; mckinley & hyde, 1996). body surveillance is accepted as the behavioural manifestation of self objectification, and as such it is measured inde‐ pendently from other facets of the original self objectification construct (i.e., body shame and control beliefs), but also used synonymously (moradi & huang, 2008; tiggemann, 2013). it is important to note that body surveillance and iac (or other aspects of intero‐ ception) are different constructs; the former includes an external perspective and evalua‐ tion, whereas the latter refers to internal body related sensations. research has indicated a relationship between body surveillance and negative body image or distortion in both clinical (i.e., eating disorders, depression) and non-clinical samples (calogero, davis, & thompson, 2005; dakanalis, timko, clerici, riva, & carrà, 2017; fitzsimmons-craft et al., 2012; moradi & huang, 2008; peat & muehlenkamp, 2011; tiggemann & kuring, 2004). self objectification is proposed to predict body image problems, and body surveillance has mediated the relationship between internalised thin ideals and body image dissatis‐ faction in previous research (fitzsimmons-craft et al., 2012; fredrickson & roberts, 1997; knauss, paxton, & alsaker, 2008; myers & crowther, 2007; tiggemann & williams, 2012). more recently, fitzsimmons-craft and colleagues (2015) found that a higher level of body surveillance was moderately associated with increased body dissatisfaction. other drew, ferentzi, tihanyi, & köteles 3 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ research suggests that less external body orientation is important for maintaining a positive body image (avalos & tylka, 2006; homan & tylka, 2014). we suggest that objectification theory (fredrickson & roberts, 1997) may provide insight into previous findings that individuals with diminished iac express higher body image dissatisfaction; while those with improved iac demonstrate a more positive body image (duschek et al., 2015; emanuelsen et al., 2015). we believe that diminished accura‐ cy in perceiving one’s internal signals may lead a person to rely on external sources of information concerning the bodily self, or vice versa. miller and colleagues (1981, p. 404) define public body consciousness, another concept of external orientation concerning one's appearance, as “a chronic tendency to focus on and be concerned with the external appearance of the body”. individuals who are high in public body consciousness typically view themselves from an outsider's perspective, monitoring their appearance and behaviour to facilitate social interaction (ainley & tsakiris, 2013; miller et al., 1981). although distinct constructs, one could argue that public body consciousness is closely related to body surveillance, insofar as both con‐ structs concern viewing oneself as a social object, an external orientation for information concerning one's body, and a preoccupation with appearance (miner-rubino, twenge, & fredrickson, 2002). body surveillance, however, primarily differs from public body consciousness in that the individual takes on the perspective of the observer, as opposed to merely being aware of it (miller et al., 1981; miner-rubino et al., 2002). in this way, it is likely a more disembodied experience than the awareness of self from a public perspective (miner-rubino et al., 2002). our aim was to investigate how internal orientation (i.e., interoception) and external orientation (i.e., public body consciousness and body surveillance) influence body im‐ age dissatisfaction. research investigating similar associations (ainley & tsakiris, 2013; duschek et al., 2015; emanuelsen et al., 2015) has not included these constructs in one empirical study. additionally, as this previous work investigated cross-sectional data, spontaneous fluctuation cannot be excluded; thus, we have used a short-term longitudi‐ nal study to explore their relation. based on the aforementioned theoretical considerations and empirical findings, low level of iac and the proclivity to assess one's body from an outsider's perspective should predict a negative body image. in the present research, we expected that iac, body surveillance and public body consciousness at baseline (t1) would predict body image dissatisfaction 8 weeks later (t2) (hypothesis 1). we also considered the possibility that low iac and high levels of body image dissatisfaction may increase the tendency to view oneself from a third party perspective. therefore, alternately, we expected that iac and body image dissatisfaction at t1 would predict body surveillance at t2 (hypothesis 2). interoceptive accuracy and body image dissatisfaction 4 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ m a t e r i a l a n d m e t h o d participants assuming α = .05, 1-β = .80, and a medium effect size (.15; in the lack of empirical data, this estimation was based on theoretical considerations), the minimum sample size for a multiple linear regression analysis with 6 predictor variables is 97 (faul, erdfelder, lang, & buchner, 2007). participants in this research were norwegian (n = 59, 74.6% female, 24.8 ± 5.09 yrs) and hungarian (n = 38, 65.8% female, 21.3 ± 1.60 yrs) students enrolled at a university in hungary. norwegian students were enrolled in an english language international program. the research was approved by the research ethics committee of the institution. participation was voluntary, and all participants signed an informed consent form before the measurements. the english versions of the questionnaires were administered for the norwegian students and the hungarian version for the hungarian participants. measures the body surveillance subscale of objectified body consciousness scale the scale was developed by mckinley and hyde (1996) to assess negative body experi‐ ence from a social constructionist point of view. the questionnaire measures the experi‐ ence of the body as an object to be viewed by others and the beliefs underlying this experience. for the purpose of this research, we have chosen to use only the 8 item body surveillance subscale, which uses a 7 point likert-scale. higher values indicate higher surveillance tendency. cronbach's alpha in the present study was .75 at t1, and .70 at t2. the public body consciousness scale the scale was developed by miller and colleagues (1981) as part of the body conscious‐ ness questionnaire, and it consists of 5 items rated on a 5 point likert-scale. higher scores indicate more importance placed on individual appearance. cronbach's alpha for the public body consciousness subscale in the present study was .71 at t1. the body image ideals questionnaire the questionnaire was developed by cash and szymanski (1995) to provide a reliable assessment of participants' evaluation of their own physical appearance, and asks two questions with regard to each of 11 physical characteristics, including muscle tone, hair texture, complexion and various physical abilities (e.g., coordination, strength). respon‐ ses are indicated on a 4 point likert-type scale. the first question asks participants to what extent they feel that they match their physical ideals; the second question asks how important it is to the participant that their actual attributes match their ideals. higher drew, ferentzi, tihanyi, & köteles 5 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ scores on the scale indicate a greater overall level of body image dissatisfaction. in the current study, the internal consistency of the questionnaire was .65 at t1, and .69 at t2. the mental heartbeat tracking method interoceptive accuracy was assessed using the mental tracking method (schandry, 1981), a widely used paradigm. in healthy individuals, there is a correspondence between the performance on the schandry-task and the mean amplitude of heartbeat evoked potential (pollatos & schandry, 2004), an eeg potential associated with the heartbeat, which is also higher during the schandry-task than during periods of rest (schulz et al., 2015). during the task, participants were asked to count their perceived heartbeats silently. they were not allowed to monitor their pulse (e.g., palpating the wrist or neck artery) or use any other physical techniques that might help them to count more accurately. they were further instructed to count uncertain sensations but to refrain from guessing. upon hearing a “start” cue, participants began to silently count their own heartbeats until a “stop” cue was given, at which point they reported the number of heartbeats counted to an experimenter. at the same time, the experimenter counted and recorded the participants’ heartbeats using a polar watch (model rs-400) with a chest strap. this procedure was administered for one 15 second warm-up trial followed by three subsequent intervals (30, 40, and 100 seconds) presented in random order, with a 10 second break in between. following the initial trial, participants were asked to indicate how they arrived at the reported number of heartbeats. subjects who reported guessing or counting seconds were encouraged to count only the perceived heartbeats for the remaining three trials. the experimenter explained that accuracy is regarded as neither positive nor negative. subjects were not aware of the length of the intervals and no feedback about performance was given. iac is the mean score of the formula: 1 – [(| recorded heartbeats – counted heartbeats|)/recorded heartbeats] calculated for each of the three time trials. cronbach’s alpha coefficient for the index was .924. procedure participants filled out an on-line test battery one day prior to a scheduled meeting with the experimenter (t1). at the meeting, participants were seated in a quiet room. after a brief introduction to the mental tracking method, participants were asked to relax, breath normally, and focus on the beating of their heart. participants completed the on-line self report battery a second time 8 weeks later (t2). this period of time appears long enough to capture short-term fluctuations and fits within a typical 12-week university semester, while avoiding the inclusion of the stressful first and final 2 weeks of the semester. this research was part of a larger study, thus participants took part in other measure‐ ments as well. concerning the variables used in the present paper, only baseline intero‐ ceptive accuracy values were included in another research (ferentzi, drew, tihanyi, & köteles, 2018). interoceptive accuracy and body image dissatisfaction 6 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ statistical analysis statistical analysis was conducted using the jasp v0.8.5.1 software (jasp team, 2019). based on the results of normality analysis (shapiro-wilk tests), parametric statistical methods were used throughout the analysis. differences between groups with respect to age and sex were checked using student t-test and chi-square test, respectively. concern‐ ing the assessed psychological variables, the two national groups were compared using student t-test. cross-sectional associations among variables at t1 were checked using pearson correlation. longitudinal associations (hypothesis 1 and 2) were investigated using multiple linear regression analysis. in step 1 the baseline value of the respective criterion variable was entered; in step 2, group affiliation (hungarian = 1; norwegian = 2), gender (male = 1; female = 2), t1 values of interoceptive accuracy, body surveillance, and (only for body image dissatisfaction) public body consciousness were stepped in. r e s u l t s descriptive statistics, group level comparisons, and baseline correlations are presented in table 1 and table 2, respectively. a statistically significant difference between groups in age, t(95) = -4.104, p < .001, d = -0.854, but not in sex ratio, χ2(1) = 0.869, p = .351, was found. the two groups showed significant differences with respect to body surveillance and public body consciousness at t1, and body image dissatisfaction at t2. concerning baseline measures, a significant negative medium level association between body sur‐ veillance and iac was found in the hungarian group. in the norwegian group, body surveillance was moderately associated with body image dissatisfaction and weakly with public body consciousness, and public body consciousness was negatively associated with iac (for details, see table 2). table 1 descriptive statistics (mean ± standard deviation) of the assessed variables split by group, and results of student t-tests comparing the two groups variable hungarians n = 38 norwegians n = 59 t(95) p cohen‘s d body surveillance at t1 36.04 ± 5.174 33.05 ± 7.454 2.159 .033 0.449 body surveillance at t2 33.68 ± 5.132 32.03 ± 6.465 1.322 .189 0.275 body image dissatisfaction at t1 1.58 ± 1.327 1.41 ± .883 0.757 .451 0.157 body image dissatisfaction at t2 1.96 ± 1.292 1.33 ± .797 3.015 .003 0.627 public body consciousness at t1 24.16 ± 2.937 21.00 ± 3.634 4.492 < .001 0.934 iac at t1 .46 ± .249 .52 ± .269 -1.087 .280 -0.226 note. iac = interoceptive accuracy; t1 = baseline; t2 = 8 weeks later. drew, ferentzi, tihanyi, & köteles 7 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ table 2 pearson’s correlations among variables at baseline variable 1 2 3 4 1. body image dissatisfaction .14 -.07 .11 2. body surveillance .44** – .18 -.40* 3. public body consciousness .11 .32* – -.18 4. iac -.11 -.11 -.33* – note. upper triangle = hungarians (n = 38); lower triangle = norwegians (n = 59); iac = interoceptive accuracy. *p < .05. **p < .01. in the multiple linear regression analysis predicting body image dissatisfaction at t2 (hypothesis 1), baseline biq score explained 23.1% of the total variance (p < .001) in step 1. in step 2, the regression equation explained 32.6% of the total variance (p < .001). predictors of body image dissatisfaction at t2 were baseline body image dissatisfaction, group, and gender (p < .1), but not iac, body surveillance, and public body consciousness (for details, see table 3). group association was negative, while gender had a positive association; thus, all other factors being equal, hungarian nationality and female gender predicted higher levels of body image dissatisfaction at t2. table 3 results of the multiple linear regression with body image dissatisfaction at t2 as the dependent variable step b seb β 95% ci (ll, ul) p zero-order correlation partial correlation step 1: r 2 = .231, p < .001 body image dissatisfaction at t1 0.474 0.089 0.481 0.298, 0.650 < .001 .481 .481 step 2: r 2 = .326, p < .001 body image dissatisfaction at t1 0.439 0.091 0.446 0.259, 0.619 < .001 .481 .455 group -0.622 0.210 -0.288 -1.038, -0.205 0.004 -.296 -.298 gender 0.371 0.214 0.159 -0.055, 0.797 0.087 .202 .179 iac at t1 -0.147 0.382 -0.036 -0.905, 0.611 0.701 -.100 -.041 body surveillance at t1 -0.005 0.015 -0.035 -0.036, 0.025 0.725 .191 -.037 public body consciousness at t1 -0.006 0.029 -0.019 -0.064, 0.053 0.851 .140 -.020 note. iac = interoceptive accuracy; t1 = baseline; t2 = 8 weeks later. the regression equation predicting body surveillance at t2 (hypothesis 2) explained 49.7% of total variance in step 1, and 51.7% in step 2. the only significant predictor was baseline body surveillance score (for details, see table 4). interoceptive accuracy and body image dissatisfaction 8 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ table 4 results of the multiple linear regression with body surveillance at t2 as dependent variable step b seb β 95% ci (ll, ul) p zero-order correlation partial correlation step 1: r 2 = .497, p < .001 body surveillance at t1 0.624 0.064 0.705 0.496, 0.752 < .001 .705 .705 step 2: r 2 = .517, p < .001 body surveillance at t1 0.640 0.071 0.724 0.499, 0.781 < .001 .705 .687 group -0.069 0.927 -0.006 -1.911, 1.773 .941 -.134 -0.008 gender 1.571 1.021 0.119 -0.458, 3.600 .128 .206 .159 iac at t1 2.468 1.770 0.108 -1.049, 5.985 .167 -.073 .145 body image dissatisfaction at t1 -0.327 0.431 -0.059 -1.184, 0.529 .450 .179 -.079 note. iac = interoceptive accuracy; t1 = baseline; t2 = 8 weeks later. d i s c u s s i o n this study investigated the temporal relationships among the external orientation toward the body, body image, and interoceptive accuracy (heartbeat tracking ability) assessing a general student sample of young hungarians and norwegians. dissatisfaction with body image 8 weeks later was predicted by baseline dissatisfaction, hungarian nationality, and female gender, but not by interoceptive accuracy or external body orientation. body sur‐ veillance was predicted only by baseline body surveillance but not by gender, nationality, interoceptive accuracy, or dissatisfaction with body image. based on past research, we expected that interoceptive accuracy (iac) and constructs representing an external body orientation (public body consciousness and body surveil‐ lance) would predict body image dissatisfaction (ainley & tsakiris, 2013; emanuelsen et al., 2015; fitzsimmons-craft et al., 2012; fredrickson & roberts, 1997). whereas these hypotheses were not supported by our data, nationality and gender were predictors of change. nationality related findings are difficult to explain as (1) the size of the two samples was not equal and (2) there was a significant difference between the two groups with respect to age. generally, hungarian adolescents experience higher levels of body concerns when compared to other european nationalities (papp, urbán, czeglédi, babusa, & túry, 2013); this tendency, along with their younger age, might have made the temporal fluctuations of body image dissatisfaction more marked. the result that female gender predicted (although only at a trend level) greater change in body image dissatisfaction was not surprising, as empirical evidence shows that females generally experience higher levels of body image dissatisfaction (grabe, ward, & hyde, 2008; grogan, 2016; tiggemann, 2004). in past studies, both norwegian and hungarian adolescent females have shown higher levels of body image dissatisfac‐ tion than their male counterparts (meland, haugland, & breidablik, 2007; papp et al., drew, ferentzi, tihanyi, & köteles 9 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ 2013). even at very young ages, girls are more likely to exhibit body concerns, and be more dissatisfied with their bodies (grogan, 2016), perpetuated by the internalised ideals promoted by modern western culture and media (grabe et al., 2008; myers & crowther, 2007). although a previous cross-sectional study revealed a medium level reverse correlation between iac and self objectification (ainley & tsakiris, 2013), this was replicated only in the hungarian sample in the present study. moreover, results of our second regression model indicate that iac does not explain variance in changes of body surveillance. according to our results, the only predictor of self objectification at t2 was the baseline self objectification score; the strong association between the two (β = 0.705) indicates high temporal stability. therefore, temporal associations with iac are difficult to detect if the effect size of iac is low and additional factors are controlled for. temporal sta‐ bility of body image dissatisfaction was lower (β = 0.481); still, low to medium level associations between body image dissatisfaction and iac reported in cross-sectional studies (duschek et al., 2015; emanuelsen et al., 2015) might have been too weak to detect in the current study. moreover, the instruction used in the schandry-task was more strict than usual with respect to allowing estimation. this might have resulted in lower iac scores with less variance than in other studies and possibly influenced participants’ response tendencies (for more detail, see the limitations section). overall, the lack of predictive associations among self-objectification, body image dissatisfaction, and iac indicates that the ability to accurately sense our bodily signals is not among the significant factors that influence how we monitor and envision our body’s appearance. for example, self-reported (i.e., conscious) aspects of interoception (e.g., interoceptive sensibility and body awareness) might play a more important role in these processes. additionally, as tiggemann (2004) has pointed out, body surveillance and body image dissatisfaction do not necessarily go hand-in-hand, especially considering the multi-face‐ ted complexity of the body image dissatisfaction construct and individual differences in the internalised-ideal used as a comparator between the perceived body and ideal body. the current study is not without limitations. first, an 8 week time frame might not be sufficient to reveal on complex time-related associations among multiple variables. second, internal consistency for the body image ideals questionnaire and public body consciousness scores were acceptable but low when compared to previous research (ainley & tsakiris, 2013; dakanalis et al., 2017; miller et al., 1981). third, although widely accepted, the mental tracking paradigm (schandry, 1981) has received some criticism for the potential that participant responses could be influenced by previous knowledge about their own heart rate, or expectations concerning their ability to detect their heart rate accurately (ring, brener, knapp, & mailloux, 2015). instruction given to participants can also bias the measurement (desmedt, luminet, & corneille, 2018). for example, participants with the tendency to please others may produce lower overall iac scores when given strict instructions that do not allow guessing, but produce inflated iac interoceptive accuracy and body image dissatisfaction 10 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://www.psychopen.eu/ scores when given permissive instructions that do allow for guessing. individuals with a desire to please others could also be likely to aspire to social norms and experience body image dissatisfaction, which may provide some explanation for why we did not find an expected relationship between increased body image dissatisfaction and lower iac at baseline. finally, although norwegian students in the present research have a high level of proficiency and study in english on a daily basis, the questionnaires were neither translated into norwegian nor validated for use with a norwegian population. there may be subtle variations in responses due to second language understanding. in summary, culture and gender differences should be considered when designing interventions for improving body image, as subgroups of the population may show disparate patterns of association among related constructs. funding: this work was supported by the hungarian national scientific research fund (k124132). the sponsor had no other involvement in the current study. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s ainley, v., apps, m. a. j., fotopoulou, a., & tsakiris, m. 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(2017). the multisensory basis of the self: from body to identity to others. quarterly journal of experimental psychology, 70(4), 597-609. https://doi.org/10.1080/17470218.2016.1181768 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. drew, ferentzi, tihanyi, & köteles 15 clinical psychology in europe 2020, vol.2(2), article e2701 https://doi.org/10.32872/cpe.v2i2.2701 https://doi.org/10.1097/psy.0000000000000195 https://doi.org/10.1016/j.neuropsychologia.2013.08.014 https://doi.org/10.1016/s1740-1445(03)00002-0 https://doi.org/10.1111/cp.12010 https://doi.org/10.1348/0144665031752925 https://doi.org/10.1037/0012-1649.37.2.243 https://doi.org/10.1177/0361684311420250 https://doi.org/10.1098/rspb.2010.2547 https://doi.org/10.1080/17470218.2016.1181768 https://www.psychopen.eu/ interoceptive accuracy and body image dissatisfaction (introduction) material and method participants measures procedure statistical analysis results discussion (additional information) funding competing interests acknowledgments references intuitive judgments in depression and the role of processing fluency and positive valence: a preregistered replication study research articles intuitive judgments in depression and the role of processing fluency and positive valence: a preregistered replication study carina remmers a, johannes zimmermann b, sascha topolinski c, christoph richter d, thea zander-schellenberg e, matthias weiler a, christine knaevelsrud a [a] division of clinical psychological intervention, department of education and psychology, freie universität berlin, berlin, germany. [b] department of psychology, university of kassel, kassel, germany. [c] social and economic cognition center, university of köln, köln, germany. [d] vivantes klinikum kaulsdorf, berlin, germany. [e] division of clinical psychology and epidemiology, department of psychology, university of basel, basel, switzerland. clinical psychology in europe, 2020, vol. 2(4), article e2593, https://doi.org/10.32872/cpe.v2i4.2593 received: 2019-12-19 • accepted: 2020-10-28 • published (vor): 2020-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: carina remmers, schwendener straße 27, 14195 berlin, germany. e-mail: carina.remmers@fu-berlin.de supplementary materials: preregistration [see index of supplementary materials] abstract background: recent preliminary evidence indicates that depression is associated with impaired intuitive information processing. the current study aimed at replicating these findings and to move one step further by exploring whether factors known as triggering intuition (positivity, processing fluency) also affect intuition in patients with depression. method: we pre-registered and tested five hypotheses using data from 35 patients with depression and 35 healthy controls who performed three versions of the judgment of semantic coherence task (jsct, bowers et al., 1990). this task operationalizes intuition as the inexplicable and sudden detection of semantic coherence. results: results revealed that depressed patients and healthy controls did not differ in their general intuitive performance (hypothesis 1). we further found that fluency did not significantly affect depressed patients’ coherence judgments (h2a) and that the assumed effect of fluency on coherence judgments was not moderated by depression (h2b). finally, we found that triads positive in valence were more likely to be judged as coherent as compared to negative word triads in the depressed sample (h3a), but this influence of positive (vs. negative) valence on coherence judgments did not significantly differ between the two groups (h3b). conclusion: overall the current study did not replicate findings from previous research regarding intuitive semantic coherence detection deficits in depression. however, our findings suggest that this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.2593&domain=pdf&date_stamp=2020-12-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ enhancing positivity in depressed patients may facilitate their ability to see meaning in their environment and to take intuitive decision. keywords depression, intuition, meaning detection, positive affect, positive valence, processing fluency, replication, semantic coherence judgments highlights • the pre-registered replication study did not find intuition deficits in patients with depression. • processing fluency did not affect coherence judgments in depressed patients or healthy controls. • depressed patients and healthy controls use positive valence as cue for intuitive coherence judgments. • future studies should test whether enhancing positivity in depressed patients boosts their ability to find meaning (e.g., meaning in life). people continuously make decisions and judgments without long consideration by rely‐ ing on their gut feelings. following one’s intuition does not only feel right (thompson et al., 2011), but also leads to adaptive outcomes, especially in complex situations, during stress or when a person is experienced in the given environment (kahneman & klein, 2009). by integrating a multitude of factors such as implicit personal needs and goals (baumann & kuhl, 2002; lieberman et al., 2004), intuitions enable people to make "smart" decisions (gigerenzer, 2007), and to interact with other people (e.g., facilitating adaptive parent-child interaction; parsons et al., 2017). moreover, intuition is associated with central aspects of mental well-being, such as experiencing meaning in life (heintzelman, trent, & king, 2013; hicks & king, 2007; hicks et al., 2010; schlegel et al., 2011). intuition relies on processes that are based on experience, run quickly and uncon‐ sciously, and allow many relevant aspects to be effortlessly integrated into a coherent whole (kahneman, 2011). by this, intuition enables people to detect coherence and meaning. the judgment of semantic coherence task (jsct; bowers et al., 1990) oper‐ ationalizes this core characteristic of intuition by asking people to discriminate word triads in terms of their semantic relatedness. research using this task consistently shows that people can intuitively discriminate semantically related word triads (e.g., deep salt foam; common denominator: sea) from semantically unrelated word triads (e.g., dream ball book; no common denominator) (bolte & goschke, 2005; bowers et al., 1990) without being able to explicitly name the basis for their judgment – they just know it without knowing why (epstein, 2008). it seems reasonable to assume that people are not always able to intuitively detect meaning and coherence. one important influencing factor seems to be the affective state intuitive judgments in depression 2 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ of a person. positive mood broadens the scope of attention, facilitates associative process‐ ing (fredrickson & losada, 2005; harel, tennyson, fava, & bar, 2016) and increases the preference for thematic processing that is needed for semantic coherence detection (e.g., maldei, baumann, & koole, 2020). in line with this, people are more likely to rely on in‐ tuition (zander-schellenberg, remmers, zimmermann, thommen, & lieb, 2019) and are more accurate in discriminating meaning from meaninglessness when in a positive mood (balas et al., 2012; bolte et al., 2003). negative mood states, in contrast, are associated with narrowing attentional focus and inhibiting associative processing (sass et al., 2012). along this line, negative mood and a tendency to brood have been shown to impair intuition (baumann & kuhl, 2002; bolte et al., 2003; remmers & zander, 2018; sweklej et al., 2015). here, we assume that intuitive processing is impaired in depressed patients in particular. depression is characterized by negative mood and a brooding, rigid, style of think‐ ing. this is opposed to an intuitively integrating and holistic style of processing (see remmers & michalak, 2016). while intuitive processing is accompanied by cognitive ease, feelings of rightness and the detection of meaning and coherent structures in the environment (see fluency-affect intuition model; topolinski & strack, 2009a), depressive thinking is doubtful – as a consequence, nothing feels easy and right anymore. further‐ more, depression is associated with experiencing less meaning in life and with lower abil‐ ities to construct coherent narratives of one’s life (baerger & mcadams, 1999; mascaro & rosen, 2005). as finding meaning is mainly a product of intuitive processing (hicks & king, 2007), and intentional, analytical search for meaning can impair the intuitive detec‐ tion of meaning (topolinski & strack, 2008), it seems reasonable to assume that intuitive meaning detection is impaired in depression where a ruminative processing style is prev‐ alent (watkins & teasdale, 2004). recent research has indeed shown that patients with depression have deficits to intuitively detect semantic coherence as compared to healthy control participants (remmers & michalak, 2016; remmers, topolinski, buxton, dietrich, & michalak, 2017; remmers, topolinski, dietrich, & michalak, 2015). the current study seeks to replicate these findings and moves one step further in exploring the underlying mechanisms of assumed intuition impairments in depression. apart from the influence of people’s mood states (balas et al., 2012; bolte et al., 2003), research has investigated further cognitive-affective processes underlying intuition and semantic coherence detection. the fluency-affect model of intuition suggests that processing fluency and subtle positive affect are major factors jointly driving coherence judgments (topolinski & strack, 2009a). coherent triads are processed more fluently (i.e., faster), and fluency leads to a brief positive affective response channeling the intuitive judgment (e.g., a positive feeling of ease that is used in the following judgment or decision; reber, schwarz, & winkielman, 2004; reber, winkielman, & schwarz, 1998). moreover, it has been shown that coherent triads are liked more than incoherent triads and that the mere reading of coherent triads activates people’s smiling muscle and remmers, zimmermann, topolinski et al. 3 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ relaxes the frowning muscle (indicating decreased negative affect and mental effort; see topolinski, likowski, weyers, & strack, 2009). these results suggest that coherence is fluently processed and triggers subtle positive affect that in turn functions as an internal cue generating the intuitive coherence judgment (topolinski & strack, 2009a; see also winkielman & cacioppo, 2001, for psychophysiological evidence on the effects of processing fluency and positive affect). in addition, there is also evidence showing that manipulating both fluency and posi‐ tive affect influences whether people feel coherence. manipulating positivity on a subtle level (e.g., by subliminal affective facial priming or by manipulating the affective valence of word triads or solution words; balas et al., 2012) increases participants’ tendency to judge triads as being coherent (independent of their actual coherence). in a similar vein manipulating the fluency of word triads (e.g., by manipulating the figure-ground contrast in which triads are presented) makes it more likely that people judge these as being coherent (as compared to less fluently processed word triads presented in a low figure-ground contrast; topolinski & strack, 2009a). yet, whether manipulated fluency and positivity also influence depressed patients’ intuitive coherence judgments has not been investigated so far. the current study the aim of the current study was to replicate and extend preliminary evidence on intuition deficits in depression. we tested a sample of depressed inpatients and compared their performance in the judgment of semantic coherence task (jsct; bowers et al., 1990) to a healthy control sample. going one step further, we also aimed at investigating potential underlying mechanisms of impairments in intuitive coherence detection in patients with depression. the following main hypotheses were pre-registered and investigated (see the supple‐ mentary materials for the preregistration): the first hypothesis (h1) refers to the replica‐ bility of recently found intuition deficits in depression (remmers et al., 2015; remmers et al., 2017). we hypothesized that patients with an acute episode of major depression are less able to intuitively discriminate semantic coherence from semantic incoherence in the jsct than healthy controls. the second hypothesis (h2a) assumes that processing fluency triggers semantic co‐ herence judgments in patients with depression. building up on basic research, we expec‐ ted that in depressed patients word triads that are presented in a high figure-ground contrast – and which are therefore presumed to be processed more fluently – are more likely to be judged to be coherent than triads presented in a low contrast. given that research using self-reports (tsourtos et al., 2002; see also o’connor et al., 1990) as well as experimental tasks supports the notion that mental activity is slowed in depression (e.g., den hartog et al., 2003), we also expected that the effect of processing fluency intuitive judgments in depression 4 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ on coherence judgments would be smaller in the depressed sample as compared to the healthy sample (h2b). the third hypothesis (h3a) was that the positive valence of stimuli influences seman‐ tic coherence judgments in patients with depression. building up on basic research (topolinski & strack, 2009a; experiment 8) showing that healthy subjects are more likely to judge triads to be coherent that consist of positive as compared to negative words, we expected that this effect would also emerge for depressed patients. however, it seemed reasonable to assume that depression moderates the effect of positive valence on coherence judgments because research shows that the preference for positive stimuli usually found in healthy samples is attenuated in depressed patients (deveney & deldin, 2006; joormann & gotlib, 2007). thus, we hypothesized that the effect of positive valence on coherence judgments is smaller in the depressed sample as compared to the healthy sample (h3b). an a priori power analysis can be found in appendix a. m e t h o d participants forty inpatients were recruited from the vivantes klinikum berlin-kaulsdorf, germany, a municipal psychiatry. the clinic staff informed the trained research assistant from the freie universität berlin about patients potentially fitting the inclusion criteria, who were then approached in person. in addition, patients were addressed in the weekly psychoeducation depression group therapy. the healthy control sample was recruited through advertisements in social media, local newspapers and online advertisement platforms and tested by research assistants at the freie universität berlin. in the clinical sample, the presence of a current episode of unipolar depression was required for inclu‐ sion. exclusion criteria for the clinical sample were presence of psychotic symptoms, a bipolar disorder and acute suicidal tendencies. for the control sample, the presence of any mental disorder was an exclusion criterion. for all participants inclusion in the study additionally required a minimum age of 18 years and signed written consent. the inclusion and exclusion criteria were verified by conducting the affective and psychotic disorder modules of the structured clinical interview according to dsm-iv with each participant (scid; german version: wittchen, zaudig, & fydrich, 1997). in the clinical sample, five subjects were excluded from the study. two subjects did not fulfill the criteria for a current depressive episode. one subject had to be excluded due to the presence of psychotic symptoms and in one patient a depressive diagnosis due to a medical condition could not be excluded. another subject could not credibly distance herself from suicidal tendencies during the interview, so that the hospital staff was called in and participation in the study was terminated. in the healthy sample, no subject was excluded. a total of 70 subjects took part in the study (35 in each group). remmers, zimmermann, topolinski et al. 5 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ procedure upon arrival both at the clinic and at the university laboratory, participants were wel‐ comed and received the informed consent that they were asked to sign. participants were then interviewed by a trained rater with the scid. either directly after the scid interview or at an appointment shortly afterwards, included subjects completed the intuition task consisting of three blocks (general intuition, fluency, valence; for a detailed description see appendix b). the procedure of the jsct was identical to that of previous studies (remmers et al., 2015, 2017). participants saw a set of word triads (e.g. deep salt foam; dream ball book) and were asked to indicate for each triad whether it was coherent or incoherent by pressing the respective key on the computer keyboard. each trial began with the presentation of a fixation cross (1000 ms), followed by the presentation of the triad (1500 ms). after disappearance of the triad from the screen, "coherent" and "incoherent" appeared on the left or right side of the computer screen. the key positions of "coherent" and "incoherent" were randomized for each participant; once assigned, the key positions remained the same for each participant throughout the experimental task. participants had 2000 ms to press the reaction key on the keyboard for their corresponding coherence judgment. if a participant failed to react within 2000 ms, "too slow" appeared on the screen and the next trial started. if participants managed to respond within the given reaction time window, they could type in an x or a possible solution word within 8 seconds. each word triad was only presented once, which prevented exposure and repetition effects as well as analytic insight. all participants performed three blocks that followed the procedure above but with varying stimulus material (see appendix b for a detailed description). in the general intuition block, only coherence (coherent triads vs. incoherent triads) was manipulated. in addition to manipulating coherence, we manipulated fluency (high figure-ground contrast vs. low figure-ground contrast) in the fluency block and valence (positive triads vs. negative triads) in the valence block, resulting in four conditions in the latter two blocks respectively. at the end of each block participants indicated how much they trusted their intuition in the respective task on a 7-point likert scale. all three blocks were programmed using jspsych, a javascript library for creating behavioral experiments in a web browser (de leeuw, 2015). after completion of the three intuition blocks, subjects filled out a demographic questionnaire as well as other self-report instruments, not of interest for the current paper (see supplementary materials for all measured variables) and then received an amazon voucher as study compensation. participating in the entire study lasted about 1 – 1.5 hours. the study was approved by the ethical committee of the freie universität berlin and in compliance with the helsinki declaration. intuitive judgments in depression 6 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ statistical analysis participants’ performance in the jsct was the main outcome of the study. trials were discarded in which participants did not provide their coherence judgment within the given time window of 2000 ms. these missed trials were analyzed separately and served us to explore whether patients and healthy controls differed in their ability to react within the given short time window. solved trials were also discarded from the following coherence judgment analyses because these trials were indicative of explicit insight and not intuition (see topolinski & strack, 2009a). a trial was considered as solved when a participant provided the correct solution word or a synonym after the coherence judgment, being rated by two raters independently. solved trials were thus analyzed separately and served us to explore whether depressed patients and healthy controls differed in the extent to which they had explicit insight. participants who had missed responding in the given time window were not asked to type in a solution word. missed trials and solved trials did not overlap. to test h1, we computed a discrimination index for each participant after exclusion of missed responses and solved trials. for this, we first computed hit rates (i.e., the proportion of coherent trials that were correctly judged as coherent, but which were not solved) and false alarm rates (i.e., the proportion of incoherent trials, which had incorrectly been judge as coherent). we then calculated a simple discrimination index by subtracting false alarm rates from hit rates (called pr in snodgrass & corwin, 1988; see also bolte & goschke, 2008). this index conveys participants’ ability to discriminate between coherent and incoherent trials (see bolte et al., 2003; remmers et al., 2017; topolinski & strack, 2009a). participants’ responses are defined as accurate to the extent that their hit rate exceeds their false alarm rate. we tested h1 using an independent samples t-test with depression as the independent variable and the discrimination index from the jsct general intuition block as the dependent variable. hypothesis h2a was tested using a random intercept model, which is conceptually equivalent to fitting a repeated measures anova. in this model, the four conditions of the jsct fluency block are nested within participants (i.e., each participant contributes four data points, and the random intercept accounts for the fact that the four assessments are usually positively correlated). we used coherence, fluency, and their interaction to predict the percentage of triads that have been judged as coherent (after deleting missed and solved triads). the relevant effect here was the effect of fluency. note that we only included participants with depression for testing this hypothesis. in contrast, h2b was tested in the full sample, again using a random intercept model. this time, we used coherence, fluency, depression, and their twoand three-way interactions to predict the percentage of triads that have been judged as coherent in the fluency block. the relevant effect here is the interaction effect of depression and fluency. hypotheses 3a and 3b were tested using the same approach, this time based on data from the jsct valence block and using valence instead of fluency as a predictor. remmers, zimmermann, topolinski et al. 7 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ in line with the preregistration, we corrected univariate outliers within groups (|z| > 2.5) prior to hypothesis testing using the winsoring method. this way, we corrected 19 data points in 21 variables across 70 participants (1.3%). the criterion for inferences for each hypothesis was p < .05 (two-tailed). satterthwaite’s approximations were used to derive p-values for fixed effects in random intercept models. all analyses were conducted within the statistical environment r (r core team, 2018). random intercept models were estimated using full maximum likelihood estimation implemented in the r package “lme4”. r e s u l t s descriptive statistics the depressive sample (m = 41.74, sd = 12.40) and the control sample (m = 44.37, sd = 16.85) did not differ significantly from each other in terms of age, t(62) = 0.74, p = .46. also, with respect to gender (depressed group: 22 females; control group: 21 females), there was no significant group difference, χ2(1) = 0.06, p = .806. however, there was a significant difference in terms of education, u(35, 35) = 445.5, p = .032, with the control sample having a higher educational degree as compared to the depressed sample. preparatory analyses of the general intuition block results suggested that depressed patients did not differ significantly from healthy con‐ trols regarding the number of missed trials (i.e., trials in which subjects did not respond within the given time window), the number of solved trials (i.e., coherent trials for which the correct solution word was typed in), and the average response time (see appendix c for details). moreover, depressed patients (m = 0.50, sd = 0.18) and healthy control participants (m = 0.47, sd = 0.21) did not differ significantly in the hit rate (i.e., proportion of triads that they correctly judged as coherent), t(68) = 0.68, p = .50, 95% ci [-0.06, 0.13]. also, with regard to the false alarm rate (i.e., proportion of triads that were incorrectly classified as coherent), there was no significant difference between the depressed sample (m = 0.32, sd = 0.17) and the healthy sample (m = 0.28, sd = 0.14), t(68) = 1.01, p = .31, 95% ci [-0.04, 0.11]. finally, on average, participants from both samples could discriminate between coherent and incoherent trials above chance level. this was indicated by one sample t-tests showing that the discrimination index differed from zero in both the depressed sample (m = 0.18, sd = 0.17, t[34] = 6.13, p < .001) and the healthy sample (m = 0.19, sd = 0.18, t[34] = 6.10, p < .001). confirmatory hypotheses testing analyses regarding h1 revealed that depressed patients and healthy control participants did not differ significantly in their ability to discriminate semantic coherence from intuitive judgments in depression 8 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ semantic incoherence in the jsct general intuition block, t(68) = 0.12, p = .90, 95% ci [-0.09, 0.08] (see figure 1). figure 1 boxplots of intuition discrimination index for patients with depression (red column) and healthy control participants (blue column) −0.2 0.0 0.2 0.4 0.6 patients with depression healthy controls groups in tu it io n d is cr im in at io n i n d ex with regard to h2a, results showed that fluency did not significantly predict the per‐ centage of triads that have been judged as coherent in depressed patients, f(1,105) = 0.21, p = .65. however, coherence had a significant effect on coherence judgments, with coherent trials being more likely to be judged as coherent as compared to incoherent trials, f(1,105) = 13.57, p < .001. the interaction between coherence and fluency was not significant, f(1,105) = 0.11, p = .74 (see left panel in figure 2). with regard to h2b, results revealed that the interaction effect of depression and fluency was not significant in predicting coherence judgments, f(1, 210) = 0.19, p = .66. thus, our findings do not support the hypothesis that the effect of fluency on coherence judgments was smaller in the depressed sample as compared to the healthy sample. in this model, only coherence, f(1, 210) = 60.95, p < .001, and the interaction of group and coherence, f(1, 210) = 4.75, p = .03, significantly predicted the percentage of triads that have been judged as coherent. fluency, depression, and further interaction effects were not significant (see figure 2). remmers, zimmermann, topolinski et al. 9 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ figure 2 coherence judgment rates for depressed patients and healthy controls in the high vs. low fluency and coherent vs. incoherent conditions patients with depression healthy controls low high low high 0.2 0.4 0.6 0.8 fluency c oh er en ce r at e coherence coherent incoherent note. figure 2 indicates no significant effect of the fluency manipulation on coherence judgments and no interaction effect between group and fluency on coherence rate. in line with h3a, analyses revealed that positive valence of word triads significantly predicted semantic coherence judgments in depressed patients, f(1, 105) = 38.45, p < .001. furthermore, the effect of coherence, f(1, 105) = 80.98, p < .001, and the interaction effect of valence and coherence were significant, f(1, 105) = 8.60, p < .01. the pattern of results suggested that coherent triads that were positive in valence were most likely to be judged as coherent (see left panel of figure 3). with respect to h3b, results did not confirm the hypothesis that depression moderated the effect of positive valence on coherence judgments. the effect of positive valence on coherence judgments was not smaller in the depressed sample as compared to the healthy sample, f(1, 210) = 0.02, p = .88. in this model, valence, f(1, 210) = 85.52, p < .001, coherence, f(1, 210) = 175.04, p < .001, and their interaction, f(1, 210) = 10.01, p < .01, were significant. the effect of group and its interaction with valence and coherence were not significant (see figure 3). intuitive judgments in depression 10 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ figure 3 coherence judgment rates for depressed patients and healthy controls in the positive vs. negative valence and coherent vs. incoherent conditions patients with depression healthy controls negative positive negative positive 0.2 0.4 0.6 0.8 valence c oh er en ce r at e coherence coherent incoherent note. figure 3 indicates a significant effect of the valence manipulation in both the depressed group and the control group and no interaction effect between group and valence on coherence rate. exploratory follow-up analyses for testing our main preregistered hypothesis regarding intuition deficits in depressed patients, we selected a simple discrimination index (i.e., the difference between hit and false alarm rates) that has also been used in previous studies (bolte & goschke, 2008). to check the robustness of our results, we calculated another index established in signal detection theory, namely a’. this non-parametric measure accounts for small numbers of observations per cell and corrects for hit rates of 1.0 and false-alarm rates of 0.0 (pollack, 1970; pollack & norman, 1964). a’ of .5 indicates performance on chance level, and perfect discrimination yields an a’ of 1. we repeated our analyses for h1 using a’ and found that results did not differ from results using the simple discrimination index (see appendix c). we also repeated our preparatory analyses and analyses for h1 combining the data from all blocks (i.e., including the data from the fluency and valence block). with regard to h1, again no significant differences emerged, neither for the simple discrimination index nor for a’. we also did not find significant differences in the number of solved remmers, zimmermann, topolinski et al. 11 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ trials. however, across all intuition blocks, depressed patients missed more trials and had significantly higher reaction times as compared to healthy controls (see appendix c). d i s c u s s i o n the aim of the present study was to replicate recently demonstrated deficits in intui‐ tive semantic coherence detection and to explore the effects of processing fluency and positivity on intuition in depressed patients. one major finding was that patients with depression did not differ from healthy controls in their ability to discriminate semantic coherence from semantic incoherence (h1). even though controls were better at discrim‐ inating coherent from incoherent triads compared to depressed patients in the fluency block (indicated by a significant interaction between group and coherence), differences in discrimination indices were not significant when considering data from all blocks. these findings may query the hypothesis of impaired intuition in depression. howev‐ er, methodological issues should be considered. the true difference between the groups might be smaller than expected (based on prior research). thus, our study may have lacked the power to detect it. moreover, hit and false alarm rates were computed after exclusion of missed trials. thus, subjects who only responded when they were relatively confident in their judgment (i.e., when seeing a comparably easy triad) might have yielded a higher intuitive discrimination index as compared to subjects who missed rela‐ tively few trials. as such, the non-significant difference in intuitive performance might have resulted from depressed patients’ higher tendency to not respond within the given time window, for example when being unsure and less confident, or when confronted with more difficult trials. indeed, depressed patients missed significantly more trials as compared to healthy control participants when considering their responses across all three intuition blocks. our exploratory analyses with reaction times also showed that on average and across all blocks, depressed patients were slower than healthy controls. together with the finding on missed trials, this result points out that future research would do well in elucidating how longer response times are associated with patients’ intuitive discrimina‐ tion accuracy. researchers should hereby distinguish between simple between-subject approaches such as mean reaction time analyses and more sophisticated within-subject methodologies. using, for example, stochastic diffusion models, can provide important insights into speed-accuracy trade-offs (voss, nagler, & lerche, 2013). the latter take information from individual distributions into account and hereby help to disentangle how performance differs between conditions (or groups), and – importantly – in which way it does and how speed-accuracy interactions may reflect cognitive biases (e.g., being more accurate when responding faster may reflect intuitive capacities). although this kind of model can be applied to many experimental paradigms and provides much more intuitive judgments in depression 12 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ insight than the analysis of mean response times, it is still rarely used in cognitive psychology and in clinical psychopathology research in specific. altogether, our findings and considerations call for more replication studies to eluci‐ date the question whether depressed patients are impaired in intuitively detecting mean‐ ing and coherence in their environment and within themselves (e.g., meaning in life). regarding the latter, it seems fruitful to connect intuitive coherence detection research with research on memory coherence, i.e., the ability to construct one’s autobiography in a coherent, integrated way. as memory coherence is associated with psychological health, positive therapy outcomes and seems to buffer protectively against the impact of early life stress (adler et al., 2013; baerger & mcadams, 1999), future research should explore to what extent performance in the jsct is associated with a person’s memory coherence. hereby, upcoming research should also take the heterogeneity of depression (monroe & anderson, 2015) as well as interindividual differences into account. hicks and colleagues (2010) showed for example how interindividual differences in self-reported preference for intuitive processing influence the interplay between positive affect and intuition. with respect to our research question arises whether intuitive processes are especially impaired in patients with recurrent forms of depression, (and) or only in patients with anhedonia? in other words: it should be explored for which patients the assumption of impaired intuitive processing holds to get a better understanding of this issue. results did not reveal any effect of our fluency manipulation, and thus our hypothe‐ ses regarding fluency (h2) were not supported. as such, the current study could not replicate previous results that bolstered the fluency model proposed by topolinski and strack (2009a, 2009b). in order to explore whether processing fluency will prove as a major determinant of coherence judgments or not, future studies should use other fluen‐ cy manipulations such as priming (see topolinski & strack, 2009a). in addition, future research should take into account that fluency may not always lead to positive affective responses (gamblin, banks, & dean, 2020) and thus also not to coherent responses. given that processing fluency and affective responses may interact differently depending on characteristics of the presented stimulus or the responding individual, future studies should disentangle the differential effects of processing ease on task performance. the results further showed that positive (vs. negative) valence triggered coherence judgments (h3a) and that this effect was – in contrast to our hypothesis (h3b) – not moderated by depression. this suggests that depressed patients may be susceptible for positive affectivity conveyed by the valence of word triads and used it – when provided externally – in their judgments. this is an important finding, because even though depression is characterized by anhedonia (i.e., the inability to experience positivity), pa‐ tients seemed to be inclined to detect meaningfulness and coherence when encountering positive valence, bolstering the idea that positivity plays a major role in finding meaning. remmers, zimmermann, topolinski et al. 13 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ how can the current findings be reconciled with previous research depressed pa‐ tients’ processing of positivity? at first glance they seem to stand in contrast to research showing that – opposed to healthy people – depressed patients do not direct their attention to positivity and are less susceptible to positive stimuli (duque & vázquez, 2015; pool, brosch, delplanque, & sander, 2016; winer & salem, 2016). in their compre‐ hensive review lemoult and gotlib (2019) conclude that biases (e.g., faster reaction time in response to negative as opposed positive stimuli) are mostly found when stimuli are presented longer and when faces as opposed to words are presented. thus, it is conceivable that depression did not moderate the effect of positive valence manipulation in our study because (a) presentation of stimuli was short enough (and hereby prevented conscious processing) and (b) words (and no faces) were presented. however, these comparative conclusions should be drawn cautiously because our main outcome were binary coherence judgments and not response times. given the heterogeneity of previous research on biases in the processing of positive affect (e.g., yoon, joormann, & gotlib, 2009), future studies would do well in examining different cognitive abilities (memory, attention, intuitive decisions) along together. also, it remains open to what extent posi‐ tivity exhibited its effect on a conscious level. future work should elucidate this issue by exploring whether rather implicit or explicit induced positive affect resonates in depressed patients. our findings also revealed a significant interaction between valence and coherence in the valence block (i.e., positive word triads that were coherent were most likely to be judged as coherent in both groups). this finding indicates that positivity (con‐ veyed by positive valence in the current study) may lead to more accurate intuitive judgments and is in line with previous research showing that not only “tonic” positive affect (e.g., manipulated or freestanding positive mood; balas et al., 2012; bolte et al., 2003) but also “phasic” positive affect (induced by the activation of positively valenced memory content) can strengthen the accuracy of coherence judgments (topolinski & strack, 2009b). in a similar fashion, balas et al. (2012) demonstrated increased accuracy for triads with positive solution words as compared to triads with negative solution words. future research should test the underlying theoretical assumptions on the positive affect-intuition-interplay by implementing measures assessing positive affect in individu‐ als, because otherwise it remains speculative whether it is indeed “affect” (within the individuals) that triggers these effects (see alves et al., 2015, for potential alternative explanations on the effects of positive valence). along this line, it is of important practical relevance to test whether depressed patients can themselves produce the positive affect needed to go with their intuition in daily life. extending laboratory research, a recent daily diary study found that people are not only inclined to make decisions intuitively when they are in a good mood (as com‐ pared to a negative mood, remmers & zander, 2018) but that people also report to feel better after intuitive as compared to analytical decisions (zander-schellenberg, remmers, intuitive judgments in depression 14 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ zimmermann, thommen, & lieb, 2019). to explore whereas these decision-mood dynam‐ ics also apply to currently depressed patients outside the laboratory, is an important next step also in terms of ecological validity and clinical relevance. from a therapeutic perspective, the current findings imply that targeting positive af‐ fect in psychotherapy may be important in fostering patients’ ability to detect coherence. it would be an important next step to investigate the intuitive detection of meaning not only with regard to laboratory stimuli but also on a broader level with regard to finding coherence and meaning in life. hereby, clinical researchers may build upon recent basic psychological research on how intuitive processing, positive affect, and finding meaning in life interact (heintzelman & king, 2013). considering that finding meaning in life is rather a product of intuitive processing than a result of analytical reasoning or explicit meaning construction (heintzelman & king, 2013), research in this field may have farreaching practical and theoretical clinical implications. a number of limitations should be taken into account. first, even though the sample size was in compliance with the a-priori power analysis, it was still relatively small. thus, future studies should test our assumptions with larger samples to increase the power and reliability of findings. furthermore, a limitation of the current study was that the samples were not matched in terms of educational level. even though the relatively lower educational level of depressed patients is consistent with epidemiological studies showing that the prevalence of psychological disorders is higher in low socioeco‐ nomic groups, future studies should take care of the matching issue to avoid potential confounds. in addition, we randomized different factors such as the key position for the coherence judgments and the stimuli that were either presented in the main intuition block or the fluency bock. even though randomization is of methodological importance, this may have led to reduced comparability of responses between subjects and thus to reduced power to detect group differences. thus, future research should use larger sets of stimuli and larger sample sizes in order to ensure randomization and reduce statistical noise. furthermore, conclusions with regard to the role of positivity should be drawn cautiously because our study was lacking a neutral control condition. thus, we cannot rule out that, for example, reduced negativity (as opposed to increased positivity) drove our effects in the valence block. future studies should test whether positivity (e.g., conveyed by the valence of stimuli) alters subtle affective responses in subjects. only by this means we can conclude whether positive affect elicited in subjects triggers coherence judgments (see topolinski & strack, 2009a for a detailed description of the fluency-affect intuition chain). albeit these considerations, the current study presents an important contribution to the field. it is a preregistered replication study which follows current state-of-the-art demands to bolster the robustness of psychological research findings. in addition, we used experimental paradigms from basic psychology and hereby build the bridge from basic to clinical research. altogether one may conclude from the current study that the remmers, zimmermann, topolinski et al. 15 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ cognitive profile of depressed patients is not merely deficient. the results elucidate the importance of positivity when it comes to detecting meaning and coherence. the latter is of major clinical importance, because in a depressed state, people often experience their life as meaningless and cannot find coherence. whether promoting positivity may not only enhance how patients feel but will also help them to find meaningfulness and to follow their intuitions is a fruitful endeavor to study for future research. funding: this research was facilitated by research funds of the forschungskommission of the freie universität berlin. competing interests: the authors have declared that no competing interests exist. acknowledgments: we thank lola hermann, isabelle klausener, and leonard wegner for their help in data collection. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include the preregistration protocol for this study (for access see index of supplementary materials below). index of supplementary materials remmers, c., zimmermann, j., topolinski, s., richter, c., zander-schellenberg, t., weiler, m., & knaevelsrud, c. 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remmers et al., 2015); the within-subjects effect size of the fluency manipulation in a student sample was dz = 0.5 (similar to h2a; topolinski & strack, 2009a, experiment 1); and the within-subjects effect size of the affect induction in a student sample was dz = 1.19 (similar to h3a; topolinski & strack, 2009a, experiment 8). we did not have any prior information about the size of the proposed interaction effects (h2b and h3b), and thus we considered here a smaller effect size of d = 0.35. based on these assumptions, we conducted a series of a priori power analyses using gpower (faul, erdfelder, buchner, & lang, 2009), focusing on the difference between two independent means (h1), the within-subjects effect of a repeated measures anova (h2a and h3a, assuming a correlation of r = .5 between the repeated measurements), and the within-between-subjects interaction effect of a repeated measures anova (h2b and h3b, again assuming a correlation of r = .5 between the repeated measurements). to detect each of these effects with a probability of 80% and an alpha error probability of 5% (two-sided), the following sample sizes (per group) are required: 33 (h1), 34 (h2a) 34 (h2b), 8 (h3a), and 34 (h3b). thus, we conclude that 35 participants per group may represent an acceptable sample size given prior findings. appendix b: procedure of the judgment of the semantic coherence task introduction phase. the first computer screens introduced subjects to the intuition task and explained that the task was about intuition. participants were informed that the task was not about right or wrong decisions or about finding a solution (i.e., typing in the correct solution word) but rather about intuitive gut reactions in response to the presented stimuli. letting participants type in a solution word served us to distinguish between intuitively detected but unsolved trials (being indicative for intuition; see remmers et al., 2015 and topolinski & strack, 2009a for detailed description) and explicitly solved trials (being indicative for insight and not intuition). the intro‐ ductory phase also included the presentation of exemplary coherent and incoherent word triads (e.g., deep salt foam; coherent triad, common denominator: sea) not reappearing later in the task. next, subjects underwent a practice block in which they were asked to react within 2000 ms and to indicate whether presented exclamation marks appeared on the right or left side of the screen by pressing the respective keyboard keys. the same keys, namely s and l on the keyboard (german qwertz keyboard layout), later served as reaction keys for the coherence judgments. keyboard button assignment was randomly assigned for each participant and remained the same for each participant once assigned during the entire experimental task. hereby, it was manipulated whether the left (s) or the right (l) keyboard button indicated a coherence or incoherence judg‐ ment. general intuition block. to measure the general ability to intuitively detect semantic coher‐ ence subjects performed the jsct according to bowers et al., 1990 (see also topolinski & strack, 2009a; remmers et al., 2015, 2017). thus, in this block, all subjects performed the jsct in which only the coherence of the triads was manipulated (coherent vs. incoherent word triads). a total of 36 triads were presented in this part to test the ability to detect semantic coherence (18 coherent, 18 remmers, zimmermann, topolinski et al. 21 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ incoherent, re-randomized order for each subject, stimulus material see bolte et al. 2003; topolinski & strack, 2009a). fluency block. to investigate the effect of processing fluency on coherence judgments, an experimental manipulation established in basic research was applied. methodologically equivalent to topolinski and strack (2009a, experiment, 1), the figure-ground contrast was manipulated as a means to alter the fluency with which stimuli are processed. for this, triads were presented in blue, red or green letters. high-fluency triads had a high figure-ground contrast (against the white background) by manipulation of the rgb (red, green, blue) components. an rgb combination of r = 255, g = 0 and b = 0 results, for example, in a red triad with a strong contrast, whereas the combination of r = 255, g = 200, b = 200 yields a light red colour and hence low contrast against the white background. in line with the procedure of topolinski & strack (2009a; but see also reber, winkielman, & schwarz, 1998; unkelbach, 2007), we designed a red high-contrast (thus high-fluency) triad by assigning a random value between 100 and 120 for the b and g component, and by assigning 255 to the r component. a red low-contrast (thus low-fluency) triad was designed by assigning a random value between 200 and 220 for the b and g components. this was one for the other colours, too. deriving from the stimulus pool of bolte et al. (2003), 36 triads were presented. using a 2 (high vs. low fluency) x 2 (coherent vs. incoherent) intra-individual factorial design, 4 experimental conditions resulted: 9 coherent triads with high figure-ground contrast; 9 incoherent triads with high figure-ground contrast; 9 coherent triads with low figure-ground contrast; 9 incoherent triads with low figure-ground contrast. it should be noted that stimuli of the general intuition block and the fluency block are taken from the same stimulus pool, but are randomly selected anew for each participant ensuring that no triad is seen twice by an individual on the one hand and that whether a triad is presented in the intuition or the fluency block is a matter of randomization and not preselected by the study team. valence block. to investigate the effect of positive valence on coherence judgments, subjects are presented with positive (e.g., luck children meadow; common denominator: game) and negative (e.g., sulfur glue black; common denominator: pitch) word triads. just like in the other two blocks, subjects’ task is to decide whether a presented triad is coherent or incoherent. taken from the stimulus pool of topolinski and strack (2009a; experiment 8), 48 triads were presented to each subject. using a 2 (positive vs. negative) x 2 (coherent vs. incoherent) intra-individual factorial design, 4 experimental conditions resulted: 12 positive coherent triads; 12 positive incoherent triads, 12 negative coherent triads, 12 negative incoherent triads). intuitive judgments in depression 22 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ appendix c: preparatory analyses and exploratory follow-up analyses ta b le c .1 p re pa ra to ry a na ly se s an d e xp lo ra to ry f ol lo w -u p a na ly se s v ar ia bl e p at ie n ts (n = 3 5) c on tr ol s (n = 3 5) tte st s m sd m sd δ m t df p c i_ lo w c i_ h ig h d g en er al i n tu it io n b lo ck d is cr im in at io n in de x 0. 18 0. 17 0. 19 0. 18 0. 00 -0 .1 2 68 0. 90 -0 .0 9 0. 08 -0 .0 3 a ‘ 0. 65 0. 13 0. 65 0. 14 0. 00 -0 .0 2 68 0. 98 -0 .0 6 0. 06 -0 .0 1 n um be r of m is se d tr ia ls 7. 17 4. 73 5. 17 4. 23 -2 .0 0 1. 86 68 0. 07 -0 .1 4 4. 14 0. 45 n um be r of s ol ve d tr ia ls 0. 63 0. 91 0. 89 1. 05 0. 26 -1 .0 9 68 0. 28 -0 .7 3 0. 21 -0 .2 6 a ve ra ge re ac tio n tim e pe r tr ia l ( in s ec on ds ) 1. 11 0. 15 1. 04 0. 20 -0 .0 8 1. 79 68 0. 08 -0 .0 1 0. 16 0. 43 c om bi n ed b lo ck s d is cr im in at io n in de x 0. 17 0. 11 0. 20 0. 10 0. 03 -0 .9 8 68 0. 33 -0 .0 8 0. 03 -0 .2 4 a ‘ 0. 64 0. 09 0. 66 0. 09 0. 02 -1 .0 7 68 0. 29 -0 .0 6 0. 02 -0 .2 6 n um be r of m is se d tr ia ls 15 .9 0 10 .7 6 10 .8 5 8. 79 -5 .0 5 2. 15 68 0. 04 0. 36 9. 74 0. 52 n um be r of s ol ve d tr ia ls 1. 87 2. 47 2. 19 2. 26 0. 31 -0 .5 5 68 0. 58 -1 .4 5 0. 82 -0 .1 3 a ve ra ge re ac tio n tim e pe r tr ia l ( in s ec on ds ) 1. 02 0. 20 0. 93 0. 19 -0 .1 0 2. 11 68 0. 04 0. 01 0. 19 0. 51 remmers, zimmermann, topolinski et al. 23 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. intuitive judgments in depression 24 clinical psychology in europe 2020, vol.2(4), article e2593 https://doi.org/10.32872/cpe.v2i4.2593 https://www.psychopen.eu/ intuitive judgments in depression (introduction) the current study method participants procedure statistical analysis results descriptive statistics preparatory analyses of the general intuition block confirmatory hypotheses testing exploratory follow-up analyses discussion (additional information) funding competing interests acknowledgments supplementary materials references appendices appendix a: power analysis appendix b: procedure of the judgment of the semantic coherence task appendix c: preparatory analyses and exploratory follow-up analyses cultural adaptation of scalable psychological interventions: a new conceptual framework latest developments cultural adaptation of scalable psychological interventions: a new conceptual framework eva heim a, brandon a. kohrt b [a] department of psychology, university of zurich, zurich, switzerland. [b] department of psychiatry, george washington university, washington, dc, usa. clinical psychology in europe, 2019, vol. 1(4), article e37679, https://doi.org/10.32872/cpe.v1i4.37679 received: 2019-06-25 • accepted: 2019-11-01 • published (vor): 2019-12-17 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: eva heim, university of zurich, department of psychology, binzmuehlestrasse 14/17, 8050 zurich, switzerland. e-mail: e.heim@psychologie.uzh.ch abstract background: the worldwide mental health treatment gap calls for scaling-up psychological interventions, which requires effective implementation in diverse cultural settings. evidence from the field of global mental health and cultural clinical psychology indicates cultural variation in how symptoms of common mental disorders are expressed, and how culturally diverse groups explain the emergence of such symptoms. an increasing number of studies have examined to what extent cultural adaptation enhances the acceptability and effectiveness of psychological interventions among culturally diverse groups. to date, this evidence is inconclusive, and there is a lack of studies that dismantle the multiple types of modifications involved in cultural adaptation. method: based on empirical evidence from ethnopsychological studies, cultural adaptation research, and psychotherapy research, the present paper offers a new conceptual framework for cultural adaptation that lays the groundwork for future empirical research. results: the cultural adaptation framework encompasses three elements: i) cultural concepts of distress; ii) treatment components; and iii) treatment delivery. these three elements have been discussed in literature but rarely tested in methodologically rigorous studies. innovative research designs are needed to empirically test the relevance of these adaptation elements, to better understand the substantial modifications that enhance acceptability and effectiveness of psychological interventions. conclusion: using a theory-driven approach and innovative experimental designs, research on cultural adaptation has the potential not only to make psychological treatments more accessible for culturally adverse groups, but also to further advance empirical research on the basic question about the “key ingredients” of psychotherapy. keywords cultural adaptation, psychological interventions, culturally diverse groups, migrant populations this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.37679&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • the phenomenology of common mental disorders, as well as mind-body concepts, vary across cultures. • cultural adaptation may enhance the acceptability and effectiveness of psychological interventions. • there is a lack of empirical evidence on the substantial modifications in cultural adaptation. • theory-driven, experimental approaches are needed in cultural adaptation research. on 10 october 2017, mental health europe celebrated world mental health day in the european parliament. participants in this conference discussed the urgent need to sup‐ port the mental health of refugees, migrants and asylum seekers (mental health europe, 2017). according to united nations, 180’000 migrants arrived in europe in 2017, and 134’000 in 2018 (un dispatch, 2018). prevalence rates of common mental disorders such as depression, anxiety, and post-traumatic stress disorder (ptsd) are high among immi‐ grants in europe, and particularly among survivors of armed conflicts (bogic, njoku, & priebe, 2015; priebe, giacco, & el-nagib, 2016). worldwide, there is a large mental health treatment gap, i.e. a high number of people in need of treatment who have not received adequate treatment. the treatment gap for common mental disorders is around 60% in high-income countries, 65% in upper-middle income countries, and over 80% in lower-middle income countries (alonso et al., 2018; thornicroft et al., 2017). although the treatment gap is lower in high-income countries, there are specific barriers to mental health care for culturally diverse groups, which in‐ clude poor command of the host country language, cultural beliefs about mental health, lack of trust in mental health services, and mental health related stigma (priebe et al., 2016). the lancet commission on global mental health and sustainable development (patel et al., 2018) calls for action to scale up mental health services as an essential com‐ ponent of universal health coverage. in response to the worldwide treatment gap, who and other research groups have invested in developing a series of potentially scalable psychological interventions (who, 2017). scalability is defined as “the ability of a health intervention shown to be effica‐ cious on a small scale and or under controlled conditions to be expanded under real world conditions to reach a greater proportion of the eligible population, while retaining effectiveness” (milat, king, bauman, & redman, 2013, p. 289). one particular question for scaling-up concerns the extent to which results from one cultural group can be transferred to another. ethnic minorities are generally underrepre‐ sented in clinical trials in high-income countries (hussain-gambles, atkin, & leese, 2004; la roche & christopher, 2008; wendler et al., 2005). there is an ongoing debate in litera‐ cultural adaptation of psychological interventions 2 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ ture on the extent to which psychological interventions developed in western, educated, industrialized, rich, and democratic (weird) societies (henrich, heine, & norenzayan, 2010) require cultural adaptation to be effective for the treatment of common mental dis‐ orders among culturally diverse groups. literature indicates cultural variety in how symptoms of common mental disorders are expressed (haroz et al., 2017; kohrt et al., 2014), and how different cultural groups explain the emergence of such symptoms, there‐ by revealing their (implicit) assumptions about mind-body relationships, and religious or spiritual beliefs (e.g., kohrt & hruschka, 2010). despite such cultural variance in symptoms and assumed causes, meta-analytic evi‐ dence suggests that evidence-based psychological interventions are effective for the treatment of common mental disorders among culturally diverse groups (cuijpers, karyotaki, reijnders, purgato, & barbui, 2018; singla et al., 2017). but to what extent cul‐ tural adaptation can further enhance the acceptability and effectiveness of such interven‐ tions is subject to current debate in literature. c u l t u r a l a d a p t a t i o n o f p s y c h o l o g i c a l i n t e r v e n t i o n s bernal, jiménez-chafey, and domenech rodríguez (2009) define cultural adaptation as “the systematic modification of an evidence-based treatment (ebt) or intervention proto‐ col to consider language, culture, and context in such a way, that it is compatible with the client’s cultural patterns, meanings, and values” (p. 362). cultural adaptation can range from relatively low investment of resources (e.g., adaptation of illustrations or case exam‐ ples) to adaptations which require a large amount of time and human resources, e.g. adaptation to cultural concepts of distress (kohrt et al., 2014). bernal and colleagues (bernal, bonilla, & bellido, 1995; bernal & sáez-santiago, 2006) developed a framework for cultural adaptation of psychological interventions which en‐ compasses eight elements: (a) language, (b) therapeutic relationship, (c) metaphors, (d) content of intervention, (e) concept of illness, (f) treatment goals, (g) delivering methods, and (h) context. meta-analytic evidence suggests that culturally adapted psychological in‐ terventions are effective when compared to a variety of control conditions (d = 0.45) (griner & smith, 2006), and more effective than unadapted versions of the same interven‐ tion in direct comparison (g = .52) (hall, ibaraki, huang, marti, & stice, 2016). moreover, two meta-analyses showed that effect sizes increased with the number of implemented adaptation elements according to the bernal framework (harper shehadeh, heim, chowdhary, maercker, & albanese, 2016; smith, domenech rodríguez, & bernal, 2011). however, a series of difficulties have been reported in cultural adaptation literature. first, the framework developed by bernal and colleagues (bernal et al., 1995; bernal & sáez-santiago, 2006) has been criticised, particularly because of its list-like format and re‐ ported difficulties with implementing the elements in real-world settings (chu & leino, heim & kohrt 3 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ 2017). the eight elements are not distinct but overlap, e.g. it is hard to differentiate be‐ tween adaptations made in language or metaphors, which are closely intertwined. in ad‐ dition, the framework was developed for face-to-face treatments, and its use for other treatment formats such as self-help interventions is limited (harper shehadeh et al., 2016). second, when looking into the original studies included in the above cited metaanalyses, it becomes evident that such studies tested a large variety of interventions such as psychoeducation, parenting programs, cognitive-behavioural therapy, interpersonal therapy, skills training, systemic therapy, problem solving, etc. the assumed mechanisms of action behind these approaches vary greatly, thus most likely not all of these interven‐ tions require the same level of cultural adaptation. what is more, most original studies and meta-analyses do not provide detailed descriptions of the cultural adaptations that were done in the original studies, with some exceptions (e.g., abi ramia et al., 2018). third, there is very little evidence to determine which cultural adaptation elements are particularly relevant for enhancing treatment acceptability and effectiveness. benish, quintana, and wampold (2011) showed that cultural adaptation of the illness myth, i.e. the explanatory model provided to patients for their symptoms (bhui, rudell, & priebe, 2006), was the sole moderator of larger effect sizes of culturally adapted psychotherapy when compared to other active treatments (d = 0.21). but this finding was based on weak empirical evidence. aside from the bernal framework, a series of other frameworks have been published in the past decade (domenech rodríguez & bernal, 2012). in an attempt to organize the variety of elements suggested in these frameworks, chu and leino (2017) conducted a systematic review and developed a new, data-driven cultural adaptation framework, in which they basically make a distinction between the adaptation of core vs. peripheral as‐ pects in psychotherapy. core components are the therapeutic ingredients that are as‐ sumed to cause symptom change, based on psychological theories, whereas peripheral components include the treatment aspects that are related to the feasibility and accepta‐ bility of the intervention (e.g., language or case examples). in their review, chu and leino (2017) found that all included studies had implemented peripheral adaptations, whereas 11% had modified and 60% had added core components. the new adaptation framework by chu and leino (2017) is an improvement when compared to other frameworks, particularly due to the fact that it was based on original studies rather than expert opinions. moreover, the division of treatment aspects into pe‐ ripheral (i.e., engagement and methods of delivery) and core aspects provides an intrigu‐ ing simplicity in comparison with other frameworks. on the other hand, this framework is based on what has been done so far and therefore cannot capture aspects that have potentially been neglected in literature. moreover, due to its heuristic nature, it does not provide the necessary theoretical assumptions of how and why cultural adaptation might cultural adaptation of psychological interventions 4 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ increase the acceptance and effectiveness of psychological interventions. a more theorybased framework can set the ground for empirical research to examine these questions. when adopting such a theory-driven rather than heuristic perspective, the division between core and peripheral aspects of psychological interventions might not be as straightforward as suggested by chu and leino (2017). two recent prominent systematic reviews conclude that current evidence is insufficient to explain change mechanisms in psychotherapy (cuijpers, cristea, et al., 2019; lemmens, muller, arntz, & huibers, 2016). it might well be that psychotherapy works through common factors, such as the thera‐ peutic alliance, positive expectations, and a convincing treatment rationale rather than the specific techniques that are assumed to cause changes in symptoms (cuijpers, reijnders, & huibers, 2019). thus, factors classified as peripheral by chu and leino (2017), e.g. psychoeducation, might actually be the core ingredients of psychotherapy, as is explained more in detail below. in a more general manner, resnicow, baranowski, ahluwalia, and braithwaite (1999) differentiate between surface and deep structure adaptations to health interventions. sur‐ face adaptations refer to matching materials (e.g., illustrations, language), as well as channels and settings for treatment delivery to observable characteristics of the target population. by contrast, deep structure adaptations take into account how cultural, so‐ cial, environmental or historical factors influence health behaviours. such adaptations are based on assumptions of how members of a particular cultural group perceive the cause, course, and treatment of a particular illness. in other words, and as highlighted by the authors, deep structure conveys salience. resnicow et al. (1999) developed their framework for health interventions in general. when applying this logic to the cultural adaptation of psychological interventions for the treatment of common mental disorders, deep structure adaptations may take into account results from ethnopsychological stud‐ ies. t h e o r e t i c a l a n d e m p i r i c a l f o u n d a t i o n s f o r c u l t u r a l a d a p t a t i o n ethnopsychology uses ethnological research to examine different populations’ notions of psychological concepts such as the self, emotions, and human nature (white, 1992). eth‐ nopsychological studies have brought forward a large body of evidence on cultural con‐ cepts of distress (ccd), a term that was introduced in dsm-5 to describe local mental health-related phenomena (american psychiatric association, 2013). ccd encompass other terms used in literature, such as culture-bound syndromes (american psychiatric association, 1994), idioms of distress (nichter, 1981, 2010), explanatory models (bhui & bhugra, 2002), or illness narratives (groleau, young, & kirmayer, 2006). kohrt et al. (2014) summarised evidence on ccd from different parts of the world in a systematic review. they found that more rigorous studies revealed ccd that clearly dif‐ heim & kohrt 5 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ fered from western diagnoses of common mental disorders. such studies examine peo‐ ple’s ways of expressing suffering, their assumptions about causes of distress and possi‐ ble ways to overcome it, physiological and spiritual meanings attributed to suffering, and the distinction between universal human suffering and mental illness (e.g., keys, kaiser, kohrt, khoury, & brewster, 2012; kohrt & hruschka, 2010; shala, morina, salis gross, maercker, & heim, 2019). one example of adapting psychological interventions to such ccd was delivered by hinton, rivera, hofmann, barlow, and otto (2012), who developed culturally adapted cognitive behavioural therapy (ca-cbt) for ptsd. ca-cbt was first developed for cambodian survivors of the khmer rouge. it targets the ccd of khyâl attacks that is based on cambodians’ assumptions about a wind-like substance that circulates in the body (hinton, pich, marques, nickerson, & pollack, 2010). according to this assumption, an imbalance in the khyâl flow causes symptoms such as dizziness and anxiety, which are accompanied by catastrophic beliefs and trauma memories. ca-cbt is based on this particular mind-body concept, and the main treatment components are emotion exposure and emotion regulation techniques (i.e., meditation and yoga-like stretching). thus, cacbt uses techniques that are not unique for cambodians, but the treatment rationale pro‐ vided to patients is rooted in their own explanatory model that is based on khyâl. this example illustrates one of the basic debates in psychotherapy research, namely the question whether the effect of the treatment is rooted in the techniques themselves, or rather the rationale provided for their use (wampold & imel, 2015). as brought to the point by wampold (2007) “[p]sychotherapy is not simply the vehicle for the delivery of psychological ingredients but is, rather, a highly entwined system that uses language to construct, or better said, reconstruct the client’s interpretations of the world” (p. 8). in psychotherapy research, older and more recent meta-analyses come to the consistent conclusion that after decades of randomised controlled trials (rcts), we do not know what the “key ingredients” of psychotherapy are (ahn & wampold, 2001; cuijpers, cristea, et al., 2019; lemmens et al., 2016). “key ingredients” are the treatment compo‐ nents that (are assumed to) cause the symptom change. the current state of the evidence does not allow to conclude whether symptom improvement is caused by specific interven‐ tions (e.g., behavioural activation or stress management techniques) or by unspecific fac‐ tors such as the therapeutic alliance, positive outcome expectations, or providing a con‐ vincing treatment rationale (cuijpers, cristea, et al., 2019). this conclusion is highly relevant for research on cultural adaptation of psychological interventions. chu and leino (2017) considered “psychoeducation” to be a peripheral as‐ pect of cultural adaptation. however, explaining the purpose of a specific therapeutic technique in a particular way to make it more congruent with the patient’s worldview might be much more than just a peripheral adaptation to make the intervention more ac‐ ceptable. such adaptations in language might touch on patients’ implicit explanatory models, which in turn might change the underlying mechanisms of action, even if the cultural adaptation of psychological interventions 6 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ intervention itself (e.g., a stress management technique) remains the same. thus, one and the same adaptation might be considered as core or peripheral. in summary, theory-driven, experimental studies are needed to better understand whether and how cultural adaptation contributes to the acceptability and effectiveness of psychological interventions. such studies may in the longer run also contribute to better understand the active ingredients of psychotherapy itself. we aim to lay the groundwork for such studies by suggesting a new conceptual framework. the elements of our frame‐ work are based on empirical evidence from ethnopsychological studies, research on the cultural adaptation of psychological interventions, and psychotherapy research outlined above. a n e w f r a m e w o r k f o r c u l t u r a l a d a p t a t i o n our framework is based on the elements of psychological interventions that could poten‐ tially be adapted – regardless of whether this has been done in previous research or not. before conducting empirical studies, it seems important to take a conceptual approach in order to include all aspects of an intervention that might contribute to symptom change. our cultural adaptation framework (figure 1) consists of three main elements which are further described below. we do not formulate pre-assumptions about the components that cause symptom change. because evidence on substantial modifications is lacking, all elements are considered to be equally relevant for empirical testing. the elements gener‐ ally reflect the two dimensions suggested by resnicow et al. (1999), i.e., surface and deep structure adaptations (see above). while resnicow et al.’s framework was developed more generally for health interventions, we further specified potential deep structure adaptations in psychological interventions for the treatment of common mental disor‐ ders. the elements are presented in what we consider to be a plausible sequence, starting with what may lie at the heart of cultural adaptations, namely the ccd. from ccd – i.e. explanatory models and idioms of distress – relevant treatment components can be de‐ rived, and hypotheses can be generated about treatment delivery. in the following, we describe the three main elements and the corresponding sub-elements of the new frame‐ work and provide examples from literature to underpin our assumptions. at the same time, we make suggestions on how to implement these adaptations. our primary aim is to provide a framework as a basis for empirical testing, but the elements outlined below can also be used for adaptations in clinical practice. heim & kohrt 7 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ figure 1. new framework for cultural adaptation. cultural concepts of distress the first element of the framework focuses on core beliefs about human suffering, and the cultural resonance of hypothesized psychological mechanisms of action with ethno‐ theories of healing. this includes two aspects: explanatory models (i.e., aetiological as‐ sumptions) and idioms of distress (i.e., the expression of symptoms). several semi-struc‐ tured interview guidelines have been developed to examine ccd, e.g., the cultural for‐ mulation interview in dsm-5 (american psychiatric association, 2013), the short explana‐ tory model interview (semi, lloyd et al., 1998), the barts explanatory model inventory (be‐ mi, rüdell, bhui, & priebe, 2009) or the mcgill illness narrative interview (mini, groleau et al., 2006). these interviews cover both aspects – idioms of distress and explanatory models – and can help to better understand patients’ realities. a. explanatory models. people who suffer from psychological distress develop explanations for their symptoms (wampold, 2007). these explanations are based on intuitive and culturally shaped notions of how mind and body interact (kirmayer, 2001; kirmayer & bhugra, 2009). above, we outlined the example of khyâl attacks among cambodian survivors of the khmer rouge (hinton et al., 2010). other examples the concept of the heart-mind described in nepal (kohrt & hruschka, 2010), or the heart narratives related to psychological distress in haiti (keys et al., 2012). another example are findings related to fatalism. an ethnopsychological study showed that albanian-speaking immigrants in switzerland understood their suffering as part of normal life, given by god or fate (fati), and something that cannot be cured but has to be borne with endurance (durim) (shala et al., 2019). fatalism was also found among turkish immigrants in germany (franz et al., 2007; reich, cultural adaptation of psychological interventions 8 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ bockel, & mewes, 2015). when compared to german patients, turkish immigrants showed more fatalistic-external control attributions for mental distress, which resulted in lower motivation for psychotherapy. the concept of fate is also described in islamic understandings of suffering: “the notion of qadar ( رَدَقلا , ‘fate’) is central to this context. this acceptance of fate should not be equated with fatalism, but can be better understood within a framework of self-abandonment, which is reflected in the value of patience in the face of helplessness and adversity, such as illness and loss. life may be viewed as a transient phase of existence, a testing place for the eternal life that comes after death” (hassan et al., 2015, p. 27). psychological interventions ideally provide explanations that differ from the patient’s own views, but that are not sufficiently discrepant from the patient’s intuitive assumptions as to be rejected (wampold, 2007). for treatment adherence and compliance, it is vital that patients understand and to some point share the rationale behind the treatment. on the other hand, it is also important to provide a new explanation and treatment rationale, in order to motivate patients to try and practice the therapeutic techniques. as an example, reich, zürn, and mewes (2019) developed a web-based intervention to address fatalism and to enhance motivation for psychotherapy among turkish immigrants in germany. in a pilot study, they found that this intervention enhanced treatment motivation and reduced fatalistic beliefs. b. idioms of distress. this element scrutinises the cultural salience of symptoms that are targeted with an intervention. common mental disorders are latent (i.e., nonvisible) concepts measured through the expression of symptoms (i.e., their phenomenology). there is a vast body of literature on the difference in symptom expression across cultures, e.g. with regard to emotional vs. somatic complaints (e.g., kirmayer, 2001; ma-kellams, 2014; ryder et al., 2008). moreover, ethnopsychological studies from different parts of the world have delivered a broad range of labels used for expressing mental distress in a socially and culturally acceptable manner (e.g., haroz et al., 2017). as an example, thinking too much is an expression that has been found in many parts of the world and can be used in health communication as a nonstigmatizing way to describe symptoms of psychological distress (kaiser et al., 2015). however, it would be erroneous to assume that such labels are simply varying expressions of the same, latent construct (e.g., depression or anxiety). such local expressions often reflect implicit assumptions about mind-body interactions as described above. therefore, it is relevant to carefully assess culturally salient symptoms, and to select or target treatment components accordingly. treatment components to describe treatment components, we draw on an existing taxonomy developed by singla et al. (2017), who conducted a systematic review and meta-analysis of psychologi‐ heim & kohrt 9 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ cal interventions in lowand middle-income countries. they applied a multistep analysis of existing taxonomies of common psychological treatment elements and behavioural change techniques used for common mental disorders. based on this analysis, they pro‐ posed a taxonomy of treatment components, which includes the following elements: spe‐ cific therapeutic elements (i.e., behavioural, cognitive, interpersonal, and emotional inter‐ ventions); nonspecific elements to enhance engagement (e.g., empathy, empathic listen‐ ing, or discussing advantages of and barriers to treatment); and in-session techniques (e.g., goal-setting, role playing, or praising). in their meta-analysis, they found that two specific techniques (i.e., interpersonal and emotional), and nonspecific elements showed the strongest association with trial effectiveness. in the following, we describe how these components may be culturally adapted. a. specific elements. studies testing psychological interventions in lowand middleincome countries have often provided reasons for choosing one technique over another, e.g. arguing that behavioural activation is easier to explain than cognitive techniques, particularly when provided by lay helpers (dawson et al., 2015). the selection of therapeutic techniques is ideally based on core assumptions about human suffering and healing in the target population, and culturally salient symptoms of psychological distress. as an example, behavioural activation is based on the theoretical assumption that inertia and avoidance are key mechanisms of action in depression (ferster, 1973; lewinsohn, 1974; veale, 2008). however, a qualitative study conducted in lebanon for the cultural adaptation of an internetbased intervention (abi ramia et al., 2018), showed that inertia and inactivity were not key symptoms of depression. depressed people in lebanon rather maintain their necessary activities, yet, they were described as becoming irritable, tired, sad, frustrated or angry while continuing to function. this appears to be a global phenomenon: a qualitative systematic review of depression around the world demonstrated similar findings with irritability, anger, and pain figuring prominently but, “[t]he majority of study populations did not raise problems with daily functioning as part of their subjective experiences of depression” (haroz et al., 2017, p. 160). in resource-scarce settings where people can simply not afford to become inactive, and where cultural values impede social withdrawal, behavioural activation might not be the first-choice psychological intervention for the treatment of depression. in addition, the focus on improving one’s mood through engaging in pleasant activities might not necessarily be a convincing treatment rationale in societies where pursuing affectively positive experiences for oneself is not a key cultural value (schwartz, 2006). as another example, tol et al. (2018) argued that for people in humanitarian settings who suffer from a broad range of symptoms related to psychological distress that cannot be easily categorized as a mental disorder (e.g., nonpathological anxiety, cultural adaptation of psychological interventions 10 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ grief reactions, and demoralization), general stress management techniques might be more relevant than disorder-specific treatments. stress management techniques that focus on dealing with negative emotions such as anger, sadness, or nervousness, might be more relevant in such contexts (hinton et al., 2012; tol et al., 2018). b. nonspecific elements (common factors). singla et al. (2017) describe these as the elements that are either universal to all treatments, or the ones that are used for enhancing treatment engagement, such as active listening or discussing advantages and disadvantages of the treatment. with regard to elements that are universal to all treatments (e.g., active listening), the cultural adaptation may be limited to surface aspects (see below), such as how active listening is expressed verbally or nonverbally. when it comes to treatment engagement, providing a convincing and culturally congruent explanatory model may be relevant (see above). for discussing advantages and disadvantages of treatment, it may be relevant to consider culturally-specific notions of stigma, and the way how mental health-related stigma threatens the life domains that “matter most” (yang, thornicroft, alvarado, vega, & link, 2014) to members of a specific cultural group (e.g., marriage, employment, social networks). advantages and disadvantages of treatment may relate to such culture-specific notions of stigma. people affected by mental disorders could fear stigmatisation if they accept a treatment. on the other hand, patients may realise that treatment and symptom reduction can help in reducing mental health-related stigma, particularly when they are re-integrated into employment or other societal domains. c. in-session techniques. singla et al. (2017) subsume a broad range of techniques under this element, such as role-playing, goal setting, homework, or behavioural experiments. formative research (e.g., key informant interviews or focus groups) can be used to better understand whether such techniques are acceptable in a particular target group, or how these techniques can be adapted to be accessible for members of this target group (ramaiya, fiorillo, regmi, robins, & kohrt, 2017). treatment delivery once the treatment components are defined, the delivery format can be selected, or dif‐ ferent formats can be used for different target groups (e.g., face-to-face interventions for older participants and mobile applications for youths). for cultural adaptation of these el‐ ements, factors such as literacy level, socio-economic status, gender, or assumptions about the patient-therapist relationship may be taken into account. a. delivery format. this element describes cultural preferences and acceptability for different treatment modalities. as an example, several trials have tested the groupbased delivery of potentially scalable interventions as opposed to individual treatment sessions (epping-jordan et al., 2016; sangraula et al., 2018; verdeli et al., heim & kohrt 11 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ 2003). furthermore, internet-based interventions are currently propagated as one potential measure to address the worldwide mental health treatment gap, as they can widely be disseminated among difficult-to-reach populations (schröder, berger, westermann, klein, & moritz, 2016). there is an ongoing debate about the necessity of guidance in internet-based or other self-help interventions (baumeister, reichler, munzinger, & lin, 2014). it is theoretically possible that the answer to that question is culturally relative – i.e. that for some cultural groups, guidance is more relevant than for others. empirical evidence is needed to answer this question. b. surface. this element comes closest to what chu and leino (2017) considered to be peripheral aspects of psychological interventions, and what resnicow et al. (1999) described as surface adaptations. a large variety of descriptions of such adaptations has been delivered in literature, such as using culturally adapted language and metaphors (ramaiya et al., 2017), providing culturally relevant illustrations and case examples (verdeli et al., 2003), or using easy-to-understand texts (carswell et al., 2018). evidence on such adaptations has been summarised in systematic reviews (chowdhary et al., 2014; harper shehadeh et al., 2016). however, so far there is no evidence to show to what extent such adaptations are necessary to enhance acceptance and effectiveness of psychological interventions. of course, there is a moral obligation not to use treatment materials that are potentially offensive or that may hurt religious feelings. and of course, an intervention is more likely to be accepted when patients feel that the contents are congruent with their own living situations, experiences, and cultural values. but so far, there is insufficient empirical evidence to support this assumption. o u t l o o k : h o w t o e n h a n c e e m p i r i c a l e v i d e n c e o n c u l t u r a l a d a p t a t i o n with this new framework, we aim to inspire a theory-driven, empirical approach to cul‐ tural adaptation of psychological interventions. a systematic review (hall et al., 2016) provided indications that culturally adapted psychological interventions are indeed more effective than the unadapted versions of the same interventions. however, there is a lack of evidence on the substantial modifications that cause the higher effectiveness of adapted interventions. in most studies, several aspects were adapted at the same time, and cultur‐ al adaptation methods are rarely documented in a replicable manner. in order to advance cultural adaptation research, it would be important to formulate theory-driven hypothe‐ ses about the components that are assumed to cause the higher acceptance and effective‐ ness of adapted interventions, and to test these components using experimental designs. when developing this framework, we mainly had potentially scalable interventions in mind, i.e., modified, low-intensity and highly standardised evidence-based treatments, which are applied in self-help or guided self-help format, or delivered by lay helpers cultural adaptation of psychological interventions 12 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ (who, 2017). such interventions are condensed versions of what is done in face-to-face treatments. for such interventions, it is of vital importance to discover which compo‐ nents are most relevant for symptom change, and which aspects are nice-to-have. this also applies to cultural adaptation. for future research and implementation, it is crucial to better understand the treatment elements that have to be culturally adapted to make sure the intervention is acceptable and effective. the main difference between lowand high-intensity interventions lies – as the names suggest – in the intensity of therapist involvement. in high-intensity interven‐ tions, trained therapists can (and most probably do) make “on-the-fly” adaptations when‐ ever working individually with patients from culturally diverse groups. in low-intensity and potentially scalable interventions, most of the treatment aspects are standardised, and in unguided self-help, no contact with a therapist or lay helper is provided at all. in view of transparency and economy of treatments and trainings, it seems helpful to iden‐ tify the potential cultural adaptations that can and should be made in a standardised manner to ensure that a treatment is acceptable and effective. in contrast to previous frameworks for cultural adaptation (bernal et al., 1995; chu & leino, 2017), we used cultural concepts of distress (ccd) as the pivotal point for deep structure adaptation (resnicow et al., 1999). we suggest starting with an assessment of ccd using semi-structured interviews such as the cultural formulation interview in dsm-5 (american psychiatric association, 2013) or the barts explanatory model inventory (bemi, rüdell et al., 2009), and to derive all relevant adaptations from results of such for‐ mative research. a desk literature review can help to identify studies that have already assessed ccd in the target population, to avoid duplication of work. however, we inten‐ tionally formulated our framework in a way that it does not make pre-assumptions about which adaptations are substantial. it might well be that experimental research (see below) will show that adapting psychological interventions to ccd does not make any differ‐ ence with regard to their acceptability and/or effectiveness. in our view, it is essential to take this step back and to start with a conceptual framework that includes what seems to be most plausible according to current evidence. from such a conceptual framework, hy‐ potheses can be formulated and tested in empirical studies. aside from a new framework, novel research approaches are needed to advance the empirical evidence on the cultural adaptation of psychological interventions. direct com‐ parison of adapted and unadapted versions of the same interventions are still rather the exception (hall et al., 2016). this is understandable, as such direct comparisons require very large sample sizes, since small effects are to be expected when comparing two simi‐ lar treatments with small deviations (cuijpers, cristea, et al., 2019). moreover, training therapists to provide two different versions of the same intervention – adapted and unad‐ apted – is a difficult task. other treatment formats such as internet or mobile-based inter‐ ventions, self-help books or audio recordings, are promising for such research. such highly standardised materials, where input from therapists or lay helpers is minimal, can heim & kohrt 13 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ be used to show users two different versions of the same intervention, without large in‐ vestments in training. innovative research approaches, e.g. factorial experiments (collins, 2018) can be used, in which several components are manipulated at the same time. such research designs can contribute to better understand the substantial modifications in cul‐ tural adaptation. results from cultural adaptation may also potentially contribute to basic psychothera‐ py research. for a long time, there has been a debate about the specific and nonspecific components of psychotherapy, and a recent meta-analysis came to the following conclu‐ sion: “based on this set of studies, the only conclusion that can be drawn is that we sim‐ ply don’t know if specific components of specific therapies are effective ingredients of these therapies, or whether all effects are caused by universal, nonspecific factors that are common to all therapies” (cuijpers, cristea, et al., 2019, p. 12). cultural adaptation research provides a promising new approach to this question. as an example, if one and the same intervention (e.g., a stress management technique) shows the same effect, re‐ gardless of the explanatory model provided to patients, this is an indicator that the spe‐ cific intervention caused the symptom change. by contrast, if the same intervention shows a higher effect if it is framed in a culturally-shaped manner, this is an indicator that providing a convincing rationale is indeed a “key ingredient” of psychotherapy, as postulated by ahn and wampold (2001). thus, aside from enhancing access to treatments for culturally diverse groups, cultural adaptation research can make an important contri‐ bution to psychotherapy research as a whole. one important challenge refers to the selection of the target population for cultural adaptation. how do we define a “cultural group”? as an example, bernal et al. (1995) de‐ veloped their framework in the context of their work with “latinos/as” in the united states, and hinton et al. (2010) worked with “cambodian refugees”. a cultural group can be defined in terms of language, country or region, religion, or other socio-demographic characteristics. migration is another important aspect, as with time, immigrants start adopting cultural values and norms of the host country, which may be relevant for cul‐ tural adaptation of psychological interventions. for research purposes, it is most relevant to carefully define the target population and to be transparent about the criteria accord‐ ing to which this population is defined, to make sure results of studies can be interpreted accordingly. in individual therapy, semi-structured interviews can be used to tailor the interventions to the specific characteristics of the patient. conclusion considering the millions of people in need of psychological treatments worldwide (the who world mental health survey consortium, 2004; turrini et al., 2017), the limited re‐ sources available for mental health (patel et al., 2018), the cultural diversity in common mental disorders (kohrt et al., 2014), and the variety of treatment components that are potentially relevant for adaptation (bernal et al., 1995; bernal & sáez-santiago, 2006; chu cultural adaptation of psychological interventions 14 clinical psychology in europe 2019, vol.1(4), article e37679 https://doi.org/10.32872/cpe.v1i4.37679 https://www.psychopen.eu/ & leino, 2017), it is vital to expand the empirical evidence as a basis for decision-making on how much and where to invest in cultural adaptation of psychological interventions. the present paper offers a conceptual framework that lays the groundwork for such empirical research. the three elements suggested in this framework are based on empiri‐ cal evidence from ethnopsychological studies, cultural adaptation research, and psycho‐ therapy research. innovative research designs are needed to evaluate the relevance of these elements. using a theory-driven approach and innovative experimental designs, re‐ search on cultural adaptation has the potential not only to make psychological treat‐ ments more accessible for culturally adverse groups, but also to further advance empiri‐ cal research on the basic question of the key ingredients and mechanisms of action in psychotherapy. funding: eh is supported by the swiss national science foundation (grant 10001c_169780) and the swiss foundation for psychiatry and psychotherapy. bak is supported by the us national institute of mental health (grants k01mh104310, r21mh111280). in addition, both authors are part of indigo. the indigo partnership research programme is a part of the indigo network; a collaboration of research colleagues in over 30 countries worldwide committed to developing knowledge about mental-illness-related stigma and discrimination, both in terms of their origins and their eradication. it is coordinated by the centre for global mental health, institute of psychiatry, psychology and neuroscience at king’s college london. this work was supported in part by the medical research council (grant number mr/r023697/1). competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. r e f e r e n c e s abi ramia, j., harper shehadeh, m., kheir, w., zoghbi, e., watts, s., heim, e., & el chammay, r. 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[2] department of psychology, eberhard-karls university tübingen, tübingen, germany. [3] institute of psychology, albert-ludwig university freiburg, freiburg, germany. clinical psychology in europe, 2021, vol. 3(3), article e3813, https://doi.org/10.32872/cpe.3813 received: 2020-06-04 • accepted: 2021-05-18 • published (vor): 2021-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: andrea s. hartmann, osnabrück university, institute of psychology, knollstr. 15, 49069 osnabrück, germany. telephone: +495419696349, fax: +49541969402. e-mail: andrea.hartmann@uos.de abstract background: body image disturbance (bid) is a hallmark feature of eating disorders (eds) and has proven to be involved in their etiology and maintenance. therefore, the targeting of bid in treatment is crucial, and has been incorporated in various treatment manuals. one of the most common techniques in the treatment of bid is body exposure (be), the confrontation with one’s own body. be has been found to be effective in individuals with eds or high body dissatisfaction. however, be is applied in a multitude of ways, most of which are based on one or a combination of the hypothesized underlying working mechanisms, with no differential effectiveness known so far. method: the aim of this paper is to selectively review the main hypothesized working mechanisms of be and their translation into therapeutic approaches. results and conclusion: specifically, we underline that studies are needed to pinpoint the proposed mechanisms and to develop an empirically informed theoretical model of be. we provide a framework for future studies in order to identify working mechanisms and increase effectiveness of be. keywords body exposure, eating disorders, body image disturbance, working mechanisms, intervention this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3813&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0002-6251-3763 https://orcid.org/0000-0001-8498-9466 https://orcid.org/0000-0002-2312-1249 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • body exposure (be) is an effective intervention for body image disturbance in eating disorders. • ways of delivery vary depending on assumed underlying working mechanisms. • impact of attention focus, verbalization, therapist presence, and dosage should be investigated. • research on working mechanisms will improve be and maximize results for specific patients. body image disturbance (bid) is a distinct risk factor for the development and mainte­ nance of eating disorders (eds), and potentially contributes to relapse after treatment (e.g., glashouwer et al., 2019). furthermore, targeting body dissatisfaction is associated with better overall treatment outcome (wilson et al., 2002). thus, the improvement of body image should be a key element of ed treatment, e.g. in the form of body exposure (be), alongside the normalization of nutrition and eating behaviors. this paper aims to selectively review the theoretical rationales underlying potential working mechanisms of be, the empirical evidence for these rationales, and the corresponding therapeutic application of be. another aim is to review future research ideas on mechanisms, be delivery, and moderators of be effects in order to foster clinicians’ use of be as an effective intervention strategy. e f f i c a c y o f b o d y e x p o s u r e a meta-analytical review indicated that be is effective as stand-alone intervention for bid (alleva et al., 2015). the analysis included 62 original studies on the effectiveness of stand-alone interventions to improve body image that had a control group, random allocation to conditions, and at least one preand posttest measure. two interventions that can be broadly viewed as be namely exposure exercises and guided imagery exercises showed significant intervention effects on body image. the meta-analysis further demonstrated that effects were stronger when targeting individuals with body concerns as compared to unselected groups (alleva et al., 2015). in an extension of this finding, a more recent review (griffen et al., 2018) focused on summarizing the effects of be in distinct groups of individuals with various ed diagnoses separately and mixed, as well as individuals with obesity, body dysmorphic disorder, and non-clinical individuals. their search yielded a total of 15 studies evaluating be. for all participant groups, at least preliminary effectiveness of be was shown. however, due to a scarcity of studies no differential effectiveness of various forms of be could be determined (griffen et al., 2018). notably, some individuals do not benefit from be, as evidenced by findings that on certain measures, between-group effects are significant while group by time interaction mechanisms of body exposure 2 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ effects are not (e.g., delinsky & wilson, 2006). research and reports on symptom deterio­ ration or treatment dropouts are rare. in a randomized controlled trial by hildebrandt and colleagues (2012), self-injurious behaviors and subsequent study dropout occurred in the be condition but not the control condition. in a study by delinsky and wilson (2006), the only dropouts occurred in the be condition (without significant attrition differences between conditions), and the participants who dropped out also had higher depression scores at the outset. accordingly, while be might deteriorate symptoms in emotionally unstable patients, frequency of symptom deterioration or treatment discontinuation can­ not be extrapolated from current data. in sum, be seems to be effective for the majority of patients. a common characteristic of be procedures is a systematic examination of one’s own body by the patient – in a mirror or through recorded videos – over a varying number of sessions. however, different be versions exist in which the specific be approach varies in several aspects, and the (clinical) decision for the specific be approach often relies on the hypothesized underlying working mechanism. h y p o t h e s i z e d w o r k i n g m e c h a n i s m s : t h e o r e t i c a l i d e a s o n h o w b e r e d u c e s b o d y i m a g e d i s t u r b a n c e the theoretical accounts of be show distinct differences, resulting in a variety of specific intervention approaches. here, we will briefly review four theoretical ideas that have previously been proposed. moreover, where available, we present empirical evidence and the respective treatment implications. of note, the field is only just beginning to develop a comprehensive understanding of how exposure might work, and an integrated model of these rationales is lacking. thus, while in the following the theoretical ideas are discussed as discrete working mechanisms, it might very well be that they all work alongside each other or interact (lass-hennemann et al., 2018). furthermore, there may also be a general working mechanism, e.g., the generally structured preoccupation with one’s body without avoidance or safety behaviors. first, a hypothesis derived from exposure research in anxiety disorders posits that habituation to negative emotion and distress on psychological and biophysiological processing levels is responsible for the positive effects of be. from a theoretical perspec­ tive, repeated and prolonged exposure to the conditioned stimulus ‘‘seeing one’s own body’’ (cs) is assumed to induce decreases in the conditioned negative reaction (cr) by preventing negative reinforcement, e.g., avoidance (benito et al., 2018; craske et al., 2014). indeed, there is evidence for a reduction of self-reported negative affect between and within exposure sessions (e.g., trentowska et al., 2017). while these findings are supported by some studies assessing physiological parameters (e.g. emotional arousal measured by means of voice stress analysis; baur et al., 2020), other findings, e.g. from hartmann, naumann, vocks et al. 3 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ studies assessing heart rate as a physiological measure of change in distress during be, are more ambiguous (trentowska et al., 2017; vocks et al., 2007). one reason for this inconsistency might be that be elicits a multitude of emotions in individuals with bid (e.g., naumann et al., 2013). for instance, in individuals with eds, disgust has been shown to play a more important role than anxiety (e.g., von spreckelsen et al., 2018). moreover, disgust seems more resistant to psychological and physiological habituation processes in other disorders (olatunji et al., 2009), and is influenced more likely by coun­ terconditioning (e.g., engelhard et al., 2014). recently, potential working mechanisms of exposure (in anxiety research) have been overhauled by the so-called inhibitory learning approach. accordingly, the working mechanism of exposure lies in the development and strengthening of nonthreat associations in memory during exposure (e.g., craske et al., 2008; foa & mclean, 2016). thus, within an exposure framework of be, three potential working mechanisms have been suggested: habituation, counterconditioning, and inhibitory learning. while all three approaches are based on an exposure rationale, each offers a distinct and differ­ ential therapeutic application of be in a clinical context. treatment manuals postulating habituation as a working mechanism recommend that patients mainly focus on their negatively valenced body parts over an extended period of time in order to activate negative affect, which consequently can be reduced (vocks et al., 2018). treatment man­ uals based on the counterconditioning mechanisms should aim to change the unwanted reaction (negative affect) when confronted with the stimulus (body). thus, they might suggest to rather focus on positively valenced body parts, coupled with an instruction to do something positive for/with one’s body (e.g., use body lotion) or, to focus on negatively valenced body parts while instructing to elicit positive thoughts about the body and/or remember what the body already has achieved (e.g, vocks et al., 2018). and lastly, treatment manuals using inhibitory learning as a rationale would aim to use as many different exposure exercises as possible in order to maximize the possibilities to create nonthreat associations. another theoretical rationale of be is based on the idea of attention bias modification. the hypothesis was derived from data demonstrating a negative attentional bias to subjectively unattractive body parts when confronted with one’s own body in individuals with eds (e.g., bauer et al., 2017). it was hypothesized that a change in this dysfunc­ tional attention pattern might alter the associated negative affect. some studies have demonstrated that a focus on positively valenced body parts leads to an improvement on measures of body image (glashouwer et al., 2016; krohmer et al., authors’ unpublished data; smeets et al., 2011), and some (krohmer et al., authors’ unpublished data) but not all (glashouwer et al., 2016) have reported a concurrent change in attention patterns. however, one study did not find differential effects between a negative and a positive focus condition on body dissatisfaction, body-related checking, body concerns, and neg­ ative mood from preto post-be (e.g., jansen et al., 2016). this contradicts the idea mechanisms of body exposure 4 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ of attention bias modification as the only working mechanism of be. following this rationale, corresponding therapeutic be approaches asked patients to focus on positively valenced body parts only (jansen et al., 2016; vocks et al., 2018) or to state their emotion­ al connotations of the respective body parts while distributing their attention evenly (svaldi & tuschen-caffier, 2018). a third theoretical rationale of be is based on the hypothesis of reduction of body perception distortion in individuals with eds. most individuals with eds overestimate the dimensions of their own body (e.g., mohr et al., 2016; volpe et al., 2018). furthermore, there is some (norris, 1984), but also contrasting (lewer et al., 2017; vocks et al., 2007) evidence that distorted body perception might change over the course of be. more recently, a systematic review suggested that the construct of distorted perception may be misleading as the distortion may rather stem from a dysfunctional cognitive-evaluative component of body image than from perceptual deficits (mölbert et al., 2017). following this rationale, one would advise an even distribution pattern and the use of non-judg­ mental language (hildebrandt et al., 2012) during be. a fourth theoretical rationale suggests that central dysfunctional cognitions (e.g., interpretation and memory biases, e.g., korn et al., 2020) of bid are changed through (implicit) cognitive restructuring in the course of be. such cognitive restructuring can be achieved by inducing cognitive dissonance (e.g., between the dysfunctional belief “my stomach looks fat” and the behavior of describing the stomach neutrally), which may in turn reduce body-related negative schemata (williamson et al., 2004). in addition to the above-mentioned induction of cognitive dissonance and cognitive restructuring, therapeutic approaches of be derived from this hypothesis instruct patients to either focus on positively valenced body parts or to focus on all body parts evenly, while describing their body positively or neutrally (i.e., with the therapist present; e.g., jansen et al., 2016; klimek et al., 2016; luethcke et al., 2011). all of these aspects are noteworthy, as be seems, in general, a promising tool to address body image disturbances in clinical and non-clinical populations (alleva et al., 2015), even though with only small effect sizes as a stand-alone technique in the latter. accordingly, there is a need to refine the theoretical rationale as well as (experimental) research on working mechanisms in order to improve the technique and potentially individualize it in the future to maximize outcome in specific patients. s u g g e s t e d f o c i i n f u t u r e r e s e a r c h it is important for future research to focus on factors that determine its positive effects. in the following, we describe variables that require systematic examination. hartmann, naumann, vocks et al. 5 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ where should one look during be? as briefly reviewed above, depending on the theoretical rationale, be approaches dif­ fer in whether patients are instructed to focus selectively on positively or negatively valenced body parts, or evenly on all body parts. given that these foci might elicit emotions that may or may not be necessary to reach the intervention goal, it is essential to understand individual needs and differences. in one study, interventions with a focus on exclusively positive or negative body parts successfully reduced body dissatisfaction, body-related checking, body concerns, and negative mood in women with high levels of body dissatisfaction (jansen et al., 2016). moreover, the negative focus condition yiel­ ded a stronger decrease in body-related avoidance behavior over the follow-up period. for comparison studies, we propose to consider another effective form of be, which comprises instructions to focus on all body parts from head to toe, successively, in order to correct distorted body perception and alter viewing patterns. furthermore, we suggest testing a form in which body parts are clustered by their indication of weight gain or status (e.g., thighs, bottom, stomach vs. knees, ankles, forearms), instead of by their subjective valence. this might be of particular interest if the hypothesized working mechanism is dissolution of the conditioned association, as it allows for exposure to the most fear-inducing body parts, given that fear of weight gain is a central concept of individuals with eds (e.g., rodgers et al., 2018). how should verbalization be instructed during be? another large difference between previous studies lies in the type of body-related descriptions provided by participants, i.e. whether they purely describe their body, or the associated emotions and cognitions, or both. while a negatively toned description might strengthen the experience of be (in the sense of a stronger habituation effect), subsequently leading to a more effective dissolution of negative body-related affect, a mainly positive or neutral, non-judgmental description might strengthen the decrease in negative affect by correcting distorted perception, thus altering dysfunctional attention processes or cognitive dissonance processes (rather like inhibitory learning). so far, only two studies have compared different forms of instructed verbalizations. in the first study, the authors compared two neutral versions of be to a cognitive dissonance version in which participants were instructed to describe body parts using positive verbalizations. while all three forms led to improvements on measures of ed and body image, only the cognitive dissonance version of be yielded an increase in body satisfaction (luethcke et al., 2011). in the second study, a positive and a negative full-body verbalization con­ dition were compared in healthy individuals. both interventions yielded improvements in emotional arousal and body satisfaction between sessions. however, within sessions, the negative but not the positive verbalization condition led to a decrease in positive affect and body satisfaction and an increase in negative affect (tanck et al., authors’ mechanisms of body exposure 6 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ unpublished data). to further disentangle different forms of verbalisation, we propose to compare a neutral description of what patients see, and a description of positive or negative aspects of each body part in future studies. thereby, while manipulating the form of verbalization, the attentional focus should be controlled (e.g., by asking patients to describe every part of their body from head to toe). is a therapist needed in be? to the best of our knowledge, there are no studies comparing be with and without a therapist present. such investigations would be highly relevant, as the presence of a therapist could impact the effectiveness of the intervention, particularly when consid­ ering cognitive dissonance as a working mechanism. comparative studies have looked at differences in the effectiveness of guided vs. unguided be (díaz-ferrer et al., 2015; díaz‐ferrer et al., 2017; moreno-domínguez et al., 2012). for example, women with body dissatisfaction and subclinical eds underwent either an unguided version, in which they freely explored self-chosen body parts and were instructed to verbalize associated emotions and cognitions, or a guided version, in which they focused on all body parts and had to describe them using neutral words. both conditions were found to be effective in reducing bid, with a slight superiority of the unguided condition. however, heart rate and skin conductance observed within sessions indicated that the two techniques might act through different mechanisms (díaz‐ferrer et al., 2017), with a stronger increase in both indicators in the unguided condition. notably, the conditions in the comparison studies varied not only with respect to therapists’ active guidance during be, but also regarding the body parts which were focused on and the way in which body parts were described. thus, in order to understand the impact of therapist presence and guidance during be, future research should compare guided and unguided versions of be while controlling for focus and type of verbalization. how much be is needed? the ideal intensity of be remains unclear. on the one hand, intensity can be captured as frequency of sessions. in anxiety disorder research, the frequency of exposure is assumed to be a major factor in treatment effectiveness (wolitzky-taylor et al., 2008). in eds, sev­ eral findings highlight that therapeutic effects might occur mostly between rather than within sessions (e.g., hilbert et al., 2002). thus, multiple sessions are necessary, which is further underlined by the finding that short-term exposure leads to an activation and deterioration of body satisfaction and negative affect (veale et al., 2016). findings from studies investigating the effects of different numbers of sessions are important, because they may, for instance, allay clinicians’ fears of overwhelming the patient when delivering multiple be sessions. hartmann, naumann, vocks et al. 7 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ on the other hand, intensity can also be captured as duration of single sessions, thus the length of a be therapy session, be sessions over a whole day, or exposure until a reduction in anxiety to a certain predefined extent is realized. in intensive exposure (“flooding”), aversive stimuli are presented at the highest level of intensity, while gradual exposure follows a stepwise approach starting at a low level of intensity. previous research in the area of obsessive-compulsive disorder suggests that intensive exposure might lead to a stronger short-term reduction of anxiety symptoms. by contrast, gradual exposure might be more helpful for reducing emotions that habituate more slowly, such as disgust (olatunji et al., 2009). more recent studies in the area of anxiety disorders ad­ vocate for variability in the exposure hierarchy in order to maximize inhibitory learning (e.g., knowles & olatunji, 2019). future research should test whether variations in inten­ sity impact be effects on bid. besides frequency and duration of sessions, potentially relevant moderating variables in the context of intensity of be may relate to the setting (e.g., mirror size, light, distance to mirror) or clothing (everyday vs. tight clothes vs. underwear). who benefits or does not benefit from be? evidence of differential effectiveness of be in specific groups is limited by the low diversity of the groups researched so far. men have been overlooked in body image research, including be interventions (burlew & shurts, 2013), and be in individuals with comorbidities remains to be investigated. additionally, as alleva et al. (2015) highlighted, individuals of middle to older age have also been neglected in past be research. furthermore, for body dysmorphic disorder, another mental illness with the core symptom of bid, be (mirror retraining), also represents an essential part of the cbt protocol (e.g., wilhelm et al., 2013). however, to date, no study has examined the effec­ tiveness of this technique detached from the overall cbt treatment. further research into the effectiveness of be in mental disorders potentially associated with bid, namely borderline personality disorder, posttraumatic stress disorder, or social anxiety disorder (dyer et al., 2013; dyer et al., 2015) is also lacking. lastly, a comprehensive evaluation of be effectiveness should also include the sys­ tematic assessment of side effects, adverse events, or predictors of non-responders, and a subsequent trade-off between positive effects and negative aspects for single patient groups. as looking at oneself in a mirror can lead to significant distress and a worsening of negative affect (veale et al., 2016; walker et al., 2012; windheim et al., 2011), be might destabilize some patients. eventually, extending research to subgroups will help to formulate diagnosisand patient group-specific treatment guidelines, which will move us closer to establishing individualized evidence-based treatments. mechanisms of body exposure 8 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ what might further influence the efficacy of be? several potential moderators may be worthy of further investigation, because they may have confounded previous research results. moderating factors may also influence practi­ tioner’s decision to implement be. given the scarcity of previous research, we are not able to quantify the impact of, for example, current weight, genderand weight-match between patient and therapist, current status of treatment, chronicity of symptoms, level of habitual checking and avoidance, and the delivery in groups vs. alone on the effectiveness of be. we suggest that all of these factors should be assessed in future studies to provide information regarding their impact on be effects and on clinician’s decision to implement be. tools for evaluating be mechanisms and efficacy past studies varied regarding outcome and process variables. to understand the differen­ tial effectiveness of be on various levels of experience, a comprehensive set of process and outcome measures needs to be considered. first, we suggest that different facets of body image should be assessed in order to capture processes and outcomes on all levels of bid (i.e. perceptual, cognitive-affective, and behavioral). second, we advocate for the adoption of a multi-method approach encompassing selfand expert-report measures, as well as objective measures in order to elucidate mechanisms of be on as many process­ ing levels as possible. the former might include selfand external report measures on body dissatisfaction and disorder-specific symptomatology. the latter might consist of psychobiological indicators of emotional activation indexing fearand anxiety-related differences in the autonomic nervous system, e.g., such as fear-potentiated startle and heart rate, but also indices of attention allocation and information processing as well as the very recent approach of vocal arousal. c o n c l u s i o n despite findings regarding the effectiveness of be in intervention studies, it is still largely unknown which version works best for whom. thus, first, lab-based experimental studies need to be conducted to isolate the effect of potential working mechanisms and test their impact within the different proposed forms of be on bid outcomes (glashouwer et al., 2020). current studies from our workgroups target this research gaps by setting out to differentiate attention foci and verbalization forms measuring self-reported, peripherphysiological, and eye-tracking outcomes. findings from these and other studies can then inform theory-based and empirically based models on key processes, and can advance refined etiological models of bid. in the future, interventions based on these models can then be tested in larger randomized controlled trials including additional analyses of moderators to identify which specific be procedure is maximally hartmann, naumann, vocks et al. 9 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://www.psychopen.eu/ successful (or unsuccessful) for a specific patient subsample. of further relevance, re­ search needs to prove that the positive effects of be outweigh the fact that this technique can be strenuous for patients, as they are confronted with the very thing they fear the most. funding: the writing of this paper was funded by a scientific network grant (body exposure and attention modification [beam-] net) awarded to the first author by the german research foundation (ha 8589/2-1). acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @ashartmann, @siljavocks data availability: data sharing is not applicable to this article as no new data were created and analyzed in this study. r e f e r e n c e s alleva, j. m., sheeran, p., webb, t. l., martijn, c., & miles, e. 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(2002). cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. journal of consulting and clinical psychology, 70(2), 267-274. https://doi.org/10.1037/0022-006x.70.2.267 windheim, k., veale, d., & anson, m. (2011). mirror gazing in body dysmorphic disorder and healthy controls: effects of duration of gazing. behaviour research and therapy, 49(9), 555-564. https://doi.org/10.1016/j.brat.2011.05.003 wolitzky-taylor, k. b., horowitz, j. d., powers, m. b., & telch, m. j. (2008). psychological approaches in the treatment of specific phobias: a meta-analysis. clinical psychology review, 28(6), 1021-1037. https://doi.org/10.1016/j.cpr.2008.02.007 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. mechanisms of body exposure 14 clinical psychology in europe 2021, vol. 3(3), article e3813 https://doi.org/10.32872/cpe.3813 https://doi.org/10.1371/journal.pone.0198532 https://doi.org/10.1016/j.bodyim.2012.06.001 https://doi.org/10.1177/0145445503259853 https://doi.org/10.1037/0022-006x.70.2.267 https://doi.org/10.1016/j.brat.2011.05.003 https://doi.org/10.1016/j.cpr.2008.02.007 https://www.psychopen.eu/ mechanisms of body exposure (introduction) efficacy of body exposure hypothesized working mechanisms: theoretical ideas on how be reduces body image disturbance suggested foci in future research where should one look during be? how should verbalization be instructed during be? is a therapist needed in be? how much be is needed? who benefits or does not benefit from be? what might further influence the efficacy of be? tools for evaluating be mechanisms and efficacy conclusion (additional information) funding acknowledgments competing interests twitter accounts data availability references this is not a christmas editorial! editorial this is not a christmas editorial! cornelia weise a, winfried rief a [a] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2020, vol. 2(4), article e5433, https://doi.org/10.32872/cpe.v2i4.5433 published (vor): 2020-12-23 corresponding author: cornelia weise, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, gutenbergstrasse 18, 35032 marburg, germany. e-mail: weise@unimarburg.de when the two editors-in-chief of this journal met to discuss whether we should strive for a christmas editorial this year, it was a moment of desperation. we began brainstorming potential topics over zoom. it had been the fourth video conference on a friday after‐ noon for both of us, and we were starting to experience headaches, fatigue, vision and concentration problems, as well as annoying noises in the ear. and we also felt that we are tired of speaking and writing about all the events that characterized this very special year. last but not least we considered: is a christmas editorial still contemporary and fresh, especially if we want to express our openness to the diversity of people, cultures, and religions? we started by investigating the background of christmas, and we did it empirically (what else would you expect?). a word search in the bible with typical, christmas-asso‐ ciated items seemed a good way to start to evaluate religious chauvinism. however, neither “rudolph, the red nosed reindeer” nor “christmas tree” led to any hits. wikipedia informed us that the christmas tree goes back to the days of nordic tribes, and many rituals of the end-of-the-year season have their roots in profane rites of celebrating the longest night. after a period of searching, even the origin of santa claus became more and more blurred. the white-bearded male with a bmi of >35 does not resemble any head of most popular religions in europe. eventually we decided that writing a christmas editorial is not cultural chauvinism, but rather that it is more of a chance to reflect before the year ends on what has happened in 2020. but to be on the safe side: this is not a christmas editorial. so what should we write about? many themes came to mind that we were tired to talk or write about. a virus posed a threat to all of us, but are our readers really keen to hear even more about the c-word at the very end of the year? although some aspects this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i4.5433&domain=pdf&date_stamp=2020-12-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ are still worth mentioning, even in a not-a-christmas-editorial. this year we learned so much about zooming, break-out rooms, and personal background preferences. what, for example, is the clinical implication of people preferring a spiderman-virtual-background vs. a fake office background, or how relevant are the number of kids and cats appearing in the speaker's background? is it really true that nations differed in terms of the choice of goods hoarded during lockdowns? are these preferences really related to the people's mental health status in the respective countries, e.g. weed in the netherlands, feta cheese in greece, toilet paper in germany, or wine and condoms in france? with a clear preference to migrate to france, we ended this discussion. now is the time to stand together and solve problems. stop, no. we have to respect physical distancing. but why is there a country in europe who really exaggerates social distancing? shall we dedicate a special paper to this topic in our “politics and education” section? how do we maintain the illusion of independent countries in the 21st century? but no, as with the c-word, we do not want to talk about the b-word either; we express our sympathies to all european and non-european countries, even if they are on islands drifting around in the north sea. you are always very welcome to join us under the umbrella of our journal. finally, in our discussion we turned to the us elections. although we are not a politi‐ cal journal, this topic offers many possible starting points for an editorial. for example, it would have provided perfect examples for psychological treatment (e.g. behaviour analy‐ sis, reality neglect, cognitive reframing and working with infantile schema modes). since classification of mental disorders started more than 100 years ago, the starting point of classifying mental disorders was always the neglect of reality: medium in neuroses, even more serious in psychosis. however, while ruminating about these topics, we became more and more worried that we would end up writing a comprehensive overview of personality disorders, which is too big a topic, and beyond our expertise. therefore, we decided to write just a brief editorial with two major points. first, we want to express our thanks to all people involved in cpe's second volume. we wish to acknowledge our authors, reviewers, section editors, guest editors, and the whole publishing team. when we started with this journal more than two years ago, we were worried how the new publication would be accepted by the scientific community? it is risky to start a new scientific journal, in an era when scientists receive daily announce‐ ments and requests to submit to obscure and unknown journals. but we did it. and it has been a really successful year for cpe. not only have we published the first two volumes, but there are also a number of exciting manuscripts in the pipeline, and further manuscripts are waiting for consideration. we are grateful for all the support we have received – particularly in this tough and challenging year – and we are extremely pleased to see cpe becoming a more and more impactful journal. second, we want to wish you a happy holiday season and a peaceful and prosperous new year. we hope it will soon be possible to meet up with family and friends, to editorial 2 clinical psychology in europe 2020, vol.2(4), article e5433 https://doi.org/10.32872/cpe.v2i4.5433 https://www.psychopen.eu/ pursue hobbies, and to do all the things that belong to our previous regular life. we all know about the challenges of the current times, and should therefore use our knowledge and expertise in clinical psychology to get through this challenging time together and support those needing help. we are looking forward to receiving your submissions in 2021 despite all the chal‐ lenges that we are all facing. thank you for your support of the journal. cornelia weise & winfried rief pandemic-compliant greetings to all of you funding: the authors have no funding to report. competing interests: cornelia weise and winfried rief are editors-in-chief of clinical psychology in europe. acknowledgments: the authors wish to thank keith petrie for language editing. weise & rief 3 clinical psychology in europe 2020, vol.2(4), article e5433 https://doi.org/10.32872/cpe.v2i4.5433 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. editorial 4 clinical psychology in europe 2020, vol.2(4), article e5433 https://doi.org/10.32872/cpe.v2i4.5433 https://www.psychopen.eu/ biased perception of physiological arousal in child social anxiety disorder before and after cognitive behavioral treatment research articles biased perception of physiological arousal in child social anxiety disorder before and after cognitive behavioral treatment julia asbrand ab, andré schulz c, nina heinrichs d, brunna tuschen-caffier a [a] institute of psychology, albert ludwigs university of freiburg, freiburg, germany. [b] institute of psychology, humboldt-universität zu berlin, berlin, germany. [c] clinical psychophysiology laboratory, institute for health and behaviour, university of luxembourg, esch-sur-alzette, luxembourg. [d] department of psychology, university of bremen, bremen, germany. clinical psychology in europe, 2020, vol. 2(2), article e2691, https://doi.org/10.32872/cpe.v2i2.2691 received: 2020-01-16 • accepted: 2020-03-11 • published (vor): 2020-06-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: julia asbrand, department of child and adolescent clinical psychology and psychotherapy, institute of psychology, humboldt-universität zu berlin, unter den linden 6, 10099 berlin, germany. phone: +49 30 2093 9334. e-mail: julia.asbrand@hu-berlin.de abstract background: a biased perception of physiological hyperreactivity to social-evaluative situations is crucial for the maintenance of social anxiety disorder (sad). alterations in interoceptive accuracy (iac) when confronted with social stressors may play a role for sad in children. we expected a biased perception of hyperarousal in children with sad before treatment and, consequently, a reduced bias after successful cognitive behavioral therapy (cbt). method: in two centers, 64 children with the diagnosis of sad and 55 healthy control (hc) children (both 9 to 13 years) participated in the trier social stress test for children (tsst-c), which was repeated after children with sad were assigned to either a 12-week group cbt (n = 31) or a waitlist condition (n = 33). perception of and worry about physiological arousal and autonomic variables (heart rate, skin conductance) were assessed. after each tsst-c, all children further completed a heartbeat perception task to assess iac. results: before treatment, children with sad reported both a stronger perception of and more worry about their heart rate and skin conductance than hc children, while the objective reactivity of heart rate did not differ. additionally, children with sad reported heightened perception of and increased worry about trembling throughout the tsst-c compared to hc children, but reported increased worry about blushing only after the stress phase of the tsst-c compared to hc children. children with and without sad did not differ in iac. contrary to our hypothesis, after treatment, children in the cbt group reported heightened perception of physiological arousal and increased worry on some parameters after the baseline phase of the tsst-c, whereas actual iac remained unaffected. iac before and after treatment were significantly related. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i2.2691&domain=pdf&date_stamp=2020-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusions: increased self-reported perception of physiological arousal may play a role in childhood sad and could be an important target in cbt. however, further studies should examine if this is an epiphenomenon, a temporarily occurring and necessary condition for change, or indeed an unwanted adverse intervention effect. keywords bodily arousal, social phobia, cbt, therapy, interoceptive awareness, heartbeat perception highlights • biased perception of physiological arousal may play a role in child social anxiety disorder (sad). • faced with standardized social stress, biased perception of heart rate but not skin conductance. • no change in biased perception due to cognitive-behavioral treatment. • further research regarding the nature of biased perception (e.g. epiphenomenon) necessary. social anxiety disorder (sad) is a highly prevalent disorder (burstein et al., 2011) that leads to great impairment in the well-being and everyday life of affected children (rao et al., 2007). cognitive models of sad (e.g., clark & wells, 1995) point to the importance of an increased focus on cognitions, feelings, and behaviors. in addition, a person with sad is also alarmed by physiological reactions in social situations. in line with cognitive models, the subjective awareness of physiological and emotional arousal is interpreted negatively, which leads to an overall negative self-perception followed by elevated fear of and avoidance of social situations. a (physiological) anxiety reaction was required in the diagnostic and statistical man‐ ual for mental disorders (4th ed., text rev.; dsm-iv-tr; american psychiatric association [apa], 2000). this has been revised in the latest version, allowing to display any sign of fear, not necessarily physiologically (dsm-5, apa, 2013). this change reflects that the objective physiological reaction is not yet fully understood: several studies have shown tonic hyperarousal in children with sad (asbrand, blechert, nitschke, tuschen-caffier, & schmitz, 2017; krämer et al., 2012; miers, blöte, sumter, kallen, & westenberg, 2011; schmitz, tuschen-caffier, wilhelm, & blechert, 2013). however, research has failed to find heightened physiological reactivity to disorder-typical stress (for an overview see siess, blechert, & schmitz, 2014). still, both children and adults with sad have reported increased perception of physiological arousal (gerlach, mourlane, & rist, 2004; schmitz, blechert, krämer, asbrand, & tuschen-caffier, 2012). therefore, it has been hypothesized that cognitive factors (e.g., attention allocation and evaluation) are also relevant for physiological factors. that is, people with sad are more prone to shift their attention towards physiological arousal and evaluate this arousal as more threatening (clark & biased perception of physiology in child sad 2 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ wells, 1995; siess et al., 2014). attentional biases have previously been examined mostly for external cues, such as angry versus happy faces, with measures of reaction times or with eye tracking (for an overview in adults see bar-haim, lamy, pergamin, bakermanskranenburg, & van ijzendoorn, 2007). similar to studies of adults, a meta-analysis of anxious compared to nonanxious children (dudeney, sharpe, & hunt, 2015) showed a significant attentional bias to threat. while these findings on external attentional biases are in line with rapee and heimberg's (1997) theoretical model of sad, the importance of other biases, also suggested by current cognitive models (e.g., clark & wells, 1995; rapee & heimberg, 1997) have received less attention, specifically internal perceptional biases. the processing of internal perceptional information is likely dependent upon their (believed) visibility for others: certain internal symptoms (e.g. increased heart rate, nausea) are relevant for the experience of anxiety in general but are not overly visible (cognition: “my heart is racing, this must mean that i am anxious”). however, other physiological symptoms are clearly visible (e.g. blushing, sweating, trembling) and are, therefore, extremely relevant for the fear of being judged (cognition: “i am blushing, others can see how anxious i am”). as such, these physiological symptoms are relevant for the experience of sad specifically. one previous study in children aged 10 to 12 years with high versus low social anxiety (schmitz et al., 2012) manipulated heart rate visibility by applying a heart rate feedback tone while children told a story in a “private” condition (head phones) and a “public” condition (with adult observers present). children with high social anxiety perceived their heart rate as higher than low socially anxious children when they listened to their (supposedly own) heart rate both in private and in public with adult observers present. further, the public condition led to more worry about the heart rate visibility only in children with high social anxiety. this study demonstrated that both perception of and worry about visibility of physiological arousal (i.e. evaluation) is elevated in socially anxious children. as this study examined a subclinical sample, it is necessary to assess children with sad to assure the stability of this phenomenon in clinically affected children. additionally, as the study used a set-up specific to perception of and worry about heart rate, it should be tested if this finding is stable in a well-established social stress test, the trier social stress test for children (tsst-c; buske-kirschbaum et al., 1997) and using more than one physiological parameter (siess et al., 2014). to reveal the underlying processes of biased perception in children with sad, it is required to assess different facets of interoception: first, ‘interoceptive accuracy’ (iac) represents the correspondence between actual and perceived physical signals (e.g., heart‐ beats). second, the subjective tendency to be focused on physical signals is considered ‘interoceptive sensibility’ (is) (garfinkel, seth, barrett, suzuki, & critchley, 2015). third, ‘interoceptive evaluation’ (ie) reflects subjective affective valence of physical sensations such as worry about visibility (pollatos & herbert, 2018). while the attentional biases refer more closely to is and ie, iac should be additionally considered. the heartbeat asbrand, schulz, heinrichs, & tuschen-caffier 3 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ counting task (hct) has been established as most common approach to assess cardiac iac in adults and in school children with and without anxiety symptoms (eley, gregory, clark, & ehlers, 2007; eley, stirling, ehlers, gregory, & clark, 2004; georgiou et al., 2015; koch & pollatos, 2014; schandry, 1981; schmitz et al., 2012). for example, antony et al. (1995) assessed iac based on hct and heart rate (hr) in adult patients with panic disorder and sad compared to healthy controls (hc). groups did not differ in iac at rest or after exercise. however, self-reported anxiety was positively related to iac. in a child community sample (eley et al., 2004), children between 8 and 11 years completed the hct. after a distinction into good and poor heartbeat perceivers based on iac scores, good perceivers reported significantly higher panic and/or somatic symptoms and were more sensitive to anxiety. similarly, higher levels of panic and/or somatic symptoms were positively related to iac. both findings suggest that a proper perception of physical sensations (iac) enhances their interpretation as potentially threatening (ie) in sad. furthermore, schmitz et al. (2012) did not find differences in iac based on the hct between children with high and low social anxiety, which implies that iac and ie may dissociate under specific circumstances. the authors assume that socially anxious children overestimate their hr under stress (i.e. over-reporting of cardiac sensations) but are able to perceive their heartbeat correctly in the recovery period after stress (mauss, wilhelm, & gross, 2004; pollatos, traut-mattausch, schroeder, & schandry, 2007). in summary, the role of iac, is and ie (including over-reporting of cardiac sensations) in fully manifested sad remains unclear. if biased perception (is) and evaluation (ie) of physiological symptoms and/or iac are central factors in childhood sad, a longitudinal assessment measuring stability and changeability by treatment is a plausible next step (e.g., siess et al., 2014). once again, previous research focused on treatment effects on other biases, for example, interpreta‐ tion biases (leigh & clark, 2018). however, theoretical models placed the misperception of physiological symptoms as central for sad (e.g., clark & wells, 1995), which leads to the assumption that cognitive behavioral therapy (cbt) might change this perception bias. interestingly though, most treatments of sad do not explicitly focus on a biased perception of physiological symptoms but rather on general cognitions in and after social situations and on behavior in children (e.g., beidel & turner, 2007). however, as pointed out above, the importance of including specific treatment components targeting physiological reactions cannot be fully supported by empirical evidence, as findings on physiological hyperarousal are inconsistent (siess et al., 2014). the current study on objective measures (heart rate, electrodermal activity [eda]), we expected children with sad to show only tonic hyperarousal and no increased reactivity to social stress compared to children in a healthy control (hc) group (asbrand et al., 2017; schmitz et al., 2013). on subjective measures, we expected all children to report perception (i.e. is) biased perception of physiology in child sad 4 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ of and worry (i.e. ie) about physiological variables (heart rate, perspiration, blushing, trembling)1 that increases from baseline to stress and then decreases to recovery. this effect, that is, heightened perceived reactivity, has been hypothesized to be stronger in children with sad compared to hc children (schmitz et al., 2012). in line with previous findings, we expect a positive correlation between physiological activation (e.g., heart rate) and iac. after children with sad were assigned to a treatment (group cbt) or waitlist control (wlc) group, we expected only small differences in objective measures (heart rate, eda) on a second tsst-c. we expected differences in subjective measures, i.e. children in the cbt group reporting less perception of and worry about physiological variables compared to children in the wlc group and compared to results of the tsst-c before treatment. m e t h o d trial design the study was designed as a randomized controlled trial (block randomization, in which half of the participants were allocated by drawing from a hat to an experimental condi‐ tion receiving immediate treatment and half to a wlc condition receiving treatment about 16 weeks later; for an overview see figure 1). randomization for each research center was conducted in a concealed fashion by the other center, based on subject codes, as soon as there were enough participants for one experimental and one wlc allocation. eligibility criteria were registered with the german research foundation (tu 78/5-2, he 3342/4-2) prior to recruitment and not changed during the study. this study was part of a larger project. the overall project consisted of experimental studies related to research questions of visual attention allocation or psychophysiological processes under (social) stress and it also aimed to measure treatment success by including several outcome variables (state anxiety, negative cognitions, physiological arousal, perception of and worry about physiological symptoms, perception of academic performance, neg‐ ative post-event processing, parental cognitions, parental fear of negative child evalua‐ tion, and related treatment outcome predictions). due to the extent of the project and limitations on length and foci in articles, not all treatment related results could be reported in a single manuscript. further results are reported elsewhere (treatment out‐ come, asbrand, heinrichs, schmidtendorf, nitschke, & tuschen-caffier, 2020; changes in post-event processing based on treatment, asbrand, schmitz, et al., 2019; stability of the cortisol response despite treatment, asbrand, heinrichs, nitschke, wolf, schmidtendorf, 1) heart rate and perspiration were chosen to be assessed objectively as well. while the project further included other physiological variables (e.g. cortisol; asbrand, heinrichs, nitschke, wolf, schmidtendorf, & tuschen-caffier, 2019), these do not have a subjective counterpart which can be assessed by self-report. due to technical limitations, we could not assess blushing and trembling as objective parameters. asbrand, schulz, heinrichs, & tuschen-caffier 5 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ figure 1 flowchart of study participants note. n1 = center 1, n2 = center 2; cbt = cognitive behavioral therapy; eda = electrodermal activity; hc = healthy control; hr = heart rate; sad = social anxiety disorder; tsst-c = trier social stress test for children; wlc = waitlist control. biased perception of physiology in child sad 6 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ & tuschen-caffier, 2019) or are being prepared for submission (social performance, detailed psychophysiological activity pre and post treatment). to ensure maximal transparency, all articles include cross-references to other reports on measures used to investigate potential treatment-related effects. the current study reports primary outcome variables relating to perception of (is) and worry about phys‐ iological symptoms heart rate and eda (ie). the inclusion of subjective perception of and worry about blushing and trembling as well as cardiac iac was included post-hoc. the sample size for the current study, based on a medium to large effect (schmitz et al., 2012) and power of (1 β) = .80, was set at n = 90 (each group n = 45). as the study was part of a larger research project (see footnote) requiring a larger sample size of n = 110, all children were included to increase power. because the data are being used in a large project, this method section has been reported before in a similar fashion (asbrand, heinrichs, et al., 2019; asbrand, schmitz, et al., 2019). participants we informed parents of anxious children (9 to 13 years) through advertisements in schools, medical facilities, and newspapers in two midsized german cities from january 2012 to november 2013 until the targeted sample size had been reached (for an overview see figure 1). no harms were reported. parents received €35, and children €25 in vouch‐ ers in compensation for participation in the laboratory study. ethical approval for this study was granted by an independent ethics committee (ethics committee of the german society for psychology). all participating children and their caregivers consented to participation in both oral and written form. inclusion criterion for children consisted of sad as a primary diagnosis in the sad group and no current or lifetime diagnosis of a mental disorder in the hc group. exclu‐ sion criteria entailed health problems or medication which could have interfered with psychophysiological assessment (e.g., asthma, cardiac arrhythmia, and methylphenidate). as can be seen in table 1, the groups did not differ in age, type of school, or any of the disorder-specific measures. social phobia and anxiety inventory for children (spai-c) scores exceeded suggested cut-offs for clinically relevant sad. table 1 participant characteristics of the experimental groups (social anxiety disorder vs. healthy controls) characteristic group statisticssad healthy controls n a 64 55 mean age (sd), in years 11.3 (1.4) 11.3 (1.4) t(117) = 0.06, n.s. female 63.6% 60.0% χ2(1) = 0.17, n.s. mean spai-c (sd) 23.3 (9.03) 4.2 (5.4) t(117) = -13.71*** asbrand, schulz, heinrichs, & tuschen-caffier 7 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ characteristic group statisticssad healthy controls net income (per month) χ2(8) = 11.42, n.s. n.a. 0% 1.3% < €1,000 0% 5.9% €1,001–1,500 1.9% 7.4% €1,501–2,000 11.1% 8.8% €2,001–3,000 35.2% 32.4% €3,001–4,000 14.8% 16.2% €4,001–5,000 14.8% 20.6% > €5,000 22.2% 7.4% mean (sd) state anxiety during tsst-c (before treatment) 6.6 (2.8) 4.5 (2.9) t(117) = 4.05*** note. table adapted from asbrand, schmitz, et al. (2019). reprinted with permission. spai-c = social phobia and anxiety inventory for children; tsst-c = trier social stress test for children; n.a. = not available. asample sizes differ as not all questionnaires were completed correctly. ***p ≤ .001, n.s. = not significant. further, in the sad group, children in the two conditions (cbt vs. wlc) did not differ in sociodemographic and psychopathological variables (see table 2). table 2 participant characteristics of children with social anxiety disorder allocated to the treatment versus waitlist group characteristic group statisticstreatment (cbt) waitlist control n a 31 33 mean age (sd), in years 11.5 (1.4) 11.2 (1.3) t(62) = 0.78, n.s. female 51.6% 67.6% χ2(2) = 1.88, n.s. mean spai-c (sd) 11.8 (7.3) 12.1 (7.1) t(62) = 0.18, n.s. net income (per month) χ2(7) = 6.65, n.s. n.a. 3.2% 0.0% < €1,000 6.5% 5.6% €1,001–1,500 9.7% 5.6% €1,501–2,000 6.5% 8.3% €2,001–3,000 41.9% 23.7% €3,001–4,000 16.1% 16.7% €4,001–5,000 9.7% 30.6% > €5,000 6.5% 8.3% mean (sd) state anxiety during tsst-c (before treatment) 6.7 (2.9) 6.6 (2.8) t(62) = 0.10, n.s. note. table adapted from asbrand, schmitz, et al. (2019). reprinted with permission. cbt = cognitive behavio‐ ral therapy; n.a. = not available; spai-c = social phobia and anxiety inventory for children; tsst-c = trier social stress test for children. asample sizes differ as not all questionnaires were completed correctly. ***p ≤ .001. n.s. = not significant. biased perception of physiology in child sad 8 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ procedure the study took place at two german universities. all analyses first considered site differ‐ ences, which were non-existent. following a short telephone screening for anxiety symp‐ toms, eligible children and their parents attended a diagnostic session (see flowchart in figure 1). both the child and a parent separately participated in the kinder-dips, a struc‐ tured interview that codes for mental disorders in children and adolescents (schneider, unnewehr, & margraf, 2008). diagnoses of sad and comorbid disorders (dsm-iv-tr, apa, 2000) were then reached through combining both interviews, supervised by an experienced clinical psychologist. diagnoses were assigned under supervision of the same licensed clinical psychologists per site throughout the project (one psychologist at the first, two psychologists at the second center). the kinder-dips is a validated interview for the most frequent mental disorders in children and adolescents (schneider et al., 2008). the kinder-dips is conducted by trained interviewers and the diagnosis is usually based on both child and parent reports. the authors have reported adequate interrater reliability (87% for anxiety disorders), good retest reliability (schneider et al., 2008), and successful validation with disorder-specific questionnaires. additionally, children and parents reported sociodemographic data, anxiety symptoms, and general psychopathology in online questionnaires. according to the diagnostic assessment, 65 children fulfilled the inclusion criterion of a primary diagnosis of sad; 55 children were included in the hc group. after the diagnostic interviews children participated in the first laboratory session, the tsst-c (buske-kirschbaum et al., 1997), which consists of a speech and a math task (see figure 2). in the speech task, children narrate a story in front of two observers after listening to the beginning of the story. in the following mental arithmetic task, children were asked to serially subtract the number 7 from 758 (9to 11-year-olds) or the number 13 from 1,023 (12to 13-year-olds) as fast and as accurately as possible again in front of two observers. both observers were instructed and trained to give neutral verbal and nonverbal feedback. the tsst-c elicits high social-evaluative stress in children (cf. allen et al., 2017). throughout the session, heart rate and skin conductance level were assessed. further, perception of (is) and worry about physiological symptoms (ie) were assessed after baseline, stress, and recovery (see figure 2). after a recovery period, children per‐ formed the hct to assess iac (see below). as the current project focused on the climax of social stress, only this time of measurement was included in the analyses. assessments of perception and worry were based on a previous study (schmitz et al., 2012): children were asked to rate their perceived level of physiological intensity during the task (e.g., “how strongly did you feel your heartbeat during the task?”) and their worry about their physiological symptoms (“how much did you worry that others could notice how fast your heart was beating?” on a scale of 0 (not at all) to 10 (extremely). after participating in a 12-week cbt program (cbt group) or waiting without treatment (wlc group), all children performed a parallel version of the first testing session. based on the original asbrand, schulz, heinrichs, & tuschen-caffier 9 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ tsst-c (buske-kirschbaum et al., 1997), the speech task was changed to a different story that was judged to be similarly interesting and difficult in a preevaluation. the math task was changed to a different start number (+10). the tsst-c reliably induces social anxiety in all children, even more so in children with sad compared to healthy control children, p < .001. figure 2 overall procedure including the trier social stress test for children (tsst-c) before (tsst-c 1) and after (tsst-c 2) treatment or waiting note. physio perception 1–3 refers to measurements of participants’ perceived level of physiological intensity and physio worry 1–3 to worry about their physiological symptoms. treatment treatment consisted of an exposure-based cbt treatment that was evaluated simultane‐ ously (asbrand, heinrichs, schmidtendorf, nitschke, & tuschen-caffier, 2020). it targets dysfunctional cognitions, possible social deficits, and social avoidance with a strong biased perception of physiology in child sad 10 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ focus on exposure. each session consisted of 100 min (including a 10-min break) in groups of five to seven children. standard cbt components were implemented in 12 sessions (psychoeducation, cognitive restructuring, social skills training, exposure, and relapse prevention). children were instructed to use their newly developed skills outside of treatment to ensure a transfer into everyday life. psychometric measure the spai-c (beidel, turner, hamlin, & morris, 2000) assesses behavioral characteristics specific to sad (26 items; e.g., “i am anxious when i meet new boys or girls”). children respond to each item using a 3-point likert-type scale ranging from “never or hardly ever” to “almost always or always.” validity and reliability were confirmed in the original sample (beidel et al., 2000) and a german sample (melfsen, walitza, & warnke, 2011). internal consistency and test–retest reliability after 4 weeks in the german sample was excellent (cronbach’s α = .92; rtt = .84). psychophysiological measures electrodermal and cardiovascular measures including heart rate were assessed at 400 hz using the varioport system (becker meditec, karlsruhe, germany). data inspection and artefact rejection were conducted offline using anslab (blechert, peyk, liedlgruber, & wilhelm, 2016). for the electrocardiogram, the cardiac interbeat interval (ibi), calculated as the interval in milliseconds between successive r waves, was extracted. for illustrative purposes the ibi was converted to heart rate (in beats per minute) for tables and figures but all statistical analyses were based on ibi values (quigley & berntson, 1996). eda, re‐ flecting electrodermal sympathetic activity (boucsein, 2012), was assessed by placing two electrodes on the middle phalanx of the middle and ring fingers of the left hand using 11-mm inner diameter ag/agcl electrodes filled with isotonic electrode paste (td-245, med associates, inc., st. albans, vermont). as a parameter of eda, skin conductance level was used. interoceptive accuracy (iac) we assessed iac using the hct. after a short training of about 10s, children were asked to silently count their heartbeats during three instructed intervals (25, 35, 45s in a fixed order), to indicate ‘zero’ if they had not perceived any, and not take their pulse or to use any other strategies such as holding their breath (eley et al., 2004). subjective reports of perceived heartbeats were checked for plausibility. for the first testing session, perceived heart beats ranged between 10 and 86 (25s interval), 10 and 90 (35s interval), and 13 and 600 (45s interval). based on the extreme value at the third interval, one child was excluded from further analyses as it is possible that the child did not understand the instructions correctly, leaving a range between 13 and 120 (45s interval). for the second asbrand, schulz, heinrichs, & tuschen-caffier 11 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ testing session, perceived heart beats ranged between 7 and 70 (25s interval), 1 and 85 (35s interval), and 6 and 105 (45s interval). to ensure comparability to an earlier study (koch & pollatos, 2014), iac was calcula‐ ted using the formula: iachct =   13  k = 1 3 1 − no. of recorded heartbeatsk − no. of perceived heatbeatskno. of recorded heartbeatsk higher scores indicate higher iac, with a maximum score of ‘1’ reflecting perfect iac. as physical symptom reporting is related to the tendency to report false alarms in a somatosensory signal detection task (brown et al., 2012), we calculated a simple iac score to distinguish overfrom underreporting using the formula (rost, van ryckeghem, schulz, crombez, & vögele, 2017): iacsimple =   13  k = 1 3 no. of perceived heartbeatsk − no. of recorded heartbeatsk no. of recorded heartbeatsk a positive score reflects over-reporting and a negative score reflects underreporting of heartbeats. statistical analysis first, for objective measures, statistical outliers 2.5 sd above or below the mean were excluded. outliers were calculated separately for groups and time. to examine biases be‐ fore treatment, we conducted analyses of variance (anovas) with repeated measures on phase (baseline, stress, recovery), using group (sad, hc) as between-subjects factor. for objective physiology, eda and heart rate were used as dependent variables in separate anovas. for subjective perception, rating (perception, worry) was further added as a factor. we included first the heart rate and perspiration scales and then the blushing and trembling scales as dependent variables in separate anovas. including objective physiology as a covariate did not lead to any significances, ps > .05, and is therefore not further reported. to consider that objective physiology and subjective perception (is) and worry (ie) might depend on each other, multiple correlation analyses were conducted for both eda and heart rate including subjective and objective measures. iac scores (iachct and iacsimple) from the first laboratory session were compared using an independent sample t test with group (sad, hc) as independent variable. for treatment effects, we once again conducted anovas with repeated measures on session (pre, post) and phase (baseline, stress, recovery), using group (cbt, wlc) as between-subjects factor. for objective physiology, eda and heart rate were used as dependent variables in separate anovas. for subjective perception, perception and wor‐ ry of all physiology questionnaires (heart rate, perspiration, blushing, trembling) were biased perception of physiology in child sad 12 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ analyzed as dependent variables in separate anovas. once again, multiple correlation analyses were conducted for both eda and heart rate including subjective and objective measures. for the analysis of treatment effects on iac scores, an anova with repeated measures on time (pre, post) was used based on treatment (cbt, wlc) as independent variable. further, a moderation analysis was conducted testing treatment as potential moderator (cbt, wlc) between iac pre (iac_1) and post treatment (iac_2) using the process macro for spss (hayes, 2013). further exploratory analyses are reported in the supplementary materials. significant main effects and interactions for all anovas were further analyzed with post hoc t tests for independent groups for the group comparisons and with t tests for de‐ pendent groups for the time comparisons (phase, session) if relevant for the hypotheses. cohen’s d effect sizes are reported for the post hoc tests. r e s u l t s before treatment: objective physiology comparison of children with and without sad we found higher heart rate (hr) during the stress as compared to the baseline and post phases, wilk’s λ = .351, f(2,94) = 87.07, p < .001, ηp2 = .649, but hr did not differ between groups, f(1,95) = 0.87, p = .354. there was a significant interaction of phase × group, wilk’s λ = .870, f(2,94) = 87.07, p < .001, ηp2 = .130. post hoc tests showed a significantly higher hr in children in the sad group during the baseline phase, t(95) = -2.30, p = .023, d = 0.47, but no further group differences, ts < 1.33, ps > .187 (see figure 3a). in the sad group, hr increased significantly from baseline to stress, t(53) = 7.12, p < .001, d = 0.41, and decreased from stress to recovery, t(53) = -7.27, p < .001, d = 0.40. similarly, in the hc group, hr increased significantly from baseline to stress, t(42) = 11.31, p < .001, d = 0.67, and decreased from stress to recovery, t(53) = -10.40, p < .001, d = 0.61. the significant interaction between group and phase and the higher effect sizes for post-hoc tests in the hc than the sad group suggest a steeper increase and decrease in the hc group compared to the sad group. eda significantly increased over time, wilk’s λ = .586, f(2,91) = 32.17, p < .001, ηp2 = .414, and differed between groups, f(1,92) = 35.12, p < .001, ηp2 = .276. furthermore, we observed a significant phase × group interaction, wilk’s λ = .750, f(2,91) = 15.14, p < .001, ηp2 = .250. post hoc tests showed that in the sad group, eda increased signif‐ icantly from baseline to stress, t(49) = 7.17, p < .001, d = 0.31, but did not decrease from stress to recovery, t(49) = 1.30, p = .199, d = 0.02. similarly, in the hc group, eda increased significantly from baseline to stress, t(43) = 4.45, p < .001, d = 0.23, but did not decrease from stress to recovery, t(43) = 1.02, p = .311, d = 0.02 (see figure 3b). again, asbrand, schulz, heinrichs, & tuschen-caffier 13 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ the significant interaction and the higher effect sizes imply a steeper increase in the hc group compared to the sad group. before treatment: subjective physiology perception comparison of children with and without sad for subjective perception of heart rate (is), we found significant main effects of phase, wilk’s λ = .468, f(4,111) = 31.49, p < .001, ηp2 = .532, and group, wilk’s λ = .861, f(2,113) = 9.10, p < .001, ηp2 = .139, with a trend for a significant interaction of phase × group, wilk’s λ = .929, f(4,111) = 2.11, p = .084, ηp2 = .071. groups differed in both perception of and worry about heart rate in all phases (see figure 4; ps < .05). the increase from baseline to stress and the decrease from stress to recovery was significant in both groups, ps < .001. similar effects were found for subjective perception of perspiration, blushing, and trembling (see supplementary materials). figure 3 group comparisons of (a) heart rate (in beats per minute, bpm) and (b) electrodermal activity during the first trier social stress test for children for children with social anxiety disorder (sad) and healthy control (hc) children biased perception of physiology in child sad 14 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ figure 4 subjective perception of (a) and worry (b) about heart rate after all phases of the first trier social stress test for children note. for other parameters, see supplementary materials. before treatment: relations between objective and subjective physiology a multiple correlation analysis between objective heartrate and subjective perception of and worry about heart rate did not reveal any significant correlation, ps > .084. similarly, no effects were found for eda and subjective perception, ps > .105. for the first laboratory session, neither the iachct scores, t(96) = -1.29, p = .200, d = 0.26, nor the iacsimple scores differed significantly between groups, t(98) = -1.48, p = .142, d = 0.30. after treatment: objective physiology comparison of children with sad after treatment versus waiting comparable to the first measurement occasion, hr was higher during stress than during baseline and post phases, wilk’s λ = .355, f(2,37) = 33.55, p < .001, ηp2 = .645. all other effects remained nonsignificant, fs < 2.77, ps < .103. again, eda was higher during stress than during baseline and post phases, wilk’s λ = .388, f(2,37) = 29.15, p < .001, ηp2 = .612. all other effects remained nonsignificant, fs < 3.91, ps < .057. asbrand, schulz, heinrichs, & tuschen-caffier 15 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ after treatment: subjective physiology perception comparison of children with sad after treatment versus waiting for subjective perception of heart rate after treatment, the anova showed a significant main effect of phase, wilk’s λ = .364, f(4,48) = 20.94, p < .001, ηp2 = .636, and a trend for a significant effect of session, wilk’s λ = .891, f(2,50) = 3.07, p = .055, ηp2 = .109. all other fs < 2.27, ps > .113 (see figure 5). figure 5 subjective perception of and worry about heart rate after all phases of the first (a, b) and second (c, d) trier social stress test for children (tsst-c), comparing the cognitive behavioral therapy (cbt) and waitlist control (wlc) groups note. for other parameters, see supplementary materials. an analysis of the main effect of session for heart rate in both groups, using t tests for paired samples, showed an overall decrease in the perception, t(56) = 2.03, p = .047, d biased perception of physiology in child sad 16 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ = 0.28, and worry after the stress phase, t(56) = 2.22, p = .030, d = 0.30. all other ts < 1.33, ps > .191. so, heart rate perception and worry decreased in all children from tsst-c 1 to tsst-c 2. similar effects were found for subjective perception of trembling (see supplementary materials). after treatment: relations between objective and subjective physiology a multiple correlation analysis at tsst-c 2 between objective hr and subjective percep‐ tion (is) of and worry (ie) of hr did not reveal any significant correlation, ps > .077. similarly, no effects were found for eda and subjective perception, ps > .229. regular iachct did not change from preto post-measurement (main effect ‘session), independent of treatment group (interaction treatment × session, fs < 1.92, ps > .174). likewise, for iacsimple, no significant effects appeared for treatment, session or session × treatment, fs < 2.19, ps > .146. additionally, the moderation analysis showed an overall significant relation, r 2 = .382, f(3,35) = 7.2, p < .001. there was a significant relation between iac_1 and iac_2, while treatment was no significant moderator (table 3). table 3 prediction of iac at second laboratory session predictor b se b t p constant -0.12 [-0.75, 0.51] 0.31 -0.38 .703 iac_1 (standardized) 0.92 [0.03, 1.18] 0.44 2.09 .044 treatment (cbt, wlc; standardized) 0.27 [-0.19, 0.74] 0.23 1.20 .237 iac_1 × treatment (cbt, wlc) -0.25 [-0.90, 0.40] 0.32 -0.79 .437 note. iac_1 = interoceptive accuracy laboratory session 1, iac_2 = interoceptive accurarcy laboratory session 2. d i s c u s s i o n the study aimed to assess alterations in perception of (is) and worry about (ie) physio‐ logical symptoms as well as iac in childhood sad. it further strived to examine possible changes after cbt. supporting our hypotheses at tsst-c 1, children with sad showed higher heart rate than children in the hc group during the baseline phase, and a lower reactivity to stress. further, eda was heightened throughout the testing session. these findings may indicate an autonomic hyperarousal and blunted stress reactivity in the sad group. moreover, children in the sad group reported heightened perception (is) of and increased worry (ie) about heart rate, perspiration, and trembling throughout the tsst-c. there seems to be no biased perception for eda. however, the pattern for the asbrand, schulz, heinrichs, & tuschen-caffier 17 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ objective and subjective side in heart rate differed: objectively, children in the hc group showed a steep increase and decrease throughout the tsst-c 1. subjectively however, hc children’s perception and worry remained below that of sad children. as blushing and trembling were not controlled on objective parameters, this effect can only be con‐ firmed for heart rate and perspiration. further, contrary to findings in adults (domschke, stevens, pfleiderer, & gerlach, 2010), no differences in iac were found between children with sad and hc children. findings after treatment were not in line with our hypotheses: objective physiolog‐ ical parameters (heart rate, eda) did not change. interestingly, children in the cbt group reported heightened perception of and increased worry about perspiration, and trembling after the baseline phase at tsst-c 2 compared to children in the wlc group. additionally, both before and after treatment subjective and objective parameters did not correlate. further, as no differences appeared between children with sad receiving treatment vs. waiting, no effects of treatment on iac can be assumed. before treatment: findings on children with sad compared to an hc group objectively in line with earlier studies (cf., asbrand et al., 2017), a tonic hyperarousal was shown in children with sad concerning eda. however, in contrast to earlier studies (schmitz et al., 2012), this was mirrored by subjective perception. part of the earlier findings in high socially anxious children (schmitz et al., 2012) still seems to be also found in our sample: concerning hr, children with sad perceived an increase in their physiological reaction that was not mirrored by the pattern of physiological reactivity. further, they worried more than children in the hc group that this physiological arousal might be observable. considering the point of (non)visibility of heart rate, children with sad might have more unrealistic worries that internal signals might be observable. as our paradigm was slightly altered to schmitz et al. (tsst-c instead of a speech task with public vs. private sound of heart rate), our findings are not replication in a narrow sense but show a robust effect in an established social stress test. however, mean scores on symptom perception intensity as well as worry were rather low (< 5 on a scale of 0 to 10). the pattern of results demonstrates that worry is linked to several physiological symptoms (but not all). further, it may be that some physiological sensations are more likely linked to sad (e.g., blushing; bögels, rijsemus, & de jong, 2002). these symptoms are more consistently associated with worry, reflecting a more general tendency to wor‐ ry about sad-related physiological symptoms instead of symptom-specific links between perception of and worry about these symptoms. this might be related to visibility of physiological symptoms. finally, a lack of correlation between iac, is and ie provides an interesting insight: it would be expected that a higher physiological arousal leads to the perception of – and possibly worry about – these symptoms. however, our results point to the independence of both sides. this might stem from the fact that children biased perception of physiology in child sad 18 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ struggle more with iac (koch & pollatos, 2014). the current study suggests that sad children do not show altered iac, but report higher subjective heart rates (is) and higher worries about cardiac perceptions (ie). sad in childhood may be reflected, therefore, by a selective increase in the subjective tendency to be focused on heart rate increases and a negative evaluation of these percepts, whereas the actual perception is unaffected. after treatment: findings on a treatment (cbt) versus a wlc group children in the cbt group reported higher perception of and more worry about perspi‐ ration as well as more worry about trembling after the baseline phase of tsst-c 2. in other words, children in the cbt group reported heightened perception of physiological arousal and increased worry on some parameters after the baseline phase. previous findings from this sample could show that cbt was in general successful in reducing the severity of sad as measured by a blind interview after treatment (cf., asbrand et al., 2020). further, some sad-relevant rumination processes such as post-event pro‐ cessing changed for the better as negative thoughts after a social situation decreased significantly after treatment (asbrand, schmitz, et al., 2019). still, cortisol levels did not change based on treatment; however, cortisol levels in the wlc group increased in the second tsst-c (asbrand, heinrichs, et al., 2019). overall, it would have been plausible that physiological awareness and biased perception also change with treatment. howev‐ er, instead of decreasing, children in the cbt group reported higher perception and worry about several physiological parameters before entering the social stress situation. it might be that children in the cbt group were sensitized to similar tasks as they had experienced exposure sessions beforehand. psychoeducation conveys a concept of anxiety that includes cognitions, behavior, and physiological reactions. often, this is the first time children are confronted with such a concept. it might direct their attention to these factors and, as such, support sensitization. further, our treatment was rather short (12 sessions), and recent research has argued that longer treatment is necessary in sad (e.g., hudson et al., 2015). as the main treatment component, exposure, had to be properly prepared (habituation rationale, first exposure in social skills sessions), only a few sessions remained to experience in-vivo exposure. thus, it is possible that treatment was already successful in reducing overall symptoms (asbrand, heinrichs, et al., 2020), but children were still in the process of handling high state anxiety. additionally, our treatment did not specifically target physiological symptoms and their interpretation. this treatment component is more common in treatment of panic disorders (e.g., clark et al., 1999; öst & westling, 1995) but should be considered for sad treatment as well, given our results. however, interpretation of these findings of elevated perception and worry in the cbt group should be evaluated cautiously as they were found only after the baseline phase of the tsst-c and not after the stress phase. in addition, even if the asbrand, schulz, heinrichs, & tuschen-caffier 19 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ pattern of results allows for interpretation of sensitization, the overall scores remain low at posttreatment (mean scores < 4 on a scale of 0 to 10). finally, while comparison of single intervals of the hct has shown high correlations between these (e.g., koch & pollatos, 2014), our study is the first to show stability over a longer period of time providing first evidence for iac as a trait marker in children. however, as we do not find differences in iac between children with and without sad in our study, iac may not play a key role for sad in children. possibly, a subsample of chil‐ dren with sad suffering from panic-like symptoms (cf. domschke, stevens, pfleiderer, & gerlach, 2010) in social situations might show both different iac scores and changes in iac based on treatment. future studies are warranted to investigate, which role other occasionor situation-specific factors, as well as error variance (wittkamp et al., 2018), contribute to iac in in children. limitations and conclusions while the study has several strengths, such as a clinical sample and inclusion of treat‐ ment, several limitations apply. first, we assessed a variety of dependent variables based on concerns to target physiological arousal broadly (siess et al., 2014). possibly, a lack of effects might stem from lack of power. however, the current sample was relatively large and could detect differences in treatment groups, even though they showed to be contrary to expectations. second, we did not assess all variables both subjectively and objectively but provide subjective data only for blushing and trembling. future studies might target these variables to examine the objective basis for subjective perception. pre‐ vious studies from adults, however, point to similar results for blushing, as this depends mainly on social anxiety instead of objective blood flow (drummond & su, 2012). third, we refrained from using an experimental setup (cf., gerlach et al., 2004; schmitz et al., 2012), instead opting for a standardized social stress task. thus, taking note of these earlier findings (gerlach et al., 2004; schmitz et al., 2012) on the importance of the per‐ ception of and worry about physiological arousal in social anxiety, we did not manipulate visibility of physiological arousal but chose to measure subjective and objective arousal in parallel during social stress. finally, we did not include a correlation analysis between a change in social anxiety symptoms and changes in perceptions of physiology as this would not have been based on a solid theoretical background. however, future studies could include this perspective to analyze a possible co-occurrence of change in anxiety and perception of physiology. in conclusion, our results indicate that sad children show a selective enhancement of subjective cardiac interoception, as proposed by cognitive models of sad (clark & wells, 1995), whereas behavioral indices of cardiac interoception and the perception of eda changes remain unaffected. cbt did not change this perception. thus, further inclusion of treatment components targeting this bias as currently proposed mainly by biased perception of physiology in child sad 20 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://www.psychopen.eu/ adult research (hofmann & otto, 2017; naim, kivity, bar-haim, & huppert, 2018; wong et al., 2017) should be considered. funding: this research was supported by a grant from the dfg given to the last authors (he 3342/4-2, tu 78/5-2). competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include additional exploratory analyses on subjective perception of perspiration, blushing and trembling before and after treatment (for access see index of supple‐ mentary materials below): index of supplementary materials asbrand, j., schulz, a., heinrichs, n., & tuschen-caffier, b. 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(2017). anticipatory processing, maladaptive attentional focus, and postevent processing for interactional and performance situations: treatment response and relationships with symptom change for individuals with social anxiety disorder. behavior therapy, 48(5), 651-663. https://doi.org/10.1016/j.beth.2017.03.004 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. asbrand, schulz, heinrichs, & tuschen-caffier 25 clinical psychology in europe 2020, vol.2(2), article e2691 https://doi.org/10.32872/cpe.v2i2.2691 https://doi.org/10.1016/j.jpsychores.2016.12.003 https://doi.org/10.1111/j.1469-8986.1981.tb02486.x https://doi.org/10.1080/15374416.2012.632349 https://doi.org/10.1007/s00787-013-0405-y https://doi.org/10.1007/s00787-013-0443-5 https://doi.org/10.1111/psyp.13055 https://doi.org/10.1016/j.beth.2017.03.004 https://www.psychopen.eu/ biased perception of physiology in child sad (introduction) the current study method trial design participants procedure treatment psychometric measure psychophysiological measures interoceptive accuracy (iac) statistical analysis results before treatment: objective physiology comparison of children with and without sad before treatment: subjective physiology perception comparison of children with and without sad before treatment: relations between objective and subjective physiology after treatment: objective physiology comparison of children with sad after treatment versus waiting after treatment: subjective physiology perception comparison of children with sad after treatment versus waiting after treatment: relations between objective and subjective physiology discussion before treatment: findings on children with sad compared to an hc group after treatment: findings on a treatment (cbt) versus a wlc group limitations and conclusions notes (additional information) funding competing interests acknowledgments supplementary materials references looking on the bright side reduces worry in pregnancy: training interpretations in pregnant women research articles looking on the bright side reduces worry in pregnancy: training interpretations in pregnant women colette r. hirsch 1 § , frances meeten 2 §, jill m. newby 3,4, sophie o’halloran 1, calum gordon 1, hannah krzyzanowski 1, michelle l. moulds 3 [1] institute of psychiatry, psychology and neuroscience, king’s college london, london, united kingdom. [2] school of psychology, university of sussex, brighton, united kingdom. [3] school of psychology, university of new south wales, sydney, australia. [4] black dog institute, hospital road randwick, new south wales, sydney, australia. §these authors contributed equally to this work. clinical psychology in europe, 2021, vol. 3(2), article e3781, https://doi.org/10.32872/cpe.3781 received: 2020-05-28 • accepted: 2021-03-22 • published (vor): 2021-06-18 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: colette r. hirsch, department of psychology, institute of psychiatry, psychology and neuroscience, king’s college london, de crespigny park, london se5 8af, uk. phone: +44 207 848 0697. e-mail: colette.hirsch@kcl.ac.uk supplementary materials: materials, preregistration [see index of supplementary materials] abstract background: recent evidence suggests that anxiety is more common than depression in the perinatal period, however there are few interventions available to treat perinatal anxiety. targeting specific processes that maintain anxiety, such as worry, may be one potentially promising way to reduce anxiety in this period. given evidence that negative interpretation bias maintains worry, we tested whether interpretation bias could be modified, and whether this in turn would lead to less negative thought (i.e., worry) intrusions, in pregnant women with high levels of worry. method: participants (n = 49, at least 16 weeks gestation) were randomly assigned to either an interpretation modification condition (cbm-i) which involved training in accessing positive meanings of emotionally ambiguous scenarios, or an active control condition in which the scenarios remained ambiguous and unresolved. results: relative to the control condition, participants in the cbm-i condition generated significantly more positive interpretations and experienced significantly less negative thought intrusions. conclusions: our findings indicate that worry is a modifiable risk factor during pregnancy, and that it is possible to induce a positive interpretation bias in pregnant women experiencing high this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3781&domain=pdf&date_stamp=2021-06-18 https://orcid.org/0000-0003-3579-2418 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ levels of worry. although preliminary, our findings speak to exciting clinical possibilities for the treatment of worry and the prevention of perinatal anxiety. keywords perinatal mental health, worry, interpretation bias, cognitive bias mediation (cbm), pregnancy, anxiety highlights • modification of interpretation bias in pregnant women with high levels of worry was examined. • participants received interpretation bias training or an active control condition. • training led to less negative interpretations and fewer negative thought intrusions. • modifying negative interpretation bias in pregnant women may have clinical utility. the perinatal period, the time from conception to 12 months post birth (austin, highet, & expert working group, 2017), is a time of significant change and adjustment. it often brings new stressors which, combined with hormonal fluctuations, can leave women vulnerable to mental health problems. women are at a higher risk of developing a serious mental illness during the first month postpartum than at any other point in their lives (stewart et al., 2003), and are also at risk for relapse or recurrence of a pre-existing mental health problem. perinatal mental health problems are associated with negative outcomes for both mother and baby; for example, poor foetal development (dipietro et al., 2002), low birth weight (hedegaard et al., 1993), and greater risk of behavioural, psychological and developmental problems (o’connor et al., 2002; stein et al., 2014). until relatively recently, most research on perinatal mental health has focused on postnatal depression, with other conditions overlooked (goodman, watson, & stubbs, 2016; howard, molyneaux, et al., 2014). in particular, perinatal anxiety has tended to be ignored in favour of depression, despite evidence that anxiety disorders are more prevalent than depression in pregnancy and postpartum (fairbrother et al., 2016). this is particularly the case in the treatment outcome literature. in a systematic review, loughnan et al. (2018) identified only one randomised controlled trial evaluating a treatment for perinatal anxiety. with prevalence rates of up to 8.5% (goodman et al., 2016), and given that maternal prenatal anxiety is associated with a twofold increase in the risk of a child developing psychological disorders (o’donnell et al., 2014), there is a clear need to develop effective, evidence-based approaches to treat perinatal anxiety. one promising approach may be to target modifiable psychological processes that maintain anxiety symptoms and their consequences, such as repetitive negative thinking (rnt). rnt refers to types of thinking which are pathological, perseverative and difficult to control (samtani & moulds, 2017); for example, worry and rumination. worry is a form of rnt that is predominantly verbal, difficult to control and involves entertaining potential negative outcomes of future situations (borkovec, 1994). rumination primarily training positive interpretations in pregnant worriers 2 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ involves focusing on events in the past, as well as one’s perceived personal inadequacies, current mood/symptoms and their causes and consequences (nolen-hoeksema, 1991). both these forms of rnt are experienced as unwanted negative intrusive thoughts that come to mind unbidden, and capture attention such that it is difficult to shift focus away from the thought. moulds et al. (2018) proposed that rnt could be an important factor to target in interventions to improve perinatal distress. in keeping with this, a recent study of pregnant women (hirsch, meeten, et al., 2020) demonstrated that worry and rnt more generally was associated with increased levels of perinatal anxiety and depression. the predictive role of worry in the development and maintenance of anxiety is well-established, and recent research has indicated that this may similarly apply in the perinatal context. for example, schmidt et al. (2016) reported that levels of worry in the first four months of pregnancy predicted anxiety and depression symptoms in the third trimester. one key cognitive process proposed to contribute to pathological worry is negative interpretation bias: the transdiagnostic tendency to perceive ambiguous information or events as threatening or negative (hirsch & mathews, 2012; hirsch et al., 2016). krahé et al. (2019) found that greater levels of negative interpretation were associated with increased worry. similarly, hirsch, meeten, et al. (2020) demonstrated that higher levels of both worry and anxiety in pregnant women are associated with more negative inter­ pretation bias. these findings speak to the clinically related possibility that modifying interpretation bias may reduce worry. one experimental methodology showing promise in this regard is cognitive bias modification for interpretation (cbm-i). the goal of cbm-i is to facilitate consistent generation of positive interpretations of ambiguous information (where the interpretation could be positive or threatening) via repeated computerised practice. specifically, participants listen to ambiguous scenarios, with ambiguity being resolved by the final word in a benign manner (see appendix a in the supplementary materials for an example scenario). evidence indicates that a single session of cbm-i can modify interpretation bias and in turn reduce worry in high worriers (feng et al., 2020; hirsch et al., 2009), as well as those with generalised anxiety disorder (gad) (hayes, hirsch, krebs, & mathews, 2010). in another gad sample, hirsch et al. (2018) demonstrated that multi-session positive cbm-i training resulted in a more positive interpretation bias and reduced worry and anxiety one month later compared to an active control condition. more recently, community participants with high levels of rnt (worry and/or rumination) completed an enhanced version of cbm-i where participants were instructed to generate positive resolutions to ambiguous scenarios (rather than be presented with a positive resolution) for half of the scenarios, in order to aid generalisation and engagement. participants were also instructed to generate positive images of the outcome for each scenario. this led to more positive interpretation bias, fewer negative interpretations, and lower levels of rnt, anxiety and depression, relative to a control condition in which ambiguity was unresolved (hirsch, krahé, whyte, bridge, hirsch, meeten, newby et al. 3 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ et al., 2020). these findings prompt the clinically interesting possibility that cbm-i can be used as a potential intervention for anxiety. to determine whether cbm-i can help reduce worry and anxiety via a web-based platform with no face-to-face contact with researchers during assessment or training, we conducted a study with a sample of individuals with gad with or without comorbid ma­ jor depressive disorder (hirsch, krahé, whyte, krzyzanowski, et al., 2020). training was highly effective at reducing negative interpretations compared to the control condition. importantly, reductions in worry, rumination, anxiety and depression were evident at three-months follow-up. furthermore, effects were mediated by changes in interpretation bias. these findings raise the possibility of cbm-i forming a low-intensity intervention for pregnant women at risk of escalating levels of anxiety or depression due to height­ ened rnt. as an online intervention, it could be completed at a location and time convenient for pregnant women, and thus has scope to be more readily integrated into daily life. the possibility that cbm-i may have utility in facilitating a more positive interpreta­ tion bias in pregnant women who engage in high levels of worry remains untested. giv­ en that pregnant women who worry have a more negative interpretation bias (hirsch, meeten, et al., 2020), and the proposal that targeting rnt, such as worry, in pregnancy may have the potential to prevent and treat postpartum anxiety (moulds et al., 2018), testing whether cbm-i can shift interpretive bias in pregnant high worriers represents a logical first step. accordingly, we recruited pregnant women with self-reported high lev­ els of worry who were randomly allocated to either (i) cbm-i (i.e., interpretation training enhanced with positive imagery and self-generation) or (ii) control (no resolution of am­ biguity nor positive imagery) conditions. we hypothesised that participants in the cbm-i condition would generate more positive interpretations and thus demonstrate a positive interpretation bias compared to those in the control condition. we also hypothesised that participants in the cbm-i condition would experience fewer negative thought intrusions (indicative of worry) during a behavioural worry task in which they were instructed to focus on their breathing, relative to participants in the control condition. m e t h o d study registration the study was registered on open science framework: https://osf.io/ye84g. see appen­ dix b in the supplementary materials for registered information. participants 49 women with high levels of self-reported worry (scoring ≥ 561 on the penn state worry questionnaire cf. hayes, hirsch, & mathews, 2010) completed the study and 47 women training positive interpretations in pregnant worriers 4 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://osf.io/ye84g https://www.psychopen.eu/ completed useable data (see table 1 for demographic information). participants were required to be 16 or more weeks pregnant, fluent in english, with normal or corrected vision and hearing, and have no history of either stillbirth or three or more miscarriages. participation involved attending a session in the lab, and participants were reimbursed £25 for taking part. table 1 mean demographic and statistics characteristics and questionnaires (standard deviation in parenthesis) characteristic cbm-i n = 23 control n = 24 t(45) p age 33.35 (4.78) 32.46 (4.65) 0.65 0.52 weeks of gestation 26.96 (7.10) 28.29 (6.62) 0.67 0.51 pswq 64.30 (5.67) 66.13 (5.66) 1.10 0.28 rtqt 39.70 (10.63) 40.67 (7.01) 0.37 0.71 pass 43.09 (15.83) 47.54 (17.87) 0.90 0.37 edps 11.87 (3.55) 14.21 (5.37) 1.76 0.09 phq-9 8.87 (3.88) 11.00 (6.09) 1.42 0.16 gad-7 8.52 (4.12) 11.42 (5.36) 2.07 0.04 rrs 54.48 (13.30) 52.63 (13.54) 0.47 0.64 note. cbm-i = cognitive bias modification for interpretation; weeks of gestation = number of weeks pregnant at time of testing; pswq = penn state worry questionnaire; rtqt = trait repetitive thinking questionnaire; pass = perinatal anxiety screening scale; epds = edinburgh postnatal depression scale; gad7 = generalised anxiety disorder questionnaire; phq9 = patient health questionnaire; rrs = ruminative response scale. individuals who expressed interest in the study were sent a screening questionnaire via qualtrics, an online data acquisition platform. 163 women completed the screening questionnaire, of whom 64 did not meet the inclusion criteria. 99 respondents were eligible to take part in the study and were invited via email to take part in the study. 63 of these responded and were offered a testing date. of these, 49 participants completed the study, while six were found to be ineligible on the day of testing due to their penn state worry questionnaire score (meyer et al., 1990) being below cut off, seven withdrew before attending and one session was cancelled due to the covid-19 pandemic. two participants’ data was not included in the study as their responses to the recognition test comprehension questions indicated they had either not understood or not engaged with the task. the final sample of 47 participants were aged between 22 and 42 years (m = 32.89, sd = 4.69), and ranged between 16 and 39 weeks pregnant (m = 27.64, sd = 1) in a sample of individuals diagnosed with gad, a pswq score of 56 was one standard deviation below the mean (molina & borkovec, 1994) and is commonly used as a cut-off in research (feng et al., 2020; hirsch, perman, et al. 2015). accordingly, we classified participants as high worriers if their pswq score was ≥ 56. hirsch, meeten, newby et al. 5 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ 6.82). 12 participants had one child and two participants had two children. the other 35 participants were pregnant with their first child. sample size an a-priori power calculation with an alpha of .05 and power of .80 was computed in gpower. the effect size was determined by a study examining the effects of interpreta­ tion bias manipulation on the recognition test (feng et al., 2020). projected sample size was 26 per condition. as we did not know whether pregnancy would influence the capacity to modify interpretation bias, we elected to increase the planned number of participants recruited per condition to 30. however, due to the covid-19 pandemic in 2020, face-to-face testing was ultimately prohibited. recruitment and testing ended prematurely after testing 49 participants (two participants were excluded due to perform­ ance on the recognition test) resulting in final samples of n = 23 and n = 24 in the cbm-i and control conditions, respectively. measures and materials questionnaires penn state worry questionnaire (pswq) — the pswq (meyer, miller, metzger, & borkovec, 1990) consists of 16 statements related to worry (e.g., my worries overwhelm me) which are rated from 1 (not at all typical of me) to 5 (very typical of me). the pswq has high internal consistency (present sample cronbach’s α = .70), convergent and discriminant validity (brown, antony, & barlow, 1992), and good test-retest reliability (meyer et al., 1990). other standardised questionnaires — perinatal anxiety was assessed using the per­ inatal anxiety screening scale (pass; somerville et al., 2014; cronbach’s α = .94 in current sample). perinatal depression was assessed with the edinburgh postnatal de­ pression scale (epds; cox, holden, & sagovsky, 1987: cronbach’s α = .84). general depressed mood was assessed using the patient health questionnaire 9 (phq-9, kroenke & spitzer, 2002; cronbach’s α = .84) and anxiety symptoms using the generalized anxiety disorder 7-item scale (gad-7; spitzer et al., 2006; cronbach’s α = .87). trait rnt was assessed with the repetitive thinking questionnaire (rtq-t [trait]; mcevoy, thibodeau, & asmundson, 2014; cronbach’s α = .90). ruminative response scale (rrs; nolen-hoeksema & morrow, 1991; cronbach’s α = .93) was used to assess depressive rumination2. 2) vas mood ratings were also taken during the study, but were not available for analysis due to the university being closed because of covid-19. training positive interpretations in pregnant worriers 6 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ tasks worry induction — participants identified a current worry topic (related to their preg­ nancy or other aspects of their life) and were asked a series of questions to prime salient features. they were instructed to silently worry about this topic as they normally would for five minutes. interpretation assessment task recognition test — the first phase of this task (hirsch et al., 2018; adapted from mathews & mackintosh, 2000) requires participants to read a series of ambiguous scenarios. the last word of each scenario (which leaves the ambiguity unresolved) is presented as a word fragment, and participants are instructed to fill in the first missing letter of that word. next, participants complete a comprehension question (yes/no) about the scenario (see appendix a in the supplementary materials for example). in the second phase, participants are presented with a scenario title and four statements in random order, then indicate how similar each statement is to the meaning of the original scenario. the statements include one positive target (in keeping with the positive interpretation of the original scenario), one negative target, one positive and one negative foil unrelated to the scenario meaning. participants rate each statement on a scale from 1 (very different in meaning) to 4 (very similar in meaning). interpretation bias is assessed by calculating a positivity index, which is calculated by subtracting the mean ratings for negative targets from the mean ratings for positive targets. higher scores indicate a more positive interpretation bias. breathing focus task — in the version of the task (feng et al., 2020; adapted from ruscio & borkovec, 2004) employed in this study, participants first practiced the breath­ ing focus task. next, they were instructed to engage in worry about a current worry topic for five minutes, then completed a five-minute breathing focus task. during this task, participants were instructed to focus on their breathing. they were given a series of prompts (12 computerised tones) throughout the task; at each prompt, participants were asked to indicate if they were focusing on their breathing as instructed, or if their mind had wandered to another topic (i.e., they were experiencing a thought intrusion). if the latter, participants were asked to indicate the valence of the intrusion (i.e., positive, negative or neutral). negative thought intrusions are interpreted to be indicative of worry, as per previous cbm-i studies (e.g., feng et al., 2020). cbm-i condition imagery practise task — participants in the cbm-i condition completed an online imagery practice task (adapted from holmes et al. (2006) and used in hirsch, krahé, whyte, bridge, et al., 2020; feng et al., 2020) to help them generate vivid mental images, and to instruct them on how to hold them in mind (see feng et al., 2020). hirsch, meeten, newby et al. 7 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ cognitive bias modification for interpretation (cbm-i) — cbm-i is a scenar­ io-based task that requires participants to listen (over headphones) to 40 scenarios which present common worry-related situations that are initially emotionally ambiguous. par­ ticipants in the active condition were provided with a positive resolution (i.e. ending) of the ambiguous scenario for 20 trials, and instructed to generate their own positive resolution for the 20 remaining trials. participants are instructed to use mental imagery to vividly picture the resolution. after each scenario, participants are presented with a ‘yes/no’ comprehension question, designed to emphasise the desired interpretation of the scenario. they then receive feedback (‘correct/incorrect’) on these answers. par­ ticipants then rate the positivity of the scenario, on a scale of 0 (‘not at all’) to 100 (‘extremely’) (see appendix a, supplementary materials, for example). control condition filler task — the feng et al. (2019) filler task was used to match the time taken to complete the imagery training in the cbm-i condition. sham training — similar to cbm-i training, participants listened to 50 ambiguous worry-related scenarios over headphones. an increased number of trials was required to match the duration of cbm-i training. in this condition ambiguity remained unresolved, and participants were not instructed to generate particular outcomes. participants com­ pleted comprehension questions without feedback, thus allowing for either positive or negative interpretations without correction. procedure participants completed the pswq online within the 24 hours prior to the experimental testing session, to ensure that they met study eligibility criteria. before coming into the lab, participants were randomly allocated to the cbm-i or control condition on the basis of an allocation by an independent researcher. they then completed the study tasks associated with their allocated condition. see figure 1. for an overview of the study procedure. training positive interpretations in pregnant worriers 8 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ figure 1 overview of study procedure hirsch, meeten, newby et al. 9 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ r e s u l t s questionnaire measures for cbm-i and control conditions see table 1 for means of questionnaire measures and statistics for participants included in the analysis. the only significant between-condition difference to emerge was for gad-7; such that participants in the control condition reported higher anxiety. impor­ tantly, however, we note that the conditions did not differ on the pass, – i.e., a measure of perinatal anxiety specifically (rather than a measure of general anxiety developed for non-pregnant populations). assessing the impact of cbm-i on interpretation bias (hypothesis 1) to examine the effect of condition on interpretation bias, we conducted a regression analysis with mean positivity index score as the dependent variable. condition3 signifi­ cantly predicted post-training positivity index score, b = 0.54, se = .19, p = .007, 95% cis [0.16, 0.92]. the mean positivity index was higher for the cbm-i (m = 0.35, sd = 0.64) than the control (m = 0.19, sd = 0.65) condition, confirming that cbm-i was effective in facilitating a positive interpretation bias. assessing the impact of cbm-i on negative thought intrusions (hypothesis 2) to examine the effect of condition on negative thought intrusions, we conducted a bootstrapped (due to non-normality of data) regression analysis with number of negative thought intrusions from the breathing focus task as the dependent variable. condition significantly predicted post-training positivity index score, b = -1.11, se = .45, p = .02, 95% cis [-1.96, -0.28]. consistent with the hypothesis, participants in the cbm-i condition reported significantly fewer intrusions (m = 1.50, sd = 1.01) than did those in the control condition (m = 2.61, sd = 1.85). d i s c u s s i o n in this first study of interpretation training in pregnant worriers, we successfully induced a positive interpretation bias using cbm-i. consistent with hirsch et al. (2009) and feng et al. (2019), participants in the cbm-i condition reported fewer negative thought 3) as gad7 scores were significantly different at baseline we re-ran the regression analysis with mean centred gad7 scores and an interaction variable of (mean centred) gad7 and condition. neither gad7 scores (p = .67) or the interaction term (p = .54) were significant predictors in the model. condition remained a significant predictor (p = .02). training positive interpretations in pregnant worriers 10 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ intrusions relative to the control condition, supporting a causal role for interpretation bias in maintaining worry in pregnant women. as the first study to employ cbm-i to test questions about interpretation bias and worry in pregnant women, our results extend the cbm literature in important ways. first, on a methodological note, they demonstrate the applicability and effectiveness of cbm-i in the perinatal context. second, they confirm that interpretation bias maintains worry in pregnant women. whilst this relationship is well-established in the broader literature (feng et al., 2019; hirsch et al., 2009; hirsch, krahé, whyte, bridge, et al., 2020) given the unique and multi-faceted circumstances and changes (e.g., biological, cognitive) which characterise the perinatal period, our results are theoretically important in confirming this link in a perinatal sample. third, by indicating that worry is a modifiable psychological risk factor in pregnancy, our findings have clinical promise. as noted earlier, the treatment of perinatal anxiety has received limited research attention. further, the treatments that have been developed are primarily generic such that they are comprised of standard cbt techniques, includ­ ing challenging cognitions by generating alternative interpretations (e.g., forsell et al., 2017; see moulds et al., 2018). in contrast, cbm-i seeks to enhance access to positive interpretations in a more direct, automatic way. our findings suggest that developing novel approaches which draw on experimental findings and directly target factors that have been identified to maintain anxiety (e.g., worry) to potentially supplement existing treatment approaches may be a promising future clinical direction. moreover, our findings speak to the issue of prevention. given growing evidence that antenatal rnt predicts perinatal mental health problems (dejong et al., 2016; schmidt et al., 2016), the prospect of reducing worry in pregnant women by targeting interpretation bias represents an exciting possibility for preventing postpartum anxiety. topper et al. (2017) found that that a preventive intervention which targeted rnt reduced the onset of depression and anxiety 12 months later. our finding that antenatal worry is a modifiable risk factor similarly raises the possibility that an intervention targeting worry may also have utility in preventing subsequent mental health problems in the postnatal period. we acknowledge some limitations and suggest future research directions. first, while single-session cbm experiments critically advance understanding of theoretical mecha­ nisms, they do not provide sufficient evidence regarding the sustained consequences of targeting interpretation bias in this way (hirsch et al., 2018). however, we note that recent studies using multiple cbm-i sessions (e.g., 10 internet-delivered sessions) have reported encouraging preliminary evidence of the longevity of effects (i.e., reductions in rnt at one-month follow-up; hirsch et al., 2018; hirsch, krahé, whyte, bridge, et al., 2020). future research employing multiple sessions with an extended follow-up period is needed before conclusions can be drawn about potential clinical benefit and preventive utility in the perinatal context. second, we did not gather detailed information about previous numbers of miscarriages or complications in participants’ current (or any hirsch, meeten, newby et al. 11 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ previous) pregnancy, leaving it unknown whether our findings generalise to pregnant women who have experienced pregnancy loss or complications in participants’ current (or any previous) pregnancy. third, we did not assess interpretation bias or the presence of negative intrusions pre-training, and thus do not know whether groups differed at the outset. however, participants were randomised to condition by a researcher outside of the study team, making these possible explanations for the results unlikely. fourth, randomisation led to differences in anxiety (gad-7) between groups. finally, due to covid-19 pandemic ruling out completion of data collection, the number of participants was slightly below that recommended in the original sample size calculation. our findings raise interesting possibilities for future research. in a recent fully web­ based study, hirsch, krahé, whyte, krzyzanowski, et al. (2020) reported that cbm-i led to reductions in depression and anxiety, as well as worry and rumination, in partici­ pants with gad with or without comorbid depression. the effects persisted to 3-month follow-up, and notably, were mediated by changes in interpretation bias. these results raise the exciting possibility that cbm-i could form a low intensity intervention to treat or prevent anxiety and worry, with potential for application in the perinatal context. further, given evidence that cbm-i may be effective in modifying interpretation bias in the context of a range of mental health conditions (e.g., depression, hirsch et al., 2018; eating disorders, turton et al., 2018; social anxiety, stevens et al., 2018), another potential research direction could be to investigate the effectiveness of cbm-i for other perinatal psychological symptoms, beyond anxiety. in sum, this study is the first to evaluate the effectiveness of single session cbm-i for reducing worry in pregnant women. our findings provide empirical support for inter­ pretive bias as a mechanism underlying antenatal worry, and thus indicate that worry is a modifiable risk factor during pregnancy. future research with a broader sample warrant investigation (where the current sample were from south london and had not experienced three or more miscarriages) to determine if findings generalise to a more heterogenous sample. furthermore, future research with pregnant women diagnosed with gad is needed to confirm that these results are generalisable to treatment-seeking, clinical samples. nonetheless, given evidence that worry early in pregnancy predicts later anxiety, these data represent an important first step in investigating whether cbm-i holds promise as a therapeutic approach to address perinatal mental health problems. funding: ch receives salary support from the national institute for health research (nihr), mental health biomedical research centre at south london and maudsley nhs foundation trust and king’s college london. acknowledgments: we are very grateful to the pregnant women who took part in the study. competing interests: the authors have declared that no competing interests exist. training positive interpretations in pregnant worriers 12 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the following supplementary materials are available (for access see index of supplementary materials below): • via the open science framework (osf) repository: the preregistration for the study • via the psycharchives repository: supplementary materials (appendices) – appendix a includes: further methodological details of cognitive bias modification for interpretation and the recognition task assessment of interpretation bias – appendix b includes: open science framework pre-registered study protocol index of supplementary materials hirsch, c. r., meeten, f., newby, j. m., o’halloran, s., gordon, c., krzyzanowski, h., & moulds, m. l. 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(2018). modifying a negative interpretation bias for ambiguous social scenarios that depict the risk of rejection in women with anorexia nervosa. journal of affective disorders, 227, 705-712. https://doi.org/10.1016/j.jad.2017.11.089 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. hirsch, meeten, newby et al. 17 clinical psychology in europe 2021, vol. 3(2), article e3781 https://doi.org/10.32872/cpe.3781 https://doi.org/10.1016/j.jad.2017.11.089 https://www.psychopen.eu/ training positive interpretations in pregnant worriers (introduction) method study registration participants sample size measures and materials procedure results questionnaire measures for cbm-i and control conditions assessing the impact of cbm-i on interpretation bias (hypothesis 1) assessing the impact of cbm-i on negative thought intrusions (hypothesis 2) discussion (additional information) funding acknowledgments competing interests supplementary materials references optimizing expectations about endocrine treatment for breast cancer: results of the randomized controlled psy-breast trial research articles optimizing expectations about endocrine treatment for breast cancer: results of the randomized controlled psy-breast trial meike c. shedden-mora ab, yiqi pan a, sarah r. heisig b, pia von blanckenburg c, winfried rief c, isabell witzel d, ute-susann albert e, yvonne nestoriuc abf [a] department of psychosomatic medicine and psychotherapy, university medical center hamburg-eppendorf, hamburg, germany. [b] department of clinical psychology and psychotherapy, hamburg university, hamburg, germany. [c] department of clinical psychology and psychotherapy, philipps-university of marburg, marburg, germany. [d] department of gynecology, university medical center hamburg-eppendorf, hamburg, germany. [e] department of gynecology, university medical center würzburg, würzburg, germany. [f ] department of clinical psychology, helmut schmidt university hamburg, hamburg, germany. clinical psychology in europe, 2020, vol. 2(1), article e2695, https://doi.org/10.32872/cpe.v2i1.2695 received: 2019-06-20 • accepted: 2019-11-05 • published (vor): 2020-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: meike c. shedden-mora, department of psychosomatic medicine and psychotherapy, university medical center hamburg-eppendorf, martinistraße 52, 20246 hamburg, germany. phone: +49-40-7410-54323. fax: +49-40-7410-54975. e-mail: m.shedden-mora@uke.de abstract background: medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients’ expectations. optimizing expectations could minimize side effect burden. this study evaluated whether brief psychological expectation management training (expect) optimizes medication-related expectations in women starting adjuvant endocrine therapy (aet) for breast cancer. method: in a multisite randomized controlled design, 197 women were randomized to expect, supportive therapy (support), or treatment as usual (tau). the three-session cognitivebehavioral expect employs psychoeducation, guided imagery, and side effect management training. outcomes were necessity-concern beliefs about aet, expected side effects, expected coping ability, treatment control expectations, and adherence intention. results: both interventions were well accepted and feasible. patients’ necessity-concern beliefs were optimized in expect compared to both tau and support, d = .41, p < .001; d = .40, p < .001. expected coping ability and treatment control expectations were optimized compared to tau, d = .35, p = .02; d = .42, p < 001, but not to support. adherence intention was optimized compared to support, d = .29, p = .02, but not to tau. expected side effects did not change significantly. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i1.2695&domain=pdf&date_stamp=2020-03-31 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: expectation management effectively and partly specifically (compared to support) modified medication-related expectations in women starting aet. given the influence of expectations on long-term treatment outcome, psychological interventions like expect might provide potential pathways to reduce side effect burden and improve quality of life during medication intake. keywords expectation management, nocebo effect, psychological intervention, side effect, adjuvant endocrine treatment, breast cancer, oncology highlights • expectation management (expect) optimizes expectations prior to endocrine therapy for breast cancer. • expect improved necessity-concern beliefs, coping and control expectations and adherence intention. • expect was partly more effective than the supportive therapy control condition. • expectation management provides a pathway to reduce side effect burden during long-term medication. medication side effects are substantially determined by mechanisms which are not di‐ rectly attributable to the pharmacodynamics of the treatment. these non-specific side effects are well-known from the nocebo phenomenon which manifests itself when ad‐ verse effects occur after placebo intake (barsky, saintfort, rogers, & borus, 2002). nocebo effects may also emerge as part of routine treatments. hence, non-specific medication side effects might aggravate the impact of specific side effects (rief, bingel, schedlowski, & enck, 2011). nocebo-related side effects are predominantly determined by psychological mech‐ anisms, most relevantly patients’ expectations (webster, weinman, & rubin, 2016). expectations are influenced by treatment information, social observation, and other learning processes through negative experiences with prior medication intake (colloca & miller, 2011). analogous to expecting treatment benefits, patients also develop expecta‐ tions about potential adverse events (laferton, kube, salzmann, auer, & shedden-mora, 2017), and form beliefs about their medication’s necessity and possible concerns (horne, weinman, & hankins, 1999). these side effect expectations and medication beliefs are linked to the actual occurrence of side effects of cancer treatments (colagiuri & zachariae, 2010; nestoriuc et al., 2016), and other therapies (faasse & petrie, 2013; nestoriuc, orav, liang, horne, & barsky, 2010). importantly, side effect expectations and medication beliefs not only predict long-term quality of life, but also medication non-adherence (horne et al., 2013; nestoriuc et al., 2016; pan et al., 2018). optimizing expectations about cancer treatment 2 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ as expectations are potentially modifiable factors, optimizing patients’ treatment expectations has been put forward as a novel strategy to improve treatment outcome and minimize side effect burden (bingel, 2014; heisig, shedden-mora, hidalgo, & nestoriuc, 2015; laferton et al., 2017; nestoriuc et al., 2016). first evidence from experimental studies suggests that psychological expectation management can effectively improve par‐ ticipants’ expectations regarding anti-cancer treatments (heisig, shedden-mora, hidalgo, & nestoriuc, 2015), reduce pain (peerdeman et al., 2016) and even reverse nocebo effects (bartels et al., 2017). to date, the psy-heart-trial (rief et al., 2017) showed that brief expectation management prior to open-heart surgery successfully changes expectations (laferton, auer, shedden-mora, moosdorf, & rief, 2016), improves long-term disability, quality of life and reduces the length of hospital stay (auer et al., 2017). this study employs expectation management in patients undergoing adjuvant en‐ docrine therapy (aet) for breast cancer. aet is the state-of-the-art treatment for hor‐ mone-receptor-positive breast cancer. intake for at least five years improves disease-free survival and time to recurrence (burstein et al., 2014). despite its proven clinical efficacy, non-adherence rates ranging from 28% to 73% within the 5-year intake period have been reported (murphy, bartholomew, carpentier, bluethmann, & vernon, 2012). as low adherence is associated with poorer survival (hershman et al., 2011), ensuring patients’ adherence is crucial. side effects such as arthralgia, hot flushes, weight gain, and loss of libido can substantially reduce quality of life (cella & fallowfield, 2008) and cause treatment discontinuation (demissie, silliman, & lash, 2001). side effects occur related to the specific pharmacodynamics of aet (e.g., hot flushes are caused by the deprivation of estrogen), but can also be treatment-unrelated (e.g., dizziness) (gibson, lawrence, dawson, & bliss, 2009). relevantly, side effect expectations predict the actual occurrence of cancer treatment side effects (colagiuri & zachariae, 2010), long-term quality of life, and non-adherence in aet (nestoriuc et al., 2016; pan et al., 2018). the aim of this study was to evaluate whether a three-session psychological ex‐ pectation management training (expect; von blanckenburg, schuricht, albert, rief, & nestoriuc, 2013; von blanckenburg et al., 2015) optimizes patients’ aet-related expecta‐ tions when starting aet. this study reports the preto post-intervention change of expectations of the psy-breast trial (expectation-focused psychological pre-treatment intervention to improve outcome in breast cancer treatment). expect was compared to a psychological control intervention (supportive therapy, support), and treatment as usual (tau). it is hypothesized that expect but not support and tau improves expectations regarding the prescribed aet medication and its side effects, the expected ability to cope with potential side effects, and treatment control expectations. secondly, it is hypothesized that only expect improves the intention to adhere to aet. shedden-mora, pan, heisig et al. 3 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ m e t h o d study design this was a three-arm multisite (two centers with four clinics), randomized controlled tri‐ al. it was registered at clinicaltrials.gov (nct01741883). ethical approval was obtained from the respective local ethics committees (marburg, hamburg). outcomes for this analysis were compared between baseline and post-intervention (figure 1). a detailed de‐ scription of the design is provided in the study protocol (von blanckenburg et al., 2013). after study inclusion, patients were randomly assigned to receive expect, support, or tau. treatment as usual (tau) in all groups consisted of the general guideline-based oncologic regime in the certified breast cancer centers, usually surgery and radiation, followed by adjuvant endocrine treatment with tamoxifen or third-generation aromatase inhibitors (kreienberg et al., 2012). the decision of the type of aet mainly depended on the women’s menopausal status. all patients were offered one session basic psycho-on‐ cological support by a trained psycho-oncologist of the hospital staff. after discharge, patients were treated in an outpatient setting by a gynecologist, general practitioner, and if desired, a psycho-oncologist with up to 12 sessions. patients were allocated in a 1:1:1 ratio stratified according to the hospital anxiety and depression scale (sum score ≤13 vs. >13) and type of medication (aromatase inhibitor vs. tamoxifen). participant enrollment data were collected between november 2012 and may 2015 at the philipps university of marburg and the university medical center hamburg-eppendorf, germany. patients were recruited post-surgery during their hospital stay. included were women aged 18-80 years, with hormone-receptor-positive breast cancer or ductal carcinoma in situ to whom first-line adjuvant endocrine treatment with tamoxifen or third generation aromatase inhibitors was prescribed. further inclusion criteria were the ability to give informed consent and sufficient german language skills. exclusion criteria were advanced breast cancer, the presence of any other cancer or comorbid somatic illness causing predomi‐ nant disability, severe psychiatric illness (e.g., psychosis, checked by structured psychiat‐ ric interview, mini-dips), and adjuvant chemotherapy. after providing written informed consent, all patients received a medication infor‐ mation leaflet accompanied by an oral briefing by trained research assistants. this previously validated information illustrated the mode of action, the desired effects, and potential side effects of aet in order to homogenize knowledge (heisig, shedden-mora, von blanckenburg, et al., 2015). the information briefing was followed by baseline assessment and randomization. outcome assessors (trained research assistants) were blinded to group allocation throughout the study. for this analysis, the sample of n = 197 patients will allow the detection of small effect sizes, f(v) = .11, with 80% power and α = .05. optimizing expectations about cancer treatment 4 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ psychological interventions patients received three individual weekly or bi-weekly treatment sessions of 50-75-mi‐ nutes by a clinical psychologist, followed by up to three 15-minutes booster phone calls at one, three, and six months. a detailed description of the interventions can be found in the study protocol (von blanckenburg et al., 2013) and case report (von blanckenburg et al., 2015). all therapists received regular supervision by experienced psycho-oncologists. therapist allegiance evaluated via video ratings was considered as high (appendix). expect – expectation management training expect is based on cognitive-behavioral therapy and aims to prevent nocebo-related side effects from aet by optimizing treatment-related expectations. the focus on side ef‐ fects is counterbalanced by therapeutic work towards strengthening beliefs of treatment control, benefit, and necessity. expect is manualized; however, topics are adapted to the patient’s individual expectations using a personalized intervention booklet. the three sessions have the following goals and topics: session 1. psychoeducation about aet (mode of action, benefits, potential side effects) is given. the impact of expectations and the nocebo effect are discussed. the aim is to strengthen beliefs about aet’s necessity while keeping concerns at a realistic minimum (heisig, shedden-mora, von blanckenburg, et al., 2015). an imagery exercise guides the patients towards visualizing the expected benefits of aet. session 2. coping strategies for managing the three individually most feared side effects are developed (mann et al., 2012). these include behavioral techniques, cognitive strategies, and management of specific triggers. strategies are summarized in a written problem-solving scheme, and patients are encouraged to create a practical ‘tool-box’. session 3. to strengthen resources for the medication intake period, resourceful activi‐ ties (e.g., gardening) are encouraged. to support defocusing from side effects, attention control strategies are discussed. to enhance effective patient-doctor communication, patients receive a communication skills training. at the end of the session, the tool-box and all previous topics are reviewed. booster calls. the three booster calls aim to provide therapeutic support during the first months of medication intake. patients are encouraged to apply the learned coping strategies for side effects, which are adapted if necessary. supportive therapy (support) supportive therapy was designed as an active psychological control condition to account for general therapeutic factors such as the therapist’s attention and the patient-thera‐ pist relationship (markowitz, manber, & rosen, 2008). it allows distinguishing specific effects of expect from psychological placebo effects. it applies common factors of psychotherapy such as elicitation of affect, empathy, and reflective listening. in contrast to expect, no explicit theoretical framework and no expectation-targeted interventions shedden-mora, pan, heisig et al. 5 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ are provided. each session is structured into three phases: the beginning (inquiring about relevant topics), the therapeutic dialog (encouraging the patient to talk about any theme of affective valence), and the ending (revising addressed themes). the booster calls are conducted analogously to expect, with focus on the patient’s emotional state. assessment patients’ expectations medication-related expectations about aet were assessed using the necessity-concern balance as measured by the beliefs about medicines questionnaire (bmq; horne et al., 1999). a difference score ranging from -4 to 4 is calculated by subtracting the mean expected necessity scale (5 items) from the mean expected concerns scale (6 items) (horne et al., 2013). positive scores indicate stronger necessity beliefs than concerns (≈ functional balance). the mean intensity of 44 expected side effects was assessed using the general assess‐ ment of expected side effects scale (gase-expect; nestoriuc et al., 2016) which measures the expected intensity of 23 general and 21 aet-specific side effects on a 0 (‘not present’) to 3 (‘severe’) scale. the expected ability to cope with the potential 44 expected side effects in case of their presence was assessed on a 1 (‘expect to cope badly’) to 4 (‘expect to cope very well’) scale. treatment control expectation was assessed with the respective item (‘how much do you think your aet can help your breast cancer?’) from the brief illness percep‐ tion questionnaire (b-ipq), ranging from 0 (‘not at all’) to 10 (‘extremely helpful’). (broadbent, petrie, main, & weinman, 2006) adherence intention adherence intention was assessed with the question ‘how certain are you about starting the endocrine therapy?’ rated on a 7-point scale (from 1 ‘very unsure’ to 7 ‘very sure’). sociodemographic and medical variables age, education, and marital status were assessed. medical variables, namely menopausal status, and breast cancer tumor stage were retrieved from the hospitals’ patient records. patients provided information on their prescribed aet and existing medical comorbidi‐ ties. the presence and intensity of 44 current somatic complaints were assessed on a 0 to 3 scale using the gase (rief, barsky, et al., 2011). patients’ evaluation of the intervention patients evaluated the intervention on nine statements rated from 1 (‘do not agree at all’) to 6 (‘fully agree’). the general satisfaction with the intervention, specific components optimizing expectations about cancer treatment 6 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ of expect, and therapeutic components imminent to supportive therapy were assessed. potential adverse events of the interventions were assessed with an open-ended question. treatment fidelity was assessed by asking patients how often they practiced the im‐ agery exercise on one 1 (‘daily’) to 5 (‘not at all’) scaled item. additionally, participation in booster sessions was assessed. therapeutic alliance was rated by patients and therapists after each session with two questions (the intervention has helped me / the patient, the psycho-oncologist un‐ derstands me / the patient felt understood) from 1 (‘do not agree at all’) to 6 (‘fully agree’). data analysis to examine whether expect resulted in improved expectations compared to support and tau, we computed linear mixed models with treatment group, time (prevs. postintervention) and treatment group by time as fixed effects and a random intercept for subject-specific effects with a restricted maximum likelihood estimation and an autoregressive residual matrix. all analyses were adjusted for study site, age, type of aet, breast cancer tumor stage, and physical symptoms (gase) as fixed effects. for the hypothesized treatment group by time interaction, pairwise comparisons were reported. pre-post-tests were performed to indicate improvements within a group. missing values on single items ranged from 0 to 3.5% and were imputed using the em-algorithm. missing data points at post-intervention were estimated within the linear mixed model using the full intention-to-treat sample. effect sizes were calculated as differences in mean growth rates between the groups, divided by the product of standard error by square rooted number of participants in tau (feingold, 2009). significance level for all analyses was set at α = .05. statistical analyses were performed using spss statistics 24. r e s u l t s participant flow of 506 women assessed for eligibility, 271 were eligible for study participation, 197 patients were randomized analyzed as the itt-sample (figure 1). of those, 165 completed post-intervention assessment (83.8%). women who discontinued aet before post-intervention assessment (expect: n = 0; support: n = 4; tau: n = 2), and women who did not start the intervention (expect: n = 5, support: n = 10), but completed post-assessment were included in the analyses to avoid selection bias. fifty-four women (79.4%) in expect and 55 women (80.9%) in support received all three sessions. shedden-mora, pan, heisig et al. 7 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ figure 1 patient flow (consort) note. aet = adjuvant endocrine treatment; tau = treatment as usual; support = supportive therapy; expect = expectation management training. aof n = 203 randomized patients, 6 were identified as non-eligible post-randomization and therefore excluded. baseline characteristics all baseline sociodemographic and clinical characteristics were comparable across the groups (table 1). optimizing expectations about cancer treatment 8 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ table 1 demographic and clinical sample characteristics variable expect (n = 68) support (n = 68) tau (n = 61) comparison f | χ2 p demographics age in years, m (sd) 56.46 (8.92) 58.44 (8.40) 59.64 (10.74) f(2, 197) = 1.92 .15 at least 13 years of education, n (%) 24 (35.8) 28 (41.8) 21 (34.4) χ2(2) = 0.85 .65 married/with partner, n (%) 42 (61.8) 45 (66.2) 36 (59) χ2(2) = 0.72 .70 clinical symptoms peri-/post-menopausal, n (%) 49 (72.1) 53 (77.9) 48 (78.7) χ2(2) = 0.96 .62 tumor stage uicc, n (%) χ2(4) = 3.49 .48 i 41 (60.3) 42 (61.8) 44 (72.1) ii 23 (33.8) 24 (33.8) 16 (26.2) iii 4 (5.9) 2 (2.9) 1 (1.6) type of aet, n (%) χ2(2) = 2.19 .34 tamoxifen 37 (54.4) 35 (51.5) 39 (63.9) aromatase inhibitors 31 (45.6) 33 (48.5) 22 (36.1) medical comorbidities, n (%) χ2(4) = 0.76 .94 0 25 (36.8) 23 (33.8) 19 (31.1) 1 or 2 35 (51.5) 38 (55.9) 36 (59) ≥ 3 8 (11.8) 7 (10.3) 6 (9.8) number of current somatic complaints (gase) m (sd) 11.10 (6.70) 9.34 (6.20) 9.98 (7.11) f(2, 197) = 1.22 .30 range 0 31 0 26 0 29 intensity of current somatic complaints (gase) m (sd) 0.33 (0.24) 0.30 (0.25) 0.31 (0.25) f(2, 197) = 0.32 .73 range 0 3 0 3 0 3 note. expect = expectation management training; support = supportive therapy; tau = treatment as usual; aet = adjuvant endocrine therapy; uicc = union for international cancer control; gase = general assessment of side effects scale. the majority of the women were diagnosed with tumor stage i (64.5%). the most frequent comorbidities were hypertension (32.0%), thyroid diseases (25.9%), and joint or dorsal pain (18.3%). most common baseline somatic symptoms comprised pain or sensitivity of the breast (71.6%), sleeping problems (52.3%), and fatigue (50.5%). changes in patients’ expectations the necessity-concern balance at baseline was rather positive in all groups (table 2). shedden-mora, pan, heisig et al. 9 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ table 2 outcome measures at baseline and post-intervention outcome expect support tau expect vs. tau expect vs. support t p d t p d medication beliefs: necessity-concern balance (bmq; range -4-4) 3.33 < .001 0.43 3.15 < .001 0.40 baseline 0.68 [0.43, 0.93] 0.82 [0.57, 1.06] 0.77 [0.51, 1.04] post-intervention 1.06 [0.79, 1.33] 0.63 [0.36, 0.90] 0.54 [0.27, 0.83] expected side effects, mean intensity (gase-expect; range 0-3) -1.69 .092 -0.22 -0.66 .51 -0.09 baseline 0.56 [0.48, 0.64] 0.50 [0.42, 0.59] 0.47 [0.38, 0.55] post-intervention 0.53 [0.44, 0.62] 0.51 [0.42, 0.60] 0.54 [0.45, 0.63] expected coping ability, mean (gase coping; range 1-4)a 2.45 .015 0.35 1.44 .15 0.21 baseline 3.49 [3.39, 3.58] 3.53 [3.44, 3.63] 3.61 [3.51, 3.72] post-intervention 3.63 [3.53, 3.74] 3.56 [3.46, 3.66] 3.55 [3.44, 3.66] expected treatment control (b-ipq; range 0-10) 3.27 < .001 0.42 1.65 .10 0.21 baseline 7.43 [6.89, 7.98] 7.51 [6.97, 8.05] 7.91 [7.33, 8.48] post-intervention 7.73 [7.14, 8.31] 7.11 [6.53, 7.69] 6.79 [6.18, 7.40] adherence intention (range 1-7) 1.85 .065 0.24 2.27 .024 0.29 baseline 6.05 [5.73, 6.37] 6.37 [6.05, 6.69] 6.32 [5.98, 6.66] post-intervention 6.66 [6.30, 7.01] 6.27 [5.91, 6.62] 6.33 [5.97 -6.70] note. values indicate estimated marginal means [95% ci]. analyses are adjusted for study side, age, type of aet, breast cancer tumor stage, and baseline physical symptoms. statistical comparisons (tand p-values) refer to the pairwise comparisons of the treatment group by time interaction. expect = expectation management training; support = supportive therapy; tau = treatment as usual. asample size for analysis n = 172 (25 patients did not expect any side effects). a significant group by time interaction indicated an improved necessity-concern balance in expect compared to both tau and support, estimated mean difference = 0.61, 95% ci [0.25, 0.98], p = .001; 0.57, 95% ci [0.21, 0.93], p = .002, respectively (figure 2). pre-post within-group comparisons indicated that significant improvements in the necessity-concern balance only occurred in expect but not in tau and support, 0.38, 95% ci [0.13, 0.64], p = .003; -0.23, 95% ci [-0.49, 0.03], p = .085; -0.19, 95% ci [-0.44, 0.07], p = .147. when the scales were analyzed separately, expect showed an increase of necessity beliefs compared to support and in trend to tau, 0.27, 95% ci [0.00, 0.54], p = .049; 0.25, 95% ci [-0.03, 0.53], p = .075, respectively. expect reported a reduction of concerns compared to tau and support, -.37, 95% ci [-.59, -.14], p = .002; -.30, 95% ci [-.53, -.08], p = .008. mean expected side effects at baseline were low. non-significant group by time interac‐ tions indicated that the groups did not differ, expect vs. support: -0.04, 95% ci [-0.16, 0.08], p = .51; vs. tau: -0.11, 95% ci [-0.23, 0.02], p = .092. pre-post comparisons showed no significant change over time in any group. the mean expected ability to cope with potential side effects, which was analyzed for 172 patients who expected at least one of the 44 side effects, was high at baseline. a optimizing expectations about cancer treatment 10 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ significant group by time interaction indicated improved coping expectations in expect compared to tau, but not to support, 0.22, 95% ci [0.04, 0.39], p = .015; 0.12, 95% ci figure 2 expectations at baseline and post-intervention note. values shown are estimated marginal means (error bars: ± 1 standard error) from linear mixed models. tau = treatment as usual, support = supportive therapy, expect = expectation management training. numbers after scale names indicate the range. *p < .05. **p < .01 shedden-mora, pan, heisig et al. 11 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ [-0.05, 0.29], p = .15. pre-post comparisons indicated that coping expectations significant‐ ly improved in expect, but not in tau or support, 0.15, 95% ci [0.03, 0.27], p = .013; -0.07, 95% ci [-0.20, 0.06], p = .30, 0.03, 95% ci [-0.09, 0.15], p = .65. treatment control expectations at baseline were moderately high. a significant group by time interaction indicated that expect developed significantly higher treatment control expectations compared to tau, but not to support, 1.41, 95% ci [0.56, 2.27], p = .001; 0.70, 95% ci [-0.14, 1.54], p = .10. pre-post comparisons indicated that treatment control expectations declined in tau, but did not change in expect or support, -1.12, 95% ci [-1.73, -.51], p < .001; 0.30, 95% ci [-0.30, 0.89], p = .33; -0.40, 95% ci [-1.00, 0.19], p = .18. changes in adherence intention adherence intention at baseline was high (table 2). expect developed a significantly higher intention to adhere to their aet compared to support, and in trend compared to tau, 0.71, 95% ci [0.09, 1.33], p = .024; 0.59, 95% ci [-0.04, 1.22], p = .065 (figure 2). pre-post comparisons indicated that adherence intention significantly increased in expect, but not in tau and support, 0.61, 95% ci [0.17, 1.04], p = .007; 0.01, 95% ci [-0.44, 0.47], p = .96; -0.11, 95% ci [-0.54, 0.33], p = .63, respectively. patients’ evaluation of the intervention the general satisfaction was very high in both groups, while the expect-specific components (e.g., feeling more prepared to face aet side effect) were evaluated more positively in expect (figure 3). support-specific components (e.g., easier to cope with emotions) were evaluated non-significantly better in support. regarding adverse events of the interventions, 14 patients in expect and 13 patients in support reported at least one adverse event. in expect, patients reported: organiza‐ tional issues (4), the number of sessions being too few (4) or too many (1), too much focus on adverse events (2), emotional distress (1), needing more recommendations on coping with side effects (1), and having no need for the intervention (1). in support, patients reported: organizational issues (4), too little focus on aet (3), too much focus on possible adverse events (1), the number of sessions being too few (1), needing more recommendations on coping with side effects (1), emotional distress (1), and wish for being asked more questions (1). regarding treatment fidelity, 39 patients in expect (70.9%, 55 datasets available) practiced their individual protective image developed in the intervention at least once a week. moreover, at least one booster session was taken up by 52 patients (76.5%) in expect and 51 patients (75%) in support. regarding therapeutic alliance, patients in both groups highly agreed that the inter‐ vention had helped them, expect: m (sd) = 5.70 (0.40); support: 5.62 (0.47), and that optimizing expectations about cancer treatment 12 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ they felt understood, 5.43 (0.52); 5.30 (0.61). therapists fully agreed that the intervention might have helped the patient, expect: 5.07 (0.75); support: 4.73 (1.09), and that patients felt understood, 5.27 (0.70); 5.32 (0.61). patient and therapist ratings showed medium correlations across both groups, item help: r = .408, p < .001; item understanding: r = .317, p < .001). d i s c u s s i o n this randomized controlled trial investigated whether a brief expectation-focused psy‐ chological intervention (expect) optimizes patients’ medication-related expectations before starting aet for breast cancer. in summary, patients’ necessity-concern beliefs about aet were significantly optimized in expect as compared to both tau and figure 3 patients’ evaluation of expect and support interventions note. general = general satisfaction with the intervention; expect-specific = specific components of expectation management training; support-specific = therapeutic components imminent to supportive therapy. statistics are between-group comparisons (anovas). *p < .05. **p < .01. shedden-mora, pan, heisig et al. 13 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ support. expected coping with side effects and expected treatment control were sig‐ nificantly optimized compared to tau but not to support. expected adherence was significantly optimized compared to support but not to tau. expected side effects did not change significantly. as predicted, patients receiving expect developed more positive aet-related ex‐ pectations compared to both support and tau. in particular, patients in expect increased their necessity beliefs and reduced their concerns, while necessity-concern beliefs remained unchanged in the other groups. this result is highly relevant given that dysfunctional necessity-concern beliefs are associated to poorer medication adherence (horne et al., 2013), which in turn predicts morbidity and mortality in breast cancer (hershman et al., 2011). the relevance of these changes is underpinned by the increase in adherence intention compared to support and in trend to tau, which is a good predictor of actual adherence (manning & bettencourt, 2011). accordingly, compared to tau, patients receiving expect expected to cope better with possible side effects and had higher expectations that aet could control their illness. to our knowledge, this is the first study investigating expectation change in cancer treatment. our findings are in line with previous evidence from the psy-heart trial targeting expectations prior to cardiac surgery (laferton et al., 2016; rief et al., 2017), an rct addressing illness perceptions after myocardial infarction (broadbent, ellis, thomas, gamble, & petrie, 2009), and experimental pain research (peerdeman et al., 2016). all showed that patients’ expectations can be effectively changed through brief interventions using expectation management, verbal suggestions, imagery, or conditioning. in breast cancer, an acupressure band combined with expectation-enhancing information reduced nausea after chemotherapy in patients with high levels of expected nausea, but the au‐ thors did not report expectation change (roscoe et al., 2010). in our opinion, thoroughly assessing expectation changes is highly relevant to understand how interventions work, and whether postulated etiological mechanisms are actually targeted. while there are effective approaches to support patients in coping with cancer-associated stress, pain, and fatigue (antoni et al., 2009), few directly address coping with side effects of cancer treatment (mann et al., 2012) and target patients’ expectations as a relevant etiological factor. with small to moderate effect sizes, expect was specifically superior to our psy‐ chological control condition (support) in changing medication beliefs and improving adherence intention. in contrast, changes in coping and treatment control expectations did not significantly differ between expect and support. while most effects indicated in the assumed direction, proving superiority to a strong, active control condition like supportive therapy might need larger sample sizes. thus, expect can be considered effective compared to tau and partly superior to support for some of the expectation measures. optimizing expectations about cancer treatment 14 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ contrary to our hypothesis, the mean intensity of expected side effects did not change significantly, for which two aspects might be relevant. firstly, discussing side effects might not actually reduce their expected intensity. importantly, our study shows that the guided therapeutic attention on side effects is not harmful, as might be feared by physicians and patients. this is in line with studies showing that the assessment of side effect expectations does not increase their occurrence (colagiuri et al., 2013). however, we will carefully monitor the occurrence of adverse effects in our trial (von blanckenburg et al., 2013). secondly, ceiling effects due to low baseline side effect expectations might explain the lack of changes. it is possible that our provision of standardized comprehensive information about aet to all patients already lowered side effect expectations (heisig, shedden-mora, von blanckenburg, et al., 2015). with regard to the patients’ evaluation, both interventions were well accepted and perceived as highly helpful, while all expect-specific elements were rated as more achieved in expect. thus, the interventions can be regarded as specific in targeting the aimed mechanism from the patients’ perspective. importantly, the therapeutic alliance from both the patients’ and the therapists’ perspective was perceived as very supportive. few patients experienced adverse events of the intervention, of which most were of organizational nature. two patients in expect feared that the focus on possible adverse events might make them more sensitive to actually experiencing them. while there was no overall increase in side effect expectations in our study, these concerns need to be taken seriously and addressed in nocebo-focused expectation management interventions. taken together, the evaluation shows that both interventions were well accepted and feasible within guideline-based breast cancer care. study limitations the results of this rct need to be interpreted in light of potential limitations. first, while the sample was recruited from four independent sites and resembled a typical early-stage breast cancer sample (burstein et al., 2014; murphy et al., 2012), a sample selection bias due to declining participation or non-initiation of aet might limit generalizability. second, the gase-expect scales need further psychometric evaluation. lastly, larger samples might be needed to detect smaller differences between expect and support. clinical implications in conclusion, this rct is the first study to show that expectations regarding breast can‐ cer treatment can be effectively changed via a brief psychological intervention. expecta‐ tion management proved to be a feasible, well-accepted, effective intervention that was partly superior to the psychological control condition. it could easily be implemented in routine care for women with early-stage breast cancer. shedden-mora, pan, heisig et al. 15 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://www.psychopen.eu/ in this study, certain aspects of expectations such as the necessity-concern balance, coping and treatment control expectations seemed more amenable to change. certainly, more validated assessment methods of patients’ expectations are needed, for which our proposed integrative model of patients’ expectations (laferton et al., 2017) might provide a framework. moreover, patients’ expectations result from a dynamic interaction of cognitive processes and experiences with medication intake (wiech, 2016) and thus might change with the actual experience of aet intake. therefore, investigating expecta‐ tion change more systematically seems worthwhile (heisig, shedden-mora, hidalgo, & nestoriuc, 2015; kube, rief, gollwitzer, & glombiewski, 2018). the long-term effects of these optimized expectations within the psy-breast trial regarding side effect burden, quality of life, and medication adherence (von blanckenburg et al., 2013) will be reported elsewhere. moreover, the course of expectations during long-term aet intake and their impact on the above mentioned outcomes will be repor‐ ted elsewhere. investigating whether expectations and beliefs can be effectively changed through brief interventions is the first important step towards improving long-term outcomes during aet treatment, and allows for analyzing the effects of expectations changes on clinical outcomes. funding: this study was funded by the german research foundation (dfg) (pi: yvonne nestoriuc, ne 1635/2-1) as a subproject of the dfg research unit (for 1328) “expectation and conditioning as basic processes of the placebo and nocebo response: from neurobiology to clinical applications”. competing interests: winfried rief is editor-in-chief of clinical psychology in europe but played no editorial role for this particular article. apart from that, the authors have declared that no competing interests exist. previously presented: this study has been previously presented at the 15th international congress of behavioral medicine; the abstract has been published (shedden-mora et al. (2018). international journal of behavioral medicine, 25(suppl. 1), s182. acknowledgments: the authors thank the staff from the department of gynecology, gynecological endocrinology and oncology, philipps university of marburg, the department of gynecology, university medical center hamburgeppendorf, the breast center at the agaplesion diakonie clinic hamburg and the breast center at the jerusalem hospital hamburg for their support with the patient recruitment. we are grateful to dr. sabine rehahn-sommer (marburg, germany) for her ongoing supervision of the psychological interventions. r e f e r e n c e s antoni, m. h., lechner, s., diaz, a., vargas, s., holley, h., phillips, k., . . . blomberg, b. 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(2013). optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients shedden-mora, pan, heisig et al. 19 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://doi.org/10.1080/08870446.2010.542815 https://doi.org/10.1176/appi.psychotherapy.2008.62.1.67 https://doi.org/10.1007/s10549-012-2114-5 https://doi.org/10.1002/acr.20160 https://doi.org/10.1093/annonc/mdw266 https://doi.org/10.1007/s10549-017-4637-2 https://doi.org/10.1097/j.pain.0000000000000540 https://doi.org/10.1002/pds.2067 https://doi.org/10.1038/clpt.2011.204 https://doi.org/10.1186/s12916-016-0767-3 https://doi.org/10.1016/j.jpainsymman.2009.12.024 https://www.psychopen.eu/ undergoing endocrine therapy: study protocol of a randomized controlled trial. bmc cancer, 13(1), article 426. https://doi.org/10.1186/1471-2407-13-426 von blanckenburg, p., schuricht, f., heisig, s. r., shedden-mora, m. c., rehahn-sommer, s., albert, u.-s., . . . nestoriuc, y. (2015). psychological optimization of expectations to prevent nocebo side effects in breast cancer – 2 case reports. verhaltenstherapie, 25, 219-227. https://doi.org/10.1159/000377711 webster, r. k., weinman, j., & rubin, g. j. (2016). a systematic review of factors that contribute to nocebo effects. health psychology, 35(12), 1334-1355. https://doi.org/10.1037/hea0000416 wiech, k. (2016). deconstructing the sensation of pain: the influence of cognitive processes on pain perception. science, 354(6312), 584-587. https://doi.org/10.1126/science.aaf8934 a p p e n d i x : t h e r a p i s t a l l e g i a n c e video ratings of 46 (of 330 available) randomly selected therapy session videos (14%; 24 of expect, 22 of support equally selected from the three sessions) were performed by two trained inde‐ pendent raters following a standardized protocol. ten specific items for expect and support assessed objective allegiance on a 1 (‘not present’) to 3 (‘strongly present’) rating-scale (e.g., adherence to manual and structure of sessions, therapeutic attitude). overall, the mean ratings (with standard deviations in parenthesis) of treatment allegiance in expect and support were 2.91 (0.11), and 2.98 (0.05). the percentage in which the two raters fully agreed in their rating of a video was 92% for expect and 99% for support. subjective allegiance was rated by the therapist after each session on one item scaled from 1 (‘low’) to 4 (‘high’). the mean subjective allegiance ratings in expect and support were 3.25 (0.78), and 2.94 (0.33). thus, therapist subjective and objective allegiance to the respective manuals can be regarded as high. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. optimizing expectations about cancer treatment 20 clinical psychology in europe 2020, vol.2(1), article e2695 https://doi.org/10.32872/cpe.v2i1.2695 https://doi.org/10.1186/1471-2407-13-426 https://doi.org/10.1159/000377711 https://doi.org/10.1037/hea0000416 https://doi.org/10.1126/science.aaf8934 https://www.psychopen.eu/ optimizing expectations about cancer treatment (introduction) method study design participant enrollment psychological interventions assessment data analysis results participant flow baseline characteristics changes in patients’ expectations changes in adherence intention patients’ evaluation of the intervention discussion study limitations clinical implications (additional information) funding competing interests previously presented acknowledgments references appendix: therapist allegiance the emerging role of clinical pharmacopsychology scientific update and overview the emerging role of clinical pharmacopsychology fiammetta cosci ab, jenny guidi c, elena tomba c, giovanni a. fava cd [a] department of health sciences, university of florence, florence, italy. [b] department of psychiatry & neuropsychology, maastricht university, maastricht, the netherlands. [c] department of psychology, university of bologna, bologna, italy. [d] department of psychiatry, state university of new york at buffalo, buffalo, ny, usa. clinical psychology in europe, 2019, vol. 1(2), article 32158, https://doi.org/10.32872/cpe.v1i2.32158 received: 2018-12-04 • accepted: 2019-01-17 • published (vor): 2019-06-28 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: giovanni a. fava, department of psychology, university of bologna, viale berti pichat, 5 40127 bologna, italy. e-mail: giovanniandrea.fava@unibo.it abstract background: clinical pharmacopsychology is an area of clinical psychology that is concerned with the application of clinimetric methods to the assessment of psychotropic effects of drugs on psychological functioning, and the interaction of such drugs with specific or non-specific treatment ingredients. clinical pharmacopsychology derives its data from observational and controlled studies on clinical populations and refers to the therapeutic use of medical drugs, not to the effects of substances used for other purposes. method: domains and operational settings of clinical pharmacopsychology are illustrated. results: the domains of clinical pharmacopsychology extend over several areas of application which encompass the psychological effects of psychotropic drugs (with particular emphasis on subclinical changes), the characteristics that predict responsiveness to treatment, the vulnerabilities induced by treatment (i.e., side effects, behavioral toxicity, iatrogenic comorbidity), and the interactions between drug therapy and psychological variables. a service for clinical pharmacopsychology is here proposed as an example of the innovative role of clinical psychology in medical settings. conclusion: clinical pharmacopsychology offers a unifying framework for the understanding of clinical phenomena in medical and psychiatric settings. its aim is to provide a comprehensive assessment of the clinical important changes that are concerned with wanted and expected treatment effects; treatment-induced unwanted side effects; and the patient's own personal experience of a change in terms of well-being and/or quality of life. it is now time to practice clinical pharmacopsychology, creating ad hoc services in europe. keywords clinical pharmacopsychology, antidepressant drugs, psychotropic medication, clinical service, psychopharmacology this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i2.32158&domain=pdf&date_stamp=2019-06-28 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • clinical pharmacopsychology assesses the effects of medications on psychological functioning • since clinical psychologists visit medicated patients, a comprehensive clinical evaluation is crucial • vulnerabilities induced by psychotropic drugs are an important area of application of clinical pharmacopsychology the term “pharmacopsychology” was introduced by kraepelin to indicate the effects of medical drugs on psychological functioning (kraepelin, 1892). he thought it was impor‐ tant to describe the psychological changes induced by pharmacotherapy. later, pierre pi‐ chot edited a volume of psychological measurements in psychopharmacology (pichot, 1974) outlining new needs that derived from measuring the changes induced by psycho‐ tropic medications. two categories of instruments were collected by pichot (pichot, 1974) for psychometric measurement in psychopharmacology: self-rating instruments (e.g., the hopkins symptom checklist hscl) (derogatis, lipman, rickels, uhlenmuth, & covi, 1974) and clinician-reported rating scales (e.g., the hamilton depression scale) (hamilton, 1974). over time, experimental pharmacopsychology was also defined, thus contributing to differentiate pharmacopsychology from psychopharmacology and intro‐ ducing psychology into the clinical and psychiatric field (eysenck, 1963; janke, 1983; janke, debus, & erdmann, 2000; janke & netter, 2004; lipton, di mascio, & killam, 1977). the term “clinical pharmacopsychology” has been introduced to indicate the clinical psychology approach to pharmacology (fava, tomba, & bech, 2017). clinical pharmaco‐ psychology was defined as the application of clinimetric methods to the assessment of psychotropic effects of medications, and the interaction of drugs with specific and nonspecific treatment ingredients (fava, tomba, & bech, 2017). it should be differentiated from the approach of experimental psychology to pharmacology, i.e., experimental phar‐ macopsychology. clinical pharmacopsychology derives its data from observational and controlled studies on clinical populations, whereas experimental pharmacopsychology derives its data mainly from the laboratory and does not necessarily involve clinical pop‐ ulations. clinical pharmacopsychology refers to the therapeutic use of medical drugs and should be differentiated from the study of the effects of substances used for other purpo‐ ses (fava, tomba, & bech, 2017). in experimental psychology the distinction between pharmacopsychology and psy‐ chopharmacology is very clear. pharmacopsychology is defined as the use of drugs as tools to discover or explain psychological functions or to detect differences in drug re‐ sponsiveness, mostly in healthy persons serving as models for psychiatric diseases (eysenck, 1963; janke, 1983; janke, debus, & erdmann, 2000) while psychopharmacology the emerging role of clinical pharmacopsychology 2 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ is defined as the discipline investigating psychological effects of drugs usually in clinical groups; it also includes treatment prediction, drug responsiveness and side effects, al‐ ways in the context of clinical investigations (lipton, di mascio, & killam, 1977). an essential characteristic of clinical pharmacopsychology is that it refers to a clini‐ metric, instead of a psychometric, conceptual model. clinimetrics has a set of rules which governs the structure of indices, the choice of component variables, the evaluation of consistency and validity, and differs from classical psychometrics (bech, 2016; fava, tomba, & sonino, 2012; feinstein, 1987). an essential clinimetric requisite for an assess‐ ment method is its discrimination properties (i.e., responsiveness/sensitivity), which means that the tool should be able to detect clinically relevant changes in health status over time (fava, tomba, & bech, 2017). just as important is incremental validity which refers to the unique contribution (or incremental increase) in predictive power associated with a particular assessment procedure in the clinical decision process (fava, rafanelli, & tomba, 2012). we will here describe the most important domains which pertain to clinical pharma‐ copsychology and propose a setting for clinical pharmacopsychology. d o m a i n s o f c l i n i c a l p h a r m a c o p s y c h o l o g y the domains of clinical pharmacopsychology extend over several areas of application which encompass the psychological effects of psychotropic drugs, the characteristics that predict responsiveness to treatment, the vulnerabilities induced by treatment (i.e., side ef‐ fects, behavioral toxicity, iatrogenic comorbidity), and the interactions between drug therapy and psychological variables. psychological effects of psychotropic drugs in 1968, dimascio and shader criticized the tendency “to select, from among the many pharmacologic actions that a drug may possess, a specific effect to consider as the main (therapeutic or beneficial) effect and to describe all others as side-effects” (dimascio & shader, 1968, p. 617). they noted that a drug effect such as sedation or motor stimulation may be considered adverse for one patient, and yet therapeutic and desired for another one. similarly, within the same patient it may be of value at one stage of an illness and adverse at a later stage. in clinical trials, a limited number of symptoms is usually selected to test efficacy and psychological measurements are targeted. these pragmatic needs have limitations since excessive reliance on symptoms that are part of diagnostic criteria of mental disorders (e.g., major depressive disorder and generalized anxiety disorder) has impoverished clini‐ cal assessment. cosci, guidi, tomba, & fava 3 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ indices may be observer-rated or self-rated. while observer-rated methods make full use of the clinical experience and comparison potential of the interviewer, self-rating methods allow a more direct assessment of the patient’s subjective perceptions. for in‐ stance, when the aim is to assess quality of life, research in this area seeks essentially two kinds of information: the functional status of the individual and the patient’s appraisal of their own health. indeed, the subjective perception of health status (e.g., lack of well-be‐ ing, demoralization, difficulties fulfilling personal and family responsibilities) is as valid as that of the clinician in evaluating outcomes (bech, 1990; topp, østergaard, søndergaard, & bech, 2015). the emphasis on patient-reported outcomes, any report coming directly from patients about how they function or feel in relation to a health con‐ dition or its therapy (clancy & collins, 2010), is in line with this conceptualization. an interesting example of standard assessment of psychological effects of antidepres‐ sant drugs can be found in placebo-controlled studies which observed that antidepres‐ sants decrease reactivity to social environment in depressed patients as assessed by the clinical interview for depression (guidi, fava, bech, & paykel, 2011). the decrease may certainly be beneficial in an acute depressive state. however, it is conceivable, even though yet to be adequately investigated, that in a residual phase the same effect may entail apathy (rothschild, raskin, wang, marangell, & fava, 2014). to ascertain this, however, one needs to rate reactivity to environmental stimuli and apathy, something that is omitted in standard clinical trials (guidi et al., 2011; rothschild et al., 2014). fur‐ ther, high sensitivity is required for detecting residual symptomatology, which was found to characterize most of the patients who were judged to be remitted according to the dsm criteria and no longer in need of active treatment (fava, rafanelli, & tomba, 2012). excessive reliance on symptoms that are part of diagnostic criteria of mental disorders (e.g., major depressive disorder, generalized anxiety disorder) does not reflect the broad spectrum of variables that affect clinical presentations: subclinical distress (fava, rafanelli, & tomba, 2012), such as demoralization and irritable mood (fava, cosci, & sonino, 2017), psychological well-being and euthymia (fava & bech, 2016), mental pain (de leon, baca-garcia, & blasco-fontecilla, 2015; verrocchio et al., 2016), social adjust‐ ment (bech, 2005) and neuroticism (tyrer, tyrer, & guo, 2016). likelihood of responsiveness richardson and doster (2014) underscored that, in the process of evidence-based deci‐ sion, one should include: 1. baseline risk of poor outcomes from an index disorder with‐ out treatment, which is important to identify if the treatment produced benefits; 2. re‐ sponsiveness to the treatment option, which is important to verify if remission has been obtained; 3. vulnerability to the adverse effects of treatment, which is important to verify if the treatment triggered an iatrogenic comorbid disorder or if the treatment caused re‐ versible or irreversible side effects. the emerging role of clinical pharmacopsychology 4 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ the likelihood of responsiveness to a certain drug treatment and the clinical charac‐ teristics that predict response are a crucial issue in psychopharmacology, even though, in recent years, excessive emphasis on the treatment of the average patient has decreased interest in these aspects (bech, 2016; fava, 2017; richardson & doster, 2014). while there is a clinical need to have the broadest picture of the effects of a drug, de‐ termination of responsiveness may be based on selected items (bech, 2016). in addition, it has become common practice in clinical trials to quantify the number of participants who, after a pharmacologic and/or psychotherapeutic trial, achieve response or remission according to specific cut-off points of rating scales (guidi et al., 2018). remission can be expressed either as a categorical variable (e.g., present/absent) or as a comparative cate‐ gory (e.g., non-recovered, slightly recovered, moderately recovered, or greatly recovered) which refers to the clinical distance between the current state of the patient and his pretreatment position (bech, 1990). this method of research has limitations and makes diffi‐ cult the translation of the research results into practice. for instance, an improvement ac‐ cording to specific cut-off points of rating scales might not mirror a real clinical improve‐ ment of the patients as it is perceived by the patient or observed by the clinician. in the same vein, many studies are concerned with relapse and recurrence as primary outcome measures, even though adequate criteria are not available for all mental health conditions and clinicians and researchers in clinical psychiatry often confuse response to treatment for full recovery (bech, 1990; fava, 1996). finally, where differentiation according to cogent subgroups is made in clinical trials, a treatment which is helpful on average in the average patient might be ineffective in some patients (i.e., no difference with placebo) and even harmful in someone else (i.e., worse than placebo) (horwitz, hayes-conroy, & singer, 2017; horwitz, singer, makuch, & viscoli, 1996). in this framework, clinimetrics can offer an accurate method to measure responsive‐ ness to a treatment. this method is based on staging an assessment of the longitudinal development and of the longitudinal rollback of mental disorders (cosci & fava, 2013). staging differs from the conventional diagnostic practice in that it does not only define the extent of progression of a disorder at a particular point in time but also where a per‐ son is currently along the continuum of the course of illness. staging defines prodromes (e.g., early symptoms and signs that differ from the acute clinical phase) and residual symptoms (e.g., persistent symptoms and signs despite apparent remission or recovery). more specifically, stage 1 is the prodromal phase -that is the time interval between the onset of prodromal symptoms and the onset of the characteristic manifestations of the fully developed illness (cosci & fava, 2013). after the acute phase (stage 2), it might be difficult to assess whether partial or full remission has occurred, and attenuated symp‐ toms, the so-called residual symptoms, might be observed (stage 3); they are due to parti‐ al persistence of the disorder or an aggravation of a pre-existing abnormal personality trait. stage 4 represents chronicity of the psychiatric disorder (cosci & fava, 2013). cosci, guidi, tomba, & fava 5 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ there appears to be a relationship between residual and prodromal symptoms. detre and jarecki (1971) provided a model defined as the rollback phenomenon: as the illness remits, it progressively recapitulates, albeit in reverse order. certain prodromal symp‐ toms may be overshadowed by the acute manifestations of the disorder, but they persist as residual symptoms and progress to become prodromes of relapse. prodromal symp‐ toms of relapse tend to mirror, in fact, those of the initial episode (cosci & fava, 2013). according to the rollback model, there is also a temporal relationship between the time of development of a disorder and the duration of the phase of recovery. this has several exemplifications in clinics. for instance, the persistence of residual symptoms after an antidepressant treatment administered to treat a major depressive episode represents a risk of relapse which should be considered by clinicians and considered as a partial re‐ sponse to the antidepressant treatment administered (tomba & fava, 2012). assessing side effects evidence based medicine is focused on the potential benefits that therapy may entail as to baseline risk, but it is likely to neglect, in addition to responsiveness, also vulnerabili‐ ties (fava, 2017; richardson & doster, 2014). a rational approach to treatment considers the balance between potential benefits and adverse effects applied to the individual pa‐ tient (fava, 2017; vandenbroucke & psaty, 2008). the achievement of such balance is hin‐ dered by the difficult integration of different sources of information. several side effects of psychotropic medications are transient and may disappear after a few weeks following treatment initiation, but potentially serious adverse events may persist or ensue later. antidepressants’ side effects encompass gastrointestinal symptoms (e.g., nausea, diarrhea, gastric bleeding, dyspepsia), hepatotoxicity, weight gain and meta‐ bolic abnormalities, cardiovascular disturbances (e.g., heart rate, qt interval prolonga‐ tion, hypertension, orthostatic hypotension), genitourinary symptoms (e.g., urinary re‐ tention, incontinence), sexual dysfunction, hyponatremia, osteoporosis and risk of frac‐ tures, bleeding, central nervous system disturbances (e.g., lowering of seizure threshold, extrapyramidal side effects, cognitive disturbances), sweating, sleep disturbances, affec‐ tive disturbances (e.g., apathy, switches, paradoxical effects), ophthalmic manifestations (e.g., glaucoma, cataract) and hyperprolactinemia (carvalho, sharma, brunoni, vieta, & fava, 2016). long-term use of antidepressants such as serotonin selective reuptake inhibitors (ssri) may induce weight gain, after an initial period characterized by reduced appetite, and the increased weight does not necessarily recede upon the drug discontinuation (carvalho et al., 2016). it has been suggested that an increase in exposure to antidepres‐ sants via a multitude of mechanisms may be a driving force for the obesity pandemic (lee, paz-filho, mastronardi, licinio, & wong, 2016). similarly, the prevalence of sexual side effects can be as high as 50-70% among individuals taking ssris and such effects the emerging role of clinical pharmacopsychology 6 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ may persist even after discontinuation (carvalho et al., 2016), the so-called post-ssri sex‐ ual dysfunction (bala, nguyen, & hellstrom, 2018). negative effects may also occur as a result of psychotherapeutic treatment, whether due to technique, patient or therapist variables, or inappropriate use (barlow, gorman, shear, & woods, 2000; linden, 2013; scott & young, 2016). the side effects of psycho‐ therapy are difficult to recognize because of the number of variables involved, including the various stages of the psychotherapeutic process (linden, 2013). targets of assessment have predominantly involved the desired effects of a medica‐ tion while the evaluation of adverse events has been often neglected, although they can be measured via both interviews and self-rated instruments. assessing the side effects that occur with any type of drug treatment requires a careful clinimetric collection of symptoms in addition to medical laboratory and investigational methods. the uku side effect rating scale (lingjærde, ahlfors, bech, dencker, & elgen, 1987) is an example of scale that considerably improved the detection of side effects, because of its comprehen‐ sive nature. for instance, sexual side effects are common and yet are some of the most under-reported adverse effects associated with the use of antidepressants, and a growing body of evidence indicates that such side effects should be monitored by use of specific instruments (balon & segraves, 2008; carvalho et al., 2016). further, karch and lasagna (1975) noted that the history of toxicology reminds us vividly of the lag that often occurs between the first introduction of a drug into humans and the recognition of certain ad‐ verse events from that drug. there is a need to update specific instruments for side ef‐ fects with findings that may derive from case reports and clinical observations. for in‐ stance, the wide range of side effects that may ensue with long-term treatment with sec‐ ond generation antidepressants (carvalho et al., 2016) would require specific methods of investigation. behavioral toxicity in 1968, dimascio and shader provided a conceptual framework for behavioral toxicity of psychotropic drugs and defined behavioral toxicity as the pharmacological actions of a drug that, within the dose range in which it has been found to possess clinical utility, may produce alterations in mood, perceptual, cognitive, and psychomotor functions, which limit the capacity of the individual or constitute a hazard to his well-being (dimascio & shader, 1968). in 1980, perl and colleagues pointed out that psychotropic drugs can cause behavioral toxicity through the extension of their primary therapeutic action and/or the onset of secondary actions as well as withdrawal, dependence, and tol‐ erance symptoms (perl, hall, & gardner, 1980). the concept of behavioral toxicity encompasses adverse events that may be limited to the period of drug administration and/or persist long after their discontinuation. any type of psychotropic drug treatment, particularly after long-term use, may increase the risk of experiencing additional psychopathological problems that do not necessarily sub‐ cosci, guidi, tomba, & fava 7 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ side with discontinuation of the drug or of modifying responsiveness to subsequent treat‐ ments (fava, cosci, offidani, & guidi, 2016). these latter phenomena can be subsumed under the rubric of iatrogenic comorbidity (fava et al., 2016). “iatrogenic comorbidity” refers to unfavorable modifications in the course, character‐ istics, and responsiveness of an illness that may be related to treatments administered previously (fava et al., 2016). such vulnerabilities may occur during treatment adminis‐ tration and/or manifest themselves after its discontinuation. the changes can be persis‐ tent and not limited to a short phase, such as in the case of withdrawal reactions, and cannot subsume under the generic rubrics of adverse events or side effects. behavioral toxicity may ensue with any type of medical drug. examples related to an‐ tidepressant drug use may be the onset of suicidality and aggression, switching from uni‐ polar to bipolar course, withdrawal phenomena upon discontinuation, post-withdrawal persistent disorders (carvalho et al., 2016; fava et al., 2016). such phenomena require ad‐ equate clinimetric indices for their detection, as the late recognition of withdrawal syn‐ dromes after antidepressant discontinuation teaches (chouinard & chouinard, 2015). behavioral toxicity may apply also to drugs directed to medical conditions (shader, 1972; tisdale & miller, 2010; whitlock, 1981), which may induce depression, anxiety, and other psychiatric symptoms. examples of behavioral toxicity that are concerned with the use of antidepressant drugs encompass switching into mania or hypomania during treatment, both in bipolar disorder (tondo, vázquez, & baldessarini, 2010) and in allegedly unipolar patients (joseph, youngstrom, & soares, 2009; offidani, fava, tomba, & baldessarini, 2013); with‐ drawal symptoms following reduction or discontinuation of antidepressant treatment, in the form of acute withdrawal symptomatology or persistent post-withdrawal disorders (chouinard & chouinard, 2015). such manifestations of behavioral toxicity may be easily misinterpreted as a sign of impending relapse or the need to keep the antidepressant at the same dosage. untreated symptoms may be mild and resolve spontaneously in one to three weeks; in other cases, they may persist for months or even years (chouinard & chouinard, 2015). their prevalence is unknown at the moment, due to their very recent definition. the high prevalence of mental disorders in the general population may also be an effect of the presence of disorders that are a consequence of previous pharmacological treatments (cosci, guidi, balon, & fava, 2015). for instance, much of the refractoriness to treatment of anxious depression may be actually due to persistent post-withdrawal disor‐ ders that are secondary to the use of antidepressant drugs in anxiety disorders (fava & tomba, 2014). all these phenomena may be explained based on the oppositional model of tolerance. continued drug treatment may recruit processes that oppose the initial acute effect of a drug. when drug treatment ends, these processes may operate unopposed, at least for some time and increase vulnerability to relapse (fava & offidani, 2011). the emerging role of clinical pharmacopsychology 8 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ interaction of medical drugs with behavioral variables and psychotherapy each therapeutic act may be a result of multiple ingredients that can be specific or nonspecific: expectations, preferences, motivation, illness behavior and patient-doctor inter‐ actions are examples of variables that may affect treatment outcome (fava, guidi, rafanelli, & rickels, 2017; rickels, 1968; schedlowski, enck, rief, & bingel, 2015). such variables may be the object of study of clinical pharmacopsychology. in 1969, uhlenhuth, lipman, and covi examined the combinations of pharmacothera‐ py and psychotherapy in psychiatric disorders. they outlined four models of interaction: a) addition (i.e., the effects of two interactions combined equals the sum of their individu‐ al effects); b) potentiation (i.e., the effect of two interventions combined is greater than the sum of their individual effects); c) inhibition (i.e., the effect of two interventions com‐ bined is less that each individual effect); d) reciprocation (i.e., the effect of the two inter‐ ventions combined equals the individual effect of the more potent intervention). most of the studies are compatible with the additive and reciprocal concepts of interaction (cuijpers et al., 2014; forand, de rubeis, & amsterdam, 2013; guidi et al., 2018; uhlenhuth et al., 1969). there are, however, some high quality and well-designed individ‐ ual studies suggesting that addition of a benzodiazepine or an antidepressant to cognitive behavioral treatment of anxiety disorders could be detrimental compared to placebo at follow-up (barlow et al., 2000; haug et al., 2003; marks et al., 1993; nordahl et al., 2016), thus indicating an inhibitory effect of the interaction. again, clinical pharmacopsycholo‐ gy could be crucial for disclosing the nature of these relationships. t h e s e t t i n g f o r c l i n i c a l p h a r m a c o p s y c h o l o g y we illustrate here a clinical pharmacopsychology service as an example of an innovative application of clinical psychology in the medical setting. a clinical pharmacopsychology service the service has been operating since 2018 at the department of health sciences, univer‐ sity of florence (florence, italy). this outpatient clinic is addressed to patients who are looking for treatment programs allowing to rationalize, reduce, and discontinue psycho‐ tropic medications. the service is run by an experienced clinical psychologist from the university of florence who has a special interest and training in psychopharmacology, psychotherapy, and psychosomatic medicine. the outpatient facility is open one day a week with space for a maximum of eight patients and at least one hour dedicated to each patient. the clinical psychologist works jointly with two psychologists (providing psycho‐ therapy) and two consultants (one internist and one psychiatrist with a strong back‐ cosci, guidi, tomba, & fava 9 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ ground in psychopharmacology). the clinical psychologist makes the initial assessment and monitors treatment choices. team members work in close coordination, with re‐ peated assessments and sequential combination of treatments (fava, park, & dubovsky, 2008). the main source of referral is the webpage1 of the service that was created to dissem‐ inate knowledge on the clinical phenomenon of withdrawal after discontinuation of anti‐ depressants. usually, the patients already looked for an aide in their environment (e.g., the psychiatrist or the general practitioner who prescribed the medication) without suc‐ cess before asking for an aide at the service. the first visit at the service is conducted as follows, although the order of the sched‐ ule could be changed as required: • complete history of psychiatric/psychological aspects according to the principles of macro-analysis (see below); • formulation of the case, also on the basis of clinimetric tools (fava, tomba, & sonino, 2012, fava, rafanelli, & tomba, 2012), staging (cosci & fava, 2013), subtyping of diagnostic categories (see below); • in addition to psychiatric diagnoses according to the dsm, the patient is evaluated via the diagnostic clinical interview for drug withdrawal 1 (did-w1) (cosci, chouinard, chouinard, & fava, 2018) and the discontinuation-emergent signs and symptoms (dess) (rosenbaum, fava, hoog, ascroft, & krebs, 1998) (see below); • the clinical psychologist goes over the patient’s documents and previous workup; • appraisal of the present situation, based on all findings (including answers to the didw1 and the dess) and patient education; • discussion of treatment choices and prescriptions. the diagnostic clinical interview for drug withdrawal 1 (did-w1) – new symptoms of selective serotonin reuptake inhibitors (ssri) or serotonin norepinephrine reuptake in‐ hibitors (snri) is a semi-structured interview assessing withdrawal syndromes according to chouinard’s diagnostic criteria (cosci et al., 2018). such criteria identify three different withdrawal syndromes: new withdrawal symptoms, rebound syndrome, and persistent post-withdrawal disorder. the discontinuation-emergent signs and symptoms (dess) is a self-administered checklist of signs and symptoms which might occur after the discon‐ tinuation of ssri. we will give an exemplification of this approach with the following case. the case of miss x. in order to illustrate, in practice, the activities at the service of pharmacopsychology, we present a clinical case. 1) https://www.smettereglipsicofarmaci.unifi.it/changelang-eng.html the emerging role of clinical pharmacopsychology 10 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.smettereglipsicofarmaci.unifi.it/changelang-eng.html https://www.psychopen.eu/ miss x. came to our attention after having been visited by several psychiatrists who suggested she should maintain paroxetine, which had been prescribed 10 years earlier for a panic disorder diagnosis. she received this suggestion each time she tried to reduce pa‐ roxetine and had the occurrence of anxiety, panic attacks, and depressed mood. at first visit, the patient did not satisfy dsm diagnostic criteria for psychiatric disor‐ ders. she was strongly determined to reduce paroxetine for the following reasons: she gained about 10 kilograms of weight in 10 years, she had dampened sexual desire, she had mild hyperglycaemia and she did not want to live with paroxetine any longer. the clinical psychologist performed the macro-analysis (fava & tomba, 2014; tomba & fava, 2012), which allows to establish a relationship between co-occurring syndromes and problems based on where treatment should begin in the first place and assuming that there are functional relationships among problematic areas and that the targets of treat‐ ment may vary during the course of disturbances. for miss x., the problematic areas were: past attempts to reduce paroxetine which invariably produced the reappraisal of anxiety, panic attacks, depressed mood, and failure to discontinue paroxetine weight gain; hyperglycaemia and sexual dysfunction. thereafter, microanalysis, a detailed analysis of symptoms for functional assessment (emmelkamp, bouman, & scholing, 1993), was performed. it requires consideration of the onset of complaints, their course, circumstances that aggravate or ameliorate symptoms, short-term and long-term impact of symptoms on quality of life, and work and social ad‐ justment (emmelkamp et al., 1993), and may include specific tests and rating scales (bech, 1993) which must be integrated into the rest of the assessment and not viewed in isolation (emmelkamp et al., 1993). in the framework of the micro-analysis, both dess and did-w1 were proposed to miss x. the dess did not provide additional information. the did-w1 disclosed that the patient met the criteria for past rebound syndrome. thus, the problematic areas in the macro-analysis were updated as follows: past attempts to re‐ duce paroxetine which failed; lifetime rebound syndromes; weight gain; hyperglycaemia and sexual dysfunction. on the basis of the macroand the micro-analysis, the clinical psychologist asked for the consultation of the internist and the psychiatrist. it was decided to taper and discon‐ tinue paroxetine. the aim was to limit weight gain, help to normalize the hyperglycae‐ mia (probably due to an excessive intake of carbohydrates) and verify whether paroxe‐ tine discontinuation improved sexual dysfunction. the clinician deferred to a second stage assessment the determination of whether paroxetine reduction triggers a with‐ drawal syndrome (chouinard & chouinard, 2015). at a second visit, which occurred eight days later and seven days after the reduction of paroxetine from 40 mg to 35 mg daily, miss x. presented also anxiety and mood swings. the clinical psychologist ran again the macroand micro-analysis, administered again did-w1 and dess and updated the problematic areas as follows: past attempts to reduce paroxetine which failed; lifetime rebound syndromes; weight gain; hyperglycae‐ cosci, guidi, tomba, & fava 11 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ mia; sexual dysfunction; current rebound syndrome characterized by anxiety and mood swings. via the diagnosis of rebound syndrome the clinician was able to subtype and dif‐ ferentiate within the broader diagnostic entity of withdrawal syndrome. at re-assess‐ ment, the clinical reasoning was also used and let the clinical psychologist go through a series of “transfer stations” where potential connections between presenting symptoms and pathophysiological process are drawn (feinstein, 1973). based on the re-assessment as well as on the clinical reasoning, the clinical psychologist proposed miss x. the psy‐ chotherapeutic management suggested by fava and belaise (2018). accomplishments and shortcomings in brief, the assessment provided to patients incorporates variables such as type and du‐ ration of psychotropic medication treatment, patterns of symptoms, stage of illness, co‐ morbid conditions, timing of phenomena, responses to previous attempts to discontinue, and other clinical distinctions that demarcate major prognostic and therapeutic differen‐ ces among patients who otherwise seem to be deceptively similar since they share the same diagnosis and the same drug treatment. such variables are filtered by the clinical judgment (fava & tomba, 2014; tomba & fava, 2012) which provides the following as‐ sessment strategies: the use of diagnostic transfer stations instead of diagnostic end‐ points using repeated assessments, subtyping versus integration of different diagnostic categories, staging, macroand micro-analysis (fava, rafanelli, & tomba, 2012). during the treatment path, patients are reassessed after the first line of treatment has been com‐ pleted to reconfirm the diagnosis and refine the treatment plan. this service fills gaps that are left with ordinary psychiatric care, and provides a com‐ prehensive assessment which goes beyond the dsm and includes clinimetric tools. of course, difficulties might emerge from a comprehensive assessment of this kind. at least two main practical issues should be raised. the first is that it is not easy to have these kinds of services as part of the national health system which commonly imposes a time constraint of 15-20 minutes per visit. second, there is an economic load for the na‐ tional health system or for the patient due to the high level of engagement of clinicians. however, if we use a medium/long-term perspective, we may see that the cost is only apparently high since the patients in the majority of cases stop medications and maintain a symptoms-free condition without needing further visits in future years. finally, a potential shortcoming of the service is that it does not cooperate with a lab‐ oratory which monitors drug blood levels which could be related to psychological with‐ drawal or treatment responses. the emerging role of clinical pharmacopsychology 12 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://www.psychopen.eu/ c o n c l u s i o n s clinical pharmacopsychology offers a unifying framework for the understanding of clini‐ cal phenomena in medical and psychiatric settings (fava, tomba, & bech, 2017). its do‐ mains encompass the clinical benefits of psychotropic drugs, the characteristics that pre‐ dict responsiveness to treatment, the vulnerabilities induced by treatment (i.e., side ef‐ fects, behavioral toxicity, iatrogenic comorbidity), and the interactions between drug treatment and psychological variables. its aim is to provide a comprehensive assessment of the clinical important changes that are concerned with wanted and expected treatment effects; 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(1981). adverse psychiatric reactions to modern medication. the australian and new zealand journal of psychiatry, 15(2), 87-103. https://doi.org/10.3109/00048678109159417 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. the emerging role of clinical pharmacopsychology 18 clinical psychology in europe 2019, vol.1(2), article 32158 https://doi.org/10.32872/cpe.v1i2.32158 https://doi.org/10.1111/j.1600-0447.2009.01514.x https://doi.org/10.1159/000376585 https://doi.org/10.1159/000444196 https://doi.org/10.1097/00005053-196901000-00006 https://doi.org/10.1001/jama.2008.723 https://doi.org/10.3389/fpsyt.2016.00108 https://doi.org/10.3109/00048678109159417 https://www.psychopen.eu/ the emerging role of clinical pharmacopsychology (introduction) domains of clinical pharmacopsychology psychological effects of psychotropic drugs likelihood of responsiveness assessing side effects behavioral toxicity interaction of medical drugs with behavioral variables and psychotherapy the setting for clinical pharmacopsychology a clinical pharmacopsychology service the case of miss x. accomplishments and shortcomings conclusions (additional information) funding competing interests acknowledgments references innovations of the icd-11 in the field of autism spectrum disorder: a psychological approach scientific update and overview innovations of the icd-11 in the field of autism spectrum disorder: a psychological approach kirstin greaves-lord 1,2 , david skuse 3,4 , william mandy 4 [1] department of psychology, clinical psychology and experimental psychopathology unit, university of groningen, groningen, the netherlands. [2] autism team north-netherlands, jonx, lentis psychiatric institute, groningen, the netherlands. [3] great ormond street institute of child health, university college london, london, united kingdom. [4] research department of clinical, educational, & health psychology, university college london, london, united kingdom. clinical psychology in europe, 2022, vol. 4(special issue), article e10005, https://doi.org/10.32872/cpe.10005 received: 2022-08-01 • accepted: 2022-11-03 • published (vor): 2022-12-15 handling editor: andreas maercker, university of zurich, zurich, switzerland corresponding author: kirstin greaves-lord, department of psychology, clinical psychology and experimental psychopathology unit, university of groningen, grote kruisstraat 2/1 9712 ts groningen, the netherlands. e-mail: k.greaves-lord@rug.nl related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si abstract background: this article aims to explain and elaborate upon the recently released icd-11 criteria for autism spectrum disorder (asd, world health organization), which endorse a medical model. method: we integrate insights from several disciplines (e.g., psychology, linguistics, sociology and lived experiences) to reflect the scientific and ethical insights derived from the biopsychosocial, neurodiversity perspective on autism. results: first, we describe the core domains of asd’s behavioural characteristics and then the lifetime, developmental perspective on the manifestations of these behaviours. subsequently, we discuss potential underlying neuropsychology, related behaviours (i.e. associated features/ conditions) and we consider some similarities and differences with the diagnostic and statistical manual of mental disorders fifth edition (dsm 5, american psychological association). conclusions: recommendations for clinical application are provided. for instance, diagnostic classification in clinical practise should be a means to provide proper, suitable care, and therefore all diagnostic assessments should be used to tailor interventions and/or care to the capacities and genuine needs of the people that ask for professional help. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10005&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0001-7229-7139 https://orcid.org/0000-0002-7891-5732 https://orcid.org/0000-0002-3564-5808 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords autism spectrum disorder, icd-11, diagnostic process policies highlights • atypical responses to sensory stimuli are included as part of the diagnostic requirements in icd-11, in contrast to icd-10, where unusual sensory processing was not yet considered a core (diagnostic) feature. • in icd-11 it is recognized that some individuals with autism spectrum disorder start to experience distress, impairment and overt social challenges once societal demands increase (e.g., during adolescence or adulthood). • unlike dsm-5, icd-11 does not emphasize the criteria related to disorders of intellectual development (id; such as flipping objects, strong attachment or preoccupation with unusual objects, excessive smelling or touching of objects, echolalia, stimming). c u r r e n t i c d 1 1 d e f i n i t i o n , c r i t e r i a a n d c o n c e p t u a l i s a t i o n s o f a u t i s m s p e c t r u m d i s o r d e r according to the current international system for the classification of diseases 11th revision (icd-11) diagnostic requirements, in order to receive a classification of autism spectrum disorder (asd), a person’s behaviour should be characterised by three essen­ tial features. first, “persistent deficits in the ability to initiate and sustain reciprocal so­ cial interaction and social communication” (world health organization, 2019a). second, by “a range of restricted, repetitive, and inflexible patterns of behaviour, interests or activities that are clearly atypical or excessive for the individual’s age and sociocultural context”. atypical responses to sensory stimuli are now included in this domain, unlike icd-10, where unusual sensory processing was not considered a core (diagnostic) fea­ ture. third, “symptoms should result in significant impairment in personal, family, social, educational, occupational or other important areas of functioning” and, as in previous definitions, the onset should have been during early development. yet, some individuals with asd can function in many contexts through exceptional effort, such that their autistic characteristics are not apparent to others during childhood. icd-11 recognises that overt symptoms are sometimes only fully manifest later, in adolescence or even adulthood, when social demands exceed capacities. consequently, the condition can present clinically at all ages. asd is a “lifelong condition, of which the manifestations and impact are likely to vary according to age [developmental stage], intellectual and language abilities, co-occurring conditions and environmental context”. the icd-11 is an international system for the classification of diseases. as such, it endorses a medical model, conceptualising autism spectrum disorder as a medical condition with an inborn, for a substantial part, genetically inherited nature, while asd in icd-11: a psychological approach 2 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ acknowledging that gene-environment interactions also play a pivotal role in neurode­ velopment (classifying this category in the over-arching category of neurodevelopmental disorders). although most people agree with this conceptualisation of neuro-biological aetiology, amongst a variety of stakeholders, the preference for a biopsychosocial model with more emphasis on how social factors affect functioning and wellbeing, is increasing (bolis et al., 2017; greaves-lord et al., 2022). in such integrative accounts of asd, an au­ tistic person’s difficulties are not seen as simply caused by individual deficits; but rather are understood as arising from a poor fit between, on the one hand, the individual’s characteristics and, on the other hand, the demands placed on them by their environment (mandy, 2022). according to this perspective, autistic symptoms are seen as a form of neurodiversity, and emphasis is placed on promoting functioning and wellbeing via environmental modifications that can improve person-environment fit. in this article, we were invited to describe and reflect upon the recently released icd-11 criteria, therefore, this will be the focus of the paper. yet, in doing so, we will try to integrate insights from several disciplines (e.g., medical, psychological, linguistic, sociological and lived experiences), to reflect the scientific and ethical insights derived from the biopsychosocial, neurodiversity perspective on autism. we will first go into the core domains of asd’s behavioural characteristics. then we will emphasize the lifetime, developmental perspective on the manifestations of these core behaviours. subsequently, we briefly discuss theories on the underlying neuropsychological mechanisms driving the core behaviours. finally, we discuss related behaviours (i.e. associated features/condi­ tions), consider similarities and differences with the diagnostic and statistical manual of mental disorders fifth edition (dsm 5, american psychiatric association, 2013) and make some final remarks for clinical application. s o c i a l c o m m u n i c a t i o n individuals on the autism spectrum display the full range of intellectual functioning and language abilities; nowadays, especially in high-income countries, an asd diagnostic classification is increasingly made in individuals who have normal-range verbal and non-verbal intellectual abilities (e.g., lord et al., 2022; zeidan et al., 2022). the key features of an asd comprise persistent deviations from the norms of social behaviour shown by most non-autistic people, including difficulties with initiating and sustaining social communication and reciprocal social interactions, and responding in a manner considered typical (conventional). whilst there is a normal distribution of such abilities in the general population, people with an asd are “outside the expected range of typical functioning”, when an individual’s age and level of intellectual development are considered (world health organization, 2019a). “specific manifestations will vary according to the individual’s chronological age, verbal and intellectual ability”, and the overall profile of their autistic characteristics (world health organization, 2019a). greaves-lord, skuse, & mandy 3 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ there are, however, a number of key characteristics of interpersonal behaviour that are the essence of the condition. first and foremost, is the difficulty of spontaneously understanding the verbal or non-verbal social communications of other people, together with the tendency not to respond typically (conventionally) to those communications. it should be noted that autistic people and professionals are increasingly aware that many of the social difficulties ascribed to autistic people as simply reflecting their impairments, are better understood as reflecting the challenges of ‘cross-neurotype’ interactions (chen et al., 2021). autistic people may struggle to understand non-autistic people, but also, non-autistic people frequently struggle to empathise with autistic people. people with an asd diagnosis vary in terms of their social motivation, although icd-11 states that there is a tendency for them, compared to non-autistic people, to show less interest in social interactions, and be less likely to pay attention to other people’s verbal and non-verbal social cues. an important nuance to make here, is that although some autistic people show less involvement in social interaction, this might not necessarily be the result of lower social motivation, but rather it may be a consequence of exhaustion from trying to emulate a typical non-autistic style of interaction, known sometimes as camouflaging (e.g., cook et al., 2021; livingston et al., 2019). moreover, there is a critical role of early communicative experiences in the development of individuals’ attention towards other people’s verbal and non-verbal social communication cues (vernetti et al., 2018). “children vary widely in the age at which they first acquire spoken language and the pace at which their speech and language become firmly established” (world health organization, 2019a). most children with early language delay eventually acquire similar language skills to their same-aged peers. early language delay alone is not strongly indicative of asd, unless there is also evidence of limited motivation to engage in social communication and of atypical social interaction skills (world health organization, 2019a). an essential feature of asd is persistent atypicality in how language is used and understood for social communication. people with an asd typically do not follow non-autistic norms (conventions) in how they integrate their spoken language with complementary non-verbal cues, such as (considered) appropriate eye-contact, gestures, facial expressions, nodding in agreement, or other demonstrations of acknowledgement. compared to non-autistic people, they are less likely to use body language to share a perspective, such as pointing to express interest in a distant object, or sharing attention in some external event or object. there is usually reduced tendency to initiate, join, or to sustain a conventional back-and-forth social conversation, which has its origins in early childhood. in general, people with an asd have difficulty understanding and using language in social contexts that are dominated by non-autistic people, and are less likely to initiate and sustain reciprocal, purely social conversations (especially ‘chat’). the pragmatic language difficulties that are typical of asd can manifest as misunderstand­ ings of others’ language due to literal interpretations, together with speech that lacks asd in icd-11: a psychological approach 4 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ ‘normal’ (i.e., non-autistic) prosody and emotional expressiveness, sometimes with a distinctly monotonous tone of voice, or contrastingly, with exaggerative expressiveness. some autistic people are unaware that, to non-autistic people, their use of language sounds atypical, and may talk with such precision that it is considered pedantic, together with the use of an arcane vocabulary. in isolation, atypical language of this nature is only indicative; the diagnostic classification of an asd requires there to be broad range of additional social reciprocity difficulties, as well as tendency towards inflexible behaviour and sensory sensitivities (see below). in the context of social relationships with non-autistic people, especially with unfa­ miliar individuals, there can be limited social awareness, which can lead to behaviour that is not appropriately modulated according to the social context. although people with asd are often characterised as ‘lacking empathy’, the evidence for diminished empathic capacity in typical asd is not strong. some research shows altered affective empathy (e.g., mazza et al., 2014), but, especially in cognitively able individuals, cognitive empathy can usually be present, although there may be an altered processing speed (i.e. due to a local rather than a global processing style, information is processed somewhat slower, but in more detail; bölte et al., 2007). according to clinical observations of autistic adults, the empathic response may be over-developed (i.e., the tendency to expe­ rience high levels of emotional contagion). moreover, whilst someone with asd may not obviously be conventionally responsive to a non-autistic person’s feelings, autistic adults often explain their atypical reaction reflects a state of anxious confusion and/or indecision, rather than unawareness or disinterest. compared to non-autistic people, those with asd are less likely to spontaneously share their interests with others, and may assume that others do spontaneously share their own interests and point of view (without the need to explicitly ask them). given that in social life, non-autistic people are often highly intolerant of even small devia­ tions from social norms, this can lead to challenges making and sustaining typical peer relationships. the impact of such peer problems changes from early childhood to adoles­ cence. intimate friendships with peers become more significant during adolescence, and difficulties building such relationships often become more overt at that time (e.g., mandy, 2022). isolation from or rejection by peers will usually have secondary consequences in terms of impaired mental health (e.g. social anxiety, depression or even trauma). genuine pervasive lack of interest in making peer relationships is rare. clinically, it is important to be aware that a young person’s withdrawal from social interactions may reflect social anxiety, and could be the result of persistent lack of acceptance by a peer majority non-autistic group. furthermore, peer victimisation is a common experience for autistic people, and clinical assessment should always explore whether bullying is occurring, how it can be stopped, and its impact on the individual. also, non-autistic individuals “vary in the pace and extent to which they acquire and master skills of reciprocal social interaction and social communication” (world health greaves-lord, skuse, & mandy 5 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ organization, 2019a). a diagnosis of asd should only be considered if there is marked and persistent difference from the expected range of abilities and behaviours in these domains given the individual’s age, level of intellectual functioning, and sociocultural context. some individuals may exhibit limited/altered social interaction due to shyness (i.e., feelings of awkwardness or fear in new situations or with unfamiliar people, due to anxiety about negative social judgement), behavioural inhibition (i.e., being slow to approach or to ‘warm up’ to new people and situations) or behavioural disinhibition (i.e. impulsiveness). limited social interactions in shy or behaviourally (dis)inhibited children, adolescents, or adults are not indicative of asd. shyness is differentiated from asd by evidence of typical, non-autistic social communication behaviours in familiar situations (world health organization, 2019a). r e p e t i t i v e , s t e r e o t y p e d b e h a v i o u r s a n d s e n s o r y   i n t e r e s t s “many children go through phases of repetitive play and highly focused interests as a part of typical development. unless there is also evidence of impaired reciprocal social interaction and social communication, patterns of behaviour characterized by repetition, routine, or restricted interests are not by themselves indicative of autism spectrum disorder” (world health organization, 2019a). clinically significant evidence requires persistent “restricted, repetitive, and inflexible patterns of behaviour, interests, or activ­ ities that are clearly atypical and excessive for the individual’s age and sociocultural context” (world health organization, 2019a). typically, children with asd are slower and/or less able to adapt to new experiences and circumstances. strong reactions (often one of acute anxiety, distress and/or anger) can be evoked by changes to a familiar environment that, to non-autistic people, seem trivial, or in response to unanticipated events. characteristic of the response to such unwelcome change and uncertainty is extreme discomfort which manifests in childhood as acute distress. this resistance to change also commonly manifests as the tendency to strongly adhere to particular routines. these may be geographic, such as the need to follow familiar routes, or may require precise timing, such as during mealtimes or when travelling. the tendency to engage in restricted and repetitive behaviours persists over time, although its frequency and overtness may diminish during adolescence. in contrast, insistence on ‘sameness’, can become more prominent in later life. other aspects of this underlying need for consistency and predictability can be observed in terms of unusually strong adherence to rules (e.g., when playing games), as well as marked “and persistent ritualized patterns of behaviour (e.g., a preoccupation with lining up or sorting objects in a particular way” (world health organization, 2019a) or analysing/systemizing all sorts of information). historically, such behaviours have been dismissed by non-autistic people as serving no apparent external purpose, but recent qualitative research with verbally asd in icd-11: a psychological approach 6 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ fluent autistic individuals has revealed that the actions of organizing and systemizing can serve to regulate arousal. thus, as their internal tension builds up, (e.g., in response to increasing social demands) an autistic person might start organizing or performing some systemic routine, in order to calm down (greaves-lord et al., 2022). specific repetitive or stereotyped behaviours will differ according to the developmen­ tal stage of the individual, but the tendency is usually life-long. in contrast, “repetitive and stereotyped motor movements, such as whole-body movements (e.g., rocking), atyp­ ical gait (e.g., walking on tiptoes), unusual hand or finger movements and posturing” (world health organization, 2019a), are more likely to be observed during childhood and are seen in situations of distress and excitement (i.e. hyperaoursal, see below). such behaviours can also persist into adulthood, especially in autistic people with a co-occurring intellectual disability (abbreviated: id). many individuals with an asd develop fascinations with specific topics, objects or activities. in icd-11, these are characterised as persistent preoccupations “with one or more special interests, parts of objects, or specific types of stimuli (including media), or an unusually strong attachment to particular objects (excluding typical comforters)” (world health organization, 2019a). the range of special interests is wide, and they may change from time to time during development. a key feature of the intensity of the special interests that are typical of asd, is their pervasiveness and the fact that they disrupt an individual’s ability to conform to conventional norms within a social setting, to some extent. for example, everyday life may be adversely influenced by the need to pursue those interests. in childhood, this could have a negative impact on the family, as could the intense attachment to favoured objects (e.g., because of the distress engendered by their being left behind or lost). nevertheless, it is important to recognise that these fascinations often enrich autistic peoples’ lives, with positive effects on identity and mood. furthermore, such fascinations can engender skill and expertise that is valued in wider society. the most recent addition to the diagnostic rubric of asd symptoms (i.e., a change from icd 10 to icd 11) is the presence of lifelong strong and persistent hypersensitivi­ ty and/or hyposensitivity to sensory stimuli. sensory sensitivities can include unusual interests in certain sensory stimuli, which may include sounds, light, textures (especially clothing and food), odours and tastes. although a strong interest in spinning objects is often illustrated in assessment tool as characteristic of asd, this clear exemplar of autistic behaviour is mainly observed in individuals with id and delayed social-emotion­ al development. a positive interest in sensory stimuli is less common than negative reactions to such stimuli, but a strong negative reaction to everyday sensory stimuli can be upsetting for the autistic person and also disruptive of family life. these typically include sensitivities to sounds, especially white noise such as hand dryers or vacuum cleaners. the sounds may not be especially loud; these reactions are most frequently observed in childhood. other negative reactions can be observed to bright lights, certain greaves-lord, skuse, & mandy 7 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ clothing textures including labels, and especially food textures. negative reactions to textures in food typically include the avoidance of mixed textures, requiring strict food separation. although such behaviours are not exclusively observed in asd, their severity and persistence, together with the consequent impact on everyday life, are more typical of asd. l i f e c o u r s e p e r s p e c t i v e a n d a d v i c e o n   a s s e s s m e n t when individuals with suspected asd present in adolescence or in adulthood, it is essential to perform an interview on developmental history, and not to rely exclusive­ ly on self-report or observations of current behaviour, however well-structured the observation. this is because one prerequisite for the diagnostic classification (although deliberately formulated in a nuanced way) is evidence that the onset of the atypical behaviours occurred during the early developmental period, typically toddlerhood/child­ hood (i.e., pre-school/primary school). in contrast to icd-10, in icd-11 there is no longer the requirement of history of delayed onset of language, or clear evidence of autistic symptoms before/around the age of four to five years. this change reflects in part the fact that asperger syndrome has been discontinued as a valid diagnosis; typically, individuals with normal-range verbal intelligence do not have delayed onset of language and they have been subsumed into the asd diagnostic rubric. also, it is now recognized that some individuals with asd start to experience distress, impairment and overt social challenges once societal demands increase (during adolescence or adulthood). late onset symptoms of asd and their differential diagnosis from personality disor­ ders in adulthood are still a complex and controversial issue. difficulties in inter-personal functioning (i.e., with understanding others’ perspectives, intimacy and self-regulation) are also characteristic of personality disorders. as we do not conventionally diagnose personality disorder in childhood, clear history of early (preschool) social communica­ tion difficulties, could be a differentiating feature. enquiries should attempt to define exactly when the atypical social behaviours started to occur, but more importantly, under what circumstances. early signs and predictors of later manifest asd, such as a lack of/altered attention to eyes (jones & klin, 2013) and limited facial recognition (eussen et al., 2015)/limited use of facial expressions, should be investigated. at the time our conventional diagnostic instruments were developed, most clinically recognised children with autism were also experiencing generalized developmental delay (i.e., id). plateauing of social communication and language skills and lack of progress in their development characterises many such children. yet the minority had a period of normal development (sometimes including age-typical language skills), but then lost their previously acquired skills, often in the second year of life. such regression can be asd in icd-11: a psychological approach 8 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ rapid, over a period of days or weeks, and usually leads to impaired language and social responsiveness. “loss of previously acquired skills is rarely (spontaneously) observed after 3 years of age” (world health organization, 2019a), but can occur in acquired conditions such as encephalitis. if it occurs after age 3, it is more likely to involve a more generalized loss of cognitive and adaptive skills (including the loss of bowel and bladder control, and impaired sleep), as well as regression of language and social abilities (world health organization, 2019a). in rare cases of spontaneous regression, recovery takes place. this is usually slow (over months or years), and usually requires intensive interdisciplinary care that focusses on restoring the lost skills, including support for the development of speech/conversational, adaptive and regulatory skills. asking and clarifying concrete examples of atypical development is therefore key when performing an interview on developmental history, and especially challenging when done only once the individual and caregivers involved are already older. therefore, training such interviewing skills is essential when educating mental health professionals. in preschool children, indicators of an asd “often include avoidance of mutual eye contact, resistance to (conventional expressions of) physical affection, lack of social imaginary play, language that is delayed in onset, or is precocious” (world health organization, 2019a), but not used for conventional back-and-forth social conversation; social withdrawal, marked fascinations with topics that are sometimes notably unusu­ al, and lack of age-typical social interaction with non-autistic peers, characterized by parallel play or apparent disinterest. “sensory sensitivities to everyday sounds, or to foods, may overshadow the underlying social communication deficits” (world health organization, 2019a). these social characteristics are often first reported by a nursery or other preschool placement where the child’s behaviour is observed to differ significantly from the majority. therefore, obtaining information from such sources (e.g., reports from infant care agencies/pre-school) can be of important additional value when charting the developmental history, especially in older cases. in children with asd without a disorder of intellectual development (or general developmental delay), "social adjustment difficulties outside the home may not be detec­ ted until school entry or adolescence", when atypical social communication all-too-com­ monly leads to peer rejection, bullying and social isolation (world health organization, 2019a). "resistance to engage in unfamiliar experiences and marked reactions to even minor change in routines is typical" (world health organization, 2019a). furthermore, a strikingly strong "focus on detail as well as rigidity of behaviour and thinking" may be present. secondary mental health problems are common, and symptoms of anxiety (i.e. social/specific phobia; e.g. verheij et al., 2015) may become evident at this stage of development (world health organization, 2019a). by adolescence, the capacity to cope with increasing social complexity in peer relationships at a period of ever-more demanding academic expectations is often over­ whelmed. in some autistic individuals, their underlying social communication difficulties greaves-lord, skuse, & mandy 9 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ may be overshadowed by the symptoms of co-occurring mental and behavioural disor­ ders. depressive or anxiety symptoms are often a presenting feature (world health organization, 2019a), and restrictive eating disorders (including anorexia nervosa) be­ come increasingly common in autistic girls at this age. thus, clinicians should be aware of potential underlying asd when performing diagnostic assessment in mental health settings. in adulthood, the capacity for those with asd to cope with complex and fluid cross-neurotype “social relationships can become increasingly challenged, and clinical presentation may occur when social demands overwhelm the capacity to compensate. presenting problems in adulthood may represent reactions to (victimisation and) social isolation” (world health organization, 2019a). also, they may reflect the challenges of planning and organising one’s professional and personal life, and regulating emo­ tions, with less support than was received in childhood and adolescence. compensation strategies may be sufficient to sustain dyadic relationships, but usually come under ex­ cessive strain in more complex group situations. “special interests, and focused attention, may benefit some individuals in education and employment. work environments may have to be tailored to the capacities (and sensitivities) of the individual. a first diagnosis in adulthood may be precipitated by a breakdown in domestic or work relationships” (world health organization, 2019a). as mentioned, if the individual is autistic, there is always history of at least some atypical signs in early childhood social communication and relationships, although this may only become apparent, or interpreted as such, in retrospect. because it is now recognised that asd represents a more intense manifestation of the wide range of behaviours that are observed in the general population, it is critical to consider the impact of those symptoms on everyday life, before making a diagnosis. diagnostic criteria, as outlined above, stipulate that autistic characteristics should “result in significant impairment in personal, family, social, educational, occupational or other important areas of functioning” (world health organization, 2019a; e.g., emotional/phys­ ical wellbeing). some individuals with asd can function well in many contexts, often through exceptional effort on their part, such that their autistic characteristics are ‘cam­ ouflaged’ and are not apparent to others. a diagnosis of asd is still appropriate in such cases, especially when such exceptional effort is no longer achievable due to aging or changing social circumstances, during which the autistic characteristics might become more apparent to others over time. camouflaging is commonly described by autistic people as exhausting and is associated with elevated risk for anxiety, depression and suicidality (cook et al., 2021). asd in icd-11: a psychological approach 10 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ h y p o t h e s i s e d n e u r o p s y c h o l o g i c a l m e c h a n i s m s d r i v i n g t h e c o r e b e h a v i o u r s d e f i n i n g a s d although asd is defined based on behavioural features, several theories exist on the neuropsychological mechanisms hypothetically underlying these behaviours. classically, three main theoretical frameworks explaining underlying neuropsychological function­ ing were presented; theory of mind (tom; e.g., andreou & skrimpa, 2020), executive functioning (ef; e.g., demetriou et al., 2019) and central coherence (cc; e.g., lópez et al., 2008). over time, nuances were made on how these theories each explain particular behavioural aspects of autism (e.g., happé et al., 2006). more recently, theories have been proposed that combine, integrate and extend these theories, e.g. the predictive coding account (pc; e.g., van de cruys et al., 2014) and the polyvagal theory (pt; e.g., brown, 2020). given the scope of this article, we cannot go into detail on all these accounts, nor can we mention the abundant literature. however, we will briefly explain these theories and illustrate them with examples of behaviours seen in autistic people, so that clinical psychologists can a) better understand what mechanisms might be driving certain behaviours, and b) use this to increase the understanding of autistic people they support. firstly, tom refers to the ability to formulate hypotheses on how other people feel, think and thus behave; i.e. mentalizing. autistic people might sometimes respond differ­ ently than conventionally would be expected. such responses can however be better understood, when being aware that depending on the circumstances the response might be either mostly to the verbal information that was primarily processed, or to the visual information that was mainly processed (e.g., chung et al., 2014). secondly, ef refers to a set of capacities used to consciously plan ahead, meet goals, display self-control, etc. speculatively, more unconscious, automatically driven cognitive distortions might appear in case of cognitive overload in autistic people (e.g., autistica, 2021). sometimes, autistic people show the tendency to categorize things or people as all good or all bad, all right or all wrong (sometimes referred to as 'dichotomous thinking'), rather than at that instance being able to consciously notice the possibilities in between, sometimes referred to dichotomous thinking. weak cc refers to difficulties in ‘seeing the bigger picture’, but rather an associative, non-linear thinking style in autistic people (e.g., grandin, 2009). simply put, some people might mainly have a global (bigger picture) processing style, while other (autistic) people might mainly have a local (detail-focussed) processing style (bölte et al., 2007). the idea of cc was taken further in pc theory. this theory of brain function stipulates that the brain is constantly generating and updating a mental model of the environment (e.g., pellicano & burr, 2012). this model is used to generate predictions of sensory input that are compared to actual sensory input. this comparison results in prediction errors that are then used to update and revise the mental model. an autistic person might be focussed more on the actual sensory input and their brain might be con­ greaves-lord, skuse, & mandy 11 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ stantly working to minimize the gap between the prediction and actual sensory input. as such, this theory might explain why some autistic people have more intolerance of uncertainty, given the larger prediction errors and the cognitive resources it takes to try and solve these. finally, although the pt (porges, 1995) is not yet well substantiated empirically, it’s popularity is growing amongst some clinical practitioners and autistic people, as it is relatable. therefore, we discuss it briefly. polyvagal theory takes its name from the vagus, a cranial nerve that is the primary component of the parasympathetic nervous system. the autonomic nervous system (ans) has two parts; the sympathetic nervous system, which is mostly activating (“fight or flight”), and the parasympathetic nervous system, which exists of two distinct branches: a "ventral vagal system" which supports social engagement, and a "dorsal vagal system" which supports immobilisation behaviours, both “rest and digest” and defensive immobilisation or “shutdown”. behav­ ioural responses that derive from the hybrid state of activation and calming are key to the ability to adaptively socially engage. it is speculated that in autistic people, the ans might (at times) be dysregulated, which could explain emotional melt downs or shut downs in autistic people. again, we emphasize that in this section we did not provide an extensive explanation of all neuropsychological concepts. rather, we illustrated some behaviours seen in autistic people and tried to stimulate readers to think about their assumed neurobiological origins. in clinical practice, for most autistic people it is key to connect abstract, neuropsychological concepts to very concrete day-to-day personal experiences, to ‘digest’ these explanations fully (e.g., gordon et al., 2015). thus, in psy­ cho-education, it is essential to help autistic people make these translational connections. f u r t h e r f e a t u r e s a n d d i s o r d e r s some individuals with an asd experience delay in the development of their intellectual abilities, and qualify for a diagnosis of id. in countries with well-established facilities for the assessment of autistic symptoms, and with experience in the manifestations of the condition among individuals with good verbal skills, individuals with id are a minority of those diagnosed with asd. by contrast, in more under-served areas, those with id constitute the majority people diagnosed with asd. “if present, a separate diagnosis of disorder of intellectual development should be assigned, using the appropriate category to designate severity (i.e., mild, moderate, severe, profound, provisional). because social difficulties are a core feature of autism spectrum disorder, the assessment of adaptive behaviour as a part of the diagnosis of a co-occurring disorder of intellectual devel­ opment should place greater emphasis on the intellectual, conceptual, and practical do­ mains of adaptive functioning than on social skills” (world health organization, 2019a). self-injurious behaviours (e.g., hitting one’s face, head banging) occur more often in autistic people with co-occurring disorder of intellectual development, perhaps because asd in icd-11: a psychological approach 12 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ they represent attempts to express and communicate painful feelings, in the absence of verbal means. even among individuals with normal-range intellectual abilities, profiles of specific cognitive skills in asd as measured by standardized assessments, may show striking and unusual patterns of strengths and weaknesses that are highly variable from individual to individual. clinical experience teaches that such a ‘spikey profile’ of cognitive strengths and difficulties can affect learning and adaptive functioning to greater extent than would be predicted from the overall scores on measures of verbal and non-verbal intelligence, yet more research on this matter is needed to substantiate such clinical claims. isolated difficulties in intellectual functioning that are associated with asd include slow/different processing speed/style (bölte et al., 2007) and limited verbal or non-verbal working memory, which may occur in the presence of strong verbal and/or visuospatial skills in other domains. "the degree of impairment in functional language (spoken or signed) should be designated with a second qualifier. functional language refers to the capacity of the individual to use language for instrumental purposes (e.g., to express personal needs and desires). this qualifier is intended to reflect primarily the verbal and non-verbal expressive language [difficulties] present in some individuals with autism spectrum disorder” (world health organization, 2019a), and not the atypical pragmatic language that is a core feature of the condition. icd-11 requires the assessment of whether the individual has a degree of functional language impairment (spoken or signed) relative to their age in the following terms: i) with mild or no impairment of functional language; ii) with impaired functional language (i.e., not able to use more than single words or simple phrases); iii) with complete, or almost complete, absence of functional language (world health organization, 2019a). it is important to note that the observable manifestation of asd will be different at different developmental stages (as discussed above), as well as in different groups (e.g., males versus females versus gender-diverse individuals, or those with and without id). for instance, parental or caregiver concerns about intellectual or other develop­ mental delays (e.g., problems in language and motor coordination) often characterise the presentation in young children during the preschool period. when there is no significant impairment of intellectual functioning, the presentation to clinical services is often prompted by staff at nursery school, who have observed unusual social or other behaviour. in middle childhood, there may be prominent symptoms of anxiety, including social anxiety disorder, school refusal, and specific phobia (verheij et al., 2015). during adolescence and adulthood, depressive disorders are a common presenting feature. for women, a restrictive eating disorder can drive engagement with mental health services, with their underlying asd and/or associated social trauma only being identified later (bentz et al., 2022). across all ages, there is strong co-occurrence with attention defi­ cit/hyperactivity disorder, and in males impulsive and disruptive behaviour often prompt greaves-lord, skuse, & mandy 13 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ referral (especially in middle childhood), although in females the symptoms are more likely to be related to attention difficulties, rather than impulsivity or hyperactivity. consequently, it is important to be aware that asd commonly co-occurs with other mental, behavioural or neurodevelopmental disorders across the lifespan. in a substantial proportion of cases, particularly in adolescence and adulthood, it is the co-occurring disorder that first brings the autistic individual to clinical attention. some people with asd are capable of functioning even in environments that are poorly adapted to accom­ modate them, by making an exceptional effort to compensate for their symptoms during childhood, adolescence or adulthood (i.e., ‘camouflaging’). such camouflaging requires sustained effort, is more typical of females (although it is common in all genders), and can have deleterious impact on mental health and well-being (cook et al., 2021). “some young individuals with autism spectrum disorder, especially those with a cooccurring disorder of intellectual development, develop epilepsy or seizures during early childhood with a second increase in prevalence during adolescence. catatonic states have also been described. a number of medical disorders such as tuberous sclerosis, chromosomal abnormalities including fragile x syndrome, cerebral palsy, early onset epileptic encephalopathies, and neurofibromatosis” are associated with an asd diagnosis (world health organization, 2019a), with or without a co-occurring disorder of intellec­ tual development. genomic deletions, duplications and other genetic abnormalities are increasingly described in individuals with asd, some of which may be important for genetic counselling. prenatal exposure to valproate is also associated with an increased risk of asd (world health organization, 2019a). recently, there is growing recognition of the fact that people with asd more fre­ quently develop more severe physical illnesses, in the worst case resulting in relatively early death, as compared to other people from the general population. potentially, this might reflect the fact that autistic people experience high levels of stress, due to having to live in environments that are poorly designed to accommodate them, with consequent elevated levels of mental health, suicidality and substance use problems. poor physical health outcomes could reflect a combination of two underlying causes. first, autistic people might have a limited capacity to sense and recognize early physical symptoms. this might be due to limited interoception, i.e. hypo-sensitivity or a limited inclination to direct their attention towards internal stimuli of the body (e.g. garfinkel et al., 2016). secondly, they might be reluctant to communicate any concerns they have about their physical health to professionals. this might result in their initially not seeking access to medical services, as well as limiting their action in following up any subsequent referral to medical specialists. research on this topic is still ongoing. nevertheless, it is important that mental health professionals are aware that there is potentially limited somatic awareness in autistic clients. they should therefore pro-actively bring up the topic of their client’s physical health. psychologists should consider referral to a medical specialist when an autistic client complains about somatic symptoms, and should be asd in icd-11: a psychological approach 14 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ aware of their potential professional biases. faced with an autistic client who has somatic symptoms they should not automatically assume a psychological explanation, but be aware that an alternative physical condition could be present, and that condition should be adequately investigated. the prevalence of premature mortality affecting people on the autism spectrum, which is excessive, could be attributable at least in part from these risk factors. c o m p a r i s o n b e t w e e n i c d 1 1 a n d d s m 5 both systems of diagnosis differ substantially from previous versions (icd-10 and dsmiv and dsm iv tr). there are differences in their conceptualization of asd as a broad category comprising many different conditions (not yet identified, the 'autisms'), and in terms of specific phenotype requirements. hence the agreed term asd, reflecting the heterogeneity of those conditions. both systems recognize that asd is a set of symptoms that exist on a continuum that blends into normal variation, and they also consider the fact that at one extreme end there is a subset of conditions that are associated with identifiable biological substrates (largely genetic, but also some environmentally induced risks). the greatest difference between the icd-11 and dsm 5 diagnostic systems is not in the social communication aspects of the condition, but in the patterns of restrictive, repetitive, and inflexible patterns of behaviour that are regarded as atypical. the blurry boundaries between id and asd bedevils research. experts who are look­ ing at genetic risk factors continue to have a heated debate about whether certain genetic anomalies increase risk for asd or id or both. icd-11 criteria are cognizant of the fact that nowadays most diagnoses of asd are made in individuals who are of normal-range intelligence. accordingly, b-scale symptoms are defined in a way that reflects behaviours that are seen in those individuals (more broadly ranging than is discussed in dsm-5). unlike dsm-5, icd-11 does not emphasize the id-related criteria (such as flipping objects, strong attachment or preoccupation with unusual objects, excessive smelling or touching of objects, echolalia, stimming; who, 2019b). the associated limited enquiry about symptoms of repetitive, restricted and stereotyped behaviour (rrsb) is one of the reasons why there was, under the former dsm-iv tr criteria, such high prevalence of pervasive developmental disorder – not otherwise specified ('pdd-nos'). by broaden­ ing the criteria and introducing concepts such as 'lack of adaptability to new experiences and circumstances...' icd-11 has aimed to reduce the perceived lack of sensitivity of the dsm-5 criteria to cognitively able and older individuals. intellectual disability is conceptualized as a homogeneous condition in dsm-5. it is said that asd may be difficult to differentiate from id in very young children (under the heading differential diagnosis), but this statement exemplifies the problem that in the usa the terms are much closer aligned than the developers of icd-11 considered to be appropriate. dsm-5 does not make distinctions between levels of intellectual impairment. greaves-lord, skuse, & mandy 15 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ in icd-11, as discussed, there is the possibility to record an associated disorder of intellectual development, and this should be assigned a degree of severity. dsm-5 criteria state that, to make an asd diagnosis, the atypical social communi­ cation should be more marked than would be anticipated from the individual's develop­ mental level when any associated id is considered. in icd-11 a similar statement is made. both diagnostic systems acknowledge that it is important to distinguish the lack of adaptive behaviours that are indicative of generalized learning disabilities from the specific difficulties that are experienced by individuals with asd. the difference in emphasis between the systems reflects the expectation in the us that it is important to identify asd symptomatology in those with id, whereas in icd-11 the emphasis is on the importance of identifying intellectual impairment in those with a primary diagnosis of asd. in dsm-5 a differential diagnosis is made between asd and social (pragmatic) com­ munication disorder, a condition that does not exist in icd-11. the developers of icd-11 criteria were not convinced that a specific disorder of this nature could be differentiated clearly from atypical social communication that is associated with asd, nor from vari­ eties of specific language impairment (mandy et al., 2017). icd-11 records the degree of impairment of functional language at three levels, but this distinction is not treated as a differential diagnosis. that decision, to record three levels of impairment appears to be similar, but more structured, than the dsm-5 stipulation to use the specifier 'with or without accompanying language impairment' with an injunction to assess the current level of language and describe it. the choice of three levels reflected the need to be more explicit for clinical purposes, and the icd-11 developer’s estimate that this distinction could be made reliably. both systems of diagnosis require the recording of loss of skills. in icd-11 there is a qualifier that records whether there is loss of previously acquired skills, or not. dsm-5 discusses loss of skills in the context of development and course and distinguishes social from loss of other skills (such as toileting or motor skills). icd-11 acknowledges that the pattern of skill loss will be different at different stages of development. dsm-5 has a section on differential diagnosis which implies that it is possible that asd could be confused with other diagnoses, such as selective mutism or adhd. icd-11 has taken a different approach, recognizing that these conditions can (and frequently do) co-occur. hence, in icd-11 they are included in a section that uses the term 'boundaries with other disorders and conditions’. the guidelines in icd-11 provide greater detail than dsm-5 about the distinction between conditions that may present with an autismlike phenotype. asd in icd-11: a psychological approach 16 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ t o w a r d s i n t e r v e n t i o n t o i m p r o v e q u a l i t y o f l i f e a n d f u n c t i o n i n g in our view, the diagnostic classification of asd should always inform and serve proper, suitable interventions and support aimed at improving the wellbeing and functioning of the autistic person. thus, clinical psychologists should remain aware that diagnostic classification is not a purpose in itself. therefore, as part of the diagnostic assessment process, clinicians should perform assessments with a purpose in mind. if the goal is to primarily acquire new insights for scientific/applied research and/or related mental health care innovations, that purpose of potential additional assessments should be transparently communicated to all involved. diagnostic classification in clinical practise should be a means to provide proper, suitable care, and therefore all diagnostic assess­ ments should be used to tailor the interventions and/or care to the capacities and genuine needs of the people that ask for professional help. even though asd is concep­ tualized as predominantly inborn, so genetically determined condition, the interaction with social factors is more and more recognized both in society as well as in research. as such, interventions to help autistic people should not simply focus on effecting change in the individual, but should also include steps to improve person-environment fit by making adaptations to the environment. furthermore, intervention targets should be identified collaboratively with the client and their family, and will often concern improv­ ing wellbeing, mental health and societal functioning. whilst practice may need to be adapted to promote access and inclusion for autistic clients, mental health care providers are in a good position to use their clinical skills to offer effective help. there is growing evidence-base for psychological treatment procedures and social support interventions. recommendations regarding suitable methods for treatment and support with sufficient evidence as well as preference base will be provided in a future follow up article. funding: the authors have no funding to report. acknowledgments: we want to thank gillian baird and graccielle rodrigues da cunha who were involved in writing a related book chapter. also, gratitude goes out to annemiek landlust, inge van balkom and sigrid piening who at the autism team north-netherlands provide an excellent environment in which much can be learned about asd, conceptually as well as practically. finally, a large thank you to all members of the academic workplace autism, the volante workgroup and autism europe who enlarged our perception and conception of what asd entails when experienced at a daily basis. competing interests: all authors were involved in the development and evaluation of the developmental, dimensional and diagnostic interview (3di), a semi-structured interview that can be used to clarify the developmental history as part of the diagnostic assessment process concerning autism spectrum disorder. greaves-lord, skuse, & mandy 17 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://www.psychopen.eu/ r e f e r e n c e s american psychiatric association. 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(2019a). 6a02 autism spectrum disorder. in international statistical classification of diseases and related health problems (11th ed.). https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/437815624 world health organization. (2019b). 6a00 disorders of intellectual development. in international statistical classification of diseases and related health problems (11th ed.). https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/605267007 zeidan, j., fombonne, e., scorah, j., ibrahim, a., durkin, m. s., saxena, s., yusuf, a., shih, a., & elsabbagh, m. (2022). global prevalence of autism: a systematic review update. autism research, 15(5), 778–790. https://doi.org/10.1002/aur.2696 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. asd in icd-11: a psychological approach 20 clinical psychology in europe 2022, vol. 4(special issue), article e10005 https://doi.org/10.32872/cpe.10005 https://doi.org/10.1037/a0037665 https://doi.org/10.1007/s10803-015-2592-5 https://doi.org/10.1016/j.dcn.2018.05.007 https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/437815624 https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/605267007 https://doi.org/10.1002/aur.2696 https://www.psychopen.eu/ asd in icd-11: a psychological approach current icd-11 definition, criteria and conceptualisations of autism spectrum disorder social communication repetitive, stereotyped behaviours and sensory interests life-course perspective and advice on assessment hypothesised neuropsychological mechanisms driving the core behaviours defining asd further features and disorders comparison between icd-11 and dsm-5 towards intervention to improve quality of life and functioning (additional information) funding acknowledgments competing interests references development and initial validation of a brief questionnaire on the patients’ view of the in-session realization of the six core components of acceptance and commitment therapy research articles development and initial validation of a brief questionnaire on the patients’ view of the in-session realization of the six core components of acceptance and commitment therapy thomas probst a, andreas mühlberger b, johannes kühner c, georg h. eifert d, christoph pieh a, timo hackbarth b, johannes mander e [a] department for psychotherapy and biopsychosocial health, danube university krems, krems, austria. [b] department of psychology, regensburg university, regensburg, germany. [c] practice for psychotherapy, würzburg, germany. [d] department of psychology, chapman university, orange, ca, usa. [e] center for psychological psychotherapy, heidelberg university, heidelberg, germany. clinical psychology in europe, 2020, vol. 2(3), article e3115, https://doi.org/10.32872/cpe.v2i3.3115 received: 2019-01-21 • accepted: 2020-03-25 • published (vor): 2020-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: thomas probst, danube university krems, dr.-karl-dorrek-str. 30, 3500 krems, austria. email: thomas.probst@donau-uni.ac.at supplementary materials: materials [see index of supplementary materials] abstract background: assessing in-session processes is important in psychotherapy research. the aim of the present study was to create and evaluate a short questionnaire capturing the patients’ view of the in-session realization of the six core components of acceptance and commitment therapy (act). method: in two studies, psychotherapy patients receiving act (study 1: n = 87) or cognitivebehavioral therapy (cbt) (study 2, sample 1: n = 115; sample 2: n = 156) completed the act session questionnaire (act-sq). therapists were n = 9 act therapists (study 1) and n = 77 cbt trainee therapists (study 2). results: factor structure: exploratory factor analyses suggested a one-factor solution for the actsq. reliability: cronbach’s alpha of the act-sq was good (study 1: α = .81; study 2, sample 1: α = .84; sample 2: α = .88). convergent validity: the act-sq was positively correlated with validated psychotherapeutic change mechanisms (p < .05). criterion validity: higher act-sq scores were associated with better treatment outcomes (p < .05). conclusion: the study provides preliminary evidence for the reliability and validity of the actsq to assess the in-session realization of the six core components of act in the patients’ view. further validation studies and act-sq versions for therapists and observers are necessary. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.3115&domain=pdf&date_stamp=2020-09-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords acceptance and commitment therapy, session report, reliability, validity highlights • the act-sq is a patient self-report on the in-session realization of the six core components of act. • data of two studies (act, cbt therapies) support the reliability and validity of the act-sq. • further validation studies and act-sq versions for therapists and observers are necessary. acceptance and commitment therapy (act; hayes, 2004) is one of the third-wave cognitive-behavioral therapies (cbt). several reviews and meta-analyses summarized the effectiveness of act for various clinically relevant problems (a-tjak et al., 2015; graham, gouick, krahé, & gillanders, 2016; öst, 2014; powers, zum vörde sive vörding, & emmelkamp, 2009; swain, hancock, hainsworth, & bowman, 2013). a central treat‐ ment strategy in act is reducing the patients’ psychological inflexibility and thereby increasing psychological flexibility. the act model of psychological flexibility consists of the following of six core components (see table 1): acceptance, cognitive defusion, contact with the present moment, self-as-context, values, and committed action. these six core components of psychological flexibility can be described as mindfulness and acceptance processes (acceptance, cognitive defusion, contact with the present moment, self-as-context) as well as commitment and behavior change processes (contact with the present moment, self-as-context, values, and committed action). the counterparts of these six components of psychological flexibility are formulated in the act model of psychological inflexibility (see table 1): experiential avoidance (vs. acceptance), cognitive fusion (vs. cognitive defusion), dominance of the conceptualized past and feared future (vs. contact with the present moment), attachment to the conceptualized self (vs. self-ascontext), lack of values (vs. values), and inaction, impulsivity, or avoidant persistence (vs. committed action). a meta-analysis on laboratory-based component studies revealed positive effects for treatment strategies on the six act core components (levin, hildebrandt, lillis, & hayes, 2012). moreover, psychotherapy research has shown that patients who improve their skills in acceptance, cognitive defusion, contact with the present moment, and values-based actions during therapy show better treatment outcomes (e. g., åkerblom, perrin, rivano fischer, & mccracken, 2015; arch, wolitzky-taylor, eifert, & craske, 2012b; baranoff, hanrahan, kapur, & connor, 2013; forman, herbert, moitra, yeomans, & geller, 2007; forman et al., 2012; hesser, westin, & andersson, 2014; niles et al., 2014; vowles & mccracken, 2008; zettle, rains, & hayes, 2011). interestingly, some of these development and validation of the act-sq 2 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ studies found improvements in act processes to be beneficial for the outcome not only in act but also in cbt as well as multidisciplinary treatments. act processes might therefore be change mechanisms in other psychotherapies than act as well, i. e. general change mechanisms. some act processes were even more strongly associated with the outcome in cbt than in act, for example in the study by arch et al. (2012b) in which cognitive defusion predicted worry reductions more in cbt than in act. table 1 act model of psychological flexibility and act model of psychological inflexibility act model of psychological flexibility act model of psychological inflexibility component description component description acceptance being open towards all experiences experiential avoidance avoiding unwanted experiences cognitive defusion observing thoughts and inner experiences come and go cognitive fusion being entangled in one’s thoughts and inner experiences contact with the present moment non-judgmental awareness of current experiences dominance of the conceptualized past and feared future ruminating on the past or worrying about the future self-as-context being aware of one’s experiences without attachment to them attachment to the conceptualized self inflexible identification with a self-image values having identified valued directions lack of values having no orientation in life committed action effective behavior related to one’s values inaction, impulsivity, or avoidant persistence problems to keep either commitments or to set goals several questionnaires have been published to measure a patient’s skill in the act components: e. g., acceptance and action questionnaire ii (bond et al., 2011); acceptance and action questionnaire for university students (levin, krafft, pistorello, & seeley, 2019); comprehensive assessment of acceptance and commitment therapy processes (francis, dawson, & golijani-moghaddam, 2016); chronic pain acceptance questionnaire (mccracken, vowles, & eccleston, 2004), cognitive fusion questionnaire (gillanders et al., 2014), multidimensional experiential avoidance questionnaire (gámez, chmielewski, kotov, ruggero, suzuki, & watson, 2014), tinnitus acceptance question‐ naire (weise, kleinstäuber, hesser, westin, & andersson, 2013), the valued living ques‐ tionnaire (wilson, sandoz, kitchens, & roberts, 2010). how strong patients improve their skills in act components might depend on the in-session realization of the act probst, mühlberger, kühner et al. 3 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ components. as far as we know, no study has yet explored this research question. this might be because only the observer-based drexel university act/cbt therapist adherence rating scale (dutars; mcgrath, 2012) is available to measure the degree the act components are realized in a psychotherapy session. the dutars was applied in previous clinical trials on act to assess treatment adherence (arch et al., 2012a; gloster et al., 2015). although such observer-based measures provide valuable data, there are several barriers to apply observer-based ratings in psychotherapy, especially under the conditions of routine practice. for example, observers must be trained to provide reliable and valid data, financial or other compensations are necessary since observing sessions or session segments consumes a serious amount of time (weck, grikscheit, höfling, & stangier, 2014), and only certain consent to being observed in-session limiting the generalizability of the results. besides observer ratings, ratings given by patients are complementary data sources. patient ratings on in-session processes are easier to obtain than observer ratings. patients can fill out session questionnaires directly after the psychotherapy session to measure the degree therapeutic factors were realized in this given psychotherapy session. patient ratings of in-session processes are especially relevant as they correlate most consistently with psychotherapy outcome (e. g, horvath & symonds, 1991; mander et al., 2013, 2015; ogrodniczuk, piper, joyce, & mccallum, 2000). several session questionnaires were published on the in-session realization of the therapeutic alliance (horvath & greenberg, 1989) and the psychotherapeutic change processes according to grawe (1997): problem actuation (activation of problems and related emotions), clarification of meaning (acquir‐ ing new insights and a deeper understanding of the problems), resource activation (rec‐ ognizing potential, strengths, and positive facets), and mastery (the ability to cope with problems) (see mander et al., 2013, 2015). yet, no session report exists, to our knowledge, which captures the in-session realization of the six core components of act. a brief, time-economic and psychometrically sound act session report would have the potential to enrich psychotherapy research as well as clinical practice. clinical implications would be that this measure could be applied in more settings than the observer-based dutars and that therapists could use this measure to obtain feedback on the patients’ perspective of the in-session realization of the act components. in the present study, we developed and evaluated a brief act session questionnaire (act-sq; see supplementary materials). the act-sq was created to obtain patient ratings on the in-session realization of the act components of psychological flexibility. in this manuscript, we present two studies. study 1 investigated the factor structure, the reliability, and the convergent validity. study 2 analyzed the factor structure, the reliability, the convergent validity, and also criterion validity. the following research questions were evaluated: 1. what is the factor structure of the act-sq? 2. how is the reliability (internal consistency) of the act-sq? development and validation of the act-sq 4 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ 3. with regard to convergent validity: how are the associations between the act-sq and general change mechanisms? the general change mechanisms proposed by grawe (1997) – problem actuation, clarification of meaning, resource activation, mastery – were used to evaluate convergent validity. the general change mechanisms of grawe were used to test convergent validity due to two reasons. first, these general change mechanisms are considered to be relevant in all psychotherapies, therefore also in act. second, act processes might also be general psychotherapeutic change mechanisms, since – as mentioned above – improvements in act processes have been found to beneficial for the outcome not only in act but also in cbt and multidisciplinary treatments. 4. are the factor structure, reliability, and convergent validity of the act-sq comparable between a sample of patients treated with act (study 1) and a sample of patients treated with cbt (study 2)? act and cbt have similarities and differences (arch & craske, 2008; harley, 2015) so that the factor structure, reliability, and convergent validity of the act-sq might resemble more the similarities or the differences. 5. regarding criterion validity: is the act-sq associated with treatment outcomes? 6. are the factor structure, reliability, convergent validity, and criterion validity of the act-sq comparable in different treatment phases? it has been discussed that the earlier and later phases of psychotherapy differ for example in common factors (ilardi & craighead, 1994; lambert, 2005) so that the factor structure, reliability, convergent validity, and criterion validity of the act-sq might depend on the treatment phase. s t u d y 1 method the study was performed according to the resolution of helsinki and the professional obligations for therapists. no ethics committee was involved in study 1 because no harmful procedures were applied and questionnaire-data were collected anonymously. the responsible psychotherapists asked their patients to take part in the study. the informed consent of the participants was implied through questionnaire completion. the anonymized questionnaires were sent by the therapists to the first author. measures the following two questionnaires were administered simultaneously to the patients during psychotherapy: the newly developed act-sq and the psychometrically sound patient version of the “scale for the multiperspective assessment of general change mechanisms in psychotherapy” (sacip; mander et al., 2013). probst, mühlberger, kühner et al. 5 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ the sacip evaluates the degree the therapeutic alliance and other change mecha‐ nisms according to grawe (1997) were realized in the given psychotherapy session. the sacip consists of adapted items from the german shortened version of the working alliance inventory (wai-s; munder, wilmers, leonhart, linster, & barth, 2010) as well as from the bernese post session report (bpsr; flückiger et al., 2010). factor analyses revealed the following six sacip scales: emotional bond, agreement on collaboration, problem actuation, clarification of meaning, mastery, and resource activation (mander et al., 2013). the emotional bond scale and the agreement on collaboration scale measure aspects of the therapeutic alliance, the problem actuation scale assesses how strong problems as well as related emotions were activated in the session, the clarification of meaning scale measures the new insights the patient gained into his/her behavior during the session, the mastery scale assesses the degree the session helped the patients to cope with his/her problems, and the resource activation scale measures how strong the patients’ strengths were used in-session. the measure demonstrated an excellent factor structure with factor loadings of .51 ≤ λ ≤ .85. confirmatory factor analyses supported the exploratory model. the instrument revealed good to excellent internal consistencies with .71 ≤ α ≤ .90. studies also demonstrated criterion validity since treatment outcome was significantly predicted by all change mechanisms except for problem actuation (e.g. mander et al., 2013, 2015). example items of the sacip patient version are the following: “today, i felt comfortable in the relationship with the therapist” (emotional bond), “in today’s session, i was highly emotionally involved” (problem actuation), “today, the therapist intentionally used my abilities for therapy” (resource activation), “today, i became more aware of the motives for my behavior” (clarification of meaning), “today, the therapist and i worked toward mutually agreed upon goals” (agreement on collabora‐ tion), “today, we really made progress in therapy in overcoming my problems (mastery). in the act-sq, patients rate how strong the act components of psychological flexibility were realized in psychotherapy sessions on a five point likert scale. each item of the act-sq represents one act component. six pilot items of the act-sq were formulated by t.p. on the basis of the act literature. t.p. then discussed the items with cbt psychotherapists with act expertise (j.k., g.h.e., and a.m.). the experts gave feedback regarding the fit of the items to the act model and provided concrete suggestions how the items could be optimized. the six pilot items were changed and refined accordingly. the resulting six items represent the items of the final act-sq and were used in the present study (the act-sq is available license free, the german and english version are included in the appendix, see supplementary materials). participants therapists: the n = 69 act therapists listed in the german section of the association for contextual behavioral science (deutschsprachige gesellschaft für kontextuelle ver‐ haltenswissenschaften e.v.; dgkv) were invited to participate in october 2015 and the development and validation of the act-sq 6 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ n = 68 act therapists listed in the e-mail list of the german act network were invited to partake in december 2014. therefore, therapists listed in both the german section of the association for contextual behavioral science and the e-mail list of the german act network were contacted twice. nine act therapists (see acknowledgements) took part and encouraged their patients to fill in the act-sq and the sacip after one psychothera‐ py session. the nine act therapists were certified in cognitive-behavioral therapy (cbt) and their average work experience with act amounted to m = 4.56 years (sd = 2.46). patients: eighty-seven patients treated by the n = 9 act therapists completed the act-sq after the m = 21.25th psychotherapy session (sd = 19.84). the description of the participating n = 87 patients is given in table 2. the diagnoses were made by the responsible therapist. table 2 description of the patients of study 1 gender n % male 33 37.9 female 53 60.9 no data 1 1.2 diagnoses according to chapter v of the icd-10 (all diagnoses, not only primary diagnosis) n % f4 53 40.2 f3 46 34.8 f1 15 11.4 f6 8 6.1 others 10 7.6 outpatients / inpatients n % outpatient 78 89.7 inpatient 9 10.3 comorbidity: amount of diagnoses according to chapter v of the icd-10 m sd 1.54 0.71 age at time of assessment m sd 42.48 14.79 note. f4 = neurotic, stress-related and somatoform disorders; f3 = mood (affective) disorders; f1 = mental and behavioural disorders due to psychoactive substance use; f6 = disorders of adult personality and behavior. number of diagnoses higher than number of patients since multiple diagnoses per patients are possible. analyses spss 25 was used to perform the statistical analyses. means (m), standard deviations (sd), frequencies (n), and percentages (%) were calculated for the sample description. to explore the factor structure of the act-sq, an exploratory factor analysis (efa) with maximum likelihood estimation and with oblique rotation (oblimin direct) was performed. the kaiser criterion (factors with eigenvalues larger than 1 were retained), the kaiser-meyer-olkin measure of sampling adequacy (kmo), and the bartlett’s test probst, mühlberger, kühner et al. 7 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ of sphericity were applied. cronbach’s alpha (α) was computed to measure reliability. furthermore, pearson correlation coefficients (r) were calculated to measure correlations between the act-sq and general change mechanisms (convergent validity). all statisti‐ cal tests were performed two-tailed and the significance value was set to p < .05. results will be presented with and without bonferroni-correction for multiple comparisons. results factor structure and reliability: the efa produced a kmo value of .79 and the bartlett’s test reached significance, χ2(15) = 150.04; p < .01. the eigenvalues amounted to 3.06, 0.85, 0.73, 0.58, 0.44, 0.34. therefore, only one factor was retained when kaiser’s criterion was applied. the loadings of the six items are presented in table 3. there were no cross-loadings. cronbach’s alpha (α) across all six items amounted to α = .81. table 3 loadings of the act-sq in study 1 the last (xy) psychotherapy session(s) helped me… loading λ item 1 acceptance “…to accept unpleasant feelings, thoughts or body sensations rather than fight them” .58 item 2 cognitive defusion “…to gain more inner distance from unpleasant feelings, thoughts or body sensations and to observe them rather than getting caught up in them” .65 item 3 contact with the present moment “…to stay in the here and now (in the present moment) rather than concerning myself with my future and my past” .60 item 4 self-as-context “…to realize that my feelings, thoughts and body sensations are part of me, but that i am more than my feelings, thoughts and body sensations” .72 item 5 values “…to recognize what is important to me in my life and what gives orientation to my life” .61 item 6 committed action “…to act in daily life according to what is important to me in my life and what gives orientation to my life” .70 note. sample of study 1: n = 87 patients treated by n = 9 act therapists. correlations with general change mechanisms: the associations between the act-sq mean score and the mean scores of the sacip scales are presented in table 4. before applying bonferroni correction (p < .05), the act-sq was significantly correlated with all general change mechanisms except for problem actuation. the association between the development and validation of the act-sq 8 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ act-sq and the emotional bond, however, was not significant anymore after (p < .008) applying bonferroni correction (p = .05 / 6 comparisons). table 4 correlations between the act-sq and the sacip scales in study 1 variable sacip emotional bond problem actuation resource activation clarification of meaning agreement on collaboration mastery act-sq .23* .10 .55** .43** .40** .64** note. sample of study 1: n = 87 patients treated by n = 9 act therapists. act-sq = act session questionnaire; sacip = scale for the multiperspective assessment of general change mechanisms in psychotherapy. *p < .05. **p < .001. discussion the results provide preliminary evidence for the factor structure, the reliability, and the convergent validity of the act-sq. regarding research question 1, we found a one-factor solution. results for research question 2 indicate a good reliability. conver‐ gent validity (research question 3) was supported by significant correlations between the act-sq and general change mechanisms except for problem actuation. a limitation of the study is the relatively small sample size of participating act therapists. future research could use recently published recommendations on how to motivate therapists for psychotherapy research (taubner, klasen, & munder, 2016) to obtain larger samples. moreover, no associations between the act-sq and treatment outcomes (criterion validi‐ ty) were evaluated. therefore, study 2 was planned to investigate the criterion validity of the act-sq. another aim was to investigate whether the factor structure, the reliability, and the convergent validity as shown in study 1 can be replicated in study 2. s t u d y 2 method the methods of study 2 were approved by the local ethics committee (ethikkommission der fakultät für verhaltensund empirische kulturwissenschaften der universität hei‐ delberg) and written informed consent was obtained from the patients. measures the act-sq and the sacip (see measures in study 1) were administered to patients after the 15th therapy session and at the end of psychotherapy. furthermore, the german versions of the brief symptom inventory (bsi; franke, 2000) and the beck depression probst, mühlberger, kühner et al. 9 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ inventory (bdi-ii; hautzinger, keller, & kühner, 2009) were administered as outcome measures at pre-treatment and post-treatment as well as after the 15th psychotherapy session. the global severity index (gsi) of the bsi and the total score of the bdi-ii were used in the study at hand. these measures are reliable and valid (see for example, franke, 2000 for the german version of bsi; derogatis & melisaratos, 1983 for the english version of bsi; kühner et al., 2007 for the german version of bdi-ii; beck & steer, 1998 for the english version of bdi-ii). references. cronbach’s alpha (α) values have been reported to be high: between .92 and .96 for the gsi of the german bsi and ≥ .84 for the german bdi-ii. participants therapists and patients were different from the therapists and patients included in study 1. between november 2016 and november 2017, n = 77 cbt trainee therapists working at a large outpatient training center took part. these therapists treated the n = 254 patients who completed the act-sq: n = 115 outpatients completed the act-sq after the 15th cbt session and n = 156 outpatients completing the act-sq at the end of cbt (post-treatment). as the act-sq was implemented for ongoing and new therapies, these two patient sample were independent from each other except for n = 17 patients who completed the act-sq at both assessment points. a subset of patients filling in the act-sq also provided data for the outcome measures (see flow-chart in figure 1) and their data was used to evaluate associations between the act-sq and pre-post outcome as well as early and late patient progress (research questions 5 and 6). figure 1 flow-chart development and validation of the act-sq 10 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ the patients answering the act-sq at the end of cbt had on average m = 39.68 (sd = 14.98) individual therapy sessions. the description of the participating patients is given in table 5. structured clinical interviews (scid) were used to make the diagnoses. table 5 description of the patients of study 2 variable 15th session sample post-treatment sample n % n % gender male 51 44.3 68 43.6 female 64 55.7 88 56.4 diagnoses according to chapter v of the icd-10 (all diagnoses, not only primary diagnosis) f4 68 36.0 87 34.3 f3 72 38.1 102 40.2 f1 10 5.3 16 6.3 f6 22 11.6 23 9.1 others 17 9.0 26 10.2 m sd m sd comorbidity: amount of diagnoses according to chapter v of the icd-10 1.64 .84 1.63 .87 age at time of assessment 36.50 13.03 35.73 13.60 note. f4 = neurotic, stress-related and somatoform disorders; f3 = mood (affective) disorders; f1 = mental and behavioural disorders due to psychoactive substance use; f6 = disorders of adult personality and behavior. number of diagnoses higher than number of patients since multiple diagnoses per patients are possible. analyses spss 25 was used to perform the statistical analyses. means (m), standard deviations (sd), frequencies (n), and percentages (%) were calculated for the sample description. an efa with maximum likelihood estimation and oblique rotation (oblimin direct) was performed to investigate the factor structure of the act-sq. the kaiser criterion (factors with eigenvalues larger than 1 were retained), the kaiser-meyer-olkin measure of sampling adequacy (kmo), and the bartlett’s test of sphericity were applied. cronbach’s alpha (α) was computed to measure reliability. furthermore, pearson correlation coefficients (r) were calculated to measure associations between the act-sq and general change mecha‐ nisms (convergent validity). moreover, associations between the act-sq and treatment outcome were explored with linear regression analyses. to measure the pre-post out‐ come, the outcome measure (gsi, bdi-ii) at post-treatment was the dependent variable and the act-sq at post-treatment as well as the outcome measure (gsi, bdi-ii) at pre-treatment were independent variables. we also investigated associations between the act-sq and early as well as late patient progress. for early patient progress, the patient reported outcome measure (gsi, bdi-ii) at the 15th cbt session was the dependent probst, mühlberger, kühner et al. 11 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ variable and the act-sq at the 15th cbt session as well as the outcome measure (gsi, bdi-ii) at pre-treatment were independent variables. for late patient progress, the patient reported outcome measure (gsi, bdi-ii) at post-treatment was the dependent variable and the act-sq at post-treatment as well as the outcome measure (gsi, bdi-ii) at the 15th cbt session were independent variables. we also performed these analyses without the act-sq as independent variable to evaluate how the r2-squared values change when including the act-sq as independent variable. all statistical tests were performed two-tailed and the significance value was set to p < .05. results will be given with and without bonferroni-correction for multiple comparisons. results factor structure and reliability for the 15th cbt session sample: the efa produced a kmo value of .86 and the bartlett’s test was significant, χ2(15) = 235.14; p < .01. the eigenvalues were 3.33, 0.81, 0.54, 0.50, 0.46, 0.36. only one factor was retained when kaiser’s criterion was applied. the loadings of the six items are given in table 6. there were no cross-loadings. cronbach’s alpha (α) across all six items was α = .84 for the 15th cbt session sample. table 6 loadings of the act-sq in study 2 the last (xy) psychotherapy session(s) helped me… loading λ 15th session sample post-treatment sample item 1 acceptance “…to accept unpleasant feelings, thoughts or body sensations rather than fight them” .53 .66 item 2 cognitive defusion “…to gain more inner distance from unpleasant feelings, thoughts or body sensations and to observe them rather than getting caught up in them” .78 .73 item 3 contact with the present moment “…to stay in the here and now (in the present moment) rather than concerning myself with my future and my past” .65 .78 item 4 self-as-context “…to realize that my feelings, thoughts and body sensations are part of me, but that i am more than my feelings, thoughts and body sensations” .67 .69 development and validation of the act-sq 12 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ the last (xy) psychotherapy session(s) helped me… loading λ 15th session sample post-treatment sample item 5 values “…to recognize what is important to me in my life and what gives orientation to my life” .67 .84 item 6 committed action “…to act in daily life according to what is important to me in my life and what gives orientation to my life” .78 .79 note. 15th session sample of study 2: n = 115 patients; post-treatment sample of study 2: n = 156 patients; both samples treated by n = 77 cbt trainee therapists. factor structure and reliability for the post-treatment sample: for the efa, the kmo value was .87 and the bartlett’s test reached significance, χ2(15) = 450.37; p < .01. the eigenvalues were 3.79, 0.58, 0.54, 0.44, 0.40, 0.25. only one factor was retained when kaiser’s criterion was applied. the loadings of the six items are shown in table 6. there were no cross-loadings. cronbach’s alpha (α) across all six items amounted to α = .88 for the cbt post-treatment sample. correlations with general change mechanisms: the associations between the actsq mean score and the mean scores of the sacip scales at cbt session 15th and at post-treatment are shown in table 7. the correlations were all positive and statistically significant before (p < .05) and after (p < .004) correcting for multiple testing (p = .05 / 12 comparisons). table 7 correlations between the act-sq and the sacip scales in study 2 act-sq sacip emotional bond problem actuation resource activation clarification of meaning agreement on collaboration mastery 15th session sample .40** .42** .75** .73** .54** .78** post-treatment sample .49** .59** .78** .74** .66** .83** note. 15th session sample of study 2: n = 115 patients; post-treatment sample of study 2: n = 156 patients; both samples treated by n = 77 cbt trainee therapists. act-sq = act session questionnaire; sacip = scale for the multiperspective assessment of general change mechanisms in psychotherapy. **p < .001. associations with treatment outcome: the results of the linear regression models are summarized in table 8. the results indicate that higher act-sq scores were associated with more beneficial pre-post outcome as well as with early and late patient progress before (p < .05) and after (p < .008) bonferroni correction (p = .05 / 6 comparisons). probst, mühlberger, kühner et al. 13 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ table 8 associations between the act-sq and treatment outcomes dependent variable / parameter unstandardized coefficient b standardized coefficient β t pβ se outcome gsi at post-treatment (n = 38) constant 1.19 0.23 5.13 < .001 gsi at pre-treatment 0.40 0.10 0.47 3.97 < .001 act-sq at post-treatment -0.36 0.07 -0.59 -5.00 < .001 bdi-ii at post-treatment (n = 38) constant 25.56 3.91 6.55 < .001 bdi-ii at pre-treatment 0.33 0.09 0.34 3.85 < .001 act-sq at post-treatment -7.91 0.99 -0.71 -8.03 < .001 early patient progress gsi at 15th therapy session (n = 112) constant 0.66 0.17 3.83 < .001 gsi at pre-treatment 0.70 0.06 0.72 11.78 < .001 act-sq at 15th therapy session -0.20 0.06 -0.21 -3.36 .001 bdi-ii at 15th therapy session (n = 111) constant 13.86 3.05 4.54 < .001 bdi-ii at pre-treatment 0.62 0.06 0.65 9.96 < .001 act-sq at 15th therapy session -4.42 1.02 -0.28 -4.31 < .001 late patient progress gsi at post-treatment therapy session (n = 61) constant 0.79 0.22 3.54 .001 gsi at 15th therapy session 0.63 0.11 0.53 5.72 < .001 act-sq at post-treatment -0.25 0.06 -0.38 -4.09 < .001 bdi-ii at post-treatment session (n = 61) constant 18.65 4.06 4.59 < .001 bdi-ii at 15th therapy session 0.51 0.10 0.45 5.04 < .001 act-sq at post-treatment -5.77 1.06 -0.49 -5.45 < .001 note. se = standard error; act-sq = act session questionnaire; gsi = global severity index of the brief symptom inventory; bdi-ii = beck depression inventory. for the pre-post outcome, the r-squared values were .17 (gsi) and .28 (bdi-ii) when predicting the outcome measure at post-treatment by the outcome measure at pre-treat‐ ment and the r-squared values changed to .52 (gsi) and .75 (bdi-ii) when predicting the outcome measure at post-treatment by the outcome measure at pre-treatment as well as by the act-sq. for the early patient progress, the r-squared values were .56 (gsi) and .46 (bdi-ii) when predicting the outcome measure at the 15th session by the outcome measure at pretreatment and the r-squared values changed to .60 (gsi) and .54 (bdi-ii) when predicting development and validation of the act-sq 14 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ the outcome measure at the 15th session by the outcome measure at pre-treatment as well as by the act-sq. for late patient progress, the r-squared values were .44 (gsi) and .49 (bdi-ii) when predicting the outcome measure at post-treatment by the outcome measure at the 15th session and the r-squared values changed to .57 (gsi) and .67 (bdi-ii) when predicting the outcome measure at post-treatment by the outcome measure at the 15th session as well as by the act-sq. discussion study 2 supported the one-factor solution (research question 1), a good reliability (re‐ search question 2), as well as associations between the act-sq and general change mechanisms (convergent validity, research question 3). the results were comparable to the results obtained in study 1 with the exception that the general change mechanism problem actuation was correlated with the act-sq only in study 2 (research question 4). the results indicate that the act-sq has many similarities in act and cbt but that there are also differences (research question 5): the overlap between the in-session real‐ ization of problem actuation and the act components was specific for cbt. criterion validity was not evaluated in study 1 (act) but the significant associations between the act-sq and pre-post outcome in study 2 (cbt) indicate criterion validity (research question 5). despite possible differences between earlier and later treatment phases (ilardi & craighead, 1994; lambert, 2005), the factor structure, reliability, convergent validity, and criterion validity of the act-sq were comparable in the earlier and later treatment phases (research question 6). a limitation of study 2 is that the sample size on associations between the act-sq and pre-post outcome was relatively small. moreover, the results on criterion validity rely on a cross-sectional basis (outcome at x+1 was associated with the act-sq at x+1) and future studies including session-to-session act-sq and outcome assessments should investigate whether the act-sq at session x-1 predicts the outcome at session x (rubel, rosenbaum, & lutz, 2017). g e n e r a l d i s c u s s i o n a brief session questionnaire act-sq was designed to obtain patient ratings on the in-session realization of the act components of psychological flexibility. the act-sq was evaluated in act as well as cbt. results showed a one-factor solution (research question 1) and a good reliability (research question 2). all kmo values were good (.7 .8) or great (.8 .9) according to hutcheson and sofroniou (1999) or field (2009). moreover, all bartlett’s tests were significant indicating that factor analysis was appropriate (field, 2009). the loadings of all items were well above .45 as recommended in the literature (see for example, probst, mühlberger, kühner et al. 15 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ bühner, 2010) and there were no cross-loadings. the one extracted factor could stand for the degree the in-session processes helped to increase the patient’s psychological flexibility. to further evaluate this hypothesis, a study is necessary investigating whether higher act-sq session scores result in more improvements on established instruments measuring skills of psychologically flexibility (e. g., acceptance and action questionnaire ii; bond et al., 2011). besides factor structure and reliability, we tested the convergent validity. convergent validity was evaluated by correlating the act-sq with the general change mechanisms proposed by grawe (1997) since these mechanisms are considered to be relevant in all psychotherapies and because act processes might also be general change mechanisms as they mediated the outcome not only in act but also in cbt and multidisciplinary treatments (e. g., åkerblom et al., 2015; arch et al., 2012b). these analyses related to research question 3 revealed that the act-sq is significantly associated with general change mechanisms (except for problem actuation in study 1) according to grawe (1997), most strongly with resource activation and mastery. a cautious clinical interpretation of these findings could be as follows: the content of the act-sq items are associated with coping and self-efficacy as is the content of the items of the sacip resource activation and mastery scales (mander et al., 2013). furthermore, the sacip emotional bond and agreement on collaboration scales reflect the interaction processes between patient and therapist. the act-sq items do not directly target this therapeutic relationship aspect. hence, stronger associations of act-sq and resource activation and mastery than with the alliance scales seem plausible. in summary, it is important to note that the act-sq items are most strongly related to proximal items (resources and mastery) but also to items with more distanced but clinically relevant content (therapeutic alliance). this further underlines the validity of the measure. with regard to similarities and differences between act and cbt (arch & craske, 2008; harley, 2015), most psychometric values were comparable between act and cbt, only a few differences emerged in the context of convergent validity (research question 4): associations between the act-sq and problem actuation reached significance only in cbt. this could indicate more overlap be‐ tween problem actuation and the act components in cbt than in act but it could also be related to the fact that the sample size of study 1 (act) was not as large as the sample size of study 2 (cbt). the same reasons might explain why the association between the act-sq and the emotional bond was not significant anymore after controlling for multiple testing in study 1 (act) but not in study 2 (cbt). in another step, we tested the criterion validity. this was related to research ques‐ tion 5 and the results showed significant associations between the act-sq and outcome measures. it should be kept in mind, however, that relations with treatment outcomes were investigated only in cbt. future research is necessary to evaluate whether the associations between the act-sq and treatment outcomes are comparable or different between cbt and act. finally, the factor structure, reliability, convergent validity, and development and validation of the act-sq 16 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ criterion validity were comparable between earlier and later treatment phases (research question 6). although differences in treatment phases have been highlighted (ilardi & craighead, 1994; lambert, 2005), these differences did apparently no affect the psycho‐ metric values of the act-sq. a limitation of the current work is that only a patient version of the act-sq was created and evaluated. a therapist version of the act-sq would be an important tool that could be developed by future studies to get a more comprehensive picture of the therapeutic process. other shortcomings of the studies at hand are that criterion validity was tested only in cbt but not in act. moreover, contrasting the psychometric values in earlier vs. later treatment phases was possible only in cbt but not in act. future studies on act are important to investigate criterion validity and similarities/differences between earlier and later act phases. a further limitation is that the mean of sessions attended was relatively high so that it remains unclear how well the results can be generalized to shorter psychotherapies. moreover, we did not include other measures of act processes to correlate them with the act-sq. further validation studies should, therefore, compare act-sq patient ratings with observer-based dutars ratings, since patient ratings are only one data source to rate in-session processes. related to the factor analysis, setting the kaiser criterion for determining the amount of factors at 1 is rather an arbitrary rule of thumb and an empirically founded way of determining the factors (i.e. horn’s parallel analysis or velicer’s map test) would have been a better method. in replication studies with larger samples, the factor structure needs to be tested with confirmatory factor analysis whether the instrument shows adequate model fit (bühner, 2010). it is per se more probable for such a short questionnaire like the act-sq to have a one-factor solution. another suggestion for future research would be to enter additional predictors to the regression analyses to test interactions between patient characteristics (e. g., amount of diagnoses) and the impact the act-sq has on the outcome. it would also be very interesting for future research to examine whether the factor structure of the act-sq remains stable when patients are treated by specific act modules (open vs. engaged, see villatte et al., 2016). the act-sq might also be useful to measure adherence to act and to continuously track the act processes during psychotherapy. parallel session-to-session assessments of the act processes and outcomes would allow investigating how the act processes are associated with patient progress on a betweenand within-person level (rubel et al., 2017). such a systematic monitoring would also enable evaluating the act processes before and after sudden losses or sudden gains (wucherpfennig, rubel, hofmann, & lutz, 2017). future research on group psychothera‐ py could also explore associations between group factors (see for example, tasca et al., 2016, and vogel, blanck, bents, & mander, 2016) and act components. in summary, the act-sq has a clear factor structure, good reliability, shows strong associations to other validated psychotherapeutic change processes and is associated with treatment outcomes. implications of this study are that the license-free act-sq is probst, mühlberger, kühner et al. 17 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ a reliable and valid measure that can be used to measure how patients experience the in-session realization of act components. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. author contributions: t.p. developed the questionnaire, wrote the manuscript and performed the statistical analyses; a.m. developed the questionnaire and revised the manuscript; j.k. developed the questionnaire and revised the manuscript; ge revised the questionnaire and the manuscript; c.p. revised the manuscript; t.h. collected data for study 1 and revised the manuscript; j.m. collected data for study 2 and revised the manuscript. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the english and german version of the act-sq (for unre‐ stricted access see index of supplementary materials below). index of supplementary materials probst, t., mühlberger, a., kühner, j., eifert, g. h., pieh, c., hackbarth, t., & mander, j. (2020). supplementary materials to "development and initial validation of a brief questionnaire on the patients’ view of the in-session realization of the six core components of acceptance and commitment therapy" [questionnaire; english and german version]. psychopen. https://doi.org/10.23668/psycharchives.3462 r e f e r e n c e s åkerblom, s., perrin, s., rivano fischer, m., & mccracken, l. m. (2015). the mediating role of acceptance in multidisciplinary cognitive-behavioral therapy for chronic pain. the journal of pain, 16, 606-615. https://doi.org/10.1016/j.jpain.2015.03.007 arch, j. j., & craske, m. (2008). acceptance and commitment therapy and cognitive behavioral therapy for anxiety disorders: different treatments, similar mechanisms? clinical psychology: science and practice, 15, 263-279. https://doi.org/10.1111/j.1468-2850.2008.00137.x arch, j. j., eifert, g. h., davies, c., plumb vilardaga, j. c., rose, r. d., & craske, m. g. 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(2011). processes of change in acceptance and commitment therapy and cognitive therapy for depression: a mediation reanalysis of zettle and rains. behavior modification, 35, 265-283. https://doi.org/10.1177/0145445511398344 development and validation of the act-sq 22 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://doi.org/10.1016/j.brat.2016.12.007 https://doi.org/10.1016/j.cpr.2013.07.002 https://doi.org/10.1080/10503307.2014.963729 https://doi.org/10.1080/10503307.2014.938256 https://doi.org/10.1016/j.brat.2015.12.001 https://doi.org/10.1055/s-0042-104495 https://doi.org/10.1037/0022-006x.76.3.397 https://doi.org/10.1016/j.beth.2014.03.003 https://doi.org/10.1080/16506073.2013.781670 https://doi.org/10.1007/bf03395706 https://doi.org/10.1037/ccp0000263 https://doi.org/10.1177/0145445511398344 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. probst, mühlberger, kühner et al. 23 clinical psychology in europe 2020, vol.2(3), article e3115 https://doi.org/10.32872/cpe.v2i3.3115 https://www.psychopen.eu/ development and validation of the act-sq (introduction) study 1 method results discussion study 2 method results discussion general discussion (additional information) funding competing interests acknowledgments author contributions supplementary materials references overall anxiety severity and impairment scale (oasis) and overall depression severity and impairment scale (odsis): adaptation and validation in buenos aires, argentina research articles overall anxiety severity and impairment scale (oasis) and overall depression severity and impairment scale (odsis): adaptation and validation in buenos aires, argentina rodrigo lautaro rojas 1 , camila florencia cremades 1 , milagros celleri 1 , cristian javier garay 1 [1] faculty of psychology, universidad de buenos aires, buenos aires, argentina. clinical psychology in europe, 2023, vol. 5(2), article e10451, https://doi.org/10.32872/cpe.10451 received: 2022-10-11 • accepted: 2023-02-15 • published (vor): 2023-06-29 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: rodrigo lautaro rojas, roma 2641 – buenos aires – argentina. e-mail: lautarorojas@psi.uba.ar supplementary materials: materials [see index of supplementary materials] abstract background: the oasis and odsis scales are two transdiagnostic brief 5-item instruments designed to assess the severity and functional impairment associated with symptoms of anxiety and depression, respectively. the present study aimed to adapt and validate the online versions of both scales in buenos aires, argentina. method: a sample of 344 women and men from the general population of buenos aires completed a test battery consisting of the oasis, the odsis, the beck depression inventory (bdi), the beck anxiety inventory (bai), the positive and negative affect scale (panas) and the multicultural quality of life index (mqli). descriptive statistics and item discrimination of both scales were analyzed, as well as their factorial structure, internal consistency, and convergent and discriminant validity, using the r programming language. results: the results showed a unidimensional factorial structure, excellent internal consistency, and adequate construct validity for both the oasis and the odsis. conclusion: these results supports the use of both scales as valid and reliable instruments to assess severity and interference due to anxiety and depression in the general population of buenos aires, argentina. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.10451&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0002-7153-5155 https://orcid.org/0000-0002-1051-6073 https://orcid.org/0000-0002-0102-339x https://orcid.org/0000-0003-4082-8876 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords anxiety, depression, adaptation, validation, psychometrics highlights • both scales are valid and reliable instruments for the assessment and detection of anxiety and depressive symptoms. • their availability is important for the reliable application of the unified protocol in our country. • they can be used in our context in an online format without compromising their psychometric properties. emotional disorders (barlow, 1991) are the most frequent psychological problems in the argentinian population. the lifetime prevalence of anxiety disorders reaches 16.4% and for major depressive disorder it reaches 8.7%, while their annual prevalence reaches 9.4% and 3.8%, respectively (stagnaro et al., 2018). additionally, both groups of disorders are costly (parés-badell et al., 2014; ruiz-rodríguez et al., 2017), interfering (kazdin & blase, 2011; olatunji et al., 2007) and highly comorbid problems (brown et al., 2001; brown & barlow, 2009). there are multiple tools to assess general anxiety and depression, such as the beck anxiety inventory (bai; beck et al., 1988; argentinian adaptation by vizioli & pagano, 2020) or the beck depression inventory (bdi; beck et al., 1996; argentinian adaptation by brenlla & rodríguez, 2006). similarly, there are also numerous instruments to assess symptoms associated with specific anxiety disorders, such as the penn state worry questionnaire (pswq; meyer et al., 1990; argentinian adaptation by rodríguez biglieri & vetere, 2011) for generalized anxiety disorder, and the panic disorder severity scale (pdss; shear et al., 1997) for panic disorder, not yet adapted to our setting. however, all of these instruments are limited to assessing the frequency and intensity of specific symptoms and do not offer a global measure of the severity and interference associated with these symptoms, either in established disorders or at subclinical levels (gonzález robles et al., 2018; norman et al., 2006). scales of this type do not adequately reflect the impact of symptoms on functioning (bentley et al., 2014) and are of little use in assessing the overall impact of treatment (ito, oe, et al., 2015). similarly, while scales designed to assess specific symptoms of specific diagnoses are ideal for detailed assessments, they are less useful in clinical settings when assessing comorbid cases (campbell-sills et al., 2009). additionally, the use of different scales can be time-consuming and impractical in settings such as primary care (campbell-sills et al., 2009; osma et al., 2019). in view of these problems, two scales have been developed to capture the severity and interference of anxious and depressive symptomatology in a brief and transdiagnostic manner–that is, regardless of the diagnostic category of these symptoms: the overall validation of oasis and odsis in argentina 2 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ anxiety severity and impairment scale (oasis; norman et al., 2006) and the overall depression severity and impairment scale (odsis; bentley et al., 2014). the oasis is a brief scale designed to assess the severity and interference associated with anxiety. it can be used with individuals with one or more anxiety disorders or with anxiety symptoms below the diagnostic threshold. it consists of 5 items referring to the past week and it’s scored on a likert-type scale ranging from 0 to 4. higher scores indicate greater anxiety-related severity and impairment. severity is captured by items that ask for the frequency and intensity of anxiety symptoms (e.g., "2. in the last week, when you have felt anxious, how intense or severe was your anxiety?"), while interference is measured by items that assess the impact of these symptoms on work/ school and social life. it also includes an item that evaluates avoidance as a specific symptom of anxiety. in its original version, it yielded a mean of 7.16 (sd = 3.05), excellent internal consistency (α = .80), a unifactorial structure and excellent convergent validity in a non-clinical sample (norman et al., 2006). the scale was developed to capture common domains of all anxiety disorders in a fast and simple way in demanding clinical settings such as primary care (gonzálezrobles et al., 2018), and to monitor changes in symptoms over the course of treatment (campbell-sills et al., 2009). it was validated in both clinical and non-clinical samples and in paper-and-pencil and online formats, showing excellent internal consistency and good convergent and discriminative validity (bragdon et al., 2016; campbell-sills et al., 2009; farrahi et al., 2020; gonzález-robles et al., 2018; hermans et al., 2015; ito, oe, et al., 2015; moore et al., 2015; norman et al., 2006; norman et al., 2011; osma et al., 2019; osma et al., 2021; sandora et al., 2021). different cut-off scores have been proposed to discriminate between people with clinical and subclinical anxiety in their different validations (see table 1). the odsis was developed based on the oasis in order to capture the severity and interference associated with depressive symptoms. it maintains the same structure of 5 items, which refer to the last week and are scored on a likert-type scale ranging from 0 to 4, with higher scores indicating greater severity and functional interference associated with depression (bentley et al., 2014). like the oasis, its items assess the frequency and intensity of depressive symptoms and their interference with work/school and social life (e.g., "5. in the past week, how much has depression interfered with your social life and relationships?"). the most notable difference is that the oasis item assessing avoidance was replaced by one assessing interference due to loss of interest and difficulty experiencing pleasure as a symptom of depression. in its original version, it yielded a mean of 5.50 (sd = 5.04), excellent internal consistency (α = .94), a unifactorial structure, and adequate convergent and discriminant validity in the clinical subsample (bentley et al., 2014). rojas, cremades, celleri, & garay 3 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ table 1 validations of the oasis authors country sample format m (sd) cutoff points bragdon et al. (2016) usa clinical sample (n = 202) paper-and-pencil ad: 9.63 (sd = 4.69) wad: 4.96 (sd = 4.26) – campbell-sills et al. (2009) usa clinical sample (n = 1036) paper-and-pencil 10.77 (sd = 4.02) 8 farrahi et al. (2020) iran students sample (n = 464) paper-and-pencil 4.83 (sd = 3.68) – gonzález-robles et al. (2018) spain clinical sample (n = 583) online 8.69 (sd = 4.21) 7.5 hermans et al. (2015) netherlands clinical sample (n = 257) paper-and-pencil ad: 8.46 (sd = 3.96) wad: 3.00 (sd = 3.51) 5 ito, oe, et al. (2015) japan clinical (n = 1667) and non-clinical sample (n = 1163) online clinical: 9.69 (sd = 5.55) non-clinical: 5.56 (sd = 4.91) 9 moore et al. (2015) usa clinical sample (n = 347) paper-and-pencil 9.35 (sd = 4.38) 8 norman et al. (2006) usa students sample (n = 711) paper-and-pencil 7.16 (sd = 3.05) – norman et al. (2011) usa students sample (n = 171) paper-and-pencil 6.61 (sd = 4.01) 8 osma et al. (2019) spain clinical sample (n = 339) paper-and-pencil 10.45 (sd = 4.49 10 osma et al. (2021) spain students sample (n = 382) online 3.92 (sd = 4.13) 4 sandora et al. (2021) czech republic non clinical sample (n = 2912) online 9.50 (sd = 4.25) 15 note. ad = anxiety disorders; wad = without anxiety disorders; sd = standard deviation. this scale was designed to be used across mood disorders and with depressive symptoms below the diagnostic threshold (bentley et al., 2014). it was validated in clinical and nonclinical samples and in paper-and-pencil and online formats, showing excellent internal consistency and good convergent and discriminative validity (bentley et al., 2014; ito, bentley, et al., 2015; mira et al., 2019; osma et al., 2019; osma et al., 2021; sandora et al., validation of oasis and odsis in argentina 4 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ 2021). different cut-off scores have been proposed to discriminate between people with clinical and subclinical depression in their different validations (see table 2). table 2 validations of the odsis authors country sample format m (sd) cutoff points bentley et al. (2014) usa 1. clinical sample (n = 100) 2. students sample (n = 566) 3. community sample (n = 189) paper-and-pencil 1. 5.50 (sd = 5.04) 2. 2.57 (sd = 3.36) 3. 5.16 (sd = 4.81) 8 ito, bentley, et al. (2015) japan clinical (n = 1667) and non-clinical sample (n = 1163) online clinical: 8.68 (sd = 6.32) non-clinical: 3.67 (sd = 4.87) 5 mira et al. (2019) spain clinical sample (n = 474) online 7.83 (sd = 4.90) 5 osma et al. (2019) spain clinical sample (n = 339) paper-and-pencil 9.87 (sd = 5.14) 10 osma et al. (2021) spain students sample (n = 382) online 2.79 (sd = 4.06) 5 sandora et al. (2021) czech republic non-clinical sample (n = 2912) online 8.73 (sd = 4.34) 12 note. m = mean; sd = standard deviation. the administration of instruments in online format has increased in recent years, due to advantages such as accessibility and ease of administration and scoring (van ballegooijen et al., 2016). although paper and online versions of the same instrument often correlate strongly, mean scores and psychometrics may differ (alfonsson et al., 2014), so specific validations need to be conducted for online administration. both the oasis and odsis were developed in paper-and-pencil format, and their online use requires specific valida­ tion in this format, as was conducted in other media (gonzález-robles et al., 2018; mira et al., 2019). considering that both anxiety disorders and depression are highly prevalent, comor­ bid and often associated with significant distress and interference, it is necessary to have transdiagnostic measures to capture the severity and interference associated with anxious and depressive symptomatology in our local environment. although there are rojas, cremades, celleri, & garay 5 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ instruments designed to assess symptoms of anxiety and depression that have been adapted and validated in our setting, none of them can quickly capture the severity and social and occupational interference associated with such symptomatology. the present study aims to carry out the linguistic, cultural and psychometric adaptation of the online versions of the oasis and odsis scales in the population of buenos aires, argentina. m e t h o d linguistic and cultural adaptation the adaptation of both instruments was carried out taking into consideration the rec­ ommendations of the international test commission (ict) for the adaptation of tests to other cultures (muñiz et al., 2013). the translation into spanish was carried out following a direct translation method by five independent translators and five judges who evaluated the quality of the translations on a likert scale from 1 (quite different) to 4 (identical). the translations that received the highest number of high scores (3 or 4) on the likert scale from the judges were selected to form the preliminary versions of both scales. with the preliminary version of the instrument, a pilot test was carried out with a sample of 12 individuals using google forms, in which the comprehension of the items was evaluated and a first analysis of the items was carried out. participants signed an informed consent form expressing their voluntary participation. the final adapted versions of both instruments can be found in appendices a and b (see supplementary materials). procedure the psychometric properties of the translated and culturally adapted versions of the oasis and the odsis were analysed. the recruitment of participants was non-probabil­ istic using the snowball method through the dissemination of flyers on social media. all participants gave their consent to participate in the study in which the confidentiality of the data, the purposes of the research and the possibility of withdrawing from the study at any time were clarified. all participants then completed a set of scales through a virtual google forms questionnaire. participants the sample consisted of 344 adults (18-65 years old) from the general population residing in the city of buenos aires (26.7%, n = 92), greater buenos aires (49.1%, n = 169) and the province of buenos aires (24.1%, n = 83), argentina. the mean age of the sample was 29.44 (sd = 10.62). the 80.5% identified with the female gender (n = 277), 19.2% with the male gender (n = 66) and the remaining 0.3% with a fluid gender (n = 1). in terms of validation of oasis and odsis in argentina 6 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ educational level, 56.1% had completed secondary school (n = 193), 43.3% had completed university (n = 149) and 0.6% had completed primary school (n = 2). instruments socio-demographic questionnaire as part of the test battery, an ad-hoc questionnaire was included in which the partici­ pants' age, gender, place of residence and level of education were asked. beck depression inventory ii (bdi ii) the bdi-ii (beck et al., 1996; argentinian adaptation by brenlla & rodríguez, 2006) is an inventory designed to assess depressive symptoms. it consists of 21 items referring to the past week and is scored on a likert-type scale from 0 (not at all) to 3 (severely). the higher the score, the greater the severity of the depressive symptomatology. the validation in our setting showed an adequate internal consistency with a cronbach's alpha coefficient of .88. beck anxiety inventory (bai) the bai (beck et al., 1988; argentinian adaptation by vizioli & pagano, 2020) is com­ posed of 21 items that assess the severity of anxiety symptoms. each item refers to specific anxiety symptoms and is scored on a likert-type scale from 0 (not at all) to 4 (it bothered me a lot). higher scores indicate greater severity of the anxiety symptomatolo­ gy. its validation in the local setting yielded a cronbach's alpha coefficient of 0.93. brief positive and negative affect schedule (panas) the panas (thompson, 2007; argentinian adaptation by moriondo et al., 2012) is an in­ strument designed to dimensionally measure positive and negative affect. in the present study, the short version of the instrument designed by thompson (2007) and adapted to argentina by moriondo et al. (2012) was selected, consisting of four subscales: trait positive affect (five items), trait negative affect (five items), state positive affect (five items) and state negative affect (five items). each item is scored on a likert-type scale from 1 (very little or not at all) to 5 (very much or completely). it was adapted in our context with a cronbach's alpha coefficient of .73 (.84 for negative affect and .75 for positive affect). multicultural quality of life index (mqli) the mqli (mezzich et al., 1996; argentinian adaptation by jatuff et al., 2007) is a self-administered instrument designed to assess quality of life in a brief, multicultural and multidimensional way. it consists of 10 items assessing different aspects of quality of life, each of which is scored on a likert-type scale from 1 (poor) to 10 (excellent). rojas, cremades, celleri, & garay 7 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ all sub-dimensions are summed to produce the global quality of life index. the higher the score, the higher the quality of life perceived. it was adapted to our setting with a cronbach's alpha of .85. overall anxiety severity and impairment scale (oasis) the oasis (norman et al., 2006) is a brief scale designed to measure the severity and interference associated with anxiety symptoms. it consists of 5 items inquiring about the frequency and intensity of anxiety symptoms, the interference caused by anxiety symptoms in school/work and social life and avoidance as a specific symptom of anxiety. each item consists of 5 response options on a likert-type scale from 0 (little or none) to 4 (extreme). it was adapted to spanish in spain with a cronbach's alpha of .86 (gonzález-robles et al., 2018). overall depression severity and impairment scale (odsis) the odsis (bentley et al., 2014) is a brief scale designed to measure the severity and interference associated with depressive symptoms. it consists of 5 items inquiring about the frequency and intensity of depressive symptoms, the interference caused by depres­ sive symptoms in school/work and social life and the difficulty experiencing pleasure and/or interest as a specific symptom of depression. each item consists of 5 response options on a likert-type scale ranging from 0 (little or none) to 4 (extreme). it was adapted to spanish in spain with a cronbach's alpha of .92 (mira et al., 2019). d a t a a n a l y s i s all analyses were carried out using the r programming language. first, the sociodemo­ graphic characteristics of the sample (n = 344) and the descriptive statistics (mean, variance, skewness and kurtosis) of both oasis and odsis items were analysed. prior to the analysis of the internal structure of both scales, the existence of adequate intercorrelation between items was assessed using the kaiser-meyer-olkin measure of sampling adequacy and bartlett's test of sphericity. to analyse the factor structure, a confirmatory factor analysis was carried out. following norman et al. (2006) and bentley et al. (2014), a one-factor model was tested for both scales. the fit of the models was assessed using the comparative fit index (cfi), the tucker-lewis index (tli) and the standardised mean squared error (srmr) as criteria. the following cut-off scores were used to determine a good fit: cfi and tli around .90 and srmr below 0.08 (marsh et al., 2004). for the analysis of internal consistency, both cronbach's alpha and omega coeffi­ cients were calculated (dunn et al., 2014). convergent and discriminant validity was explored by calculating pearson's r correlations between the oasis and odsis and well-established measures of anxiety (bai), depression (bdi), positive and negative affect validation of oasis and odsis in argentina 8 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ (panas) and quality of life (mqli). to interpret the correlation values, the p-value was calculated and the benchmarks for r-values proposed by hinkle et al. (2003) were used. r-values between .90 and 1.00 were considered very high, those between .70 and .90 were considered high, those between .50 and .70 were considered moderate and those between .30 and .50 were considered low. corrected item-total correlations were also calculated to analyze the discrimination of the items of both scales. we also wanted to explore the existence of differences in the scores of both scales regarding gender. for this purpose, a student's t-test for independent samples was per­ formed. because the criteria of normality and homoscedasticity of variances were not met in all groups, a wilcoxon test was also performed. finally, a linear regression was performed to determine whether age was a good predictor of change in severity levels of depression and anxiety. r e s u l t s descriptive analysis of the items the mean score of the oasis in the sample analysed was 6.52 (sd = 3.90). the mean, variance, skewness and kurtosis of each item were analysed. all items had skewness and kurtosis values between -1 and 1, suggesting a normal distribution (see table 3). table 3 mean, standard deviation, skewness, and kurtosis of oasis items item m sd skewness kurtosis 1 1.88 0.96 0.38 -0.43 2 1.62 0.86 0.01 -0.32 3 0.96 1.03 1 0.54 4 1.98 0.95 0.75 0.06 5 0.99 1.04 0.83 -0.06 as for the odsis, the mean score in the sample analysed was 4.48 (sd = 4.40). all items had skewness and kurtosis values between -1 and 1.03, suggesting a normal distribution (see table 4). item discrimination analysis item discrimination was calculated using corrected item-total correlations. all oasis items showed to discriminate adequately (r > .30) [item 1 (r = .66), item 2 (r = .68), item 3 (r = .65), item 4 (r = .73), item 5 (r = .67)]. similarly, the odsis items also showed rojas, cremades, celleri, & garay 9 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ adequate discrimination (r > .30) [(item 1 (r = .84), item 2 (r = .83), item 3 (r = .87), item 4 (r = .84), item 5 (r = .81)]. internal structure analysis first, the existence of adequate intercorrelation between items was assessed using the kaiser-meyer-olkin measure of sampling adequacy and bartlett's test of sphericity, ob­ taining evidence suggesting the feasibility of conducting a factor analysis for both the oasis (kmo = .83; χ2 = 227.86, gl = 10, p < .001) and the odsis (kmo = .87; χ2 = 452.48, gl = 10, p < .001). confirmatory factor analysis (cfa) was then conducted on the one-factor model proposed in previous research for the oasis (norman et al., 2006) and odsis (bentley et al., 2014). model fit was determined by the comparative fit index (cfi = .991 for the oasis; cfi = .999 for the odsis), the tucker-lewis index (tli = .982 for the oasis; tli = .997 for the odsis) and the standardised root mean square error (srmr = .061 for the oasis; srmr = .031 for the odsis), obtaining adequate goodness-of-fit indices. internal consistency analysis for the analysis of internal consistency, cronbach's alpha coefficient was calculated, obtaining a value of α = .90 for the oasis and α = .97 for the odsis. the omega coefficient yielded a value of ω = .93 for the anxiety scale and ω = .93 for the depression scale. convergent and discriminant validity pearson's r correlations between the oasis, the odsis and related scales are shown in table 5. a high and significant positive association was found between the oasis and the odsis, r(343) = .70, p < .01, the bdi, r(343) = .70, p < .01, and between the oasis and the bai, r(343) = .73, p < . 01. a moderate and significant positive association was table 4 mean, standard deviation, skewness, and kurtosis of odsis items item m sd skewness kurtosis 1 0.96 0.98 0.92 0.45 2 0.88 0.92 0.72 -0.19 3 0.89 1.05 1.02 0.2 4 0.77 0.93 1.03 0.15 5 0.77 1 1.02 1 validation of oasis and odsis in argentina 10 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ found between the oasis and the negative trait affectivity, r(343) = .61, p < .05, and state, r(343) = .54, p < .05, subscales of the panas. on the other hand, a moderate and significant negative association was found between the oasis and the mqli, r(343) = -.66, p < .01, and a low and significant negative association between the oasis and the positive trait affectivity, r(343) = -.46, p < .05, and state, r(343) = -.42, p < .01, subscales of the panas. table 5 correlations between oasis and odsis and other scales oasis odsis bdi bai mqli panast na panast pa panass na panass pa oasis – .70** .70** .73** -.66* .61* -.46* .54* -.42** odsis .70** – .73** .62** -.65** .51** -.49** .46** -.40** note. oasis = overall anxiety severity and impairment scale; odsis = overall depression severity and impairment scale; bdi = beck depression inventory; bai = beck anxiety inventory; mqli = multicultural quality of life index; panast = positive and negative affect scale trait; panass = positive and negative affect scale state; na = negative affect; pa = positive affect. *p < .05. **p < .01. a high and significant positive association was found between odsis and bdi, r(343) = .73, p < .01, a moderate and significant positive association between odsis and bai, r(343) = .62, p < .01, and the negative trait affectivity subscale, r(343) = .51, p < .01, of the panas and a low and significant positive association with the negative state affectivity subscale, r(343) = .46, p < .01. on the other hand, a moderate and significant negative association was found between the odsis and the mqli, r(343) = -.65, p < .01, and a low and significant negative association between the odsis and the positive trait, r(343) = -.49, p < .01, and state, r(343) = -.40, p < .01, subscales of the panas. differences according to gender and age differences in oasis and odsis scores were assessed regarding gender. a t-test was conducted to compare the oasis and odsis scores of those who reported identifying with the female gender and those who reported identifying with the male gender to explore the existence of significant gender differences. it was found that females scored significantly higher than males on both the oasis, t(107) = -2.76, p < .01, and odsis, t(117) = -2.91, p < .01. considering that the assumption of normality in the groups was not met, a wilcoxon test was also performed, which also yielded statistically significant differences for oasis, w = 10935, p < .05, and odsis, w = 10783; p < .05. finally, to assess whether age functioned as a good predictor of anxiety severity and interference, a linear regression was performed taking the oasis score as the dependent rojas, cremades, celleri, & garay 11 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ variable and age as the predictor variable. it was found that the higher the age, the lower the severity and interference due to anxiety, β = -0.10, f(1, 342) = 27.75, p < .001, r 2 = .07. the same procedure was performed to determine whether age functioned as a good predictor of severity and interference due to depression, finding that the older the age the lower the severity and interference due to depression, β = -0.10, f(1, 342) = 23.13, p < .001, r 2 = .06. d i s c u s s i o n the aim of the present study was to carry out the adaptation and validation of the oasis and odsis in the argentine population in an online format. the psychometric validation included the analysis of item discrimination, factorial structure, internal con­ sistency, convergent and discriminant validity, and differences in scores as a function of sociodemographic variables for both scales. considering only those adaptations that took participants from the general popula­ tion, both the oasis (m = 6.52; sd = 3.90) and the odsis (m = 4.48; sd = 4.40) yielded mean scores higher than those obtained in the japanese (ito, oe, et al., 2015; ito, bentley, et al., 2015) adaptations, but lower than those obtained in the czech study (sandora et al., 2021). the latter may be due to the fact that in the czech study the data were collected during the covid-19 pandemic, which may have influenced the scores obtained. also, the odsis yielded higher mean scores than those obtained in the non-clinical subsample of the original validation (bentley et al., 2014). the higher scores obtained in local adap­ tations compared to japanese or american ones may be linked to the high prevalence of problems linked to anxiety and depression in argentina (stagnaro et al., 2018). on the other hand, taking into account the adaptations that were performed in online format, as expected the local adaptations presented lower scores than those that took a clinical sample (gonzález-robles et al., 2018; mira et al., 2019) but higher than the one that took a sample of students (osma et al., 2021). however, all the above comparisons should be taken with caution because there have been no studies investigating the cross-cultural measurement invariance of these scales. the 5 items of both scales were found to discriminate adequately (r > .30), indicating that they allow to distinguish between people with different levels of severity and interference due to anxiety and depression, respectively. as in previous research (bentley et al., 2014; norman et al., 2006; osma et al., 2019), confirmatory factor analysis revealed a unidimensional factor structure with strong factor loadings for all items of both scales. regarding reliability, both the oasis and the odsis demonstrated excellent internal consistency in the sample of argentinian participants (α = .90 and ω = .93. for the oasis and α = .97 and ω = .93. for the odsis), showing values similar to those of previous validations performed in the general validation of oasis and odsis in argentina 12 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ population (bentley et al., 2014; ito, bentley, et al., 2015; ito, oe, et al., 2015; sandora et al., 2021). regarding construct validity, significant positive correlations were found between the oasis and the bai and between the odsis and the bdi, providing evidence for the convergent validity of both scales with two of the most widely used instruments for the assessment of anxiety and depression. the fact that significant positive correlations were also found between the oasis and the odsis, the bdi and the panas subscales of trait and state negative affect, but lower than that found for the bai, is interpreted as evidence of the discriminant validity of the instrument. likewise, the fact that significant positive correlations were also found between the odsis and the oasis, the bai and the negative trait and state affect subscales of the panas, but lower than that found in relation to the bdi, is interpreted as evidence of the instrument's discriminant validity. taken together, these findings provide evidence of adequate construct validity for both the oasis and the odsis, in agreement with previous research (gonzález-robles et al., 2018; mira et al., 2019; osma et al., 2019; osma et al., 2021). in contrast to previous adaptations (gonzález-robles et al., 2018; ito, bentley, et al., 2015; ito, oe, et al., 2015; mira et al., 2019), significant differences were found in the oasis and odsis total scores as a function of gender and age. individuals who identified with the female gender scored significantly higher on both scales than males, which is consistent with previous literature that indicates that argentinian women are 85% more likely to suffer from anxiety disorders than men (stagnaro et al., 2018). furthermore, in line with the research by stagnaro et al. (2018), which reported a higher prevalence of emotional disorders in younger individuals, it was found that the levels of severity and interference due to anxiety and depression decrease with increasing age. the older the age, the lower the severity and interference due to anxiety and depression. in sum, the results of the present study are consistent with those obtained in previous validations performed in the general population (bentley et al., 2014; ito, bentley, et al., 2015; ito, oe, et al., 2015; sandora et al., 2021), and support the oasis and odsis scales as valid and reliable instruments to assess the severity and functional interference due to anxiety and depression in the general population of buenos aires, argentina. this is the first study to evaluate the psychometric properties of the oasis and odsis scales in argentina. having instruments adapted to our environment that allow us to measure the severity of anxiety and depression and their level of interference in daily functioning is essential to assess and detect both groups of disorders, which are highly prevalent in our population (stagnaro et al., 2018), whether they occur in isolation or in comorbidity, both in clinical and non-clinical settings. their availability is also a first step for the reliable application of the unified protocol, a transdiagnostic treatment designed to address emotional disorders that uses both scales to measure the patient's change in anxiety and depressive symptomatology on a weekly basis (barlow et al., 2011). rojas, cremades, celleri, & garay 13 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ furthermore, and in line with previous research (gonzález-robles et al., 2018; ito, bentley, et al., 2015; ito, oe, et al., 2015; mira et al., 2019), the results also suggest that both the oasis and the odsis can be used in our setting in an online format without compromising their psychometric properties. having adapted instruments in online format is important because it enables their use in the context of internet-based interventions, which have proliferated in recent decades in the field of cognitive-be­ havioral therapies (andersson et al., 2019). the development of these interventions is especially important in argentina, where access to evidence-based treatments is difficult and the inclusion of the technology in academia is still scarce (distéfano et al., 2015). the availability of both scales in online format represents a contribution to this promising field in argentina. limitations limitations of the study include the fact that the sample consisted of people from the general population of buenos aires, which limits the generalizability of the results to clinical settings and people from another regions of the country. in addition, no methods were used to guarantee whether the participants were receiving psychological treatment or have an actual mental disorder. also, the mean age of the participants was very young and the educational level very high, which may have been related to the method chosen to reach them. another limitation was that the proportion of males and females was not balanced, which may have affected the representativeness of the results. unlike previous studies (sandora et al., 2021), the comparison between men and women was performed without having calculated measurement invariance between both genders because the sample size was smaller than recommended in the literature (<100) to calculate it (meade & bauer, 2007; putnick & bornstein, 2016). finally, unlike previous adaptations, test-retest reliability, sensitivity to change and cut-off scores for both scales could not be established in our population. it would be desirable for future research to consider these aspects and analyse them in a clinical sample. funding: research institute, university of buenos aires. acknowledgments: we would like to thank all the people who served as translators and judges, and who kindly collaborated with this adaptation: arias, ricardo; bendinger, mayra; bregman, claudia; fabrissin, javier; facio, alicia; gallagher, paula; korman, guido; rutsztein, guillermina; sarudiansky, mercedes; tenreyro, cristina; vizioli, nicolás; wolfzun, camila. competing interests: the authors have declared that no competing interests exist. data availability: materials and analysis code for this study are available by emailing the corresponding author. validation of oasis and odsis in argentina 14 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • appendix a: presents the argentine version of the overall anxiety severity and impairment scale (oasis) • appendix b: presents the argentine version of the overall depression severity and impairment scale (odsis). index of supplementary materials rojas, r. l., cremades, c. f., celleri, m., & garay, c. j. (2023). supplementary materials to "overall anxiety severity and impairment scale (oasis) and overall depression severity and impairment scale (odsis): adaptation and validation in buenos aires, argentina" [argentine versions of the oasis and odsis]. psychopen gold. https://doi.org/10.23668/psycharchives.12903 r e f e r e n c e s alfonsson, s., maathz, p., & hursti, t. (2014). interformat reliability of digital psychiatric self-report questionnaires: a systematic review. journal of medical internet research, 16(12), article e268. https://doi.org/10.2196/jmir.3395 andersson, g., titov, n., dear, b. f., rozental, a., & carlbring, p. (2019). internet‐delivered psychological treatments: from innovation to implementation. world psychiatry, 18(1), 20–28. https://doi.org/10.1002/wps.20610 barlow, d. h. (1991). disorders of emotion. psychological inquiry, 2(1), 58–71. https://doi.org/10.1207/s15327965pli0201_15 barlow, d. h., farchione, t. j., fairholme, c. p., ellard, k. k., boisseau, c. l., allen, l. b., & ehrenreich-may, j. (2011). the unified protocol for transdiagnostic treatment of emotional disorders: therapist guide. oxford university press. beck, a. t., epstein, n., brown, g., & steer, r. a. (1988). an inventory for measuring clinical anxiety: psychometric properties. journal of consulting and clinical psychology, 56(6), 893–897. https://doi.org/10.1037/0022-006x.56.6.893 beck, a. t., steer, r. a., & brown, g. k. (1996). manual for the beck depression inventory ii. psychological corporation. bentley, k. h., gallagher, m. w., carl, j. r., & barlow, d. h. 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(2007). development and validation of an internationally reliable short-form of the positive and negative affect schedule (panas). journal of cross-cultural psychology, 38(2), 227–242. https://doi.org/10.1177/0022022106297301 van ballegooijen, w., riper, h., cuijpers, p., van oppen, p., & smit, j. h. (2016). validation of online psychometric instruments for common mental health disorders: a systematic review. bmc psychiatry, 16(1), article 45. https://doi.org/10.1186/s12888-016-0735-7 vizioli, n. a., & pagano, a. e. (2020). adaptación del inventario de ansiedad de beck en población de buenos aires [adaptation of the beck anxiety inventory in a buenos aires population]. interacciones, 6(3), article e171. https://doi.org/10.24016/2020.v6n3.171 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. rojas, cremades, celleri, & garay 19 clinical psychology in europe 2023, vol. 5(2), article e10451 https://doi.org/10.32872/cpe.10451 https://apsa.org.ar/docs/vertex142.pdf https://doi.org/10.1177/0022022106297301 https://doi.org/10.1186/s12888-016-0735-7 https://doi.org/10.24016/2020.v6n3.171 https://www.psychopen.eu/ validation of oasis and odsis in argentina (introduction) method linguistic and cultural adaptation procedure participants instruments data analysis results descriptive analysis of the items item discrimination analysis internal structure analysis internal consistency analysis convergent and discriminant validity differences according to gender and age discussion limitations (additional information) funding acknowledgments competing interests data availability supplementary materials references the phenomenon of treatment dropout, reasons and moderators in acceptance and commitment therapy and other active treatments: a meta-analytic review research article the phenomenon of treatment dropout, reasons and moderators in acceptance and commitment therapy and other active treatments: a meta-analytic review maria karekla a, pinelopi konstantinou a, myria ioannou a, ioannis kareklas b, andrew t. gloster c [a] university of cyprus, nicosia, cyprus. [b] university at albany, new york, ny, usa. [c] university of basel, basel, switzerland. clinical psychology in europe, 2019, vol. 1(3), article e33058, https://doi.org/10.32872/cpe.v1i3.33058 received: 2019-01-13 • accepted: 2019-05-09 • published (vor): 2019-09-20 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: maria karekla, department of psychology, university of cyprus, p.o. box 20537, nicosia 1678, cyprus. tel: 357 22 892100; fax: 357 22 892071. e-mail: mkarekla@ucy.ac.cy abstract background: treatment dropout is one of the most crucial issues that a therapist has to face on a daily basis. the negative effects of premature termination impact the client who is usually found to demonstrate poorer treatment outcomes. this meta-analysis reviewed and systematically examined dropout effects of acceptance and commitment therapy (act) as compared to other active treatments. the goals of this study were to compare treatment dropout rates and dropout reasons, examine the influence of demographic variables and identify possible therapy moderators associated with dropout. method: the current meta-analysis reviewed 76 studies of act reporting dropout rates for various psychological and health-related conditions. results: across reviewed studies (n = 76), the overall weighted mean dropout rate was 17.95% (act = 17.35% vs. comparison conditions = 18.62%). type of disorder, recruitment setting and therapists’ experience level were significant moderators of dropout. the most frequently reported reasons for dropout from act were lost contact, personal and transportation difficulties, whereas for comparative treatments they were lost contact, therapy factors and time demands. conclusion: given that most moderators of influence are not amenable to direct changes by clinicians, mediation variables should also be explored. overall, results suggest that act appears to present some benefits in dropout rates for specific disorders, settings and therapists. keywords acceptance and commitment therapy, dropout, attrition, meta-analysis, premature termination this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i3.33058&domain=pdf&date_stamp=2019-09-20 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • there was no difference in dropout rate between act and control conditions (17.35% vs.18.62%). significant moderators were client disorder, therapists’ experience level and recruitment and setting. • comparison condition frequently reported therapy related dropout factors, suggesting that act may be a more acceptable option. acceptance and commitment therapy (act), is a so-called third wave cognitive behav‐ ior therapy (cbt) and has been applied successfully to treat numerous problems and dis‐ orders (hayes, luoma, bond, masuda, & lillis, 2006; ruiz, 2012). act helps clients choose to do what takes them closer to their goals (especially when dealing with prob‐ lematic thoughts and emotions) rather than aiming to reduce symptoms directly (hayes, hayes, strosahl, & wilson, 2012). the focus is placed on the experience of the person and the function of any behavior rather than on actions being carried out based on the literal content of a belief (hayes et al., 2006). the overall aim of treatment is to increase psycho‐ logical flexibility or the ability to fully contact the present moment, choosing to act gui‐ ded by the person’s values in the context at hand (fletcher & hayes, 2005). most existing reviews and meta-analyses of act support that it is at least as equally effective as tradi‐ tional cognitive behavioral therapy (tcbt) on indices of symptom reduction and more effective than other comparison conditions (a-tjak et al., 2015; powers, vörding, & emmelkamp, 2009; ruiz, 2012). treatment outcomes and effectiveness, however, are affected not only by the specific treatment provided but also by other factors such as premature termination/dropout or non-completion of the specified interventions (barrett, chua, crits-christoph, gibbons, & thompson, 2008). premature therapy termination or treatment dropout is a significant problem or obstacle limiting the effectiveness of any therapeutic approach and results in detrimental outcomes in patients (barrett et al., 2008; wierzbicki & pekarik, 1993). un‐ fortunately, there is no consensus definition about what constitutes treatment dropout. general definitions of dropout include: termination of the intervention prior to the pa‐ tient recovering from the problem(s) for which treatment was initially sought (hatchett & park, 2003; swift, callahan, & levine, 2009), or treatment termination without the agreement of the therapist and before the scheduled end point (stone & rutan, 1984). however, in research protocols premature termination may be considered as missing a number of pre-arranged sessions (e.g., four consecutive weeks in dbt; linehan, 1993) ir‐ respective of the patient’s recovery status. reviews and meta-analyses of this phenomenon focus on examining first the rates of dropout and, secondly, variables associated with its occurrence. swift and greenberg (2012) examined dropout definition as a moderator of dropout rates and found higher rates when the therapist judged dropout status, compared to other definitions. this was treatment dropout in act 2 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ one of the first comprehensive reviews of the dropout phenomenon encompassing vari‐ ous forms of psychotherapy and concluded that 1 in 5 clients drop out prematurely, a rate somewhat lower than previous reviews (e.g., wierzbicki & pekarik, 1993). client diagno‐ sis, age, education, gender, marital status, time-limitations of treatment, use of manual or protocol, treatment setting, providers’ level of experience, dropout definition, study type and search strategy were found to be significant moderators of dropout. however, this meta-analysis did not include studies of third wave psychological treatments, like act. moreover, it focused only on adult populations and did not include substance or alcohol abuse disorders, health-related problems (e.g., weight management, emotional burnout), and self-help interventions. finally, it focused on providing a broad analysis of premature discontinuation in psychological treatments and not on reasons for dropout. this study aims to examine the dropout phenomenon in act (compared to other ac‐ tive interventions) because of act’s emphasis on connecting clients with their deeply held values and through this process to motivate them towards behavior change. if act is successful in mobilizing individuals via the treatment process, we expect that this would prevent premature termination and thus act would result in lower dropout rates compared to other interventions. to date, only one meta-analysis on dropout has inclu‐ ded act (ong, lee, & twohig, 2018). this study found that only therapist experience sig‐ nificantly predicted dropout, specifically that when act was provided by master’s level therapists higher dropout rates were observed, compared to other levels of therapists’ ex‐ perience (e.g., phd level psychologist, md physician, graduate student). however, under‐ standing dropout in act can be further facilitated in four important ways. first, inclu‐ sion of variables found to predict dropout in previous meta-analyses (e.g., gender, race, marital status, employment and years of education) will allow for comparison across studies and methods (e.g., swift & greenberg, 2012). second, inclusion of variables that assess how the therapy and study were implemented (e.g., length of intervention, hours of intervention, setting, definition of dropout, study type, year of publication and region) can reveal clues as to how interventions can actively minimize dropout. third, testing the reasons and timing of dropouts provides hypotheses for researchers and therapists to ac‐ tively intervene to prevent this phenomenon of paramount clinical significance. finally, some methodological details regarding comparison groups are worthy of reexamination. for example, we believe that including waitlist control conditions in the comparisons may bias the dropout findings in favor of waitlist control. this is because people on the waitlist are fundamentally different to patients in a control condition. in the waitlist, pa‐ tients usually maintain hope that things will get better once the treatment begins and are not motivated to actively change during the waiting period. when clients do drop out during this period, by definition it has nothing to do with the active treatment. thus a cleaner comparison of treatment dropout should be carried out between different active treatments (including active controls). towards this goal, comparative conditions should be other active interventions. karekla, konstantinou, ioannou et al. 3 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ a minority of patients may drop out because they improved or met their goals; how‐ ever numerous individuals drop out because of a problem with the treatment or thera‐ pists or for other unforeseen circumstances. specifically, proposed problems or reasons associated with increased dropout rates include: client demographic characteristics (e.g., younger age, female gender, low socioeconomic status; wierzbicki & pekarik, 1993); type of psychopathological difficulties (e.g., eating or personality disorders); therapist charac‐ teristics (e.g., provider in training); therapy setting (e.g., university-based clinics); and specific factors (e.g., non-time limited therapy), and environmental variables or acute problems that take greater priority (bados, balaguer, & saldaña, 2007; roe, dekel, harel, & fennig, 2006; swift & greenberg, 2012). researching these reasons is difficult as variables and methods vary widely depend‐ ing on the study and its focus, the population studied, the treatment setting or the treat‐ ment offered (roe et al., 2006; todd, deane, & bragdon, 2003). however, there is an agreement that certain common reasons account for dropout. these include: lack of im‐ provement or accomplishment of goals, dissatisfaction with the treatment, and environ‐ mental obstacles and constraints (hunsley, aubry, verstervelt, & vito, 1999; pekarik, 1992; roe et al., 2006; todd et al., 2003). in addition to common factors, clients report spe‐ cific reasons for discontinuation, including: external circumstantial problems and difficul‐ ties (e.g., transportation problems, moving away, timetables), illness and new responsibil‐ ities, improvement due to therapy, satisfactory achievement of treatment goals, high treatment costs, dissatisfaction with the therapist and psychotherapy, no need for serv‐ ices and need for independence and trying to solve problems without therapy (bados et al., 2007; roe et al., 2006; todd et al., 2003). interestingly, very little attention has been given to the timing during treatment when premature termination occurs and most studies do not even report this information. some have proposed that the first two sessions are critical for premature termination, given that most dropouts (70%) occur at this point, making it a critical period to success‐ fully engage the client in treatment (olfson, mojtabai, sampson, hwang, & kessler, 2009). karekla (2004) observed that in a comparison trial of cbt vs. act for panic disorder, though dropout rates between the two approaches were similar, most individuals who dropped out in the cbt condition did so immediately after the introduction of exposure. such a pattern was not evident for the act group, where individuals dropped out at var‐ ious times during treatment unrelated to specific treatment components. it was conclu‐ ded that act might present an advantage over cbt not in terms of symptom reduction but that it may better prepare individuals to engage in exposure of previously avoided internal and external events and in dealing with the dropout problem. to date, none of the reported reviews or meta-analyses of act have examined in depth dropout, dropout reasons, extensive list of moderators, and compared to active treatments. treatment dropout in act 4 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ current study the purpose of this study is to examine dropout rates, dropout reasons’ associated fac‐ tors, and potential moderators of dropout, in act compared to active comparison condi‐ tions. the goals of this study were to: (i) compare treatment dropout rate and timing be‐ tween act and other active treatments; (ii) examine the influence of demographic varia‐ bles such as age, gender, treatment setting, race, education, duration of treatment, ethnic‐ ity and diagnosis on dropout; (iii) identify possible therapy-associated moderators of dropout; and (iv) examine timing and possible reasons for dropout. m e t h o d this review was registered in the international prospective register of systematic re‐ views (see supplementary materials). literature search the literature search was conducted using the computerized literature databases google scholar, ebscohost (academic search ultimate, medline, psychology and behavioral sci‐ ences collection, psycarticles, psychinfo, opendissertations) and science direct (until june 2018) with the following keywords based on title: “acceptance and commitment training”, “acceptance-based behavior therapy”, “act-based”, “experiential avoidance”, “psychological flexibility”, “rft-based”, “cbs-based”, “third wave cbt therapies” “ac‐ ceptance and commitment therapy”, and “act”; alone first and then also combined with the terms “drop out” or “dropout” or “discontinuation” or “outcome” or “premature termi‐ nation” or “termination”. the reference lists of all identified articles were examined for additional potentially eligible studies, as well as existing meta-analyses and reviews. a request for unpublished studies was sent to the acceptance and commitment therapy (act) listserv (https://contextualscience.org/emailing_lists), as well as to the primary or secondary authors of identified articles, via email. eligibility criteria identification and selection of the included studies was performed by the second author, a clinical psychology doctoral student, who was first trained and instructed in the proce‐ dure of conducting meta-analysis by the first and last authors. everything was checked by the first author. the last three authors all have experience in meta-analysis and served to check all steps taken in the process of this study. this study includes all published and unpublished (e.g., dissertation) acceptance and commitment therapy studies that included dropout information and met the following criteria. studies were included if they: (1) were in english, (2) reported dropout rates after beginning psychotherapy or reported no dropouts (i.e., all participants completed treat‐ karekla, konstantinou, ioannou et al. 5 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://contextualscience.org/emailing_lists https://www.psychopen.eu/ ment), and (3) used an active comparison condition. studies were excluded if: (a) data ori‐ ginated from the same sample as another included study (so as to avoid violating the meta-analytic assumption of data independence); (b) information to calculate effect sizes was lacking and contact with authors was not possible; and (c) case studies. the literature search resulted in 4399 articles in total. after screening the titles and abstracts, and following the examination of the full papers, 76 studies met all aforemen‐ tioned inclusion criteria and were retained for analysis (see figure 1 for procedure de‐ tails). based on the rosenthal’s suggestions for computing the fail-safe n, it was found that the total z value was -1.181 and the number of missing studies we would need to retrieve and incorporate to result in a non-significant p-value was 147 studies (see also borenstein, hedges, higgins, & rothstein, 2009). coding procedures treatment dropout was defined as the percentage of patients who began treatment, but according to the author(s) dropped out prematurely, thus utilizing the author(s)’ defini‐ tion. for reliability and validity purposes we included only studies that reported dropout rates during treatment and not prior to treatment initiation. participant, therapist, treatment and study characteristics were coded (see table 1 for details about coding of each of the variables). eight participant characteristics included: client disorder, gender, age, race, marital status, employment, years of education and pop‐ ulation. eight treatment variables were comparison condition, treatment status, length of intervention, length of intervention in sessions, hours of intervention, format of treat‐ ment, treatment setting and description of treatment setting (as per swift & greenberg, 2012). two treatment provider variables regarding experience level: 1) experience level of act therapists, and 2) experience level of therapists in comparison groups. finally, four study variables included: definition of dropout, study type, year of publication and re‐ gion. the second and third authors coded all variables separately and these were checked for accuracy by the first authors. there was a 95% agreement rate between coders with disa‐ greements resolved via a consensus among the authors (for further coding details contact the authors). treatment dropout in act 6 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ figure 1. flow chart of information from identification to inclusion of studies in this review. karekla, konstantinou, ioannou et al. 7 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ table 1 details regarding the coding of each of the variables participant characteristics client disorder anxiety disorder (including social phobia, public speaking anxiety, generalized anxiety disorder and obsessive compulsive disorder), depression, substance abuse or dependence, chronic pain (including fibromyalgia, osteoarthritis and headaches), eating pathology/disorder (including diabetes, obesity, weight problems and eating disorders), health conditions and chronic illnesses (i.e. parkinson’s disease, multiple sclerosis, brain injury, cancer and hiv), smoking, other health problems (stress, distress, physical activity, tinnitus, procrastination and sickness absence) and severe psychopathology (including borderline personality disorder, treatment resistant and psychosis) gender percentage of female participants in each study age average age in years of participants in each sample race percentage of white (including caucasian, australian and european), black (including african american) and other (hispanic, latino, asian american/ pacific islander, native american, alaskan american and american indian/ alaskan native) marital status percentage of participants who were single (non-married, never married, divorced, separated or widowed) vs. married (cohabiting, living with partner/spouse/family or in a relationship) employment percentage of participants who were working, either full-time or part-time years of education participants’ average number of completed education years in each study. in cases where the mean number of education in years was not provided, we calculated this based on the data reported. population adults or children and adolescents treatment variables comparison condition cbt, treatment as usual (tau; studies in which tau consisted of only administrating medication were coded as medication only), medication only (i.e., medication treatment as usual plus enhanced assessment and monitoring, recommended pharmacological treatment, specialty medical management, methadone maintenance, selective serotonin reuptake inhibitors, medical treatment as usual, nicotine replacement treatment and bupropion regimen), other active treatment (i.e., narcotics anonymous, applied behavior analysis, smokefree.gov, online discussion forum, usual care, counseling services, workplace dialogue intervention, presentcentered therapy, physical exercise, drug counseling, tinnitus retraining therapy and expressive writing), component of cbt (including progressive relaxation training, systematic desensitization, applied relaxation, cognitive therapy, stress inoculation training, relaxation training) and education only (education, befriending, pedometer-based walking program) treatment status providing any treatment/training to the comparison condition or not length of intervention total length of treatment in weeks (in cases where months were reported, each month was calculated to equal 4 weeks) length of intervention in sessions total number of treatment sessions hours of intervention the overall duration of intervention in hours format of treatment individual, self-help (including web-based and online format), group, or combination (group & individual) treatment setting outpatient, inpatient or self-help (including web-based and online format) description of treatment setting university affiliated clinic (psychology department training clinic and university counseling center), outpatient clinic affiliated with a hospital or medical school, public/community outpatient clinic, research/specialty clinic, private outpatient clinic/practice, therapy took place at participant’s home (i.e., web-based/online intervention or self-help) and inpatient or residential treatment treatment dropout in act 8 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ treatment provider variables experience level of act therapists master level therapists or doctoral students/interns/residents, doctoral level or licensed therapists, mix of doctoral level, student trainees, and others (e.g., licensed clinicians, psychiatrists, social workers, psychiatric nurses), no therapists (i.e., for online/web-based or self-help formats), mix of different psychologist levels and non-psychologists (e.g. drug staff, alcohol counselor, physician, psycho-pharmacologist) experience level of therapists in comparison groups. master level therapists or doctoral students/interns/residents, doctoral level or licensed therapists, mix of doctoral level, student trainees, and others (e.g., licensed clinicians, psychiatrists, social workers, psychiatric nurses), no therapists (i.e. it was applicable for online/web-based or self-help formats), mix of different psychologist levels, psychiatrists and non-psychologists (e.g. drug staff, alcohol counselor, physician, psycho-pharmacologist). study variables definition of dropout failed to complete treatment/discontinued treatment/left before treatment end, or refused to return to treatment, failed to attend all sessions, failed to submit pre and post treatment data and attended less than or equal to either: 25-40%, 50-75% or 76-90% of total sessions study type efficacy (i.e., studies that emphasize internal validity) or effectiveness (i.e., emphasize external validity of the experimental design). if the study type was not specifically reported, efficacy was coded as studies utilizing: (a) strict exclusion criteria, (b) careful pre-selection of clients, (c) treatment following a strict protocol and was more controlled than effectiveness studies, (d) randomization of participants to treatments, and/or (e) therapists receiving training before and supervision during the study year of publication region in which each study was conducted data analysis first, the dropout rate for each study condition (act vs. comparison group) was calcula‐ ted (i.e., the total number of patients who dropped out of each treatment group, out of the total number of patients included in each group). then, the weighted average drop‐ out rate (i.e., weighted dropout rate for each study condition based on the total number of patients included in the study) was computed for each of the 76 included studies. the number of participants dropped from each group was included in the comprehensive meta-analysis software (cma; version 2.0, biostat, englewood, nj), along with the sam‐ ple size of each group (treatment and comparison). odds ratio was then computed. odds ratios higher than 1 suggest that dropout rates are higher in the intervention versus the comparison condition (i.e., comparison group is better). random-effects models were used to estimate the effect size of rate ratio in the inclu‐ ded studies, as the assumptions of random-effect models suggests that study characteris‐ tics influence the true effect of treatments, and that sampling error varies between stud‐ ies (dersimonian & kacker, 2007). the q statistic and the i2 statistic were calculated. ran‐ dom-effects models are considered appropriate when there is significant heterogeneity (p < .05) according to the q index, and when heterogeneity is high (>75%) based on the i 2 index. first, an unconditioned model without having any predictors or moderators was cal‐ culated using cma, in order to detect the general rate ratio of dropouts between treat‐ karekla, konstantinou, ioannou et al. 9 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ ment and comparison conditions. in order to examine if the results of the general model were subject to biases related to the publication of studies with favorable outcomes, pub‐ lication bias was investigated by assessing the asymmetries evident in a funnel plot, with the egger’s regression test (egger, smith, schneider, & minder, 1997) and the begg and mazumdar test (kendall’s statistic). a stratified subgroup analyses was then run in order to test the moderating role of categorical study characteristics and meta-regression anal‐ yses to test the moderating role of continuous study characteristics. q statistic was calcu‐ lated for the subgroup analyses, in order to examine if the differences detected between the mean effect sizes of the groups of studies with a particular characteristic were signifi‐ cant. the meta-regression analyses were computed using a general mixed-effects meth‐ od-of-moments (kacker, 2004) estimate for the inter-study variance τ2 (dersimonian & kacker, 2007). r e s u l t s characteristics of reviewed studies all identified studies were included in the meta-analysis; no structured qualitative assess‐ ment of the reviewed articles was performed. the large majority of included studies em‐ ployed a randomized controlled trial design, or at least a controlled trial design. this sug‐ gests that all studies are at least of a moderate methodological quality (petrisor & bhandari, 2007), and attempted to compare act to an active treatment comparison con‐ dition. see table 2 for characteristics of included studies. most studies dealt with the treat‐ ment of anxiety (n = 14, 18.4%) and chronic pain (n = 14, 18.4%); and targeted adults (n = 73, 96.1%) using a group treatment format (n = 34, 44.7%). act was compared mostly with tau (n = 17, 22.4%) and cbt (n = 17, 22.4%). most studies were delivered in an out‐ patient setting (n = 60, 78.9%) and participants were most frequently recruited via com‐ munity advertisements (n = 21, 27.6%). treatment in act groups was delivered mostly by psychologists of various training levels (n = 19, 25%) and licensed or doctoral level psy‐ chologists (n = 15, 19.7%). in comparison group treatment was provided mostly by a mix of doctoral level, student trainees and others (n = 15, 19.7%) and a mix of psychologists with different training levels (n = 13, 17.1%). the most frequent definition of dropout was “failed to complete treatment, left treatment prior to its end, or refused to return to treat‐ ment” (n = 53, 69.7%). finally, efficacy-type studies (n = 42, 55.3%) were more than effec‐ tiveness-type studies (n = 34, 44.7%). treatment dropout in act 10 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ ta bl e 2 c ha ra ct er is ti cs o f st ud ie s in cl ud ed in t he m et aa na ly si s (n = 7 6) st ud y & r eg io n d is or de r n c on tr ol g ro up (s ) % d ro po ut a c t % d ro po ut co n tr ol gr ou p( s) m ea n a ge % f em al e se tt in g fo rm at t x w ee k s a ba d et a l. (2 01 6) ; a si a c an ce r 36 c bt 0. 00 16 .6 6 n i 10 0 ο g n i a lo ns ofe rn án de z et a l. (2 01 6) ; eu ro pe c p 10 1 m s 43 .4 0 29 .1 7 83 78 o g 9 a rc h et a l. (2 01 2) ; u s a nx ie ty 12 8 c bt 35 .0 9 32 .3 9 38 52 o in d 12 a vd ag ic , m or ri ss ey , & b os ch en (2 01 4) ; a us tr al ia g a d 51 c bt 12 .0 0 23 .0 8 36 67 o g 6 a zk ho sh e t a l. (2 01 6) ; a si a su bs ta nc e a bu se 60 n ar co tic s a no ny m ou s 20 .0 0 15 .0 0 27 n i o i 12 be th ay e t a l. (2 01 3) ; u s in te lle ct ua l d is ab ili ty 34 a ba 10 .0 0 11 .1 1 38 77 o g 3 br ic ke r et a l. (2 01 3) ; u s sm ok in g 22 2 sm ok ef re e. go v 45 .9 5 46 .8 5 45 62 s s 3 bu hr m an e t a l. (2 01 3) ; e ur op e c p 76 o nl in e d is cu ss io n fo ru m 15 .7 9 15 .7 9 49 59 s s 7 bu tr yn e t a l. (2 01 1) ; u s ph ys ic al a ct iv ity 54 ed uc at io n 20 .0 0 5. 26 23 10 0 o g 3 c la rk e et a l. (2 01 4) ; e ur op e tr ea tm en t r es is ta nt 61 ta u -c bt 13 .3 3 22 .5 8 43 67 o g 16 c la rk e et a l. (2 01 7) ; e ur op e o st eo ar th ri tis 31 u su al c ar e 31 .2 5 0. 00 67 71 o g 6 c ra sk e et a l. (2 01 4) ; u s sp 87 c bt 20 .6 9 36 .3 6 28 46 o in d 12 d av ou di e t a l. (2 01 7) ; a si a sm ok in g 70 o th er a ct iv e tr ea tm en t 2. 86 5. 71 30 0 o in d 8 d jo rd je vi c & f rö gé li (2 01 2) ; e ur op e st re ss 11 3 ta u 28 .9 9 29 .5 5 25 79 o g 6 en gl an d et a l. (2 01 2) ; u s a nx ie ty 45 h a b 23 .8 1 20 .8 3 32 80 o g 6 fi nn es e t a l. (2 01 7) ; e ur op e si ck ne ss a bs en ce 35 2 w d i 7. 32 12 .9 0 46 78 o in d 10 karekla, konstantinou, ioannou et al. 11 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ st ud y & r eg io n d is or de r n c on tr ol g ro up (s ) % d ro po ut a c t % d ro po ut co n tr ol gr ou p( s) m ea n a ge % f em al e se tt in g fo rm at t x w ee k s fl ax m an & b on d (2 01 0) ; e ur op e d is tr es s 10 7 si t 13 .5 1 10 .8 1 39 72 o g 3 fo rm an e t a l. (2 00 7) ; u s a nx ie ty 10 1 c t 33 .9 0 42 .2 0 28 80 o in d m = 1 5. 27 fo rm an e t a l. (2 01 3) ; u s o be si ty 12 8 sb t 9. 46 20 .3 7 46 10 0 o g 40 g au di an o & h er be rt (2 00 6) ; u s ps yc ho si s 40 ta u 5. 26 4. 76 40 36 in p in d 3 g au di an o et a l. (2 01 5) ; u s d ep re ss io n 13 m ta u 16 .6 6 42 .8 6 50 54 o in d 16 g hi el en e t a l. (2 01 7) ; e ur op e pa rk in so n 46 ta u 13 .0 4 8. 70 63 39 o g 6 g iff or d et a l. (2 00 4) ; u s sm ok in g 76 n rt 36 .4 0 38 .1 0 43 59 o g & in d 7 g iff or d et a l. (2 01 1) ; u s sm ok in g 30 3 bp 33 .0 8 46 .8 2 46 59 o g & in d 10 g la ss m an (2 01 4) ; u s a nx ie ty 25 tc bt 0. 00 8. 33 24 73 o in d 1 g on zá le zfe rn án de z et a l. (2 01 8) ; eu ro pe c an ce r 66 ba 29 .4 1 22 .7 3 52 92 o g 12 g re gg , c al la gh an , h ay es , & g le nn la w so n (2 00 7) ; u s ty pe 2 d ia be te s 81 ed uc at io n 0. 00 0. 00 51 47 o g 1 h an co ck e t a l. (2 01 8) ; a us tr al ia a nx ie ty 19 3 c bt 20 .5 9 9. 52 11 58 o g 10 h ay es e t a l. (2 00 4) ; u s po ly su bs ta nc ea bu si ng o pi at e a dd ic ts 12 4 m m , i ts f 45 .2 4 24 .0 0 42 51 o g & in d 16 h ay es , b oy d, & s ew el l ( 20 11 ); a us tr al ia d ep re ss io n 38 ta u 13 .6 3 31 .2 5 15 71 o in d n i h ay es -s ke lto n, r oe m er , & o rs ill o (2 01 3) ; u s a nx ie ty 81 a r 25 .0 0 21 .9 5 65 33 o in d 16 h er ná nd ez -l óp ez e t a l. (2 00 9) ; e ur op e sm ok in g 81 c bt 37 .2 1 23 .6 8 42 64 o g 7 h es se r et a l. (2 01 2) ; e ur op e ti nn itu s 99 c bt 2. 86 6. 25 49 43 s s 8 ju ar as ci o et a l. (2 01 3) ; u s ed 14 0 ta u 15 .1 5 8. 11 27 10 0 in p g m = 3 .9 1 treatment dropout in act 12 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ st ud y & r eg io n d is or de r n c on tr ol g ro up (s ) % d ro po ut a c t % d ro po ut co n tr ol gr ou p( s) m ea n a ge % f em al e se tt in g fo rm at t x w ee k s ke m an i e t a l. (2 01 6) ; e ur op e pa in 60 a r 0. 00 16 .6 6 40 73 o g 12 k in gs to n (2 00 8) ; e ur op e tr ea tm en t r es is ta nt 40 c bt 15 .0 0 40 .0 0 44 60 o g 16 ko co vs ki , f le m in g, h aw le y, h ut a, & a nt on y (2 01 3) ; u s sa d 13 7 c bt 30 .1 9 39 .6 2 35 54 o g 12 la ng e t a l. (2 01 7) ; u s d is tr es s 16 0 pc t 33 .7 5 30 .0 0 34 20 o in d 12 la nz a, g ar ci a, l am el as , & g on zá le zm en én de z (2 01 4) ; e ur op e su bs ta nc e u se 50 c bt 0. 00 0. 00 33 10 0 n i g 16 la ss en (2 01 0) ; u s ps yc ho si s 28 ta u 14 .2 9 42 .8 6 42 39 o g 2 li lli s et a l. (2 01 6) ; u s w ei gh t l os s 16 2 c bt 16 .0 5 13 .5 8 50 85 o g 52 lu ci an o et a l. (2 01 4) ; e ur op e fi br om ya lg ia 15 6 rp t 9. 80 11 .5 4 48 96 ο g n i lu om a, k oh le nb er g, h ay es , & fl et ch er (2 01 2) ; u s su bs ta nc e u se 13 3 ta u 10 .2 9 0. 00 34 46 in p g 1 m cc ra ck en e t a l. (2 01 4) ; e ur op e c p 73 ta u 18 .9 2 2. 78 58 68 o g 5 m cm ill an e t a l. (2 00 2) ; e ur op e tb i 14 5 pe 12 .0 0 19 .1 5 34 22 s s 4 m of fit t & m oh r (2 01 5) ; a us tr al ia ph ys ic al a ct iv ity 76 pw p 0. 00 5. 40 44 83 s s 12 m oi tr a et a l. (2 01 7) ; u s h iv 34 ta u 11 .7 7 5. 88 34 21 o in d 3 m or to n, s no w do n, g op ol d, & g uy m er (2 01 2) ; a us tr al ia bp d 41 ta u 23 .8 1 30 .0 0 35 93 o g 12 m os he r et a l. (2 01 8) ; e ur op e br ea st c an ce r 47 ed uc at io n 21 .7 4 12 .5 0 56 10 0 o ι 6 m o' ta m ed i, re za ie m ar am , & t av al la ie (2 01 2) ; a si a c hr on ic h ea da ch e 30 m ta u 26 .6 7 0. 00 36 10 0 o g 8 n or di n & r or sm an (2 01 2) ; e ur op e m ul tip le s cl er os is 21 rt 9. 09 0. 00 46 76 o g 15 pa lm ei ra e t a l. (2 01 7) ; e ur op e o be si ty 73 ta u 8. 33 10 .8 1 42 10 0 o g pa rl in g et a l. (2 01 6) ; e ur op e ea tin g d is or de rs 43 ta u 25 .0 0 15 .8 0 26 98 o in d 19 karekla, konstantinou, ioannou et al. 13 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ st ud y & r eg io n d is or de r n c on tr ol g ro up (s ) % d ro po ut a c t % d ro po ut co n tr ol gr ou p( s) m ea n a ge % f em al e se tt in g fo rm at t x w ee k s pe te rs en & z et tle (2 00 9) ; u s c om or bi d de pr es si on a nd al co ho l u se 24 ta u 20 .0 0 7. 69 38 50 in p in d m = 3 .2 sc ot t e t a l. (2 01 8) ; e ur op e c p 63 sp m 25 .8 1 21 .8 8 46 64 s in d 12 sh aw ye r et a l. (2 01 2) ; a us tr al ia ps yc ho si s 44 be fr ie nd in g 4. 76 9. 09 39 44 o in d 15 sh aw ye r et a l. (2 01 7) ; a us tr al ia ps yc ho si s 96 be fr ie nd in g 6. 12 8. 51 36 39 o in d 8 sh ay eg hi an e t a l. (2 01 6) ; a si a d ia be te s 10 6 ed uc at io n 5. 66 0. 00 55 60 o g 10 si m is te r et a l. (2 01 8) ; u s fi br om ya lg ia 67 ta u 9. 09 0. 00 40 95 s s 8 sm ou t e t a l. (2 01 0) ; a us tr al ia m u d 10 4 c bt 56 .8 6 56 .6 0 31 40 o in d 12 st ei ne r et a l. (2 01 3) ; u s fi br om ya lg ia 28 ed uc at io n 0. 00 0. 00 49 10 0 o in d 8 st ot ts e t a l. (2 01 2) ; u s m et ha do ne d et ox ifi ca tio n 56 ta u 40 .0 0 53 .8 5 40 37 o in d 24 th or se ll et a l. (2 01 1) ; e ur op e c p 90 a r 36 .5 4 18 .4 2 46 64 s s 7 tr om pe tt er , b oh lm ei je r, ve eh of , & sc hr eu rs (2 01 5) ; e ur op e c p 23 8 ew 28 .0 5 36 .7 1 53 76 s s 12 tw oh ig e t a l. (2 01 0) ; u s o c d 79 pr t 9. 80 13 .2 0 37 61 o in d 8 ty rb er g, c ar lb ri ng , & l un dg re n (2 01 7) ; e ur op e ps yc ho si s 21 ta u 4. 55 0. 00 41 38 i in d 1 va ki li et a l. (2 01 3) ; a si a o c d 27 ss ri s 10 .0 0 27 .2 7 27 44 o g n i w an g et a l ( 20 17 ); a si a pr oc ra st in at io n 79 c bt 11 .5 4 7. 69 21 47 ο g 8 w ei ne la nd e t a l. (2 01 2) ; e ur op e bs 39 ta u 21 .0 5 10 .0 0 43 90 s s 6 w es tin e t a l. (2 01 1) ; e ur op e ti nn itu s 64 tr t 0. 00 10 .0 0 51 47 o in d 10 w et he re ll et a l. (2 01 1a ); u s a nx ie ty 21 c bt 0. 00 44 .4 4 71 48 o in d 12 w et he re ll et a l. (2 01 1b ); u s c p 11 4 c bt 10 .5 3 14 .0 3 55 51 o g 8 w hi te e t a l. (2 01 1) ; e ur op e ps yc ho si s 27 ta u 0. 00 23 .0 8 34 22 o in d 10 treatment dropout in act 14 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ st ud y & r eg io n d is or de r n c on tr ol g ro up (s ) % d ro po ut a c t % d ro po ut co n tr ol gr ou p( s) m ea n a ge % f em al e se tt in g fo rm at t x w ee k s w ic ks el l, m el in , l ek an de r, & o ls so n (2 00 9) ; e ur op e lp p 32 m d t 0. 00 0. 00 15 78 o in d 12 w ol itz ky -t ay lo r, a rc h, r os en fie ld , & c ra sk e (2 01 2) ; u s a nx ie ty 12 1 c bt 36 .3 6 25 .7 6 38 57 o in d 12 ze tt le (2 00 3) ; u s m at he m at ic s a nx ie ty 24 sd 14 .2 9 36 .8 4 31 83 o in d 6 n ot e. n i = n ot in di ca te d; u s = u ni te d st at es ; o c d = o bs es si ve c om pu ls iv e d is or de r; sp = s oc ia l p ho bi a; m u d = m et ha m ph et am in e u se d is or de rs ; s a d = s oc ia l a nx ie ty d is or de r; g a d = g en er al iz ed a nx ie ty d is or de r; c p = c hr on ic p ai n; l pp = l on gs ta nd in g pe di at ri c pa in ; t bi = t ra um at ic b ra in in ju ry ; b s = ba ri at ri c su r‐ ge ry ; e d = e at in g di so rd er s; b pd = b or de rl in e pe rs on al ity d is or de r; m s = m in im al s up po rt g ro up ; c bt = c og ni tiv e be ha vi or al t he ra py ; c t = c og ni tiv e th er ap y; pr t = pr og re ss iv e re la xa tio n tr ai ni ng ; s d = s ys te m at ic d es en si tiz at io n; s sr is = s el ec tiv e se ro to ni n re up ta ke in hi bi to rs ; n c c = n on -s ta nd ar di ze d c on tr ol c on di ‐ tio n; r pt = r ec om m en de d ph ar m ac ol og ic al t re at m en t; ta u = t re at m en t a s u su al ; m m = m et ha do ne m ai nt en an ce ; i ts f = in te ns iv e tw el ve s te p fa ci lit at io n th er a‐ py p lu s m et ha do ne m ai nt en an ce ; p e = ph ys ic al e xe rc is e; a r = a pp lie d re la xa tio n; m d t = m ul tid is ci pl in ar y tr ea tm en t a nd a m itr ip ty lin e; m ta u = m ed ic al tr ea t‐ m en t a s us ua l; ew = e xp re ss iv e w ri tin g; s bt = s ta nd ar d be ha vi or al t re at m en t; sp m = s pe ci al ty m ed ic al m an ag em en t; bp = b up ro pi on r eg im en ; n rt = n ic ot in e re pl ac em en t t re at m en t; a ba = a pp lie d be ha vi or a na ly si s; p w p = pe do m et er -b as ed w al ki ng p ro gr am ; t rt = t in ni tu s re tr ai ni ng t he ra py ; w d i = w or kp la ce d ia ‐ lo gu e in te rv en tio n; r t = re la xa tio n tr ai ni ng ; b a = b eh av io ra l a ct iv at io n; s it = s tr es s in oc ul at io n tr ai ni ng ; h a b = ex po su re w ith h ab itu at io n ra tio na le ; p c t = pr es en tc en te re d th er ap y; tc bt = t ra di tio na l c og ni tiv e be ha vi or al t he ra py ; o = o ut pa tie nt ; i np = in pa tie nt ; s = s el fhe lp ; g = g ro up ; i nd = in di vi du al . karekla, konstantinou, ioannou et al. 15 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ regarding reasons reported for dropout, the majority of studies did not report data about client variables separately for dropout and completers. of the 65 studies presenting drop‐outs in the act condition, only 27 studies (41.54%) reported reasons for dropout. regard‐ing comparisons, all participants completed treatment in 11 studies, whereas for the re‐maining 65 studies with dropouts, only 30 (45.15%) reported dropout reasons. for act, the most frequently reported reasons for dropout were: lost contact (n = 15, 55.55%), per‐sonal (n = 12, 44.44%), transportation difficulties (n = 10, 37.04%) and therapy factors (n = 9, 33.33%). however, for comparison condition(s) the main reasons for dropout were: lost contact (n = 19, 63.33%), therapy factors (n = 11, 36.67%) and time demands (n = 10, 33.33%). for percentages of clients reporting each of the reasons for the included studies, see appendix a in supplementary materials. dropout rates across all studies and comparison conditions, the overall weighted mean dropout rate was 17.95%, 95% ci [15.12, 20.77]. act trials reported an average dropout rate of 17.35%, 95% ci [14.33, 20.37] and comparison conditions reported an average dropout rate of 18.62%, 95% ci [15.29, 21.96]. in the cma, the unconstrained model with the 76 studies of act vs. comparison conditions, showed that the heterogeneity detected using the fixedeffects model was very small and non-significant, with q(75) = 79.371, p = .343, i2 = 5.507%. it was thus justifiable to hypothesize that the random errors among the studies were not considerably different and that fixed-effects models could be followed. despite dropout rates in act appearing to be lower than in comparison groups when examining the overall weighted mean dropout rate the difference did not reach statistical signifi‐ cance, as the point estimate of the odds ratio and its confidence intervals included value 1 (i.e., equal odds/risk to dropout) with or = 0.931, 95% ci [0.809, 1.070], z = -1.011, p = .312; see appendix b in supplementary materials). the funnel plot for the investiga‐ tion of publication bias in the meta-analysis (see appendix b in supplementary materi‐ als) indicated no asymmetry, suggesting that there was no statistically significant publi‐ cation bias, with egger test t(74) = 0.591, 95% ci [-0.617, 0.334], p = .556) or the begg and mazumdar kendall’s tau, with τ = -0.079, p = .313. quantitative synthesis of the findings of the reviewed studies: meta-analysis participant moderators eight participant variables were first examined as moderators of therapy dropout (see table 3). treatment dropout in act 16 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ ta bl e 3 r es ul ts f ro m t he s ub gr ou p a na ly si s of p ar ti ci pa nt , s tu dy a nd p ro vi de r c at eg or ic al m od er at or s on t he ra py d ro po ut m od er at or n m ea n d ro po ut r at e 95 % c i z p q p a c t c on tr ol a c t c on tr ol c li en t di so rd er 7. 10 1 0. 52 6 a nx ie ty d is or de r or s oc ia l p ho bi a 14 19 .4 1 27 .2 7 13 .0 3, 2 5. 79 21 .0 5, 3 3. 49 -0 .6 63 0. 50 7 d ep re ss io n 2 16 .8 2 19 .4 7 10 .5 7, 2 3. 06 -3 .6 2, 4 2. 56 -0 .5 67 0. 57 1 su bs ta nc e ab us e or d ep en de nc e 6 28 .7 3 24 .9 1 11 .0 8, 4 6. 38 4. 72 , 4 5. 09 0. 12 2 0. 90 3 o th er h ea lth re la te d pr ob le m s 10 12 .8 0 12 .9 0 5. 88 , 2 0. 01 7. 16 , 1 8. 64 0. 06 4 0. 94 9 c hr on ic p ai n 14 18 .2 3 11 .9 3 10 .8 9, 2 5. 66 5. 61 , 1 8. 24 0. 73 8 0. 46 1 c hr on ic h ea lth c on di tio ns 7 13 .8 6 12 .2 3 6. 92 , 2 0. 81 6. 33 , 1 8. 13 0. 21 5 0. 82 9 ea tin g pa th ol og y/ di so rd er 8 12 .5 9 9. 83 6. 86 , 1 8. 32 4. 88 , 1 4. 79 0. 37 9 0. 70 5 sm ok in g 5 31 .1 0 32 .2 3 16 .6 5, 4 5. 55 16 .8 1, 4 7. 65 -1 .2 65 0. 20 6 se ve re p sy ch op at ho lo gy 10 10 .3 8 22 .3 7 5. 84 , 1 4. 92 12 .2 8, 3 2. 47 -2 .4 73 0. 01 3 p op ul at io n 0. 02 9 0. 86 6 c hi ld re n an d ad ol es ce nt s 3 11 .4 1 13 .5 9 -0 .4 5, 2 3. 26 -4 .5 4, 3 1. 72 0. 75 9 0. 44 8 a du lts 73 17 .5 9 18 .8 3 14 .4 9, 2 0. 70 15 .4 2, 2 2. 24 -1 .1 49 0. 25 1 c ou n tr y 1. 47 0 0. 68 9 u ni te d st at es 32 19 .7 5 23 .0 6 15 .0 2, 2 4. 49 17 .2 0, 2 8. 93 -1 .5 38 0. 12 4 a us tr al ia 8 17 .2 2 21 .6 8 4. 82 , 2 9. 62 9. 60 , 3 3. 76 -0 .4 41 0. 65 9 eu ro pe 29 16 .2 8 14 .8 8 11 .7 0, 2 0. 86 10 .9 0, 1 8. 86 0. 49 3 0. 62 2 a si a 7 10 .9 6 10 .3 3 3. 91 , 1 8. 01 2. 98 , 1 7. 68 0. 22 1 0. 82 5 t h er ap is t ex pe ri en ce le ve l i n a c t g ro up s 5. 61 1 0. 46 8 m as te rs / m as te r le ve l t he ra pi st s or d oc to ra l st ud en ts , i nt er ns , r es id en ts 13 23 .2 6 24 .2 0 14 .5 6, 3 1. 96 15 .5 3, 3 2. 87 0. 74 7 0. 45 5 ph d th er ap is ts , d oc to ra te 15 15 .2 4 14 .2 5 8. 69 , 2 1. 80 9. 01 , 1 9. 50 0. 00 6 0. 99 5 m ix p hd , s tu de nt s an d ot he rs 15 16 .3 4 21 .9 0 10 .1 7, 2 2. 52 13 .3 2, 3 0. 48 -2 .3 66 0. 01 8 n ot in fo rm ed 5 10 .9 0 11 .5 7 3. 08 , 1 8. 73 0. 20 , 2 2. 94 -0 .7 38 0. 46 1 ps yc ho lo gi st s m ix ed le ve ls 19 16 .1 5 18 .3 5 10 .3 4, 2 1. 95 11 .4 3, 2 5. 26 -0 .0 80 0. 93 6 n o th er ap is ts (o nl in e) 8 19 .9 2 17 .4 3 8. 87 , 3 1. 16 6. 10 , 2 8. 75 0. 05 9 0. 95 3 n on -p sy ch ol og is ts 1 21 .7 4 12 .5 0 0. 83 3 0. 40 5 karekla, konstantinou, ioannou et al. 17 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ m od er at or n m ea n d ro po ut r at e 95 % c i z p q p a c t c on tr ol a c t c on tr ol t h er ap is t ex pe ri en ce le ve l i n c om pa ri so n g ro up s 5. 99 0 0. 54 1 m as te rs / m as te r le ve l t he ra pi st s or d oc to ra l st ud en ts , i nt er ns , r es id en ts 10 24 .3 7 23 .1 0 14 .6 5, 3 4. 09 13 .3 8, 3 2. 82 0. 76 5 0. 44 4 m ix p hd , s tu de nt s an d ot he rs 15 14 .9 9 20 .5 8 9. 82 , 2 0. 15 14 .2 1, 2 6. 95 -1 .4 79 0. 13 9 ps yc hi at ri st s 2 34 .7 4 42 .4 6 31 .4 9, 3 7. 99 33 .9 1, 5 1. 01 -2 .0 87 0. 03 7 ph d th er ap is ts , d oc to ra te 9 17 .8 5 17 .8 4 7. 37 , 2 8. 34 10 .2 8, 2 5. 41 1. 22 1 0. 22 2 n on -p sy ch ol og is ts (d ru g st af f, al co ho l co un se lo r, ph ys ic ia n, p sy ch oph ar m ac ol og is t) 9 13 .4 9 18 .0 6 8. 05 , 1 8. 94 7. 18 , 2 8. 94 -0 .1 22 0. 90 3 n ot in fo rm ed 12 14 .4 9 9. 45 9. 37 , 1 9. 61 3. 05 , 1 5. 85 -0 .5 79 0. 56 3 ps yc ho lo gi st s m ix ed le ve ls 13 15 .0 3 17 .2 9 6. 41 , 2 3. 66 8. 05 , 2 6. 52 0. 06 0 0. 95 3 n o th er ap is ts (o nl in e) 6 21 .5 3 21 .5 7 6. 74 , 3 6. 33 8. 14 , 3 5. 00 -0 .2 84 0. 77 7 d ef in it io n o f dr op ou t 0. 16 6 0. 99 9 fa ile d to c om pl et e tr ea tm en t/ d is co nt in ue tr ea tm en t/ le av e be fo re th e en d of tx /r ef us ed to re tu rn in tx 53 15 .3 5 18 .4 0 11 .6 5, 1 9. 06 14 .3 6, 2 2. 43 -0 .2 34 0. 81 5 at te nd ed le ss th an o r eq ua l t o 50 -7 5% o f t ot al se ss io ns /w ee ks 11 22 .8 2 18 .6 8 15 .6 9, 2 9. 94 9. 51 , 2 7. 86 -1 .2 67 0. 20 5 at te nd ed le ss th an o r eq ua l t o 76 -9 0% o f t ot al se ss io ns 6 24 .6 3 20 .4 7 14 .9 4, 3 4. 31 5. 70 , 3 5. 23 -0 .3 58 0. 72 0 fa ile d to a tt en d al l s es si on s 2 20 .5 4 21 .4 5 -5 .3 7, 4 6. 44 4. 69 , 3 8. 21 -0 .1 31 0. 89 6 at te nd ed le ss th an o r eq ua l t o 25 -4 0% o f t ot al se ss io ns o r gr ou ps 2 21 .6 0 22 .4 1 8. 96 , 3 4. 24 -5 .6 2, 5 0. 44 -0 .3 17 0. 75 1 fa ile d to s ub m it pr e an d po st -t re at m en t d at a 2 10 .9 6 12 .1 5 1. 48 , 2 0. 43 5. 02 , 1 9. 28 -0 .2 79 0. 78 1 st ud y ty pe 0. 36 6 0. 54 5 ef fic ac y 42 17 .3 7 20 .3 7 13 .0 6, 2 1. 67 15 .7 1, 2 5. 03 -1 .2 48 0. 21 2 ef fe ct iv en es s 34 17 .3 3 16 .4 6 13 .1 0, 2 1. 56 11 .7 4, 2 1. 18 -0 .0 64 0. 94 9 n ot e. t ab le d ar e w ei gh te d m ea n dr op ou t r at es o f c lie nt , d es ig n an d pr ov id er m od er at or s us in g ra nd om -e ffe ct s an al ys is . k = nu m be r of re le va nt s tu di es in cl ud ed in e ac h an al ys is ; m ea n d ro po ut r at e = th e m ea n pe rc en ta ge o f p ar tic ip an ts te rm in at in g pr em at ur el y; c i = c on fid en ce in te r‐ va ls ; z = tw ota ile d te st in di ca tin g w hi ch le ve ls o f t he m od er at or s ar e si gn ifi ca nt ; q = te st o f h et er og en ei ty b et w ee n le ve ls o f e ac h m od er at or . *p < .0 5. ** p < .0 1. ** *p < .0 01 . treatment dropout in act 18 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ regarding categorical moderators, there were no significant differences between sub‐ groups. this was expected as heterogeneity among the studies was very small and the studies were generally favoring act groups but this finding did not reach statistical sig‐ nificance. however, separate investigation of the effect sizes in each subgroup of studies showed that a significant finding was noted in the subgroup analysis for the type of dis‐ order under investigation (see appendix c in supplementary materials); where in studies with a population with a severe psychopathology (i.e., borderline personality disorder, treatment resistant and psychosis) the dropouts were significantly lower in act groups compared to comparisons (or = 0.473, z = -2.473, p = .01). in terms of the six participant continuous moderators, meta-regression analyses based on the odds ratio using a meth‐ od-of-moments estimation showed that none of them (gender, marriage, ethnicity, em‐ ployment and mean age) were independent predictors of the effect size. treatment moderators eight treatment variables were tested as moderators of dropout rate (see table 4 for cate‐ gorical variables). subgroup analyses of treatment setting showed again non-significant between-group differences for all the variables examined. however, a statistically signifi‐ cant effect was noted in the subgroup analysis using the recruitment setting, as having recruited the population from a public outpatient clinic and/or community advertise‐ ments resulted in significantly lower odds of the population to drop out from act groups compared to comparison groups, or = 0.652, z = -2.985, p = .003. no significant differences were found among the rest of the examined treatment moderators and no other significant effect sizes in specific subgroups were noticed. provider and study moderators only a small amount of studies reported therapist gender, age, and ethnicity, deeming it impossible to analyze them as moderators. the experience levels of the therapists in act and comparison groups showed non-significant differences. however, in the subgroup analysis of the act therapists’ experience level a significant effect size was found for the subgroup of therapists from mixed experience levels, including doctoral level, student trainees, and others (e.g., licensed clinicians, psychiatrists, social workers, psychiatric nurses). the odds on dropout from act groups were significantly lower than from com‐ parison groups when the act therapists consisted of a multi-level and multi-domain team, with or = 0.734, z = -2.366, p = .018. also, in the subgroup analysis of the compari‐ son groups’ therapists a significant effect favoring act groups was found in the sub‐ group of psychiatrists. when the comparison groups had psychiatrists as the main and only therapists, then participants had significantly higher odds to dropout, compared to act groups, with or = 0.638, z = -2.087, p = .037. regarding study moderators, subgroup analyses based on region and type of study, or when examining the predictive ability of the year of publication in meta-regression analyses showed no significant results. karekla, konstantinou, ioannou et al. 19 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ ta bl e 4 r es ul ts f ro m t he s ub gr ou p a na ly si s of t re at m en t c at eg or ic al m od er at or s on t he ra py d ro po ut m od er at or n m ea n d ro po ut r at e 95 % c i z p q p a c t c on tr ol a c t c on tr ol t re at m en t fo rm at in a c t g ro up s 0. 13 1 0. 98 8 g ro up 34 15 .9 2 15 .2 6 12 .3 2, 1 9. 52 11 .0 6, 1 9. 47 -0 .1 54 0. 87 8 in di vi du al 30 16 .3 7 20 .9 6 11 .0 9, 2 1. 66 15 .1 2, 2 6. 80 -0 .5 18 0. 60 5 c om bi ne d 3 38 .2 4 36 .3 1 31 .1 3, 4 5. 35 23 .2 8, 4 9. 34 -1 .1 12 0. 26 6 se lfhe lp 9 19 .0 4 17 .6 2 8. 97 , 2 9. 10 7. 62 , 2 7. 61 -0 .5 21 0. 60 2 d es cr ip ti on o f re cr ui tm en t se tt in g 9. 25 4 0. 23 5 o ut pa tie nt c lin ic a ffi lia te d w ith h os pi ta l o r m ed -s ch oo l 11 16 .8 8 18 .7 2 6. 28 , 2 7. 48 7. 46 , 2 9. 98 0. 73 8 0. 46 1 pr iv at e ou tp at ie nt c lin ic /p ra ct ic e 2 12 .0 5 28 .0 3 7. 64 , 1 6. 45 -1 .0 4, 5 7. 10 -1 .3 51 0. 17 7 pu bl ic o ut pa tie nt c lin ic a nd c om m un ity ad ve rt is em en ts 21 14 .4 4 21 .3 0 9. 39 , 1 9. 49 14 .8 4, 2 7. 76 -2 .9 85 0. 00 3 re se ar ch o r sp ec ia lty c lin ic 6 17 .4 9 17 .9 1 6. 94 , 2 8. 03 11 .5 7, 2 4. 25 0. 98 9 0. 32 3 u ni ve rs ity a ffi lia te d cl in ic (p sy ch ol og y tr ai ni ng cl in ic a nd u ni ve rs ity c ou ns el in g ce nt er ) 10 26 .0 4 24 .4 1 19 .0 1, 3 3. 07 13 .9 8, 3 4. 84 -0 .4 49 0. 65 3 in pa tie nt o r re si de nt ia l t re at m en t 6 9. 21 3. 43 3. 27 , 1 5. 14 0. 28 , 6 .5 7 0. 44 2 0. 65 9 a t h om e (s el fhe lp a nd w eb -b as ed tr ea tm en ts ) 11 19 .9 0 17 .5 4 11 .6 6, 2 8. 14 9. 36 , 2 5. 72 -0 .4 76 0. 63 4 n ot in fo rm ed 9 18 .4 6 15 .6 6 8. 72 , 2 8. 21 8. 76 , 2 2. 56 1. 03 1 0. 30 2 t re at m en t se tt in g 0. 44 2 0. 80 2 o ut pa tie nt 60 17 .7 7 20 .2 4 14 .3 4, 2 1. 20 16 .4 8, 2 4. 00 -1 .0 63 0. 28 8 in pa tie nt 6 9. 21 3. 43 3. 27 , 1 5. 14 0. 28 , 6 .5 7 0. 44 2 0. 65 9 se lfh el p (in cl ud in g w eb -b as ed ) 10 19 .7 1 18 .0 5 10 .6 1, 2 8. 81 9. 07 , 2 7. 02 -0 .4 05 0. 68 6 t re at m en t st at us 1. 27 3 0. 25 9 pr ov id in g tr ea tm en t 59 16 .3 1 19 .2 3 12 .9 2, 3 1. 95 15 .5 0, 2 2. 95 -1 .1 39 0. 25 5 n on -p ro vi di ng tr ea tm en t 17 20 .9 4 16 .5 3 14 .5 0, 2 7. 39 8. 93 , 2 4. 13 -0 .0 35 0. 97 2 treatment dropout in act 20 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ m od er at or n m ea n d ro po ut r at e 95 % c i z p q p a c t c on tr ol a c t c on tr ol c om pa ri so n g ro up 2. 84 5 0. 72 4 c bt 17 18 .7 3 24 .2 5 11 .1 8, 2 6. 27 16 .8 9, 3 1. 61 -0 .1 88 0. 85 1 ta u 17 14 .3 0 13 .6 0 10 .5 7, 1 8. 04 7. 42 , 1 9. 79 0. 41 3 0. 68 0 m ed ic at io n on ly 9 22 .6 3 23 .6 1 13 .0 8, 3 2. 18 12 .3 0, 3 4. 92 -1 .0 37 0. 30 0 o th er a ct iv e tr ea tm en t 12 20 .5 8 21 .4 2 12 .0 7, 2 9. 09 11 .9 3, 3 0. 92 -1 .4 52 0. 14 7 c om po ne nt o f c bt 12 17 .0 7 19 .3 6 10 .0 3, 2 4. 10 12 .8 3, 2 5. 89 -0 .5 96 0. 55 1 ed uc at io n on ly 9 11 .3 0 7. 77 1. 78 , 2 0. 82 1. 77 , 1 3. 77 1. 23 3 0. 21 8 n ot e. t ab le d ar e w ei gh te d m ea n dr op ou t r at es o f t re at m en t m od er at or s us in g ra nd om -e ffe ct s an al ys es . k = nu m be r of re le va nt s tu di es in cl ud ed in e ac h an al ys is ; m ea n d ro po ut r at e = th e m ea n pe rc en ta ge o f p ar tic ip an ts te rm in at in g pr em at ur el y; c i = c on fid en ce in te r‐ va ls ; z = tw ota ile d te st in di ca tin g w hi ch le ve ls o f t he m od er at or s ar e si gn ifi ca nt ; q = te st o f h et er og en ei ty b et w ee n le ve ls o f e ac h m od er at or . *p < .0 5. ** p < .0 1. ** *p < .0 01 . karekla, konstantinou, ioannou et al. 21 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ sensitivity analyses we performed sensitivity analyses based on decisions taken before, or based on the pre‐ vious findings of the meta-analysis. the exclusion of the three studies that consisted of dissertations, showed that the main effect did not change significantly, with or = 0.951, 95% ci [0.826, 1.094], z = -0.705, p = .481, even though heterogeneity was slightly re‐ duced, with q(72)= 73.808, p = .419, i2 = 2.450. the next sensitivity analysis concerned the exclusion of studies with very wide confidence intervals of the odds ratio and showed again no change of the main effect. later on, we investigated the main effect when ex‐ cluding recent papers (2016-2018), as the meta-regression analysis for the predictive abili‐ ty of the year of publication showed a trend to significance. this sensitivity analysis (see appendix d in supplementary materials) showed that the main effect became marginally significant, with or = 0.852, 95% ci [0.727, 0.998], z = -1.984, p = .047, even though heter‐ ogeneity was slightly increased but remained at small levels, with q(54) = 60.961, p = .240, i2 = 11.418. the finding of the sensitivity analysis concerning the year of publi‐ cation suggested that when considering research done before 2016, the dropouts from act groups were significantly lower than from active comparison groups. d i s c u s s i o n treatment dropout is an important parameter impacting treatment outcomes (barrett et al., 2008; wierzbicki & pekarik, 1993). despite the acknowledgement of the importance of considering dropout rates and how these influence treatment effectiveness conclusions, this phenomenon has not been extensively examined. this paper aimed to investigate the phenomenon of dropout in a relatively newly developed therapeutic approach, accept‐ ance and commitment therapy. compared to other cognitive behavioral approaches, act presents with advances in improving client engagement to treatment, emphasizes the therapeutic relationship, and provides meaning for any changes to be made during treatment, postulated to be associated with more participant engagement. indeed, change in values has been found to precede changes in suffering (gloster et al., 2017). as such, we aimed to examine if those advances presented in act could overcome some of the treatment acceptability criticisms presented with older generations of interventions, which may have contributed to increased dropout rates from psychological treatments. however, the overall dropout rate was not significantly different between act and com‐ parison groups in the present meta-analysis. as noted by others, we found that there is no consensus regarding the definition em‐ ployed by investigators. we adopted a broad definition of treatment dropout, utilizing what was reported by each study author and particularly considering dropouts to be the percentage of cases of individuals who began treatment but did not complete it as inten‐ ded by its developer. based on this definition, the yielded overall dropout rate across all treatment dropout in act 22 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ studies included in this meta-analysis was 17.95%, which is comparable to recent previ‐ ously meta-analytically reported rates (i.e., 19.70%; swift & greenberg, 2012). for act, the calculated mean dropout rate was 17.35%. this is similar again to the rates reported by galloway-williams, martin, clum, and cooper (2013) and ong et al. (2018) for act. when including all possible reasons and comparing across all comparison conditions, the dropout rate was not significantly different (18.62%) from act groups. however, the rea‐ son why individuals terminate their treatment prematurely needs to be considered in re‐ lation to dropout rates. unfortunately, the majority of examined studies did not include dropout reasons, lim‐ iting our ability to draw conclusions regarding the reasons for dropout. despite the limi‐ ted number of studies presenting reasons for dropouts, some important differences be‐ tween act and other groups were identified. for example, most individuals who drop‐ ped out from act groups did so because of lost contact and for (unrelated to therapy) personal reasons. dropout reasons in comparison conditions however, included addition‐ ally therapy-related reasons (e.g., not satisfied with the treatment or feeling that the ther‐ apy was too time consuming). in particular, when act was compared to cbt, the most frequent reason for dropping out of cbt was therapy factors (i.e., of the 5 studies who reported reasons for dropout from cbt, all of them mentioned therapy factors). in con‐ trast, in act, the reasons of time demands, transportation, personal and therapy were equally reported. this is in line with findings reported by karekla (2004) who found dif‐ ferences in the timing of dropout in relation to the treatment components between tcbt and act participants. the pattern of dropout in tcbt was linked to the initiation of ex‐ posure whereas the same pattern was not found for those in the act condition (where individuals who dropped out did so for unrelated reasons to treatment and discontinued at different time points and not before exposure was introduced). these findings lend support to the idea that act may be a more acceptable treatment choice over previous waves of tcbt, and may better prepare (e.g., via use of values) individuals to engage and ultimately benefit from even the most difficult of treatment content (e.g., exposure to feared stimuli; see also gloster et al., 2014, 2015). in the future, researchers are advised to examine and report upon the timing and reasons for dropout. in this review, we found that acts’ premature termination rates were lower for deal‐ ing with certain types of psychopathology (severe psychopathology). this finding may highlight the important addition of act skills for severe psychopathologic conditions; however this needs to be further explored. interestingly, participants’ age did not moder‐ ate dropout rates, suggesting that all age groups result in similar dropout rates. this is a divergence from the swift and greenberg (2012) meta-analysis, where younger individu‐ als had higher dropout rates (barrett et al., 2008). the subgroup analyses based on the description of the treatment setting showed that dropout rates from act groups were lower for studies in which the treatment was deliv‐ ered in a public outpatient clinic and population was recruited by community advertise‐ karekla, konstantinou, ioannou et al. 23 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ ments. however, one should note that these studies were highly heterogeneous, includ‐ ing participants with anxiety disorders, eating disorders, substance abuse, other health problems, chronic pain, health conditions/chronic illnesses, smoking, severe psychopa‐ thology (i.e., bpd, psychosis, treatment resistant), and depression. additionally, in most of these studies the comparison condition was not another psychologically active inter‐ vention (i.e., in 57% of them the comparison group was treatment as usual, medication only and education). due to the high heterogeneity of these studies, this finding should be interpreted with caution and further examined in the future. in terms of provider moderators, experience level of providers in act and compari‐ son groups were significantly related to dropout rates. specifically, when treatment was delivered by a multi-level and multi-domain team, act had lower dropout rates than comparison conditions. this is a divergence from the studies of ong et al. (2018) and swift and greenberg (2012), who reported no significant results when treatment was de‐ livered by multidisciplinary teams. in particular, in the study of ong et al. (2018), act had higher dropout rates than comparison groups when treatment was administered by master's-level clinicians/therapists whereas in the study of swift and greenberg (2012) dropout rates were higher when the treatment was provided by trainees. differences be‐ tween these studies may be a result of the definition used for therapist experience level, therefore more research is needed in this domain to be able to conclusively make recom‐ mendations as to the level of experience or the consistency of the therapeutic team that leads to higher effect sizes. for the guidance of future researchers examining dropouts in treatments, a checklist of definitions and variables to be collected which can be utilized before, during and while reporting their findings, to ensure that adequate information re‐ garding dropouts is available, is presented in appendix e (see supplementary materials). limitations this study has several limitations that need to be considered in the interpretation of find‐ ings. first, the inclusion criteria were made broad enough in order to include a large number of studies. all age groups were included; as well as various psychopathological and non-psychopathological problems, and studies combining act with other interven‐ tions or medication. though we attempted to deal with this heterogeneity in the disor‐ ders, interventions, populations and age conditions by examining moderators of interest, this heterogeneity may have still affected the clarity of any differences between act and comparison groups on dropout rates. a second limitation may be related to the coding procedure. specifically, for the vari‐ able of comparison condition, when a study had two comparison conditions we selected to compare only the active treatment (e.g., cbt) and excluded the inactive comparison condition (e.g., wait-list). a third limitation has to do with reasons reported for dropouts. specifically, the majority of studies did not report dropout reasons, making conclusions about true reasons for dropout impossible or biased for the studies that reported these treatment dropout in act 24 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ reasons. in order to further elucidate the phenomenon of treatment dropout, future stud‐ ies should examine and report reasons why participants drop out as well as the timing when this occurs. finally, in our meta-analysis it was not possible to carry out a compari‐ son between the demographic characteristics of dropouts and completers due to insuffi‐ cient data provided by studies. we would like to encourage researchers to ensure that they report information separately for completers and dropouts so as to facilitate further understanding into the phenomenon of dropout. clinical implications this review examined dropout rates of a third wave cbt intervention in a range of disor‐ ders, populations, ages and comparison conditions. our findings show that overall drop‐ out rates between act and comparison conditions were not found to differ significantly. additionally, moderation analyses suggest that experience level of therapists in act and comparison conditions, description of treatment setting, and client diagnosis are associ‐ ated with an increased likelihood of dropout. therefore, interventions aiming to lower attrition should plan a-priori how to better engage users belonging to these groups. our findings suggest that act may present some potential advances for improving client engagement and retention, such as emphasizing that any behavior change needs to be linked with the persons’ values, or it may include more interesting treatment content through the use of metaphors and experiential exercises. however, more research is still needed prior to being able to assertively make these conclusions. future research the findings of the present study offer possible hypotheses about which therapeutic pro‐ cesses are associated with client retention. however, more studies are needed that will examine particular reasons for premature treatment termination, timing when this phe‐ nomenon occurs and how it may be linked to specific treatment components, and associ‐ ated variables in third wave treatments. moderators of the dropout effect for different therapeutic approaches are critical in that they illuminate areas that may still have potential for improvement in the context of an otherwise effective intervention. this needs to be further examined. for example, even if act has lower dropout rates than some comparison conditions overall, but fe‐ males drop out more from act than comparison conditions, then act may need to con‐ sider how females are being engaged in the intervention and attempt to find ways to im‐ prove engagement (e.g., maybe more gender sensitive metaphors). additionally, common vs. specific factors in the psychotherapies being examined and in relation to how these may affect dropout also need to be examined. researchers are encouraged to examine and report the reasons for dropout when a person discontinues the treatment premature‐ ly. further understanding of these reasons should allow us to examine whether it is dis‐ karekla, konstantinou, ioannou et al. 25 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://www.psychopen.eu/ satisfaction with the common factors (e.g., therapeutic alliance, expectations, cultural adaptations, empathy) that contribute to premature discontinuation or whether dropout is related to specific factors (e.g., specific ingredients of the intervention provided). it is essential that participant engagement and premature termination continue to serve as topics of exploration in the clinical psychology arena, so as to improve the effectiveness of interventions, decrease treatment dropout rates, and enhance the possible treatment effects for participants. funding: the authors received no financial support for the research, authorship, and/or publication of this article. competing interests: the authors declare no conflicts of interest. acknowledgments: the authors have no support to report. data availability: datasets for the studies are freely available (see the supplementary materials section). s u p p l e m e n t a r y m a t e r i a l s the following data and materials are available for this study (for access see index of supplementa‐ ry materials below): via the psycharchives repository: • appendix a: percentages of clients reporting each of the reasons for the included studies • appendix b: forest and funnel plots of included studies • appendix c: forest plot of subgroup analyses based on the type of disorder under investigation • appendix d: sensitivity analysis for the year of publication • appendix e: checklist of definitions and variables to be collected in order to properly document dropouts via the international prospective register of systematic reviews (prospero): • preregistered protocol (crd42017068456) of the current study index of supplementary materials karekla, m., konstantinou, p., ioannou, m., kareklas, i., & gloster, a. t. (2019). supplementary materials to "the phenomenon of treatment dropout, reasons and moderators in acceptance and commitment therapy and other active treatments: a meta-analytic review". psychopen. https://doi.org/10.23668/psycharchives.2594 karekla, m., konstantinou, p., ioannou, m., kareklas, i., & gloster, a. t. (2017, july 7). treatment drop-out in acceptance and commitment therapy compared to other treatments: a systematic treatment dropout in act 26 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://doi.org/10.23668/psycharchives.2594 https://www.psychopen.eu/ review and meta-analysis. (prospero 2017 crd42017068456). prospero. https://www.crd.york.ac.uk/prospero/index.php r e f e r e n c e s note. asterisk (*) marks references of studies included in the meta-analysis. *abad, a. n. s., bakhtiari, m., kashani, f. l., & habibi, m. 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(2003). acceptance and commitment therapy (act) vs. systematic desensitization in treatment of mathematics anxiety. the psychological record, 53(2), 197-215. https://doi.org/10.1007/bf03395440 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. treatment dropout in act 36 clinical psychology in europe 2019, vol.1(3), article e33058 https://doi.org/10.32872/cpe.v1i3.33058 https://doi.org/10.1037/0735-7028.24.2.190 https://doi.org/10.1037/a0029418 https://doi.org/10.1007/bf03395440 https://www.psychopen.eu/ treatment dropout in act (introduction) current study method literature search eligibility criteria coding procedures data analysis results characteristics of reviewed studies dropout rates quantitative synthesis of the findings of the reviewed studies: meta-analysis sensitivity analyses discussion limitations clinical implications future research (additional information) funding competing interests acknowledgments data availability supplementary materials references monetary valuation of a quality-adjusted life year (qaly) for depressive disorders among patients and non-patient respondents: a matched willingness to pay study research articles monetary valuation of a quality-adjusted life year (qaly) for depressive disorders among patients and non-patient respondents: a matched willingness to pay study laura ulbrich 1 , christoph kröger 1 [1] department of psychology, university of hildesheim, hildesheim, germany. clinical psychology in europe, 2021, vol. 3(4), article e3855, https://doi.org/10.32872/cpe.3855 received: 2020-06-15 • accepted: 2021-05-23 • published (vor): 2021-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: laura ulbrich, universitätsplatz 1, 31141 hildesheim, germany. e-mail: christoph.kroeger@uni-hildesheim.de supplementary materials: materials [see index of supplementary materials] abstract background: as estimated by the world health organization, depressive disorders will be the leading contributor to the global burden of disease by 2030. in light of this fact, we designed a study whose aim was to investigate whether the value placed on health-related quality of life (hrqol) for a depressive disorder is higher in patients diagnosed with a major depressive disorder (mdd) compared to non-patients in a matched sample. method: we collected data on willingness to pay (wtp) for a total of four health-gain scenarios, which were presented to 18 outpatients diagnosed with a mdd versus 18 matched non-patient respondents with no symptoms of depression. matching characteristics included age, income, level of education, and type of health insurance. respondents were presented with different hrqol scenarios in which they could choose to pay money to regain their initial health state through various treatment options (e.g., inpatient treatment, electroconvulsive therapy). to test whether the probability of stating a positive wtp differed significantly between the two samples, fisher’s exact test was used. differences regarding stated wtp between the samples were investigated using the mann-whitney u-test. results: for most of the health scenarios, the probability of stating a positive wtp did not differ between the two samples. however, patient respondents declared wtp values up to 7.4 times higher than those stated by matched non-patient respondents. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3855&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0002-5434-7355 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: although the perceived necessity to pay for mental-hrqol gains did not differ between respondents with mdd and respondents with no symptoms of depression, patient respondents stated higher values. keywords depressive disorders, quality-adjusted life years, willingness to pay, quality of life, electroconvulsive therapy highlights • the probability of stating a positive wtp did not differ between samples. • however, patient respondents stated wtp values as much as 7.4 times higher than non-patients. the global burden of disease is shifting from premature death to years lived with disabili­ ty (gbd 2017 dalys and hale collaborators, 2018; licher et al., 2019; vigo et al., 2019). for this reason, the promotion of mental health has become a priority for health policies and action plans around the world (e.g., world health organization, 2013). over the past several decades, the disease burden attributed to depressive disorders has increased tre­ mendously, ranking them among the three leading causes of years lost due to disability (yld; gbd 2016 dalys and hale collaborators, 2017), as well as disability-adjusted life years (dalys; murray et al., 2012). by 2030, unipolar depression is estimated to be the leading factor within the global burden of disease (world health organization, 2008). cost-effectiveness analyses due to limited resources in the health-care sector, cost-effectiveness analyses are used as guidelines in priority setting, resource allocation, and reimbursement decisions. the preferred metric of health benefits in cost-effectiveness analyses is commonly the meas­ urement of quality-adjusted life years (qalys), combining the impact of health benefits on both health-related quality of life and quantity of life years (sund & svensson, 2018). additionally, this measurement facilitates the comparison of different interventions with­ in a disease or in comparison with other diseases (pennington et al., 2015). from a health–economic perspective, the preference for and value of health-care interventions can be assessed by estimating a person’s willingness to pay (wtp) for health gains (sund & svensson, 2018). the elicitation of preferences usually follows a two-stage process: 1) if the respondent indicates whether he or she is willing to pay money (yes/no); and 2) if the respondent indicates ‘yes’, that he or she is willing to pay money, the amount of money the respondent is willing to pay is further assessed. value of quality-adjusted life year for depression 2 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ willingness to pay for a quality-adjusted life year various studies have tried to estimate the value of a qaly through the wtp method (e.g., ahlert et al., 2013; donaldson et al., 2011; igarashi et al., 2019; pennington et al., 2015). a systematic review including 24 studies on wtp per qaly found that wtp estimates range from €1,000 to €4,800,000, with mean wtp estimates of €118,839 and median estimates of €24,226 (ryen & svensson, 2015). currently, preferences for health treatments are commonly elicited from the general public due to the recommendations of the washington panel on cost-effectiveness in health and medicine (gold et al., 1996) and the united kingdom’s national institute for health and care excellence (national institute for health and care excellence, 2013). recently, however, arguments for elicit­ ing the preferences based on appraisals of persons suffering from the health condition in question have been discussed (for a systematic overview on these arguments, see helgesson et al., 2020). effects of contextual and individual characteristics on wtp per qaly wtp per qaly seems to be related to several contextual factors, such as duration (e.g., 0.1 qalys over 10 years vs. 0.25 qalys over 4 years), timing (i.e., qaly gain at the end of life vs. in the near future), and type of qaly gain valued (i.e., life extension vs. quality-of-life improvements), as well as the type and severity of the illness presented (igarashi et al., 2019; ryen & svensson, 2015). additionally, several individual characteris­ tics seem to influence the stated values for health gains. the most common predictor effect was found for income: a higher household income significantly increased the probability to state a positive wtp (ahlert et al., 2013), as well as increasing the amount of money respondents were willing to pay (igarashi et al., 2019; pennington et al., 2015). also, individuals with a higher level of education stated greater amounts than individuals with fewer years of schooling (ahlert et al., 2013; pennington et al., 2015). the effect of age on wtp was significant in two large samples, but results showed inconsistent findings: while one study found that younger respondents stated higher amounts (ahlert et al., 2013), pennington and colleagues (2015) found a contrary effect. a study of the german general population investigated the effects of the german health care system1 on wtp per qaly and found that respondents with private health insurance were willing to pay higher amounts for a qaly, even when controlling for income effects (ahlert et al., 2013). 1) unlike other european countries, germany has a universal health-care system with two types of health insurance: germans can choose between public (statutory) insurance and private health insurance, which is co-financed by employer and employee. ulbrich & kröger 3 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ to the best of our knowledge, no study has ever investigated the effects of the individual relevance of the presented health-gain scenario on the respondent’s wtp per qaly. additionally, several studies argued that the plurality of different perspectives should be acknowledged, and that values for health benefits (i.e., qalys) should be based on preferences from both patients and the general public (dolan, 2009; ogorevc et al., 2019; versteegh & brouwer, 2016). a meta-analysis assessed whether values for qalys differed between patients and the general public, comparing different valuation methods (time trade-off, visual analogue scale and standard gamble; peeters & stiggelbout, 2010). however, preferences from patients and the general public using the wtp method have yet to be investigated. study aims with an eye toward this need for more specific information on patient and non-patient preferences, the aim of our study was to assess whether wtp preferences for mental health gains differ between outpatients with a diagnosed major depressive disorder (the patient sample) and respondents from the general public with no symptoms of depression (the non-patient sample). to control for the effects of the above-mentioned individual characteristics on wtp, we matched respondents from the patient sample with respondents from the non-patient sample based on income, level of education, age, and type of health insurance (see section ‘participants and procedures’). the above-men­ tioned meta-analytical comparison of patient and non-patient health-state assessments found that patients give higher valuations than non-patients (peeters & stiggelbout, 2010). therefore, we aim to investigate the following hypotheses: 1. the probability of indicating a positive wtp (wtp > 0) is higher throughout all the scenarios in the patient sample compared to its likelihood among respondents with no self-reported symptoms of depression (the non-patient sample). 2. respondents from the patient sample are willing to pay significantly higher amounts for the health gains presented than respondents with no self-reported symptoms of depression (the non-patient sample). m e t h o d ethics approval this study was performed in accordance with the principles of the declaration of helsin­ ki. the ethical review committee of the university of hildesheim, germany, approved the study (application number: 107). value of quality-adjusted life year for depression 4 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ participants and procedure patient sample individuals with a suspected depressive disorder were screened at a german university outpatient clinic between may 2019 and march 2020. possible participants were informed as to the objective of the study both verbally and in writing, and were required to provide their written consent. participants were eligible for inclusion if they were more than 18 years of age and met the dsm-5 criteria of a major depressive disorder, using the german version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), clinical version (scid-5-cv; beesdo– baum et al., 2019). one master-level psychologist and three bachelor-level research-assis­ tants conducted the interviews. all four interviewers had been trained in the adminis­ tration and scoring of the scid-5-cv in a workshop conducted by the second author, who is a licensed interviewer. the ratings of the diagnoses in question were discussed with the attending psychotherapist. we excluded patients who showed indications of mental retardation or dementia, substance-dependence disorders, bipolar disorder, or schizophrenia. patients with other co-occurring mental disorders were not excluded. after the scid-5-cv interview, patients who met the inclusion criteria and consented to participating in the study were asked to answer the questions of the online survey (further described in section ‘online questionnaire’) on a laptop that we provided. after completing the survey, patients were thanked for their participation in the study. non-patient sample for each respondent in the patient sample, we compared one matched respondent from the german general population who reported no symptoms of depression. comput­ er-based matching was conducted using the following characteristics: age at index rate (± 8 years), income category (see table 2), highest level of education (basic, secondary, or advanced), and type of health insurance (statutory vs. private). respondents from the german general population were recruited from an internet panel run by an independent research institute (usuma gmbh; http://www.usuma.com/) between march 6, 2019 and march 25, 2019. the research institute we selected complied with the esomar interna­ tional code on market, opinion, and social research and data analytics. internet-panel participants were informed about the online survey via email. after completing the survey, participants received survey ‘reward’ points from the internet-panel company, which they could exchange for an online gift certificate or merchandise. online questionnaire on the first page of the online questionnaire, respondents were informed about the objective of the study and were asked to give their consent. the hypothetical scenario that was introduced assumed that no sickness funds exist in germany, and therefore, ulbrich & kröger 5 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 http://www.usuma.com/ https://www.psychopen.eu/ respondents would not have to pay premiums or contributions toward health insurance, increasing their monthly net income by that amount. respondents were asked to imagine that instead, they would need to pay for every medical service out of their own pocket. the concept of measuring health on a visual analog scale was introduced: based on the european quality of life 5-dimensions 3-level version (eq-5d-3l; szende et al., 2007), three health states and numerical valuations derived from survey values (dolan et al., 1999) were used to indicate different levels of health on the scale. demographical questions (e.g., age, income, health insurance, pre-existing diseases, region of residence) were presented. respondents were then asked to estimate their life expectancy, and to rate the current state of their health on the european quality of life visual analogue scale (eq-vas; szende et al., 2007), with values between 0 and 100. using items of the patient-health questionnaire (phq-2; kroenke et al., 2003) and eq-5d-3l (szende et al., 2007), respondents were asked to briefly assess their symptoms of depression and current health-related quality of life. the phq-2 is a two-item, self-administered depression module that scores the two main criteria from the dsm-5. answer categories range from 0 (“not at all”) to 3 (“nearly every day”), and the total severity score ranges from 0 to 6. regarding the total value of the phq-2 in the patient sample, the internal consistency was good (α = .82). a cut-off score of ≥ 3 (see kroenke et al., 2007) proved to be most suitable regarding sensitivity and specificity for the diagnosis of a major depressive disorder. next, a description of typical symptoms of depressive disorders and their impact on everyday life, including mortality rates by suicide, was presented (see online resource 1 in the supplementary materials). the respondents were given four different scenarios of health loss of either one qaly (scenarios a and b) or a fraction of a qaly (scenarios c and d), due to a depressive episode. these scenarios, which are further described in table 1, were presented in random order. the order of the questions and the wording of one sample scenario are displayed in online resource 2 (see supplementary materials). the respondents were asked if they were willing to pay money for each of the presented health-gain scenarios. if the respondents answered “yes,” that they would be willing to pay money for treatment, a table with three columns was presented, with a series of values in euros ranging from €10 to €300,000 in accordance with previous studies (ahlert et al., 2013; donaldson et al., 2011; pennington et al., 2015). to facilitate decision-making, the respondents were asked to sort the euro values into one of three columns, indicating which amounts they would be willing to pay, the amounts they would not be willing to pay, and the amounts that left them unsure about whether or not they would pay. in order to summarize the maximum amount that the respondent was willing to pay and the minimum that he or she was not willing to pay, the respondent was asked to state his or her maximum wtp as an open-ended response. if the respondent answered that he or she would not be willing to pay money for the presented health-gain scenario, several pre-coded responses (translated from the eurovaq study) and a free text option value of quality-adjusted life year for depression 6 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ were presented. lastly, respondents were asked to rate how much they currently knew about electroconvulsive therapy (ect), which was offered as a treatment method in one of the scenarios2. if they indicated that they knew at least “a little” about ect, they were asked to state whether they thought this method was adequate. respondents were given the chance to view and change their answers in the recapitulation section on the last page. the feasibility and validity of the questions were examined by pilot respondents who provided detailed feedback prior to the development of the survey. table 1 health gains valued scenario health gain duration time initial health state achieved? treatment a 25 points 4 years in 1 year 100% pain-free treatment b 10 points 10 years in 1 year 100% pain-free treatment c 25 points 4 years in 1 year 90% 8-week inpatient treatment d 25 points 4 years in 1 year 90% 8-week inpatient treatment plus electroconvulsive therapy exclusion criteria to ensure that the questions were relevant to the individual respondents, and in accord­ ance with the eurovaq report (donaldson et al., 2011), the following exclusion criteria were applied: general exclusion criteria respondents who indicated that “the government should pay” from the set of pre-coded responses as the reason for zero wtp (so-called “protest respondents”), were excluded due to their not having understood the hypothetical nature of the scenario (as is standard for wtp studies; see olsen & donaldson, 1998; pennington et al., 2015). scenario-specific exclusion criteria additionally, respondents were excluded from data analysis regarding scenarios a, c, and d if they rated their health state at less than 35 points (indicating poor health), and 2) this treatment method was used because its efficacy is recognized by the german association for psychiatry, psychotherapy, and psychosomatics (dgppn), and because it is a highly standardized procedure with rapid response rates (dgppn et al., 2015). ulbrich & kröger 7 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ if they expected to live for less than 6 years as of that day. respondents were excluded from data analysis regarding scenario b if they rated their health state at less than 20 points, and if their life expectancy was assumed to be below 12 years. the intention was to ensure that no health loss reduced the respondent’s health to below 10 points, and that all health gains were complete at least one year before the respondent expected to die. data analysis all analysis was undertaken with ibm spss statistics 26. the collection of open-ended responses allowed us to determine the mean and median values reported for each scenar­ io, which were collected in euros. the current study does not report trimmed means because ahlert and colleagues (2013) found that trimming the top 1% or 5% of wtp val­ ues may lead to the exclusion of potentially reasonable cases (e.g., younger respondents with a higher income). the kolmogorov–smirnoff test and q-q plots indicated that the assumption of normal distribution was violated: distribution of wtp scores for scenario a (d(20) = 0.385, p < .001), scenario b (d(20) = 0.416, p < .001), scenario c (d(20) = 0.363, p < .001), and scenario d (d(20) = 0.270, p < .001) all differed significantly from normal. to test hypothesis 1 — whether the likelihood of expressing a positive wtp differed across both samples — wtp responses were dichotomized as zero and non-zero values. because of the small sample size, fisher’s exact test and odds ratios were calculated. to assess hypothesis 2 — whether wtp values for the described health gains differed between the patient and the non-patient sample — the nonparametric mann–whitney u-test was applied, due to the skewed distribution of the wtp scores. effect size r was calculated by dividing the z-scores for the test statistic by the square root of the sample size (field, 2018; rosenthal, 1991). bias-corrected accelerated 95% confidence intervals around means were estimated. r e s u l t s sociodemographic characteristics of the samples figure 1 depicts the flowchart. a total of n = 36 participants were included in the study, with n = 18 participants in each sample. most of the total sample (75%) was female, with a mean age of 48 years (sd = 14.88). value of quality-adjusted life year for depression 8 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ figure 1 flowchart patient sample from an initial sample of 20 screened outpatients, n = 18 patients met the dsm-5 criteria of a major depressive disorder. no co-occurring mental disorders were diagnosed. the cut-off score of the phq-2 was exceeded by 16 patients (88.9%), while the mean score was 4.33 (sd = 1.57). the mean overall health state of the patient sample was indicated as poor (m = 61.67; sd = 18.31). matched non-patient sample the matching process based on income, level of education, type of health insurance, and age resulted in a sample of n = 18 matched respondents from the german general population. we ensured that respondents of the matched non-patient sample reported no symptoms of depression (phq-2 sum score = 0). the mean overall health state of the non-patient sample was indicated as rather good (m = 89.94, sd = 9.17). ulbrich & kröger 9 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ table 2 displays the sociodemographic characteristics of the two samples. no be­ tween-group differences were found in terms of the sociodemographic data. none of our subjects had to be excluded as protest respondents. table 2 sociodemographic characteristics of both samples characteristic patient sample n = 18 non-patient sample n = 18 m (sd) min/max m (sd) min/max age (in years) 48.33 (15.22) 22/77 47.89 (14.97) 22/70 life expectancy (age) 82.28 (9.49) 65/99 83.78 (8.45) 70/110 health status (0-100) 61.67 (18.31) 20/95 89.94 (9.17) 70/100 n % n % 20 to 69 (poor) 11 61.1 0 0.0 70 to 79 (rather poor) 2 11.1 2 11.1 80 to 89 (rather good) 4 22.2 2 11.1 90 to 100 (very good) 1 5.6 14 77.8 low remaining lifetime (< 16 years) 4 22.2 1 5.6 females (rather than males) 16 88.9 11 61.1 educational level basic (nine years) 0 0.0 0 0.0 secondary (ten years) 8 44.4 7 38.9 tertiary (> ten years) 10 55.6 11 61.1 monthly household income no answer 1 5.6 1 5.6 below 500 € 0 0.0 0 0.0 500 to below 1.000 € 1 5.6 1 5.6 1.000 € to below 1.500€ 1 5.6 1 5.6 1.500€ to below 2.000€ 4 22.2 4 22.2 2.000€ to below 3.000€ 4 22.2 4 22.2 3.000€ to below 4.000€ 6 33.3 6 33.3 4.000€ and more 1 5.6 1 5.6 health insurance social insurance 17 94.4 17 94.4 private insurance 1 5.6 1 5.6 icd-10 diagnosis depressive episode 8 44.4 recurrent mdd 10 55.6 note. m = mean; sd = standard deviation; min/max = minimum/maximum; n = sample size; mdd = major depressive disorder. value of quality-adjusted life year for depression 10 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ results regarding hypothesis 1: probability of indicating a positive wtp results from fisher’s exact test indicate no association between the sample (patient vs. non-patient sample) and the probability of stating a positive wtp (wtp > 0) in three of four scenarios (scenarios b, c, and d). only in scenario a was the probability of expressing a positive wtp higher in the patient sample compared to the non-patient sample (χ2 = 6.84, p < .05). odds ratios could not be calculated, as 100% of the patient sample indicated a positive wtp. in the patient sample, the number-one reason for being unwilling to pay for the presented health gains across all scenarios was: “the effects of treatment are too small.” in the non-patient sample, the number-one reason stated was: “it would not be so bad/i could live with it.” table 3 shows the frequency of reasons stated for zero wtp. table 3 frequencies of reasons for zero wtp scenario n zero wtp it would not be so bad/ i could live with it effects of treatment are too small i want my family to have the money i would get better without treatment i value the treatment but cannot afford it other reasons patient sample a 0 0 0 0 0 0 0 b 1 0 1 (6.3) 0 0 0 0 c 2 0 0 0 0 0 2 (11.8) d 8 0 2 (11.8) 0 0 0 6 (35.4) non-patient sample a 6 1 (5.6) 0 1 (5.6) 1 (5.6) 1 (5.6) 2 (11.2) b 7 4 (22.2) 0 1 (5.6) 0 1 (5.6) 1 (5.6) c 6 1 (5.6) 0 0 2 (11.2) 2 (11.2) 1 (5.6) d 8 2 (11.2) 0 0 2 (11.2) 2 (11.2) 2 (11.2) note. percentages are in parentheses. n = sample size; wtp = willingness to pay. results regarding hypothesis 2: wtp differences between patient and non-patient respondents mean, median, and maximum wtp values, as well as bias-corrected accelerated 95% confidence intervals around means, are displayed in table 4. in the patient sample, mean wtp values ranged from €15,778 (scenario d) to €54,794 (scenario a). in the matched non-patient sample, mean values ranged from €2,277 (scenario b) to €4,650 (scenario a). results from the mann–whitney u-test indicated that patient respondents stated significantly higher wtp values than non-patients in all scenarios: scenario a (u = 33.50, z = –3.05, p < .01, r = –.56), scenario b (u = 25.50, z = –2.97, p < .01, r = –.58), scenario ulbrich & kröger 11 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ c (u = 22.50, z = –3.31, p < .001, r = –.64) and scenario d (u = 10.50, z = –2.83, p < .01, r = .65). for all scenarios, differences between samples represented a medium effect in accordance with cohen (1988). table 4 mean, median and maximum values in euros (€) for both samples after applying general and scenario-specific exclusion criteria scenario na n wtp > 0 m bootstrapped 95% ci mdn maximum wtp patient sample a 17 17 54,794 14,646-116,424 15,000 350,000 b 16 15 52,667 6,956-121,249 10,000 350,000 c 17 15 23,867 10,714-45,548 10,000 150,000 d 17 9 15,778 7,667-25,762 13,000 50,000 non-patient sample a 18 12 4,650 2,322-7,686 2,500 15,000 b 18 11 2,277 1,000-4,126 1,500 10,000 c 18 12 3,433 2,245-4,737 2,750 10,000 d 18 10 2,415 1,183-3,567 1,750 5,000 note. na= sample size after applying scenario-specific exclusion criteria; n = sample size; ci = confidence interval. d i s c u s s i o n a vital assessment of patient preferences as currently discussed (e.g., dolan, 2009; ogorevc et al., 2019; versteegh & brouwer, 2016), the present study is one of the first attempts to directly compare experience-based preferences from patients to ‘hypothetical’ preferences of the general population using the wtp method. results indicate that the probability of stating a positive wtp does not differ between patients and non-patient respondents. however, when assessing the number-one reasons indicated for zero wtp (patient sample: “effects of treatment are too small,” vs. non-pa­ tient sample: “it would not be too bad/i could live with it”), it seems that respondents with no prior experience of depression underestimate the burden of depressive symp­ toms. as discussed by dolan (2007), “hypothetical” preferences of the general public, as elicited through assessing wtp values, may not be a reliable basis for judgment because the “general public are not good at assessing what it would be like to experience different states of health” (dolan, 2007, p. 6). however, contrary to the assumption that “hypothet­ ical” preferences by the public tend to overestimate the severity of a loss of health value of quality-adjusted life year for depression 12 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ (dolan, 2007, p. 6), patients stated significantly higher wtp values than non-patients. these findings are in accordance with previous studies (ogorevc et al., 2019; versteegh & brouwer, 2016) and emphasize the need to consider both the perspectives of the general public and those of patients when assessing values or preferences for health benefits. in this study, we assessed respondents’ wtp for one specified treatment (electrocon­ vulsive therapy) in detail due to its high standardization when compared to other psy­ chotherapeutic interventions. thus, when assessing results for this specified scenario, it seems unexpected that only 53% of the patient sample and 55% of the non-patient sample were willing to pay money for ect. one possible explanation might be that 83% of the patient sample stated that they knew nothing or little about ect, compared to 72% of the non-patient sample. the present findings accord with the conclusion of a recent study, which found that ect is still largely underutilized due to persisting stigma and lack of knowledge about modern ect techniques (kellner et al., 2020). in particular, considering recent discussions of advocating for patients in the decision-making process regarding treatment options (e.g., barry, 2011; couët et al., 2015), the present findings underline the importance of an informed patient. so-called patient-decision aids — tools designed to help patients make an informed choice, which include explanations about treatment options based on scientific evidence — can be used to improve patients’ knowledge of which treatment route to choose, as well as the risks and benefits of various treatments (for an overview, see perestelo‐perez et al., 2017). the cost-effectiveness of primary care for depressive disorders has been investigated by, for example, chisholm et al. (2004) and pyne et al. (2003). low-cost, non-medical interventions for relief from depression, such as exercise, relaxation, and bibliotherapy, are also readily available (for a systematic review, readers are referred to morgan & jorm, 2008). their (cost-)effectiveness in reducing symptoms of depression is, however, yet to be assessed in randomized controlled trials in a clinical population (bellón et al., 2021; lawlor & hopker, 2001; philippot et al., 2019) strengths and limitations matching the respondents from the patient sample to respondents from the non-patient sample allowed us to control for the effects of individual characteristics (e.g., income, level of education) on wtp. presenting the scenarios in a randomized order let us control for ordering effects. however, some limitations should be also mentioned. first, the size of both samples (n = 18 in each sample) was quite small, and the post-hoc power analysis indicated medium power (1– β = 0.89), assuming a medium effect size (|d| = 0.5, according to the convention of cohen (1988)). second, the broad majority (88.9%) of the recruited patient sample was female. results from the eurovaq study indicate that men stated a higher wtp (donaldson et al., 2011, p. 76). still, ahlert and colleagues (2013) investigated the effect of gender in more detail, and found that although women were significantly more likely than men to state a ulbrich & kröger 13 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ positive wtp, males were willing to pay significantly higher amounts than females. therefore, generalization of results may be limited, and a more representative patient sample should be recruited in subsequent studies. additionally, presenting scenarios that emphasize the certainty of successful treat­ ment — which may be especially unlikely with respect to mental health — may have led to the overestimation of estimated wtp values. more scenarios with uncertainty charac­ teristics should be evaluated in further research, as well as other specified treatment options, such as psychotherapeutic treatment approaches or antidepressant medication (dgppn et al., 2015). fourth, the assessment of the variable “knowledge about ect” consisted of one item only, and did not objectively specify how much respondents know or how and where they became informed (e.g., movies, media, medical services). during administration of the present survey, a measure to assess perceptions and knowledge of ect was published (tsai et al., 2020), and we believe that it should be used in future studies to guarantee an objective, more detailed measurement of the respondents’ attitudes toward and knowledge of ect. additionally, we only recruited people who were being seen at an outpatient clinic. it is possible that patients of an inpatient clinic with more severe depressive symptoms would place higher values on mental-health-related quality of life, and might also be bet­ ter informed about their treatment options — ect in particular. generalization of results may therefore be limited to patients from an outpatient setting with no co-occurring mental disorders. finally, the health-care system (including psychiatric and psychological care) in ger­ many is unique compared to that of other european systems (see melcop et al., 2019, for an overview). in germany, health insurance is mandatory, and germans can choose between public or private health insurance. access to mental health care is free of additional charges in germany, which is uncommon among the other european union member states (strauß, 2009). additionally, the mental-health-care spending proportion­ ate to the gross domestic product is higher in germany (4.8%) than the european average (4.1%), and is only exceeded by that of denmark (5.4%; oecd, 2018). therefore, external validity may be limited to countries with similar health services for mental disorders. c o n c l u s i o n this study investigated the effect of the personal relevance of a presented health-gain scenario on the respondent’s wtp per qaly, and produced findings that add valuable information toward estimating the effects that individual characteristics have on the value that respondents place on a qaly. additionally, our findings emphasize the need to assess hypothetical population preferences alongside actual patients’ preferences for health benefits. value of quality-adjusted life year for depression 14 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.psychopen.eu/ funding: the authors have no funding to report. acknowledgments: we would like to thank lars paternoster and robert szczepanski for their help in implementing the questionnaire versions online. in addition, we would like to thank sina haider, marieke hansmann, laura lefarth and kira schamke, who conducted the screening interviews together with one of the authors. competing interests: the authors have declared that no competing interests exist. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): supplementary material 1: translation of the health state description supplementary material 2: sample scenario index of supplementary materials ulbrich, l., & kröger, c. 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(2007). eq-5d value sets: inventory, comparative review and user guide. springer. https://doi.org/10.1007/1-4020-5511-0 value of quality-adjusted life year for depression 18 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://www.oecd.org/berlin/presse/hohe-kosten-durch-psychische-erkrankungen-in-europa-22112018.htm https://www.oecd.org/berlin/presse/hohe-kosten-durch-psychische-erkrankungen-in-europa-22112018.htm https://doi.org/10.1016/j.healthpol.2017.03.011 https://doi.org/10.1016/s0277-9536(97)00129-9 https://doi.org/10.1111/j.1524-4733.2009.00610.x https://doi.org/10.1002/hec.3018 https://doi.org/10.1111/hex.12553 https://doi.org/10.3389/fpsyg.2019.01820 https://doi.org/10.1046/j.1525-1497.2003.20611.x https://doi.org/10.4135/9781412984997 https://doi.org/10.4135/9781412984997 https://doi.org/10.1002/hec.3085 https://doi.org/10.1080/13642530902927352 https://doi.org/10.1007/s10198-017-0929-z https://doi.org/10.1007/1-4020-5511-0 https://www.psychopen.eu/ tsai, j., huang, m., wilkinson, s. t., edelen, c., rosenheck, r. a., & holtzheimer, p. e. (2020). a measure to assess perceptions and knowledge about electroconvulsive therapy: development and psychometric properties. the journal of ect, 36(1), e1-e6. https://doi.org/10.1097/yct.0000000000000609 versteegh, m. m., & brouwer, w. b. f. (2016). patient and general public preferences for health states: a call to reconsider current guidelines. social science & medicine, 165, 66-74. https://doi.org/10.1016/j.socscimed.2016.07.043 vigo, d. v., kestel, d., pendakur, k., thornicroft, g., & atun, r. (2019). disease burden and government spending on mental, neurological, and substance use disorders, and self-harm: cross-sectional, ecological study of health system response in the americas. the lancet public health, 4, e89-e96. https://doi.org/10.1016/s2468-2667(18)30203-2 world health organization. (2008). the global burden of disease: 2004 update. https://www.who.int/healthinfo/global_burden_disease/gbd_report_2004update_full.pdf?ua=1 world health organization. (2013). mental health action plan 2013-2020. https://apps.who.int/iris/bitstream/handle/10665/89966/9789241506021_eng.pdf clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. ulbrich & kröger 19 clinical psychology in europe 2021, vol. 3(4), article e3855 https://doi.org/10.32872/cpe.3855 https://doi.org/10.1097/yct.0000000000000609 https://doi.org/10.1016/j.socscimed.2016.07.043 https://doi.org/10.1016/s2468-2667(18)30203-2 https://www.who.int/healthinfo/global_burden_disease/gbd_report_2004update_full.pdf?ua=1 https://apps.who.int/iris/bitstream/handle/10665/89966/9789241506021_eng.pdf https://www.psychopen.eu/ value of quality-adjusted life year for depression (introduction) cost-effectiveness analyses willingness to pay for a quality-adjusted life year effects of contextual and individual characteristics on wtp per qaly study aims method ethics approval participants and procedure online questionnaire exclusion criteria data analysis results sociodemographic characteristics of the samples results regarding hypothesis 1: probability of indicating a positive wtp results regarding hypothesis 2: wtp differences between patient and non-patient respondents discussion a vital assessment of patient preferences strengths and limitations conclusion (additional information) funding acknowledgments competing interests supplementary materials references increased anxiety of public situations during the covid-19 pandemic: evidence from a community and a patient sample research articles increased anxiety of public situations during the covid-19 pandemic: evidence from a community and a patient sample andre pittig 1,2 , valentina m. glück 1 , juliane m. boschet 1 , alex h. k. wong 1 , paula engelke 1 [1] department of psychology (biological psychology, clinical psychology, and psychotherapy), university of würzburg, würzburg, germany. [2] center of mental health, university of würzburg, würzburg, germany. clinical psychology in europe, 2021, vol. 3(2), article e4221, https://doi.org/10.32872/cpe.4221 received: 2020-09-05 • accepted: 2021-03-22 • published (vor): 2021-06-18 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: andre pittig, department of psychology i, university of würzburg, marcusstrasse 9-11, 97070 würzburg, germany. e-mail: andre.pittig@uni-wuerzburg.de abstract background: increases in emotional distress in response to the global outbreak of the sarscov-2 (covid-19) pandemic have been reported. so far, little is known about how anxiety responses in specific everyday public life situations have been affected. method: self-reported anxiety in selected public situations, which are relevant in the covid-19 pandemic, was investigated in non-representative samples from the community (n = 352) and patients undergoing psychotherapy (n = 228). situational anxiety in each situation was rated on a 5-point likert scale (0 = no anxiety at all to 4 = very strong anxiety). situational anxiety during the pandemic was compared with retrospectively reported situational anxiety before the pandemic (direct change) and with anxiety levels in a matched sample assessed before the pandemic (n = 100; indirect change). results: in the community and patient sample, indirect and direct change analyses demonstrated an increase in anxiety in relevant public situations but not in control situations. average anxiety levels during the pandemic were moderate, but 5-28% of participants reported high to very high levels of anxiety in specific situations. interestingly, the direct increase in anxiety levels was higher in the community sample: patients reported higher anxiety levels than the community sample before, but not during the pandemic. finally, a higher increase in situational anxiety was associated with a higher perceived danger of covid-19, a higher perceived likelihood of contracting covid-19, and stronger symptoms of general anxiety and stress. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4221&domain=pdf&date_stamp=2021-06-18 https://orcid.org/0000-0003-3787-9576 https://orcid.org/0000-0002-7316-1652 https://orcid.org/0000-0002-2607-912x https://orcid.org/0000-0003-2227-0231 https://orcid.org/0000-0003-1618-4935 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusions: preliminary findings demonstrate an increase in anxiety in public situations during the covid-19 pandemic in a community and a patient sample. moderate anxiety may facilitate compliance with public safety measures. however, high anxiety levels may result in persistent impairments and should be monitored during the pandemic. keywords anxiety, covid-19, emotional distress, public situations highlights • anxiety in public situations has increased in germany in response to the covid-19 pandemic. • average anxiety levels were moderate, but 5-28% of participants reported high to very high levels of anxiety. • a stronger increase of anxiety was linked to a higher perceived likelihood and dangerousness of a covid-19 infection. • large-scale representative studies monitoring the development of persistent anxiety are needed. emotional distress has increased in response to the global outbreak of the sars-cov-2 (covid-19) pandemic. moderate to severe increases in distress have been reported inter­ nationally, for example, in china, the usa, canada, iran, and europe (e.g., asmundson et al., 2020; mazza et al., 2020; moghanibashi-mansourieh, 2020; pierce et al., 2020; salari et al., 2020; torales et al., 2020; wang et al., 2020). while early reports focused on the general increase in emotional distress, more recent studies specifically reported increases in symptoms of anxiety, depression, and stress (asmundson et al., 2020; taylor et al., 2020; torales et al., 2020). to date, little is known about emotional responses in specific public situations that are characterized by an increased threat of covid-19 infection. these specific emotional responses are, however, important to fully understand emotional responses to the covid-19 pandemic and how they may influence our daily life. public policy measures (i.e., behavioral recommendations or restrictions) to reduce the spread of covid-19 vary internationally. in germany, public life was largely “shut down” for approximately four weeks at the beginning of the covid-19 pandemic (i.e., from mid-march 2020 to mid-april 2020). after covid-19 infection numbers declined, some restrictions were revoked, but others were continued as the pandemic was ongoing (for german policy measures, see steinmetz et al., 2020). especially physical distancing, the use of disinfectant, and wearing face masks were recommended in most public situa­ tions (see robert koch institute, 2020). relevant public situations for covid-19 related restrictions concerned public transport, restaurants and supermarkets, and effectively every crowded public area. as had been communicated to the general public, these anxiety of public situations during covid-19 2 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ public situations are especially salient for covid-19 related threats. the resulting threat salience may be linked to elevated situational anxiety in these public situations. in the ongoing pandemic, moderate situational anxiety levels may indeed be adaptive as they may support safety behaviors to prevent covid-19-related harm (e.g., arnaudova et al., 2017; pittig et al., 2020). however, high anxiety levels may also lead to severe distress without additionally supporting safety behaviors and may even persist in the absence of threat (pittig et al., 2020). preliminary evidence showed that patients with anxiety-re­ lated and mood disorders exhibited stronger covid-related stress responses than a healthy sample (asmundson et al., 2020), suggesting that individuals with mental health conditions are prone to experiencing covid-related anxiety. it is therefore important to explore the potential increase of situational anxiety in public situations during the covid-19 pandemic, in both general community and clinical samples. methodologically, an increase in situational anxiety can be assessed by direct and indirect change measures (stieglitz & baumann, 2001). as a measure of direct change, current anxiety levels, which are assessed during the pandemic, can be compared with retrospectively assessed anxiety levels before the pandemic. retrospective self-reports pose a risk of recall biases (van den bergh & walentynowicz, 2016), whereby recall inaccuracies of affective states might differ between clinical and general community samples (ben-zeev, young, & madsen, 2009). nevertheless, this direct approach reflects perceived individual increases in anxiety, i.e., whether individuals feel that their anxiety has increased in response to the pandemic. as an indirect change measure, current anxi­ ety levels, which are assessed during the pandemic, can be compared with anxiety levels assessed before the pandemic, optimally within the same sample. the indirect approach is unbiased by retrospective recall but requires repeated measurements. the fast onset of the covid-19 pandemic prohibited the arrangement of such controlled longitudinal designs. alternatively, indirect change can be measured by comparing anxiety levels in a sample surveyed during the pandemic with anxiety levels in a different sample assessed before the pandemic. potential biases caused by differences in certain characteristics between the two samples (e.g., differences in age or biological sex distribution) can be prevented by matching the samples based on these characteristics. the current study examined both direct and indirect changes in situational anxiety in public situations, which are relevant to the covid-19 pandemic, in a non-representa­ tive community sample and a patient sample. in an online survey, individuals reported their anxiety levels for ten relevant public situations (e.g., taking the bus, going to the supermarket, or being at a crowded public place) and three control situations (e.g., being outdoors alone). we assessed retrospective anxiety levels (i.e., before the pandemic) and current anxiety levels in the previous two weeks (i.e., during the pandemic). besides comparing these ratings (direct change), situational anxiety during the pandemic was compared with a matched sample that was surveyed before the pandemic (indirect change). to highlight the clinical relevance (i.e., high levels of anxiety may result in pittig, glück, boschet et al. 3 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ impairments), we complemented these analyses by calculating the proportion of individ­ uals who reported high or very high anxiety levels in these situations. we hypothesized that both the community and the patient sample show an increase in situational anxi­ ety during the covid-19 pandemic, with a stronger increase in the patient sample (asmundson et al., 2020). furthermore, we explored the association between increased situational anxiety and symptoms of anxiety, depression, stress, the perceived likelihood of contracting covid-19, and the perceived dangerousness of a covid-19 infection. we expected that these clinical symptoms and perceived threat of covid-19 are positively associated with situational anxiety. m e t h o d a n d m a t e r i a l s participants and recruitment the study was approved by the local ethics committee (gzek 2020-31). three samples of participants anonymously completed an online survey. participants had to be ≥ 18 years of age. the pre-covid sample was recruited from the general community before the pandemic (february to april 2019) as part of the validation of an online survey (n = 100, age: m = 27.73, sd = 10.47, females: 69.8%). the community sample (n = 352, age: m = 35.90, sd = 14.09, females: 69.9%) and the patient sample (n = 228, age: m = 39.07, sd = 14.50, females: 60.5%) were recruited during the covid-19 pandemic (mid of may to mid of july 2020). as present restrictions may influence situational anxiety, we briefly report restrictions that were continuously active across the recruitment period (steinmetz et al., 2020): most public situations, e.g., going to supermarkets and shops, using public transport as well as attending religious meetings and demonstrations, were accessible on the condition that specific regulations were followed (e.g., physical distanc­ ing, face masks, a limited number of people). restaurants and entertainment venues (e.g., theaters and cinemas) re-opened stepwise starting between mid of may and mid of june (regionally depending). meetings of persons from more than two different households were permitted in germany as from mid of june, but group size was mostly still limited, e.g., to a maximum of ten people. major public events remained prohibited during the whole recruitment period. both the pre-covid and the community sample were recruited from the general community in germany via identical online recruitment pathways (e.g., via a german internet platform for online surveys, german local social media groups, and the partici­ pant management tool of the university of würzburg). the patient sample was recruited via the outpatient clinic for psychotherapy at the university of würzburg. 109 out of 689 participants completed opt-in informed consent but discontinued the survey before providing anxiety ratings for at least one situation and were thus excluded (15.8%). the remaining 580 participants in the community and patient sample completed all anxiety of public situations during covid-19 4 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ situational anxiety ratings, i.e., there were no missing data for the variables of interest, as the completion of sociodemographic data, trait anxiety, and symptom measures was required before answering the situational anxiety ratings. all patients had provided writ­ ten informed consent to be contacted for research purposes prior to the study and were currently undergoing psychotherapeutic treatment. a total of 496 patients was invited to participate in the study (response rate = 46.0%). the distribution of main primary diagnoses within the invited patients was 33.4% affective disorders, 23.7% anxiety disor­ ders, 15.3% adjustment disorder, 7.4% somatoform disorders, 5.0% obsessive-compulsive disorder, 3.9% posttraumatic stress disorder, 2.9% eating disorders. online survey the online survey measured self-reported anxiety in selected public situations, trait anxiety, symptoms of emotional distress, and basic demographic data (i.e., age, sex, em­ ployment status). trait anxiety was assessed with the anxiety subscale of the neo-pi-r (n1 subscale; costa & mccrae, 1992). symptoms of anxiety, depression, and stress over the previous week were assessed with the german short version of the depression anxiety stress scales (dass-21; lovibond & lovibond, 1995; nilges & essau, 2015). all participants, including the pre-covid sample, completed these two questionnaires. the community and patient sample additionally rated the perceived dangerousness of covid-19 (5-point likert-scale from very harmless to very dangerous) and the subjective likelihood of contracting covid-19 (5-point likert-scale from very unlikely to very likely). self-reported anxiety was assessed for 13 selected public situations, mostly taken from a well-established questionnaire for agoraphobia (mobility inventory; chambless et al., 1985). ten of these situations were regarded as highly relevant in the covid-19 pandemic: taking the bus, taking the train, going to the supermarket, going to the cinema/theater, shopping mall, restaurant, waiting in line, talking to others, and being at an outdoor or indoor public area with people. three additional situations were used to control whether general changes in anxiety occurred in situations that are unrelated to covid-19 but may still provoke some anxiety, i.e., being alone in an unknown area. all participants were instructed to rate their anxiety level for each situation during the previous two weeks (5-point likert scale; 0 = no anxiety at all to 4 = very strong anxiety). the community and patient samples retrospectively rated each situation regarding how anxious they were before the covid-19 outbreak. if participants had not approached a particular situation in the previous two weeks, they were asked to imagine being in the situation and rate the anxiety level accordingly. pittig, glück, boschet et al. 5 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ statistical analysis the main research aim was to examine changes in self-reported anxiety in public situations during the covid-19 pandemic. to this end, we calculated the direct and indirect change in self-reported anxiety. direct change was analyzed by comparing anxiety ratings for the 13 selected public situations during the previous two weeks with retrospectively reported anxiety for these situations before the pandemic (with­ in-subjects comparison). therefore, we conducted repeated measures anovas for each situation with group (community vs. patient sample) as between-subjects factor and time (previous two weeks vs. before covid-19) as within-subjects factor, including all participants from both samples recruited during the covid-19 pandemic. indirect change was analyzed by comparing anxiety ratings in the previous two weeks in the community and patient sample separately with anxiety ratings for the same situations in the matched pre-covid sample (between-subjects comparison). as these indirect change analyses may be biased due to different sample characteristics, we aimed to reduce sample bias by matching participants. precisely, we matched the three samples on age, sex, and employment status using nearest neighbor matching (ho et al., 2011). as the smallest sample (i.e., the pre-covid sample) included 100 participants, we selec­ ted the closest neighbors in the other samples, respectively. as a result, the indirect change analyses were conducted with 100 participants per sample. analyses with the complete, but unmatched samples yielded the same pattern of results. indirect change was analyzed using a manova with anxiety ratings in the previous two weeks in the 13 situations as dependent variables, followed by one-way anovas for each situation with the between-subjects factor group (pre-covid, community, patient). bonferroni-holm correction was applied in all analyses. cohen’s d and eta-squared are reported as effect sizes. to highlight the clinical relevance of these analyses, we aimed to provide descriptive data on the frequency of high anxiety levels in public situations in response to the cov­ id-19 pandemic. for each situation, we calculated the relative number of participants from the complete sample who indicated “strong” or “very strong” anxiety. finally, we exploratorily examined the associations between the increase in self-reported anxiety (difference score: anxiety during covid-19 – anxiety before covid-19) and clinical variables (trait anxiety, symptoms of depression, stress, and anxiety) as well as covid-19 related variables (perceived dangerousness and likelihood of contracting covid-19) in the unmatched community and patient samples. to this end, robust winsorized correla­ tions (trim = 0.2) were calculated using the wrs2 package (mair & wilcox, 2020) in r (r core team, 2020). anxiety of public situations during covid-19 6 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ r e s u l t s increased anxiety of public situations direct change for all situations, there was an increase in self-reported anxiety during the covid-19 pandemic (see figure 1a and table 1). for the control situations, this increase was relatively small and there were no significant effects involving group. for most cov­ id-relevant situations, repeated measures anovas yielded a significant interaction of group and time. post-hoc wilcoxon tests indicated that anxiety increased in all situa­ tions in the patient sample, ps < .001, rs = .86 to 1.00, and in the community sample, ps < .001, rs = .81 to 1.00. the patient compared to the community sample reported higher retrospective anxiety before the covid-19 pandemic in most situations, us > 42606.0, ps < .020, rs = .06 to .25, except for “being alone in an unknown area”, u = 39955.0, p = .924, r = .04. interestingly, the groups did not differ in anxiety during the covid-19 pandemic, us < 42858.0, ps > .077, rs = -.05 to .07. this overall pattern differed only for the situations “waiting in line” and “talking to others”. for both, anxiety was higher during than before the pandemic (table 1), and the patient sample reported higher anxiety. however, there was no significant interaction between group and time. in sum, direct change analyses indicated a slight increase in self-reported anxiety in the control situations and a larger increase in all covid-relevant public situations. interestingly, the latter increase was higher in the community sample compared with the patient sample, as indicated by patients’ higher anxiety levels before but not during the pandemic in most public situations. indirect change for the matched samples, the significant manova, pillais’ trace = .33, f(26, 572) = 4.27, p < .001, was followed up by one-way anovas for each situation, comparing self-reported anxiety levels during the previous two weeks between the three samples. as expected, no significant differences were found for the three control situations (see figure 1b and table 1). in all covid-relevant public situations, self-reported anxiety during the previous two weeks differed between groups. for almost all situations, anxi­ ety ratings did not differ between the community and the patient sample, ts < 1.58, ps > .116, ds = -0.19 to 0.05, but were higher than in the pre-covid sample, respectively, ts > 4.61, ps < .001, ds = 0.68 to 1.20. this pattern only differed for the situation “talking to others”: while the patient sample again reported higher anxiety than the pre-covid sample, t = 3.48, p = .002, d = 0.48, the community sample did not differ from the other two samples, ts < 2.03, ps > .087, ds < 0.30. in sum, indirect change analyses of the matched samples indicated higher self-reported anxiety levels during the previous two weeks than before the covid-19 pandemic in all relevant public situations. pittig, glück, boschet et al. 7 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ figure 1 average self-reported anxiety in selected public situations before and during the covid-19 pandemic (with standard error of the mean) note. situational anxiety was rated for each situation on a 5-point likert scale (0 = no anxiety at all to 4 = very strong anxiety). a: direct change as indicated by comparing anxiety ratings during the previous two weeks (during the pandemic) with retrospectively reported anxiety before the pandemic (within-subject comparison; community sample: n = 352, patient sample: n = 228). b: indirect change as analyzed by comparing anxiety ratings for the previous two weeks in a matched community and patient sample with anxiety ratings in the matched pre-covid sample (between-subject comparison, n = 100 for each subsample). anxiety of public situations during covid-19 8 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ table 1 overview of statistical results for direct and indirect change direct change indirect change situation / effect f p η2 effect f p η2 outdoor public area w/o people time 41.32 < .001 .011 group 0.34 .710 .002group 1.43 .232 .002 time*group 2.80 .095 < .001 indoor public area w/o people time 72.25 < .001 .024 group 0.02 .997 < .001group 6.12 .014 .008 time*group 0.88 .349 < .001 being alone in unknown area time 37.33 < .001 .003 group 0.32 .729 .002group 0.10 .755 < .001 time*group 0.67 .413 < .001 taking bus time 408.01 < .001 .188 group 28.32 < .001 .160group 7.80 .005 .007 time*group 4.79 .029 .002 taking train time 342.30 < .001 .174 group 19.30 < .001 .115group 8.17 .004 .007 time*group 4.80 .029 .002 supermarkets time 352.66 < .001 .173 group 22.33 < .001 .131group 6.20 .013 .006 time*group 4.64 .032 .002 cinema/theater time 390.67 < .001 .194 group 32.62 < .001 .180group 4.71 .030 .004 time*group 12.86 < .001 .006 shopping mall time 357.68 < .001 .170 group 25.31 < .001 .146group 6.10 .014 .006 time*group 9.39 .002 .004 restaurant time 364.73 < .001 .197 group 20.82 < .001 .123group 1.49 .223 .001 time*group 9.45 .002 .005 pittig, glück, boschet et al. 9 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ direct change indirect change situation / effect f p η2 effect f p η2 waiting in line time 311.01 < .001 .149 group 18.66 < .001 .112group 10.23 .001 .010 time*group 0.68 .409 < .001 talking to others time 222.51 < .001 .071 group 6.12 .002 .040group 15.43 < .001 .019 time*group 0.03 .865 < .001 outdoor public area w/o people time 283.91 < .001 .106 group 15.37 < .001 .094group 16.99 < .001 .019 time*group 8.17 .004 .003 indoor public area w/o people time 398.88 < .001 .167 group 22.48 < .001 .131group 15.08 < .001 .015 time*group 8.28 .004 .003 note. the factor time refers to the within-subject factor for ratings before (retrospective) vs. during pandemic. the factor group refers to community vs. patient sample (direct change) or pre-covid vs. community vs. patient sample (indirect change). frequency of high and very high anxiety in public situations the proportion of individuals indicating high or very high anxiety levels is displayed in table 2. overall, the frequency of high or very high anxiety increased by approximately 10%. in the community sample, the average increase was 8% (indirect) to 10% (direct). in the patient sample, the average increase was 11% (direct) to 12% (indirect). associations between anxiety increase, symptoms, and covid-19 related variables robust winsorized correlations within the patient and the community samples are shown in table 3. most correlations were similar in both samples. a stronger increase in self-re­ ported anxiety (i.e., a higher direct change score) was associated with a higher perceived dangerousness and a higher perceived likelihood of contracting covid-19 (the latter two correlated positively in the patient sample, r = .41, p < .001, and in the community sample, r = .33, p = .003). moreover, a stronger increase in self-reported anxiety was associated with stronger symptoms of anxiety and stress, but not with symptoms of depression, or with trait anxiety. anxiety of public situations during covid-19 10 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ table 3 associations between direct increase of anxiety in public situations and covid-19 variables, clinical, and demographic data sample covid-19 variable clinical variable danger likelihood contraction trait anxiety anxiety stress depression community sample .25* .19 .16 .21* .23* .03 patient sample .26* .26* .12 .21* .28* .14 note. zero-order robust winsorized correlations (trim = 0.2) with direct change score (anxiety during covid-19 minus before covid-19). *p < .05. table 2 relative frequency of high or very high anxiety to distinct public situations public situation community sample (n = 352) patient sample (n = 228) pre-covid sample (n = 100) duringa (before)b duringa (before)b beforea outdoor public place w/o people 0.9% (0.3%) 1.8% (0.9%) 0.0% indoor public place w/o people 2.3% (0.6%) 1.8% (1.3%) 2.0% being alone in unknown area 8.5% (7.1%) 10.5% (7.5%) 18.0% taking bus 15.1% (1.4%) 19.3% (4.8%) 4.0% taking train 15.1% (1.1%) 18.9% (5.3%) 2.0% supermarkets 7.7% (0.6%) 11.0% (2.6%) 4.0% cinema/theater 15.6% (1.4%) 20.6% (6.1%) 0.0% shopping mall 10.5% (0.9%) 11.0% (3.9%) 4.0% restaurants 13.1% (0.9%) 12.7% (3.5%) 6.0% waiting in line 5.7% (1.1%) 11.8% (3.1%) 2.0% talking to others 5.1% (1.1%) 9.2% (3.9%) 2.0% outdoor public area w/ people 8.8% (1.1%) 15.8% (6.6%) 8.0% indoor public area w/ people 20.5% (3.1%) 27.6% (7.9%) 6.0% note. proportion of participants responding with “strong anxiety” or “very strong anxiety” in the different public situations. aanxiety during the previous two weeks. bretrospective anxiety before the covid-19 pandemic. pittig, glück, boschet et al. 11 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ d i s c u s s i o n the current study investigated changes in anxiety in public situations in response to the covid-19 pandemic. in all relevant public situations, anxiety increased strongly, both in a community sample and in a clinical sample of patients affected by mental disorders. in both samples, evidence for increased anxiety was supported by direct and indirect change analyses. for direct change, levels of situational anxiety during the pandemic were higher than retrospective anxiety levels of the same individuals before the pandem­ ic. for indirect change, situational anxiety during the pandemic was higher than anxiety in the same situations assessed before the pandemic in a matched community sample. thus, the present findings expand previous reports concerning an increase in general emotional distress during the covid-19 pandemic (e.g., asmundson et al., 2020; taylor et al., 2020), as the current results highlight a distinct increase in self-reported anxiety in covid-relevant public situations. the increase in situational anxiety in response to the pandemic was not driven by outdoor situations per se. no strong increase in anxiety was found in situations that do not involve potential physical contact with others (e.g., being alone in a public area). in these control situations, self-reported anxiety during the pandemic was only slightly higher than retrospectively reported anxiety. also, anxiety levels in these control situations before the pandemic and during the pandemic did not differ. thus, increased situational anxiety was linked to physical closeness to other individuals, presumably due to the associated risk of contracting covid-19. in support, a higher perceived likelihood of contracting covid-19 and a higher perceived danger of covid-19 infections were associated with a stronger increase in situational anxiety. in sum, increased anxiety of public situations likely resulted from a higher perceived threat of contracting covid-19. average situational anxiety levels during the pandemic were moderate. as the ongo­ ing pandemic represents a realistic threat to the individual and the society, moderate lev­ els of anxiety in situations that pose a higher risk of contraction can be seen as adaptive responses. anxiety activates the defensive network and facilitates defensive behaviors such as avoidance or safety behavior (pittig et al., 2018, 2020). in this regard, moderate anxiety levels could promote compliance with safety measures. however, extremely high anxiety levels may not entail additional benefits for preventing infections but may lead to severe distress and impairments. on average, there was an increase of 8-12% in individuals who reported high to very high anxiety in public situations. up to 20-28% of participants indicated high or very high anxiety when being in an indoor public area with others during the pandemic. importantly, high anxiety levels may result in avoidance of relevant situations, which may persist even in the absence of threat (pittig et al., 2020). it therefore seems important to identify individuals with high anxiety and to monitor the development of persistent maladaptive anxiety and potential avoidance. notably, individuals who perceived covid-19 as being more dangerous and perceived the likelihood of contracting covid-19 as being higher showed a stronger increase in anxiety of public situations during covid-19 12 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ situational anxiety. moreover, a stronger increase in situational anxiety has been linked to stronger general symptoms of stress and anxiety. these findings suggest that caution should be placed on these individuals, given that they are more likely to experience a higher level of psychological distress and detrimental effects on their overall well-being (kang et al., 2020; torales et al., 2020). interestingly, there were some expected, but also unexpected, differences between the community and the patient sample. as expected, patients reported higher levels of retrospective anxiety than participants of the community sample. these heightened anxiety levels before the covid-19 outbreak may reflect higher perceived threat in these situations due to relevant psychopathologies (e.g., agoraphobia, social anxiety). howev­ er, no group differences in situational anxiety during the pandemic were observed. in other words, both samples showed similar anxiety levels in public situations during the covid-19 pandemic. importantly, the lack of group differences was not due to a ceiling effect, considering that the average self-reported anxiety was moderate in both samples. these results are not in line with previous findings of higher levels of covid-19-related distress in clinical samples than in the general population (asmundson et al., 2020). there may be multiple explanations. first, whereas previous studies assessed general emotional distress, the present study examined anxiety in specific public situations. the higher levels of general distress found in previous studies may be caused by factors different from anxious responding in covid-relevant situations (e.g., troubles coping with self-isolation, general worries about the future, or the socio-economic impact of covid-19; see asmundson et al., 2020). second, the patient sample consisted of patients with mental disorders undergoing cognitive-behavioral treatment. the ongoing treatment may have buffered negative effects of the pandemic and facilitated adaptive coping strategies. third, patients and non-patients may have applied diverging scaling in covid-related anxiety ratings (e.g., patients who have frequently experienced highly anxious states may classify levels of anxiety as “moderate” when non-patients may classify similar levels as “high”). finally, the lack of differences between the patient and community sample under realistic threat is in line with findings from experimental fear learning research. specifically, a meta-analysis found no differences in learning novel fear responses to a stimulus signaling threat between healthy individuals and patients with anxiety disorders (duits et al., 2015). however, patients showed elevated responses to a safety signal and ongoing fear responses in the absence of threat. thus, patients seemingly do not show elevated responses to stimuli and situations signaling realistic threat but rather show a bias to stimuli and situations signaling safety or the absence of previous threat. therefore, it is important to monitor increased anxiety responses in patients when the risk for contraction of covid-19 decreases. moreover, the present study did neither assess the effects of psychotherapy on the negative psychological effects of the covid-19 pandemic, nor did it assess potential increases in anxiety in currently untreated clinical samples. thus, additional research is warranted. pittig, glück, boschet et al. 13 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://www.psychopen.eu/ the present results are limited by the non-representative samples, which were re­ cruited from a german-speaking population. the generalizability to other populations requires further research. the current findings may only represent a subset of the popu­ lation but provide the insight that at least in this portion of the german population, an increase in covid-19-related situational anxiety occurred. as no data about the current place of the participants’ residence were collected, the potential influence of regional variances in covid-19 incidence values and, relatedly, official regulations at the time of the survey on situational anxiety cannot be ruled out. however, incidences were generally low in germany and did not exceed 25 per 100,000 population in any german state at the period of the survey (robert koch institute, 2021) and official restrictions did not differ substantially between german regions (see steinmetz et al., 2020). the study’s results may also be used to generate more elaborate hypotheses on the associations between covid-19-related and clinical variables on the one side and an increase in situational anxiety on the other side. as outlined above, monitoring general and situa­ tion-specific anxiety levels and identifying individuals at risk for developing persistent anxiety and impairments is important for understanding and potentially preventing pan­ demic-related psychological distress. public policymakers should facilitate appropriate large-scale, long-term studies. another limitation is the missing assessment whether participants experienced the public situations during the previous two weeks or whether they imagined being in the situations. future research may disentangle these potentially diverging responses. finally, the patient sample was diagnosed with heterogeneous men­ tal disorders, which could not be matched to situational anxiety changes. thus, we could not evaluate whether there were any differences between different mental disorders or whether a specific disorder may be linked to a higher recall bias. in conclusion, the current study provides preliminary evidence for an increase in situational anxiety in public situations in a community and a patient sample during the covid-19 pandemic. both groups showed similar levels of moderate situational anxiety, which may facilitate compliance with public safety recommendations and restrictions for preventing covid-19 contractions. however, some individuals display high levels of anxiety, which should be monitored during and after the pandemic. funding: the authors have no funding to report. acknowledgments: the authors thank kristina schneider, julian koch and naja kärcher for their help with data collection. competing interests: the authors have declared that no competing interests exist. twitter accounts: @andrepittig, @gluckvalentina, @julianeboschet, @psycalexwong, @engelkepaula anxiety of public situations during covid-19 14 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://twitter.com/andrepittig https://twitter.com/gluckvalentina https://twitter.com/julianeboschet https://twitter.com/psycalexwong https://twitter.com/engelkepaula https://www.psychopen.eu/ r e f e r e n c e s arnaudova, i., kindt, m., fanselow, m., & beckers, t. 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(2020). the outbreak of covid-19 coronavirus and its impact on global mental health. the international journal of social psychiatry, 66(4), 317-320. https://doi.org/10.1177/0020764020915212 van den bergh, o., & walentynowicz, m. (2016). accuracy and bias in retrospective symptom reporting. current opinion in psychiatry, 29(5), 302-308. https://doi.org/10.1097/yco.0000000000000267 wang, c., pan, r., wan, x., tan, y., xu, l., ho, c. s., & ho, r. c. (2020). immediate psychological responses and associated factors during the initial stage of the 2019 coronavirus disease (covid-19) epidemic among the general population in china. international journal of environmental research and public health, 17(5), article 1729. https://doi.org/10.3390/ijerph17051729 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. pittig, glück, boschet et al. 17 clinical psychology in europe 2021, vol. 3(2), article e4221 https://doi.org/10.32872/cpe.4221 https://doi.org/10.1177/0020764020915212 https://doi.org/10.1097/yco.0000000000000267 https://doi.org/10.3390/ijerph17051729 https://www.psychopen.eu/ anxiety of public situations during covid-19 (introduction) method and materials participants and recruitment online survey statistical analysis results increased anxiety of public situations frequency of high and very high anxiety in public situations associations between anxiety increase, symptoms, and covid-19 related variables discussion (additional information) funding acknowledgments competing interests twitter accounts references medication-enhanced psychotherapy for posttraumatic stress disorder: recent findings on oxytocin’s involvement in the neurobiology and treatment of posttraumatic stress disorder scientific update and overview medication-enhanced psychotherapy for posttraumatic stress disorder: recent findings on oxytocin’s involvement in the neurobiology and treatment of posttraumatic stress disorder katrin preckel 1 , sebastian trautmann 2 , philipp kanske 1,3 [1] max planck institute for human cognitive and brain sciences, leipzig, germany. [2] institute of clinical psychology and psychotherapy, department of psychology, medical school hamburg, hamburg, germany. [3] clinical psychology and behavioral neuroscience, faculty of psychology, technische universität dresden, dresden, germany. clinical psychology in europe, 2021, vol. 3(4), article e3645, https://doi.org/10.32872/cpe.3645 received: 2020-04-30 • accepted: 2021-08-25 • published (vor): 2021-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: katrin preckel, max planck institute for human cognitive and brain sciences, stephanstraße 1a, 04103 leipzig, germany. phone: +49 341 9940-2653. e-mail: preckel@cbs.mpg.de abstract background: traumatic experiences may result in posttraumatic stress disorder (ptsd), which is characterized as an exaggerated fear response that cannot be extinguished over time or in safe environments. what are beneficial psychotherapeutic treatment options for ptsd patients? can oxytocin (oxt), which is involved in the stress response, and safety learning, ameliorate ptsd symptomatology and enhance psychotherapeutic effects? here, we will review recent studies regarding oxt’s potential to enhance psychotherapeutic therapies for ptsd treatment. method: we conducted a literature review on the neurobiological underpinnings of ptsd especially focusing on oxt’s involvement in the biology and memory formation of ptsd. furthermore, we researched successful psychotherapeutic treatments for ptsd patients and discuss how oxt may facilitate observed psychotherapeutic effects. results: for a relevant proportion of ptsd patients, existing psychotherapies are not beneficial. oxt may be a promising candidate to enhance psychotherapeutic effects, because it dampens responses to stressful events and allows for a faster recovery after stress. on a neural basis, oxt modulates processes that are involved in stress, arousal and memory. oxt effectively counteracts memory impairments caused by stress and facilitates social support seeking which is a key resilience factor for ptsd and which is beneficial in psychotherapeutic settings. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3645&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0003-1498-3813 https://orcid.org/0000-0002-8976-3244 http://orcid.org/0000-0003-2027-8782 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: oxt has many characteristics that are promising to positively influence psychotherapy for ptsd patients. it potentially reduces intrusions, but preserves memory of the event itself. introducing oxt into psychotherapeutic settings may result in better treatment outcomes for ptsd patients. future research should directly investigate oxt’s effects on ptsd, especially in psychotherapeutic settings. keywords ptsd, oxytocin, treatment, medication-enhanced therapy, stress highlights • lower endogenous oxt levels after traumatic experiences are associated with developing ptsd. • oxt administration around the time of the traumatic event may result in fewer intrusive memories. • abnormal signaling of the hippocampus and the vmpfc to the amygdala result in hyperactivation of the amygdala in ptsd. • oxt facilitates social support seeking and safety learning while reducing personal distress. • oxt’s characteristics are promising to enhance psychotherapeutic treatment for ptsd patients. traumatic experiences may result in posttraumatic stress disorder (ptsd), which is characterized as an exaggerated fear response that cannot be extinguished over time or in safe environments. the lifetime prevalence of developing ptsd lies at about 4% (koenen et al., 2017). this number is relatively low considering that 80% of the general population experience traumatic events during their lifetime. critical factors that determine if someone develops ptsd after experiencing or witnessing traumatic events include female gender, history of mental disorder (tortella-feliu et al., 2019), childhood adversities (mclaughlin et al., 2017), but also individual emotional contagion and empathy (trautmann et al., 2018). in particular, for witnessed trauma, the ability to distinguish own feelings from that of others is crucial to avoid excessive personal distress and anxiety (preckel, kanske, & singer, 2018). also, emotion regulation abilities may be indicative of ptsd development after a traumatic experience, as prospective studies on emotion regulation and trauma symptoms show (bardeen, kumpula, & orcutt, 2013; ehring & ehlers, 2014). treatment approaches for ptsd are not yet sufficiently successful, this is shown by patient drop-out rates, for instance, which are highly variable with rates between 16% to 53.1% (hatchett & park, 2003; lewis, roberts, gibson, & bisson, 2020), depending on how the drop-out rates were defined. importantly, although trauma‐focused cognitive behav­ ior therapy is the best‐validated treatment for ptsd, it has failed to develop over the oxytocin’s role in the neurobiology and treatment of ptsd 2 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ past few decades. importantly, only two‐thirds of ptsd patients respond effectively to this therapy. besides, the majority of ptsd patients does not take part in evidence‐based treatment, this applies predominately to low‐ and middle‐income countries (bryant, 2019). this underlines the need for better therapeutic approaches and ongoing research on this topic. behavioral and medication treatment approaches for ptsd have different strengths and weaknesses (flanagan & mitchell, 2019), which makes a combination, of a medication-enhanced psychotherapy approach very promising. regarding the common symptoms of ptsd such as intrusive memories and flashbacks, avoidance behavior, (negative) changes in cognition and in arousal (american psychiatric association, 2013), as well as deficits in social cognition (e.g. empathy, compassion and theory of mind) (couette, mouchabac, bourla, nuss, & ferreri, 2020; palgi, klein, & shamay-tsoory, 2016), the neuropeptide and hormone oxytocin (oxt) may bear relevance for the treatment of ptsd (palgi, klein, & shamay-tsoory, 2016). oxt may be a relevant treatment enhancer, because it has been found to influence memory (lee et al., 2015), approach-avoidance behavior (preckel, scheele, kendrick, maier, & hurlemann, 2014), social cognition (e.g. emotion recognition) (schwaiger, heinrichs, & kumsta, 2019) and arousal (rash & campbell, 2014). due to oxt’s broad influence on human well-being, it has been introduced as a promising treatment agent for various disorders including ptsd (koch et al., 2014; misrani, tabassum, & long, 2017; preckel, kanske, singer, paulus, & krach, 2016). furthermore, oxt attenuates the development of ptsd symp­ toms after trauma exposure in patients with high acute symptomatology (van zuiden et al., 2017) and is useful as an early preventive intervention (frijling, 2017). another study found that oxt was able to reduce ptsd symptoms which were triggered by trauma-script exposure (sack et al., 2017). in this update article, we review the latest literature on the relationship of biological underpinnings of ptsd, memory formation and oxt. we investigate the question: what role can/ does oxt play in ptsd symptom development and how might it improve ptsd symptoms? we start our article by describing the stress physiology and the roles that oxt and cortisol play in it, we then continue by discussing the influence of oxt on the neural circuits of fear conditioning, ptsd and memory and, before summarizing our thoughts, we discuss the potential benefits of oxt as a treatment enhancer for ptsd psychotherapy. s t r e s s p h y s i o l o g y a n d t h e r o l e s o f o x y t o c i n a n d c o r t i s o l the stress response involves multiple levels, which include cognitive, behavioral and physiological processes. on the physiological level, highly stressful or traumatic experi­ ences, activate the hypothalamic-pituitary-adrenal (hpa) axis as well as the oxytociner­ preckel, trautmann, & kanske 3 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ gic system (donadon, martin-santos, & osório, 2018). activity of the hpa axis and its end-product cortisol facilitate adaption to the faced stressor (e.g. de kloet, joëls, & holsboer, 2005). a typical physiological stressful response involves the following steps: the hypothalamus releases the cortiocotropin-releasing-hormone (crh) to the pituitary gland, which in turn releases the adrenocorticotropic hormone (acth) into systemic circulation. acth prompts the adrenal gland to release glucocorticoids such as cortisol. when cortisol levels in the blood increase, this is perceived by brain regions (e.g. hypo­ thalamus) and the release of crh is stopped to return to homeostasis (smith & vale, 2006). in ptsd patients, the reinstating of homeostasis fails (yehuda, 2002), resulting in an indiscriminately heightened physiological stress responses (e.g. mcfarlane, atchison, rafalowicz, & papay, 1994). hypocortisolism is often reported in ptsd patients, which might at first sight be counterintuitive. yet, the downregulation of available cortisol could be an attempt of the body to compensate for exaggerated stress responses (thaller, vrkljan, hotujac, & thakore, 1999). this compensatory attempt, however, results in a sensitization to the glucocorticoid system (rohleder, wolf, & wolf, 2010), meaning that low concentrations of cortisol are sufficient to induce a fear or stress response. furthermore, the observed hypocortisolism may be dependent on the type of cortisol measure, because in the cerebrospinal fluid of patients with ptsd, a sustained increase of the corticotropin-releasing hormone was observed (sherin & nemeroff, 2011). while hair cortisol levels are commonly reported to be lower in ptsd patients when compared to those of healthy controls (steudte-schmiedgen, kirschbaum, alexander, & stalder, 2016; steudte-schmiedgen et al., 2015; van zuiden et al., 2019), but there are contradictory findings (van den heuvel et al., 2020). exogenously administered oxt promotes a faster recovery after the stress response (heinrichs, baumgartner, kirschbaum, & ehlert, 2003; kubzansky, mendes, appleton, block, & adler, 2012), and it attenuates salivary cortisol elevations after a physical stres­ sor (cardoso, ellenbogen, orlando, bacon, & joober, 2013). endogenous oxt levels are frequently measured in the periphery and lower endogenous oxt levels after traumatic experiences are associated with developing ptsd (donadon, martin-santos, & osório, 2018), even though endogenous oxt levels of individuals who suffer from ptsd and those of healthy controls did not differ (engel et al., 2019). interestingly, oxt and cortisol levels are positively correlated when participants were able to anticipate a stressor (brown, cardoso, & ellenbogen, 2016). anticipation and predictability seem to strongly influence oxt’s action, because also exogenously administered oxt has ambiguous effects on threatening responses which is partly due to the predictability or unpredicta­ bility of threatening cues. this means that oxt administration results in anxiogenic effects when threat cues are unpredictable, because defensive responses to unpredictable shocks were significantly increased by oxt (as compared to placebo and vasopression administration), while predictable shocks were not influenced by oxt administration oxytocin’s role in the neurobiology and treatment of ptsd 4 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ (grillon et al., 2013). furthermore, oxt’s effects on anxiety depend on the timing of oxt administration and threat content, because both anxiolytic and anxiogenic effects have been reported (frijling, 2017; neumann & slattery, 2016). importantly though, in people who experienced moderate emotional trauma, anxiolytic effects of oxt have been found (donadon et al., 2018). while oxt’s effects on cortisol are diverse, a recent meta-analysis reported that oxt attenuated the cortisol response to a greater extend, when the hpa-axis was strongly activated and this effect was strongest among clini­ cal populations (patients with ptsd, major depressive disorder and bipolar disorder) (cardoso, kingdon, & ellenbogen, 2014). these ambiguous findings may be due to the cross-binding ability of oxt and vasopressin, (for more detail see: preckel & kanske, 2018). moreover, oxt enables rapid and flexible adaptation to fear signals in social contexts, which can be advantageous in preventing ptsd; but simultaneously it may elevate vulnerability for interpersonal trauma (eckstein et al., 2016). thus, we assume that the dampening effect of oxt on the hpa axis (neumann, krömer, toschi, & ebner, 2000) may act on different levels and result in reduced stress responses, thereby eliciting the opposite effects of typical stress tasks such as the trier social stress test (tsst; kirschbaum, pirke, & hellhammer, 1993). this assumption is grounded in the observation that oxt is associated with faster recovery of the endocrine and the autonomic system after stressful events (engert et al., 2016), as well as on skin conductance findings which were measured directly after traumatic events and predicted subsequent chronic ptsd development (hinrichs et al., 2019). consequently, oxt’s dampening effect on the hpa axis activation may function as a stress-buffer for traumatic events and by buffering stress responses it may prevent the development of chronic ptsd after trauma exposure. the anxiolytic oxt effects may also result in fewer treatment dropouts. cortisol, like oxt, has time-sensitive effects on the hpa-axis activity. activating the hpa-axis by exposing participants to a stress task, for instance the tsst, before they participate in a trauma analogue paradigm (trauma film), results in increased numbers of intrusive memories (in participants who biologically respond to the tsst) as compared to participants who perform a control task (placebo tsst) and are not stressed prior to the trauma film paradigm (schultebraucks et al., 2019). in contrast, administering cortisol after a trauma results in fewer intrusions (de quervain, 2006). outcomes of post-trauma cortisol administration are, however, also somewhat inconclusive, because not all stud­ ies report fewer subsequent intrusions (graebener, michael, holz, & lass-hennemann, 2017; ludäscher et al., 2015). cortisol (here: hydrocortisone) as a treatment enhancer augmented psychological treatment successfully, meaning that prolonged exposure ther­ apy resulted in greater retention when participants received cortisol (yehuda et al., 2015). thus, oxt as well as cortisol are promising agents for medication-tailored treatment for ptsd patients. preckel, trautmann, & kanske 5 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ o x t ’ s i n f l u e n c e o n f e a r c o n d i t i o n i n g , a n d i t s r o l e i n p t s d a n d m e m o r y to investigate the mechanisms, which underlie ptsd, pavlovian fear conditioning para­ digms are helpful models. in fear conditioning experiments, an aversive stimulus is used as an unconditioned stimulus (us) in order to establish fear as soon as the conditioned stimulus (cs) is presented. in ptsd, one traumatic event is sufficient to establish a cs. the main brain structures that are involved in fear conditioning and ptsd include the amygdala, the hippocampus and the ventromedial prefrontal cortex (vmpfc) (careaga, girardi, & suchecki, 2016; koenigs & grafman, 2009). the amygdala is the core structure of fear conditioning (duvarci & pare, 2014; ehrlich et al., 2009) and extinction (maren, 2011; myers & davis, 2002). the different nuclei of the amygdala have specialized roles in the fear learning and extinction processes. the lateral nucleus of the amygdala (lan) provides the amygdala primarily with input and is important for mediating fear learning via neural plasticity, while the basolateral and basomedial nuclei converge sensory information of the conditioned stimulus and the unconditioned stimulus (herry & johansen, 2014). the hippocampus is important for encoding information, and for modulating appropriate emotional responses to potentially fearful stimuli (acheson, gresack, & risbrough, 2012; lissek & van meurs, 2015). furthermore, lower hippocampal activation has been linked to direct memory suppression in healthy participants (benoit & anderson, 2012), that can be interpreted as reduced voluntary recall. the vmpfc mediates the extinction of conditioned fear by inhibiting the amygdala (koenigs et al., 2008). in ptsd patients, these brain regions differ on a structural and functional level in comparison to healthy controls. for example, reduced hippocampal volume is associated with ptsd development (gilbertson et al., 2002; logue et al., 2018; pitman et al., 2006) as well as being a consequence of stressful experiences (admon et al., 2013). on a functional level, abnormal hippocampus activation hindered extinction learning in safe contexts (patel, spreng, shin, & girard, 2012) and reduced top-down regulation to the amygdala which results in enhanced fear conditioning (rauch, shin, & phelps, 2006). a reduction of functional and structural connectivity between the hippocampus and the vmpfc has also been reported (admon et al., 2013). the amygdala is also crucially involved in associative learning (ledoux, 1996; mcgaugh, 2000) and its dysfunction may be responsible for increased fear conditioning responses in ptsd patients, which in turn results in stronger memory formation of the traumatic event (= intrusive memories) (careaga et al., 2016). also, vmpfc activation is lower and results in decreased top-down regulation of the amygdala (rauch, shin, & phelps, 2006). the hippocampus as well as the vmpfc project to the amygdala and their failure to adequately inhibit amygdala activation causes its hyperactivity which is frequently found in ptsd patients (hayes, hayes, & mikedis, 2012; liberzon & abelson, 2016; patel, spreng, shin, & girard, 2012; pitman et al., 2012; shin & liberzon, 2010). oxytocin’s role in the neurobiology and treatment of ptsd 6 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ amygdala hyperactivation is especially pronounced when compared to non-trauma ex­ posed controls, but not necessarily when compared to trauma-exposed controls (patel et al., 2012), therefore it cannot be ruled out that this mechanism is related to trauma exposure rather than to ptsd (van wingen, geuze, vermetten, & fernandez, 2011). however, the evidence that amygdala hyperactivation might be causally related to ptsd development, could be shown by previous lesion studies in veterans with and without ptsd (koenigs & grafman, 2009). another lesion study showed that elevated amygdala activation is related to dysfunctional vmpfc activity (motzkin et al., 2015). furthermore, ptsd patients (as compared to healthy controls) display an initially increased amygdala response when confronted with trauma-related negative (vs. non-trauma related nega­ tive) stimuli (protopopescu et al., 2005). the elevated amygdala activation may explain the emotional memory quality in ptsd patients, especially, because this activation does not habituate over time (protopopescu et al., 2005). diminished structural connectivity between the amygdala and vmpfc has been found in ptsd patients (koch et al., 2017). the functional connectivity between these regions, could be increased by oxt (in men with ptsd), thereby reducing amygdala hyperactivity (koch et al., 2014). returning to fear conditioning experiments, administering intranasal oxt before fear conditioning results in faster fear conditioning, (eckstein et al., 2016) while administra­ tion after fear-conditioning and before fear extinction results in better fear extinction and inhibited amygdala activation (eckstein et al., 2015). moreover, reduced skin conductance responses to electric shocks after oxt as opposed to placebo administration in human studies support the notion of oxt’s “anti-stress-properties” (eckstein et al., 2016). thus, exogenous oxt effects are time sensitive and remain currently inconclusive. the amygdala is further suggested to mediate influences of medication on memory consolidation (mcgaugh, 2000), therefore it may also mediate oxt effects on memory and potentially change the emotional content of memories in ptsd patients. a recent study showed that the severity of childhood trauma exposure (as reported from memory) was related to oxytocin-modulated amygdala responses in patients with ptsd while this was not the case in healthy controls (flanagan et al., 2019). if oxt has the potential to change the content of memories to turn more positively, this may already result in less hyperactivity of the amygdala, which is strongly influenced by negative valence (preckel et al., 2019). this is further supported by oxt’s inhibiting effects on the activation of (para-)limbic structures, its facilitating action on cognitive performance and its inhibiting effects on arousal (lischke, herpertz, berger, domes, & gamer, 2017; misrani et al., 2017; solomon et al., 2018). animal studies report that exogenous oxt has “anti-stress proper­ ties” on hippocampal plasticity and memory (lee et al., 2015). the hippocampus plays an important role in the negative feedback loop of the hpa-axis (joseph & whirledge, 2017) and it is altered in ptsd patients (schumacher et al., 2019). preckel, trautmann, & kanske 7 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ regarding oxt’s effects on memory, earlier studies found that oxt impairs mem­ ory recall, the generation of associated target words, or explicit memory (heinrichs, meinlschmidt, wippich, ehlert, & hellhammer, 2004). recent findings, however, suggest that exogenous oxt may also have positive influences on memory. for example, oxt improves safety learning in healthy humans (eckstein et al., 2019) and animal studies show that oxt effectively counteracts memory impairments caused by stress on a cellular level, thereby preventing memory impairments (lee et al., 2015). another animal study found changes in long-term synaptic plasticity in the amygdala (medial nucleus) due to oxt’s action. these oxytocin-induced synaptic changes are strongly related to social recognition memory (rajamani, wagner, grinevich, & harony-nicolas, 2018). these findings indicate that oxt may have restoring functions on plasticity related to memory processes. furthermore, oxt improves memory performance which is accompanied by in­ creased connectivity between the dorsolateral (dl)pfc and the acc in traumatized as compared to trauma exposed individuals without ptsd (flanagan et al., 2018). this is an important finding, because decreased connectivity between the dlpfc and the acc is described as a maladaptive neural process (= reduced neural processing efficiency) in demanding cognitive tasks. furthermore, the decrease in connectivity between these brain regions is associated with the trait measure “worry” (as a dimension of anxiety) in healthy individuals (barker et al., 2018). regarding the association between worry and ptsd that has been found in previous studies (blazer, hughes, & george, 1987), it may be assumed that similar neural maladaptations take place in ptsd and which may be positively influenced by oxt administration. increased acc activation after oxt administration has also been reported elsewhere (preckel, scheele, eckstein, maier, & hurlemann, 2015). to sum up, oxt positively influences memory on a cellular, neural activation and behavioral level. moreover, exogenous oxt was able to improve social behavioral deficits in autism spectrum disorder patients (asd) via reinstating vmpfc activation, during a social-com­ munication task (aoki et al., 2015). in male ptsd patients, oxt reinstated diminished connectivity between the amygdala and the vmpfc and in female patients it reestablish­ ed increased connectivity between the amygdala and the dorsal anterior cingulate cortex (dacc), accompanied by reduced subjective anxiety and nervousness (koch et al., 2016b). a recent study showed that oxt dampened amygdala activation in ptsd patients, when they saw emotional faces (regardless of valence), while amygdala activation was increased in trauma-exposed control participants (koch et al., 2016a). assuming that oxt’s action in asd patients is the same as in ptsd patients, as the common action on brain activity suggests, oxt may also improve social and affective functioning in ptsd by restoring vmpfc activation. oxytocin’s role in the neurobiology and treatment of ptsd 8 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ o x y t o c i n ’ s p o t e n t i a l b e n e f i t i n p s y c h o t h e r a p y f o r p t s d apart from different comorbidities such as depression, anxiety or alcohol abuse, social support is one of the strongest predictors for successful ptsd therapy (dewar, paradis, & fortin, 2020), just like therapeutic alliance (lantz, 2004). the willingness to share thoughts and emotions is clearly related to perceived social support (kahn & cantwell, 2017). as mentioned previously, oxt increases social support seeking and the perception of received social support (cardoso, valkanas, serravalle, & ellenbogen, 2016) and it also increases the willingness to verbally share one’s emotions with someone else (lane et al., 2013). this makes it specifically promising for medication-enhanced psychother­ apeutic interventions, because it might facilitate emotional disclosure. oxt increases social support seeking and the perception of received social support (cardoso, valkanas, serravalle, & ellenbogen, 2016) as well as safety learning (eckstein et al., 2019) in healthy individuals. assuming that oxt unfolds the same characteristics in ptsd patients, it is likely that oxt can ameliorate ptsd symptoms successfully. in a study on trauma disclosure, oxt alone did not increase the tendency to disclose trauma (scheele et al., 2019). this might be due to insufficient(ly perceived) social support, because it has also been suggested that the presence of social support might be necessary to elicit prosocial oxt effects (cardoso et al., 2016), to mention one of many context-dependent oxt effects. therefore, administering oxt in a psychotherapeutic setting, where social support is available, might result in increased disclosure. concerning the therapeutic relationship which is important for successful therapy outcomes, increased sensitivity to social reward may result in increased social support seeking and may thus increase the likelihood of a positive psychotherapeutic relationship. notably, it has been found that anterior insula activation was normalized, during social reward processing, in ptsd patients after oxt administration (nawijn et al., 2017). psychotherapeutic interventions that have been successful in ameliorating ptsd symptoms include eye movement desensitization and reprocessing (shapiro, 2014) pro­ longed exposure (singh, 2019), imagery rescripting and reprocessing therapy (grunert, weis, smucker, & christianson, 2007), exposure therapy (paunovic & ost, 2001) as well as exposure-based cognitive-behavioral group therapy (cbgt) (schwartze, barkowski, strauss, knaevelsrud, & rosendahl, 2019). clinical trials which have investigated oxt’s enhancing effects on different treatment options, revealed that oxt could enhance expo­ sure-therapy in ptsd patients (flanagan et al., 2019) and patients with arachnophobia (acheson et al., 2015). a study, which focused on physiological responses to oxt, found one notable difference and that was a higher skin conductance baseline level in the oxt group (pitman et al., 1993). here, we take cbgt as an example to explain how simultaneous oxt administration can enhance psychotherapy. preckel, trautmann, & kanske 9 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ oxt improves various aspects of social cognition, for example trust (kosfeld, heinrichs, zak, fischbacher, & fehr, 2005). trust is an essential component of psycho­ therapy that needs to be established first, before the actual therapy can begin (wampold, 2015). therefore, if oxt facilitates trust, by decreasing amygdala and dorsal striatum activation as neuroimaging studies were also able to show (baumgartner, heinrichs, vonlanthen, fischbacher, & fehr, 2008), it may have beneficial effects on psychothera­ peutic outcomes. a recent study on food intake reported that oxt enhances brain activation in areas that govern cognitive control, including the vmpfc (spetter et al., 2018). should oxt have the same effects on the vmpfc in ptsd patients, oxt might be particularly beneficial for ptsd patients who take part cbgt. there is a growing literature body which investigates oxt’s potential on psychotherapies for ptsd patients (e.g. engel et al., 2021; koch et al., 2014; koch et al., 2019). though oxt appears to be a promising candidate to ameliorate ptsd symptoms, especially when combined with psy­ chotherapies, further studies are required to disentangle the exact mechanism of oxt. it is also crucial to find out which ptsd patients can benefit most from oxt-enhanced psychotherapy, because oxt has many person-specific characteristics, ranging from a person’s attachment style to oxytocin receptor gene variations which differentially influence oxt’s action in individuals (bartz, zaki, bolger, & ochsner, 2011; olff et al., 2013). thus, studies with precise designs which combine behavioral, biological, imaging and clinical aspects are required to further address these questions (giovanna et al., 2020). c o n c l u s i o n a n d o u t l o o k in this update paper, we described the mechanisms underlying ptsd by discussing the most recent studies on structural and functional brain changes associated with ptsd, including findings on structural and functional connectivity. we have discussed potential oxt mechanisms of action from the healthy population and asd patients and related these to mechanisms that are malfunctioning in ptsd patients, thereby building direct implications for oxt’s potential action mechanism. most importantly, we like to emphasize oxt’s promising characteristics as a psychotherapeutic enhancer. however, there are still uncertainties, which need further investigation. these include the critical aspects of pharmacodynamics and the ideal dosage. it became clear that therapeutic approaches are not yet sufficiently successful in treating ptsd patients, because patients drop out of therapy frequently and some symptoms remain after treatment. oxt remains a promising candidate for medication-tailored ptsd therapy and research on this topic should be continued. oxytocin’s role in the neurobiology and treatment of ptsd 10 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://www.psychopen.eu/ funding: kp is supported by german federal ministry of education and research within the asd-net (bmbf fkz 01ee1409a). st is supported by the german research foundation (dfg r 1489/1-1) and the federal ministry of defense (e/u2ad/hd008/cf550) pk is supported by german federal ministry of education and research within the asd-net (bmbf fkz 01ee1409a), the german research foundation (dfg ka 4412/2-1; ka 4412/4-1; ka 4412/5-1) and die junge akademie at the berlin-brandenburg academy of sciences and humanities and the german national academy of sciences leopoldina. acknowledgments: the authors have no support to report. competing interests: the authors declare no conflicts of interest. twitter accounts: @katrin_preckel, @pkanske r e f e r e n c e s acheson, d. t., feifel, d., kamenski, m., mckinney, r., & risbrough, v. b. 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(2019). associations among hair cortisol concentrations, posttraumatic stress disorder status, and amygdala reactivity to negative affective stimuli in female police officers. journal of traumatic stress, 32(2), 238-248. https://doi.org/10.1002/jts.22395 wampold, b. e. (2015). how important are the common factors in psychotherapy? an update. world psychiatry, 14(3), 270-277. https://doi.org/10.1002/wps.20238 yehuda, r. (2002). post-traumatic stress disorder [reply]. the new england journal of medicine, 346(19), 1497. yehuda, r., bierer, l. m., pratchett, l. c., lehrner, a., koch, e. c., van manen, j. a., & hildebrandt, t. (2015). cortisol augmentation of a psychological treatment for warfighters with posttraumatic stress disorder: randomized trial showing improved treatment retention and outcome. psychoneuroendocrinology, 51, 589-597. https://doi.org/10.1016/j.psyneuen.2014.08.004 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. preckel, trautmann, & kanske 21 clinical psychology in europe 2021, vol. 3(4), article e3645 https://doi.org/10.32872/cpe.3645 https://doi.org/10.1016/j.biopsych.2016.11.012 https://doi.org/10.1002/jts.22395 https://doi.org/10.1002/wps.20238 https://doi.org/10.1016/j.psyneuen.2014.08.004 https://www.psychopen.eu/ oxytocin’s role in the neurobiology and treatment of ptsd (introduction) stress physiology and the roles of oxytocin and cortisol oxt’s influence on fear conditioning, and its role in ptsd and memory oxytocin’s potential benefit in psychotherapy for ptsd conclusion and outlook (additional information) funding acknowledgments competing interests twitter accounts references cultural adaptation of cbt for afghan refugees in europe: a retrospective evaluation latest developments cultural adaptation of cbt for afghan refugees in europe: a retrospective evaluation schahryar kananian 1 , annabelle starck 1, ulrich stangier 1 [1] department of clinical psychology and psychotherapy, goethe university frankfurt, frankfurt, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e5271, https://doi.org/10.32872/cpe.5271 received: 2020-11-25 • accepted: 2021-05-09 • published (vor): 2021-11-23 handling editor: eva heim, university of lausanne, lausanne, switzerland corresponding author: schahryar kananian, goethe university frankfurt, department of clinical psychology and psychotherapy, varrentrappstr. 40-42, 60486 frankfurt, germany. tel: 0049 69 25367. e-mail: kananian@psych.unifrankfurt.de related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si abstract background: culturally adapted cbt (ca cbt) is a well-evaluated, culture-sensitive intervention for refugees that utilizes psychoeducation, problem solving training, meditation, and stretching exercises. however, there is a lack of standard procedures for adapting psychotherapeutic interventions to a specific cultural context. our working group adapted ca cbt for afghan refugees at two different stages, which yielded promising results from a pilot trial and an rct with a waitlist control group. this article aimed to illustrate the ongoing adaptation process of ca cbt for afghan refugees over the course of several trials and to highlight potential limitations by evaluating how systematic adaptations were performed. method: the adaptation process of ca cbt was described in detail, including the methods and rationale for changes to the protocol. this process was analyzed according to a new set of proposed reporting criteria. results: according to the defined target population and based on multiple research strategies, culturally-specific components, such as the rationales for interventions, metaphors, and idioms of distress, were adapted. relevant surface adaptations were implemented. however, although the steps of our adaptation process corresponded with the reporting criteria, some of the adaptation processes did not follow explicit criteria but resulted from implicit judgments. conclusion: in the future, compliance with and the documentation of adaptation processes following explicit guidelines are crucial for the transfer of evidence-based approaches for managing the diversity of refugee populations. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5271&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0002-9783-3978 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords reporting criteria, cultural adaptation, afghan refugees, transdiagnostic, group therapy highlights • the reporting criteria (heim et al., 2021, this issue) can be applied to analyze the documentation process of cultural adaptation in a post hoc analysis. • the documentation process of culturally adapted cbt for afghan refugees shows a high agreement with the reporting criteria. • this detailed documentation of the adaptation process for afghan refugees may facilitate the cultural adaptation for similar subgroups in future studies. approximately 18% of the refugees arriving in germany in 2016 originated from afgha­ nistan. epidemiological studies revealed high prevalence rates for ptsd (32.2%), affective disorders (21.9%), and anxiety disorders (33.9%) among afghan refugees (richter et al., 2015). in afghanistan, war and armed conflicts have occurred since 1979, with only short periods of truce. however, after fleeing and seeking asylum in western countries, distress can persist, due to long asylum procedures and restrictive housing regulations. this postmigration stress may contribute to the worsening or even development of psychopathological symptoms (li et al., 2016; miller & rasmussen, 2017; schock et al., 2016). a noticeable gap between the high prevalence rates of mental disorders and the low rates of seeking of treatments (german organization for psychotherapists [bptk], 2015) may indicate a low acceptance and familiarity with cbt among afghan refugees, which is also reflected by the higher dropout rates (de haan et al., 2018). this may be related to the western influence on cbt and how this may conflict with the values of ethnic minorities (scorzelli & reinke-scorzelli, 1994). as a low-threshold and easily accessible program, culturally adapted cbt (ca cbt), which was developed by hinton et al. (2005), was chosen as the basic treatment concept (hinton et al., 2005, 2009). although other cbt interventions, as well as trauma-focused approaches, have been culturally adapted and evaluated with promising results (hall et al., 2016; shehadeh et al., 2016), ca cbt has been evaluated for several ethnicities, including cambodian, vietnamese, egyptian, and hispanic refugees (hinton et al., 2005; jalal et al., 2017). the treatment program focuses on the development of resilience, psychological flexibility, and emotional regulation. furthermore, the group setting of ca cbt aims at overcoming the often experienced sense of isolation and in helping to establish new social networks. finally, within a stepped care approach, ca cbt can be integrated into existing community settings and activities; thus offering the perspective to meet some of the principles that have been postulated for an ecological approach to mental health care for refugees (miller & rasco, 2004). as a theoretical framework for the adaptation process, we followed the guidelines by barrera et al. (2013), which included five stages: information gathering, preliminary adaptation design, preliminary adaptation ca cbt adaptation for afghan refugees 2 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ tests, adaptation refinement, and cultural adaptation trials. although the effectiveness of cultural adaptation has been shown in several meta-analyses (hall et al., 2016; shehadeh et al., 2016), there is currently a lack of standardized documentation criteria. in this article, we aimed to illustrate the adaptation process of ca cbt for afghan refugees and to depict the adaptations that were administered throughout ongoing trials by applying the criteria for reports of cultural adaptation, as suggested by heim et al. (2021, this issue). culturally adapted cbt (ca cbt) the program is conceptualized as being resilience-focused and subclinical, and it can be delivered in an individual or group setting and includes 14 sessions. interventions, such as psychoeducation, stretching, meditation, guided imagery, and cognitive techniques (e.g., socratic questioning), are a part of each session. it should be mentioned that due to its resilience-focused and transdiagnostic nature, ca cbt does not include prolonged exposure to trauma memories; instead, it focuses on emotional regulation and addresses different psychopathological symptoms, including depression, anxiety disorders, and somatic symptoms, as well as related disorders. the original ca cbt group program by hinton contained transcultural concepts and key idioms of distress, such as “thinking a lot” (hinton et al., 2016), which are meant to be suitable for a variety of ethnic groups and were included in the protocol for afghan refugees. additionally, hinton and colleagues (jalal et al., 2017) adapted specific components, such as the rationales for meditation and guided imagery, for refugees from middle eastern islamic cultures. the analysis of the modifications in the different protocols by hinton and colleagues provided a blueprint of scalable components that we used to adapt the program to the afghan culture. m e t h o d focus groups subsequently, for the pilot trial (kananian et al., 2017), a focus group was conducted to assess the experiences of the participants. in addition, the proposed changes to the ongoing ca cbt trials were evaluated. the focus group consisted of n = 7 participants who had participated in the group program and whose native language was farsi/dari; additionally, the participants were male and over 18 years of age. the interview was con­ ducted for approximately one hour and was audio-recorded, transcribed, and translated into german. the results were discussed by a group of experts, native speakers, and key informants. no specific qualitative analysis of the data was applied. experts were defined as professionals who had been working in the field of counsel­ ing psychotherapy with refugees or migrants for at least three years. kananian, starck, & stangier 3 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ adaptations following the reporting criteria in the following, cultural adaptions of the ca cbt are described based on the reporting criteria by heim and colleagues (2021, this issue). definition of the target population at an early stage, we defined farsiand dari-speaking refugees as the target population. in addition to afghan and syrian refugees, iranian refugees constituted the third largest group of refugees in germany in 2015 (richter et al., 2015). we discussed similarities be­ tween afghan and iranian cultures. although key informants raised concerns regarding potential conflicts between these two groups, due to their major differences in history and culture, many cultural similarities were recognized. this was also reflected in several articles that included afghan and iranian patients in a joint sample (e.g., shishehgar et al., 2015; steel et al., 2011). nevertheless, throughout the group program, we identified idioms of distress that were not understood by all of the participants. cultural concepts of distress literature review — we mostly derived the cultural concept of distress (ccd) for afghan and iranian refugees from qualitative studies that were conducted via interviews with afghan populations (alemi et al., 2016; sulaiman-hill & thompson, 2011; yaser et al., 2016). after a thorough review of the existing literature following idioms of distress for farsi/dari-speaking refugees, we included ‘asabi’ (nervous agitation), ‘gham’ (sadness), ‘jigar khun’ (a general expression of intense psychological distress), ‘tashwee­ sh’ (worry, as proposed by miller et al., 2006), ‘goshe-giri’ (self-isolation), ‘fekro khial’ (rumination and worrying), and ‘faramooshi’ (forgetfulness, as proposed by alemi et al., 2016). qualitative interviews — first, we evaluated ca cbt in individual treatments of af­ ghan refugees. after the treatment, we interviewed the respective patients and integrated specific suggestions into the first group manual. many patients expressed concerns that “[they] might go crazy” and that the occurrence of the symptoms was a consequence of personal sin. although we did not systematically analyze the qualitative data, we extended the ccd by the information that was gathered through these interviews. further idioms of distress were identified through interviews with key informants and experts. formative research although the main aspects of the adaption process in addition to the publications of the pilot trial and the rct (kananian et al., 2020) were reported, no additional papers on formative research were published. ca cbt adaptation for afghan refugees 4 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ documenting the decision-making process we documented the statements of the experts, key informants, and native speakers who were involved in the adaptation process. nevertheless, we did not systematically document how specific decisions were derived. team and roles — professor devon e. hinton, associate professor of psychiatry, developed the original protocol of ca cbt for several ethnic groups (hinton et al., 2005, 2009; jalal et al., 2017). professor ulrich stangier, professor in clinical psychology and psychotherapy, who is the head of the center for psychotherapy and of the counseling center for refugees, as well as a supervisor and licensed psychotherapist. ph.d. sarah ayoughi, who had many years of experience in counseling in kabul, afghanistan, and in speaking farsi/dari. monitoring and documentation — the adaptation process did not follow a documen­ tation or monitoring methodology. diagnostics and outcome assessment clinical interviews — all of the diagnostic interviews were conducted by independent farsi-speaking postgraduate psychologists. the m.i.n.i. in the original english version (sheehan et al., 1998) was used for the assessment, whereas key symptoms of the respec­ tive disorders were translated in advance for a more fluent and standardized assessment. questionnaires — if they were not already available and validated in farsi, all of the instruments were translated and back-translated, in accordance with the suggested standard procedure that were proposed by van ommeren et al. (1999). deep structure adaptations specific components — inner child metaphor. some trauma-focused approaches to ptsd use the inner child metaphor to explain symptoms and trauma-related catastrophic cognitions (hestbech, 2018). we did not-presume the use of this technique because it was not accepted by refugees who were individually treated. instead, we used the metaphor of an alarm system, which was suggested to be more neutral and accessible for our specific refugee group. nevertheless, we used the “soothing” metaphor for emotion regulation processes that were associated with the awareness of a secure environment. meditation and guided imagery. due to the fact that association with positive imagery is one of the key techniques for bridging cultural barriers in psychotherapy with refugees (hinton et al., 2005), we included guided imagery of a peaceful garden (‘bagh’) for afghan refugees. kananian, starck, & stangier 5 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ problem-solving training. inspired by treatments that were developed in programs by rahman et al. (2016) and sijbrandij et al. (2017), we added problem-solving training to the treatment program, which was labeled ca cbt+. moreover, the implementation of prob­ lem-solving targets was meant to empower patients to take independent actions within their social contexts, to further their basic needs, and to broaden their socioeconomic adversities, as suggested by miller and rasco (2004). unspecific components — the explanation of the treatment rationale was adapted to make it plausible and meaningful for the patients. when conveying information about the treatments to the patients, the detected ccds and adapted specific components were taken into account to provide the treatment rationale in a culturally sensitive (e.g., values) and culturally understandable (e.g., easy language) manner. our therapists were native speakers, which included different nonspecific components, such as a sense of belonging-and familiarity. surface adaptations — all of the interventions (psychoeducation, problem solving training, yoga/stretching, and meditation) were explained in short written handouts in farsi. to improve the comprehension of this information, these handouts were also au­ dio-recorded, and both the written handouts and audiotaped information were uploaded on a website that was accessible by the participants (stangier et al., 2020). mode of delivery — ca cbt is available as an individual and as a group treatment. we chose a group setting for the following reasons: destigmatization through exchanges about symptoms with members of the same culture or peer group, the use of group cohesion to enhance feelings of connectedness, and dialogue about one’s experience regarding the asylum procedures. translation — due to the fact that all of the group therapists were native speakers, no translations were required in addition to the material. matching materials — all of the material was edited in a culturally sensitive manner and translated into farsi/dari via translation and retranslation. cultural sensitivity, as for all of the other aspects of the adaptation procedure, implies the consideration of the cultural concepts of distress, gender, or religious aspects that may conflict with the values that are present in afghan society (eggerman & panter-brick, 2010). to ensure easier access to the content, audio material was prepared. documentation of adaptations during the trials (“on the fly”) some of the on-the-fly adaptions were incorporated into the group manual (stangier et al., 2020). for example, problem-solving training has been misunderstood as a technique for simultaneously solving all problems. the rationale for the selection of problems ca cbt adaptation for afghan refugees 6 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ was explained as “picking only one stone at once from mountain”. however, we did re-evaluate on-the-fly adaptation through further discussions. d i s c u s s i o n the examination of how we adapted ca cbt to afghan refugees in germany comprised a complex sequence of implicit and explicit developmental steps over three years. to analyze this process in a post hoc manner, we applied the criteria as suggested by heim et al. (2021), this issue. the process clearly showed that cultural adaptation contains multiple levels and aspects of an intervention, and the feedback of our interviews demonstrated its major contribution to the acceptance and, thereby, to the potentially increased effectiveness of an intervention. due to the staged nature of cultural adaptation, even in our case of adapting an intervention that was already adapted to another culture, it remains a highly difficult and nearly impossible challenge to document all of the facets. this can be illustrated by the farsi idiom for “thinking too much”. after the decision for the farsi idiom “fekro khial”, we had experiences with several interpreters who suggested other translations that would be more adequate regarding the meaning of the original idiom. throughout the varying translations of “thinking too much”, we also experienced mixed reactions from patients. the specific interpretation of the idiom that was used was dependent on the region that the patient came from. this effect demonstrated how cultural adaptation can be a meandering procedure at various times. detailed documen­ tation may enable other mental health professionals to profit from the thoughts, ideas, and particular adaptation steps for their own adaptation process. our documentation shows adaptation at different steps in a way that can possibly be exemplary for other professionals. when regarding adaptation to other target groups, it may be possible to transfer or adjust adaptations, due to detailed documentation. in the clinical context, we assume that a complete traceability of adaptations will enhance the adherence of therapists for adaptations that may seem alien to them. fur­ thermore, knowledge of the reasons for adaptations will increase the cultural sensitivity of mental health professionals, not only for the specific intervention, but also for the entire treatment situation. this may prevent other misunderstandings. nevertheless, this complexity in the communication between therapists and refugees highlights how important it is to control as much of the process as possible, in order to make the process as transparent and comprehensive as possible. only through a stand­ ardized approach for cultural adaptation can the need for culturally sensitive psychother­ apy be met. the application of explicit criteria is an important tool for establishing a standard procedure for cultural adaptations. kananian, starck, & stangier 7 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ funding: this work was supported by the bundesministerium für bildung und forschung (grant no.: 01ef1804a). acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s alemi, q., james, s., & montgomery, s. 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(2016). beliefs and knowledge about post-traumatic stress disorder amongst resettled afghan refugees in australia. international journal of mental health systems, 10(1), article 31. https://doi.org/10.1186/s13033-016-0065-7 ca cbt adaptation for afghan refugees 10 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://doi.org/10.3402/ejpt.v7.32106 https://doi.org/10.1177/0011000094224006 https://doi.org/10.2196/mental.5776 https://doi.org/10.1186/s12914-015-0058-7 https://doi.org/10.1080/20008198.2017.1388102 https://doi.org/10.1016/j.socscimed.2011.02.007 https://doi.org/10.1186/1472-698x-11-2 https://doi.org/10.1177/136346159903600304 https://doi.org/10.1186/s13033-016-0065-7 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. kananian, starck, & stangier 11 clinical psychology in europe 2021, vol. 3(special issue), article e5271 https://doi.org/10.32872/cpe.5271 https://www.psychopen.eu/ ca cbt adaptation for afghan refugees (introduction) culturally adapted cbt (ca cbt) method focus groups adaptations following the reporting criteria discussion (additional information) funding acknowledgments competing interests references third wave treatments for functional somatic syndromes and health anxiety across the age span: a narrative review scientific update and overview third wave treatments for functional somatic syndromes and health anxiety across the age span: a narrative review lisbeth frostholm a, charlotte ulrikka rask b [a] research clinic for functional disorders and psychosomatics, aarhus university hospital, aarhus, denmark. [b] child and adolescent psychiatry department, psychiatry, aarhus university hospital, skejby, denmark. clinical psychology in europe, 2019, vol. 1(1), article e32217, https://doi.org/10.32872/cpe.v1i1.32217 received: 2018-12-06 • accepted: 2019-02-13 • published (vor): 2019-03-29 handling editor: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: lisbeth frostholm, research clinic for functional disorders and psychosomatics, aarhus university hospital, aarhus c, denmark. e-mail: lisfro@rm.dk abstract background: functional disorders (fd) are present across the age span and are commonly encountered in somatic health care. psychological therapies have proven effective, but mostly the effects are slight to moderate. the advent of third wave cognitive behavioural therapies launched an opportunity to potentially improve treatments for fd. method: a narrative review of the literature on the application of mindfulness-based therapies (mbt) and acceptance & commitment therapy (act) in children and adult populations with fd. results: there were very few and mainly preliminary feasibility studies in children and adolescents. for adults there were relatively few trials of moderate to high methodological quality. ten mbt randomised trials and 15 act randomised trials of which 8 were internet-delivered were identified for more detailed descriptive analysis. there was no evidence to suggest higher effects of third wave treatments as compared to cbt. for mbt, there seemed to be minor effects comparable to active control conditions. a few interventions combining second and third wave techniques found larger effects, but differences in outcomes, formats and dosage hamper comparability. conclusions: third wave treatments are getting established in treatment delivery and may contribute to existing treatments for fd. future developments could further integrate second and third wave treatments across the age span. elements unambiguously targeting specific illness beliefs and exposure should be included. the benefit of actively engaging close relatives in the treatment not only among younger age groups but also in adults, as well as the effect of more multimodal treatment programmes including active rehabilitation, needs to be further explored. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.32217&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords functional disorders, functional somatic syndromes, health anxiety, somatic symptom disorder, third wave treatments, mindfulness, acceptance and commitment therapy, narrative review highlights • the methodological quality of third wave interventions for fd should be improved, especially in younger age groups. • the effect of act interventions may be comparable to cbt in adults with fd. • the evidence for third wave interventions in young people with fd is still very limited. • newer studies combining second and third wave treatments show some promise. • agreement on, and for child populations further development of, core outcomes, could help determine effect across studies. functional disorders (fd) can be defined as conditions where the individual’s experiences of physical symptoms cause excessive discomfort and/or worry and where no adequate organ pathology in terms of conventional medical disease can be determined to explain the symptoms (fink & rosendal, 2015). fd are a burden for sufferers and their families, they are difficult to treat and costly as they incur a high health expenditure and derived societal costs (henningsen, zipfel, sattel, & creed, 2018). diagnostic classification functional disorders can clinically be split into two overall categories (see table 1). the first category refers to conditions characterised by bodily distress, a now wellaccepted term to describe the phenomenon of clusters of disabling unspecific bodily symptoms often designated as functional somatic syndromes (fss); the best known being chronic fatigue syndrome (cfs), fibromyalgia/chronic pain (fm/cp) and irritable bowel syndrome (ibs) (fink & schröder, 2010). the second category refers to conditions domi‐ nated by health anxiety (ha), i.e. impairing illness worry and persisting ruminations about harbouring or getting serious illness (fink et al., 2004). although the two catego‐ ries overlap in their clinical presentations and can be comorbid, the primary problem dif‐ fers which has implications for the treatment focus. in the psychiatric classifications icd-10 (who, 1992) and dsm-iv (american psychiatric association, 1994), fd are mainly categorised under somatoform and related disorders. however, the terminology of these diagnoses has been criticised for being too exclusive in their diagnostic criteria as well as over-emphasising a mind-body dualism in contrast to the prevailing understanding of these disorders within an integrated biopsy‐ third wave treatments for functional disorders 2 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ chosocial framework (dimsdale, sharma, & sharpe, 2011; henningsen, zipfel, & herzog, 2007). in the more recent dsm-5 (american psychiatric association, 2013), fd are classi‐ fied primarily as somatic symptom disorders (ssd) with an added category of illness anxiety disorder designated to conditions with ha but without concurrent distressing bodily symptoms (in which case ssd is used). in contrast to icd-10, developmental as‐ pects are to some degree incorporated in dsm-5 as it specifies that in children, a single prominent symptom such as recurrent abdominal pain, headache, fatigue or nausea is more common than in adults. it also emphasises that parents’ response to the symptoms is crucial as this may determine levels of associated distress and the extent to which med‐ ical help is sought. in daily clinical practice, the psychiatric classifications are rarely used, as fd are pri‐ marily diagnosed in primary and specialised somatic health care. thus, each medical spe‐ cialty has developed its own classification leading to the use of a vast number of both unspecific symptom diagnoses as well as the previously mentioned fss diagnoses. as a consequence, management in both the paediatric and adult health care settings is very heterogeneous, often formed by biomedical practices in each medical specialty and often not evidence-based. in addition, it is well-established that excessive biomedical treatment efforts cause iatrogenic harm in these conditions (henningsen et al., 2007; lindley, glaser, & milla, 2005). table 1 two main categories of functional disorders characteristics disorders dominated by bodily distress (fss) health anxiety (ha) primary problem experience of disabling physical symptoms experience of worries and anxiety related to physical sensations functional impairment severe physical disability (e.g. sick leave, bedridden. in children and adolescents often long-term school absence) less severe physical disability (e.g. going to work serves as a distraction from distressing thoughts. in children and adolescents it will often be going to school or playing computer games) typical initial treatment expectations body can be fixed and the symptoms disappear wish for 100% reassurance that they do not harbour a severe or deadly illness. note. fss = functional somatic syndromes; ha = health anxiety. frostholm & rask 3 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ developmental aspects of fd young children usually present a single prominent symptom (domènech-llaberia et al., 2004; rask et al., 2009) such as abdominal pain, headaches, fatigue or muscle pains rather than the varied symptom presentation often seen in adults. the long-term prognosis var‐ ies from complete recovery to persistent symptoms into adulthood. with increasing age, full recovery seems to become more and more unlikely (joyce, hotopf, & wessely, 1997; norris et al., 2017). with respect to ha, key features such as symptom preoccupation and medical help seeking predominate mostly with the parents, although ha-like symptoms may present already in preschool children (rask, elberling, skovgaard, thomsen, & fink, 2012; schulte & petermann, 2011). also, preadolescents can report excessive illness worries with fears, beliefs and attitudes very similar to the cognitive and behavioural features of ha in adults (eminson, benjamin, shortall, woods, & faragher, 1996; rask et al., 2016; van geelen, rydelius, & hagquist, 2015; wright & asmundson, 2003). however, ha is still sparsely examined as a distinct concept in youth. epidemiology across the age span, the severity of both fss and ha varies on a spectrum from mild and moderate to severely disabling conditions. new studies suggest that fss affect 15% of the adult population, whereas approximately 2% of the population has very disabling condi‐ tions (eliasen et al., 2018). in comparison, 4-10% of the general child and adolescent pop‐ ulation experiences daily or high levels of impairing functional symptoms persisting for months or years (hoftun, romundstad, zwart, & rygg, 2011; janssens, klis, kingma, oldehinkel, & rosmalen, 2014; rask et al., 2009). the prevalence estimates for ha vary considerably across studies, but a recent study reported a prevalence of 3.4% (sunderland, newby, & andrews, 2013) in the general population. around 8-9% of the preadolescent general population reports high levels of illness worry (rask et al., 2016), but prevalence estimates for ha as a disorder are not available in young age groups. cognitive behavioural therapies for fd chronicity, severity and multiplicity of symptoms are all predictors of poor prognosis (rosendal et al., 2017). therefore, timely and evidence-based treatment is essential for improving the long-term physical, psychosocial and financial consequences. across age groups, patient-activating therapies are the most promising treatments, and cognitive be‐ havioural therapy (cbt) has so far been the most prevailing in intervention studies (abbott et al., 2018; bonvanie et al., 2017; henningsen et al., 2018). while moderate to large effect sizes (es) have been reported for cbt-based treatment for ha (hedman et al., 2011; newby et al., 2018; thomson & page, 2007; weck, neng, schwind, & hofling, third wave treatments for functional disorders 4 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ 2015), improvements are only small to moderate for fss in adults (henningsen et al., 2018; van dessel et al., 2014). in children and adolescents, the use of cbt for ha has only been reported in a single case study (roberts-collins, 2016). with regard to fss, existing studies have almost ex‐ clusively focused on cbt-based treatments for single symptoms or syndromes; primarily functional abdominal symptoms, chronic fatigue, tension-type headache, fibromyalgia or mixed pain complaints in children as young as 6 years of age (abbott et al., 2018; bonvanie et al., 2017). overall, the es are found to be somewhat larger than the corre‐ sponding estimates in adult studies (bonvanie et al., 2017). this may indicate that chil‐ dren and adolescents are more susceptible to psychological treatments than adults or that young people present less chronic and/or severe fss. however, the results should be in‐ terpreted with caution as the majority of these studies are quite small and heterogeneous with regard to e.g. inclusion criteria, setting, dose and type of delivered treatment and therapist experience (abbott et al., 2018; bonvanie et al., 2017). overall, these results, especially as to fss, suggest that the efficacy of existing psy‐ chological treatments for fd could be improved. this has spurred interest in studies ex‐ ploring the potential of the newer third wave behavioural therapies for these disorders. t r e a t m e n t w i t h t h i r d w a v e p s y c h o l o g i c a l t h e r a p i e s f o r f d mindfulness-based therapies (mbt) mbt translate meditation from buddhism and other spiritual practices into clinical inter‐ ventions. while classical cbt approaches tend to prioritise changing the content of pri‐ vate experiences like thoughts, mbt emphasise the awareness of thoughts, feelings and sensations as transient events that can potentially be problematic but do not have to be. thus, compared to cbt, there is no explicit focus on behavioural activation or modifica‐ tion. in most interventions, mindfulness is taught in groups emphasising an experiential format with sharing of experiences in the enquiry phase after formal meditations. the most well-known mbt programmes are mindfulness based stress reduction (mbsr) and mindfulness based cognitive therapy (mbct). the primary homework in most mbt is daily mindfulness practice. mbt are proposed to work through at least four processes: 1) attention regulation, 2) body awareness, 3) emotion regulation and 4) change in self-perspective (hölzel et al., 2011) (see figure 1). frostholm & rask 5 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ figure 1. a model of proposed processes in mindfulness-based therapies. note. adapted from hölzel et al., 2011. mbt could potentially change the perception of bodily symptoms through changes in in‐ teroception at a subconscious level and carry reductions in negative appraisal of symp‐ toms. furthermore, mbt might improve emotion regulation, which is proposed to play a prominent role in fss (dahlke, sable, & andrasik, 2017) and as a by-product reduce co‐ morbid anxiety and depression. in ha especially, one may hypothesise that mindfulness exercises can function as a direct exposure to anxiety-provoking bodily sensations and that the development of a more non-judgmental and accepting stance towards these bod‐ ily sensations may alleviate the symptom experience. acceptance and commitment therapy the overarching goal of act is to increase psychological flexibility, defined as the ability to stay in contact with the present moment regardless of unpleasant thoughts, feelings and bodily sensations, while choosing one’s behaviours based on the situation and per‐ sonal values. in act, there are specific assumptions regarding the role of language for how human beings tend to handle ‘the universal experience of pain’ (loss, illness, con‐ flict, and trauma) with avoidance of inner experience (hayes, luoma, bond, masuda, & lillis, 2006). act proposes six core therapeutic processes which interact to promote psychological flexibility (see figure 2). experiential techniques such as mindfulness, defusion, meta‐ phors and self-as-context exercises are used to illustrate and teach these processes. com‐ pared to mbt, the kinship with second wave cognitive behavioural therapies is more ob‐ vious both in terms of format and content, e.g. the use of functional analyses, in which third wave treatments for functional disorders 6 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ behaviours are analysed in terms of shortand long-term consequences (hayes, 2016) and the focus on commitment to behaviour change. figure 2. a model of the six core processes of act. note. adapted from hayes et al., 2006. specifically for fss, a main treatment focus in act is on a behavioural shift from control and avoidance behaviours to choosing values-based actions even when aversive symp‐ toms are present. acceptance of bodily symptoms might both increase the engagement in behaviour change and lead to a reduction in symptom experience. in ha, where rumina‐ tions about bodily sensations are prominent (see table 1), the focus on defusion from dis‐ tressing illness-related thoughts could be helpful in alleviating the anxiety attached to ill‐ ness labels such as cancer or sclerosis. functional analysis may help foster a clearer un‐ derstanding of the negative long-term effects of control and avoidance behaviours typical for ha (e.g. bodily checking and seeking information on symptoms on the internet). t h e e v i d e n c e b a s e f o r m b t a n d a c t f o r h a a n d f s s an overview of the search methods and criteria for selection of studies for the current paper is provided in table 2. frostholm & rask 7 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ table 2 search methods and criteria for selection of studies • publications on treatment outcome using acceptance & commitment therapy or mindfulness-based therapies for health anxiety and various functional somatic syndromes were identified in searches performed in september 2018 on pubmed by the help of a research librarian. • the database was searched for english language studies using the terms 'third wave' or 'mindfulness-based stress reduction' or 'mindfulness-based cognitive therapy' or 'mbct' or 'mbsr' or 'acceptance and commitment therapy' or 'mindfulness' combined with 'chronic pain' or 'fibromyalgia' or 'fatigue syndrome' or 'irritable bowel syndrome' or 'abdominal pain' or 'functional gastrointestinal disorders' or 'somatoform disorders' or 'health anxiety' or 'hypochondriasis' or 'illness anxiety disorder' or 'somatic symptom disorder'. • for studies on adult populations, the search was restricted to systematic reviews and the reference lists of included studies were examined for additional eligible studies. the web of science was used for forward citation to identify additional papers. only studies which randomised ≥50 patients were includeda. with regard to chronic pain populations, studies were excluded if a substantial part of the population did not have an idiopathic or functional pain condition. pure online self-help programmes with no therapist contact were not included. • for child and adolescent papers the search terms were further combined with the terms 'child' or 'adolescent' or 'youth or 'paediatrics' or 'minor' or 'juvenile' or 'teen'. based on the overall small number of studies no restriction was here applied with regard to study type. • the methodological quality of the studies, including randomised controlled trials were rated using the psychotherapy outcome study rating scale (öst, 2008). athis cut-off was set in order to exclude studies which would better be classified as pilot trials (bell, whitehead, & julious, 2018). evidence for ha in adults and children mbt for ha the first preliminary results on the use of mbt in adults with ha were encouraging as a pilot study found significant improvements of mbct on disease-related thoughts and so‐ matic symptoms at 3-month follow-up (lovas & barsky, 2010), and a qualitative study re‐ ported mbct adapted to ha to be acceptable for the patients (mcmanus, surawy, muse, vazquez-montes, & williams, 2012; williams, mcmanus, muse, & williams, 2011). in the following rct (mcmanus et al., 2012), 74 patients were randomised to either mbct in addition to usual unrestricted service or usual unrestricted services alone (table 3). third wave treatments for functional disorders 8 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ ta bl e 3 o ve rv ie w o f in cl ud ed r c t s tu di es t re at m en t fo rm at & do se c om pa ri so n se tt in g c on di ti on m ai n in cl us io n cr it er ia e xc lu si on c ri te ri a d ur at io n o f sy m pt om s/ di so rd er (s d )a d ia gn os ed co m or bi di ty a a ge , y (s d )a females % n o of su bj ec ts ra n do m is ed (d ro po ut a t la te st f u ) ig |c g m ai n o ut co m es b quality score (0-42) h a a du lt s tu di es m cm an us e t al . ( 20 12 ); u k m bc t 1 in di vi du al se ss io n pl us 8 gr ou p se ss io ns ta u u ni ve rs ity se tt in g h a d ia gn os is o f hy po ch on dr ia si s ac co rd in g to d sm iv -t r su bs ta nc e ab us e • s ev er e ps yc hi at ri c co m or bi di ty • u ns ta bl e ps yc ho tr op ic m ed ic at io n 8. 8 y (1 0. 2) 50 % |4 7% 41 .3 (1 2. 0) | 43 .9 (1 1. 0) 78 36 |3 8 (4 )|( 2) fu (1 2 m o) : h a c om po si te (c om bi na tio n of s el fre po rt a nd c lin ic ia n ra te d) : + (e s: 0 .4 8) 30 e il en be rg e t al . ( 20 16 ); d en m ar k a c t 10 g ro up se ss io ns w l sp ec ia lis ed cl in ic fo r fu nc tio na l di so rd er s, un iv er si ty ho sp ita l h a se ve re h a a cc or di ng to c ri te ri a by f in k et al . ( 20 04 )) se ve re p sy ch ia tr ic c om or bi di ty • o th er s om at ic /p sy ch ia tr ic co nd iti on p ri m ar y • p re gn an cy 10 .0 y (1 0. 3) | 11 .0 y (1 0. 5) 60 % |5 2% 37 .0 (9 .9 )| 35 .5 (7 .6 ) 71 63 |6 3 (1 1) |(8 ) fu (1 0 m o) : ill ne ss w or ry : + (e s: 0 .8 9) 24 m b t : f ss a du lt s tu di es a st in e t al . ( 20 03 ); u sa m bs r/ q ig on g 8 gr ou p se ss io ns ed uc at io n su pp or t g ro up u ni ve rs ity se tt in g fm c lin ic al d ia gn os is o f fm su bs ta nc e ab us e • s ev er e ps yc hi at ri c co m or bi di ty • i m pe nd in g lit ig at io n/ ju dg m en t fo r di sa bi lit y co m pe ns at io n • s ev er e ch ro ni c m ed ic al co nd iti on • pr eg na nc y 4. 9 y (4 .2 )| 5. 2 y (7 .3 ) n o of o th er di ag no se s: 2. 2 (1 .6 )| 2. 0 (2 .0 ) 47 .7 (1 0. 6) 99 64 |6 4 (to ta l: 63 ) fu (2 m o) : te nd er p oi nt c ou nt (m ya lg ic s co re ): = pa in a nd fu nc tio ni ng : = d ep re ss io n: = m ed ic al c ar e: = 20 g ay lo rd e t al . ( 20 11 ); u sa m bs r 8 gr ou p se ss io ns p lu s on e ha lfda y re tr ea t so ci al s up po rt gr ou p nr ib s ph ys ic ia n di ag no si s ac co rd in g to r o m eii cr ite ri a m aj or p sy ch ia tr ic d is or de r • s ev er e ga st ro in te st in al w el lde fin ed il ln es s • p re gn an cy nr nr 44 .7 (1 2. 5) | 41 .0 (1 4. 7) 10 03 6| 39 (2 )|( 7) fu (3 m o) : ib s se ve ri ty : + (e s: n r) h rq o l: + (e s: n r) 16 sc h m id t et a l. (2 01 1) ; g er m an y m bs r 8 gr ou p se ss io ns p lu s 7 hr w or ks ho p a ct iv e co nt ro l gr ou p to c on tr ol fo r no nsp ec ifi c fa ct or s, or w l in te rd is ci pl in ar y pa in u ni t, un iv er si ty m ed ic al c en te r fm d ia gn os is a cc or di ng to a c r cr ite ri a pa rt ic ip at io n in o th er c lin ic al tr ia l • l ife -t hr ea te ni ng d is ea se • s up re ss ed im m un e fu nc tio ni ng 14 .3 y (1 0. 2) nr 52 .5 (9 .6 ) 10 05 9| 59 |5 9 (1 2) |(1 0) |(3 ) fu (2 m o) : fm im pa ct : = h rq o l: = 25 v an r av es te ij n e t al . ( 20 12 ); n et h er la n ds m bs r 8 gr ou p se ss io ns p lu s 6 hr s ile nt d ay c om bi ne d eu c an d w l u ni ve rs ity se tt in g fr eq ue nt at te nd an ce in g p fo r pe rs is te nt m u s ≥ 6 m o sy m pt om du ra tio n sy m pt om s fu lly e xp la in ed b y m ed ic al c on di tio n • s ub st an ce ab us e • m aj or p sy ch ia tr ic di so rd er • c og ni tiv e im pa ir m en t • p ri or m bc t tr ea tm en t nr 81 % ≥ o ne ph ys ic al di se as e 35 % a nx ie ty an d/ or de pr es si on 47 .6 (1 1) | 46 .5 (1 2) 74 64 |6 1 (1 5) |(1 2) fu (9 m o) : g en er al h ea lth s ta tu s (v a s) : = sf 36 p c s: = sf 36 m c s: = 19 frostholm & rask 9 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ t re at m en t fo rm at & do se c om pa ri so n se tt in g c on di ti on m ai n in cl us io n cr it er ia e xc lu si on c ri te ri a d ur at io n o f sy m pt om s/ di so rd er (s d )a d ia gn os ed co m or bi di ty a a ge , y (s d )a females % n o of su bj ec ts ra n do m is ed (d ro po ut a t la te st f u ) ig |c g m ai n o ut co m es b quality score (0-42) z er n ic k e et a l. (2 01 3) ; c an ad a m bs r 8 gr ou p se ss io ns p lu s 3 hr w or ks ho p w l u ni ve rs ity se tt in g ib s o n st ab le m ed ic at io n se lfre po rt ed d ia gn os es o f m oo d, a nx ie ty , o r ps yc ho tic di so rd er s • u se o f p sy ch ot ic s • p ri or p ar tic ip at io n in m bs r nr nr 45 .0 y (1 2. 4) | 44 .0 y (1 2. 6) 90 43 |4 7 (2 3) |(1 3) fu (6 m o) : ib sse ve ri ty : = ib sq o l: = 16 fj or ba ck e t al . ( 20 13 ); d en m ar k m bs r 8 gr ou p se ss io ns p lu s 3 hr fo llo w -u p se ss io n eu c sp ec ia lis ed cl in ic fo r fu nc tio na l di so rd er s, un iv er si ty ho sp ita l m ul tior ga n bd s (i. e. , m ul tip le fs s) d ia gn os is a cc or di ng to re se ar ch c ri te ri a fo r bd s (f in k & sc hr öd er , 2 01 0) su bs ta nc e ab us e • m aj or ps yc hi at ri c di so rd er • pr eg na nc y 12 .0 y (1 0. 6) | 15 .0 y (1 2. 6) 22 % |2 0% m aj or de pr es si on 24 % |2 3% an xi et y 38 .0 (9 .0 )| 40 .0 (8 ) 80 59 |6 0 (1 3) |(1 6) fu (1 2 m o) : sf 36 p c s: = h rq o l: = 28 c as h e t al . ( 20 15 ); u sa m bs r 8 gr ou p se ss io ns p lu s ha lfda y m ed ita tio n re tr ea t w l u ni ve rs ity se tt in g fm ph ys ic ia nve ri fie d di ag no si s • a bl e to at te nd s es si on s nr nr 73 % m ed ic al co m or bi di ty in cl ud in g ch ro ni c fa tig ue sy nd ro m e pe ri m en op au sa l (a ge n r) 10 05 1| 40 (1 0) |(1 3) fu (2 m o) : fm im pa ct q ue st io nn ai re , p hy si ca l fu nc tio ni ng (p f) : = fm im pa ct q ue st io nn ai re , p ai n se ve ri ty (p s) : + (e s: 0 .6 2) 13 la c ou r et a l. (2 01 5) ; d en m ar k m bs r 9 gr ou p se ss io ns p lu s 4½ h r fo llo w up s es si on w l sp ec ia lis ed p ai n cl in ic , un iv er si ty ho sp ita l n on sp ec ifi c ch ro ni c pa in co nd iti on s nr u ns ta bl e m ed ic at io n • c og ni tiv e im pa ir m en t 7. 8 y (5 .2 )| 11 .8 y (1 1. 1) nr 46 .5 (1 2. 4) | 48 .8 (1 2. 2) 72 54 |5 5 (1 4) |(2 2) pt (n o fu fo r co m pa ri so n) : sf 36 v ita lit y sc or e: + (e s: 0 .3 9) pa in s ev er ity (p s) : = 14 a c t : f ss a du lt s tu di es w et h er el l e t al . ( 20 11 ); a c t 8 gr ou p se ss io ns c bt 8 gr ou p se ss io ns pr im ar y ca re se tt in g c hr on ic no nm al ig na nt pa in ≥ 6 m on th s pa in in te rf er en ce a nd se ve ri ty ≥ 5 o n 10 po in t s ca le su bs ta nc e ab us e or m aj or ps yc hi at ri c di so rd er w ith in pr ev io us 6 m on th s • i nt er fe ri ng m ed ic al c on di tio ns • c ur re nt ly in p sy ch ot he ra py fo r pa in 15 .0 y (1 3. 5) 54 % c ur re nt ps yc hi at ri c di so rd er 55 .0 (1 2. 5) 51 57 |5 7 (6 )|( 8) fu (6 m o) : br ie f p ai n in ve nt or y sh or t f or m (b pi ), in te rf er en ce s ca le : = sf 12 : = 28 m cc ra ck en e t al . ( 20 13 ); u k a c t 4 gr ou p se ss io ns ta u pr im ar y ca re se tt in g m ix ed ch ro ni c pa in co nd iti on s ≥ 3 m o pa in if g p ju dg ed fu rt he r m ed ic al te st s an d pr oc ed ur es n ec es sa ry • c on di tio ns in te rf er in g w ith pa rt ic ip at io n in tr ea tm en t 10 .0 y (n r) 81 % ≥ o ne co m or bi d di so rd er (s om at ic o r ps yc hi at ri c) 58 .0 (1 2. 8) 69 37 |3 6 (9 )|( 8) fu (3 m o) : d is ab ili ty : + (e s: 0 .3 7) sf 36 p hy si ca l f un ct io ni ng : = d ep re ss io n: = pa in in te ns ity : = 19 b uh rm an e t al . ( 20 13 ); sw ed en a c t 7 gu id ed on lin e m od ul es p lu s 2 ph on e ca lls o nl in e di sc us si on fo ru m an d w l pa in c en tr e, un iv er si ty ho sp ita l c hr on ic pa in m ed ic al in ve st ig at io n w ith in p as t y ea r • i m pa ir m en t c au se d by p ai n o ng oi ng m ed ic al in ve st ig at io ns or tr ea tm en t w hi ch c ou ld in te rf er e w ith tr ea tm en t • a cu te ph ys ic al o r ps yc hi at ri c co nd iti on s 15 .3 y (1 1. 7) 57 % m ed ic al co nd iti on 58 % ps yc hi at ri c pr ob le m 49 .1 (1 0. 3) 59 38 |3 8 (6 )|( 6) pt (n o fu fo r co m pa ri so n) : c hr on ic p ai n a cc ep ta nc e q ue st io nn ai re (c pa q ): + (e s: 0 .4 1) pa in in te rf er en ce : + (e s: 0 .5 6) 18 third wave treatments for functional disorders 10 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ t re at m en t fo rm at & do se c om pa ri so n se tt in g c on di ti on m ai n in cl us io n cr it er ia e xc lu si on c ri te ri a d ur at io n o f sy m pt om s/ di so rd er (s d )a d ia gn os ed co m or bi di ty a a ge , y (s d )a females % n o of su bj ec ts ra n do m is ed (d ro po ut a t la te st f u ) ig |c g m ai n o ut co m es b quality score (0-42) lu ci an o et a l. (2 01 4) ; s pa in a c t 8 gr ou p se ss io ns pr eg ab al in p lu s du lo xe tin e/ ot he r m ed ic at io ns , o r w l pr im ar y ca re se tt in g fm n o ph ar m ac ol og ic al tr ea tm en t • n o ps yc ho lo gi ca l tr ea tm en t d ur in g pr ev io us y ea r se ve re p sy ch ia tr ic o r m ed ic al di so rd er s, dr ug /a lc oh ol a bu se 13 .0 y 25 % de pr es si on 49 (6 .0 )| 47 .8 (5 .9 )| 48 .3 (5 .7 ) 96 51 |5 2| 53 (6 )|( 8) |(6 ) fu (6 m o) : fm im pa ct q ue st io nn ai re : + • a c t vs m ed ic at io n: (e s: 1 .4 3) • a c t vs . w l: (e s: 2 .1 1) pa in c at as tr op hi zi ng : + • a c t vs m ed ic at io n: (e s: 0 .6 9) • a c t vs . w l: (e s: 0 .7 2) 27 t ro m pe tt er e t al . ( 20 15 ); h ol la n d a c t 9 gu id ed on lin e m od ul es ex pr es si ve w ri tin g, o r w l u ni ve rs ity se tt in g c hr on ic pa in pa in in te ns ity ≥ 4 • p ai n ≥ 3 da ys p er w ee k fo r ≥ 6 m o lo w p sy ch ol og ic al in fle xi bi lit y • l ow p sy ch ol og ic al d is tr es s & se ve re p sy ch ol og ic al d is tr es s • m aj or d ep re ss iv e di so rd er • c on cu rr en t c bt -b as ed tr ea tm en t ≥ 5 y du ra tio n: 59 % |7 0% |6 1% rh eu m at ic di se as e: 1 0% | 8% |1 2% 52 .9 (1 3. 3) | 52 .3 (1 1. 8) | 53 .2 (1 2. 0) 76 82 |7 9| 77 (2 9) |(2 9) |(1 3) fu (6 m o) : pa in in te rf er en ce : • g ui de d a c t vs . e xp re ss iv e w ri tin g: + (e s: 0 .4 7) • g ui de d a c t vs . w l: = 24 k em an i e t al . ( 20 15 ); sw ed en a c t 12 g ro up se ss io ns a pp lie d re la xa tio n sp ec ia lis ed p ai n cl in ic , un iv er si ty ho sp ita l m ix ed p ai n co nd iti on s ≥ 6 m o pa in c on cu rr en t c bt -b as ed tr ea tm en t • m aj or p sy ch ia tr ic di so rd er • n ot a bl e to fi ll in qu es tio nn ai re s 9. 9 y (7 .5 ) 20 % m aj or de pr es si on • 2 0% g en er al an xi et y • 1 8% so ci al p ho bi a • 1 8% p an ic di so rd er 40 .3 (1 1. 4) 73 30 |3 0 (1 1) |(1 2) fu (6 m o) : pa in d is ab ili ty : + (e s: 0 .6 3) h rq o l: = 31 li n e t al . ( 20 17 ); g er m an y a c t g ui de d on lin e in tr o pl us 7 m od ul es n on -g ui de d on lin e a c t, o r w l h ea lth in su ra nc e pr ov id er c hr on ic pa in ≥ 6 m o pl us in te rf er en ce c om pu te r lit er ac y tu m or -r el at ed p ai n • o ng oi ng or p la nn ed p sy ch ol og ic al p ai n in te rv en tio n • e le va te d su ic id e ri sk 11 4. 5 m o (1 21 ) 57 .3 % m ed ic al co nd iti on s • 3 9. 4% m en ta l co nd iti on s 51 .7 (1 3. 1) 84 10 0| 10 1| 10 1 (4 6) |(4 5) |(2 6) fu (6 m o) : pa in in te rf er en ce : • g ui de d a c t vs w l: + (e s: 0 .5 8) • g ui de d vs u ngu id ed a c t: = ph ys ic al fu nc tio ni ng : = 22 p ed er se n e t al . ( 20 18 ); d en m ar k a c t 9 gr ou p se ss io ns br ie f a c t (g ro up w or ks ho p pl us 1 in di vi du al co ns ul ta tio n) , o r eu c sp ec ia lis ed cl in ic fo r fu nc tio na l di so rd er s, un iv er si ty ho sp ita l m ul ti or ga n bd s (i. e. , m ul tip le fs s) d ia gn os is a cc or di ng to re se ar ch c ri te ri a fo r bd s (f in k & sc hr öd er , 2 01 0) su bs ta nc e ab us e • m aj or ps yc hi at ri c di so rd er • pr eg na nc y 9. 8 y (8 .8 )| 9. 9 y (7 .3 )| 9. 3 y (6 .7 ) 22 % 38 .8 (8 .0 )| 38 .7 (8 .6 )| 40 .1 (8 .5 ) 82 59 |6 1| 60 (1 5) |(1 1) |(1 4) fu (1 4 m o) : se lfra te d gl ob al h ea lth im pr ov em en t (c g i): + sf 36 p c s: = 25 si m is te r et a l. (2 01 8) ; c an ad a a c t 7 on lin e m od ul es ta u u ni ve rs ity se tt in g fm • se lfre po rt ed pa in > 3 (0 -1 0) d ia gn os is a cc or di ng to a c r cr ite ri a m aj or p sy ch ia tr ic d is or de r • s ev er e so m at ic d is ea se • c hr on ic fa tig ue s yn dr om e 10 .2 y (7 .8 ) nr 39 .7 (9 .4 ) 95 33 |3 4 (8 )|( 9) fu (3 m o) : fm im pa ct q ue st io nn ai re re vi se d (f iq r) : + (e s: 1 .5 9) 6m in ut e w al k te st : = 18 frostholm & rask 11 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ t re at m en t fo rm at & do se c om pa ri so n se tt in g c on di ti on m ai n in cl us io n cr it er ia e xc lu si on c ri te ri a d ur at io n o f sy m pt om s/ di so rd er (s d )a d ia gn os ed co m or bi di ty a a ge , y (s d )a females % n o of su bj ec ts ra n do m is ed (d ro po ut a t la te st f u ) ig |c g m ai n o ut co m es b quality score (0-42) sc ot t et a l. (2 01 8) ; u k a c t 45 m in in di vi du al se ss io n pl us 8 on lin e m od ul es p lu s 45 m in in di vi du al se ss io n ta u pa in m an ag em en t ce nt re , un iv er si ty ho sp ita l c om pl ex ch ro ni c pa in >3 m o pl us d is tr es s an d di sa bi lit y pr ev io us a c t or c bt fo r pa in • o th er c ur re nt p sy ch ol og ic al tr ea tm en t • s ev er e ps yc hi at ri c di so rd er m ed ia n 6. 8 y (r an ge 0. 847 .5 ) nr 45 .5 (1 4) 65 31 |3 2 (8 )|( 6) fu (9 m o) : fe as ib ili ty : + pa tie nt g lo ba l i m pr es si on o f c ha ng e (p c ig ): = pa in in te rf er en ce : + (e s: 0 .4 ) 20 c om bi n ed s ec on d an d th ir d w av e: f ss a du lt s tu di es lj ót ss on e t al . ( 20 10 ); sw ed en c bt b as ed o n ex po su re a nd m in df ul ne ss ex er ci se s (ic bt ), 5 on lin e m od ul es o nl in e di sc us si on fo ru m u ni ve rs ity ho sp ita l s et tin g ib s pr io r di ag no se d w ith ib s by p hy si ci an • f ul fil r o m eiii ib s cr ite ri a d is pl ay in g "a la rm s ym pt om s" fo r or ga ni c ga st ro en te ro lo gi ca l di se as e • c ur re nt o r pr ev io us in fla m m at or y bo w el d is ea se • l ac to se o r gl ut en in to le ra nc e no t p ro pe r co rr ec te d w ith d ie t • s ub st an ce a bu se • m aj or ps yc hi at ri c di so rd er • < 2 y of ib s sy m pt om s 6. 3 y (7 .3 ) nr 34 .6 (9 .4 ) 85 43 |4 3 (5 )|( 0) pt (n o fu fo r co m pa ri so n) : ib s sy m pt om s ev er ity (g sr sib s) : + (e s: 1 .2 1) ib s to ta l p ai n: + (e s: 0 .6 4) ib sq o l: + (e s: 0 .9 3) 22 lj ót ss on e t al . ( 20 11 ); sw ed en ic bt 5 on lin e m od ul es in te rn et de liv er ed s tr es s m an ag em en t u ni ve rs ity ho sp ita l s et tin g ib s pr io r di ag no se d w ith ib s by p hy si ci an • f ul fil r o m eiii ib s cr ite ri a d is pl ay in g "a la rm s ym pt om s" fo r or ga ni c ga st ro en te ro lo gi ca l di se as e • c ur re nt o r pr ev io us in fla m m at or y bo w el d is ea se • l ac to se o r gl ut en in to le ra nc e no t p ro pe r co rr ec te d w ith d ie t • s ub st an ce a bu se • m aj or ps yc hi at ri c di so rd er • < 2 y of ib s sy m pt om s 14 .9 y (1 1. 2) nr 38 .9 (1 1. 1) 79 98 |9 7 (1 1) |(1 5) fu (6 m o) : ib s sy m pt om s ev er ity (g sr sib s) : + (e s: 0 .4 4) ib sq o l: (e s: 0 .3 1) 28 lj ót ss on e t al . ( 20 14 ); sw ed en ic bt 5 m od ul es ic bt w ith ou t ex po su re co m po ne nt u ni ve rs ity ho sp ita l s et tin g ib s pr io r di ag no se d w ith ib s by p hy si ci an • f ul fil r o m eiii ib s cr ite ri a d is pl ay in g "a la rm s ym pt om s" fo r or ga ni c ga st ro en te ro lo gi ca l di se as e • c ur re nt o r pr ev io us in fla m m at or y bo w el d is ea se • l ac to se o r gl ut en in to le ra nc e no t p ro pe r co rr ec te d w ith d ie t • s ub st an ce a bu se • m aj or ps yc hi at ri c di so rd er • i ns uf fic ie nt la ng ua ge o r co m pu te r sk ill s 15 .9 y (1 2. 4) nr 42 .4 (1 4. 5) 80 15 6| 15 3 (2 1) |(1 9) fu (6 m o) : ib s sy m pt om s ev er ity (g sr sib s) : + (e s: 0 .4 8) ib sq o l: (e s: 0 .2 6) 28 k le in st au be r et a l. (i n p re ss ); g er m an y c bt w ith em ot io n re gu la tio n tr ai ni ng (e n c er t) , in di vi du al 20 -2 5 se ss io ns c on ve nt io na l c bt 7 un iv er si ty m en ta l h ea lth ou tp at ie nt cl in ic s ss d d ia gn os is a cc or di ng to d sm -5 su bs ta nc e ab us e • m aj or ps yc hi at ri c di so rd er • sp ec ifi c ty pe s of p sy ch op ha rm ac ol og ic al tr ea tm en t 14 .6 y (2 .9 ) 50 .4 % 43 .4 (1 2. 9) 64 12 7| 12 8 (3 8) |(3 6) fu (6 m o) : sy m pt om s ev er ity : = d is ab ili ty : = 35 third wave treatments for functional disorders 12 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ t re at m en t fo rm at & do se c om pa ri so n se tt in g c on di ti on m ai n in cl us io n cr it er ia e xc lu si on c ri te ri a d ur at io n o f sy m pt om s/ di so rd er (s d )a d ia gn os ed co m or bi di ty a a ge , y (s d )a females % n o of su bj ec ts ra n do m is ed (d ro po ut a t la te st f u ) ig |c g m ai n o ut co m es b quality score (0-42) fs s ch il d st ud y w ic k se ll e t al . ( 20 09 ); sw ed en a c t 10 in di vi du al se ss io ns , 1 -2 pa re nt al se ss io ns m ul tid is ci pl in ar y tr ea tm en t sp ec ia lis ed p ai n cl in ic , un iv er si ty ho sp ita l m ix ed p ai n sy nd ro m es ≥ 3 m o pa in ex pl ai ne d by o rg an ic p at ho lo gy • m aj or p sy ch os oc ia l o r ps yc hi at ri c is su es • m aj or co gn iti ve d ys fu nc tio ns • a lr ea dy c bt tr ea tm en t • p re vi ou s am itr ip ty lin e tr ea tm en t 32 m o (n r) nr 14 .8 (2 .4 ) 78 16 |1 6 (3 )|( 5) fu (4 .7 m o) : d is ab ili ty (f d i: pa re nt & c hi ld ve rs io n) : = pa in -r el at ed fe ar (p a ir s) : + (e s: 0 .2 9) pa in in te rf er en ce : = sf 36 p c s: = sf 36 m c s: = 20 n ot e. a c r = a m er ic an c ol le ge o f r he um at ol og y; a c t = a cc ep ta nc e an d c om m itm en t t he ra py ; b d s = bo di ly d is tr es s sy nd ro m e; c bt = c og ni tiv e be ha vi ou ra l th er ap y; c g = c on tr ol g ro up ; e s = ef fe ct s iz e; e u c = e nh an ce d u su al c ar e; f d i = f un ct io na l d is ab ili ty in ve nt or y; f m = f ib ro m ya lg ia ; f ss = f un ct io na l s om at ic sy nd ro m es ; f u = f ol lo w -u p; g p = g en er al p ra ct ic e; h a = h ea lth a nx ie ty ; h rq o l = h ea lth -r el at ed q ua lit y of l ife ; i bs = ir ri ta bl e bo w el s yn dr om e; ig = in te r‐ ve nt io n g ro up ; m bc t = m in df ul ne ss b as ed c og ni tiv e th er ap y; m bs r = m in df ul ne ss b as ed s tr es s re du ct io n; m bt = m in df ul ne ss -b as ed th er ap ie s; m c s = m en ta l c om po ne nt s um m ar y; m u s = m ed ic al ly u ne xp la in ed s ym pt om s; n r = no t r ep or te d; p a ir s = pa in a nd im pa ir m en t r el at io ns hi p sc al e; p c s = ph ys ic al c om po ne nt su m m ar y; p t = po st t re at m en t; sf 36 /1 2 = 36 -i te m /1 2ite m s ho rt f or m h ea lth s ur ve y; q o l = q ua lit y of l ife ; s sd = s om at ic s ym pt om d is or de r; ta u = t re at m en t as u su al ; v a s = v is ua l a na lo gu e sc al e; w l = w ai t l is t. a n um be rs e ith er s ho w n fo r th e to ta l s tu dy s am pl e or fo r ea ch tr ea tm en t a rm . b pl us s ig n (+ ) i nd ic at es im pr ov em en t i n fa vo ur o f t he in te rv en tio n gr ou p, e qu al s ig n (= ) in di ca te s no e ffe ct . i f s ev er al fo llo w -u ps th e la te st ti m epo in t i s re po rt ed . frostholm & rask 13 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ a medium es of 0.48 was reported at one-year follow-up, which is at the lower end com‐ pared to existing cbt approaches. however, the drop-out rate was only 3%, which is no‐ ticeably lower than rates reported in some of the cbt-based treatments for ha (e.g. 25% from cbt in greeven et al. (greeven et al., 2007) and 35% from cbt in visser & bouman (visser & bouman, 2001)). act for ha only one rct study using act for ha has been reported (eilenberg, fink, jensen, rief, & frostholm, 2016) (table 3). the rct was preceded by an uncontrolled pilot study sug‐ gesting that act group therapy may be an effective and acceptable treatment of ha (eilenberg, kronstrand, fink, & frostholm, 2013). for the larger controlled study, the be‐ tween-group effect sizes were large (es = 0.89), and the treatment programme was well accepted by the patients. thus, only 9 out of 135 eligible participants declined participa‐ tion, and the drop-out rate in the act treatment was low as only 4 (6%) out of 63 pa‐ tients discontinued and one never attended the treatment. the programme was recently translated into an internet-based format, iact for ha, with promising feasibility and ef‐ ficacy reported in a pilot study (hoffmann, rask, hedman-lagerlof, ljótsson, & frostholm, 2018). the results from a subsequent larger rct with inclusion of 101 pa‐ tients randomized to either iact or an active control condition with an internet-deliv‐ ered discussion forum are pending (hoffmann, 2018). the literature search revealed no published treatment studies using any of the above approaches for children and adoles‐ cents with ha. evidence for fss in adults mbt for fss eight studies were located (table 3). three were on fm (astin et al., 2003; cash et al., 2015; schmidt et al., 2011). one study focused on chronic pain (la cour & petersen, 2015), 2 on ibs (gaylord et al., 2011; zernicke et al., 2013), 1 on persistent mus (van ravesteijn, lucassen, bor, van weel, & speckens, 2013) and 1 on multi-organ bds (fjorback et al., 2013). the smaller study on fm population found a potentially clinically relevant effect on symptom severity (cash et al., 2015) of the mbsr program compared to treatment as usu‐ al (tau). the two larger studies on fm (astin et al., 2003; schmidt et al., 2011) which both included an active control condition, an education support group and an education support including stretching and relaxation training, found no differences in their main outcomes (table 3). schmidt et al. thus concluded that mbsr cannot be recommended as a treatment for fm (schmidt et al., 2011). the study on chronic pain (la cour & petersen, 2015) used an mbsr programme on top of usual care in a hospital-based pain clinic and found moderate effects on the main third wave treatments for functional disorders 14 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ outcome of vitality, symptoms of anxiety and depression and control over pain immedi‐ ately post-treatment but did not include long-term outcomes. the two studies on ibs (gaylord et al., 2011; zernicke et al., 2013) both used mbsr and randomised 75 and 90 patients respectively. both studies found clinically relevant within-group changes on the ibs symptom severity and other outcome measures. how‐ ever, in the zernicke study (zernicke et al., 2013), which had a 6-month follow-up as op‐ posed to 3 months in the gaylord study (gaylord et al., 2011), there was no significant difference between the mbsr and the waitlist at this final follow-up. a dutch study on high utilizers with persistent medically unexplained symptoms in primary care employed mbct and found no effect on their primary outcome of general health status nine months after end of treatment. this also applied for the secondary out‐ comes except for the mindfulness skills of observing and describing (van ravesteijn et al., 2013). the other study in the more severe spectrum (fjorback et al., 2013) was also nega‐ tive as there was no difference between the two groups even though the mbsr group had improved more on the main outcome of sf-36 physical component summary to‐ wards the end of the active treatment period, whereas the enhanced treatment as usual caught up during the 1-year follow-up. act for fss the majority of act studies in fss have been conducted in chronic pain populations in‐ cluding fm, and the number of participants is surprisingly small. in the two most recent reviews on act for chronic pain, only five of 11 studies (veehof, trompetter, bohlmeijer, & schreurs, 2016) and six of 10 studies (hughes, clark, colclough, dale, & mcmillan, 2017) respectively randomised at least 50 participants. when including these larger trials, seven act studies were located for chronic pain, three of which were face-to-face (kemani et al., 2015; mccracken, sato, & taylor, 2013; wetherell et al., 2011) and four of which were guided internet-delivered studies (buhrman et al., 2013; lin et al., 2017; scott, chilcot, guildford, daly-eichenhardt, & mccracken, 2018; trompetter, bohlmeijer, veehof, & schreurs, 2015). two studies were specifically on fm of which one was face-to-face (luciano et al., 2014) and one guided internet-delivered (simister et al., 2018). for multiple fss, one study was located (pedersen et al., 2018). that is, all in all 10 studies on fss of which five were internetdelivered. on top of the above distinct act interventions, one very recent study examined cbt with or without added acceptance-based emotion-regulation strategies for multiple medi‐ cally unexplained symptoms (kleinstauber et al., in press). finally, three consecutive studies from one research group examined internet-delivered acceptance-based exposure therapy for ibs (ljótsson et al., 2010; ljótsson et al., 2011; ljótsson et al., 2014). kemani and colleagues (kemani et al., 2015) randomised 60 patients with chronic pain to either 12 90-minute weekly group sessions of act or applied relaxation (ar) but only frostholm & rask 15 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ obtained 6-month follow-up data on 37 participants. they found significantly larger ef‐ fects of the act intervention immediately post-treatment on pain disability, but the ar group caught up in the follow-up period. a pilot rct of a 4x4-hour primary care based act group intervention for chronic pain found only small effects compared to treatment as usual (mccracken et al., 2013). wetherell (wetherell et al., 2011) compared group cbt to the same amount of group act, all in all 12 hours, and overall found small and compa‐ rable effects of the two conditions on all outcomes (wetherell et al., 2011). interestingly, they found that participants assigned to cbt rated this as more credible after the first session, whereas act participants reported more satisfaction at the end of treatment. four studies examined the effect of guided internet-delivered act for chronic pain randomising 76, 238, 302, and 63 participants, respectively (buhrman et al., 2013; lin et al., 2017; scott et al., 2018; trompetter et al., 2015). the two largest trials were threearmed (lin et al., 2017; trompetter et al., 2015) (table 3). both of these studies found clin‐ ically relevant improvements of small to moderate effect of the act intervention com‐ pared to the control conditions, although the trompetter study found unexpected im‐ provements in the waitlist control (ibid). the results from these two larger internet-based studies were generally supported by the two smaller studies (buhrman et al., 2013; scott et al., 2018), even though the buhrman study (buhrman et al., 2013) included a large number of outcome measures given the small sample size. the two studies on fm both found promising effects (luciano et al., 2014; simister et al., 2018). a group-based intervention carried out at primary health care centres in spain was found superior on most outcome measures at 6-month follow-up compared to both recommended pharmacological treatment and to a waitlist control with large effects on fibromyalgia impact (luciano et al., 2014). this finding was generally supported by the smaller study randomising 67 participants to either online act or treatment as usual (simister et al., 2018). pedersen et al. (pedersen et al., 2018) conducted a tree-armed intervention study ex‐ amining group-based act with a brief act intervention (group workshop + individual session) and enhanced care (pedersen et al., 2018) for patients with multiple fss. they found effect of extended act on the primary outcome of patient-rated overall health im‐ provement 14 months after randomisation but failed to replicate this finding on any of the secondary outcomes such as illness, worry, emotional distress and health-related quality of life. a german multicentre study included patients with multiple medically unexplained symptoms (kleinstauber et al., in press) and compared two active treatments, namely conventional cbt for fss, which mainly focused on causing and maintaining factors and encert: encert was cbt with a primary focus on negative emotions as cause and consequence of fss. this treatment arm included emotion regulation strategies such as acceptance and mindfulness-based strategies and cognitive reappraisal (ibid). they found medium to high effects on most outcomes in both conditions but also superior outcomes third wave treatments for functional disorders 16 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ of encert on a number of secondary outcomes such as health anxiety, symptom dis‐ tress and emotion regulation skills. finally, a series of three studies on the same treatment programme for ibs (ljótsson et al., 2010; ljótsson et al., 2011; ljótsson et al., 2014) combined acceptance strategies with mindfulness training and exposure. in the first modules of the treatment, they intro‐ duced mindfulness training and acceptance of symptoms together with a psychological model of ibs with the core message that behaviours which serve to avoid or control symptoms often increase the intensity of, and attention given to, symptoms (ljótsson et al., 2010). the last phase of the treatment introduced exposure such as attending contexts where symptoms normally occur, exercises to provoke symptoms and abolishment of be‐ haviours to control the occurrence of symptoms (ibid.). they found high effects of this treatment compared to an online discussion forum (ljótsson et al., 2010). in a subsequent study, the treatment was found superior with medium effect sizes on several outcomes compared to stress management, which emphasised symptom control through relaxation, dietary changes and problem-solving skills (ljótsson et al., 2011). finally, in a disentan‐ glement study, they examined the effect of the intervention with and without the final exposure phase of the treatment programme and found a medium effect size in favour of the inclusion of systematic exposure (ljótsson et al., 2014). evidence for fss in children and adolescents mbt for fss our search identified 8 studies on mbt for fss in children; the first study published in 2013 (jastrowski mano et al., 2013). the studies were generally small (n, range 6-21). most used pilot designs and mainly examined a developmentally adapted version of the mbsr programme in tertiary care settings on children and adolescents in the age range from 12 to 18 years with mixed chronic pain conditions. only one smaller study has been on young patients with various fss including chronic fatigue (ali et al., 2017). attrition and recruitment problems were described in five of the studies (hesse, holmes, kennedy-overfelt, kerr, & giles, 2015; jastrowski mano et al., 2013; lovas et al., 2017; ruskin, gagnon, kohut, stinson, & walker, 2017; ruskin, kohut, & stinson, 2015) as well as problems with obtaining sufficient post test data to draw valid conclusion about outcome (ruskin, gagnon, kohut, stinson, & walker, 2017). however, three other recent studies indicate better feasibility results with low attrition and high acceptability but het‐ erogeneous results when it comes to potential efficacy (ali et al., 2017; chadi et al., 2016; waelde et al., 2017). ali et al. (ali et al., 2017) conducted an open trial on 18 adolescents with various fss and found preliminary evidence for the mbsr programme with regard to improvement of functional disability, symptom impact and anxiety with consistency between parent and child measures. chadi et al. (chadi et al., 2016) evaluated a combina‐ tion of mbsr and mbct on 20 female adolescents who were randomised to either an in‐ tervention group or a waitlist control group. they reported no improvements in psycho‐ frostholm & rask 17 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ logical or pain symptoms but did find significant reductions in pre and post-mindfulness session salivary cortisol levels. waelde et al. (waelde et al., 2017) conducted an open trial on 20 adolescents with chronic pain who received a six-week group intervention based on an adult programme named 'inner resources for stress' combining meditation practi‐ ces, breath-focused cue word repetition and visualisation. functional disability and fre‐ quency of pain complaints improved with small effect sizes (d = 0.2-0.3). though parents in the study did not receive any specific interventions, their worry about their child’s pain decreased with a large effect size (d = 0.75). act for fss also with regard to act, the evidence is still sparse in younger age groups. we identified 6 act studies (gauntlett-gilbert, connell, clinch, & mccracken, 2013; kanstrup et al., 2016; kemani, kanstrup, jordan, caes, & gauntlett-gilbert, 2018; wicksell, dahl, magnusson, & olsson, 2005; wicksell, melin, lekander, & olsson, 2009; wicksell, melin, & olsson, 2007) including only one smaller rct (wicksell et al., 2009) (table 3). a sev‐ enth study included several modalities, i.e. cbt, act and multi-family therapy (huestis et al., 2017). all studies relate primarily to adolescents diagnosed with various types of chronic idiopathic pain and four were performed at the same research centre. wicksell et al. were the first to describe an act-oriented outpatient intervention in young patients with high levels of pain-related disability; first in a case study (wicksell et al., 2005), next in a case series on 14 adolescents (wicksell et al., 2007) and subsequently in an rct on 32 adolescents (mean age 14.8 yrs). the rct compared 10 sessions of act and one to two parent sessions with a multidisciplinary treatment including amitripty‐ line medication (wicksell et al., 2009). overall significant improvements with decreased disability were observed in all three studies, and specifically in the rct, effects in favour of act were seen post-treatment in pain-related fear, pain interference and in quality of life. however, prolonged treatment in the control group complicated comparisons be‐ tween the groups at follow-up assessments where all primary outcomes except pain-rela‐ ted fear became comparable (table 3). the same research group later compared different formats of an extended version of this act programme, provided either individually (n = 18) or as group-based treatment (n = 12). medium to large effects post-treatment were reported in both formats on pain interference, depression, pain reactivity and psychologi‐ cal flexibility as well as in parent pain reactivity and psychological flexibility post-treat‐ ment (kanstrup et al., 2016). in an uncontrolled trial (gauntlett-gilbert et al., 2013), 98 adolescents (mean age 15.6 yrs) with non-malignant pain underwent a 3-week residential multidisciplinary act treatment (approx. 90 hrs) in a specialised setting. the programme comprised physical conditioning, activity management and psychotherapy with promotion of acceptance of pain and related distress as well as engagement in values-consistent behaviour. parent in‐ volvement was included in most sessions. the adolescents improved in self-reported third wave treatments for functional disorders 18 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ functioning and objective physical performance at a 3-month follow-up. they were less anxious and catastrophic, attended school more regularly and used health care facilities less often. the programme was re-evaluated on another 164 patients as regards both ado‐ lescent and parental variables and the relationship between parental psychological flexi‐ bility and adolescent pain acceptance (kemani et al., 2018). as in the former study, results indicated positive effects on the adolescents' functioning and pain acceptance but also a significant positive relationship between changes in parental psychological flexibility and adolescent pain acceptance. a last study from 2017 describes the utility and outcomes of a multimodal interven‐ tion (captives) including cbt, act and multi-family therapy in 17 youth (aged 13-17 years) with chronic pain and their parents (huestis et al., 2017). the programme included weekly concurrent 60 min. youth and parent groups, concluded with an additional 30 min. multi-family group session. the families found the programme engaging and con‐ structive and large effects were reported on pain catastrophising, acceptance and protec‐ tive parenting. similar effects were found for functional disability, pain interference, fati‐ gue, anxiety and depression. recently, a study protocol describing the design of a large rct comparing groupbased act with enhanced usual care for adolescents with various fss was published (kallesøe et al., 2016). however, the results are still pending (personal communication). d i s c u s s i o n even though third wave treatments are employed increasingly, there are still relatively few intervention studies in adults of moderate to high methodological quality in fd. thus, in the updated 2016 review (veehof et al., 2016) of a 2011 review (veehof, oskam, schreurs, & bohlmeijer, 2011) on acceptance and mindfulness-based interventions, the authors concluded that the study quality had not improved in the five years since the first review, a finding supported by öst's review on act for a broad range of conditions (öst, 2014). as is the case with many emerging treatments, most studies in children and adolescents are small and uncontrolled in design. evidence for third wave treatment in ha for ha, the only two third wave rcts on adults found a medium effect of mbct tailored to ha (mcmanus et al., 2012) and high effect of act (eilenberg et al., 2016). there were no studies in children or adolescents. again, more studies are needed to replicate the findings from the above studies, especially the promising results of the act study, which reported high es on the primary outcome and medium to high effect on most secondary outcomes and high retention of patients. it is worth noting that this study did, together with the vast majority of act interventions, include elements from second wave cbt frostholm & rask 19 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ such as psychoeducation using the vicious circle of anxiety and interoceptive exposure http://funktionellelidelser.dk/fileadmin/www.funktionellelidelser.au.dk/publikationer/ act_manual.pdf with regard to younger age groups, ha is an emerging topic in the scientific litera‐ ture. integrating potential early childhood and family risk factors can help inform the de‐ velopment of specialised third wave therapies in children and adolescents (thorgaard, frostholm, & rask, 2018) as well as for parents with so-called health anxiety by proxy (thorgaard et al., 2017), i.e. parents who present with excessive and seemingly unreason‐ able concern about their child's symptoms. evidence for third wave treatment in fss overall, there seems to be only minor effects of mbt in fss. these findings are in line with the conclusions from a meta-analytic review that es were higher for act therapies compared to mbt for the majority of the examined outcomes (veehof et al., 2016). some of the mbt studies in both adults and younger age groups are hampered by attrition, which may also suggest that mbt does not offer an alternative to second wave treat‐ ments in terms of retention. the two studies on mbt for ibs in adults (gaylord et al., 2011; zernicke et al., 2013) might suggest a bigger potential for this subgroup of patients given the clinically relevant change on the main outcome, but the effects may be transi‐ ent. in children, there may be recruitment and retention problems for mbt programmes if the intervention is not properly modified and tailored according to developmental as‐ pects. children and adolescents in general require more explanation and rationale, short‐ er formal exercises (e.g. around 3-5 min compared to 20-45 min in adults) as well as a greater variety of practices if they are to engage fully (perry-parrish, copeland-linder, webb, & sibinga, 2016; thompson & gauntlett-gilbert, 2008). from a clinical viewpoint, quite a few patients seem to benefit from mbt formats, and some of the target processes such as body awareness and emotional regulation could have promise. however, the mindfulness training may need to be embedded with other methods to prevent attrition and to increase effect. there is no evidence to suggest that act is superior to cbt in fss. more high quality studies are needed to conclude whether act is just as effective as cbt since the smaller studies, which have been included in many reviews, inherently have an increased risk of bias. there seems to be a potential in act-based therapist-guided internet-delivered in‐ terventions with a number of studies in chronic pain conditions reporting effects compa‐ rable to that of face-to-face interventions. especially noteworthy here are the studies on acceptance-based exposure-based therapy for ibs (ljótsson et al., 2010; ljótsson et al., 2011), where acceptance-based techniques, mindfulness training and strict exposure training are combined to produce consistently large effects, and where the exposure ele‐ ment has been shown to add considerable effect (ljótsson et al., 2014). further studies third wave treatments for functional disorders 20 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 http://funktionellelidelser.dk/fileadmin/www.funktionellelidelser.au.dk/publikationer/act_manual.pdf http://funktionellelidelser.dk/fileadmin/www.funktionellelidelser.au.dk/publikationer/act_manual.pdf https://www.psychopen.eu/ could potentially benefit from tailoring symptom-specific exposure in the context of ac‐ ceptance methods. for conditions characterised by multiple symptoms from several organ systems, it was likewise the study which combined conventional cbt with third wave methods that had more convincing results (kleinstauber et al., in press). worth noting here is the dos‐ age of treatment with 20-25 individual sessions as compared to e.g. 9 group sessions in the other trial on multiple symptoms (pedersen et al., 2018). a secondary analysis of a group-based cbt intervention for multiple fss (schröder, sharpe, & fink, 2015b) found higher effect in the subgroup of patients with fewest symptoms. this suggests that illness severity should be taken into account when designing interventions, and more extensive interventions may be needed in the severe spectrum of fss. with regard to children, the evidence is surprisingly low with small and mostly un‐ controlled studies on paediatric chronic pain conditions. therefore, it remains unclear whether observed effects reflect differences in samples, designs, instruments used, meth‐ od of analysis or actual effects of different treatment modalities. however, the emphasis on experiential exercises and metaphors in act may render this approach particularly appropriate for children. concepts that would normally be too abstract for children can become accessible through experience and metaphorical language (coyne, mchugh, & martinez, 2011; murrell, coyne, & wilson, 2004). still, larger and well-designed trials are needed to compare act to cbt interventions to examine the potential superiority of this approach in youth with fss. involvement of family and close relatives in third wave treatment the paediatric studies specifically emphasised inclusion of caregivers in treatment. this is supported by a number of studies reporting that parents may inadvertently reinforce maladaptive illness perceptions and illness behaviours in their child (chow, otis, & simons, 2016; guite, mccue, sherker, sherry, & rose, 2011; palermo, valrie, & karlson, 2014; simons, smith, kaczynski, & basch, 2015). engaging parents may both help them ameliorate their own concerns and teach them how to reinforce and model adaptive be‐ haviours. recent studies have shown improvements in parental psychological flexibility of an 8-week act group programme (wallace, woodford, & connelly, 2016) and a onesession mbt workshop (ruskin, campbell, stinson, & ahola kohut, 2018) in parents of children with chronic pain, i.e. parents' abilities to accept their distress about their child's suffering and to focus on broader goals rather than being absorbed by worries about whether their child's pain improved. in adult patients with fss (cfs), their illness also seems to have a negative impact on the family (higgins et al., 2015; leonard & cano, 2006), and partners' responses may even influence the course of the disorder (schmaling, smith, & buchwald, 2000). dynamic management involving family systems and close relatives to promote adaptive function‐ frostholm & rask 21 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ ing, quality of life and resilience may therefore also be an interesting focus for future studies on adults. potential challenges with third wave treatment for fd, there is agreement that illness beliefs play a prominent role and that changes in beliefs such as perceived control (christensen, frostholm, ornbol, & schröder, 2015) and fear-avoidance beliefs (chalder, goldsmith, white, sharpe, & pickles, 2015) have been found to mediate the effect of cbt. one may speculate that there is a risk that the third wave meta-cognitive processes aimed at a general shift in perspective on inner experi‐ ence and the self may not sufficiently address the specific cognitive beliefs that may per‐ petuate the symptoms for each individual patient. this risk may be further enhanced by the fact that all the included act studies, which were not internet-based, were groupbased (kemani et al., 2015; luciano et al., 2014; mccracken et al., 2013; pedersen et al., 2018; wetherell et al., 2011). group-based therapy may have advantages in terms of pro‐ viding support, promoting social skills and mirroring processes etc. but may also have risks in terms of not properly addressing the specific needs of each patient. large differences exist in use of outcome domains making it difficult to compare stud‐ ies. some act studies have used pain interference and pain acceptance as primary out‐ comes taking the point of departure that greater acceptance of symptoms and less inter‐ ference of the pain in daily life are essential goals in act. even though that may ring true from a theoretical perspective, we need more knowledge of the clinical importance of such changes. other studies use syndrome-specific outcomes, hampering the compara‐ bility between syndromes. including as a minimum the two numeric analog scale items on symptom intensity and symptom interference recommended by the european net‐ work on somatic symptom disorders in future adult trials (rief et al., 2017) could have a major impact on the interpretation and comparability of studies. these scales encompass both the third wave focus on decreasing interference of symptoms as well as symptom reduction (see figure 3). for children and adolescent populations, the availability of validated questionnaires is ex‐ tremely scant, and much more work is needed to develop and test such measures. third wave treatments for functional disorders 22 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 https://www.psychopen.eu/ figure 3. two numeric rating scales recommended in future trials for fd. note. the scales are available at http://links.lww.com/psymed/a408 in more than 20 languages. conclusion and perspectives in sum, the evidence for third wave behavioural approaches for fd are still limited when it comes to larger controlled studies and very sparse and almost non-existing in younger age groups. there may have been hype surrounding the advent of third wave treatments which have hampered the ability among researchers and clinicians to communicate accu‐ rately about the advantages and disadvantages of these methods (van dam et al., 2018). especially for children and adolescents, much progress remains to be made in empirically evaluating the effectiveness of third wave treatment. thus, cbt-based programs still have much better evidence for this age group (bonvanie et al., 2017). there is often an unfortunate division between researchers and clinicians who study and treat adults with fd and those who work with children and adolescents with the same disorders. joint efforts with mutual exchange of experiences and results could pave the way for further development of existing programmes such as the involvement of the family system in adult programmes. even though the field of fd will continue to be challenged by problems with diagnos‐ tic classification, agreement on joint outcomes across syndrome diagnoses and possibly more dismantling studies using e.g. single-case designs and/or experimental studies could also be a way forward to further explore which patient characteristics are compatible with certain approaches and techniques, both when it comes to children, adolescents and adults. finally, more studies explicitly combining methods from second and third wave ap‐ proaches may be a promising avenue for patients across the age span. frostholm & rask 23 clinical psychology in europe 2019, vol.1(1), article e32217 https://doi.org/10.32872/cpe.v1i1.32217 http://links.lww.com/psymed/a408 https://www.psychopen.eu/ funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. r e f e r e n c e s abbott, r. a., martin, a. e., newlove-delgado, t. v., bethel, a., whear, r. s., thompson coon, j., & logan, s. 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(2013). mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial. international journal of behavioral medicine, 20(3), 385-396. https://doi.org/10.1007/s12529-012-9241-6 frostholm & rask 33 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org https://doi.org/10.1016/j.janxdis.2015.05.008 https://doi.org/10.1016/j.pain.2011.05.016 https://doi.org/10.1016/s1077-7229(05)80069-0 https://doi.org/10.1016/j.pain.2008.11.006 https://doi.org/10.1016/j.ejpain.2006.02.012 https://doi.org/10.1111/j.2044-8260.2010.02000.x https://doi.org/10.1080/16506070310014691 https://doi.org/10.1007/s12529-012-9241-6 https://www.leibniz-psychology.org/ https://www.psychopen.eu/ third wave treatments for functional disorders (introduction) diagnostic classification developmental aspects of fd epidemiology cognitive behavioural therapies for fd treatment with third wave psychological therapies for fd mindfulness-based therapies (mbt) acceptance and commitment therapy the evidence-base for mbt and act for ha and fss evidence for ha in adults and children evidence for fss in adults evidence for fss in children and adolescents discussion evidence for third wave treatment in ha evidence for third wave treatment in fss involvement of family and close relatives in third wave treatment potential challenges with third wave treatment conclusion and perspectives (additional information) funding competing interests acknowledgments references examination of the new icd-11 prolonged grief disorder guidelines across five international samples latest developments examination of the new icd-11 prolonged grief disorder guidelines across five international samples clare killikelly a § , mariia merzhvynska a § , ningning zhou ab , eva-maria stelzer ac , philip hyland d , jose rocha e , menachem ben-ezra f , andreas maercker a [a] department of psychology, university of zurich, zurich, switzerland. [b] department of psychology and cognitive science, east china normal university, shanghai, china. [c] department of psychology, university of arizona, tucson, az, usa. [d] department of psychology, maynooth university, maynooth, ireland. [e] instituto universitário de ciências da saúde, gandra, portugal. [f] school of social work, ariel university, ariel, israel. §these authors contributed equally to this work. clinical psychology in europe, 2021, vol. 3(1), article e4159, https://doi.org/10.32872/cpe.4159 received: 2020-08-03 • accepted: 2020-12-30 • published (vor): 2021-03-10 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: clare killikelly, department of psychology, university of zurich, binzmuehlestrasse 14/17, ch-8050 zurich, switzerland. e-mail: c.killikelly@psychologie.uzh.ch supplementary materials: materials [see index of supplementary materials] abstract background: prolonged grief disorder (pgd) is a new disorder included in the 11th edition of the international classification of diseases (icd-11). an important remit of the new icd-11 is the global applicability of the mental health disorder guidelines or definitions. although previous definitions and descriptions of disordered grief have been assessed worldwide, this new definition has not yet been systematically validated. method: here we assess the validity and applicability of core items of the icd-11 pgd across five international samples of bereaved persons from switzerland (n = 214), china (n = 325); israel (n = 544), portugal (n = 218) and ireland (n = 830). results: the results confirm that variation in the diagnostic algorithm for pgd can greatly impact the rates of disorder within and between international samples. different predictors of pgd severity may be related to sample differences. finally, a threshold for diagnosis of clinically relevant pgd symptoms using a new scale, the international prolonged grief disorder scale (ipgds), in three samples was confirmed. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4159&domain=pdf&date_stamp=2021-03-10 https://orcid.org/0000-0003-2661-4521 https://orcid.org/0000-0002-8871-2875 https://orcid.org/0000-0002-5680-2446 https://orcid.org/0000-0002-3589-8602 https://orcid.org/0000-0002-9574-7128 https://orcid.org/0000-0003-0955-810x https://orcid.org/0000-0002-7890-2069 https://orcid.org/0000-0001-6925-3266 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusions: although this study was limited by lack of questionnaire data points across all five samples, the findings for the diagnostic threshold and algorithm iterations have implications for clinical use of the new icd-11 pgd criteria worldwide. keywords prolonged grief disorder, icd-11, psychometric validity, global applicability highlights • the first study to explore core items of the icd-11 pgd definition in five large international samples • comparison of three different diagnostic algorithms • preliminary analysis of different thresholds for diagnosis in different groups • preliminary estimates of pgd prevalence in 2019 prolonged grief disorder (pgd) was included in the international classification of diseases (icd-11) for the first time. the diagnostic criteria for a disorder of grief have a long history and there are several previous definitions and iterations (prigerson et al., 2009; shear, 2015; wagner & maercker, 2010). the current definition represents a new focus of the world health organization (who) on the clinical utility and global applica­ bility of the disorder (maercker et al., 2013). the rationale for the updated iteration in the new icd-11 definition was to standardize this diagnosis internationally, however, the validity of the diagnostic criteria across different international samples has yet to be established. in this brief report, we test, for the first time, the core items of the pgd icd-11 criteria in five international datasets. the who working groups for the icd-11 adopted a two-phase strategy to update disorder definitions. the first phase involved developing the structure of the definition based on a large international survey of psychologists and psychiatrists (evans et al., 2013; reed, correia, esparza, saxena, & maj, 2011). they called for flexible diagnostic guidelines, recognition of cultural factors, and fewer disorder categories with no sub­ types. the resulting pgd definition included two core symptoms (intense yearning or preoccupation with the deceased), examples of emotional pain (i.e anger, sadness, guilt), at least 6 months duration since loss, and an impairment criterion. for a full description see killikelly and maercker (2017). importantly, the working group also included a cultural caveat whereby symptoms of grief must exceed expected socio-cultural norms. the second phase in the who’s research approach was to evaluate the usability (clinical utility) of these guidelines in diagnostic decision making. recent field studies have been conducted to explore the clinical utility and validity of pgd through clinicians’ assessments of vignettes (keeley et al., 2016; reed et al., 2018) and proposals for further evaluation (gureje, lewis-fernandez, hall, & reed, 2019). these studies confirmed that, icd-11 prolonged grief disorder guidelines across five international samples 2 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ when compared with the icd-10, the current icd-11 including pgd improved the diag­ nostic sensitivity of grief related psychopathology, especially once the duration since loss criteria was included. however, until now this evaluative phase is limited and there are large scientific gaps in establishing the validity of the new icd-11 pgd, particularly in a global context (boelen, spuij, & lenferink, 2019; eisma & lenferink, 2018). previous research has confirmed that pgd may have different prevalence rates in different samples. for example, worldwide rates of a disorder of grief may range from 1% to 10% (kristensen, weisæth, & heir, 2012; lundorff, holmgren, zachariae, farver­ vestergaard, & o’connor, 2017). in a recent scoping review we found that the rates of disordered grief appear to be much higher in asian countries compared to countries in europe and north america (stelzer, zhou, maercker, o’connor, & killikelly, 2020). this may depend on different factors including heterogeneity in the diagnostic criteria used, the sample characteristics, and, perhaps, specific cultural factors that may influence the assessment and reporting of grief symptoms. in this study, we sought to eliminate the methodological variability of previous studies by directly comparing some of the same diagnostic criteria items across multiple national samples, as well as exploring the sample characteristics and their influence on pgd symptoms. this paper explores core items of the new icd-11 pgd disorder criteria along with some of the supplementary items indicating emotional distress, across five international samples. the aims include: firstly, the examination of rates of possible pgd caseness using the same core items and diagnostic formulations in each country. secondly, exami­ nation of criterion validity through the identification of predictors of pgd across and between countries. thirdly, to find provisional cut-off scores and assess the thresholds for the best sensitivity and specificity in each country using the receiver operating characteristic analysis (roc). m e t h o d participants data from participants who experienced the loss of a loved one were analyzed. data sets were obtained from five different countries: switzerland (n = 214), china (n = 325), israel (n = 544), portugal (n = 218), and ireland (n = 830). for demographic information see table 1.1. for additional demographic characteristics for each sample please see tables 1-4 in the supplementary materials. recruitment and sampling across all of the studies participants were recruited using online survey methods. in addition, the portuguese data also includes a clinical outpatient sample. switzerland: data was collected using an online survey (qualtrics). participants were recruited through killikelly, merzhvynska, zhou et al. 3 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ online and in person fliers posted at german speaking grief and bereavement support groups, online forums and community services (i.e. churches, townhalls, libraries). china: participants were recruited to participate in an online survey (qualtrics) using social media (wechat) and online bereavement forums. israel: participants were recruited as part of a large national online survey using stratified and random sampling methods. ireland: a nationally representative sample were recruited using the company qualtrics. stratified sampling methods were used to select participants based on sex, age and geographical location. portugal: the ‘general’ group were recruited using limesurvey anonymous online survey protocol using the snowball method. the ‘clinical group’ is based on participants from a hospital setting (centro hospitalar tâmega e sousa) where participants received outpatient support for grief difficulties. participants in this group were referred to the grief consultation service part of the clinical psychology unit and had completed informed consent procedures. this service is focused on supporting parental and perinatal losses and data was collected in face-to-face interviews with self-evaluation questionnaires. measures to assess prolonged grief disorder, the international prolonged grief disorder scale with 15 items (killikelly et al., 2020) and the inventory of complicated grief-revised with 8 items (icg-r; prigerson et al., 2009; prigerson & jacobs, 2001) were used. both instruments include two core pgd symptoms (i.e. yearning for the deceased and preoc­ cupation), emotional distress symptoms as well as a measure of functional impairment, and time since loss. for the items of the ipgds please see killikelly et al. (2020). the following 8-items of the icg-r were assessed: core items 1) ‘i think about him/her so much that it can be hard for me to do the things i normally do’ 2) ‘i feel myself longing and yearning for him/her’; accessory symptoms or examples of emotional distress, 3) ‘i feel as if a part of me died’ 4) ‘i feel disbelief over his/her death’ 5) ‘ever since he/she died, i find it difficult to move on with my life’ 6) ‘i am bitter over his/her death’ 7) ‘i feel that it is unfair that i should live when he/she died’ and functional impairment criterion, 8) ‘i believe that my grief has resulted in impairment in my social, occupational or other areas of functioning. unlike the icg-r, the ipgds includes one cultural item (i.e. my grief would be considered worse, e.g., more intense, severe and/or of longer duration, than for others from my community or culture). participants were asked to rate their grief symptoms on a five-point scale (i.e. “not at all” on ipgds or “almost never” on icg-r (1), “rarely” (2), “sometimes” (3), “often” (4), “always” (5)). when filling out the ipgds, participants were asked to mark the answer that best describes their feelings, thoughts and behaviour during the last week. in case of icg-r, they were requested to select an answer that best describes how they felt during the last month. pgd was assessed using the ipgds in switzerland, china, and portugal, and the icg-r in all five countries. recently the ipgds was confirmed to be psychometrically reliable and icd-11 prolonged grief disorder guidelines across five international samples 4 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ valid with strong internal consistency (cronbach's α = .92), high concurrent and criterion validity (see killikelly et al., 2020). previously the 8-item icg-r was shown to have good reliability (cronbach's α = .94) (killikelly et al., 2019). predictors life events checklist (lec) (gray, litz, hsu, & lombardo, 2004) and international trauma exposure measure (item) (hyland et al., 2020) items were measured on a binary scale (0 = no; 1 = yes). for the lec response options 1-2 (happened to me, witnessed it) were merged into ‘yes’ while all other response options were merged into ‘no’. information about traumatic events was not collected for the portuguese sample. furthermore, in the portuguese sample, the duration since loss was not assessed and the data set revealed a high quantity of missing values (100 out of 218 participants) on the icg-r scale. therefore, the portuguese sample was excluded from the data analysis when the association between predictors and pgd was investigated. the cultural item was collected only in switzerland, china, and portugal. the following variables were included in the data analysis as predictors of pgd: 1. gender (measured in all 5 samples) 2. age (measured in all 5 samples) 3. cultural criteria (measured in swiss, chinese, portuguese samples) 4. severe human suffering (measured in swiss, chinese, israeli samples with lec, and in irish sample with item) 5. sudden, violent or accidental death (measured in swiss, chinese, israeli samples with lec and in irish sample with item) 6. serious injury, harm or death you caused to someone (measured in swiss, chinese, israeli samples with lec and in irish sample with item) statistical analysis to estimate possible pgd rates, three different diagnostic algorithms were applied; pgd strict criteria set, pgd moderate criteria set, and the criteria set according to maciejewski et al. (2016). pgd strict criteria set requires the endorsement of at least one core item, at least one item of emotional distress symptoms, and functional impairment; all of which are rated as 4 (often) or higher. pgd moderate criteria set has almost the same require­ ments except all items are rated 3 (sometimes) or higher (killikelly et al., 2020). criteria according to maciejewski et al. includes at least one of two core items, three or more emotional distress items (all rated 4 (often) or above), and no functional impairment. in all three diagnostic algorithms the same time criterion was applied (i.e., loss occurred 6 months ago or longer). the estimated rates of possible pgd were calculated across the five samples with 95% confidence interval (ci). however, it is important to note that some key items were missing in the datasets. in the portuguese and the israeli samples killikelly, merzhvynska, zhou et al. 5 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ the time criteria was not applied due to the absence of the data about time since loss and in the portuguese dataset the functional impairment criterion was not evaluated. therefore we can only examine estimates of possible pgd caseness not prevalence. logistic regression was used to examine the associations between pgd (strict criteria) and some items representing traumatic life events, gender (male/female), age, and cultur­ al caveat item using odds ratio (or) and 95% ci. the outcome was the endorsement of pgd strict criteria; coded as binary variable “yes, possible pgd caseness” (1) or “no” (2). of note, due to the use of heterogeneous questionnaires across the samples, we could only include a few traumatic life event items. in terms of missing values, the default settings of spss were used whereby cases were deleted in a list wise manner. third, re­ ceiver operating characteristic analysis (roc) was used to examine cut-off scores for the ipgds and icg-r, i.e. the threshold for the best fit in terms of sensitivity (high > .80) and specificity (.80). this analysis is presented as an initial exploration and may be highly dependent upon the samples used. roc curves and logistic regression were calculated only for pgd strict criteria (i.e. 12 symptom items plus functional impairment). statistical analyses were performed using spss version 23. r e s u l t s rates of pgd the proportion of people in each sample who met the criteria for possible pgd caseness differed within the country depending on (1) whether strict, moderate or maciejewski et al. (2016) diagnostic criteria were applied and (2) whether ipgds or icg-r were used to assess it. furthermore, there was a difference in rates between the countries, even if assessed with the same diagnostic algorithm and the same measure instrument. for example using the strict criteria of the ipgds the rates ranged from 6.9% to 12.6%, whereas for the icg-r rates ranged from 2.0% to 21.1%. for detailed rates and confidence intervals (ci) see table 1.1 and table 1.2. table 1.1 basic sociodemographic characteristics and predictors in five samples variable swiss (n = 214) (mage = 38.7) chinese (n = 325) (mage = 33.3) israel (n = 544) (mage = 41.4) portuguese (n = 218) (mage = 32.8) irish (n = 830) (mage = 45.4) n % n % n % n % n % gender male 33 15.4 104 32 246 45.2 43 17.5 411 49.5 female 178 83.2 212 65.2 298 54.8 203 82.5 419 50.5 other 3 2 0 0 0 icd-11 prolonged grief disorder guidelines across five international samples 6 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ variable swiss (n = 214) (mage = 38.7) chinese (n = 325) (mage = 33.3) israel (n = 544) (mage = 41.4) portuguese (n = 218) (mage = 32.8) irish (n = 830) (mage = 45.4) n % n % n % n % n % item severe human suffering (lec item 13) 83 38.8 65 20.0 39 7.1 – – – – sudden, violent death (lec item 14)a 62 29.0 53 16.3 71 13.0 – – – – accidental death (lec item 15) 57 26.6 99 30.5 173 31.8 – – – – serious injury, harm or death you caused (lec item 16) 6 2.8 49 15.1 11 2.0 – – – – serious injury, harm or death you caused (item item 12) – – – – – – – – 35 4.2 sudden, violent or accidental death (item item 13) – – – – – – – – 224 27.0 alec items 14 and 15 were merged in the logistic regression. data was not collected for the portuguese sample. table 1.2 estimates of possible pgd using different diagnostic rules across five countries scale swiss (n = 214) china (n = 325) israela (n = 544) portugueseb (n = 218) irish (n = 830) % 95% ci % 95% ci % 95% ci % 95% ci % 95% ci ll ul ll ul ll ul ll ul ll ul ipgds strict criteria 7.0 4.0 11.3 12.6 9.2 16.7 – – – 6.9 3.9 11.1 – – – moderate criteria 21.5 16.2 27.6 37.5 32.3 43.1 – – – 27.5 21.7 34.0 – – – maciejewski criteria 15.9 11.3 21.5 33.5 28.4 39.0 – – – 23.4 17.9 29.6 – – – icg-r (n = 118) estimate only strict criteria 5.1 2.6 9.0 7.1 4.5 10.4 2.0 1.0 3.6 21.1 14.2 29.7 4.1 2.9 5.7 moderate criteria 18.2 13.3 24.1 29.2 24.3 34.5 8.5 6.3 11.1 48.3 39.0 57.7 13.9 11.6 16.4 maciejewski criteria 6.1 3.3 10.2 10.5 7.4 14.3 4.2 2.7 6.3 7.6 3.5 14.0 4.7 3.4 6.4 ain israel dataset for icg-r – no time criteria applied. bin portuguese dataset for icg-r – no time criteria applied, no functional criteria (item 8) applied; for ipgds no time criteria applied, pooled across the general and clinical groups. logistic regression results from the logistic regression analyses showed that pgd assessed with ipgds was significantly associated with the cultural caveat criteria in switzerland, or = 2.463, 95% ci [1.707, 3.554], and in china, or = 3.152, 95% ci [2.361, 4.209]; with serious injury, harm or death to someone else, or = 14.016, 95% ci [1.856, 105.854], in switzerland, and killikelly, merzhvynska, zhou et al. 7 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ with gender (higher risk for women), or = 0.508, 95% ci [0.259, 0.998] in china (see table 2.1). table 2.1 logistic regressions for a set of predictor variables associated with pgd measured with ipgds variable swiss (n = 201) china (n = 302) or 95% ci or 95% ci ll ul ll ul ipgds gendera 1.240 0.331 4.646 0.508* 0.259 0.998 age 1.018 0.989 1.049 1.022 0.996 1.048 cultural criteria 2.463*** 1.707 3.554 3.152*** 2.361 4.209 severe human suffering 2.321 0.898 6.000 1.256 0.507 3.111 sudden, violent or accidental death 1.821 0.734 4.517 0.703 0.342 1.448 serious injury, harm or death you caused 14.016* 1.856 105.854 1.471 0.534 4.055 afemale compared to male. *p < .05. **p < .01. ***p < .001. when pgd was assessed with icg-r, the logistic regression analyses revealed significant associations with the cultural caveat criteria within switzerland, or = 8.148, 95% ci [2.629, 24.782], and china, or = 4.501, 95% ci [2.671, 7.586]; with serious injury, harm or death person caused to someone in china, or = 5.494, 95% ci [1.309, 23.050]; with age, or = 0.964, 95% ci [0.933, 0.966], severe human suffering, or = 5.095, 95% ci 1.670, 15.547], and with sudden, violent or accidental death, or = 3.271, 95% ci [1.178, 9.086], in israel, and finally with gender, or = 0.993, 95% ci [0.967, 1.020], and sudden, violent or accidental death, or = 0.297, 95% ci [0.127, 0.694], in ireland (see table 2.2). examination of provisional cut-off scores the roc analysis was used to determine a cut-off score for those participants meeting the strict criteria for the ipgds and icg-r. the results can be found in table 3. the chinese sample required a slightly higher cut-off score (42.5) for the ipgds when compared to the swiss (37.5) and portuguese (36.5) samples. additionally, for the icg-r the portuguese sample had a lower cut-off (16.5) when compared with the swiss (24.5), chinese (25.5), israeli (24.5) and irish (22.5) samples. icd-11 prolonged grief disorder guidelines across five international samples 8 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ ta b le 2 .2 lo gi st ic r eg re ss io ns f or a s et o f p re di ct or v ar ia bl es a ss oc ia te d w it h p g d a s m ea su re d by i c g -r v ar ia bl e sw is s (n = 2 01 ) c h in a (n = 3 02 ) is ra el (n = 5 44 ) ir is h (n = 8 30 ) or 95 % c i 95 % c i or 95 % c i or 95 % c i ll ul or ll ul ll ul ll ul ic g -r g en de ra 1. 31 9 0. 10 9 15 .9 84 0. 40 7 0. 13 9 1. 19 2 0. 84 7 0. 34 7 2. 06 8 0. 30 3* * 0. 96 7 1. 02 0 a ge 1. 06 0 1. 00 0 1. 12 4 1. 02 3 0. 98 4 1. 06 3 0. 96 4* 0. 93 3 0. 96 6 0. 99 3 0. 13 3 0. 69 2 c ul tu ra l c ri te ri a 8. 14 8* ** 2. 62 9 24 .7 82 4. 50 1* ** 2. 67 1 7. 58 6 – – – – – – se ve re h um an s uf fe ri n g 1. 49 5 0. 29 0 7. 70 8 0. 28 6 0. 05 7 1. 42 8 5. 09 5* * 1. 67 0 15 .5 47 0. 53 5 0. 24 9 1. 14 9 su dd en , v io le n t or a cc id en ta l d ea th 0. 77 9 0. 14 7 4. 11 7 0. 80 9 0. 24 7 2. 64 8 3. 27 1* 1. 17 8 9. 08 6 0. 29 7* * 0. 12 7 0. 69 4 se ri ou s in ju ry , h ar m o r de at h y ou c au se d 19 .5 36 0. 26 6 14 33 .8 30 5. 49 4* 1. 30 9 23 .0 50 0. 96 4 0. 07 9 11 .7 48 0. 33 9 0. 10 2 1. 13 1 a f em al e co m pa re d to m al e. *p < .0 5. * *p < .0 1. * ** p < .0 01 . ta b le 3 r ec ei ve r o pe ra ti ng c ha ra ct er is ti c a na ly si s (r o c ) sc al e sw is s (n = 2 14 ) c h in a (n = 3 25 ) is ra el (n = 5 44 ) p or tu gu es e (n = 2 18 ) ir is h (n = 8 30 ) cu tof f [m in ; m ax ] se n si ti vi ty / sp ec if ic it y cu tof f [m in ; m ax ] se n si ti vi ty / sp ec if ic it y cu tof f [m in ; m ax ] se n si ti vi ty / sp ec if ic it y cu tof f [m in ; m ax ] se n si ti vi ty / sp ec if ic it y cu tof f [m in ; m ax ] se n si ti vi ty / sp ec if ic it y ip g d s 37 .5 [1 3; 6 3] 0. 93 3/ 0. 81 4 42 .5 [1 3; 6 5] 0. 90 2/ 0. 81 0 n /a n /a 36 .5 [1 3; 5 6] 0. 93 3/ 0. 81 8 n /a n /a ic g -r 24 .5 [8 ; 4 0] 0. 81 8/ 0. 85 7 25 .5 [8 ; 4 0] 0. 95 7/ 0. 85 4 24 .5 [8 ; 4 0] 1. 00 0/ 0. 94 7 16 .5 [7 ; 3 5] 0. 92 0/ 0. 87 1 22 .5 [8 ; 4 0] 0. 94 1/ 0. 89 6 killikelly, merzhvynska, zhou et al. 9 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ d i s c u s s i o n this paper provides the first systematic exploration of core items of the new icd-11 pgd criteria across five international samples. the results confirm large differences in the rates between and within samples depending on the diagnostic algorithm used; predictors of pgd severity may vary across samples due to the type of loss (violent or nonviolent) and the cultural caveat item of the ipgds may be an important risk screening item; finally, a threshold for a clinically relevant diagnosis may be different depending on cultural group. core items of the new icd-11 pgd criteria, as tested by the ipgds (in swiss, chinese and portuguese samples) and the icg-r (in irish and israeli samples), revealed substantially different rates depending on the diagnostic algorithm used. overall, the strict criteria for both the ipgds and the icg-r seems to capture the expected rates across the five samples, which ranged from 2-21.2%. however, substantially higher rates were found in the chinese and portuguese samples. there could be several explanations for these higher rates including sample differences and lack of cultural sensitivity of assessment measures (stelzer, zhou, & maercker, et al., 2020). when the strict criteria of the ipgds were applied, the swiss (7.0%) and portuguese (6.9%) samples had similar rates on the ipgds, whereas the chinese sample had a higher rate (12.6%) on the ipgds. a higher rate in the chinese sample is consistently found across all iterations of the ipgds but also for most of the icg-r comparisons. conversely, when assessing the icg-r the swiss, chinese, israeli and irish samples had similar rates, whereas the portuguese sample was much higher (21.1%). the portuguese sample also had high rates on the icg-r for the strict and moderate criteria, perhaps due to the exclusion of the impairment criteria in this particular sample. therefore, the results for the portuguese sample must be interpreted with caution and it points to the importance of including the functional impairment item and ensuring consistency in the use of time criterion in the assessment measure. additionally, the portuguese sample included pooled data from the general and clinical sample. the inclusion of the clinical sample could increase the prevalence rates in the portuguese data compared to the non-clinical samples obtained from the other countries. the portuguese sample consisted of a large proportion of bereaved people who expe­ rienced an unexpected loss (10%). although not explicitly recorded, this would mostly include the unexpected loss of a child as participants were from the outpatient perinatal loss clinic. loss of a child is known to predict high levels of pgd (zetumer et al., 2015) lack of culturally sensitive assessment measures or items could explain differences in the symptom ratings and severity levels across the samples. for example, our previ­ ous study confirmed that chinese bereaved may present with slightly different symp­ toms than those assessed by the icd-11 (killikelly & maercker, 2017; stelzer, zhou, merzhvynska, et al., 2020). the ipgds standard scale does not explore somatic symptoms or culturally specific symptoms such as ‘a loss of a part of oneself’ (stelzer, zhou, icd-11 prolonged grief disorder guidelines across five international samples 10 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ merzhvynska, et al., 2020). additionally, there could be a cultural bias in responding to these questionnaires which may lead to overreporting and overestimation of symptoms. chentsova-dutton et al. (2007) found that chinese participants may overreport certain symptoms in order to ensure that they receive health care and support. in terms of predictors of pgd severity we assessed a limited selection of predictors available across the datasets. interestingly, when the cultural caveat item was included (e.g. endorsement of item 14 of the ipgds), violating the cultural norms for grief was found to significantly predict more severe grief scores on the ipgds and the icg-r. al­ though we only had the data for the swiss and chinese participants, further examination of this item might indicate its importance as a screening item for grief severity. in both the israeli and irish sample grief severity was predicted by sudden violent or accidental death whereas this was not found for the swiss and chinese samples. this may be due to differences in sampling. the israeli and irish data are from large nationally representa­ tive samples that may include more instances of sudden violent or accidental death. the chinese and swiss samples are mostly student populations who experienced the loss of older relatives. the larger israeli and irish datasets contain participants who experienced a high level of violent loss (more than 25%) and this could explain the differences in predictors. previous research has confirmed that violent loss is a strong predictor of pgd severity and chronicity (lobb et al., 2010; schaal, jacob, dusingizemungu, & elbert, 2010). additionally, israel and ireland have recently experienced acts of terrorism that may preclude an added cultural vulnerability to trauma and loss (duffy, gillespie, & clark, 2007; silverman, johnson, & prigerson, 2001). the final research question was to determine a possible threshold for establishing a clinically significant severity score on the ipgds. all five datasets could not be com­ pared with the ipgds however across the swiss, chinese and portuguese data, a score above 36.5 will most likely represent clinically significant pgd symptoms. as a control, the icg-r was also examined and a score above 22 for all datasets was consistently found, except for the portuguese sample (16.5). this attests to the variation that can occur across different samples, even with gold standard clinical assessments (boelen & lenferink, 2020). limitations due to inconsistencies in data collection across the five international samples it was not possible to directly compare the ipgds or the icg-r across all data sets. the full icd-11 pgd criteria could therefore not be assessed. in particular the time criterion was not assessed consistently across the datasets for example not in the portuguese or israeli datasets. therefore, a diagnosis of pgd is not possible. however, the core items of the pgd (yearning and preoccupation) as well as some supplementary items of emotional distress could be evaluated and indications of possible caseness implied. it is important to include the time criterion for disorder as individuals may experience severe killikelly, merzhvynska, zhou et al. 11 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ distress in the first weeks and months after a loss and this should not be pathologized. importantly the estimates of prevalence rates for the portuguese data must be interpreted with caution as there was a high amount of missing data. furthermore, the portuguese sample included a clinical subgroup. this may explain why the estimates of prevalence are significantly higher. across the german, portuguese and chinese samples there is a high proportion of female responses. in the future it would be important to provide an analysis of a more representative sample. additionally, there were only a limited number of similar predictors across all datasets. the data in each country was collected separately at different times, so only a cross sectional comparison is possible on some questionnaire items. of note, the confidence intervals are very wide for some of the items in the logistic regression, particularly for the cultural criteria. this is perhaps due to a small number of values in some of the cells (response options). in the future a larger sample size should reveal more precise confidence intervals. finally, in the future and with a more complete dataset the roc analysis should also be conducted on the moderate and maciejewski et al. (2016) criteria to provide a full estimate of possible thresholds for sensitivity and specificity. conclusion this paper confirms the importance of establishing international guidance on the consis­ tent use of a diagnostic algorithm for pgd in order to ensure reliability across heteroge­ neous samples. currently, we recommend the use of the strict criteria as an indicator of pgd caseness, however this must be confirmed in a clinical sample. future studies should examine the different pgd algorithms (moderate vs strict) in clinical and cultural samples and include important items that are missing in some of the current data (i.e. the impairment and time criteria as well as the cultural caveat). additionally, clinicians should be aware of specific risk factors such as violent, sudden loss or screening ‘yes’ on the cultural caveat ipgds item as these may predict clinically severe grief. in the future it may be important for clinicians to note that different cultural groups may need different cut-off thresholds for a clinical diagnosis on the ipgds or other scales. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: we would like to acknowledge the dedication of the participants who completed the questionnaires, the efforts of the grief and bereavement organizations that supported our recruitment, and the many student interns that assisted with data collection, input and coding. icd-11 prolonged grief disorder guidelines across five international samples 12 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary information contains tables of additional demographic characteristics for each of the five samples (for access see index of supplementary materials below). index of supplementary materials killikelly, c., merzhvynska, m., zhou, n., stelzer, e.-m., hyland, p., rocha, j., . . . maercker, a. (2021). supplementary materials to "examination of the new icd-11 prolonged grief disorder guidelines across five international samples" [additional information]. psychopen. https://doi.org/10.23668/psycharchives.#### r e f e r e n c e s boelen, p. a., & lenferink, l. i. m. (2020). comparison of six proposed diagnostic criteria sets for disturbed grief. psychiatry research, 285, article 112786. https://doi.org/10.1016/j.psychres.2020.112786 boelen, p. a., spuij, m., & lenferink, l. i. m. (2019). comparison of dsm-5 criteria for persistent complex bereavement disorder and icd-11 criteria for prolonged grief disorder in help-seeking bereaved children. journal of affective disorders, 250, 71-78. https://doi.org/10.1016/j.jad.2019.02.046 chentsova-dutton, y. e., chu, j. p., tsai, j. l., rottenberg, j., gross, j. j., & gotlib, i. h. 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(2015). the impact of losing a child on the clinical presentation of complicated grief. journal of affective disorders, 170, 15-21. https://doi.org/10.1016/j.jad.2014.08.021 killikelly, merzhvynska, zhou et al. 15 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://doi.org/10.1371/journal.pmed.1000121 https://doi.org/10.1002/j.2051-5545.2011.tb00034.x https://doi.org/10.1002/wps.20524 https://doi.org/10.1186/1471-244x-10-55 https://doi.org/10.1056/nejmcp1315618 http://www.ncbi.nlm.nih.gov/pubmed/11725418 https://doi.org/10.3389/fpsyg.2019.02982 https://doi.org/10.1159/000505074 https://doi.org/10.5334/pb-50-1-2-27 https://doi.org/10.1016/j.jad.2014.08.021 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. icd-11 prolonged grief disorder guidelines across five international samples 16 clinical psychology in europe 2021, vol.3(1), article e4159 https://doi.org/10.32872/cpe.4159 https://www.psychopen.eu/ icd-11 prolonged grief disorder guidelines across five international samples (introduction) method participants recruitment and sampling measures predictors statistical analysis results rates of pgd logistic regression examination of provisional cut-off scores discussion limitations conclusion (additional information) funding competing interests acknowledgments supplementary materials references functional somatic symptoms and emotion regulation in children and adolescents research articles functional somatic symptoms and emotion regulation in children and adolescents stefanie m. jungmann 1 , louisa wagner 1, marlene klein 1 , aleksandra kaurin 2 [1] department of clinical psychology, psychotherapy, and experimental psychopathology, johannes gutenberguniversity mainz, mainz, germany. [2] department of clinical psychology and psychotherapy, university witten/ herdecke, witten, germany. clinical psychology in europe, 2022, vol. 4(2), article e4299, https://doi.org/10.32872/cpe.4299 received: 2020-09-04 • accepted: 2021-11-29 • published (vor): 2022-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: stefanie m. jungmann, johannes gutenberg-university mainz, department of clinical psychology, psychotherapy, and experimental psychopathology, wallstraße 3, 55122 mainz, germany. phone: +49 (0)6131 – 39 3920. e-mail: jungmann@uni-mainz.de supplementary materials: materials [see index of supplementary materials] abstract background: functional somatic symptoms (fss; i.e. symptoms without sufficient organic explanation) often begin in childhood and adolescence and are common to this developmental period. emotion regulation and parental factors seem to play a relevant role in the development and maintenance of fss. so far, little systematic research has been conducted in childhood and adolescence on the importance of specific emotion regulation strategies and their links with parental factors. method: in two studies, children and adolescents (study 1/study 2: n = 46/68; 65%/60% female, age m = 10.0/13.1) and their parents completed questionnaires on children's fss and adaptive and maladaptive emotional regulation (in study 2, additionally parental somatization and child/parental alexithymia). results: in both studies, child-reported fss were negatively associated with children's adaptive emotion regulation (r = -.34/-.31, p < .03; especially acceptance) and positively with children's maladaptive emotion regulation and alexithymia (r = .53/.46, p < .001). moreover, children’s maladaptive emotion regulation (β = .34, p = .02) explained incremental variance in child-reported fss beyond children’s age/sex, parental somatization and emotion regulation. in contrast, parental somatization was the only significant predictor (β = .44, p < .001) of parent-reported fss in children/adolescents. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4299&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0003-0201-9517 https://orcid.org/0000-0002-4131-1142 https://orcid.org/0000-0002-8687-4395 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: our results suggest that particularly rumination and alexithymia and parental somatization are important predictors of fss in children/adolescents. overall, the results showed a dependence on the person reporting children's fss (i.e., method-variance). so, for future studies it is relevant to continue using the multi-informant approach. keywords adolescents and children, alexithymia, emotion regulation, functional somatic symptoms, parents, transgenerational highlights • two studies found negative associations between child-reported fss and adaptive emotion regulation. • we found positive associations between child-reported fss and maladaptive emotion regulation. • parental somatization was the only significant predictor of parent-reported fss. • dependence on the rater stresses the importance of the multi-informant approach. about 10–25% of children and adolescents suffer from functional somatic symptoms (fss), i.e. bodily complaints such as abdominal pain or headaches that cannot be suffi­ ciently explained by an underlying physical condition (berntsson & köhler, 2001; rask et al., 2009). these bodily complaints interfere with daily activities and potentially impair academic and psychosocial functioning. children and adolescents suffering from bodily complaints report frequent absences from school, absent-mindedness, impaired leisure behavior, and lower levels of life quality (beck, 2008; hoftun et al., 2011; malas et al., 2017), fss represent a key feature of somatoform disorders (according to icd-10; world health organization, 1993) or somatic symptom disorders (according to dsm-5; american psychiatric association, 2013), (functional) somatic symptoms also co-occur with a variety of other disorders and are thus of transdiagnostic relevance (aldao et al., 2010; dufton et al., 2009; tegethoff et al., 2015). according to the perseverative cognition hypothesis (brosschot et al., 2006), a preoccu­ pation with stressful events or chronic stress may increase the likelihood to experience bodily symptoms through physiological activation. in adulthood, the importance of af­ fect-regulatory processes to fss and somatoform disorders is well established (bailer et al., 2017; schwarz et al., 2017). previous studies found that negative affect or depression and anxiety disorders are associated with reports of bodily symptoms (bekhuis et al., 2015; watson & pennebaker, 1989; wessely et al., 1999). moreover, difficulties in emotion processing, expression, and regulation have been reported to be related to higher levels of fss (okur güney et al., 2019; schwarz et al., 2017). adaptive emotion regulation strat­ egies such as reappraisal were negatively and maladaptive strategies such as expressive suppression and alexithymia were positively associated with fss (brooks et al., 2017; fss and emotion regulation 2 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ erkic et al., 2018). the construct alexithymia describes difficulties in recognizing and describing one's own feelings and is associated with deficits in emotional processing and dysfunctional emotion regulation (bagby et al., 1994; luminet et al., 2021). less attention has been paid to the relationship between emotional dysregulation and fss in childhood and adolescence. for instance, in a sample of youth with recurrent abdominal pain (7–18 years), coping strategies including regulating attention or cogni­ tions (“secondary control engagement” such as e.g., acceptance and distraction) were associated with fewer bodily symptoms, and involuntary engagement (including e.g., rumination and intrusive thoughts) with higher levels of bodily symptoms (thomsen et al., 2002). regarding emotion-focused (dealing with the emotional experience) and bodyfocused (dealing with bodily experience, e.g. taking a pill) regulation strategies, children with functional abdominal pain (8–13 years) showed the highest level of body-focused regulation compared to children with no/few and many bodily symptoms, whereas the three groups did not differ in emotion-focused regulation (rieffe et al., 2007). gilleland, suveg, jacob, and thomassin (2009) found that child-reported fss were associated with reduced emotional awareness. mother-reported fss in children/adolescents, in addition, was associated with low emotion regulation abilities including low emotion expression, empathy, and self-awareness. while there are hardly any studies on specific emotion regulation strategies in the context of fss in children and adolescents, some previous studies have focused on emotion awareness and alexithymia. a further study (jellesma et al., 2006) found that children with many somatic symptoms (highest 30% of a symptom scale) as well as a clinical group of children with functional abdominal pain (8–13 years) reported significantly stronger negative affect and more difficulties in differentiating and communicating feelings compared to children with few somatic symptoms (whereas the first two groups do not differ in that regard). according to a recent systematic review, seven of eight identified studies on self-reported alexithymia showed that children with fss reported significantly higher levels of alexithymic traits compared to healthy con­ trols (hadji-michael et al., 2019). in terms of a development perspective it is important to consider the development and maintenance of youth fss in interaction with parental and family factors (beck, 2008). models of transgenerational transmissions of psychopathology (hosman et al., 2009) and particularly those with a focus on pain or emotion regulation (morris et al., 2007; stone & wilson, 2016) suggest that parenting (especially e.g., regarding coping with affect) and children’s emotion regulation might account for the relationship between pa­ rental emotional dysregulation/psychopathology and children’s psychological outcomes. gilleland et al. (2009) found that parental somatization and youth deficits in emotion regulation were significant predictors of mother-reported child somatization and only parental somatization was a significant predictor of father-reported child somatization. in line with the transmission model (stone & wilson, 2016), the association between jungmann, wagner, klein, & kaurin 3 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ parental pain catastrophizing and adolescent symptom-related impairment was shown to be mediated by the pain catastrophizing of adolescents (wilson et al., 2014). so far, there is relatively little research on the relationship between emotion regula­ tion and fss in the field of clinical child and adolescent psychology. in particular, there is hardly any study on concrete emotion regulation strategies (e.g., reappraisal, suppres­ sion, see findings above in adulthood) and very little on the role of parental somatization. therefore, to narrow this gap in the literature, in two studies we aimed at systematically investigating the relationships between parent and child emotion regulation and parent and child somatization (parental somatization only assessed in study 2). study 1 was designed as a pilot study and investigated relationships between child and parental emotion regulation and children’s fss. we hypothesized that child and parental reappraisal and acceptance would be negatively associated and rumination and catastrophization would be positively associated with children’s fss. based on the transgenerational model (stone & wilson, 2016) and previous findings, suggesting that female gender and increasing age in youth are associated with fss (lieb et al., 2000; stone & wilson, 2016), it was assumed that beyond age and gender and parental emotion regulation, child emotion regulation is a significant predictor of fss in children and adolescents. study 2 aimed at replicating the results of study 1 in a second sample of youth and their parents (and child and parental alexithymia and parental somatization were assessed). in addition to the hypotheses in study 1, we expected a positive relationship between child and parental alexithymia and fss. to expect a specific relationship be­ tween emotion regulation and fss, we also hypothesized that beyond parental somatiza­ tion, parental and child emotion regulation would explain additional variance in fss in children and adolescents. in line with current dimensional-hierarchical approaches to psychopathology (hier­ archical taxonomy of psychopathology; hitop; conway et al., 2019) and the preference for the dimensional view especially of somatic symptoms (jasper et al., 2012), fss were investigated in the general population. m e t h o d participants the participants of study 1 and 2 were recruited in the general population using flyers posted in schools in german cities. the inclusion criteria were an age of the children and adolescents between 7-14 (study 1)/8-17 years (study 2) and a consent of a parent or guardian. there was no drop-out in study 1. in study 2 (conducted online), originally n = 79 children and parents (each) participated. due to incorrect completion of the child version by parents and unassigned codes of child and parent, n = 11 cases had to be fss and emotion regulation 4 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ excluded. the socio-demographic data of both samples (n = 46/n = 68) are shown in table 1. table 1 sociodemographic characteristics of children/adolescents and their parents for study 1 (n = 46) and study 2 (n = 68) sociodemographic variables study 1 study 2 n (%) m (sd) n (%) m (sd) age children 9.96 (1.58) 13.09 (2.22) parents 44.74 (4.63) 44.97 (6.19) sex children (female) 30 (65.2%) – 41 (60.3%) – parents (female) 40 (87.0%) – 62 (91.2%) – children: type of school elementary school 29 (63.0%) – 6 (8.8%) – grammar school 15 (32.6%) – 25 (36.8%) – secondary school 1 (1.5%) – comprehensive school – – 35 (51.5%) – other school type/no statement 2 (4.3%) – 1 (1.5%) – parents: native languagea german 34 (73.9%) – 61 (89.7%) – others/no statement 12 (26.1%) 7 (10.3%) parents: family status married or partnership 34 (73.9%) – 57 (83.8%) – single/divorced/widowed 6 (13.0%) – 11 (16.2%) – no statement 6 (13.0%) – – – parents: education (% higher education) 24 (52.2%) – 29 (42.6%) – parents: occupation unemployed 1 (2.2%) – 1 (1.5%) – in training – – 1 (1.5%) – employee/civil servant 30 (65.2%) – 53 (77.9%) – self-employed 2 (4.3%) – 5 (7.4%) – housewife/-husband 10 (21.7%) – 7 (10.3%) – retired – 1 (1.5%) no statement 3 (6.5%) – – – astudy 2 also asked for nationality: 95.6% german or dual citizenship including german (e.g. czech, romanian, croatian), 1.5% american, 1.5% bulgarian and 1.5% czech. jungmann, wagner, klein, & kaurin 5 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ procedure the data collection of study 1 was part of a larger project on the behavioral assess­ ment of psychopathology in children and adolescents from the general population (in 2017-2018). the study took place on a single date in a research laboratory of the psychological institute. the study design required the accompaniment of one parent, which one was not pre-determined by the study, but according to the time capacity of the parents (in 87% of the cases the mother as accompaniment). as compensation, the children received a small game (e.g., board game) and the parents 10€ per hour. study 2 was an online study about body awareness and dealing with feelings (over 8 weeks in 2019). in both studies, parents and children/adolescents gave informed consent prior to participation. as compensation for their participation, children and parents were given the opportunity to take part in a lottery for 5 x 15 € gift vouchers. the study protocols of both studies were approved by the institutional review board of the psychological institute. measures children and adolescents the screening for somatoform disorders in children and adolescents (soms-ca; winter et al., 2018) is a validated self-reported measure for assessing fss. the soms-ca was used in study 1 and 2. participants report on 33 somatic symptoms (pain, gastrointestinal, cardiorespiratory, and pseudo-neurological symptoms) that have occurred in the last 6 months and for which the doctor has not found a clear medical explanation. a total number of complaints is calculated from the sum of the 33 bodily symptoms. this score showed high internal consistencies in both studies (cronbach’s α = .91/.84). additionally, the soms-ca assesses further characteristics of fss, such as illness-related behavior (e.g., doctor visits) and functional impairments. an additional score can be calculated includ­ ing these factors, whereby an earlier study (jungmann & witthöft, 2020) showed that this score can be ambiguous due to jump rules, so this study focused on the above-mentioned total number score of fss. the questionnaire to assess emotion regulation in children and youths (fragebogen zur erhebung der emotionsregulation bei kindern und jugendlichen, feel-kj; abler & kessler, 2009) is a validated 90-item self-report measure for assessing different strategies of emotion regulation when children and adolescents feel sad, anxious, and angry. emo­ tion regulation can be divided into the superordinate scales “adaptive” (e.g., acceptance and reappraisal), “maladaptive” (e.g., rumination), and “other strategies” (e.g., social sup­ port). a five-point likert scale (1 = almost never to 5 = almost always) is used to indicate the degree of agreement with each statement. the feel-kj showed acceptable to high reliability as well as construct and external validity (cracco et al., 2015). both studies focused on “adaptive” (α = .95/.85), “maladaptive emotion regulation” (α = .91/.77), and fss and emotion regulation 6 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ the individual strategies of “acceptance” (α = .75/.56), “reappraisal” (α = .76/.52), and “rumination” (α = .77/.46). based on previous studies on the links between depression, emotion regulation, and bodily complaints (allen et al., 2011), study 2 focused only on strategies in response to sadness (each strategy with two items). additionally, study 2 used the alexithymia questionnaire for children (aqc; rieffe et al., 2006), a 20-item self-report questionnaire for assessing alexithymia in children/ado­ lescents. the items (e.g., "i don't know what's going on inside me.") are rated on a three-point likert scale (0 = not true to 2 = often true). the internal consistency was α = .82. parents the screening for somatoform disorders in children and adolescents for parents (soms-p; voß, 2013) measures the severity of children’s fss from the parents’ perspective. the structure and scoring are analogous to the soms-ca (α = .82/.81). the cognitive emotion regulation questionnaire (cerq; loch et al., 2011) assesses cognitive emotion regulation strategies used in the context of negative experiences or life events. the frequency of using the different strategies is measured with a five-point likert scale (1 = almost never to 5 = almost always). based on our hypotheses, both studies focused on the superordinate scales “adaptive” (α = .93/.80) and “maladaptive emotion regulation” (α = .81/.72) and on the individual strategies “acceptance” (α = .84/.82), “reappraisal” (α = .85/.63), “rumination” (α = .66/.53), and “catastrophizing” (α = .65/.73). following garnefski and kraaij (2006), study 2 used a shortened version with two items per strategy. additionally, study 2 included the toronto alexithymia scale (tas; bagby et al., 1994; popp et al., 2008) and the brief symptom inventory (bsi; franke, 2000). the tas-20 is a 20-item self-report measure for assessing alexithymia in adults and comprises a five-point likert scale from 1 = not at all true to 5 = completely true (α = .85). the bsi is a 53-item screening questionnaire assessing various psychopathological characteristics within the last 7 days in adulthood. the items are rated on a scale from 0 = not at all to 4 = very strong. based on our hypotheses, we have focused on the subscale of somatization (7 items, α = .62). statistical analyses statistical analyses were carried out with spss 23.0. for study 2, an a priori power analysis using g*power with ρ h1 = .4, an alpha error = .05, and a statistical power = .90 for bivariate correlations resulted in a minimum sample size of n = 61 (not for study 2 due to a pilot study as a part of a larger project). in the online study (study 2), the survey response was set so that no questions could be omitted. in study 1, the pairwise deletion method was used for individual missing items. to test the relationships, we first calculated pearson correlation coefficients (most variables were approximately normally jungmann, wagner, klein, & kaurin 7 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ distributed). to examine the incremental variance explained by parental/child emotion regulation, multiple hierarchical regression models were computed for the dependent variable fss (once for child-reported/parent-reported fss). for regression analyses, first multicollinearity was checked (correlations of the predictors were each below r = .70; tabachnick & fidell, 1996). in study 1, sex and age were controlled for in step 1, parental adaptive and maladaptive emotion regulation were entered in step 2 (cerq), and child emotion regulation in step 3 (feel-kj) (order in line with the transgenerational model; stone & wilson, 2016). in study 2, parental somatization was added in step 2 and parental/child emotion regulation in steps 3 and 4 (cerq, feel-kj) (order in line with gilleland et al., 2009). r e s u l t s participant characteristics regarding fss and emotion regulation in study 1, boys and girls did not differ significantly in fss and emotion regulation (p ≥ .23, d ≤ 0.40). with regard to age of the children, significant positive correlations were found with children’s maladaptive emotion regulation (r = .38, p = .011) and children’s rumination (r = .33, p = .030). in study 2, girls showed higher scores compared to boys in reporting maladaptive emotion regulation, t(66) = -2.97, p = .004, d = 0.73, and rumination, t(66) = -3.18, p = .002, d = 0.78. children’s age correlated positively with the child-reported gastrointestinal symptoms (r = .30, p = .015) and maladaptive emotion regulation (r = .32, p = .008). appendix a (see supplementary materials) shows the participant characteristics of study 1 and 2. relationships between fss and emotion regulation study 1 as expected, in study 1 we found a negative correlation between children’s adaptive emotion regulation and child-reported fss (r = -.34, p = .026). at the level of individual strategies, there were no significant associations with reappraisal (r < .01, p > .99) and ac­ ceptance (r = -.26, p = .096). as hypothesized, there were significant positive correlations between children’s maladaptive emotion regulation (r = .53, p ≤ .001) and rumination (r = .41, p = .001) with child-reported fss. no significant correlations were found between children’s emotion regulation and parent-reported fss in children/adolescents (r ≤ |.20|, p ≥ .198). concerning parental emotion regulation, as expected, parental rumination was significantly positively associated with child-reported fss (r = .34, p = .028) and parental maladaptive emotion regulation (r = .37, p = .011) was well as parental rumination (r = .37, p = .011) were significantly positively correlated with parent-reported fss. appendix fss and emotion regulation 8 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ b (see supplementary materials) describes the correlations between child and parental somatization and child and parental emotion regulation. study 2 as in study 1, study 2 found a significant negative correlation between children’s adap­ tive emotion regulation and child-reported fss (r = -.31, p = .011). at the level of individ­ ual strategies, there was a significant negative association between children’s acceptance and child-reported fss (r = -.36, p = .003). children’s maladaptive emotion regulation (r = .46, p ≤ .001) and alexithymia (r = .39, p = .001) were significantly positively correlated with child-reported fss. additionally, children’s acceptance was significantly negatively correlated with parent-reported fss (r = -.25, p = .047). regarding parental emotion regu­ lation, parental acceptance showed a significant negative correlation with child-reported fss (r = -.30, p = .018). in addition, parental maladaptive emotion regulation (r = .29, p = .018) and alexithymia (r = .29, p = .018) were positively correlated with parental somatization (see appendix b in the supplementary materials). regression analyses for predicting fss in children and adolescents study 1 in study 1, children’s emotional regulation (∆r 2 = .34, p = .001) explained variance in child-reported fss over and above children’s age/gender and parental emotional regula­ tion (appendix c, supplementary materials). as the correlations showed, both child adaptive (β = -.30, p = .040) and maladaptive emotion regulation (β = .50, p = .002) were significant predictors of child-reported fss. to investigate specific regulation strategies, this multiple hierarchical regression was repeated by using the specific hypothesized emotion regulation strategies (acceptance, reappraisal, and rumination) instead of gener­ al adaptive and maladaptive emotion regulation. child acceptance (β = -.36, p = .028) was found to be a negative predictor and rumination a positive predictor (β = .46, p = .007) of child-reported fss. the same analyses were carried out for the dependent variable parent-reported fss (appendix d, supplementary materials). in this model, children’s emotional regulation showed no incremental explanation for variance in parent-reported fss (∆r 2 = .01, p = .892) in addition to age/gender, and parental emotional regulation. parental emotion regulation provided a significant explanation of variance in parent-reported fss (∆r 2 = .22, p = .010), which can be attributed to maladaptive emotion regulation as a significant predictor (β = .37, p = .025). including individual strategies (catastrophization and rumi­ nation), parental rumination (β = .48, p = .017) was found to demarcate a significant predictor of parent-reported fss. jungmann, wagner, klein, & kaurin 9 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ study 2 as in study 1, in study 2 children’s emotion regulation explained incremental variance in child-reported fss (∆r 2 = .14, p = .009) beyond age/sex, parental somatization, and pa­ rental emotion regulation (appendix c, supplementary materials). maladaptive emotion regulation (β = .34, p = .020) was shown to be a significant predictor of child-reported fss, whereby the assumed individual strategy rumination did not prove to be a signifi­ cant predictor (β = .04, p = .777) this analysis was repeated for the dependent variable parent-reported fss in chil­ dren/adolescents (appendix d, supplementary materials). as in study 1, in study 2 children’s emotion regulation did not explain significant incremental variance in parentreported fss (∆r 2 = .014, p = .594) beyond age/sex, parental somatization, and parental emotion regulation. in this model for predicting parent-reported fss, parental somatiza­ tion was the only significant predictor (β = .44, p < .001). d i s c u s s i o n two studies were conducted to investigate the relationships between child and parental emotional regulation and child and parental somatization. based on previous research and the transgenerational model for the development of fss in children/adolescents (gilleland et al., 2009; stone & wilson, 2016), we hypothesized that children’s emotion regulation should explain additional variance in children’s fss beyond parental somati­ zation and emotional regulation. we tested our hypotheses in a pilot sample, and then replicated the findings in an independent sample. to evaluate the levels of fss in our studies, we have set them in relation with a previ­ ous study among children/adolescents in the general population (jungmann & witthöft, 2020). compared to the study by jungmann and witthöft (2020), in the present studies the total number of child-reported fss was higher (d = .31/.66). regarding socio-demo­ graphic data, the children in our two studies were on average younger (m = 10.0/13.1 vs. m = 14.2 in jungmann & witthöft, 2020), the gender distribution was comparable (59 – 65% female). there are inconsistent findings on the relationship between fss and age, lieb et al. (2000), for example, describe a steep increase between the ages of 8 and 12, other studies found no relationship between age and fss in children and adolescents (cerutti et al., 2017; dhossche et al., 2001). also, only study 2, but not study 1, found a significant correlation between age and gastrointestinal symptoms. presumably, additional factors or an interaction of factors can better explain the level of fss. since jungmann and witthöft's (2020) study used the same measuring instrument to record fss, situational factors (e.g., holidays), the type of survey (laboratory/at home), and/or parent-child interactions (e.g., parents’ reactions to child’s symptoms) would be conceivable. the latter point could also be in line with the transgenerational model fss and emotion regulation 10 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ (stone & wilson, 2016), which assumes that the parental influence on the perception and expression of body symptoms is greater in younger children. in accordance with the hypothesis and consistently in both studies, significant negative correlations were found between children’s adaptive emotion regulation and child-reported fss. this is also compatible with previous studies on bodily complaints in children and adolescents, whereby the present studies have examined more specifically adaptive emotion regulation in comparison with coping processes (thomsen et al., 2002) and emotion regulation abilities such as empathy and self-awareness (gilleland et al., 2009). as assumed, study 2 also found a negative association between acceptance and child-reported fss, in accordance with the study by thomsen et al. (thomsen et al., 2002) in which acceptance represented a kind of secondary control engagement. possible reasons why study 1 missed the significance level for this association (p = .096) could be the smaller sample, but also, for example, the younger age. possibly, younger children may use this strategy less or have less understanding of what it meant (e.g., "i accept what makes me angry."). in contrast to the study by erkic et al. (2018), which showed a reduced level of the reappraisal strategy in adults with ssd, no significant correlations between children’s reappraisal and child-reported fss were found in both studies. on the one hand, this strategy could be less developed in childhood, which is also shown by the fact that the mean scores for reappraisal were lower than those for acceptance; on the other hand, this correlation could also only become apparent in the pathological manifestation of ssd. as expected and consistent in both studies, positive associations between childhood maladaptive emotional regulation and child-reported fss were also found. only study 1 showed a significant positive correlation with rumination. in study 2, the subscale rumination showed a low internal consistency (α = .46), which could possibly be due to the fact that rumination in terms of the shortened version of the feel-kj was recorded with only two items. in addition, our study also confirmed the positive correlation between alexithymia and child-reported fss (hadji-michael et al., 2019). in comparison to the relationships between the child reports, only a significant asso­ ciation was found between child acceptance and parent-reported fss. this association might indicate that when children show higher acceptance, parents perceive or report less body symptoms of their children. moreover, in line with previous studies (de los reyes et al., 2015), this finding also suggests that the child's and parent's judgements can differ more significantly in the case of personal experiences and internalizing symptoms, and consequently it is relevant (even if the children are younger) to question the children themselves. explaining child-reported fss, children’s emotional regulation consistently showed the highest variance explanation in both studies (14–34%) and explained additional variance in addition to age/gender and parental emotional regulation. especially malad­ aptive emotion regulation was found to be a significant predictor. this suggests the jungmann, wagner, klein, & kaurin 11 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ importance of children’s emotional regulation for children’s fss and confirms findings in adults (erkic et al., 2018). like first approaches in adulthood (kleinstäuber et al., 2019), the promotion of adaptive emotion regulation/reduction of dysfunctional emotion regulation could be a promising approach for the psychotherapeutic treatment of fss in childhood and adolescence. for variance explanation of parent-reported fss, parental emotion regulation (22%), especially parental maladaptive emotion regulation, showed a significant incremental variance explanation in study 1, but when parental somatization was also included in study 2, it was the only significant predictor. thomsen et al. (2002) also found only parental somatization as a significant predictor of father-reported physical complaints in children. this result could indicate that the estimation/perception of childhood fss depends on the parents' own experience of physical complaints, which should also be taken into account, for example, when exploring/treating fss in children. the findings could also be consistent with current interoceptive predictive coding mod­ els of symptom perception (e.g., van den bergh et al., 2017) which assume that the perception and evaluation of body symptoms is influenced by previous experience. this could be the case not only for the perception of one's own body symptoms, but also for those of children. some limitations should be mentioned. the samples of both studies are rather small (especially study 1, see also power analysis) and not representative in terms of sociodemographic data (e.g., parents’ high education, 80–90% mothers). our cross-sectional design does not allow us to draw any causal conclusions; longitudinal studies would also be of interest, e.g., to examine the temporal course of deficits in the emotion regulation of fss and the transgenerational model more closely. the survey conditions (study 1/2: laboratory/online), samples (age), and, in some cases, the measuring instruments differ between study 1 and 2. we cannot exclude the influence of these factors on our results. for example, the partly found divergences of study 1 and study 2 might have resulted from different survey conditions. in study 2, the shortened version of the feel-kj found partially low internal consistencies of the individual strategies, which should be examined in further studies. in this context, it should also be mentioned that some questionnaires for children are not validated in german or for an age below 10/11 years. validation studies are needed here in the future. this could contribute to biases (e.g., too low scores) because the items are still too difficult for younger children (8-10 years). conclusion in summary, our studies indicate that in childhood and adolescence, emotion regulation is related to fss. thus, the promotion of functional emotion regulation/reduction of maladaptive emotion regulation likely represents a promising complementary approach for the treatment of fss in children and adolescents. in predicting parent-reported fss, parental somatization was the only significant predictor. this finding highlights the dependence on the perspective and previous experience with body symptoms of the fss and emotion regulation 12 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ person making the assessment. therefore, the consideration of parental factors is also relevant in the treatment of fss in children. furthermore, it shows the importance of multidimensional approaches, whereby in addition to a multi-informant approach the inclusion of experimental procedures could present a key source of information in future studies (e.g., promoting adaptive emotion regulation in children with fss). funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @steffi_jungmann, @m4rleneklein, @aleksakaurin s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below). • appendix a. participant characteristics regarding functional somatic symptoms (fss) and emotion regulation. • appendix b. pearson correlations between fss and emotion regulation. • appendix c. multiple hierarchical regression analyses for predicting child-reported fss in children and adolescents. • appendix d. multiple hierarchical regression analyses for predicting parent-reported fss in children and adolescents. index of supplementary materials jungmann, s. m., wagner, l., klein, m., & kaurin, a. 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(1993). the icd-10 classification of mental and behavioural disorders: diagnostic criteria for research. https://apps.who.int/iris/handle/10665/37108 jungmann, wagner, klein, & kaurin 17 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://doi.org/10.1097/j.pain.0000000000000637 https://doi.org/10.1016/j.jpain.2015.06.009 https://doi.org/10.1093/jpepsy/27.3.215 https://doi.org/10.1016/j.neubiorev.2017.01.015 https://doi.org/10.17169/refubium-16470 https://doi.org/10.1037/0033-295x.96.2.234 https://doi.org/10.1016/s0140-6736(98)08320-2 https://doi.org/10.1093/jpepsy/jst094 https://apps.who.int/iris/handle/10665/37108 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. fss and emotion regulation 18 clinical psychology in europe 2022, vol. 4(2), article e4299 https://doi.org/10.32872/cpe.4299 https://www.psychopen.eu/ fss and emotion regulation (introduction) method participants procedure measures statistical analyses results participant characteristics regarding fss and emotion regulation relationships between fss and emotion regulation regression analyses for predicting fss in children and adolescents discussion conclusion (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references an overview of the evidence for psychological interventions for psychosis: results from meta-analyses scientific update and overview an overview of the evidence for psychological interventions for psychosis: results from meta-analyses tania m. lincoln a, anya pedersen b [a] institute of psychology, universität hamburg, hamburg, germany. [b] institute of psychology, christian-albrechtsuniversität, kiel, germany. clinical psychology in europe, 2019, vol. 1(1), article e31407, https://doi.org/10.32872/cpe.v1i1.31407 received: 2018-11-06 • accepted: 2019-02-13 • published (vor): 2019-03-29 handling editor: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany corresponding author: tania m. lincoln, universität hamburg, institut für psychologie, klinische psychologie und psychotherapie, von-melle-park 5, 20146 hamburg, germany. e-mail: tania.lincoln@uni-hamburg.de abstract background: there are numerous psychological approaches to psychosis that differ in focus, specificity and formats. these include psychodynamic, humanistic, cognitive-behavioural and third-wave-approaches, psychoeducation, various types of training-based approaches and family interventions. method: we briefly describe the main aims and focus of each of these approaches, followed by a review of their evidence-base in regard to improvement in symptoms, relapse and functioning. we conducted a systematic search for meta-analyses dating to 2017 for each of the approaches reviewed. where numerous meta-analyses for an approach were available, we selected the most recent, comprehensive and methodologically sound ones. results: we found convincing shortand long-term evidence for cognitive behavioural approaches if the main aim is to reduce symptom distress. evidence is also strong for psychoeducative family interventions that include skills training if the main aim is to reduce relapse and rehospitalisation. acceptance and commitment therapy, mindfulness-based approaches, meta-cognitive and social skills training, as well as systemic family interventions, were also found to be efficacious, depending on the outcome of interest, but meta-analyses for these approaches were based on a comparatively lower number of outcome studies and a narrower selection of outcome measures. we found no convincing evidence for psychodynamic approaches, humanistic approaches or patient-directed psychoeducation (without including the family). conclusions: an array of evidence-based psychological therapies is available for psychotic disorders from which clinicians and patients can choose, guided by the strength of the evidence and depending on the outcome area focused on. increased effort is needed in terms of dissemination and implementation of these therapies into clinical practice. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.31407&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords psychosis, schizophrenia, psychological therapy, intervention, evidence highlights • meta-analyses show convincing evidence for cbt if the main target is psychotic symptoms. • meta-analyses show convincing evidence for family interventions if the main target is relapse. • effects are promising for act, mindfulness-based and systemic approaches, but more research is needed. • the array of effective approaches allows clinicians and patients to select the most appropriate one. patients with psychotic disorders often face a diverse and complex set of problems. one part of these problems are the symptoms as such. these include persecutory delusions, hearing voices and feeling driven, or negative symptoms, such as the loss of drive. not only do these symptoms tend to cause severe distress (lincoln, 2007; woodward et al., 2014), they can also be accompanied by an array of interpersonal problems or social withdrawal (depp et al., 2016; mondrup & rosenbaum, 2009). accordingly, relatives and other people involved also often report difficulties in communication or feeling helpless (treanor, lobban, & barrowclough, 2013). moreover, an acute episode that might have in‐ volved voluntary or involuntary hospitalisation can be traumatizing (paksarian et al., 2014) and many patients and relatives report continuous worry about possible relapse (gumley et al., 2015; lal et al., 2019). unsurprisingly, therefore, many patients and their relatives seek professional help. since the discovery of antipsychotic drugs in the early 1950s, this help has been pri‐ marily pharmacological in nature. although medication is valuable in the acute phase, the effect sizes in randomised trials for medication alone are only small to moderate (leucht et al., 2012) and may come at the cost of disadvantageous long-term side effects (murray et al., 2016). also, medication is not well accepted by many patients (wade, tai, awenat, & haddock, 2017). based on the requirement to inform evidence-based additions and alternatives to antipsychotic medication (morrison, hutton, shiers, & turkington, 2012), and an increasingly better understanding of the psychological mechanisms that cause and maintain psychotic symptoms (for a comprehensive and service-user oriented overview of this research see cooke, 2014) different psychological approaches have been developed over the past decades. these differ in their focus and formats, but ultimately all aim to help patients to either overcome or to cope better with symptoms and to im‐ prove functioning and well-being. psychological interventions for psychosis 2 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ m e t h o d s o f t h e r e v i e w the scope of the present review covers the efficacy of different psychological approaches for psychosis offered in combination with pharmacotherapy as reflected in meta-analy‐ ses. a systematic search for methodologically sound meta-analyses via web of science, psycinfo, psyndex, and medline was conducted to establish a german guideline for the psychological treatment of schizophrenia and psychotic disorders (lincoln, pedersen, hahlweg, wiedl, & frantz, 2019). this guideline was initiated by the german society for clinical psychology and psychotherapy as an adjunct to the s-3 german guideline, which has a broader focus. considering recommendations by the association of the scientific medical societies in germany (awmf), evidence derived for the different psychological approaches is based on recent meta-analyses including well-conducted randomised con‐ trolled trials (rcts). starting out from the comprehensive meta-analysis on the treatment and management of psychosis and schizophrenia in adults (national collaborating centre for mental health [nccmh], 2014 [update]) conducted for the nice-guidelines (national institute for health and care excellence) in 2009 we searched the literature from 2010 to 2017 for additional meta-analyses (note. the guideline covered research un‐ til 2016. for the present overview we updated this search to cover meta-analyses publish‐ ed up to the end of 2017). when a psychological approach was not covered in the niceguidelines (nccmh, 2014), we additionally searched for meta-analyses published before 2010. the identified meta-analyses were critically appraised for methodological quality as well as overlap and we selected the most recent, comprehensive and methodologically sound analyses (e.g. conducted by the cochrane collaboration or other independent re‐ searchers). a complete list of the reviewed and selected meta-analyses is added in the appendix. meta-analyses were included if they focused on schizophrenia, delusional dis‐ orders, schizoaffective disorders and acute and transient psychotic disorders following dsm-iii-r, dsm-iv or dsm-5 criteria. the outcome measures covered include improvement in symptoms (overall symp‐ toms, positive symptoms and negative symptoms), relapse rates and rehospitalisations as well as psychosocial functioning. psychological approaches reviewed covered individual and group interventions con‐ ducted within inand out-patient settings. we report the effectiveness of each approach on the basis of randomised-controlled trials that compared the approach either to the usual treatment (tau; e.g. pharmacotherapy and consultation) condition alone or to a tau plus an active control condition (e.g. supportive therapy or psychoeducation) at post-treatment and/or at follow-up (ranging from weeks to years). in order to be able to compare the effectiveness of these approaches we focus on comparisons to “any control”, because meta-analyses on approaches which have not been comprehensively investigated often do not differentiate between comparisons to tau versus active controls. only ef‐ fect sizes based on at least two independent original studies were considered. lincoln & pedersen 3 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ d e s c r i p t i o n o f t h e r e v i e w e d a p p r o a c h e s a n d t h e i r r e s p e c t i v e e v i d e n c e b a s i s cognitive behavioural therapy for psychosis description cognitive behavioural interventions for psychosis (cbtp) build on the assumption that psychotic symptoms lie on a continuum with normal experiences. they are also informed by research suggesting that psychotic experiences result from normal, though exagger‐ ated, mechanisms of perception and reasoning. this understanding has formed the basis for cognitive models of psychosis. as one of the most influential of these models, garety, kuipers, fowler, freeman, & bebbington (2001) postulate that psychotic symptoms devel‐ op when stressors overload a person, causing them to have unusual experiences. accord‐ ing to this model, not the unusual experience itself is crucial but its appraisal. a variety of approaches within the cbtp-framework have been described (fowler, garety, & kuipers, 1995; morrison, renton, dunn, williams, & bentall, 2004). most descriptions converge in stressing the importance of building a stable therapeutic relationship through the process of listening and validating, of taking a collaborative approach and of working with an individual case formulation. the use of cognitive and behavioural inter‐ ventions for working with psychotic symptoms as well as for changing dysfunctional be‐ liefs and interventions to prevent relapse are also essential elements. evidence base beyond the nice-meta-analysis conducted in 2009 our review is based on seven further meta-analyses (burns, erickson, & brenner, 2014; jauhar et al., 2014; jones, hacker, cormac, meaden, & irving, 2012; lutgens, gariepy, & malla, 2017; turner, van der gaag, karyotaki, & cuijpers, 2014; van der gaag, valmaggia, & smit, 2014; velthorst et al., 2015) selected from a larger pool of 13 meta-analyses. as can be seen in table 1, with the exception of the cochrane-analysis by jones et al., (2012), the meta-analyses consistently detected small effects on overall symptoms at posttreatment and at various follow-up periods favouring cbtp over tau. the findings were less consistent, however, when cbtp was compared to active control. the picture is simi‐ lar for positive symptoms, with jones et al. (2012) reporting mixed findings, while the oth‐ er meta-analyses consistently revealed effects in favour of cbtp compared to tau, both at post-treatment and at follow-ups. again, the comparisons to active control groups were less consistent. for negative symptoms there were small post-therapy effects (jauhar et al., 2014; lutgens et al., 2017) and small follow-up effects (nccmh, 2014), overall, however, the non-significant findings outweighed the significant ones. relapse rates, re‐ hospitalisations and functioning were only investigated in two meta-analyses (jones et al., 2012; nccmh, 2014), and are based on a smaller number of studies. neither meta-analy‐ psychological interventions for psychosis 4 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ sis showed an effect on relapse and the effects for rehospitalisations and functioning were mixed. third-wave-approaches to psychosis description third-wave-approaches are new developments in cbt which emphasise the relevance of acceptance, mindfulness and emotions, the relationship, values, goals, and meta‐cogni‐ tion (hayes & hofmann, 2017). in psychosis, adaptations of mindfulness-based therapy, acceptance and commitment therapy (act) and compassion focused therapy (cft) have been studied most. in order to ease distress and achieve acceptance as well as to support the regaining of control, mindfulness-based interventions for psychosis guide patients to notice sensations and their own emotional and cognitive reactions to them with aware‐ ness (chadwick, 2014). in meditation-based practices, patients learn to observe their thoughts, feelings and symptoms in an accepting and non-judgmental way. mindfulness interventions for psychosis have been implemented as single treatments (e.g. chadwick, 2014) or combined with cbt (e.g. wright et al., 2014). in act (hayes, strosahl, & wilson, 1999) experiential avoidance and cognitive fusion are suggested to be the core processes of suffering. in order to increase psychological flexibility and reduce distress associated with psychotic symptoms, patients are guided to develop a balance between committed value-guided action when solving actual problems and acceptance when control of thoughts and feelings is limited (e.g. in the case of hallu‐ cinations). act has been adapted for the treatment of psychosis (o’donoghue, morris, oliver, johns, & hayes, 2018; combined with cbt, wright et al., 2014). compassion-focused therapy (cft, gilbert & procter, 2006) encourages patients to be more compassionate towards themselves and others while reducing shame and self-criti‐ cism. compassionate mind training includes appreciation and imagery exercises as well as aspects of mindfulness and aids the patient to experience different aspects of compas‐ sion in order to promote mental wellbeing. cft has been adapted for the treatment of psychosis (brähler, harper, & gilbert, 2013). evidence base we selected two (cramer, lauche, haller, langhorst, & dobos, 2016; louise, fitzpatrick, strauss, rossell, & thomas, 2018) from an identified pool of four meta-analyses. no metaanalysis reported effects-sizes for cft based on more than one original study, hence, on‐ ly mindfulness-based interventions and act are reviewed. both meta-analyses revealed no significant effect of act, but a significant small effect of mindfulness-based interventions on overall symptoms at post-treatment (cramer et al., 2016; louise et al., 2018). one meta-analysis analysed the effect at follow-up and reported an even increased effect (cramer et al., 2016). lincoln & pedersen 5 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ act showed a significant moderate effect on positive symptoms, but not on negative symptoms at post-treatment (cramer et al., 2016). the number of rehospitalisations was only investigated for act, revealing a signifi‐ cant small effect (based on two studies; cramer et al., 2016). relapse and functioning were not analysed. psychodynamic therapy for psychosis description early psychoanalytic conceptions of psychosis understand psychotic symptoms as a man‐ ifestation of the mind being invaded by the unconscious and by dreams (federn, 1928/1952). more contemporary approaches underline the importance of early relation‐ ship patterns (e.g. bion, 1962; winnicott, 1991). internal representations of experiences with significant others and current relationships are assumed to result in tension and psychotic symptoms are considered as a “constructive” way of dealing with this tension (von haebler & freyberger, 2013). psychodynamic therapy focuses on these processes and helps the patient to gain self-awareness and understanding of the influence of the past on present behaviour and it fosters new positive relationship experiences. an em‐ pathic, respectful and supportive attitude allows re-enactment of internalised relational patterns in the therapist-patient interaction (lempa, montag, & von haebler, 2013). evidence base we identified two meta-analyses. however, both the meta-analysis conducted for the nice-guidelines (nccmh, 2014) and the one of the cochrane collaboration (malmberg, fenton, & rathbone, 2001) were based on four original studies only. the aggregated data of the two analyses did not indicate significant improvement in overall symptoms, func‐ tioning (nccmh, 2014) or rehospitalisations (malmberg et al., 2001) in patients treated with psychodynamic therapy compared to any control. the inclusion criteria for the present review were not fulfilled as none of the relevant outcome measures were covered by more than one original study; hence, psychodynamic therapies are not included in table 1. humanistic or client-centred approaches description in client-centred or humanistic therapy, unconditional positive regard, accurate empathy and genuineness are assumed to help a patient to increase the congruence between the real self and the ideal self (rogers, gendlin, kiesler, & truax, 1967). rogers and collea‐ gues’ concept of “actualizing tendency” points to an inherent tendency to achieve per‐ sonal growth and reach one’s full potential. in this framework psychotic symptoms are understood as a distortion of this actualising tendency. client-centred therapy focuses on psychological interventions for psychosis 6 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ personal experiences, whereas relieving specific symptoms is secondary. thus, no specif‐ ic therapeutic strategies have been established for psychosis. however, therapists are rec‐ ommended to pay particular attention to understanding the client’s perspective, ensuring that the patient is being heard and emphasising the personal relationship (gendlin, 1962). evidence base client-centred or humanistic therapy for psychosis has not been covered in a meta-anal‐ ysis and the only known rct dates back to 1967 (rogers) and did not reveal convincing effects. psychoeducation for patients description to enhance knowledge and understanding of psychosis and to improve coping skills psy‐ cho-educational interventions are routinely offered in the treatment of psychosis. mainly in group format, patients receive systematic and structured information on psychosis and its consequences, early warning signs, triggering and maintaining factors, relapse pre‐ vention, and modalities of treatment. psychoeducation aims to help patients to increas‐ ingly take personal responsibility and improve coping skills. evidence base two comprehensive meta–analyses (nccmh, 2014; turner et al., 2014) that provided sub-analyses on the effect of psychoeducation for patients without involving family members did not show any significant effect of psychoeducation on overall symptoms, positive or negative symptoms (turner et al., 2014), relapse rates or rehospitalisations (nccmh, 2014). training-based approaches description from the range of different training-based approaches that cannot be fully covered with‐ in the scope of this review, we exemplarily focus on two widely used training-based in‐ terventions – one targeting positive symptoms (metacognitive training) and one primari‐ ly addressing negative symptoms (social skills training). metacognitive training (mct; moritz & woodward, 2007) was designed to address positive symptoms in patients with schizophrenia. as cognitive biases have been related to positive symptoms (e.g. jumping to conclusions or externalizing attributional bias, see garety & freeman, 1999), mct aims to extent patient’s knowledge of cognitive biases and to provide corrective experiences. implementing a wide range of examples and exer‐ cises, patients participating in a mct group training are encouraged to identify and gain lincoln & pedersen 7 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ insight into these cognitive biases and reduce conviction in delusional ideas. mct is mainly administered in group format. social skills trainings (sst) build on the observation that patients with psychotic dis‐ orders tend to show impaired social skills. sst involve therapist modelling and instruct‐ ing socially confident behaviour in specific situations combined with role-plays. patients receive supportive feedback from the therapist and video feedback can also be used. dur‐ ing the end of the training that usually takes place in group-format patients are encour‐ aged to practice the newly learnt skills in daily life. a frequently used treatment manual was published by bellack, mueser, gingerich, and agresta (2013). evidence base for mct a significant small effect on positive symptoms was reported in two of three identified meta-analyses on the effect of mct in psychosis (eichner & berna, 2016; jiang, zhang, zhu, li, & li, 2015), whereas one did not reveal a significant effect at post-treatment (van oosterhout et al., 2016). regarding overall and negative symptoms, relapse / rehospitali‐ sations and functioning no aggregated effect sizes were reported. evidence base for social skill trainings we identified and included three meta-analyses: the nice meta-analysis (nccmh, 2014), the cochrane meta-analysis (almerie et al., 2015) and the meta-analysis by turner et al. (2014). there was no effect of sst on overall symptoms compared to control conditions at post-therapy in any of the meta-analyses, follow-up effects were not reported. there was also no effect in favour of sst for positive symptoms (turner et al., 2014). for nega‐ tive symptoms there were significant post-therapy effects (nccmh, 2014; turner et al., 2014). a significant follow-up effect for sst versus tau was found in one meta-analysis (almerie et al., 2015). for relapse and rehospitalisation, the findings were mixed. there was no significant effect for functioning, neither at post-assessment nor at follow-up. family interventions description interventions that include the family are subsumed under the term “family intervention”. the patient may be included in all, some, or – in some programmes – no sessions. de‐ pending on the approach, a family intervention will involve 12 to 25 treatment sessions during the course of a year or longer and accompany the family through the remission phase. the diverse approaches can be broadly subdivided into psycho-educative family interventions, comprehensive interventions that combine information with problemsolving, social and communication skills, and systemic family interventions. the psychoeducational approach builds on the observation that patients with psycho‐ sis often rely on relatives for support (dixon, adams, & lucksted, 2000) and the assump‐ psychological interventions for psychosis 8 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ tion that involved family members thus require information and assistance to cope with the challenges posed to the family system. it thus conveys basic knowledge about psy‐ chosis, building on the vulnerability-stress models. it sees psychosis as mental illness and enlists family members as therapeutic agents, taking care not to make the relatives feel blamed (lucksted, mcfarlane, downing, & dixon, 2012). it aims to convey the relevance of medical and psychosocial treatment, reduce misconceptions and provide a basis on which to promote the self-management skills, improve family coping and reduce relapse. the skill-training approach builds on findings showing higher rates of relapse if a pa‐ tient’s family displays a communication style characterised by high levels of criticism, hostility, or emotional over-involvement (“high expressed emotion”, butzlaff & hooley, 1998). it builds on the assumption that problems that arise from caring for a mentally ill family member can be solved if the family develops good problem solving strategies and a supportive way of communicating. the therapist models the verbal and non-verbal communication rules and assists the family to use the communication skills in a series of role-plays. the improved skills are then used to solve practical problems within the fami‐ ly context, using a problem solving approach. a well-established program of this type is described by falloon, boyd, and mcgill, (1984). systemic approaches assume that relationships within the family (or other relevant so‐ cial systems) influence the feelings, beliefs and behaviour of the “index patient” and vice versa and therefore, that psychotic symptoms may have arisen from specific interaction patterns within the family. the therapy aims to identify and change these patterns in or‐ der to reduce symptoms. if, for example, family members have stopped communicating about relevant issues with the patient, the therapist would attempt to re-include the pa‐ tient in the communication processes. changes in interactions are promoted by specific systemic questioning and reframing (e.g. retzer, 2004). evidence base for family interventions in general we selected three meta-analyses (claxton, onwumere, & fornells-ambrojo, 2017; nccmh, 2014; pharoah, mari, rathbone, & wong, 2010) from a pool of four available ones. these did not differentiate between different types of family interventions and thus report omnibus effects, with the bulk of the interventions covered in these analyses being psychoeducational in nature, with or without additional skill training. as can be seen in table 1, short-term benefits were mixed, but family interventions demonstrated significant long-term benefits over any control conditions on overall symp‐ toms in any of the three meta-analyses. the effects on positive and negative symptoms were short-term in nature (nccmh, 2014). for relapse and rehospitalisation the majority of the effects were significant and in the moderate to large range, both at post therapy and at follow-ups, although the long-term effects were non-consistent. small to moderate effects were also found for short(claxton et al., 2017; nccmh, 2014) and long-term functioning (nccmh, 2014; pharoah et al., 2010). lincoln & pedersen 9 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ in order to provide a picture on differential effectiveness, we reviewed three addition‐ al meta-analyses each focusing on one of the three specific subtypes, psychoeducative family interventions (lincoln, wilhelm, & nestoriuc, 2007), comprehensive programs in‐ cluding skilltraining (pfammatter, junghan, & brenner, 2006) and systemic approaches (pinquart, oslejsek, & teubert, 2016). moreover, the nice meta-analysis (nccmh, 2014) provided a sub-analysis for psychoeducative interventions that included the family. as can be seen in table 1, psychoeducative family interventions demonstrated no sig‐ nificant effect on any of the symptom measures (lincoln et al., 2007; nccmh, 2014), but a significant small follow-up effect on relapse and rehospitalisation (combined) in one meta-analysis (es = 0.48; lincoln et al., 2007) but not in the other (nccmh, 2014). for comprehensive programmes including skill-trainings, one meta-analysis (pfammatter et al., 2006) demonstrated a small follow-up effect on general psychopathol‐ ogy, relapse and rehospitalisation and a short-term benefit on functioning. for systemic family approaches there was an overall significant effect on all outcome measures combined, without differentiating between the different outcomes (pinquart et al., 2016). psychological interventions for psychosis 10 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ ta bl e 1 r es ul ts f ro m m et aa na ly se s on t he e ff ic ac y of p sy ch ol og ic al a pp ro ac he s to p sy ch os is m et aan al ys is g en er al p sy ch o‐ pa th ol og y (e s) p os it iv e sy m pt om s (e s) n eg at iv e sy m pt om s (e s) r el ap se (r r ) r eh os pi ta li ‐ sa ti on (r r ) fu n ct io n in g (e s) p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps c og n it iv ebe h av io ur al t h er ap y (c b t p) n c c m h , 2 01 4 (n ic e, k = 1 9) c om pa ri so n: t a u 0. 27 * 0. 23 * 0. 40 * 0. 19 * 0. 17 * 0. 15 * 0. 51 * n. s. 0. 16 * 0. 38 * n. s. n. s. 0. 76 * * n. s. n. s. n. s. 0. 20 * n. s. n c c m h , 2 01 4 (n ic e, k = 1 4) c om pa ri so n: a ct iv e tr ea tm en ts n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. 0. 50 * n. s. jo ne s et a l., 2 01 2 (c oc hr an e, k = 2 0) c om pa ri so n: a ny c on tr ol n. s. n. s. * * n. s. n. s. n. s. * n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. n. s. * a n. s n. s. bu rn s et a l., 2 01 4 (k = 1 2) c om pa ri so n: a ny c on tr ol 0. 52 * 0. 40 * 0. 47 * 0. 41 * ja uh ar e t a l., 2 01 4 (k = 5 0) c om pa ri so n: a ny c on tr ol 0. 33 * 0. 25 * 0. 13 * va n de r g aa g et a l., 2 01 4 (k = 1 8) c om pa ri so n: a ny c on tr ol 0. 44 * 0. 36 * ve lth or st e t a l., 2 01 5 (k = 3 0) c om pa ri so n: a ny c on tr ol n. s. n. s. n. s. tu rn er e t a l., 2 01 4 (k = 2 2) c om pa ri so n: a ct iv e tr ea tm en ts 0. 16 * 0. 16 * n. s. lu tg en s et a l. (2 01 7) c om pa ri so n: t a u 0. 34 * lincoln & pedersen 11 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ m et aan al ys is g en er al p sy ch o‐ pa th ol og y (e s) p os it iv e sy m pt om s (e s) n eg at iv e sy m pt om s (e s) r el ap se (r r ) r eh os pi ta li ‐ sa ti on (r r ) fu n ct io n in g (e s) p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps m in df ul n es sba se d in te rv en ti on s c ra m er e t a l., 2 01 6 (k = 4 ) c om pa ri so n: t a u 0. 62 * 1. 27 * 1. 40 * lo ui se e t a l., 2 01 7 (k = 4 ) c om pa ri so n: a ny c on tr ol 0. 46 * a cc ep ta n ce a n d co m m it m en t th er ap y (a c t ) c ra m er e t a l., 2 01 6 (k = 4 ) c om pa ri so n: t a u n. s. 0. 63 * n. s. 0. 41 * lo ui se e t a l., 2 01 7 (k = 4 ) c om pa ri so n: a ny c on tr ol n. s. p sy ch od yn am ic t h er ap y – h um an is ti c ap pr oa ch es – p sy ch oe du ca ti on n ot in vo lv in g fa m il y m em be rs n c c m h , 2 01 4 (n ic e, s ub -a na ly se s, k = 12 ) c om pa ri so n: a ny c on tr ol n. s n. s. n. s. tu rn er e t a l., 2 01 4 (k = 8 ) c om pa ri so n: a ct iv e tr ea tm en ts n. s. n. s. n. s. psychological interventions for psychosis 12 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ m et aan al ys is g en er al p sy ch o‐ pa th ol og y (e s) p os it iv e sy m pt om s (e s) n eg at iv e sy m pt om s (e s) r el ap se (r r ) r eh os pi ta li ‐ sa ti on (r r ) fu n ct io n in g (e s) p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps m et ac og n it iv e tr ai n in g jia ng e t a l., 2 01 5 (k = 4 ) c om pa ri so n: a ny c on tr ol * ei ch ne r & b er na , 2 01 6 (k = 1 5) c om pa ri so n: a ny c on tr ol 0. 34 * va n o os te rh ou t e t a l., 2 01 6 (k = 1 1) c om pa ri so n: a ny c on tr ol n. s. so ci al s k il ls t ra in in g n c c m h , 2 01 4 (n ic e, k = 2 0) c om pa ri so n: a ny c on tr ol n. s. 0. 37 n. s n. s. n. s. n. s. po st n .s. ; f ol lo w -u p n. s.b a lm er ie e t a l., 2 01 5 (c oc hr an e, k = 1 0) c om pa ri so n: t a u * 0. 52 * a lm er ie e t a l., 2 01 5 (c oc hr an e, k = 3 ) c om pa ri so n: a ct iv e tr ea tm en ts n. s. n. s. tu rn er e t a l., 2 01 4 (k = 1 6) c om pa ri so n: a ct iv e tr ea tm en ts n. s. n. s. 0. 27 * fa m il y in te rv en ti on s o v e r a ll n c c m h , 2 01 4 (n ic e, k = 3 2) c om pa ri so n: a ny c on tr ol s 0. 36 * 0. 30 * 0. 46 * n. s. 0. 26 * n. s. 0. 55 * 0. 66 * 0. 62 * 0. 80 * 0. 53 * 0. 57 * * n. s. * n. s. n. s. n. s. 0. 22 * 0. 38 * 0. 58 * n. s. ph ar oa h et a l., 2 01 0 (c oc hr an e, k = 5 3) c om pa ri so n: a ny c on tr ol s * n. s. 0. 55 * 0. 64 * 0. 64 * n. s. 0. 78 * 0. 46 * n. s. * * * lincoln & pedersen 13 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ m et aan al ys is g en er al p sy ch o‐ pa th ol og y (e s) p os it iv e sy m pt om s (e s) n eg at iv e sy m pt om s (e s) r el ap se (r r ) r eh os pi ta li ‐ sa ti on (r r ) fu n ct io n in g (e s) p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps p os t fo ll ow -u ps c la xt on e t a l., 2 01 7 (k = 1 4) c om pa ri so n: a ny c on tr ol s n. s. 0. 85 c om bi ne d an al ys is o f r el ap se a nd re ho sp ita lis at io n: p os t: *; fo llo w -u p: n. s. 0. 74 fa m il y ps yc h oe du ca ti on li nc ol n et a l., 2 00 7 (k = 6 ) c om pa ri so n: a ny c on tr ol s n. s. c om bi ne d an al ys is o f r el ap se a nd re ho sp ita lis at io n at fo llo w -u p: 0 .4 8* n c c m h , 2 01 4 (n ic e, k = 2 ) c om pa ri so n: a ny c on tr ol s n. s. fa m il y co m pr eh en si ve p ro gr am s pf am m at te r et a l., 2 00 6 (k = 3 1) c om pa ri so n: a ny c on tr ol s 0. 40 * 0. 42 * 0. 22 * 0. 51 * 0. 38 * sy st em ic f am il y in te rv en ti on s pi nq ua rt e t a l., 2 01 6 (k = 7 ) c om pa ri so n: t a u a na ly si s of d iff er en t o ut co m e m ea su re s co m bi ne d at p os t: 0. 69 * a nd fo llo w -u p: 0 .6 9* n ot e. e ffe ct s iz es b as ed o n at le as t t w o in de pe nd en t o ri gi na l s tu di es a re re po rt ed . c om pa ra bl e ef fe ct s iz es (c oh en ’s d , h ed ge ’s g , a nd s ta nd ar di se d m ea n di ffe re nc es ) ar e de no te d as e s (e ffe ct s iz e) w ith ou t r ep or tin g co nf id en ce in te rv al s. if on ly o dd s ra tio , r is k ra tio s, pa rt ia l e ta s qu ar ed a nd n ot -s ta nd ar di se d m ea n di ffe re nc es w er e re po rt ed in a m et aan al ys is w e on ly in di ca te d if th e ef fe ct w as s ta tis tic al ly s ig ni fic an t a t p < 0 .0 5 (* ) v s n on -s ig ni fic an t ( n. s.) . i f a va ila bl e, e ffe ct s co m pa re d to “ an y co nt ro ls ” ar e re po rt ed , i f t he se d at a w er e no t a va ila bl e ef fe ct s co m pa re d to tr ea tm en t a s us ua l ( “t a u ”) o r “a ct iv e tr ea tm en ts ” (fo r in st an ce o th er p sy ch ol og ic al a p‐ pr oa ch es fo r ps yc ho si s or u ns pe ci fie d tr ea tm en ts ) a re re po rt ed . p os t = p os ttr ea tm en t; fo llo w -u p = al l f ol lo w -u p tim epo in ts c om bi ne d; k = n um be r of s tu di es re ‐ vi ew ed in th e m et aan al ys is o r su ban al ys is , a “ an y co nt ro l” w as s up er io r to th e tr ea tm en t. b e ffe ct s iz es b as ed o n st ud ie s re po rt in g co m bi ne d an al ys is o f r el ap se a nd re ho sp ita lis at io n on ly . psychological interventions for psychosis 14 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ d i s c u s s i o n as has become apparent from this review, there are now a variety of different psycholog‐ ical interventions available, of which the majority have a good evidence base for the out‐ comes that they focus on primarily. if the aim is to reduce general psychopathology or positive symptoms, cbt has the strongest evidence-base both in terms of the number of studies conducted and in regard to the robustness of effects over follow-up periods. oth‐ er approaches, such as acceptance and commitment therapy, mindfulness-based ap‐ proaches, and meta-cognitive training are also promising for these outcomes. negative symptoms, however, appear to respond better to social skills trainings. family interventions are also well-researched and appear to be effective for a broader array of outcomes, including relapse and rehospitalisation as well as functioning. within family interventions, the strongest effects are found for a combination of psychoeduca‐ tive and skill-training with families, although it needs noting that this specific combina‐ tion was only the focus in one meta-analysis. systemic approaches are also promising, but more high-quality randomised controlled trials are necessary to ascertain their effec‐ tiveness for different types of outcomes. there was no convincing evidence for patientdirected psychoeducation (without family involvement) despite the fact that this ap‐ proach is widespread. however, it may be more difficult to construct a fair evaluation of this approach in rcts because any control condition is likely to involve psychoeducation to a certain extent. psychodynamic therapies and humanistic approaches were also not found to be effective, but more rcts are required in order to draw definite conclusions in this regard. no approach has a consistently good evidence-base for the entire range of outcomes investigated. this may be partly due to the fact that different types of interventions have focused on different types of outcomes. for example, family interventions have a tradi‐ tional focus on relapse, whereas cbt focusses on the positive symptoms. thus, studies investigating these approaches did not consistently include a wider spectrum of outcome measures. more rcts focusing on the full spectrum of outcome areas are required in or‐ der to understand whether different approaches are truly differentially effective. also, with the exception of a few large effect sizes for family interventions, the effect sizes were largely in the small to marginally moderate range – and thus no higher than those found for pharmacotherapy. however, all original studies in the meta-analyses included here are based on designs that compare psychological interventions combined with medi‐ cation to medication alone or to medication combined with an additional control condi‐ tion. thus, the effects need to be interpreted as “add-on” effects to medication and can‐ not be directly compared with the effect sizes for medication. so far, it is unclear whether psychological therapy would fare better or worse without the combination with medica‐ tion as this question has not been investigated. lincoln & pedersen 15 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ limitations of this analysis the wide scope of interventions reviewed comes at the price of detail. for reasons of space, we did not include the specific search-terms or provide a full account of each of the meta-analyses excluded along with the reasons for inor exclusion. also, we did not report the evidence available for questions regarding specific subgroups, formats (e.g. group versus individual, short versus long) or settings (e.g. is family intervention more effective when delivered to individual families versus in groups of families). in table 1, we focused on the comparison to all control conditions for reasons of brevity and in or‐ der to be able to compare different approaches for which such distinctions were not al‐ ways available. naturally, differentiating between comparisons to tau versus active con‐ trols is more conclusive and therefore these distinctions were made in the section on cbt for which they are consistently available. moreover, we abstained from detail in the reporting of effect-sizes (e.g., we did not report standard-deviations, the type of effects, or the number of studies for each comparison). finally, we disregarded any reported ef‐ fect-size based on one original study only. readers seeking more detailed evidence re‐ ports are referred to the british or german guidelines (lincoln et al., 2019; nccmh, 2014), and to the original meta-analyses cited. the method as such, a summary of meta-analyses, also has its limitations due to the overlap between meta-analyses. moreover, the differences in methodological rigour, the inclusion criteria, and the classification of therapy approaches (e.g. inconsistency in what is counted as cbt) result in high levels of heterogeneity in the findings and make it diffi‐ cult to directly compare different meta-analyses. we attempted to control this bias to a certain extent by disregarding meta-analyses with strong overlap or questionable quality. another limitation is that the focus on meta-analyses does not provide information on psychological approaches, that are not represented well in the meta-analytic literature. finally, the continuous accumulation of further evidence renders meta-analyses and re‐ views outdated at an increasing speed and several new ones have been published since finalizing the selection for this overview. in this context, it is also worth mentioning a recent meta-analysis that also approach‐ ed the question of the effectiveness of different psychological approaches to psychosis (bighelli et al., 2018). this network meta-analysis aggregated data on the level of individ‐ ual trials on cbt, metacognitive training, mindfulness and acceptance and commitment therapy among other approaches. similar to our findings, cbt was the most represented among the included treatments and was found to have significant efficacy in comparison with treatment as usual for positive, overall and negative symptoms and functioning. it also showed higher efficacy in comparison with inactive control conditions for positive symptoms whereas there was no convincing proof of efficacy of other treatments. thus, cbt fared slightly better, even, than in our approach, while third-wave approaches and meta-cognitive therapy were less well supported. family interventions were not inclu‐ ded. psychological interventions for psychosis 16 clinical psychology in europe 2019, vol.1(1), article e31407 https://doi.org/10.32872/cpe.v1i1.31407 https://www.psychopen.eu/ final conclusions the variety of efficacious interventions available for psychotic disorders is reassuring. unfortunately, however, efficacy studies and clinical guidelines alone do not guarantee the implementation of evidence-based interventions, in routine clinical practice (pilling & price, 2006). for example, despite the nice guideline recommendation to offer cbt to all patients with psychosis, only a minority of eligible patients with psychosis are being of‐ fered cbt in the uk (prytys, garety, jolley, onwumere, & craig, 2011). in germany, studies indicate that only a minority of psychosis patients have access to evidence-based psychotherapy (schlier & lincoln, 2016). to our knowledge, this serious implementation problem of evidence-based interventions is not restricted to germany and the uk. thus, although further high quality rcts focusing on the full spectrum of outcomes are nee‐ ded, the most relevant challenge to date is that of implementation. funding: the authors have no funding to report. competing interests: tl is section editor of clinical psychology in europe but played no editorial role for this particular article. acknowledgments: the authors have no support to report. r e f e r e n c e s almerie, m. q., al marhi, m. o., jawoosh, m., alsabbagh, m., matar, h. e., maayan, n., & bergman, h. 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for patients training-based approaches family interventions discussion limitations of this analysis final conclusions (additional information) funding competing interests acknowledgments references appendix: not included meta-analyses laudatio for distinguished scholar dr. aaron t. beck editorial laudatio for distinguished scholar dr. aaron t. beck claudi l. h. bockting 1 [1] amsterdam umc, university of amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2021, vol. 3(2), article e6871, https://doi.org/10.32872/cpe.6871 published (vor): 2021-06-18 corresponding author: claudi l. h. bockting, department of psychiatry, amsterdam university medical center, university of amsterdam, meibergdreef 5, 1105 az amsterdam, the netherlands. e-mail: c.l.bockting@amsterdamumc.nl on behalf of the european association of clinical psychology and psychological treat­ ment (eaclipt), i am honored to have the opportunity to award dr. aaron t. beck (md) with the european ‘diamond distinguished contributor to psychological interventions award’. on july 18, 2021, dr. beck will celebrate his 100th birthday. as a psychiatrist and scientist, he spent almost his entire career on reducing human suffering. with a medical and academic career spanning more than 70 years, 600 published articles, 25 books, and numerous awards, it is without doubt that dr. beck has greatly influenced and shaped our current thinking on psychopathology and clinical practice beyond the measurable. albeit, measurability was of utmost concern to him during his career. originally starting out as a neurologist after his medical training at yale, particularly liking the precision of this field, he soon found himself becoming absorbed in psychoanalysis. carrying over his interest in empirical work, he later widely explored and rigorously tested the psychoanalytic model of depression as a psychiatrist at the university of pennsylvania. other than expected he did not find evidence for the psychoanalytic concept, but rather unraveled the core assumptions of cognitive therapy. due to his unremitting work, psychological interventions became more evidence-based, client-focused, and accessible to a wide variety of people with different conditions across the globe. today, cognitive behavior therapy (cbt) is the most studied psychotherapy (>2000 studies on cbt) for most mental health problems globally. even more so, his cognitive behavioral theoretical model has led to groundbreaking insights on the etiology, maintenance, and recurrence of psychopathology. dr. beck is not only the founding father of cbt, he also played a crucial role in demonstrating time and time again that research and clinical practice go hand in hand. that is, already in the early years of dr. beck, the concept scientist practitioner was this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6871&domain=pdf&date_stamp=2021-06-18 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ ‘a given’. most people who had the pleasure to see dr. beck on stage will recall his onstage role-plays. without hesitation, until recent times he was always prepared to do a role-play in public at a conference or at events of the beck institute. in each role-play, dr. beck managed to give the audience the impression it was a piece of cake to conduct cbt. we all know better: it requires a lot of training. nevertheless, it is indeed doable with the right amount of practice, which dr. beck was always aware of. one of the greatest achievements of dr. beck together with the beck institute, and probably one of the ingredients of the therapy’s success, is that cbt is highly transferable by training. the worldwide dissemination of cbt demonstrates clearly that cbt is highly transferable, even across different cultures. dr. aaron t. beck received the diamond distinguished contributor psychological interventions award by the eaclipt on a personal note, i vividly remember my first introduction to dr. beck when he received an honorary membership at the dutch association for cbt. i was invited to join for dinner with dr. beck and a small group, and i was shocked to find out i was seated next to him. as a classical dutch person (usually too direct), i had to actively inhibit my urge to immediately confront him with my slightly provocative questions that challenge laudatio for distinguished scholar dr. aaron t. beck 2 clinical psychology in europe 2021, vol. 3(2), article e6871 https://doi.org/10.32872/cpe.6871 https://www.psychopen.eu/ the cbt model. given all the research on inhibition, you will most likely know how hard it can be to inhibit these questions once they are on top of your mind. they can almost become intrusive, and even rebounce once you attempt to suppress them. so, well aware that pure suppression was not an option, i had to choose a more problem-focused approach. therefore, i decided to discuss something completely different with dr. beck to distract my own mind. and what could be more impartial, universal and pleasing, than talking about music? obviously, having my mental set of beck associations activated, i couldn’t think of any other artist than the famous american musician beck. so, my opening line was: “do you know the very popular song loser, in which beck sings ‘i am a loser baby (so why don’t you kill me)’?”. we discussed that the song might indeed be inspired by cbt. could it be that this song could even lead to cognitive restructuring in listeners? taken together, it includes the identification of rigid negative beliefs, evaluat­ ing the evidence, as well as the formulation of alternative beliefs! after this small talk, of course, my suppressed thoughts rebounced – how could they not? fortunately, dr. beck was happy to discuss all my burning questions, as he has always been after. for instance, why not intervene immediately on beliefs/schema level, instead of starting working on thought level before going there? he gave the only right answer: ‘that is an empirical question. you should study it’. this is, most certainly, another way in which dr. beck influenced science and clinicians: transfer curiosity to an empirical question and study it. i indeed did study this, later on in several trials. i can only imagine the large number of people he inspired throughout his life, and continues to do. dr. beck’s lifework is living and still developing. by the way, dr. beck asked me to send him a disk of the song, and i did. he later told me that he didn’t know the song, but liked the idea of using music or other means to evaluate beliefs on a large scale. he was and is more than willing to provide feedback on articles and research. hereby, he teaches us all an important lesson: curiosity should never stop. after all this time, he still serves as an inspiration to the scientific commun­ ity, numerous scientist practitioners, clinicians all over the world. more importantly he contributed and still contributes significantly to reduce human suffering of many individuals all over the world that suffer from mental health problems and mental health conditions. the eaclipt is proud that dr. beck accepts our european ‘diamond distinguished contributor to psychological interventions award’. claudi bockting professor of clinical psychology in psychiatry amsterdam umc/university of amsterdam president of eaclipt bockting 3 clinical psychology in europe 2021, vol. 3(2), article e6871 https://doi.org/10.32872/cpe.6871 https://www.psychopen.eu/ funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. laudatio for distinguished scholar dr. aaron t. beck 4 clinical psychology in europe 2021, vol. 3(2), article e6871 https://doi.org/10.32872/cpe.6871 https://www.psychopen.eu/ starc-sud – adaptation of a transdiagnostic intervention for refugees with substance use disorders latest developments starc-sud – adaptation of a transdiagnostic intervention for refugees with substance use disorders annett lotzin 1,2, jutta lindert 3,4, theresa koch 5, alexandra liedl 5, ingo schäfer 1,2 [1] department of psychiatry and psychotherapy, university medical center hamburg-eppendorf, university of hamburg, hamburg, germany. [2] centre for interdisciplinary addiction research, university of hamburg, hamburg, germany. [3] university of applied sciences, emden / leer, emden, germany. [4] women`s research center, brandeis university, waltham, ma, usa. [5] refugio münchen, munich, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e5329, https://doi.org/10.32872/cpe.5329 received: 2020-12-01 • accepted: 2021-09-05 • published (vor): 2021-11-23 handling editor: eva heim, university of lausanne, lausanne, switzerland corresponding author: annett lotzin, department of psychiatry and psychotherapy, university medical center hamburg-eppendorf, martinistr. 52, 20246 hamburg, germany. phone: +49-(0)40-7410-55356. e-mail: a.lotzin@uke.de related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: data [see index of supplementary materials] abstract background: refugees often suffer from multiple mental health problems, which transdiagnostic interventions can address. starc (skills-training of affect regulation – a culture-sensitive approach) is a culturally sensitive transdiagnostic group intervention that has been developed for refugees to improve affect regulation. in refugees with substance use disorders (sud), the consideration of sud-specific elements might improve the acceptance and effectiveness of such an intervention. we aimed to adapt the starc program for refugees with sud in a culturally sensitive way. method: the conceptual framework of heim and kohrt (2019) was used to culturally sensitively adapt the starc program to the needs of syrian refugees with sud. the results of five focus group discussions with refugees on cultural concepts of sud and their treatment informed the adaption. an expert group suggested adaptions and decided by consensus on their implementation. two pilot groups were conducted with the adapted starc-sud program. interviews with the therapists of these pilot groups informed further adaption. results: the concepts related to sud identified in focus groups and therapists’ interviews that differed from western concepts were integrated into the starc intervention. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5329&domain=pdf&date_stamp=2021-11-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ discussion: further studies should assess the acceptance and effectiveness of the culturally sensitive starc-sud program for refugees with sud. keywords emotion regulation, affect regulation, substance use disorders, addiction, refugees, group treatment, cultural adaption, formative research highlights • the study offers insight into the adaptation process of a culturally sensitive group intervention. • we report the adaptation of a group intervention for refugees with substance use. • cultural concepts of syrian refugees related to substance use are considered in the adaptation. the rising global burden of forced migration is one of the most pressing public health issues (unhcr, 2019). forced migration is related to many stressors that increase the risk for sud, including loss of loved ones, different types of abuse, family separation, social and economic inequality, and discrimination in the host country (horyniak et al., 2016). in refugees, substance use disorders (sud) have received increasing awareness (horyniak et al., 2016), with a prevalence rate of hazardous or harmful alcohol use ranging from 4% to 7% in community settings (horyniak et al., 2016). the availability of substances and the often higher acceptance of substance use in the host country (e.g., drinking alcohol in public) might additionally increase the risk of sud (priebe et al., 2016). while there is a need for sud health care for refugees, this need often is not met (welbel et al., 2013). several barriers to access services exist. lack of knowledge about the mental health care system in the host country prevents access (posselt et al., 2017). in addition, refugees are often required to attend multiple psychosocial services before entering sud treatment, risking disengagement. interpreters are unavailable, or if availa­ ble, the health insurance does not cover the costs (jaeger et al., 2019). additional barriers to accessing sud health services concern different concepts of suffering and sud-related stigma (penka et al., 2012). the lack of knowledge and skills in cultural sensitivity in professionals further contributes to the sud health care gap among refugees. the culturally sensitive adaption of the existing western evidence-based interven­ tions seems central to reduce barriers to mental health care in refugees. the adaption of the language, culture, and context of an intervention to be compatible with the user’s cultural patterns, meanings, and values (bernal et al., 2009) may enhance its acceptability and effectiveness (hall et al., 2016). indeed, evidence has accumulated that cultural adaptations enhance the efficacy of treatments based on western psychotherapeutic ap­ starc-sud – adaptation of an intervention for refugees with sud 2 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ proaches in populations with other cultural backgrounds (anik et al., 2021; chowdhary et al., 2014). as refugees often suffer from multiple mental disorders, the need for evidence-based transdiagnostic treatments has received increasing attention (martin et al., 2018). trans­ diagnostic interventions address mechanisms underlying common mental disorders. such interventions may be preferable to disorder-specific interventions, as therapists can apply them to a group of refugees with heterogeneous symptoms. group therapy with people who have survived the same experience seem to be more effective than individual therapeutic approaches (kira et al., 2012). a few transdiagnostic treatment approaches have been developed for non-western cultures. problem management plus (pm+; dawson et al., 2015) is a five-session low-in­ tensity intervention developed for low and middle-income countries targeting persistent distress and mild symptoms of depression and anxiety (dawson et al., 2015). pm+ was effective in reducing psychological distress (e.g., bryant et al., 2017), but no research ex­ amined its effects on sud. “common elements treatment approach” (ceta) is another brief intervention for common mental health disorders developed for low-resource set­ tings (murray et al., 2014). ceta effectively reduced hazardous alcohol use in an at-risk sample for interpersonal violence in zambia (murray et al., 2020). culturally sensitive evidence-based interventions for refugees in the middleor high-income countries are needed to target sud and other mental disorders in refugees. the starc intervention a culturally sensitive group intervention developed for refugees in the western mid­ dleor high-income countries is starc (skills-training of affect regulation – a cul­ ture-sensitive approach; koch & liedl, 2019). starc is a 14-session culture-sensitive transdiagnostic intervention to improve affect regulation in refugees. the intervention is based on western skills-based elements from skills training in affective and interperso­ nal regulation therapy (stair; cloitre & schmidt, 2015), the dialectic behavioral thera­ py (dbt; bohus et al., 2011), and the culturally adapted cognitive behavioral therapy (ca-cbt; hinton et al., 2011). the authors developed the starc program according to guidelines for developing culturally sensitive interventions (bernal & sáez-santiago, 2006). the manual includes culturally-sensitive metaphors and expressions and uses easy language. a pilot study in afghan refugees indicated preliminary evidence that the inter­ vention reduces difficulties in emotion regulation, general distress, and post-traumatic stress disorder symptoms (koch et al., 2020). difficulties in regulating emotions play a key role in sud (aldao et al., 2010). im­ proving emotion regulation via culturally sensitive interventions such as starc seems essential to reduce substance use and relapse in individuals with sud. such interventions need to address managing emotions effectively to regulate craving when the risk of substance abuse is high. previous research showed that individuals with sud benefited lotzin, lindert, koch et al. 3 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ from tailored emotion regulation interventions that considered their specific needs, e.g., coping with craving beliefs (choopan et al., 2016). while emotion regulation strategies are a centerpiece of the starc intervention, it does not focus on the interrelations between emotion regulation and substance use. adapting the starc intervention for the specific needs of refugees with sud might further enhance its acceptance and effectiveness in this vulnerable group. therefore, the aim of this study was to adapt the starc program for syrian refugees with sud. m e t h o d the adaption of the starc program was conducted in preparation of a randomized controlled trial of the starc-sud program in refugees with substance use problems (schäfer et al., 2020), which is part of a research network on the prevention and treat­ ment of substance use disorders in refugees (prepare, prevention, and treatment of substance use disorders in refugees; bmbf 01ef1805a). the ethics committee of the medical council of hamburg approved this study (pv7123). intervention the starc program (koch & liedl, 2019) was developed in a participatory approach with refugees. starc is a weekly group program conducted with six to eight refugees of the same gender and an interpreter if required. it consists of fourteen 90-min ses­ sions. the program contains four modules: 1) introduction and training of emotional perception; 2) training of specific emotion regulation strategies; 3) dealing with specific emotions, and 4) rehearsal and closure. module 1 aims at improving emotional awareness. emotions and their functions are discussed, and the interrelations between feelings, thoughts, and body reactions are ex­ plained. personal warning signals for different emotional intensities are also introduced. in module 2, emotion regulation strategies are conveyed, including cognitive approaches, body-based strategies, and strategies to cope with intense feelings. in module 3, coping with specific emotions, such as anger or fear, is discussed. in module 4, the group reviews the learned skills and celebrates program completion (for a more detailed de­ scription, see koch & liedl, 2019). procedure of adaption in the current study, we focused on syrian refugees as they represent one of the largest refugee groups in germany. due to restricted resources, we shortened the program to ten sessions. the sessions were reviewed with the authors of starc, sessions with overlapping content were merged. the shortened starc program was extended with sud-specific elements while keeping the basic concept of the program. the starc ses­ starc-sud – adaptation of an intervention for refugees with sud 4 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ sions were adapted by referring to substance use as a dysfunctional emotion regulation strategy throughout the sessions. in addition, we integrated elements used in sud group treatment, such as discussions about the risk and protective factors of sud and the short and long-term consequences of substance use (körkel & schindler, 2003; lindenmeyer, 2016). in accordance with heim and kohrt (2019), cultural concepts of substance abuse were collected as a first step of the cultural adaption process. five focus groups with three to nine refugees were conducted to assess their core assumptions, beliefs, and concepts of sud. the focus group discussions were based on a published interview guideline and followed standard procedures for reporting qualitative studies (lindert et al., 2021). the focus groups included 19 purposively recruited male adult syrian refugees. they were aged 20 to 50 years and lived in germany in metropolitan, urban, or rural areas. a native-speaking professional translator and one facilitator conducted the focus groups. the facilitator was a female phd student in psychology with a background in ethnology. inductive content analysis (mayring, 2014) was applied to analyze the transcribed data and extract common themes. the results of the focus groups with refugees yielded culture-specific information about core assumptions, beliefs, and concepts related to sud and its treatment with refugees. the results of the focus groups were published in a separate paper (lindert et al., 2021). based on the results of the focus groups, three experts proposed adaptions in a standardized adaption sheet. the first expert (second author) was a researcher in the field of migration research; the second expert (first author) was a mental health professional and expert in the field of traumatic stress and psychotherapy research; the third expert was a mental health professional from afghanistan working with refugees with a flight history. in a consensus meeting, the three experts commented on the suggestions of each other and then discussed and decided on the adaptions. in case of disagreement, the suggestion was discussed together until an agreement between the discussants was reached. a starc-sud prototype was created and then piloted in two groups with syrian refugees with sud. the pilot groups were conducted by trained therapists in routine sud care facilities. the therapists had a german background. all content was translated simultaneously during the sessions. after completion of the program, the therapists were invited to an unstructured interview to provide feedback on their experience with the program. the interviews were conducted by a clinical psychologist experienced in the conduction of group therapies. the interviewer noted the key points in the adaption sheet during the interview. these interviews informed further adaption of the program that were documented and consented by the same expert group in a second consensus meeting. all adaptations are described in supplement 1. in accordance with the procedure of heim et al. (2021), this issue, and heim and knaevelsrud (2021), this issue, a standardized lotzin, lindert, koch et al. 5 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ template was used to document the adaptations (see supplement 2). this template in­ cludes the following sections: i) target group; ii) formative research methods; iii) cultural concepts of distress (i.e., idioms of distress, explanatory models); iv) target intervention; v) deep structure adaptations (i.e., specific and unspecific elements and in-session techni­ ques); and vi) surface adaptations (i.e., mode of delivery, materials). r e s u l t s cultural adaption of starc-sud the adapted elements of the starc program are documented in supplement 2, the content of the different sessions of the adapted program is described in supplement 3. 1. unspecific elements the results of the focus group discussions and therapists’ interviews indicated that some refugees were unfamiliar with the western concept of psychotherapy which suggests that individuals solve mental health problems by themselves (rather than within the family) by consulting a mental health professional. in contrast to this approach, some refugees found it more appropriate to solve mental health problems collectively within the family system. hence, we included psychoeducation about the concept of western psychotherapy in the introductory session. furthermore, the therapists stressed that the approach to talk about mental health problems in a group with other patients needed to be introduced. therefore, we included psychoeducation about the group setting as a common intervention approach in western cultures to support and learn from each other in the introductory session. 2. sud-specific elements not all refugees shared the concept of sud as a treatable mental disorder. consequently, we added information on the western concept of addiction as a recognized treatable mental disorder and the availability of professional addiction services to the starc manual. most refugees stressed that rules and norms differed between the host and home country; the greater availability of substances was perceived as contributing to sud. the greater societal acceptance of substance use was frequently mentioned as another reason for sud. thus, we incorporated information about the substances commonly used in the host and home country, as well as their availability and acceptance in the starc-sud program. refugees and therapists reported refugee-specific risk factors for sud, e.g., traumat­ ic experiences in the home countries or during flight, worries about family members that remained in the home country, and not feeling accepted by the host country. refu­ gee-specific risk factors for sud were therefore included in the starc-sud program. starc-sud – adaptation of an intervention for refugees with sud 6 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ in addition to these refugee-specific risk factors, refugees mentioned culture-specific protective factors for not developing sud, such as societal and family norms, and social support. these factors were incorporated into the manual. 3. other specific elements the therapists reported that some of the male refugees hesitated to play a group dynamic game with a ball of wool to get familiar with other group members in the introductory session. these male refugees perceived the game as more appropriate for women. hence, we changed the manual instruction recommending to be sensitive to gender-based pref­ erences regarding group games. some refugees participating in the pilot groups reported being unfamiliar with the relaxation exercises introduced in the program (breathing exercise and progressive mus­ cle relaxation) to regulate tension or intense feelings. rather, they preferred more active strategies (e.g., physical exercises and singing). we adapted the program to instruct the therapists to offer both relaxation exercises and alternative active strategies. according to the therapists’ feedback obtained in the interviews, some participants preferred religious statements of encouragement as a strategy to regulate emotions, while others preferred non-religious statements, as they were non-religious or persecu­ ted for religious reasons. therefore, it was more strongly emphasized in the manual to be mindful in proposing religious rituals, e.g., reading the koran or bible, or talking to god or allah. 4. treatment delivery some refugees with a high level of education found that the easy language used in the starc manual appeared unfamiliar to them. therefore, we added an instruction to the manual that therapists could adapt the complexity of the language according to the language skills and education of the participants. the therapists reported that the translator needed to have read the manual before the session to translate the content correctly. in addition, therapists emphasized the need of having sufficient time to ensure that all participants correctly understood the translation of the session content, e.g., by asking comprehension questions and providing additional information as needed. a briefing of the translators on the translation procedure before the session might also be helpful. therefore, we underlined these aspects more strongly in the introductory part of the program. d i s c u s s i o n based on the focus group discussions with syrian refugees on cultural concepts of sud and its treatment, we integrated elements relevant for the treatment of sud in a culturally sensitive way into the starc program. after piloting the first version of the lotzin, lindert, koch et al. 7 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ starc-sud prototype, we further adapted the program based on interviews with the therapists that conducted two starc-sud pilot groups. unspecific elements we found that some of the refugees were unfamiliar with the western concept to solve mental health problems with a mental health specialist. this finding is in line with the results of previous research showing that the western concept of psychotherapy, i.e., to consult a mental health professional to talk about mental health problems, may be unfamiliar to people from non-western cultures (gopalkrishnan, 2018). earlier research also revealed that provision of knowledge about (western) mental health services and how to access them may increase trust in refugees (duden et al., 2020; sandhu et al., 2013). furthermore, we found that the group setting (vs. individual setting) used for the starc program needed to be introduced in more detail. psychoeducation about the western concept of (psycho-)therapy as a common ap­ proach in german healthcare to cope with mental health problems seems important. this may include discussing the approach to solve problems individually in a professional setting with a health care specialist as an alternative or complementing strategy to collectivistic approaches to enhance understanding, acceptance, and adherence to the program. sud-specific elements in the focus groups that were conducted prior to the cultural adaptation, refugees out­ lined several sud-specific aspects as essential to be incorporated in a culturally sensitive intervention (lindert et al., 2021). these included different concepts and norms for addiction, as well as for substance use, their availability, and acceptance. the finding that some of the refugees were unfamiliar with western concepts of addiction as a recognized and treatable mental disorder is in line with the results of earlier qualitiatve research among afghan populations showing that the concepts of mental disorders, such as de­ pression (alemi et al., 2016) and posttraumatic stress disorder (yaser et al., 2016), differed from those reported by western populations. the acceptance of interventions addressing sud in refugees might be improved by introducing the western concept of addiction as a recognized treatable mental disorder, and by discussing differences and similarities with other concepts of addiction. psychoeducation about commonly used substances, their availability and acceptance in the host and home countries might also increase acceptance and adherence to the intervention. furthermore, our results indicated that refugee-specific risk and protective factors for sud needed to be considered to provide a relevant model of the development of sud, e.g., traumatic experiences or worries about family members. starc-sud – adaptation of an intervention for refugees with sud 8 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ other specific elements gender-specific preferences for dynamic group games needed to be considered in the starc-sud program. previous studies with refugees also reported gender-specific pref­ erences for group therapy content that were related to gender-specific socialization experiences (kira et al., 2012). these results speak to the importance of conducting gender-separated therapy groups. we also found that the type of exercises to regulate emotions needed to be chosen culturally sensitively. a study by somasundaram (2010) indicated that relaxation techni­ ques might be an effective component in treating mental disorders in refugees if they include techniques known and used in the respective culture. the sensitive use of religious content in the program was another important finding of our study. while some refugees perceived religion as a source of strength, others experienced it as a source of threat. these results indicate the need to consider religious content carefully in mental health interventions for refugees. however, in refugees that perceive religion as a source of strength, religious content in a culturally sensitive intervention might be particularly helpful, as religious believes are an integral part of ones’ own understanding of the world in many non-western cultures (machleidt, 2019). consistent with this assumption, relaxation techniques (somasundaram, 2010) and thera­ peutic interventions (hasanović, 2017) including religious content have been perceived as helpful among refuges in previous research. treatment delivery while the easy language used in the program seemed essential to improve the compre­ hensiveness of the program content for non-native speakers, it became clear that easy language could appear artificial for high-educated refugees, indicating the need for indi­ vidual adaption of the used language to the participants of the respective intervention. we also found that the translations improved if the translators read the program sessions beforehand. these findings are consistent with a previous qualitative study by duden et al. (2020), which reported that patients and mental health providers were concerned that not everything said had been translated correctly. the quality of the translation could be increased by having interpreters that familiarize themselves with the session content in advance. our results also indicated that enough time-related resources are needed during the session to ensure that all refugees understood the translated content correctly. overall, this study identified a number of necessary adaptions of a therapeutic in­ tervention, developed within western cultures, to the needs of individuals from other cultural backgrounds. attention should be payed to the clarification of the underlying concepts. for refugees, it might be an unfamiliar concept that speaking about one's problems in groups is appropriate, and learning from others might have healing effects. lotzin, lindert, koch et al. 9 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ moreover, if such therapies include skills-based approaches, there is a need to consider their appropriateness from a gender and culture-sensitive perspective. our results indicate implications concerning offering support for sud in refugees. when adapting western therapeutic approaches to the needs of refugees with sud, western concepts of mental disorders underlying the intervention should be discussed, such as the concept of addiction as a recognized and treatable mental disorder. in addition, the different societal norms for substance use, the types of substances, and their availability and acceptance in the host and home countries should be addressed. limitations there are limitations concerning the methodology of our cultural adaptation. the pro­ gram was culturally adapted by integrating non-western metaphors, opinions from non-western cultures about diseases and healing, and easy-to-understand language. nevertheless, it seems impossible to make psychotherapy a culture-free concept, as it is rooted in the western culture. the database used for our adaption is limited by only considering male refugees. future studies need to examine the appropriateness of the program for female refugees. another limitation is that we did not assess sociodemo­ graphic characteristics except age to guarantee confidentiality for the study participants. conclusion according to the results obtained from focus groups (lindert et al., 2021) and the thera­ pists’ interviews, we adapted several elements in a culturally sensitive way. although the original version of the starc manual had already been developed culturally sensitively (koch & liedl, 2019), further potentially beneficial adaptations could be made from the sources included in the present study. this suggests that qualitative research such as focus groups should be used to inform cultural adaptions of existing interventions to consider the specific needs of a target group, such as refugees with sud. further studies might evaluate whether the cultural and sud-specific adaptions increase the starc-sud intervention's acceptance and effectiveness. funding: this study was funded as a part of a research network on the prevention and treatment of substance use disorders in refugees (prepare, prevention, and treatment of substance use disorders in refugees; bmbf 01ef1805a). acknowledgments: we would like to thank nahid yakmanesh for reviewing, discussing, and consenting to the proposed manual adaptions. we also thank the starc-sud therapists, the participants of the starc-sud groups, and the participants of the focus groups for supporting this research. competing interests: the authors have declared that no competing interests exist. starc-sud – adaptation of an intervention for refugees with sud 10 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • supplement 1 describes the adaptation steps of the starc-sud intervention. • supplement 2 summarizes the results of the focus group discussions with refugees and the interviews with therapists, as well as the adaptations of the starc-sud intervention decided by consensus. • supplement 3 provides an overview of the adapted sessions of the starc-sud intervention. index of supplementary materials lotzin, a., lindert, j., koch, t., liedl, a., & schäfer, i. 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(2016). beliefs and knowledge about post-traumatic stress disorder amongst resettled afghan refugees in australia. international journal of mental health systems, 10, article 31. https://doi.org/10.1186/s13033-016-0065-7 starc-sud – adaptation of an intervention for refugees with sud 14 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://doi.org/10.1371/journal.pmed.1003056 https://doi.org/10.1007/s00103-012-1538-8 https://doi.org/10.1186/s12889-017-4186-y http://www.ncbi.nlm.nih.gov/books/nbk391045/ https://doi.org/10.1007/s00127-012-0528-3 https://doi.org/10.17605/osf.io/nhxd4 https://doi.org/10.17605/osf.io/nhxd4 https://doi.org/10.1080/17542860903411615 https://www.unhcr.org/5b27be547.pdf https://doi.org/10.3109/09687637.2012.706757 https://doi.org/10.1186/s13033-016-0065-7 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. lotzin, lindert, koch et al. 15 clinical psychology in europe 2021, vol. 3(special issue), article e5329 https://doi.org/10.32872/cpe.5329 https://www.psychopen.eu/ starc-sud – adaptation of an intervention for refugees with sud (introduction) the starc intervention method intervention procedure of adaption results cultural adaption of starc-sud discussion unspecific elements sud-specific elements other specific elements treatment delivery limitations conclusion (additional information) funding acknowledgments competing interests supplementary materials references a brief history of aaron t. beck, md, and cognitive behavior therapy editorial a brief history of aaron t. beck, md, and cognitive behavior therapy judith s. beck 1,2, sarah fleming 1 [1] beck institute for cognitive behavior therapy, philadelphia, pa, usa. [2] perelman school of medicine, university of pennsylvania, philadelphia, pa, usa. clinical psychology in europe, 2021, vol. 3(2), article e6701, https://doi.org/10.32872/cpe.6701 published (vor): 2021-06-18 corresponding author: sarah fleming, beck institute for cognitive behavior therapy, po box 2152, bala cynwyd, pa 19004-6152, usa. e-mail: sfleming@beckinstitute.org on july 18th, 2021, the medical and mental health community around the world will celebrate the 100th birthday of aaron t. beck, md. dr. beck is globally recognized as the father of cognitive behavior therapy (cbt) and is one of the world’s leading researchers in psychopathology. since he developed cbt in the 1960s and 1970s, this revolutionary treatment has been found to be effective in over 2000 clinical trials for a wide range of mental disorders, psychological problems, and medical conditions with psychological components. a prolific and productive researcher with a career spanning more than 70 years, dr. beck has published over 600 articles and authored or co-authored 25 books. he is also the recipient of numerous awards, including the 2006 albert lasker award for clinical medical research and the gustave o. lienhard award from the institute of medicine for “outstanding national achievement in improving personal health care services in the united states.” he has dedicated his life to alleviating human suffering through the development of an evidence-based psychological therapy and continues his work to this day. cbt is based on the psychological construct that individuals’ interpretations of situations influence their reaction (emotional, behavioral, physiological), more so than the situation itself. further, people’s interpretations may be distorted, inaccurate or unhelpful, particularly when psychopathology is present. these interpretations, termed “automatic thoughts”, are often linked to maladaptive underlying beliefs that individuals have about themselves, other people, the world, or the future. dr. beck found that when he helped his patients evaluate and change their distorted thinking, they felt better and were able to modify their behavior. when he helped them evaluate and change their underlying beliefs, their improvement was long-lasting. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6701&domain=pdf&date_stamp=2021-06-18 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ dr. aaron t. beck and dr. judith s. beck co-founded beck institute in 1994 photo © 2019 beck institute for cognitive behavior therapy t h e d e v e l o p m e n t o f c o g n i t i v e t h e r a p y as a young psychiatrist in the 1950s, dr. beck wholly subscribed to the dominant psy­ chotherapeutic modality at the time: psychoanalysis. his earliest research sought to vali­ date psychoanalytic constructs. he was surprised when his research appeared to refute the underlying tenets of psychoanalytic theory. rather than confirm the psychoanalytic theory that depressed clients felt an innate need to suffer, dr. beck’s initial studies with depressed patients seemed to point to underlying negative beliefs associated with loss and failure. he soon began to understand that these underlying beliefs were consistent with the patients’ automatic thoughts, which could be accessed and collaboratively eval­ uated in session. dr. beck moved his patients from the couch to a chair, where he worked with them to examine their automatic thoughts and identify cognitive distortions. by helping patients correct negative information processing biases, he was able to help them feel better and engage in more adaptive behaviors. he called his new therapy “cognitive therapy”. in 1977, the results of the first major clinical trial comparing cognitive therapy to anti-depressant medication were published (rush et al., 1977). cognitive therapy became the first talking therapy shown to be more efficacious than medication for the treatment of depression. when a second study, conducted in the uk and published in 1981, appeared to replicate the results (blackburn et al., 1981), interest in the approach grew nationally and internationally. a brief history of aaron t. beck, md, and cognitive behavior therapy 2 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://www.psychopen.eu/ dr. aaron t. beck and the dalai lama photo © 2019 beck institute for cognitive behavior therapy dr. beck (and colleagues) began to apply cognitive therapy to other disorders, such as anxiety, personality disorders, substance use, and suicidality. he developed a comprehen­ sive theory of psychopathology that provided the basis for treatment and methods to evaluate the validity of his theories and the efficacy and effectiveness of the therapy. for each new condition, he would begin by making clinical observations, identifying typical maladaptive beliefs associated with the disorder. he often developed scales and instruments to assess these beliefs. he would then develop a treatment to target the dys­ functional beliefs and associated maladaptive behavioral strategies. the therapy would be validated using a randomized controlled trial, then disseminated in the literature so that others could study, practice, and refine the treatment (beck, 2019). other researchers followed suit. in the uk, for example, a group at oxford used a similar method to devise and test cognitive therapy treatment protocols for panic disorder, social anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder (clark, 1986; clark & wells, 1995; salkovskis, 1999; ehlers et al., 2005). cognitive therapy was also successfully applied to eating disorders, couples’ problems, anger and hostility, psychosis, and other mental health problems. it was also successfully applied to children, adoles­ cents, adults, and older adults in a variety of settings, including hospitals, outpatient clinics, residential placements, schools, and prisons. beck & fleming 3 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://www.psychopen.eu/ dr. aaron t. beck at the beck excellence summit photo © 2019 beck institute for cognitive behavior therapy additionally, researchers found that patients with medical conditions can benefit from cognitive therapy, or cognitive behavior therapy (cbt), as it is known today. in many cases, cbt can help reduce symptoms. in other cases, cbt can help patients cope better with their conditions. research has shown that patients with scores of medical problems from dementia and insomnia to irritable bowel syndrome, migraine headaches, obesity, and chronic pain have benefited from cbt. a c h i e v e m e n t s i n c o g n i t i v e t h e r a p y cbt has become the most widely practiced (knapp et al., 2015) and heavily researched (david et al., 2018) psychotherapy in the world. much of its success can be attributed to the careful attention paid to its dissemination and implementation and to the training and credentialing of cbt therapists around the world. to this end, dr. aaron beck and his daughter, dr. judith beck, founded the nonprofit beck institute for cognitive behavior therapy (bi) in 1994. the mission of bi is to improve lives worldwide through excellence and innovation in cbt training, practice, and research. the organization has trained more than 28,000 health and mental health professionals from 130 countries through a variety of in person and virtual programs and distance supervision, including some of the leading researchers in cbt today. all of the organization’s programs operate in service of its mission. one of the largest and most successful implementations of cbt has been the improv­ ing access to psychological therapies (iapt) program. dr. david m. clark, a prominent cbt researcher, who had maintained a close working relationship with dr. aaron beck a brief history of aaron t. beck, md, and cognitive behavior therapy 4 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://www.psychopen.eu/ since he was a doctoral student, partnered with economist lord richard layard to radi­ cally expand access to evidence-based psychological therapies throughout england via a massive overhaul of england’s national health service (nhs). through iapt, dr. clark and his colleagues have trained over 10,500 clinicians in cbt and other evidence-based therapies. as of 2019, one million people pass through the program each year, with over half a million receiving a course of treatment. the program has collected outcome data on 99% of those treated. around seven in every ten treated individuals (67%) show substantial reductions in their anxiety or depression. for five in every ten (51%) the reductions are large enough for the person to be classified as recovered (clark, 2019). by 2024, the iapt program plans to increase its reach from one million to 1.9 million individuals annually. the iapt program has shown that improving public mental health is not only possible but is also cost-effective. the program should serve as a blueprint for countries around the world who want to address the growing global mental health crisis. dr. aaron t. beck and family at his 95th birthday celebration photo © 2019 beck institute for cognitive behavior therapy dr. aaron beck has continued his research into the treatment of psychopathology even until today. he is most passionate about the work he and colleagues at the university of pennsylvania and now at the beck institute undertook two decades ago. they devel­ oped recovery-oriented cognitive therapy (ct-r), which provides concrete, actionable steps to promote recovery and resilience among individuals with serious mental health conditions. ct-r is beginning to change the way severe mental illness is conceptualized and treated. initial research has supported this approach (grant et al., 2012; grant et al., 2017). originally developed to treat schizophrenia, the principles of ct-r can be incorpo­ rated into cbt (j. beck, 2020) and may be especially useful for individuals experiencing beck & fleming 5 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://www.psychopen.eu/ extensive behavioral, social, and physical health challenges. ct-r is highly collaborative, person-centered, and strengths-based, focusing on developing and strengthening positive beliefs of purpose, hope, efficacy, empowerment and belonging (and deemphasizing a focus on symptoms and negative beliefs). this approach has been implemented in a variety of inpatient, residential, and community settings, resulting in the reduction or elimination of controlling interventions such as seclusion, restraint, and as-needed medication, as well as reducing the length of hospital stays for individuals (beck et al., 2020). t h e f u t u r e o f c o g n i t i v e t h e r a p y building on cbt’s demonstrated efficacy, one important continuing challenge for re­ searchers and clinicians is to develop ways to deliver quality cbt treatment to the indi­ viduals who need it most. this involves both adapting treatment for diverse cultures and populations and creating effective and efficient treatment delivery models, including the expansion of digital and online methods of delivery and integrating cbt into primary care settings and public health clinics. it also entails robust and effective training pro­ grams for health and mental health professionals, peer specialists, care givers, teachers, and other groups. dr. aaron beck has devoted his life to alleviating human suffering through his study and application of psychological principles. the cbt community looks forward to honoring his 70-year legacy by continuing to study and disseminate evidence-based cbt around the world. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s beck, a. t. (2019). a 60-year evolution of cognitive theory and therapy. perspectives on psychological science, 14(1), 16-20. https://doi.org/10.1177/1745691618804187 beck, a. t., grant, p., inverso, e., brinen, a., & perivoliotis, d. (2020). recovery-oriented cognitive therapy for serious mental health conditions. new york, ny, usa: guilford press. beck, j. s. (2020). cognitive behavior therapy, third edition: basics and beyond. new york, ny, usa: guilford press. blackburn, i. m., bishop, s., glen, a. i. m., whalley, l. j., & christie, j. e. (1981). the efficacy of cognitive therapy in depression: a treatment trial using cognitive therapy and a brief history of aaron t. beck, md, and cognitive behavior therapy 6 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://doi.org/10.1177/1745691618804187 https://www.psychopen.eu/ pharmacotherapy, each alone and in combination. the british journal of psychiatry, 139(3), 181-189. https://doi.org/10.1192/bjp.139.3.181 clark, d. m. (1986). a cognitive approach to panic. behaviour research and therapy, 24(4), 461-470. https://doi.org/10.1016/0005-7967(86)90011-2 clark, d. m. (2019). iapt at 10: achievements and challenges. https://www.england.nhs.uk/blog/iapt-at-10-achievements-and-challenges clark, d. m., & wells, a. (1995). a cognitive model of social phobia. in r. g. heimberg, m. liebowitz, d. hope, & f. scheier (eds.), social phobia: diagnosis, assessment and treatment (pp. 69–93). new york, ny, usa: guilford press. david, d., cristea, i., & hofmann, s. g. (2018). why cognitive behavioral therapy is the current gold standard of psychotherapy. frontiers in psychiatry, 9, article 4. https://doi.org/10.3389/fpsyt.2018.00004 ehlers, a., clark, d. m., hackmann, a., mcmanus, f., & fennell, m. (2005). cognitive therapy for post-traumatic stress disorder: development and evaluation. behaviour research and therapy, 43(4), 413-431. https://doi.org/10.1016/j.brat.2004.03.006 grant, p. m., bredemeier, k., & beck, a. t. (2017). six-month follow-up of recovery-oriented cognitive therapy for low-functioning individuals with schizophrenia. psychiatric services, 68, 997-1002. https://doi.org/10.1176/appi.ps.201600413 grant, p. m., huh, g. a., perivoliotis, d., stolar, n. m., & beck, a. t. (2012). randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. archives of general psychiatry, 69, 121-127. https://doi.org/10.1001/archgenpsychiatry.2011.129 knapp, p., kieling, c., & beck, a. t. (2015). what do psychotherapists do? a systematic review and meta-regression of surveys. psychotherapy and psychosomatics, 84(6), 377-378. https://doi.org/10.1159/000433555 rush, a. j., beck, a. t., kovacs, m., & hollon, s. (1977). comparative efficacy of cognitive therapy and pharmacotherapy in the treatment of depressed outpatients. cognitive therapy and research, 1, 17-37. https://doi.org/10.1007/bf01173502 salkovskis, p. m. (1999). understanding and treating obsessive—compulsive disorder. behaviour research and therapy, 37, s29-s52. https://doi.org/10.1016/s0005-7967(99)00049-2 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. beck & fleming 7 clinical psychology in europe 2021, vol. 3(2), article e6701 https://doi.org/10.32872/cpe.6701 https://doi.org/10.1192/bjp.139.3.181 https://doi.org/10.1016/0005-7967(86)90011-2 https://www.england.nhs.uk/blog/iapt-at-10-achievements-and-challenges https://doi.org/10.3389/fpsyt.2018.00004 https://doi.org/10.1016/j.brat.2004.03.006 https://doi.org/10.1176/appi.ps.201600413 https://doi.org/10.1001/archgenpsychiatry.2011.129 https://doi.org/10.1159/000433555 https://doi.org/10.1007/bf01173502 https://doi.org/10.1016/s0005-7967(99)00049-2 https://www.psychopen.eu/ a brief history of aaron t. beck, md, and cognitive behavior therapy (introduction) the development of cognitive therapy achievements in cognitive therapy the future of cognitive therapy (additional information) funding acknowledgments competing interests references argentinian mental health during the covid-19 pandemic: a screening study of the general population during two periods of quarantine research articles argentinian mental health during the covid-19 pandemic: a screening study of the general population during two periods of quarantine martín juan etchevers a , cristian javier garay a , natalia inés putrino a , natalia helmich a , gabriela lunansky b [a] faculty of psychology, university of buenos aires, buenos aires, argentina. [b] faculty of psychology, university of amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2021, vol. 3(1), article e4519, https://doi.org/10.32872/cpe.4519 received: 2020-10-05 • accepted: 2021-01-03 • published (vor): 2021-03-10 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: cristian javier garay, pacheco de melo 2549 2c (c1425auc) ciudad autónoma de buenos aires, argentina. e-mail: cristiangaray@psi.uba.ar abstract background: due to the covid-19 pandemic, argentina has been under mandatory quarantine. we have aimed to investigate the state of mental health of the argentine population and the behaviours adopted to cope with mental distress during quarantine. method: an online survey was conducted using a probabilistic sampling technique and stratified according to the geographic regions of the country. the survey covered days 7-11 (n = 2,631) and days 50-55 (n = 2,068) after compulsory quarantine. the psychological impact was measured using the 27-item symptom checklist (scl-27), which provides a global severity index (gsi). an ad hoc questionnaire registered problematic, healthy and other behaviours. two network models were estimated using a mixed graphical model. data from the two periods were compared and analysed. outcomes: higher gsi scores and greater risk of experiencing mental disorder were found in period 2 as compared with period 1. the lowest gsi scores were associated with physical activity in both periods, and meditation and yoga in period 1. drug users reported the highest gsi scores in both periods. the network comparison test confirmed a significant change in symptomatology structure over the two quarantine periods. conclusion: this study showed that psychological symptoms and the risk of experiencing mental disorder increased significantly from period 1 to period 2. network analysis suggested that the quarantine might have brought about changes in the relationships between symptoms. overall this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4519&domain=pdf&date_stamp=2021-03-10 https://orcid.org/0000-0003-2798-7178 https://orcid.org/0000-0003-4082-8876 https://orcid.org/0000-0001-8205-9070 https://orcid.org/0000-0001-5483-9387 https://orcid.org/0000-0001-6226-2258 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ results revealed the relevance of mental health and the need to take mental health actions upon imposing quarantine during the current covid-19 pandemic. keywords covid-19 pandemic, mental health, argentina, quarantine highlights • the length of the quarantine is associated with increased psychological symptoms. • the youngest, the ones with a low income and females reported the most symptoms. • physical activity is less associated with psychological symptoms. • access to mental health assistance is crucial to minimize the psychological impact of quarantine. pandemics are epidemics on a large scale which affect people in multiple countries and which sometimes, as is the case of the current covid-19 pandemic, can spread globally (world health organization [who], 2010). there is a long history of fighting epidemics and pandemics (huremovic, 2019). it is pertinent to highlight that, in the absence of adequate biomedical treatments, behavioural methods such as good hygiene practices and social distancing have been frequently implemented to reduce morbidity and mortality (taylor, 2019). quarantine is the restriction of movement of people who have been exposed to an infectious disease to determine if they have been infected and thus, reduce the risk of spreading the disease. isolation, on the other hand, is the separation of people who have been diagnosed with an infectious disease from those who have not (centers for disease control and prevention [cdc], 2017; hurtado & fríes, 2010). recently, quarantine has been implemented against the coronavirus disease 2019 (covid-19) outbreak. on march 3, argentina confirmed its first covid-19 case. school classes were suspended on march 16 with a strong non-mandatory recommendation for social iso­ lation and, as of march 20, the mandatory quarantine came into effect; exemption was secured for health professionals, security and defence personnel, journalists and media professionals, and the food industry (decreto necesidad y urgencia [emergency decree, argentina], 2020). at the beginning of the quarantine, 30 cases and 3 deaths by covid-19 were confirmed in argentina (ministerio de salud [ministery of health, argentina], 2020). the quarantine was enforced through police controls; city and town limits and provincial borders were closed, resulting in a 54.78% reduction in public transport usage (reaching 86%) (google, 2020). the psychological effects of quarantine have been studied in different past occasions and countries. from previous epidemic and pandemic studies, it appears that the longest quarantine studied was a 21-day quarantine instituted in 2015 in liberia, a country in argentinian mental health during the covid-19 pandemic 2 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ west africa, on account of an ebola virus outbreak. three studies showed that prolonged quarantine was associated with symptoms of post-traumatic stress, avoidance behaviours and anger, among the most prevalent (brooks et al., 2020). also, an association between higher levels of psychological symptoms and low income, job and financial insecurity, and healthcare workers was also established (holmes et al., 2020). studies of recent and dramatic experiences with covid-19 show similar or more serious results. (de girolamo et al., 2020; wang et al., 2020; williams, armitage, tampe, & dienes, 2020). although mental health aspects of the covid-19 crisis play an important role in managing the pandemic, there is a pre-existing lack of mental health research studies in argentina. given factors such as quarantine duration, culture, politics and economic situation are unique to this study. this study, which aims to determine the psychological impact of these factors on the argentine population, was carried out 55 days after imposition of mandatory quarantine and 72 days after the first confirmed covid-19 case. more specifically, it intends to establish the impact of the pandemic and quarantine on psychological symptomatology in the argentine population, and its relationship with certain behaviours, defined as healthy, problematic and others. we also aim to establish whether quarantine duration is related to symptom severity. apart from investigating changes in symptom severity, we are likewise interested in the changes in symptomatol­ ogy structure as well as in the relationships between symptoms and reported healthy and problematic behaviours as the quarantine period is extended. network models are used for studying unique relationships between individual symptoms and the reported behav­ iours (borsboom, 2017; borsboom & cramer, 2013). furthermore, symptom network models show the unique associations between behaviours and symptoms, elucidating the possible pathways via which healthy or problematic behaviours can (negatively or positively) influence specific symptom development (isvoranu, borsboom, van os, & guloksuz, 2016). to this means, we will attempt to identify changes in symptomatology structure and symptom-behaviour relationships between the early and later quarantine phases by constructing a network model of psychological symptoms and behavioural variables. m e t h o d study design and participants we adopted a survey design to assess the impact of covid-19 and quarantine by using an anonymous online questionnaire. the sample was probabilistic and stratified according to geographic regions of argentina and its population distribution (see table 1 and table 2). the online survey was conducted on days 7-11 (from march 27 to 31, 2020) and days 50-55 (may 8 to 12, 2020) of the compulsory quarantine. etchevers, garay, putrino et al. 3 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ table 1 sample characteristics of the period 1 (days 7-11 of quarantine) and 2 (days 50-55 of quarantine) participants’ characteristics period 1 (n = 2631) period 2 (n = 2068) n % n % age 18-20 113 4 119 6 21-29 472 18 321 15 30-39 750 28 439 21 40-49 469 18 661 32 50-59 450 17 280 14 > 60 377 14 248 12 gender women 1210 46 1056 51 men 1421 54 1012 49 educational level primary 143 5 80 4 secondary 1056 40 777 37 vocational 708 28 594 29 higher 724 27 617 30 income low 1201 45 843 41 middle 1281 49 1072 52 high 149 5.5 153 7 table 2 samples’ geographic distribution of the period 1 (days 7-11 of quarantine) and 2 (days 50-55 of quarantine) region period 1 (n = 2631) period 2 (n = 2068) n % n % buenos aires metropolitan area 1159 44 1011 49 buenos aires province 409 16 257 12 córdoba 322 12 257 11 rosario 269 10 178 9 mendoza 246 9 157 8 tucumán 226 9 111 5 neuquén – 132 6 argentinian mental health during the covid-19 pandemic 4 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ psychological symptomatology the psychological impact of covid-19 was measured using the 27-item symptom check­ list (scl-27; hardt & gerbershagen, 2001). the scl-27 has been adapted and well-vali­ dated to the argentine population (castro solano & góngora, 2018). two indexes were calculated: 1) the global severity index (gsi -27), which is the total item mean scores; and 2) the risk of mental disorder index, which included participants who answered over 50% of the items (14 or more out of the 27 items in this instrument) with the options "quite" or "much”; these participants being thus regarded as at risk of developing mental disorders. problematic, healthy and other behaviours through an ad hoc questionnaire, problematic behaviours (alcohol, illegal drug and tobacco abuse), healthy behaviours (sports and physical activity, sex life and religious practice) and other behaviours (use of over-the-counter and prescription drugs, yoga or meditation practice) were registered. associations with these behaviours and their changes during mandatory quarantine were analysed with gsi-27 indicators and the "risk of mental disorder" index provided by scl-27. procedures after completing the informed consent process, participants filled an online question­ naire sent through a social network. it contained a socio-demographic section, the scl-27 (castro solano & góngora, 2018), and an ad hoc questionnaire on healthy, problematic and other behaviours mentioned below. statistical analysis in order to compare the gsi-27 between the two periods, we conducted a paired-samples t-test. in addition, we compared risk of mental disorder and suicidal thoughts in the two periods through the z-test for population proportions. in order to compare the effects of sex, age, and income on gsi in each period, we performed a one-way between-subjects anova. for the purpose of comparing the effects of problematic behaviours (tobacco, drug, and alcohol use), healthy behaviours (sports and physical activity, sex life and religious practice), and other behaviours (medication use, yoga or meditation practice) on gsi in each period, we carried out an independent-samples t-test. in an attempt to examine the relation between yoga practice and the risk of mental disorder, we performed a chi-square test of independence. data were analysed using the statistical package for the social sciences (spss), version 18.0. the network model was estimated with a mixed graphical model (mgm), using the “mgm” implementation in the “bootnet” package in r (epskamp, borsboom, & fried, etchevers, garay, putrino et al. 5 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ 2018; haslbeck & waldorp, 2020). this model combined the use of categorical and gaussian variables which allowed us to combine behaviours and symptoms into one network model. the mgm is not yet available for ordinal data, so we used the “gaussian” option for the 5-point likert scale symptom data, as suggested by haslbeck and waldorp (2020). relationships between variables were statistically estimated based on conditional dependencies of the data. in order to test if symptomatology structure significantly changed from period 1 to period 2, we conducted the network comparison test (nct; van borkulo et al., 2021) by using the “nct” software package in r (van borkulo, epskamp, & millner, 2016). the nct compared the symptom networks from the two periods based on their structure and overall connectivity (i.e., the strength of statistical associations between symptoms). this test cannot be performed on mixed data, which is why we conducted it on symptom networks only containing the scl-27 symptom data (i.e., without behaviours). r e s u l t s 2631 participants completed the online survey in period 1 and 2068 participants comple­ ted it in period 2. psychological symptomatology firstly, it was evaluated if the psychological symptoms differed between period 1 and period 2. in addition, the risk of experiencing a mental disorder and suicidal ideation in both periods was estimated. a significant difference was observed in gsi scores, t(2067) = -50.664, p < .001, between the two periods; period 2 yielding the highest score. we also identified a significant difference between the two population proportions according to the mental health risk index, z = 3.48, p < .01. during period 1, 4.86% of participants were at risk of mental health disorder, while during period 2, 7.2% of participants were at risk. an independent-sample t-test comparing gsi values of individuals with suicidal thoughts and individuals without suicidal thoughts showed a significant difference in period 1, t(2629) = 18.16, p < .001, (individuals with suicidal thoughts [m = 1.9, sd = 0.82] and individuals without suicidal thoughts [m = 0.81, sd = 0.61]). important differ­ ences were also detected in period 2, t(2066) =18.03, p < .001, (individuals with suicidal thoughts [m = 2.96, sd = 0.71] and individuals without suicidal thoughts [m = 1.9, sd = 0.66]). a z-test for population proportions was performed between the two periods for suicidal thoughts (ad hoc question). significant differences were found; period 2 yielding the highest score (z = 3.28, p < .01, period 1 = 4.22%; period 2 = 6.53%). regarding sleep disturbances, period 1 showed that 73.7% of the sample had sleep related problems. in period 2, 76.06% of the sample reported sleep disorders. concerning argentinian mental health during the covid-19 pandemic 6 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ sex life, 43.97% in period 1 and 44.39% in period 2 reported sexual dissatisfaction. no significant differences were observed. see table 3. table 3 screening symptomatology comparing samples of the period 1 (days 7-11 of quarantine) and 2 (days 50-55 of quarantine) measure, index and symptomatology period 1 (n = 2631) period 2 (n = 2068) p mean gsi-27 (sd) 0.85 (0.66) 1.96 (0.71) < .001b scl-27 mental disorder risk 128/2631 (4.86%) 149/2,068 (7.2%) < .01a suicidal thoughts 111/2,631 (4.22%) 135/2,068 (6.53%) < .01a sleep disturbance 1,572/2,631 (73.7%) 1,939/2,068 (76.02%) ns sexual life dissatisfaction 1,157/2,631 (43.97%) 918/2,068 (44.39%) ns note. gsi-27 = global severity index of scl-27; scl-27 = symptom check list-27. scl-27 mental disorder risk = participants who choose score 3 or 4 in at least 50% of the items; ns = not significant. az-test. bt-test. age, sex and income we compared gsi values with socio-demographic characteristics (i.e., age, sex, and in­ come). the lowest gsi values corresponded to the eldest participants in the sample, in both periods, f(5, 2625) = 31.322, p < .001, and f(5, 12.88) = 26.67, p < .001. the highest scores corresponded to women, also in both periods: period 1, t(2618) = 10.77, p < .001, and period 2, t(2055) = 8.91, p < .001. lowest income participants reported the highest gsi scores as compared to middle and highincome participants in both periods: period 1, f(2, 2349) = 29.65, p < .001, and period 2, f(2, 6.82) = 13.45, p < .001). see table 4 for post hoc analysis and descriptive results. etchevers, garay, putrino et al. 7 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ table 4 gsi post hoc comparisons using hsd test on age, sex and income, in period 1 and 2 participants’ characteristics period 1: gsi-27 period 2: gsi-27 m sd m sd age 18-20 1.05 0.06 2.41 0.80 21-29 1.02 0.03 2.18 0.73 30-29 0.96 0.02 2.01 0.74 40-49 0.85 0.03 1.90 0.66 50-59 0.69 0.03 1.84 0.67 60 or more 0.58 0.03 1.68 0.71 sex men 0.77 0.58 1.80 0.66 women 1.00 0.71 2.10 0.73 income low 0.98 0.71 2.06 0.69 middle 0.75 0.59 1.90 0.69 high 0.74 0.59 1.87 0.66 note. in period 1, post hoc comparisons using the tukey hsd test indicated that the mean score for the 18-20 and 21-29 years old subgroups had significantly more symptoms than the 40-49, 50-59, and 60 plus years old subgroups. also, the 40-49 years old subgroups had a higher gsi than the 50-59 and 60 plus years old subgroups. in period 2, the 18-20 years old subgroup had significantly more symptoms than 21-29, 30-39, 40-49, 50-59 and 60 plus years old subgroups. the 21-29 subgroup had significantly more symptoms than 30-39, 40-49, 50-59 and 60 plus years old subgroups. also, the 30-39 years old subgroup had a higher gsi than the 50-59 and 60 plus years old subgroups. the 40-49 years old subgroup had more symptoms than the 60 plus subgroup. in period 1, post hoc comparisons using the tukey hsd test indicated that the mean score for the low-income participants had a significant difference with the middle and high-income participants. in period 2, the low-in­ come participants reported the highest gsi score. low-income participants had a significant difference with the middle and high-income participants. problematic, healthy and other behaviours with respect to problematic, healthy and other behaviours, lower gsi scores were found in individuals who did physical activity both in period 1, t(2629) = -6.63, p < .001, and in period 2, t(2066) = -6.46, p < .001. in a similar manner, lower gsi scores were found in those who practiced meditation in period 1, t(2629) = -3.19, p = .001). again in period 1, lower proportions of participants in the risk of mental health index were associated with the practice of yoga, χ2(1, n = 2630) = 9.94, p < .01. regarding religious practice, we did not find considerable differences. drug users reported the highest gsi scores in period 1, t(2601) = 4.93, p < .001, and period 2, t(2033) = 3.54, p < .001. tobacco users showed higher gsi scores during period 1, t(2629) = -3.76, p < .001). argentinian mental health during the covid-19 pandemic 8 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ alcohol was consumed by 37.51% of participants (n = 987) in period 1 and 41.15% of participants (n = 851) in period 2. 27.43% (n = 271/988) of participants in period 1 and 33.73% (287/851) in period 2 referred that their alcohol consumption had increased. differences were not significant. over-the-counter and prescription drugs were used by 33.33% (n = 877) of partici­ pants in period 1 and 33.12% (n = 686) in period 2. differences were not significant. more participants used prescription drugs for coping with distress (anxiety, “nerves”, relaxation, sleep) in period 2 than in period 1, but we did not find a marked difference. considering mental health care, in period 2, 14.02% (n = 290) of participants were in psychological treatment and 37.55% (n = 668) of responders that were not receiving mental health care considered that they needed treatment but pointed to difficulties in accessing mental health care systems. network analysis figure 1 and figure 2 show the estimated network models for both periods. figure 1 estimated network model – period 1 sports religion meditation yoga sexual medication tobacco alcohol drugs scl1 scl2 scl3 scl4 scl5 scl6 scl7 scl8 scl9 scl10 scl11 scl12 scl13 scl14 scl15 scl16 scl17 scl18 scl19 scl20 scl21 scl22 scl23 scl24 scl25 scl26 scl27 problematic behaviors tobacco: tobacco use alcohol: alcohol use drugs: illicit drugs use healthy behaviors sports: physical/sports activity religion: religious practice sexual: sexual life satisfaction other behaviors meditation: practice of meditation yoga: practice of yoga medication: medication use scl−27 : social phobia scl1: feeling very self−conscious with others scl8: feeling that people are unfriendly or dislike you scl21: feeling inferior to others scl23: feeling uneasy when people are watching or talking about you scl−27 : depression scl2: feeling blue scl5: thoughts of death or dying scl15: feeling hopeless about the future scl22: thoughts of ending your life scl−27 : agoraphobia scl3: feeling afraid to go out of your house alone scl4: feeling fearful scl20: feeling afraid you will faint in public scl25: having to avoid certain things, places or activities that frighten you scl27: feeling afraid in open spaces or on the streets scl−27 : dysthymia scl6: your mind going blank scl7: trouble remembering things scl9: feeling low in energy or slowed down scl24: trouble concentrating scl−27 : vegetative scl10: nausea or upset stomach scl11: hot or cold spells scl13: faintness or dizziness scl16: a lump in your throat scl18: heart pounding or racing scl26: trouble getting your breath scl−27 : mistrust scl12: others not giving you proper credit for your achievements scl14: feeling that people will take advances of you if you let them scl17: feeling that most people cannot be trusted scl19: having ideas or beliefs that others do not share note. the estimated network model includes the scl-27 variables and behavioural variables for quarantine period 1. the nodes in the figure represent the variables, and the lines between the nodes represent the edges, which encode the statistical associations between variables. the colour etchevers, garay, putrino et al. 9 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ of the edges represents the nature of this association: blue edges represent positive associations; red edges represent negative associations. thickness of edges represents the strength of associations. regarding the structure of symptom network models, the network model for period 1 shows that symptoms cluster together according to their domain: this means that the items designed to measure the same domain have indeed strong positive associations amongst each other. figure 2 estimated network model – period 2 sports religion meditation yoga sexual medication tobacco alcohol drugs scl1 scl2 scl3 scl4scl5 scl6 scl7 scl8 scl9 scl10 scl11 scl12 scl13 scl14 scl15 scl16 scl17 scl18 scl19 scl20 scl21 scl22 scl23 scl24 scl25 scl26scl27 problematic behaviors tobacco: tobacco use alcohol: alcohol use drugs: illicit drugs use healthy behaviors sports: physical/sports activity religion: religious practice sexual: sexual life satisfaction other behaviors meditation: practice of meditation yoga: practice of yoga medication: medication use scl−27 : social phobia scl1: feeling very self−conscious with others scl8: feeling that people are unfriendly or dislike you scl21: feeling inferior to others scl23: feeling uneasy when people are watching or talking about you scl−27 : depression scl2: feeling blue scl5: thoughts of death or dying scl15: feeling hopeless about the future scl22: thoughts of ending your life scl−27 : agoraphobia scl3: feeling afraid to go out of your house alone scl4: feeling fearful scl20: feeling afraid you will faint in public scl25: having to avoid certain things, places or activities that frighten you scl27: feeling afraid in open spaces or on the streets scl−27 : dysthymia scl6: your mind going blank scl7: trouble remembering things scl9: feeling low in energy or slowed down scl24: trouble concentrating scl−27 : vegetative scl10: nausea or upset stomach scl11: hot or cold spells scl13: faintness or dizziness scl16: a lump in your throat scl18: heart pounding or racing scl26: trouble getting your breath scl−27 : mistrust scl12: others not giving you proper credit for your achievements scl14: feeling that people will take advances of you if you let them scl17: feeling that most people cannot be trusted scl19: having ideas or beliefs that others do not share note. the estimated network model includes the scl-27 variables and behavioural variables for quarantine period 2. however, this does not apply to the network model for period 2. here, symptoms no lon­ ger cluster together according to their domain and symptom relations are interchanged. results from the nct confirm the change in symptom structure: the structure of the symptom networks changed substantially over the two quarantine periods (p < .01). however, the global connectivity of the symptom networks was not altered (p = .98). this argentinian mental health during the covid-19 pandemic 10 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ means that associations between different symptoms changed significantly over the two periods, but overall associations between symptoms did not increase or decrease. d i s c u s s i o n this study is limited in the sense that participants were recruited through a social network and completed an online survey; therefore, individuals lacking access to the internet or an electronic device, or presenting more severe symptoms, have not been in­ cluded in the sample (pierce et al., 2020). this is particularly important in argentina, as it is a country with high poverty rates (instituto nacional de estadísticas y censos [indec, 2019]). however, the number of registered cell phone users in argentina exceeds its total population. nevertheless, this study is a contribution to the understanding of the mental health impact of covid-19 pandemic and its subsequent mandatory quarantine. this study showed that symptom indicators notably increased as the quarantine was extended. in addition, there is an indication that the risk of mental health disorders is al­ so increased. whereas diffuse symptoms may require lower intensity interventions, deep seated psychological problems call for more complex interventions by mental health professionals. individuals with mental disorders were identified as the most vulnerable group, and the literature endorses the need to approach this group with a more compre­ hensive evaluation (duan & zhu, 2020). the percentage of participants having suicidal thoughts increased greatly from period 1 to 2. this surge is correlated with the increase in clinical psychological symptoms and risk of mental disorder mentioned above. although certain symptoms are expected to increase in such extraordinary circumstances, there is concomitant risk that increased mental disorders lead to pathological behaviours such as self-harm, suicide and domestic violence (holmes et al., 2020). a recent us study on covid-19 and suicide mortality reported the highest rates since 1941 (reger, stanley, & joiner, 2020). preventing suicide risk is a priority which requires immediate interventions and actions (gunnell et al., 2020). in regard to participant’s sex life, our findings were consistent with evidence in the scientific literature which reports higher levels of overall prevalence of psychological symptoms in women compared to men (mazza et al., 2020). in addition to biology-based roles, women in latin america exhibit greater levels of stress on account of the number of tasks they perform and the social pressure to which they are subjected, as well as their exposure to gender discrimination and violence (economic commission for latin america and the caribbean [eclac], 2020). in both periods, younger women reported more symptoms than older women. in argentina, 35.5% of the general population and 42.5% of its youth live below the poverty line (indec, 2020). young people are therefore more vulnerable, have greater job instability, and fewer resources in general. the pre­ existing argentine economic recession has been exacerbated by the adverse economic etchevers, garay, putrino et al. 11 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ effects of the quarantine on the entire population. indeed, our study confirmed that lower income sectors experienced higher risk of mental disorder. this population is more exposed to labour, housing and economic uncertainty, factors that can impede quarantine compliance. hence, the official slogan "stay at home" was adapted to the reality of these vulnerable areas and became: "stay in your neighbourhood". for the middle class sector, monthly rent fees became an additional stressor in the face of financial uncertainty and, in fact, during the quarantine, the argentine government issued a controversial decree for the suspension of payment of rental fees and yet another decree which prohibited dismissals. higher income sectors presented less symptoms possibly resulting from its access to greater resources to face the mandatory restrictive measures for the quarantine period and the loss of income during the pandemic. besides, this social sector has access to health insurance or prepaid health coverage, which can prove crucial during the covid-19 crisis. according to our findings, more than half of the population did not engage in the healthy behaviours considered. furthermore, as quarantine duration kept getting moved, a tendency to dismiss them was observed. it should be borne in mind that the mandatory quarantine during the period studied only allowed people to go outside their homes to get food and medicines. in addition, given that sport facilities and recreational areas remained closed, the population was forced to seek more restrictive alternatives such as video tutorials, online learning and workout classes in small spaces at home. despite the fact that healthy behaviours could decrease the emotional impact of quarantine (e.g., those who did physical activity showed less psychological symptomatology in both periods), only a small percentage of the population resorted to these protective conducts, and this became accentuated as the quarantine progressed. furthermore, the decrease in healthy activities can also be explained as a consequence of the changes in psychological symptomatology. the network analysis conducted provided an insight into the specific relationships between symptoms and behaviours. domain-specific symptoms clustered together during the first period, but were significantly interchanged during the second period. this means that quarantine might have changed the symptom rela­ tionships which govern the specific symptomatology from which participants might suffer. although there was no significant increase in global connectivity (i.e., associations between the symptoms of the network as a whole did not increase), this change in symptomatology structure, where the symptoms decreased in their domain-specific clus­ tering, might indicate a worsening in symptomatology. decrease in model fit regarding underlying symptom clusters has been related to a worsening of depression symptoms (elhai et al., 2013). however, future research should focus on the implications of change in symptomatology network structure on symptom severity. sleep disturbances affected about 75% of participants in both periods of this study. sleep problems are highly prevalent in both anxiety disorders and depression. decreased physical activity and low exposure to sunlight in large cities alter sleep cycles. over­ argentinian mental health during the covid-19 pandemic 12 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ sleeping was the most frequent sleep disturbance recorded in period 1 of the study, while insomnia predominated in period 2. regarding sex life satisfaction, almost 45% of participants in the present research reported that their sex life worsened during both period 1 and 2. in comparison to the previous year, 35% considered that their sex life had deteriorated (etchevers, garay, castro solano, & fernández liporace, 2019). sexuality is regarded as a healthy behaviour, together with physical activity and social life. diminished sex life is associated with discomfort rates and widespread social restriction. mandatory quarantine hinders sexual encounters for single or divorced / separated persons. it is to be expected that once the quarantine is over, these bonding difficulties will persist out of fear of contagion. even in consolidated couples, human sexuality can be explained in the tension between presence and absence, which increases fantasy and desire. however, this item should be regarded with caution, because the great majority of respondents preferred not to provide an answer. our results showed that alcohol consumption increased as the quarantine progressed. the same was not observed with respect to tobacco or illegal drugs. consumption of sub­ stances constituted one of the problematic behaviours adopted to deal with psychological distress. although they provide relief by altering the effects of neurotransmitters, thus producing feelings of pleasure or sedation, prolonged use eventually results in general health deterioration. about 40% of participants reported the need for mental health treatment but poin­ ted out to barriers to access mental health care. among the reasons for this, they stressed personal financial problems together with a set of barriers associated with lack of medical coverage and lack of response from nearby health centres. additionally, partial closure of mental health services, which provided only emergency consultations, together with the fact that clinical psychologists have not yet been authorized to resume face-to-face therapy sessions, made it even more difficult for the population to get access to psychological care. to the best of our knowledge, like it was discussed (andersson, berg, riper, huppert, & titov, 2020), the problems that can be effectively addressed through distance modality (i.e., tele-psychiatry or tele-psychology) and there is evidence that digital psychological interventions are moderately effective in low-income and middle-income countries according to a recent meta-analysis (fu, burger, arjadi, & bockting, 2020). although the number of professionals adequately trained in this modali­ ty in argentina have yet to be determined. the percentage of the population having the digital resources to access these approaches has not been established either. improving the population's access to mental health care is a priority at this point in the quarantine. our findings emphasize the need to improve monitoring of the psychological impact of the quarantine and pandemic, and to evaluate crisis interventions or approaches and face-to-face and non-face-to-face treatments in order to identify and implement optimal models. likewise, it is essential to identify the degree of psychological support required etchevers, garay, putrino et al. 13 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://www.psychopen.eu/ by health care workers on the front line and its accessibility since this population is at greater risk of suffering psychological consequences. the general results of this study show the relevance of mental health and the need to take action to protect it when implementing mandatory quarantine measures during the covid-19 pandemic. increased psychological symptomatology and the risk of mental disorder can in turn increase alcohol consumption or other risky behaviours for oneself or others, and medium-term quarantine compliance depends on the level of understand­ ing and emotion regulation ability of the quarantined population. as the covid 19 pan­ demic continues to sweep the world and mandatory quarantine in argentina is extended, more methodologically rigorous studies need to be conducted in order to determine how to reduce their impact on mental health. funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: we appreciate the generous help provided by jorge biglieri, alejandro castro solano, and mercedes fernández liporace. we also express our thanks to gustavo gonzález, edgardo etchezahar, and joaquín ungaretti. r e f e r e n c e s andersson, g., berg, m., riper, h., huppert, j. d., & titov, n. 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(2021). comparing network structures on three aspects: a permutation test. manuscript submitted for publication. argentinian mental health during the covid-19 pandemic 16 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://doi.org/10.1016/s2215-0366(20)30168-1 https://doi.org/10.1007/978-3-030-15346-5_2 https://www.indec.gob.ar/uploads/informesdeprensa/eph_pobreza_01_19422f5fc20a.pdf https://doi.org/10.1093/schbul/sbw049 https://doi.org/10.3390/ijerph17093165 https://www.argentina.gob.ar/salud/coronavirus-covid-19/sala-situacion https://doi.org/10.1016/s2215-0366(20)30237-6 https://doi.org/10.1001/jamapsychiatry.2020.1060 https://www.psychopen.eu/ wang, c., pan, r., wan, x., tan, y., xu, l., ho, c., & ho, r. (2020). immediate psychological responses and associated factors during the initial stage of the 2019 coronavirus disease (covid-19) epidemic among the general population in china. international journal of environmental research and public health, 17(5), article 1729. https://doi.org/10.3390/ijerph17051729 williams, s., armitage, c. j., tampe, t., & dienes, k. (2020). public perceptions and experiences of social distancing and social isolation during the covid-19 pandemic: a uk-based focus group study. bmj open, 10(7), article e039334. https://doi.org/10.1136/bmjopen-2020-039334 world health organization. (2010). what is a pandemic? retrieved from https://www.who.int/csr/disease/swineflu/frequently_asked_questions/pandemic/en/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. etchevers, garay, putrino et al. 17 clinical psychology in europe 2021, vol.3(1), article e4519 https://doi.org/10.32872/cpe.4519 https://doi.org/10.3390/ijerph17051729 https://doi.org/10.1136/bmjopen-2020-039334 https://www.who.int/csr/disease/swineflu/frequently_asked_questions/pandemic/en/ https://www.psychopen.eu/ argentinian mental health during the covid-19 pandemic (introduction) method study design and participants psychological symptomatology problematic, healthy and other behaviours procedures statistical analysis results psychological symptomatology age, sex and income problematic, healthy and other behaviours network analysis discussion (additional information) funding competing interests acknowledgments references title of “ambassador of clinical psychology and psychological treatment” awarded to peter fonagy letter to the editor, commentary title of “ambassador of clinical psychology and psychological treatment” awarded to peter fonagy martin debbané 1,2 [1] faculty of psychology and educational sciences, university of geneva, geneva, switzerland. [2] department of clinical, educational, and health psychology, university college london, london, united kingdom. clinical psychology in europe, 2022, vol. 4(1), article e7781, https://doi.org/10.32872/cpe.7781 published (vor): 2022-03-31 corresponding author: martin debbané, university of geneva fpse, boulevard du pont d'arve 40, 1205 geneva, switzerland. e-mail: martin.debbane@unige.ch professor peter fonagy (obe) leads a career in clinical psychology that epitomizes an integrative approach to the psychological care for children, adolescents and adults, with a continued determination to alleviate mental pain in those suffering from often chronic psychological distress. driven by the ambition of increasing access to quality care for the vulnerable, he has occupied a number of key national leadership positions in the uk, including chair of the outcomes measurement reference group at the department of health, chair of two nice guideline development groups, chair of the strategy group for national occupational standards for psychological therapies and co-chaired the department of health's expert reference group on vulnerable children. his clinical interests centre on issues of early attachment relationships, resilience, social cog­ nition, borderline personality disorder and vi­ olence. drawing from psychoanalysis, develop­ mental psychology, attachment theory as well as cognitive and affective neuroscience, peter fona­ gy puts forward a clinical approach based on evidence as well as best practice, closely articula­ ted to the most recent developments in research on psychopathology and psychotherapy. a ma­ jor focus of his contribution has been an innova­ tive research-based psychodynamic therapeutic approach, mentalization-based treatment, which was developed in collaboration with a number of clinical sites in the uk and usa. he has peter fonagy (2013) this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7781&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0002-4677-8753 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ published over 500 scientific papers, 260 chapters and has authored or co-authored 19 books. embracing communication and collaboration over competition and hostility be­ tween different theoretical frameworks in psychotherapy, his most popular books include “what works for whom” and “affect regulation, mentalization and the development of the self”, which collectively have attracted over ten thousand citations. his recognition as a scientist include fellow of the british academy, the academy of medical sciences, the academy of social sciences and the american association for psychological science, and he was elected to honorary fellowship by the american college of psychiatrists. he has received lifetime achievement awards from several national and international professional associations including the british psychological society, the international society for the study of personality disorder, the british and irish group for the study of personality disorder, the world association for infant mental health and was in 2015 the first uk recipient of the wiley prize of the british academy for outstanding achievements in psychology by an international scholar. peter fonagy’s academic achievements are recognized not only in the uk and in europe, but also at the international level. he is currently head of the division of psychology and language sciences at university college london; chief executive of the anna freud national centre for children and families, london; consultant to the child and family programme at the menninger department of psychiatry and behavioural sciences at baylor college of medicine; and holds visiting professorships at yale and harvard medical schools. most importantly perhaps, peter fonagy’s work influences hundreds of clinical psy­ chologists across many different theoretical approaches to reflect on the common factors leading to salutogenesis, that is, the psychological mechanisms which sustain mental health in the face of the regular and more impactful challenges individuals face across the lifespan. beyond individual and group psychotherapy, peter fonagy advocates for a social and political approach to mental health, and his work underlines the responsibili­ ties we carry as families, communities and political entities to strive to care for each other and be kind to one another. profound humanism can be experienced from peter fonagy’s approach to clinical psychology. he has agreed to share and defend these values as a dedicated ambassador to the european association for clinical psychology and allied disciplines. details on his life and professional trajectories in the media • https://www.theguardian.com/society/2019/apr/27/peter-fonagy-refugee-childpsychologist-anna-freud-centre • https://www.bbc.co.uk/sounds/play/m000dpj2 ambassador of clinical psychology and psychological treatment: peter fonagy 2 clinical psychology in europe 2022, vol. 4(1), article e7781 https://doi.org/10.32872/cpe.7781 https://www.theguardian.com/society/2019/apr/27/peter-fonagy-refugee-child-psychologist-anna-freud-centre https://www.theguardian.com/society/2019/apr/27/peter-fonagy-refugee-child-psychologist-anna-freud-centre https://www.bbc.co.uk/sounds/play/m000dpj2 https://www.psychopen.eu/ citation from an interview with e. l. jurist (2010, p. 7) p. f.: (…) when we understand the mechanism of a disorder at the level of biology, at the level of neuroscience, we will also understand (…) that the only way to alter those things will be psychological. they will be much more targeted, better targeted, but they will be psychological interventions. e. l. j.: so there’s something ineradicable about the role of psychology. p. f.: we are here for the duration. funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. r e f e r e n c e s jurist, e. l. (2010). elliot jurist interviews peter fonagy. psychoanalytic psychology, 27(1), 2–7. https://doi.org/10.1037/a0018636 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. debbané 3 clinical psychology in europe 2022, vol. 4(1), article e7781 https://doi.org/10.32872/cpe.7781 https://doi.org/10.1037/a0018636 https://www.psychopen.eu/ has the time come to stop using the “standardised mean difference”? scientific update and overview has the time come to stop using the “standardised mean difference”? pim cuijpers 1 [1] department of clinical, neuro and developmental psychology, amsterdam public health research institute, vrije universiteit amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2021, vol. 3(3), article e6835, https://doi.org/10.32872/cpe.6835 received: 2021-05-31 • accepted: 2021-07-25 • published (vor): 2021-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: pim cuijpers, professor of clinical psychology, department of clinical, neuro and developmental psychology, amsterdam public health research institute, vrije universiteit amsterdam, van der boechorststraat 7-9, 1081 bt amsterdam, the netherlands. e-mail: p.cuijpers@vu.nl abstract background: most meta-analyses use the ‘standardised mean difference’ (effect size) to summarise the outcomes of studies. however, the effect size has important limitations that need to be considered. method: after a brief explanation of the standardized mean difference, limitations are discussed and possible solutions in the context of meta-analyses are suggested. results: when using the effect size, three major limitations have to be considered. first, the effect size is still a statistical concept and small effect sizes may have considerable clinical meaning while large effect sizes may not. second, specific assumptions of the effect size may not be correct. third, and most importantly, it is very difficult to explain what the meaning of the effect size is to nonresearchers. as possible solutions, the use of the ‘binomial effect size display’ and the numberneeded-to-treat are discussed. furthermore, i suggest the use of binary outcomes, which are often easier to understand. however, it is not clear what the best binary outcome is for continuous outcomes. conclusion: the effect size is still useful, as long as the limitations are understood and also binary outcomes are given. keywords effect size, standardised mean difference, meta-analysis, outcome studies it was a historical event for the field of clinical psychology. in his presidential address to the american educational research association in 1976 in san francisco, gene glass this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6835&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0001-5497-2743 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ not only coined the term “meta-analysis” but he also introduced the basic ideas of modern meta-analyses (hunt, 1997). this event is broadly considered as the starting point of modern meta-analyses (hunt, 1997). since then this method has conquered the field of clinical psychology and beyond, and meta-analyses have become the standard for integrating the results of multiple studies on the same research question into one estimate of the effects or associations. meta-analyses are now considered to be the gold standard for estimating the effects of interventions and are at the basis of treatment guidelines for mental health and other problems as well as policy recommendations about treatments. glass brought forward two basic ideas that are at the core of modern meta-analyses. the first idea he brought forward was the ‘standardized mean difference’, or what is often called the ‘effect size’. the effect size indicates the difference between two condi­ tions after the intervention in terms of standard deviations instead of actual scores on an outcome instrument. this makes the outcomes ‘standardised’ and therefore they can be compared across studies. the other basic idea of meta-analyses that glass brought forward was that these standardised outcomes can be pooled across studies, while weighting them based on the size of the samples. this pooling of the standardised outcomes results in one overall estimate of the true effect size across multiple studies. it is now 45 years ago that these two basic ideas were introduced. the second idea, the pooling of outcomes according to the size of the study, has hardly been disputed since the introduction by glass. but the idea of the standardised mean difference has been more controversial over the years. in this paper, i will focus on the standardised mean difference. i will discuss whether this is still the best way of indicating the out­ comes of interventions or associations between variables or whether it is better to start using binary outcomes instead. i will call the standardised mean difference the ‘effect size’ which is in fact not correct (higgins & green, 2011), but i will still do that to increase the readability of this paper. t h e e f f e c t s i z e it was a brilliant idea to indicate the difference between two groups in terms of the standard deviation of the outcome measure, instead of the actual difference in scores between the groups. this not only allows to compare these outcomes across different studies regardless of the outcome instrument used, but it also gives an indication of the size of the effect. previous research often only indicated whether the difference between two groups was significant or not. however, that is not very informative and does not say anything about the size of the difference. whether or not a difference is significant depends on the size of the sample, and even a tiny difference becomes significant when the sample size is large enough. the effect size solved this problem, because it goes beyond significance levels and indicates how large the difference is. cohen suggested has the time come to stop using the “standardised mean difference”? 2 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 https://www.psychopen.eu/ that an effect size of 0.2 should be considered as small, 0.5 as moderate and 0.8 as large (cohen, 1988). however, the use of effect sizes also has several important limitations. one important limitation is that it is still a statistical concept. it may indicate the strength of an outcome, but it still cannot say anything about the clinical relevance of the outcome (cuijpers, turner, koole, van dijke, & smit, 2014). the clinical relevance of an effect size depends on the content. for example, an effect size of 0.1 would be considered a major breakthrough if years to mortality would be the outcome. and effect size of 0.1 with “knowledge of depression” as outcome, however, would be considered trivial by most people. this means that the categories of small, moderate and large effect sizes, as given by cohen (1988) may be misleading because the effect size depends too much on what the outcome actually is. it should be noted that this was fully acknowledged by cohen. one solution to the problem that the effect size is a statistical concept, could be the use of the ‘minimal clinically important difference’ (mcid; mcglothlin & lewis, 2014). the mcid is the smallest difference in score considered clinically worthwhile by the patient and it captures both the magnitude of improvement and the value the patient places on that improvement. for example, it was found in one study that a reduction of 17.5% from baseline to post-test on the bdi-ii can be considered as the minimal clinically important difference (button et al., 2015). currently, it is also possible to convert different measures into one common metric (e.g., wahl et al., 2014), making the use of the effect size no longer needed. the effect size has other problems. for example, it assumes that different outcome scales are linear transformation of each other and the standard deviation units are indeed the same across all studies (cummings, 2011). these assumptions do not necessarily need to be true in all situations. furthermore, the effect size may be influenced by how narrow the inclusion criteria are (cummings, 2011). if a trial only includes participants with a narrow severity range at baseline, it can be expected that the distribution of the severity at post-test is also relatively narrow. if patients with a broader severity range are included, the distribution of severity will be broader as well. this implies that if two trials, one with a narrow severity range and one with a broad severity range, show the same absolute difference (points on a severity scale), the effect size can still vary widely, because the distribution differs across the two studies. w h a t d o e s t h e e f f e c t s i z e m e a n ? the most important problem of the effect size is, however, that it is so difficult to explain what it exactly means to non-scientists. imagine a patient who considers to accept a treatment and asks the clinician what the chances are to get better after treatment. the clinician will have to say something like “if you get the treatment you will score 0.5 standard deviation lower on the outcome measure than not receiving the intervention”. cuijpers 3 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 https://www.psychopen.eu/ of course a patient has no clue for what this actually means, and many clinicians also find it hard to understand what it means. there are some solutions to this problem. one older solution is to transform the effect size into the ‘binomial effect size display’ (besd) (rosenthal & rubin, 1982). the besd reduces an outcome to a simple dichotomy (for example whether a score is below or above the mean on the outcome instrument) and indicates the difference between the two treatment groups (e.g., therapy and control) in percentages of participants who score below (or above) the mean (randolph & edmondson, 2005). for example, an effect size of 0.2 indicates a difference of 0.10 in the proportion of participants reaching this threshold. one could say that such a value of the besd means that 45% of the control group and 55% of the treatment group had reached the threshold of 'success'. however, this is still a relative outcome and can in no way be interpreted as if 55% of the participants will score below the mean of the outcome measure. another way to make the effect size easier to interpret is to transform it into the number-needed-to-treat (nnt). the nnt indicates the number of patients that have to be treated in order to have one more positive outcome than no treatment (or an alternative treatment) (laupacis, sackett, & roberts, 1988). there are several ways to transform the effect size into the nnt (da costa et al., 2012; furukawa & leucht, 2011), but all are based on the normal distribution of the outcome measure and a cut-off on this normal distribution for a ‘positive outcome’. however, again it is not clear what this ‘positive outcome’ exactly is and the nnt still does not answer the question of the patient what the chances are to get better after treatment. transforming the effect size into the nnt is, however, done by many meta-analyses to make the outcomes easier to interpret from a clinical point of view. m o v i n g t o b i n a r y o u t c o m e s ? binary outcomes are easier to understand than effect sizes. for example, in a trial the re­ searchers can calculate the proportion of participants that respond (for example defined as a 50% reduction in symptoms from baseline to post-test) in the treatment and control group. they can also calculate the proportion of participants who recover completely (for example by scoring below a cut-off on a symptom measure), who reliably improved, or who reliably deteriorated, or dropped out from treatment. these binary outcomes can answer the question of the imaginary patient that we presented earlier very well. the patient will hear an exact chance of getting better after the treatment compared to no treatment. for example, we recently conducted a meta-analysis of psychotherapies for depres­ sion (cuijpers, karyotaki, de wit, & ebert, 2020) and found that the effect size for psychotherapy versus control conditions was g = 0.72, 95% ci [0.67, -0.78]. that is a considerable effect according to the criteria of cohen. but what does it really mean? has the time come to stop using the “standardised mean difference”? 4 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 https://www.psychopen.eu/ what is the chance of getting better for a patient receiving therapy compared to the chance in the control conditions? in another recent meta-analysis, we calculated the ex­ act proportions of response (50% reduction of symptoms between baseline and post-test) (cuijpers, karyotaki, ciharova, miguel, noma, & furukawa, 2021) for psychotherapies with at least 10 trials for which the response rate was reported or could be estimated using a validated method (furukawa, cipriani, barbui, brambilla, & watanabe, 2005). we found that the response rate for psychotherapies was 41% (using the most conservative estimate), while the response rate was 17% in the usual care groups. this is definitely more informative for patients and clinicians than the effect size. it shows for example that about 60% of patients do not respond after therapy and that the proportion of patients responding to usual care is really very low. the effect size gives no indication at all for such outcomes. it just says that the effect are “large”, but this “hides” in a way that the majority of patients still don’t respond to treatment. d i s a d v a n t a g e s o f b i n a r y o u t c o m e s so does this solve the problem? should we all move away from the effect size and instead use binary outcomes? unfortunately, binary outcomes also have problems. maybe the most important problem is that outcomes may be best considered as a continuous phenomenon and not as a binary outcome. one can use binary outcomes that are informative, such as response or remission, but that does not solve the problem that in principle outcomes are still continuous. another problem is that in individual trials binary outcomes have less statistical power to find significant differences between treat­ ment and comparison conditions. furthermore, there is no way to decide what the best binary outcome is. in many trials on psychological treatments the reliable change index (rci) is used (jacobson & truax, 1991), a psychometric criterion used to evaluate whether the change between baseline and post-test is considered statistically significant (the difference between baseline and post-test means divided by the standard error of the difference between the two scores is greater than 1.96, conservatively assuming a cronbach’s alpha of 0.75) (jacobson & truax, 1991). other studies use the response (50% reduction in symptoms from baseline to post-test) or remission (scoring below a cut-off on a rating scale indicating the return to ‘normal’ functioning) as the main outcome. there is no way to decide what the most important binary outcome is and that may therefore vary widely across studies, making meta-analyses of these outcomes more complicated. but it also makes the answer to the question of the patient more complicated. it can be said what the chance of getting better is, but what getting better actually is, is not so clear. another problem with reporting the chance of getting better in the treatment and control conditions is that these chances can be very well reported for individual trials, but pooling them in meta-analyses may be problematic. the problem with exact percen­ cuijpers 5 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 https://www.psychopen.eu/ tages is that when you pool them, the heterogeneity of the outcome is often very high. heterogeneity indicates the variability in the outcomes of the included studies in a meta­ analysis. if heterogeneity is too high that means that the outcomes are too different from each other to allow pooling. and that is typically the case when proportions are pooled. but on the other hand, these outcomes are so important for patients and clinicians, that one could make the case to pool anyway, but always say that the outcomes can vary considerably. usually, binary outcomes in meta-analyses are not reported in terms of absolute per­ centages, because of the high heterogeneity. in most cases binary outcomes are reported in terms of relative outcomes, such as the relative risk (rr) or the odds ratio (or). the or indicates the odds of getting better in the treatment group compared to the control group. this is also difficult to interpret, because it is not immediately clear what the odds are and it can be argued that the or should be avoided as well because it is not clear what it means (higgins & green, 2011). the rr is easier to interpret. an rr of 1.40 for example indicates that the chance of getting better is 40% higher in the treatment group than in the control group. sometimes the nnt is also used. the nnt is actually the inverse of the risk difference (rd). so if 60% get better in the treatment group and only 40% in the control group, the rd is 20% and the nnt is 5 (1/0.20). but all relative outcomes do not answer the question of the patients what the chances are of getting better after the treatment. in order to answer that, it cannot be avoided to give the actual chances. c o n c l u s i o n so should we stop using the effect size and instead move to reporting the proportions of participants who improve in the treatment and the control group? i don’t think that is needed. many studies already give the effect size and one or more binary outcomes. that is probably the best solution. but we should avoid to obscure outcomes by just saying that a treatment is effective and the effect size is large, moderate or small. such a statement can mean many different things. a large effect size can still indicate that many people don’t get better, and a small effect size can be a major breakthrough. it is important to add in trials but also in meta-analyses what the effect sizes exactly mean in terms of relative but also absolute binary outcomes. has the time come to stop using the “standardised mean difference”? 6 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 https://www.psychopen.eu/ funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. twitter accounts: @pimcuijpers r e f e r e n c e s button, k. s., kounali, d., thomas, l., wiles, n. j., peters, t. j., welton, n. j., ades, a. e., & lewis, g. 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(2014). standardization of depression measurement: a common metric was developed for 11 self-report depression measures. journal of clinical epidemiology, 67, 73-86. https://doi.org/10.1016/j.jclinepi.2013.04.019 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. has the time come to stop using the “standardised mean difference”? 8 clinical psychology in europe 2021, vol. 3(3), article e6835 https://doi.org/10.32872/cpe.6835 http://www.handbook.cochrane.org https://doi.org/10.1037/0022-006x.59.1.12 https://doi.org/10.1056/nejm198806303182605 https://doi.org/10.1001/jama.2014.13128 https://doi.org/10.7275/zqwr-mx46 https://doi.org/10.1037/0022-0663.74.2.166 https://doi.org/10.1016/j.jclinepi.2013.04.019 https://www.psychopen.eu/ has the time come to stop using the “standardised mean difference”? (introduction) the effect size what does the effect size mean? moving to binary outcomes? disadvantages of binary outcomes conclusion (additional information) funding acknowledgments competing interests twitter accounts references social media use and mental health in young adults of greece: a cross-sectional study research articles social media use and mental health in young adults of greece: a cross-sectional study epameinondas leimonis 1, katerina koutra 1 [1] department of psychology, school of social sciences, university of crete, rethymno, greece. clinical psychology in europe, 2022, vol. 4(2), article e4621, https://doi.org/10.32872/cpe.4621 received: 2020-10-30 • accepted: 2022-02-08 • published (vor): 2022-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: katerina koutra, department of psychology, school of social sciences, university of crete, gallos campus 74100 – rethymno, crete, greece. telephone: ++30 2810324999/++30 6977357108. e-mail: koutra.k@gmail.com abstract background: social media use has vastly increased during the past few years, especially among young adults. studies examining the relationship of social media use with mental health have yielded mixed findings. additionally, such studies are extremely limited in greece. the present study aimed to investigate the association between social media use, depressive symptoms and self-esteem among greek young adults. method: a total of 654 individuals (50.5% male) aged 18-30 years (μ = 23.62, sd = 2.71) completed self-reported questionnaires regarding social media use, depressive symptoms and self-esteem. results: increased daily use of youtube (more than five hours) showed a significant association with higher depressive symptomatology, b = 2.99, 95% ci [.78, 5.20], p = .008, while daily use of facebook between two and five hours was related to significantly higher self-esteem, b = 1.61, 95% ci [.78, 2.44], p < .001, after adjusting for participants’ gender, age, educational level and employment status. the association of increased daily use of youtube with depressive symptoms was more pronounced in males than in females. moreover, self-reported active use of facebook and instagram were linked with significantly lower depressive symptoms and higher self-esteem compared to passive involvement. conclusion: the results suggest that social media use is closely related to self-esteem and depressive symptomatology in young adults. these findings may contribute to a deeper clinical understanding of the association between electronic social networking and mental health. keywords social media, mental health, self-esteem, depressive symptoms, young adults this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4621&domain=pdf&date_stamp=2022-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • increased daily time spent in youtube (more than five hours) was significantly associated with higher depressive symptomatology. • youtube daily use of more than five hours showed a stronger association with depressive symptoms for males than for females. • daily use of facebook between two and five hours was related to significantly higher self-esteem. • self-reported active use of facebook and instagram were linked with significantly lower depressive symptoms and higher self-esteem compared to passive involvement. electronic social networking is undoubtedly a worldwide technological phenomenon with various extensions in modern human life. through social media people are able to communicate and interact with each other, while they also have the opportunity to develop and share electronic data (ellison et al., 2007; kaplan & haenlein, 2010). during the past few years, social media have become extremely popular, especially among young adults (pew research center, 2015). specifically, 90% of u.s. adults aged 18-29 are frequent users of at least one online social network, while youtube and facebook are the most popular platforms (pew research center, 2019). in greece, almost 60% of total population are involved in social media use (hootsuite & we are social, 2020), while young adults constitute the vast majority of users (belenioti, 2015). similarly to other countries, facebook and youtube are the two most widely used social networks in greece (drosos et al., 2015). due to the fast and constantly increasing penetration of social media in everyday life, their association with mental health has gained considerable attention within the scien­ tific community. recent studies have provided mixed results, either indicating harmful effects of social networks on users’ psychological well-being (e.g. rasmussen et al., 2020; sujarwoto et al., 2019) or suggesting non-significant associations (e.g. coyne et al., 2020). social media users facing mental health difficulties appear to experience both benefits, such as easy social interaction, access to peer support, increased involvement in various services, and negative consequences, including increased symptoms and exposure to aggressive online behaviour (naslund et al., 2020). overall, international research has showed that social networking can affect mental health both positively and negatively (sharma et al., 2020). depression is a mood disorder considered as the primary cause of disability and one of the most common causes of death between the ages of 15 and 29 years, since it is responsible for more than 800,000 annual suicides (world health organization, 2020). the relationship between social media use and depression has been in the spotlight of research for about a decade, with many studies suggesting that increased involvement in online social networking is associated with higher levels of depressive symptomatology (ivie et al., 2020; mcdougall et al., 2016; pantic et al., 2012; woods & scott, 2016). elon­ social media use and mental health 2 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ gated daily time spent in social media has been linked to higher odds of depression in young adults (lin et al., 2016), while the use of multiple social networking platforms has been related to increased depressive symptoms (primack et al., 2017). in a recent study, the reduction of time spent in social networks was linked to significantly less negative mental health outcomes, including less depressive symptoms, in young adults (hunt et al., 2018). social comparison has often mediated the aforementioned associations (e.g. brown & tiggemann, 2016; lup et al., 2015), while envy has displayed a mediating effect on the relationship between social comparison and adult users’ depressive symptoms (wang et al., 2020). finally, addiction to social media has been significantly associated with depression (donnelly & kuss, 2016). despite what appears to be evidence for a negative association between social media and depressive symptomatology, other studies have showed that social media use can have positive effects on individuals’ well-being. communication and interaction through these networks have been found to contribute to an increase in social capital and, thus, a reduction in depressive symptoms (bessière et al., 2010; de la peña & quintanilla, 2015; ellison et al., 2007). platforms such as snapchat, twitter, instagram and facebook provide opportunities for participation in positive social interactions among various sources of social support, which can alleviate depressive symptoms (bessière et al., 2010). moreover, these platforms may help people form connections with other individuals suffering from stigmatised health conditions such as depression (merolli et al., 2014). in a similar vein, active use of social networks (e.g. sharing content and communicating with other users) has been linked with decreased depressive symptoms and pertinent outcomes compared to passive use (e.g. avoiding posting new content, visiting other users’ profiles and following their posts) (escobar-viera et al., 2018; verduyn et al., 2015). in general, the relationship between social media use and depressive symptoms appears to be complicated and influenced by various individual and psychosocial factors (baker & algorta, 2016). previous studies have suggested a negative association between depressive symptoms and self-esteem (conti et al., 2014; franck et al., 2007). self-esteem is defined as the subjective way in which individuals perceive their personal value (macdonald & leary, 2012). with respect to the association between social media use and self-esteem, findings appear to be mixed. specifically, recent research indicates that increased involvement in social networks is linked to lower self-esteem in adolescents and young adults (e.g. bergagna & tartaglia, 2018; vogel et al., 2014; woods & scott, 2016). on the contrary, some researchers have found that social media use is related to higher self-esteem (e.g. gonzales & hancock, 2011; wilcox & stephen, 2013). two mechanisms that seem to ex­ plain or mediate such relationships include the kind of feedback that users receive from online social networks (valkenburg et al., 2017; valkenburg et al., 2006) as well as social comparison (bergagna & tartaglia, 2018; vogel et al., 2014). moreover, cyberbullying through social media has been related to lower self-esteem levels (palermiti et al., 2017). leimonis & koutra 3 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ little research has been conducted so far regarding electronic social networking and aspects of mental health in the greek population. recent findings suggest that almost 34% of greek adolescent users report intense activity in social networks, while approximately 10% display problematic use, which refers to addictive behaviour (boer et al., 2020). with regard to greek young adults, excessive social media use has been linked with higher levels of loneliness and decreased life satisfaction (vasilikou, 2016). in addition, excessive use of social networking sites has been significantly associated with personality factors, such as neuroticism, along with increased depressive sympto­ matology in young greeks (giota & kleftaras, 2013). although little research has been conducted, recent findings have suggested that the frequency of social media use, such as facebook, is not associated with self-esteem in adolescents (botou & marsellos, 2018). however, cyberbullying has been related to low self-esteem in university students of greece (giovazolias & malikiosi-loizos, 2016). there is considerable evidence that social media use is linked with mental health, including depressive symptomatology and self-esteem, positively or negatively (e.g. bessière et al., 2010; lin et al., 2016). however, approximately half of previous studies have examined social media use in general (schønning et al., 2020), and many of them as a single variable, without providing results regarding the use of different platforms (e.g. escobar-viera et al., 2018; lin et al., 2016; woods & scott, 2016). studies assessing the use of specific social networks in relation to mental health outcomes have focused mainly on facebook (e.g. bergagna & tartaglia, 2018; wilcox & stephen, 2013). furthermore, the amount of greek data concerning the relationship between social networks and human behaviour is extremely limited. taking into consideration the above-mentioned gap in the literature, the aim of the present study was to investigate the association of different popular social media with self-esteem and depressive symptoms in a large greek sample of emerging adults. we hypothesised that increased time of social media use was significantly associated with higher depressive symptoms and lower self-esteem in young adults. we, also, hypothesised that active social media users would have lower symptoms of depression and higher self-esteem compared to passive social media users. m e t h o d participants to be eligible for inclusion in the study, participants had to meet the following criteria: (i) to be between 18 and 30 years old, (ii) to use at least one electronic social network, and (iii) to have a good understanding of the greek language. the sample included 654 young adults (50.5% male and 49.5% female) aged 18-30 years (μ = 23.62, sd = 2.71). the vast majority of them were greek (98.9%) and residents of urban areas (94.3%). the sample composition of participants’ highest level of education completed was: 58.3% social media use and mental health 4 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ high school/vocational education and training, 33.9% university/college degree, and 7.8% postgraduate studies. furthermore, 98.6% of the participants were unmarried and 59.9% reported a low monthly income (up to 500€). regarding employment status, 59.5% of participants were not working. the sociodemographic characteristics of the participants are presented in table 1. table 1 sociodemographic characteristics of participants and associations with depressive symptoms and self-esteem (n = 654) sociodemographic variables depressive symptoms self-esteem n % m sd p m sd p gender .330 .140 male 330 50.5 9.24 7.98 30.86 4.59 female 324 49.5 9.85 8.18 30.31 4.97 nationality .514 .079 greek 647 98.9 9.50 7.99 30.62 4.79 other 7 1.1 13.29 14.44 27.43 3.74 place of origin .086 .496 urban 527 80.6 9.28 8.09 30.65 4.78 rural 127 19.4 10.65 7.96 30.33 4.81 place of residence .167 .483 urban 617 94.3 9.43 8.11 30.62 4.81 rural 37 5.7 11.32 7.27 30.05 4.43 educational level .396 .610 high school/v.e.t. 381 58.3 9.85 8.25 30.67 4.61 university/college 222 33.9 8.94 7.49 30.36 5.01 postgraduate studies 51 7.8 9.88 9.19 30.98 5.09 employment status .191 .448 working 265 40.5 10.04 8.23 30.76 5.03 non-working 389 59.5 9.20 7.96 30.47 4.62 net monthly income .396 .051 0 € 500 € 392 59.9 9.70 8.35 30.29 4.73 > 500 € 249 38.1 9.15 7.49 31.05 4.86 marital status .097 .814 unmarried 645 98.6 9.60 8.10 30.59 4.81 married 9 1.4 5.11 5.09 30.78 2.28 m sd minmax r p r p participants' age 23.62 2.71 18–30 -.043 .273 .058 .139 note. t-test and anova were used for differences between continuous variables; pearson’s r was used for correlation between continuous variables. leimonis & koutra 5 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ measures sociodemographic characteristics sociodemographic variables included participants’ gender, age, nationality (greek or other), place of origin and residence (urban vs. rural), educational level that each partic­ ipant had completed (high school/vocational education and training, university/college degree, postgraduate studies), employment status (working vs. non-working), marital status (unmarried vs. married), and net monthly income (0-500€ vs. 501€ and above). social media use we assessed participants’ social media involvement based on daily time use and type of user (active/passive user), influenced by recent studies (escobar-viera et al., 2018; lin et al., 2016). due to the lack of greek standardised psychometric tools concerning the above-mentioned variables, we designed a brief self-reported questionnaire consisting of three items based on a previous study about internet and social media use in relation to consumer behaviour (koutsogiannopoulou, 2013). first, participants were asked whether they had been using social media (“do you use social media?”), responding to an alterna­ tive form question (“yes” or “no”), and provided estimates about their daily use of specific popular platforms, including facebook, twitter, instagram, youtube, tumblr, linkedin, skype, and blogs. four response choices were offered in a likert-type scale (“not at all”, “less than two hours”, “two to five hours”, “more than five hours”). moreover, individuals were asked to characterise their involvement on each one of these networks as “pas­ sive” or “active” after explanation of these two terms was offered. specifically, passive users were considered those who maintained activities such as limited communication and sharing of electronic content, along with passive following of other users’ posts. conversely, individuals who engaged more in interaction with others and sharing of various types of content were considered as active users. to ensure participants’ best comprehension of these patterns of activity, we used definitions and examples based on previous studies (e.g. escobar-viera et al., 2018). self-esteem self-esteem was measured by means of the rosenberg self-esteem scale (rses; rosenberg, 1965). the rses consists of 10 items in form of statements which are related to self-esteem (e.g. “i feel i do not have much to be proud of”). of these statements, five are positively graded (1, 2, 4, 6, 7) and five are negatively graded (3, 5, 8, 9, 10). each individual is asked to respond to a four-point likert scale, ranging from 1 (“strongly disagree”) to 4 (“strongly agree”). total score ranges from 10 to 40 with higher scores indicating higher levels of self-esteem. high self-esteem scores suggest that individuals have self-respect and consider him or herself worthy. low self-esteem scores suggest an unfavorable opinion of oneself and self-dissatisfaction. the scale has been translated and social media use and mental health 6 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ validated for the greek population by tsagarakis et al. (2007). in the present study, the scale demonstrated satisfactory internal consistency (α = .84). depressive symptoms depressive symptomatology was measured using the beck depression inventory-ii (bdiii; beck et al., 1996). the bdi-ii is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (beck et al., 1996), while it taps major depression symptoms according to diagnostic criteria listed in the diagnostic and statistical manual for mental disorders (american psychiatric association, 2000). each item is assessed on a four-point scale (0–3). the total score indicates whether the individual presents a mild, moderate or major depression (possible range 0-63). the bdi-ii has been translated and validated in greek by giannakou et al. (2013). in the present study, the scale showed satisfactory internal consistency (α = .86). procedure participants were recruited through the research team contacting different academic departments, and disseminating a web link to each student which provided details of the study. moreover, non-university student participants were recruited via online posts at social media groups. information about anonymous and voluntary participation was pro­ vided to participants prior to data collection. confidentiality was assured and informed consent was obtained from the participants. finally, participants were given written instructions for filling out the questionnaires and were informed about the estimated time needed for completing the measures (approximately 15 minutes). the study was conducted in accordance with the ethical standards delineated in the 1964 declaration of helsinki and its later amendments or comparable ethical standards. ethical approval was granted by the psychology department’s research ethics committee. informed consent was obtained from all individual participants included in the study. data analysis with regard to descriptive data, we computed percentages of sociodemographic varia­ bles, daily time use of social networks and type of social media use (active and passive use). in terms of descriptive indices, we calculated means (m) and standard deviations (sd) in order to better frame our results. social media use was not assessed as a single numeric variable, since we focused our analyses on daily time of use (less than two hours, two to five hours, more than five hours) and self-reported type of use (passive vs. active). considering that youtube, facebook and instagram showed by far the highest percentages of daily users, our analyses were focused on the specific platforms. t-test and anova were used for the comparison of independent groups. specifically, we employed one-way anovas, including post-hoc comparisons using tukey, to sepa­ leimonis & koutra 7 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ rately investigate differences in depressive symptomatology and self-esteem between categories regarding daily use of youtube, facebook and instagram (less than two hours, two to five hours, more than five hours). moreover, we used independent samples t-tests to assess differences in depressive symptoms and self-esteem between categories concerning self-reported type of youtube, facebook and instagram use (active and pas­ sive). pearson’s r correlation coefficient was used to estimate the strength of the associ­ ation between self-esteem and depressive symptoms. multiple linear regression models were also implemented to further and separately examine the associations of youtube, facebook and instagram use (daily time and type of use) with depressive symptoms and self-esteem, after adjusting for confounding variables. potential confounders related with both the outcome and/or the independent variables in group comparisons with a p-value < .2 were included in the models. therefore, each model was adjusted for participants’ gender, age, educational level and employment status, while estimated asso­ ciations were described in terms of b-coefficients (beta). we were also able to examine effect modification stratifying by gender. for interaction terms, we considered p-value < .05 as nominally significant. all other hypotheses testing was conducted assuming a .05 significance level and a two-sided alternative hypothesis. all analyses were conducted by means of the ibm spss statistics 26 software. r e s u l t s prevalence of social media use in terms of daily time of engagement in social media, youtube was the most popular platform with respect to users (97.6%), followed by facebook (93.3%), instagram (81.8%), blogs (15.9%), skype (12.1%), linkedin (10.9%), twitter (4.3%) and tumblr (3.1%). only 17.7% of the participants reported using some other platform except for the specific ones. overall, 99.4% of the participants were found to use more than one platform daily. concerning the self-reported type of social media use, 65.8% of daily youtube users reported being passive, while 51.3% of daily facebook users mentioned being active. instagram demonstrated the highest self-reported active online engagement (75%). additionally, more than 50% of daily users of blogs, skype, linkedin and twitter stated passive involvement in these platforms, whereas half of tumblr everyday users reported being active. associations between sociodemographic characteristics and study variables tables 1 and 2 show associations between participants’ sociodemographic characteristics and the outcome variables of our study. specifically, non-significant relationships were found between sociodemographic variables, depressive symptomatology and self-esteem social media use and mental health 8 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ at a level of p-value < .05 (table 1). according to table 2, significant differences between men and women were found in terms daily use of youtube, χ2(2, n = 638) = 10.11, p = .006, and instagram, χ2(2, n = 535) = 11.74, p = .003, as well as self-reported type of instagram use, χ2(1, n = 535) = 9.20, p = .002. in addition, participants’ age was significantly related to all social media use variables, while educational level showed significant associations with self-reported type of youtube, facebook and instagram use. employment status was linked with daily use of youtube, χ2(2, n = 638) = 11.17, p = .004, along with self-reported type of youtube, facebook and instagram use. individuals’ net monthly income was significantly associated with daily use of youtube, χ2(2, n = 625) = 6.59, p = .037. table 2 participants’ sociodemographic characteristics and social media use (n = 654) sociodemographic variables social media daily use social media user type youtubea facebooka instagrama youtubeb facebookb instagramb χ2 p c χ2 p c χ2 p c χ2 p c χ2 p c χ2 p c gender 10.11 .006** 4.50 .105 11.74 .003** 3.79 .053 1.51 .219 9.20 .002** nationality 1.58 .455 1.02 .602 1.05 .592 .00 .965 1.99 .160 .00 1.000 place of origin 2.48 .289 .01 .995 1.38 .501 .04 .837 .69 .406 1.36 .244 place of residence 2.07 .356 .16 .923 1.20 .548 .22 .638 .47 .494 .70 .404 educational level 5.41 .247 6.18 .186 5.09 .278 40.78 < .001*** 18.02 < .001*** 16.91 < .001*** employment status 11.17 .004** 1.26 .532 1.55 .461 9.54 .002** 4.78 .029* 4.22 .040* net monthly income 6.59 .037* 1.72 .422 1.81 .405 1.04 .307 2.40 .121 3.11 .078 marital status 2.19 .700 1.00 .911 6.14 .189 .62 .733 1.68 .431 5.72 .057 f p d f p d f p d t p e t p e t p e participants' age 3.78 .023* 5.33 .005** 4.78 .009** 4.77 < .001*** 3.93 < .001*** 4.94 < .001*** aincludes daily use of less than 2 hours, 2-5 hours, and more than 5 hours. bincludes self-reported active user and passive user. cp value derived using chi-square analysis. dp-value derived using one-way anova. ep-value derived using independent samples t-test. *p < .05. **p < .01. ***p < .001. differences in depressive symptomatology and self-esteem by social media groups table 3 shows differences in depressive symptomatology and self-esteem by social media groups. one-way anova results indicated a statistically significant difference in the mean score of self-esteem between the different categories of facebook daily use, f(2, 607) = 6.88, p = .001, η2 = .02. particularly, a post-hoc tukey test showed that individuals who reported two to five hours of facebook everyday use had significantly higher self-esteem (n = 185, m = 31.62, sd = 4.87) compared to those who had been using facebook for less than two hours daily (n = 365, m = 30.04, sd = 4.51, p = .001). leimonis & koutra 9 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ table 3 group differences in depressive symptomatology and self-esteem by social media use (n = 654) social media use depressive symptomatologya self-esteema n m sd f p b η2 m sd f p b η2 youtube daily use 2.94 .053 .01 .35 .703 .00 less than 2 hours 316 9.23 7.59 30.63 4.69 2-5 hours 262 9.33 7.87 30.73 4.68 more than 5 hours 60 11.90 10.31 30.15 5.67 facebook daily use .94 .391 .00 6.88 .001** .02 less than 2 hours 365 9.59 7.98 30.04 4.51 2-5 hours 185 9.03 7.60 31.62 4.87 more than 5 hours 60 10.62 8.56 30.72 5.33 instagram daily use .74 .477 .00 1.00 .370 .00 less than 2 hours 215 9.37 8.07 30.33 4.59 2-5 hours 254 9.69 7.91 30.95 4.91 more than 5 hours 66 10.74 8.35 30.86 5.30 n m sd t p c d m sd t p c d youtube user type .47 .641 .04 -1.56 .119 .13 active users 218 9.32 7.97 31.03 4.96 passive users 420 9.63 8.05 30.41 4.68 facebook user type 2.55 .011* .21 -4.30 < .001*** .35 active users 313 8.73 7.27 31.18 4.75 passive users 297 10.36 8.51 29.75 4.61 instagram user type 3.33 .001** .32 -2.32 .021* .23 active users 401 9.03 7.61 30.97 4.81 passive users 134 11.67 8.91 29.86 4.84 adepressive symptomatology and self-esteem were treated as continuous numeric variables. bp-value derived using one-way anova. cp-value derived using independent samples t-test. *p < .05. **p < .01. ***p < .001. according to t-test results, a significant mean difference was found between self-repor­ ted active facebook users (n = 313, μ = 8.73, sd = 7.27) and passive facebook users (n = 297, μ = 10.36, sd = 8.51), t(583) = 2.55, p = .011, d = .21. there was also a significant difference in depressive symptoms between self-reported active instagram users (n = 401, μ = 9.03, sd = 7.61) and passive instagram users (ν = 134, μ = 11.67, sd = 8.91), t(533) = 3.33, p = .001, d = .32. a significant difference was observed in self-esteem between self-reported active facebook users (ν = 313, μ = 31.38, sd = 4.75) and passive facebook users (ν = 297, μ = 29.75, sd = 4.61), t(608) = -4.30, p < .001, d = .35. likewise, there was a significant difference in self-esteem between active instagram users (ν = 401, μ = 30.97, sd = 4.81) and passive instagram users (ν = 134, μ = 29.86, sd = 4.84), t(533) = -2.32, p = .021, d = .23. finally, self-esteem was significantly and negatively correlated with depressive symptomatology, r(652) = -.55, p < .001. social media use and mental health 10 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ multivariable associations of social media daily use and user type with depressive symptomatology and self-esteem according to multiple linear regression results (table 4), daily youtube use of more than five hours was associated with significantly higher bdi-ii scores, after controlling for gender, age, educational level and employment status, b = 2.99, 95% ci [.78, 5.20], p = .008. the model explained 2% (adjusted 1.1%) of the variance in bdi-ii scores (r 2 = .02). daily use of facebook and instagram showed non-significant associations with depressive symptoms. table 4 adjusted associations of social media daily use and user type with depressive symptomatology and self-esteem (n = 654) modelsa depressive symptomatologyb self-esteemb bc se b 95% cic p bc se b 95% cic p youtube daily use 2-5 hours vs. < 2 hoursd .30 .67 [-1.01, 1.62] .652 .09 .40 [-.70, .88] .819 > 5 hours vs. < 2 hoursd 2.99 1.13 [.78, 5.20] .008** -.45 .68 [-1.78, .89] .512 facebook daily use 2-5 hours vs. < 2 hoursd -.60 .71 [-1.99, .80] .402 1.61 .42 [.78, 2.44] < .001*** > 5 hours vs. < 2 hoursd .70 1.11 [-1.47, 2.87] .525 .83 .66 [-.46, 2.12] .205 instagram daily use 2-5 hours vs. < 2 hoursd .01 .75 [-1.46, 1.47] .995 .82 .45 [-.06, 1.70] .068 > 5 hours vs. < 2 hoursd 1.04 1.13 [-1.17, 3.26] .356 .81 .68 [-.53, 2.14] .236 youtube user type active vs. passived -.60 .69 [-1.96, .75] .383 .64 .41 [-.17, 1.45] .122 facebook user type active vs. passived -1.92 .65 [-3.18, -.65] .003** 1.74 .38 [.99, 2.49] < .001*** instagram user type active vs. passived -3.25 .81 [-4.83, -1.66] < .001*** 1.45 .49 [.49, 2.41] .003** aall models adjusted for participants’ gender, age, educational level, and employment status. bdepressive symptomatology and self-esteem were treated as continuous numeric variables. cb-coefficients and 95% ci of b retained from linear regression. dreference variable. *p < .05. **p < .01. *** p < .001. daily facebook use of two to five hours was associated with significantly higher self-es­ teem, after controlling for gender, age, educational level and employment status, b = 1.61, 95% ci [.78, 2.44], p < .001. the model explained 2% (adjusted 1%) of the variance in depressive symptoms (r 2 = .02). daily use of youtube showed non-significant results regarding self-esteem. leimonis & koutra 11 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ active facebook use was significantly associated with lower bdi-ii scores, after con­ trolling for gender, age, educational level and employment status, b = -1.92, 95% ci [-3.18, -.65], p = .003. the model explained 2% (adjusted 1.5%) of the variance in depressive symptoms (r 2 = .02). likewise, self-reported active instagram use was related to signifi­ cantly reduced depressive symptoms, after controlling for gender, age, educational level and employment status, b = -3.25, 95% ci [-4.83, -1.66], p < .001). the model explained 4% (adjusted 3.4%) of the variance in bdi-ii scores (r 2 = .04). self-reported type of youtube use showed non-significant results concerning depressive symptoms. active facebook use was associated with significantly increased levels of self-esteem, after controlling for gender, age, educational level and employment status, b = 1.74, 95% ci [.99, 2.49], p < .001. the model explained 4% (adjusted 3.4%) of the variance in depressive symptoms (r 2 = .04). similar results were also found concerning active use of instagram, after controlling for gender, age, educational level and employment status, b = 1.45, 95% ci [.49, 2.41], p = .003). the model explained 3% (adjusted 2.5%) of the variance in depressive symptoms (r 2 = .03). self-reported type of youtube use showed non-significant results regarding self-esteem. interaction effect analyses youtube daily use of more than five hours showed a stronger association with depressive symptoms for males than for females (p for interaction = .026). d i s c u s s i o n the present study investigated the association of social media use with self-esteem and depressive symptomatology in young adults. according to the results, increased daily time spent in youtube (more than five hours) showed a significant association with higher depressive symptoms, while daily use of facebook between two and five hours was related to significantly increased self-esteem, after adjusting for gender, age, educational level and employment status. youtube daily use of more than five hours showed a stronger association with depressive symptoms for males than for females. additionally, self-reported active use of facebook and instagram were associated with significantly lower depressive symptoms and higher self-esteem as compared to passive use. in accordance with previous findings from greece (drosos et al., 2015), youtube and facebook displayed the highest percentages of everyday involvement with regard to our sample. moreover, in line with our first hypothesis and previous studies (e.g. lin et al., 2016; pantic et al., 2012), daily youtube use of more than five hours was associated with increased depressive symptomatology. recent research has suggested that youtube, unlike facebook and instagram, has been linked to increased perceived information social media use and mental health 12 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ overload for users due to the great amount of available video content. in addition, information overload in social media has been associated with higher depressive symp­ toms overtime (matthes et al., 2020). on the other hand, depression is often associated with social withdrawal (girard et al., 2014), hence it is possible that individuals with high depressive symptomatology tend to use youtube more in comparison with other platforms, as it encourages less interactive involvement (burgess & green, 2009). we also found that the association of increased daily time use of youtube with de­ pressive symptoms was more pronounced in males than in females. conversely, twenge and martin (2020) have recently indicated that the relationship between increased time of social media use and low levels of psychological well-being is stronger in females. women appear to use social media more in order to sustain their existing relationships compared to men (muscanell & guadagno, 2012), which has been associated with higher self-esteem (wilcox & stephen, 2013). therefore, female users could exhibit lower de­ pressive symptomatology compared to male, given that self-esteem is negatively related to depressive symptoms (conti et al., 2014). additionally, men with increased depressive symptoms have been found to be more susceptible to internet overuse compared to women (liang et al., 2016), which could also apply to social media use. in contrast with our first hypothesis and recent studies (bergagna & tartaglia, 2018; woods & scott, 2016), our results showed that increased daily use of facebook is sig­ nificantly related to higher self-esteem, although the effect size is small. according to walther’s hyperpersonal model of computer-mediated communication (walther, 2007) and previous research (gonzales & hancock, 2011), selective self-presentation on face­ book can lead to higher self-awareness and, therefore, an increase in users’ self-esteem. moreover, individuals focusing on close friendly relationships on social networks have exhibited higher levels of self-esteem (e.g. wilcox & stephen, 2013). a possible mecha­ nism explaining this relationship could be the positive feedback that users receive from their online friends, as it has been related to increased self-esteem levels (valkenburg et al., 2017; valkenburg et al., 2006). this study also indicated that self-reported active use of facebook and instagram are linked with significantly lower depressive symptoms and higher self-esteem compared to passive use. these results correspond to recent findings (escobar-viera et al., 2018; verduyn et al., 2015) and align with our second hypothesis. according to previous re­ search, passive use of social networks has been related to feelings of envy and decreased life satisfaction (krasnova et al., 2013), while envy on social media, such as facebook, has significantly predicted depressive symptoms (tandoc et al., 2015). on the other hand, higher self-esteem has been linked with increased life satisfaction (moksnes & espnes, 2013), and decreased feelings of envy (vrabel et al., 2018). thus, it appears that social comparison as a mechanism might provide explanation concerning our findings, since it could induce feelings of envy, while being related to passive activity in social media (rozgonjuk et al., 2019). furthermore, it is possible that high self-esteem encourages leimonis & koutra 13 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ active behaviour in social media, as previous data has suggested a significant association between decreased feelings of self-worth and passive activities on platforms such as facebook (tazghini & siedlecki, 2013). strengths and limitations to our knowledge, the present study was one of the few focusing on the investigation of the association between social media use and mental health in a greek sample of young adults. the large sample size along with the equal distribution of men and women provided adequate power to detect small effects. additionally, self-esteem and depressive symptomatology were measured via standardised, valid and reliable psychometric tools displaying good psychometric properties with regard to our sample. finally, the simulta­ neous assessment of different social networking platforms, instead of examining social media as a whole or focusing exclusively on a specific platform, was an additional strength of this study. our fine-grained assessment of multiple platforms likely improved our measurement of overall frequency of social media use. we acknowledge that there are also some limitations in our study. given the crosssectional design of the study, we are not able to establish the direction of the observed associations. furthermore, even though both university students from various academic departments and non-university students from different regions in greece were included in our study, generalizability in the greek population may be limited. moreover, due to the lack of a standardised greek scale assessing social media use we used three items with specific artificial categories to measure daily time of social media involvement, which could be a noteworthy limitation as well. a number of methodological studies highlight a substantial loss of information as well as biased estimates when a continuous measure is broken up in artificial categories. it is also important to note that there are many different types of interactions that can be observed over social media, and our study assessed only overall time spent and type of use (active vs. passive) to social media sites. the type of social media use in terms of activity/passivity was examined only through self-reported questions, which could have relied our results and deductions exclusively on participants’ understanding of the terms “passive use” and “active use”. additionally, the assessment of self-esteem and depressive symptomatology through self-reported scales instead of interviewing techniques, combined with our focus on non-clinical population, could restrict the possible clinical extensions of our findings. furthermore, the small effect size reported was obtained in a sample of the general popu­ lation which is expected to underestimate the effect size expected to occur in a clinical sample comprising persons displaying higher variability in self-reported symptom scales such as the bdi-ii and rses, and are in principle more vulnerable to social stressors. additionally, the results from the multivariate linear regression analyses should be inter­ preted with caution given that the explained variance ranges between 1% and 4%; thus, if reported the other way around 96% to 99% of variance is not explained by the predictors social media use and mental health 14 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://www.psychopen.eu/ in that model. finally, although in our regression models we were able to adjust for a large number of confounding factors, because of the observational study design, residual confounding of other unmeasured confounders such as home environment or negative life events may still occur. conclusion the present study showed that there is a significant association between social media use and young adults’ mental health in terms of self-esteem and depressive symptoma­ tology. overall, our results add strength to previous research and could contribute to a deeper understanding of the association between social networks and human behaviour. however, a longitudinal investigation of this association is required to fully understand the temporal relationships aiding early identification of youth at risk and thus effective management of the social media use that lead to negative outcomes in mental health. in addition, future research could further explore gender differences concerning the relationship between social networking and young 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(2020). depression. geneva, switzerland. https://www.who.int/news-room/fact-sheets/detail/depression clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. social media use and mental health 20 clinical psychology in europe 2022, vol. 4(2), article e4621 https://doi.org/10.32872/cpe.4621 https://doi.org/10.26253/heal.uth.4875 https://doi.org/10.26253/heal.uth.4875 https://doi.org/10.1037/xge0000057 https://doi.org/10.1037/ppm0000047 https://doi.org/10.1016/j.paid.2017.11.001 https://doi.org/10.1016/j.chb.2006.05.002 https://doi.org/10.1016/j.jad.2020.03.173 https://doi.org/10.1086/668794 https://doi.org/10.1016/j.adolescence.2016.05.008 https://www.who.int/news-room/fact-sheets/detail/depression https://www.psychopen.eu/ social media use and mental health (introduction) method participants measures procedure data analysis results prevalence of social media use associations between sociodemographic characteristics and study variables differences in depressive symptomatology and self-esteem by social media groups multivariable associations of social media daily use and user type with depressive symptomatology and self-esteem interaction effect analyses discussion strengths and limitations conclusion (additional information) funding acknowledgments competing interests references announcement of the registered report "effect of cultural adaptation of a smartphone-based self-help programme on its acceptability and efficacy" announcements announcement of the registered report "effect of cultural adaptation of a smartphone-based self-help programme on its acceptability and efficacy" eva heim a, sebastian burchert b, mirëlinda shala a, marco kaufmann c, arlinda cerga pashoja de, naser morina f, michael p. schaub f, christine knaevelsrud b, andreas maercker a [a] department of psychology, university of zurich, zurich, switzerland. [b] department of education and psychology, freie universität berlin, berlin, germany. [c] epidemiology, biostatistics and prevention institute, university of zurich, zurich, switzerland. [d] faculty of population health, london school of hygiene and tropical medicine, london, united kingdom. [e] public health england, london, united kingdom. [f ] swiss research institute for public health and addiction, zurich, switzerland. clinical psychology in europe, 2020, vol. 2(3), article e4281, https://doi.org/10.32872/cpe.v2i3.4281 published (vor): 2020-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: eva heim, university of zurich, department of psychology, binzmuehlestrasse 14/17, 8050 zurich, switzerland. phone: +41 (0)44 635 7326. e-mail: e.heim@psychologie.uzh.ch editor's note: this is an announcement of a registered report which received in-princi‐ pal-acceptance (ipa) to be published in "clinical psychology in europe". the study protocol is publicly accessible at https://doi.org/10.23668/psycharchives.3152. in this announcement, a brief summary of the study protocol is presented. in order to narrow the world-wide treatment gap, innovative interventions are needed that can be used among culturally diverse groups, e.g., immigrant populations in high-in‐ come countries. research on cultural adaptation of psychological interventions indicates that a higher level of adaptation is associated with a higher effect size of the intervention. however, direct comparisons of different levels of adaptations are scarce and have not been done with self-help interventions. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v2i3.4281&domain=pdf&date_stamp=2020-09-30 https://doi.org/10.23668/psycharchives.3152 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ aims the registered study will use a smartphone-based self-help programme called step-bystep (albanian: hap-pas-hapi) for the treatment of psychological distress among albani‐ an-speaking immigrants in switzerland and germany. two levels of cultural adaptation (i.e., surface vs. deep structure adaptation) will be compared. we hypothesise that the deep structure adaptation will enhance the acceptance and effect size of the intervention. the deep structure adaptation was done based on an ethnopsychological study to exam‐ ine the target population’s cultural concepts of distress. method in the registered study, we will conduct a two-arm, single-blind randomised controlled trial. participants will be randomly assigned to the surface vs. deep structure adaptation version of hap-pas-hapi (1:1 allocation using permuted block randomization). inclusion criteria are good command of the albanian language, age above 18, and elevated psycho‐ logical distress (kessler psychological distress scale score above 15). primary outcome measures are the total score of the hopkins symptom checklist and the number of participants who completed at least three (out of five) sessions. secondary outcomes are global functioning, well-being, symptoms of post-traumatic stress, and self-defined problems. in addition, we will test a mediation model, hypothesizing that the deep structure adaptation will address fatalistic beliefs and enhance alliance with the self-help programme, which in turn increases the acceptance and effect size of the intervention. and finally, we will measure acculturation and hypothesise, that with higher levels of acculturation, the effect of the deep structure adaptation will diminish. discussion the registered study is the first study to directly compare two different levels of cultural adaptation of an online self-help programme for the treatment of psychological distress among immigrants in high-income countries. we aim to deliver theory-driven and meth‐ odologically rigorous empirical evidence regarding the effect of cultural adaptation on the acceptance and effect size of this self-help programme. funding: the project described in the registered report is supported by the swiss national science foundation (grant 10001c_169780) and the swiss foundation for psychiatry and psychotherapy. competing interests: the authors have declared that no competing interests exist. acknowledgments: the authors have no support to report. registered report announcement 2 clinical psychology in europe 2020, vol.2(3), article e4281 https://doi.org/10.32872/cpe.v2i3.4281 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the study protocol for this registered report is publicly accessible via psycharchives.org (see index of supplementary materials below). index of supplementary materials heim, e., burchert, s., shala, m., kaufmann, m., cerga pashoja, a., morina, n., . . . maercker, a. (2020). effect of cultural adaptation of a smartphone-based self-help programme on its acceptability and efficacy: study protocol for a randomized controlled trial. psycharchives. https://doi.org/10.23668/psycharchives.3152 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. heim, burchert, shala et al. 3 clinical psychology in europe 2020, vol.2(3), article e4281 https://doi.org/10.32872/cpe.v2i3.4281 https://doi.org/10.23668/psycharchives.3152 https://www.psychopen.eu/ standardised research methods and documentation in cultural adaptation: the need, the potential and future steps latest developments standardised research methods and documentation in cultural adaptation: the need, the potential and future steps eva heim 1,2 , christine knaevelsrud 3 [1] institute of psychology, university of lausanne, lausanne, switzerland. [2] department of psychology, university of zürich, zürich, switzerland. [3] department of education and psychology, freie universität berlin, berlin, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e5513, https://doi.org/10.32872/cpe.5513 received: 2020-12-27 • accepted: 2021-06-08 • published (vor): 2021-11-23 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: eva heim, university of lausanne, institute of psychology, géopolis, bureau 4114, 1015 lausanne, switzerland. e-mail: eva.heim@unil.ch related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: materials [see index of supplementary materials] abstract background: refugees and asylum seekers in europe are affected by high prevalence of common mental disorders. under the call ‘mental health of refugee populations’, the german federal ministry of education and research (fmer) funded a series of research projects to test evidencebased psychological interventions among refugee populations in germany. in addition, the “task force for cultural adaptation of mental health interventions for refugees” was established to develop a structured procedure for harmonising and documenting cultural adaptations across the fmer-funded research projects. method: a template for documenting cultural adaptations in a standardised manner was developed and completed by researchers in their respective projects. documentation contained original data from formative research, as well as references and other sources that had been used during the adaptation process. all submitted templates and additional materials were analysed using qualitative content analysis. results: research projects under the fmer call include minors, adults, and families from different origins with common mental disorders. two studies used and adapted existing manuals for the treatment of ptsd. four studies adapted existing transdiagnostic manuals, three of which had already been developed with a culture-sensitive focus. four other studies developed new this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5513&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0001-7434-7451 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ intervention manuals using evidence-based treatment components. the levels of cultural adaptation varied across studies, ranging from surface adaptations of existing manuals to the development of new, culture-sensitive interventions for refugees. conclusions: cultural adaptation is often an iterative process of piloting, feedback, and further adaptation. having a documentation system in place from start helps structuring this process and increases transparency. keywords cultural adaptation, refugees, randomised controlled trials, documentation, monitoring, formative research highlights • a series of evidence-based psychological interventions are tested among refugees in germany. • a structured procedure for harmonising and documenting cultural adaptations was developed. • cultural adaptation is often an iterative process of piloting, feedback, and further adaptation. • documenting the decision-making process, based on evidence from formative research, is key. in view of the increasing numbers of refugee populations worldwide (unhcr, 2020) and the high prevalence of common mental disorders among them (turrini et al., 2017), there is an urgent need for evidence-based mental health interventions to target these populations. according to the world health organization (who, 2017), common mental disorders include depression, anxiety, and posttraumatic stress disorder (ptsd). substantial empirical evidence reveals cultural variation in how symptoms of com­ mon mental disorders are expressed (haroz et al., 2017; kohrt et al., 2014). in addition, culture-specific assumptions about mental health and mental disorders (e.g., grupp et al., 2018; kohrt & hruschka, 2010) and beliefs about treatment and recovery (e.g., reich et al., 2015; shala et al., 2020) have been documented. based on this evidence, the term cultural concepts of distress (ccd) was introduced in the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5, american psychiatric association, 2013). ccd include i) idioms of distress, ii) cultural explanations, and iii) cultural syndromes (lewis­ fernández & kirmayer, 2019). evidence shows that ccd differ from diagnostic categories in the dsm (kohrt et al., 2014). there is an ongoing debate on the extent to which psychological interventions de­ veloped in western, educated, industrialised, rich, and democratic (weird) societies (henrich et al., 2010) require cultural adaptation to be effective for the treatment of common mental disorders among ethnic and cultural minorities. ethnic minorities are generally underrepresented in clinical trials in high-income countries (hussain-gambles standardised research methods and documentation in cultural adaptation 2 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ et al., 2004; la roche & christopher, 2008; wendler et al., 2005), which means that the term ‘evidence-based interventions’ has to be used with caution in this context. for this reason, the who and other groups of researchers increasingly invest in cultural adaptation of psychological interventions prior to testing them in randomised controlled trials (rcts) (e.g., abi ramia et al., 2018; heim et al., 2019; tol et al., 2018). resnicow et al. (1999) differentiate between surface and deep structure adaptations. surface structure adaptations refer to matching materials (e.g., illustrations, language), as well as channels and settings for treatment delivery to observable characteristics of the target population. by contrast, deep structure adaptations convey salience of an intervention by considering how members of a particular cultural group perceive the cause, course, and treatment of a particular illness. several meta-analyses showed that culturally adapted psychological interventions are effective when compared to a variety of control conditions (e.g., chowdhary et al., 2014; griner & smith, 2006). one meta-analysis (hall et al., 2016) found that culturally adapted versions were more effective than the unadapted versions of the same intervention in direct comparison (g = 0.52). and one meta-analysis showed that the adaptation of the ‘illness myth’ (i.e., the explanatory model and the treatment rationale) was the most important factor contributing to higher efficacy of adapted interventions (benish et al., 2011). although the meta-analytic evidence seems promising, it is important to mention that it is based on rather low quality of evidence, caused by the following three specific flaws in prior studies: first, there is a lack of theoretical underpinnings in cultural adaptation literature. most of the literature is based on heuristic frameworks that were developed based on expert opinions and previous studies. a theory-based approach that takes into account literature from the field of cultural clinical psychology and transcul­ tural psychiatry could potentially contribute to a better understanding of what to adapt and why. second, previous frameworks for cultural adaptation have focused on clinical practice (e.g., bernal et al., 2009; castro et al., 2010; chu & leino, 2017; hwang, 2006), but there are no frameworks or guidelines for implementing and documenting cultural adaptations in psychological trials. this is a particularly relevant gap in the literature, as it hinders the replicability and transparency of trials, both of which are increasingly demanded in the scientific realm. in most published studies, adaptation methods are not well documented (harper shehadeh et al., 2016), which leads to a ‘black box’ with regard to how the cultural adaptation was implemented. this lack of documentation also adds to blurring sources of bias when assessing and analysing factors of intervention efficacy. third, and as a consequence of the first two flaws, there is a lack of empirical evidence on the kinds of adaptations that lead to higher acceptability or efficacy of treatments (heim & kohrt, 2019). in order to foster empirical research and replicability, transparent criteria on how to implement and document the process of cultural adaption are needed (heim et al., 2021, this issue). heim & knaevelsrud 3 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ to address the first problem — the lack of theory — heim and kohrt (2019) developed a new conceptual framework for the cultural adaptation of psychological interventions as a basis for empirical research. the authors suggest using ccd as the pivotal element for cultural adaptation and to adapt treatment elements to ccd. treatment elements are defined in accordance with a taxonomy developed by singla et al. (2017). this taxonomy differentiates among specific treatment elements (i.e., interventions based on theoretical assumptions such as behavioural or cognitive treatment elements), unspecific treatment elements (i.e., common factors such as the therapeutic relationship or provid­ ing a meaningful treatment rationale), and therapeutic techniques (i.e., exercises and other interventions that are done to transmit the therapeutic components, such as role plays or homework). in accordance with resnicow et al. (1999), adaptations of specific and unspecific treatment elements are deep structure adaptations. with regard to surface adaptations, heim and kohrt (2019) suggest considering different modes of treatment delivery (e.g., internet-based, face-to-face, and group interventions). in addition, surface cultural adaptations include, for example, modifications to texts, illustrations, or case examples. the present paper addresses the second problem, the lack of documentation. it outlines the work and outcomes achieved by the task force for cultural adaptation of mental health interventions for refugees. this task force was established by a group of researchers from germany and switzerland. in 2016, the german federal ministry of ed­ ucation and research (fmer) launched a call for research proposals covering the ‘mental health of refugee populations’. seven research projects were funded. one exclusively focuses on diagnostics, and the other six projects will test evidence-based psychological interventions. each of those six projects consists of three or more sub-projects, in which different interventions with different target groups are tested, implementation methods are compared, and other aspects such as cost-effectiveness are addressed. a total of 11 rcts (rcts) will be conducted within these six larger projects. these research projects are currently ongoing. a total of 11 rcts will be conducted within these six larger projects. the task force for cultural adaptation of mental health interventions for refugees was launched as a cross-cutting project to harmonise and document cultural adaptation across the 11 sub-projects. the parallel implementation of 11 rcts that include diverse target populations and a variety of interventions offered a unique opportunity to develop and test such a standardised procedure and to consolidate the experiences in a shared learning process. regarding the third problem — the lack of empirical evidence — more consistent doc­ umentation of cultural adaptation procedures will contribute to enhancing transparency and replicability in clinical trials. consistent documentation will also foster meta-analytic evidence, as it will be possible to compare studies with regard to the level (and quality) of cultural adaptation applied in such trials. standardised research methods and documentation in cultural adaptation 4 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ aim the task force for cultural adaptation of mental health interventions for refugees aimed to develop a structured procedure for harmonising and documenting cultural adaptations of psychological interventions in clinical trials. the present paper describes the proce­ dures and outcomes of this joint initiative. m e t h o d procedures the task force started its work in july 2019. it consisted of the coordinator (first author, eh) and representatives of the 11 rcts. representatives were principal investigators and post-doctoral researchers in charge of the cultural adaptation process in each study. in a first step, the coordinator revised the project descriptions and gathered additional information in telephone interviews with representatives of each project. after these initial contacts, a first workshop was held in september 2019 in which the members of the task force agreed on a common procedure to guide and monitor the cultural adaptation process across the 11 projects. thereafter, a series of webinars and conference calls was held between october and december 2019 to discuss upcoming topics in the cultural adaptation process. in a second workshop, which was held in february 2020, all members of the task force presented their results of the cultural adaptation process. experiences were shared and consolidated in small group discussions about specific topics. documentation a template for documenting cultural adaptations in a standardised manner was devel­ oped based on the theoretical framework by heim and kohrt (2019). it consisted of the following sections: i) target group; ii) formative research methods; iii) ccd (i.e., idioms of distress, explanatory models); iv) target intervention; v) deep structure adaptations (i.e., specific and unspecific elements, in-session techniques); and vi) surface adaptations (i.e., mode of delivery, materials). researchers in their respective projects used the tem­ plate to document the cultural adaptation process. this documentation contained origi­ nal data (e.g., gathered through key informant interviews of focus group discussions), as well as references and other sources that had been used during the adaptation process (e.g., published papers on ccd in the target population, pilot studies, or formative work). a revised version of the template can be found in heim et al. (2021), this issue. heim & knaevelsrud 5 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ data analysis all submitted templates and additional materials were entered into an nvivo database and analysed using qualitative content analysis. codes corresponded to the sections of the template (i.e., target group, ccd, elements of the target intervention, etc.). a few sub-codes were developed inductively from the data, where researchers had provided information that did not correspond to one of the sections of the template (e.g., cultural concepts of attachment). data were analysed by the first author (eh). since researchers themselves had allocated information on their projects to the corresponding sections and sub-sections of the template, no second coder was involved in the data analysis. dis­ agreements were clarified between the first author and researchers who had completed the template. r e s u l t s overview of studies an overview of the 11 projects is provided in table 1 in the appendix, supplementary materials). eight of the 11 sub-projects returned the completed templates and additional material. the other three had already completed the cultural adaptation, with limited possibilities to document this process. in four studies, the process of cultural adaptation was documented retrospectively by analysing qualitative data collected during the adap­ tation process that had not been analysed nor published. and four studies adapted their interventions during the course of the present project and documented this process continuously. target populations and disorders the first section of the template contained the target population and the ‘western’ diag­ nostic categories addressed in the respective trials. three studies focused on minors, five on adults, and two on families (i.e., parents and their children). the majority (seven stud­ ies) included refugees from different countries of origin, three studies included afghan and syrian refugees, and one study included arabic-speaking refugees. studies including refugees from different countries of origin developed a ‘culture-sensitive’ rather than a ‘culture-specific’ treatment approach (e.g., lotzin et al., 2021, this issue). across the 11 projects, the targeted disorders were post-traumatic symptoms (five studies), common mental disorders (three studies as primary outcome, and one study as secondary out­ come), and substance use disorder (one study). in addition, one study aimed at increasing knowledge about common mental disorders, psychological resources, and services of care (mewes et al., 2021, this issue). standardised research methods and documentation in cultural adaptation 6 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ formative research methods researchers in the respective projects gathered relevant information for cultural adap­ tation from published literature and through qualitative research. formative research revealed information related to ccd, as well as information regarding the target inter­ ventions themselves (e.g., acceptance, suggestions for adaptations). a literature review was conducted in all but one project. in three studies, information on ccd (i.e., idioms of distress and explanatory models) was gathered through focus group discussions or individual interviews ahead of starting the process of cultural adaptation. cultural concepts of distress results of literature reviews and qualitative research revealed mind–body concepts, idioms of distress, and explanatory models, which are described more in detail in the respective papers in this special issue. in addition to ccd, other related concepts were taken into account: two studies considered assumptions about help-seeking, and one study reported on cultural concepts of attachment. in addition, four studies reported that fatalistic beliefs were relevant in their target populations. and one study also included cultural resources alongside ccd. target interventions the studies varied with regard to their therapeutic approaches. two studies used and adapted existing manuals for the treatment of ptsd. four studies adapted existing trans­ diagnostic manuals, three of which had already been developed with a culture-sensitive focus. four other studies developed new intervention manuals using evidence-based treatment components. cultural adaptations: surface and deep structure the levels of cultural adaptation varied across studies, ranging from surface adaptations of existing manuals to the development of new, culture-sensitive interventions for refu­ gees. other studies conducted deep structure adaptations of existing interventions, such as by adding, changing, or modifying specific treatment components. in addition, several studies considered the mode of delivery of the intervention, such as online vs. face-to­ face, or group vs. individual. most studies described surface adaptations (resnicow et al., 1999), such as the use of a culture-specific or culture-sensitive language, the inclusion of specific idioms of distress, the use of illustrations and non-verbal material for non-ger­ man speaking participants, or the consideration of gender-related aspects and religious concerns (e.g., not offering food in a closing ritual during ramadan). psychoeducation materials were culturally adapted in most studies, and psychoeduca­ tion was extensively discussed during the second workshop of the task force. some of the considerations around psychoeducation involved metaphors and analogies to describe heim & knaevelsrud 7 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ the therapeutic process, such as the wound metaphor (trauma as a wound), the process of healing (e.g., of a broken leg), psychotherapy as training (e.g., muscle training), or the metaphor of the messy cupboard that must be cleaned up. another relevant issue in psychoeducation concerned mental health-related stigma, which was addressed in some studies through normalising, the use of non-stigmatising terms, or using an encouraging rather than a problematising language. regarding specific therapeutic elements, all studies conducted a careful analysis of interventions to address the most common symptoms of psychological distress in their respective target populations. as an example, three studies discussed the inclusion or exclusion of problem solving in their respective interventions (böttche et al., 2021, this issue; kananian et al., 2021, this issue; unterhitzenberger et al., 2021, this issue). this discussion showed that, on the one hand, problem solving seemed to be a helpful inter­ vention to address the refugees’ most pressing concerns, such as asylum status or family reunification. on the other hand, problem solving seemed to be overly cognitive for some participants, and it bears the risk that such practical problems become more important than the psychotherapeutic work in the sessions. the discussion across the three projects contributed to finding ways to use problem solving while keeping these downsides to a minimum. documentation process the level of detail of information provided in the adaptation template varied across stud­ ies. researchers in two studies used the template to guide and document their process of cultural adaptation, whereas two other studies (and four sub-studies) used it to structure the documentation process retrospectively. this was mainly because in these projects, an iterative process of intervention development, cultural adaptation, and piloting had been implemented before acquiring the funding for the rcts, and hence before the task force had started its work. during the project, it became clear that the template required more detailed instruc­ tions on the information required in the sub-sections. in addition, researchers expressed difficulties in making decisions about cultural adaptations based on the evidence they had gathered on their target population. two studies specifically focused on this deci­ sion-making process from formative research to adaptation (i.e., böttche et al., 2021, this issue; lotzin et al., 2021, this issue). only one study documented the decision-making process itself, that is, the opinions expressed by the different researchers on the team. d i s c u s s i o n despite the growing body of literature on cultural adaptation of psychological interven­ tions, there is still a lack of evidence on adaptations that will contribute to increase standardised research methods and documentation in cultural adaptation 8 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ the feasibility, acceptance, and efficacy of such interventions. we have argued that this is mainly due to a lack of theory-based approaches to cultural adaptation (heim & kohrt, 2019), of systematic documentation (harper shehadeh et al., 2016), and of rigorous empirical studies. in this project, a standardised documentation procedure was developed and applied across 11 studies that will evaluate psychological interventions in clinical trials with refugee populations in germany. the parallel implementation of 11 rcts with refugee populations provided a unique opportunity to develop and test such a standardised procedure and to better understand the process, challenges, and specific requirements of cultural adaptation in psychological trials. experiences in this project revealed important lessons learned concerning the content (i.e., what) and the process (i.e., how) of cultural adaptation. regarding content, researchers in this task force described both surface and deep structure adaptations (resnicow et al., 1999). surface adaptations are increasingly descri­ bed in the literature (e.g., chowdhary et al., 2014). deep structure adaptations, such as the selection or development of treatment elements in accordance with ccd and other relevant aspects, is less prominent in the literature (hall et al., 2016). based on the theoretical framework by heim and kohrt (2019), several studies included here used ccd (i.e., idioms of distress, explanatory models, and culturally salient symptoms) as a starting point for cultural adaptation. aside from ccd, other aspects that are relevant for cultural adaptation were mentioned, such as cultural resources (mewes et al., 2021, this issue), gender and religious aspects (kananian et al., 2021, this issue), or cultural concepts other than ccd (e.g., attachment). researchers considered the use of specific treatment elements in function of participants’ needs and conditions, such as problem solving (böttche et al., 2021, this issue; kananian et al., 2021, this issue). regarding process, our experiences showed that the documentation system must be in place from the beginning of the adaptation process. in three studies, the adaptation was done in parallel with the work of the task force. in other studies, the adaptation process was documented retrospectively based on unpublished data, and some projects had already completed their adaptation process, with limited possibilities for retrospec­ tive documentation. it became clear that retrospective documentation is very difficult, even if unpublished data are available (e.g., transcripts from focus groups), particularly due to the difficulty to replicate the decision-making process. in addition, our experien­ ces showed that the template for documentation should be simple and contain clear instructions to avoid additional workload for the research staff. decision making is a major challenge in cultural adaptation. only one study docu­ mented the different views of the team members as a basis for decisions (lotzin et al., 2021, this issue). another study mentioned the risk of excluding other groups if adaptations are too specific for one particular group (böttche et al., 2021, this issue). our experiences show that the decision of what to adapt, and why, remains a subjective heim & knaevelsrud 9 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ process to some extent. in view of transparency, it is therefore essential to document the considerations behind this process, the different views of team members, and the strength of evidence that supported decisions. that said, a further process-related lesson learned is that cultural adaptation takes time. several studies went through an iterative process of piloting, feedback, and further adaptation. some of the projects used culture-sensitive interventions and further adapted them to their target population (böttche et al., 2021, this issue; kananian et al., 2021, this issue; lotzin et al., 2021, this issue). keeping track of this process and documenting the different stages of adaptation is a labour-intensive and time-consuming process. one study concluded that the balance between investment (i.e., time and financial expen­ diture) and outcome was not yet determined (böttche et al., 2021, this issue). indeed, experimental studies are needed to determine the effects of cultural adaptation on the feasibility and effectiveness of interventions (heim et al., 2020). the present paper has several limitations. first, due to administrative reasons, not all project included in the task force were in the same adaptation phase when the task force started its activities. some projects had concluded their cultural adaptation process, while other studies conducted the cultural adaptation as part of the task force activities. how­ ever, this allowed for considering challenges occurring at different moments throughout the cultural adaptation process, which enhanced the richness of our lessons learned. second, all studies included in this task force were conducted in germany, which limits the generalisability to other contexts. and third, this task force focused on the process of documentation only. examining the effect of cultural adaptation on trial efficacy was beyond the scope of this task force. the main focus of this task force was on establishing a standardised documentation system, which will hopefully be an important step in guiding and improving the quality of cultural adaptation research in the future. based on our experiences, a sub-group of the task force elaborated a set of reporting criteria for cultural adaptation in psychological trials (recapt), which are presen­ ted in this special issue (heim et al., 2021, this issue). as a next step, experimental research is needed to determine the impact of surface and deep structure adaptations on the acceptability and effectiveness of psychological interventions. such experimental research may include rcts comparing different levels of cultural adaptation (heim et al., 2020) or other research designs like factorial experiments. in addition, standardised documentation of cultural adaptation can contribute to meta-analytic evidence, in which the association between levels of cultural adaptation and trial effectiveness is analysed in meta-regression (e.g., harper shehadeh et al., 2016). in view of the increasing need to develop and test psychological interventions for di­ verse cultural and ethnic groups, cultural adaptation can no longer remain the unwanted stepchild in psychological science. over the past decades, high-quality standards have been increasingly applied in clinical trials in general, which are defined in the consort statement (moher et al., 2001). transparency and replicability are increasingly demanded standardised research methods and documentation in cultural adaptation 10 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://www.psychopen.eu/ for clinical trials with psychological interventions, not least as a consequence of the open science movement. it is essential that we request the same level of quality, transparency, and replicability for cultural adaptation in clinical trials with culturally diverse groups and ethnic minorities. by using such high-quality standards, the interventions we devel­ op will hopefully be used, have a positive effect, and help people manage their lives. funding: german federal ministry of education and research (01ef1806h). acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: eva heim is one of the guest editors of this special issue of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • appendix appendix a provides an overview table of the research projects described in this paper, i.e., target populations, target symptoms and disorders, interventions, and information on the cultural adaptation process. • recapt template a template for documenting the cultural adaptation process that was developed by the “task force for cultural adaptation of mental health interventions for refugees”. a documented version for better understanding is provided, along with an empty template in word format that can be used for future studies. index of supplementary materials heim, e., & knaevelsrud, c. (2021a). supplementary materials to "standardised research methods and documentation in cultural adaptation: the need, the potential and future steps" [appendix]. psychopen gold. https://doi.org/10.23668/psycharchives.5200 heim, e., mewes, r., abi ramia, j., glaesmer, h., hall, b., harper shehadeh, m., ünlü, b., kananian, s., kohrt, b. a., lechner-meichsner, f., lotzin, a., moro, m. r., radjack, r., salamanca-sanabria, a., singla, d. r., starck, a., sturm, g., tol, w., weise, c., & knaevelsrud, c. (2021b). supplementary materials to "reporting cultural adaptation in psychological trials – the recapt criteria" [recapt template]. psychopen gold. https://doi.org/10.23668/psycharchives.5192 heim & knaevelsrud 11 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://doi.org/10.23668/psycharchives.5200 https://doi.org/10.23668/psycharchives.5192 https://www.psychopen.eu/ r e f e r e n c e s abi ramia, j., harper shehadeh, m., kheir, w., zoghbi, e., watts, s., heim, e., & el chammay, r. (2018). community cognitive interviewing to inform local adaptations of an e-mental health intervention in lebanon. global mental health, 5, article e39. https://doi.org/10.1017/gmh.2018.29 american psychiatric association. (2013). diagnostic and statistical manual of mental disorders (5th ed.). american psychiatric publishing. benish, s. g., quintana, s., & wampold, b. e. 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(2021). “same same or adapted?” therapists’ feedback on the implementation of trauma-focused cognitive behavioral therapy with unaccompanied young refugees. clinical psychology in europe, 3(special issue), article e5431. https://doi.org/10.32872/cpe.5431 standardised research methods and documentation in cultural adaptation 14 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://doi.org/10.1177/1354067x08092637 https://doi.org/10.1177/1363461519861795 https://doi.org/10.32872/cpe.5329 https://doi.org/10.32872/cpe.4577 https://doi.org/10.1016/s0140-6736(00)04337-3 https://doi.org/10.1007/s40615-014-0054-y https://doi.org/10.1007/s11013-019-09638-5 https://doi.org/10.1146/annurev-clinpsy-032816-045217 https://doi.org/10.1017/gmh.2018.14 https://doi.org/10.1186/s13033-017-0156-0 https://www.unhcr.org/figures-at-a-glance.html https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ wendler, d., kington, r., madans, j., wye, g. v., christ-schmidt, h., pratt, l. a., brawley, o. w., gross, c. p., & emanuel, e. (2005). are racial and ethnic minorities less willing to participate in health research? plos medicine, 3(2), article e19. https://doi.org/10.1371/journal.pmed.0030019 world health organization. (2017). depression and other common mental disorders: global health estimates. world health organization (licence: cc by-nc-sa 3.0 igo). https://apps.who.int/iris/handle/10665/254610 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. heim & knaevelsrud 15 clinical psychology in europe 2021, vol. 3(special issue), article e5513 https://doi.org/10.32872/cpe.5513 https://doi.org/10.1371/journal.pmed.0030019 https://apps.who.int/iris/handle/10665/254610 https://www.psychopen.eu/ standardised research methods and documentation in cultural adaptation (introduction) aim method procedures documentation data analysis results overview of studies target populations and disorders formative research methods cultural concepts of distress target interventions cultural adaptations: surface and deep structure documentation process discussion (additional information) funding acknowledgments competing interests supplementary materials references special issue editorial: cultural adaption of psychological interventions editorial special issue editorial: cultural adaption of psychological interventions eva heim 1,2 , cornelia weise 3 [1] institute of psychology, university of lausanne, lausanne, switzerland. [2] department of psychology, university of zürich, zürich, switzerland. [3] division of clinical psychology and psychotherapy, department of psychology, philippsuniversity of marburg, marburg, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e7627, https://doi.org/10.32872/cpe.7627 published (vor): 2021-11-23 corresponding author: eva heim, institute of psychology, university of lausanne, géopolis, bureau 4114, 1015 lausanne, switzerland. e-mail: eva.heim@unil.ch related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si cultural adaptation of psychological interventions has been discussed controversially in literature. on the one hand, culturally diverse groups are underrepresented in psycholog­ ical trials, and evidence on acceptability and efficacy of interventions cannot necessarily be transferred from one cultural group to another (hussain-gambles et al., 2004; la roche & christopher, 2008; wendler et al., 2006). on the other hand, some researchers are concerned about the fidelity of treatment if culturally adapted (castro et al., 2010). there is also considerable debate about what to adapt, and the effect of such adapta­ tions. empirical evidence on substantial modifications is scarce, and cultural adaptation methods are often insufficiently reported in literature (chowdhary et al., 2014; harper shehadeh et al., 2016). this does not only include adaptations implemented before a trial starts, but also the so called “on-the-fly” adaptations that are done during an ongoing trial. in this special issue, experiences and empirical evidence on the cultural adaptation of psychological interventions for refugee populations are brought together. in 2016, the german federal ministry of education and research (fmer) launched a call for research proposals covering the ‘mental health of refugee populations’. seven research projects were funded. one exclusively focuses on diagnostics, and the other six projects test evi­ dence-based psychological interventions. each of those six projects consists of three or more sub-projects, which are testing diagnostic tools, the efficacy and cost-effectiveness this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7627&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0001-7434-7451 https://orcid.org/0000-0001-5216-1031 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ of interventions, and implementation methods. a total of eleven randomised controlled trials (rcts) are implemented to test different kinds of psychological interventions among a diversity of target groups, i.e., age groups, specific disorders, or unspecific psychological distress. in the context of the fmer call, a “task force for cultural adaptions of mental health interventions for refugees” was launched. it pursued two major goals: first, it aimed to develop a common understanding and methodology for documenting and monitoring cultural adaptations in clinical trials. second, it aimed to integrate the findings of the first step and compile criteria on how cultural adaptations in clinical trials could be reported. the conceptual framework for cultural adaptation by heim and kohrt (2019) was used as a basis for this work. this special issue features experiences, empirical evidence and recommendations resulting from this task force, as well as the final composition of the reporting criteria. the paper by heim and knaevelsrud (2021, this issue) provides an introduction to the methodology developed by the task force and describes how cultural adaptations across the different projects and studies were documented and monitored. a content analysis of the documented adaptations is presented in this paper. the subsequent papers highlight five examples of studies that applied the jointly developed cultural adaptation method­ ology, with different thematic foci. these papers are based on empirical evidence from formative research (e.g., focus groups or key informant interviews) and pilot studies. mewes et al. (2021, this issue) describe the development of a culture-sensitive, transdiagnostic intervention to increase knowledge about mental health problems and available treatments. this study highlights the importance of differentiating between the culture-specific adaptation of interventions (for one particular group) and the devel­ opment of culture-sensitive interventions that can be used for culturally diverse groups. kananian et al. (2021, this issue) used culturally adapted cognitive behavioural therapy (ca-cbt, hinton et al., 2012), an intervention that had already been tested among different cultural groups (i.e., cambodian, latino, and arabic-speaking popula­ tions). in this study, ca-cbt was prepared to be tested in a new, culturally different group (i.e., afghan refugees in germany). based on a pilot study and focus groups, the intervention was further adapted to be tested in an rct. böttche et al. (2021, this issue) focus on the process from formative research to adaptation. a transdiagnostic intervention, the common elements treatment approach (ceta, murray et al., 2014), was adapted for arabic-speaking refugees in germany and will be provided both face-to-face and through the internet in a non-inferiority trial. in preparation of this study, cultural concepts of distress were assessed among the target population. the main focus of the paper is on the decision-making process, and the authors provide a summary of their most salient decisions. the process of adapting an already culturally-sensitive, transdiagnostic treatment to also include substance use disorders is described in the paper by lotzin et al. (2021, editorial 2 clinical psychology in europe 2021, vol. 3(special issue), article e7627 https://doi.org/10.32872/cpe.7627 https://www.psychopen.eu/ this issue). the authors used skills-training of affect regulation – a culture-sensitive approach (starc, koch & liedl, 2019) in their study. focus group discussions were conducted to examine culture-specific assumptions about substance use. this data was used to adapt the treatment manual that will be tested in an upcoming rct. unterhitzenberger et al. (2021, this issue) tested trauma-focused cognitive behav­ ioral therapy (tf-cbt, cohen et al., 2017) in a pilot study with unaccompanied refu­ gee minors (urms). the paper highlights “on-the-fly” adaptations implemented by the therapists during the pilot study. the main adaptation concerned the so-called “crisis of the week”, i.e., participants struggles and concerns in their daily lives. this shows that post-migration stressors are a very important factor when adapting psychological interventions to refugee populations – an aspect that may sometimes be even more relevant than ethnic origin. finally, heim et al. (2021, this issue) present the reporting cultural adaptation in psychological trials (recapt) criteria. the recapt criteria were developed jointly by the above-described task force. to achieve a broader consent on the recapt criteria, an online survey was conducted among eleven international experts in the field of global mental health and psychological interventions for refugee populations. in summary, this special issue features the experience of a variety of studies in which a diversity of psychological interventions were culturally adapted and tested among refu­ gee populations in germany. the task force provided a unique opportunity for exchange and discussions, with the aim of advancing the emerging field of cultural adaptations in mental health interventions. the recapt criteria (heim et al., 2021, this issue) will hopefully contribute to a more systematised and transparent documentation of cultural adaptation in psychological research in the future. this is an important precondition to enhance the empirical evidence concerning the effect of such adaptations on the efficacy and acceptability of psychotherapy among culturally diverse groups. funding: german federal ministry of education and research (nr 01ef1806h). acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: cornelia weise is one of the editors-in-chief of clinical psychology in europe. r e f e r e n c e s böttche, m., kampisiou, c., stammel, n., el-haj-mohamad, r., heeke, c., burchert, s., heim, e., wagner, b., renneberg, b., böttcher, j., glaesmer, h., gouzoulis-mayfrank, e., zielasek, j., konnopka, a., murray, l., & knaevelsrud, c. (2021). from formative research to cultural adaptation of a face-to-face and internet-based cognitive-behavioural intervention for arabicheim & weise 3 clinical psychology in europe 2021, vol. 3(special issue), article e7627 https://doi.org/10.32872/cpe.7627 https://www.psychopen.eu/ speaking refugees in germany. clinical psychology in europe, 3(special issue), article e4623. https://doi.org/10.32872/cpe.4623 castro, f. g., barrera, m., jr., & holleran steiker, l. k. (2010). issues and challenges in the design of culturally adapted evidence-based interventions. annual review of clinical psychology, 6, 213-239. https://doi.org/10.1146/annurev-clinpsy-033109-132032 chowdhary, n., jotheeswaran, a. t., nadkarni, a., hollon, s. d., king, m., jordans, m. j. d., rahman, a., verdeli, h., araya, r., & patel, v. (2014). the methods and outcomes of cultural adaptations of psychological treatments for depressive disorders: a systematic review. psychological medicine, 44(6), 1131-1146. https://doi.org/10.1017/s0033291713001785 cohen, j. a., mannarino, a., & deblinger, e. (2017). treating trauma and traumatic grief in children and adolescents, second edition (2nd ed.). guilford publications. harper shehadeh, m., heim, e., chowdhary, n., maercker, a., & albanese, e. (2016). cultural adaptation of minimally guided interventions for common mental disorders: a systematic review and meta-analysis. jmir mental health, 3(3), article e44. https://doi.org/10.2196/mental.5776 heim, e., & knaevelsrud, c. (2021). standardised research methods and documentation in cultural adaptation: the need, the potential and future steps. clinical psychology in europe, 3(special issue), article e5513. https://doi.org/10.32872/cpe.5513 heim, e., & kohrt, b. a. (2019). cultural adaptation of scalable psychological interventions: a new conceptual framework. clinical psychology in europe, 1(4), article e37679. https://doi.org/10.32872/cpe.v1i4.37679 heim, e., mewes, r., abi ramia, j., glaesmer, h., hall, b., harper shehadeh, m., ünlü, b., kananian, s., kohrt, b. a., lechner-meichsner, f., lotzin, a., moro, m. r., radjack, r., salamanca-sanabria, a., singla, d. r., starck, a., sturm, g., tol, w., weise, c., & knaevelsrud, c. (2021). reporting cultural adaptation in psychological trials – the recapt criteria. clinical psychology in europe, 3(special issue), article e6351. https://doi.org/10.32872/cpe.6351 hinton, d. e., rivera, e. i., hofmann, s. g., barlow, d. h., & otto, m. w. (2012). adapting cbt for traumatized refugees and ethnic minority patients: examples from culturally adapted cbt (cacbt). transcultural psychiatry, 49(2), 340-365. https://doi.org/10.1177/1363461512441595 hussain-gambles, m., atkin, k., & leese, b. (2004). why ethnic minority groups are underrepresented in clinical trials: a review of the literature. health & social care in the community, 12(5), 382-388. https://doi.org/10.1111/j.1365-2524.2004.00507.x kananian, s., starck, a., & stangier, u. (2021). cultural adaptation of cbt for afghan refugees in europe: a retrospective evaluation. clinical psychology in europe, 3(special issue), article e5271. https://doi.org/10.32872/cpe.5271 koch, t., & liedl, a. (2019). stark: skills-training zur affektregulation – ein kultursensibler ansatz: therapiemanual für menschen mit fluchtund migrationshintergrund. schattauer. la roche, m., & christopher, m. s. (2008). culture and empirically supported treatments: on the road to a collision? culture and psychology, 14(3), 333-356. https://doi.org/10.1177/1354067x08092637 editorial 4 clinical psychology in europe 2021, vol. 3(special issue), article e7627 https://doi.org/10.32872/cpe.7627 https://doi.org/10.32872/cpe.4623 https://doi.org/10.1146/annurev-clinpsy-033109-132032 https://doi.org/10.1017/s0033291713001785 https://doi.org/10.2196/mental.5776 https://doi.org/10.32872/cpe.5513 https://doi.org/10.32872/cpe.v1i4.37679 https://doi.org/10.32872/cpe.6351 https://doi.org/10.1177/1363461512441595 https://doi.org/10.1111/j.1365-2524.2004.00507.x https://doi.org/10.32872/cpe.5271 https://doi.org/10.1177/1354067x08092637 https://www.psychopen.eu/ lotzin, a., lindert, j., koch, t., liedl, a., & schäfer, i. (2021). starc-sud – adaptation of a transdiagnostic intervention for refugees with substance use disorders. clinical psychology in europe, 3(special issue), article e5329. https://doi.org/10.32872/cpe.5329 mewes, r., giesebrecht, j., weise, c., & grupp, f. (2021). description of a culture-sensitive, lowthreshold psychoeducation intervention for asylum seekers (tea garden). clinical psychology in europe, 3(special issue), article e4577. https://doi.org/10.32872/cpe.4577 murray, l. k., dorsey, s., haroz, e., lee, c., alsiary, m. m., haydary, a., weiss, w. m., & bolton, p. (2014). a common elements treatment approach for adult mental health problems in lowand middle-income countries. cognitive and behavioral practice, 21(2), 111-123. https://doi.org/10.1016/j.cbpra.2013.06.005 unterhitzenberger, j., haberstumpf, s., rosner, r., & pfeiffer, e. (2021). “same same or adapted?” therapists’ feedback on the implementation of trauma-focused cognitive behavioral therapy with unaccompanied young refugees. clinical psychology in europe, 3(special issue), article e5431. https://doi.org/10.32872/cpe.5431 wendler, d., kington, r., madans, j., van wye, g., christ-schmidt, h., pratt, l. a., brawley, o. w., gross, c. p., & emanuel, e. (2006). are racial and ethnic minorities less willing to participate in health research? plos medicine, 3(2), article e19. https://doi.org/10.1371/journal.pmed.0030019 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. heim & weise 5 clinical psychology in europe 2021, vol. 3(special issue), article e7627 https://doi.org/10.32872/cpe.7627 https://doi.org/10.32872/cpe.5329 https://doi.org/10.32872/cpe.4577 https://doi.org/10.1016/j.cbpra.2013.06.005 https://doi.org/10.32872/cpe.5431 https://doi.org/10.1371/journal.pmed.0030019 https://www.psychopen.eu/ repetitive negative thinking about suicide: associations with lifetime suicide attempts research articles repetitive negative thinking about suicide: associations with lifetime suicide attempts tobias teismann 1, thomas forkmann 2, johannes michalak 3, julia brailovskaia 1 [1] mental health research and treatment center, ruhr-universität bochum, bochum, germany. [2] department of clinical psychology, university of duisburg-essen, essen, germany. [3] department of clinical psychology and psychotherapy, universität witten-herdecke, witten, germany. clinical psychology in europe, 2021, vol. 3(3), article e5579, https://doi.org/10.32872/cpe.5579 received: 2021-01-08 • accepted: 2021-06-28 • published (vor): 2021-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: tobias teismann, mental health research and treatment center, ruhr-universität bochum, germany, massenbergstraße 9-13, 44787 bochum. phone: 0049-234-3227787. e-mail: tobias.teismann@rub.de supplementary materials: materials [see index of supplementary materials] abstract background: repetitive negative thinking has been identified as an important predictor of suicide ideation and suicidal behavior. yet, only few studies have investigated the effect of suicide-specific rumination, i.e., repetitive thinking about death and/or suicide on suicide attempt history. on this background, the present study investigated, whether suicide-specific rumination differentiates between suicide attempters and suicide ideators, is predictive of suicide attempt history and mediates the association between suicide ideation and suicide attempts. method: a total of 257 participants with a history of suicide ideation (55.6% female; age m = 30.56, age sd = 11.23, range: 18–73 years) completed online measures on suicidality, general and suicide-specific rumination. results: suicide-specific rumination differentiated suicide attempters from suicide ideators, predicted suicide attempt status (above age, gender, suicide ideation, general rumination) and fully mediated the association between suicide ideation and lifetime suicide attempts. conclusion: overall, though limited by the use of a non-clinical sample and a cross-sectional study design, the present results suggest that suicide-specific rumination might be a factor of central relevance in understanding transitions to suicidal behavior. keywords repetitive negative thinking, rumination, suicide ideation, suicide attempts this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5579&domain=pdf&date_stamp=2021-09-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • suicide-specific rumination was investigated in participants with a history of suicide ideation. • suicide-specific rumination differentiated suicide attempters from suicide ideators. • suicide-specific rumination predicted suicide attempt status. • suicide-specific rumination mediated the association between suicide ideation and lifetime suicide attempts. • suicide-specific rumination might be a factor of central relevance in understanding transitions to suicidal behavior. repetitive negative thinking (rnt) is defined as a style of thinking about one’s problems or negative experiences with three key characteristics: the thinking is repetitive, it is at least partly intrusive, and it is difficult to disengage from. two additional features of rnt are that individuals perceive it as unproductive and it captures mental capacity (ehring et al., 2011). the two most intensively studied types of rnt are worry and depressive rumination. rnt – in the form of rumination and worry – has been identified as a critical factor in the development and maintenance of psychiatric symptoms and dis­ orders (ehring & watkins, 2008; teismann & ehring, 2019; watkins, 2008). in prospective studies, rumination was found to predict the future onset of a major depressive episode (nolen-hoeksema, 2000; nolen-hoeksema et al., 2007; robinson & alloy, 2003; wilkinson et al., 2013) and to mediate the effect of various risk factors on the onset of depression (spasojević & alloy, 2001). additional studies have shown that rumination prospectively predicts the onset of post-traumatic stress disorder (moulds et al., 2020; szabo et al., 2017) and is linked to the maintenance of social anxiety disorder (penney & abbott, 2014), insomnia (takano et al., 2014) and eating disorder psychopathology (smith, mason, & lavender, 2018). moreover, a close association between rnt, suicide ideation and suicide attempts has been shown in cross-sectional and longitudinal studies (rogers & joiner, 2017) – even when different types of rnt as well as different methodologies, samples (clinical and non-clinical) and measures of suicidality were used (kerkhof & van spijker, 2011; law & tucker, 2018). as such, rumination significantly predicted suicide ideation in prospective studies using student and community samples (miranda & nolen-hoeksema, 2007; smith, alloy, & abramson, 2006). furthermore, rumination was found to be more common in suicide attempters than in non-attempters (e.g., horwitz et al., 2019). galynker (2017) understands intensive, persistent and uncontrollable brooding (ruminative flooding) as a core feature of an acute suicidal state, the so-called suicide crisis syndrome. taken together, there is strong empirical evidence for the importance of rnt with respect to understanding suicide ideation and behavior. in the vast majority of these studies, the relationship between general rnt and suicidal ideation and suicide attempts was investigated. however, rogers and joiner (2018a, 2018b) have recently started to study the effect of suicide-specific rumination, repetitive thinking and suicide 2 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ that is, rnt about death and/or suicide. they found that suicide-specific rumination is associated with lifetime suicide attempts over and above a large array of known risk factors, including suicide ideation, general rumination, depression and anxiety (rogers & joiner, 2018a). furthermore, they could show that the association between suicide-specif­ ic rumination and lifetime suicide attempts is mediated by an acute suicidal state, called acute suicidal affective disturbance (asad; rogers & joiner, 2018b). in both of these studies, suicide-specific rumination was assessed using either a 5-item (rogers & joiner, 2018b) or an 8-item (rogers & joiner, 2018a) version of the suicide rumination scale (srs). this scale assesses the tendency to ruminate or fixate on one’s suicidal thoughts, intention and plans. however, it cannot be excluded that some items of the srs may confound general preparation behavior (“when i have thoughts of suicide, i think about how i want to kill myself”; “… i wonder what the fastest and easiest way to die is”) or so called flash forwards (“when i have thoughts of suicide, i imagine the process of how i want to kill myself”), with generic features of rnt (“when i have thoughts of suicide, i have trouble getting the suicidal thoughts out of my mind”). it is therefore unclear whether the significant association between suicide-specific rumination – as assessed with the srs – and lifetime suicide attempts are in fact due to rnt or rather a consequence of increased preparation and planning behavior. on this background, the current study aims at investigating the association between suicide-specific rumination and suicidal behavior with a suicide-specific version of the perseverative thinking questionnaire (ptq; ehring et al., 2011), a self-report measure designed to assess core characteristics of rnt (repetitiveness, intrusiveness, difficulties with disengagement, perceived unproductiveness). the study had three aims: 1. to inves­ tigate whether suicide-specific rumination – as assessed with an unconfounded measure – differentiates between lifetime suicide attempters and non-attempters; 2. to investi­ gate, whether suicide specific rumination is associated with lifetime suicide attempts – above and beyond age, gender, current suicide ideation and general rumination; 3. to investigate whether suicide-specific rumination mediates the association between current suicide ideation and lifetime suicide attempts. since most suicide ideators do not show suicidal behavior, the necessity to understand what differentiates attempters from ideators has recently been highlighted (may & klonsky, 2016). m e t h o d a n d m a t e r i a l s participants and procedure between march and may 2019, n = 300 (58% female; mage= 32.25, sdage = 13.68, range: 18–77 years) and again between february and june 2020, n = 276 (67% female; mage = 32.08, sdage = 10.73, range: 18–64 years) participants took part in a single assessment using an online survey. the assessments took part within the context of two other teismann, forkmann, michalak, & brailovskaia 3 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ studies (teismann & brailovskaia, 2020; teismann et al., 2020), that were advertised as investigating the association between well-being and psychological strain. it was assured that no participant took part in both of these studies. of the two samples, n = 257 (55.6% female; mage = 30.56, sdage = 11.23, range: 18–73 years) reported lifetime suicide ideation and were included in the present study. one-hundred and twenty-nine participants (50.2%) reported some suicide ideation in the last four weeks (ssevscore ≥1); fifty-two participants (20.2%) indicated that they had attempted suicide at least once in their lifetime (range: 1–6). all participants – except for one asian participant – were caucasian. participants were recruited through postings at local university as well as social media postings on facebook and twitter. data was collected through an anonymous online survey using the sosci-server (https://www.soscisurvey.de/). participation in the study was not compensated; yet, participating students were eligible to receive course credits. in order to take part in the study, participants had to be at least 18 years old and to give their consent to participation at the beginning of the study. prior to assessments, all participants were informed about the purpose of the study, the voluntary nature of their participation, data storage and security. the study was approved by the responsible ethics committee. measures suicide ideation and behavior scale (ssev) the ssev (teismann et al., 2021) assesses with six items the frequency of suicide ideation in the past four weeks (e.g., “during the past four weeks, … i thought it would be better if i wasn't alive, … i've been thinking about killing myself, … i have seriously considered killing myself”). all items are answered on a 6-point likert scale ranging from “1=never” to “5=many times every day”, with higher scores indicating greater severity of suicidal ideation. occurrence (“in the course of my life i have tried to kill myself and i really wanted to die”) and number of lifetime suicide attempts (“how many times have you tried to kill yourself?”) are assessed with two further ssev-items. the scale has been shown to have a good internal consistency (cronbach’s α ≥ .92; teismann et al., 2021). accordingly, internal consistency was good in the current sample, (α = .84). perseverative thinking questionnaire (ptq) the ptq (ehring et al., 2011) is a 15-item self-report measure designed to assess process characteristics of perseverative thinking (“the same thoughts keep going through my mind again and again”; “i keep asking myself questions without finding an answer”; “thoughts intrude into my mind”; “my thoughts take up all my attention”). all items are to be answered on a 5-point scale ranging from 0 (“never”) to 4 (“almost always”). the scale has been shown to have good internal consistencies (cronbach`s α ≥ .93; ehring repetitive thinking and suicide 4 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.soscisurvey.de/ https://www.psychopen.eu/ et al., 2011). accordingly, internal consistencies were excellent in the current sample, α = .95. perseverative thinking about suicide questionnaire (ptsq) the ptsq (teismann, 2018) is modeled after the ptq and assesses with nine items suicide specific rumination (“i can´t stop dwelling about suicide”; “i am thinking about suicide the whole time”; “thoughts about suicide intrude into my mind”; “my thoughts about suicide repeat themselves”). in the adaption process the word “thoughts” from the original ptq was replaced by the term “suicidal thoughts” in the ptsq: for example the ptq-item “the same thoughts keep going through my mind again and again” became the ptsq-item “the same thoughts about suicide keep going through my mind again and again”. items from the ptq that were not adjustable in the described manner (i.e., “i think about many problems without solving any of them”) were not included in the ptsq. the adaptation was conducted by the first author and consented with all co-au­ thors. all items are to be answered on a 5-point scale ranging from 0 (“never”) to 4 (“al­ most always”). participants are only asked to answer all these items, if they affirm a first screening item (“in my lifetime i have thought about suicide”). the scale has been shown to have high internal consistency (cronbach`s α = .94; höller et al., in preparation). accordingly, an exploratory factor analysis (efa) using principal component analysis (pca; rotation method: varimax) revealed a unidimensional factor structure within the present sample as well as excellent internal consistency, α =.95. statistical analyses statistical analyses were conducted with spss 26 and the process macro version 3.5 (www.processmacro.org/index.html; rockwood & hayes, 2020). descriptive statistics and zero-order bivariate correlations between the investigated variables were calculated. differences between groups (lifetime suicide ideators: n = 205 vs. lifetime attempters: n = 52) were analyzed using one-way anovas. considering the different sizes of both groups, hedges’g was included as effect size (see hedges, 1981). notably, the current data fit the assumptions for the calculation of multivariate analyses (no significant outliners > 3 and < -3, number of significant outliners > 2 and < -2 below 5%; no violation of multicollinearity assumption as all values of tolerance > 0.25, and all variance inflation factor values < 5; interaction between the independent variables and their logarithmic transformations is not significant) (see field, 2013; tabachnick & fidell, 2014; urban & mayerl, 2006). next, a three-step multiple logistic regression analysis was calculated to examine the relative contribution of current suicide ideation (ssev), general rumina­ tion (ptq) and suicide-specific rumination (ptsq) to the prediction of lifetime suicide attempt status (coded: 0 = no attempts, 1 = attempts). the variable age was significantly correlated with current suicide ideation (r = -.163, p < .01), general rumination (r = -.189, p < .05), and suicide-specific rumination (r = -.161, p < .05). the variable gender (coded: 0 teismann, forkmann, michalak, & brailovskaia 5 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 http://www.processmacro.org/index.html https://www.psychopen.eu/ = woman, 1 = man) was negatively correlated with general rumination (r = -.147, p < .05), and lifetime suicide attempt status (r = -.129, p < .05). considering the relationships of age and gender with the potential predictors and the outcome of the regression model, both were included as control variables. thus, age and gender were included in step 1 of the regression model, current suicide ideation and general rumination were included in step 2, and suicide-specific rumination was included in step 3. finally, a mediation analysis was conducted that included current suicide ideation (predictor), suicide-specific rumination (mediator), and number of lifetime suicide attempts (outcome). the basic association between current suicide ideation and lifetime suicide attempts was denoted by c (the total effect). the path of current suicide ideation to suicide specific rumination was denoted by a, and the path of suicide specific rumination to lifetime suicide attempts was denoted by b. the combined effect of path a and path b presented the indirect effect. the direct effect of current suicide ideation on lifetime suicide attempts after inclusion of suicide specific rumination in the model was denoted by c’. the mediation effect was assessed by the bootstrapping procedure (10.000 samples) that provides percentile bootstrap confidence intervals (95% ci). r e s u l t s descriptive statistics, correlations and group differences descriptive statistics for each measure and correlations are presented in table 1. cor­ relation analyses indicated that all study variables correlated significantly with each other (see table 1). the correlations ranged between r = .354 and r = .806 (all: p < .01), indicating medium to large effects (see cohen, 1988). table 1 means, standard deviations and correlations of study variables measure m (sd) min–max skewness kurtosis 2 3 4 1. ssev 8.00 (3.35) 6–23 2.130 4.449 .354** .806** .406** 2. ssev-sa 0.32 (0.84) 0–6 3.932 18.382 – .463** .265** 3. ptsq 15.07 (7.32) 9–44 1.509 1.813 – .490** 4. ptq 47.04 (13.07) 16–75 -.043 -.448 – note. n = 257; m = mean; sd = standard deviation; min = minimum; max = maximum; ssev = suicide ideation and behavior scale; ssev-sa = suicide ideation and behavior scale – lifetime number of suicide attempts; ptsq = perseverative thinking about suicide questionnaire; ptq = perseverative thinking questionnaire. ssev-sa was dichotomized (0 = no attempts, 1 = attempts) for the correlation analyses. **p < .01. repetitive thinking and suicide 6 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ lifetime suicide ideators (assessed with the ptsq-screening item) and lifetime suicide attempters differed significantly in ptsq-scores (suicide ideators: n = 205; m = 13.50, sd = 5.88, range: 9–36; suicide attempters: n = 52; m = 21.29, sd = 9.02, range: 9–44), f(1,255) = 57.52, p < .001, effect size: hedges’g = 1.17 (large effect). furthermore, lifetime suicide ideators (m = 45.36, sd = 12.61, range: 16–75) and lifetime suicide attempters (m = 53.67, sd = 12.89, range: 23–75) differed significantly in ptq-scores, f(1,255) = 17.89, p < .001, effect size: hedges’g = 0.65 (medium effect); with suicide attempters reporting more rnt than suicide ideators. prediction of lifetime suicide attempts associations between study variables and lifetime suicide attempts are shown in table 2. in the multiple logistic regression model, current suicide ideation (or: 1.19; small effect, see chen, cohen, & chen, 2010) and general rumination (or: 1.03; small effect, see chen et al., 2010) served as a significant predictor of lifetime suicide attempts in step 2. however, in step 3, only the new included variable suicide-specific rumination emerged as a significant predictor of lifetime suicide attempts (or: 1.14; small effect, see chen et al., 2010). table 2 results from a three-step multiple logistic regression analysis predicting lifetime suicide attempts (dichotomized: 0 = no attempts, 1 = attempts) step or (95% ci) p step 1 age 0.98 [0.95-1.01] .163 gender 0.47 [0.25-0.90] .023 step 2 age 0.99 [0.96-1.03] .720 gender 0.56 [0.28-1.14] .110 ssev 1.19 [1.09-1.31] < .001 ptsq 1.03 [1.00-1.06] .047 step 3 age 1.00 [0.96-1.03] .796 gender 0.50 [0.24-1.04] .065 ssev 0.97 [0.85-1.12] .719 ptq 1.01 [0.98-1.04] .461 ptsq 1.14 [1.06-1.23] < .001 note. n = 257; ssev-si = suicide ideation and behavior scale; ptq = perseverative thinking questionnaire; ptsq = perseverative thinking about suicide question­ naire; or = odds ratio from logistic regression; ci = confidence interval. teismann, forkmann, michalak, & brailovskaia 7 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ mediation analysis figure 1 shows results of the bootstrapped mediation analysis. the basic relationship between current suicide ideation (predictor) and lifetime suicide attempts (outcome) was significant (total effect, c: p < .001). the association between current suicide ideation and suicide-specific rumination (mediator) (a: p < .001), as well as the link between suicide-specific rumination and lifetime suicide attempts (b: p < .001) were also signifi­ cant. in contrast, the relationship between current suicide ideation and lifetime suicide attempts was no longer significant after the inclusion of suicide-specific rumination in the model (direct effect, c’: p = .445). the indirect effect (ab) was significant, b = .10, se = .03, 95% ci [.04, .17]. thus, suicide-specific rumination significantly mediated the relationship between current suicide ideation and lifetime suicide attempts. figure 1 mediation model with suicide ideation (predictor), suicide-specific rumination (mediator), and lifetime suicide attempts (outcome). note. c = total effect; c’ = direct effect; b = standardized regression coefficient; se = standard error; ci = confidence interval. d i s c u s s i o n the present study investigated the association between rnt – that is, suicide-specific rumination and general rumination – and (lifetime) suicide attempts. the main findings were as follows: (1.) general rumination and suicide-specific rumination differentiated between lifetime suicide attempters and suicide ideators; (2.) suicide-specific rumination was predictive of lifetime suicide attempt status – controlling for age, gender, current suicide ideation and general rumination; (3.) the association between current suicide ideation and lifetime suicide attempts was fully mediated by suicide-specific rumination. these results complement previous research showing an association between general rumination and suicide ideation/behavior (rogers & joiner, 2017) as well as between sui­ cide-specific rumination and lifetime suicide attempts (rogers & joiner, 2018a, 2018b). in accordance with findings by rogers and joiner (2018a) it was shown that suicide-specific repetitive thinking and suicide 8 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ rumination outperformed other suicide risk factors – including current suicide ideation – in the prediction of lifetime suicide attempt status. of note, findings could be replica­ ted with a new – potentially unconfounded – measure of suicide-specific rumination. though further study results have to be awaited, these findings suggest a rather robust effect of suicide-specific rumination. accordingly, it seems as if rnt about suicide may be more pernicious in increasing the risk for suicidal behavior than ruminative thoughts about one’s distress more generally. nonetheless, both general rumination and suicide-specific rumination differentiated between (lifetime) suicide attempters and (lifetime) suicide ideators (cf., horwitz et al., 2019). klonsky and may (2015) recently emphasized that it is crucial to understand factors that differentiate those who consider suicide from those who make suicide attempts. yet, in a comprehensive meta-analysis may and klonsky (2016) found only few studies that directly compared suicide ideators and suicide attempters and only few variables that differentiated the two groups. though the importance of single factors in differentiating suicide attempters and suicide ideators has recently been disputed (huang et al., 2020), these findings point to the potential potency of (suicide-specific) rnt in understanding transitions to suicidal behavior. a further analysis showed that the association between current suicide ideation and (lifetime) suicide attempts is completely mediated by suicide-specific rumination, that is, the risk of suicidal behaviour only increases when suicide is considered in a repeti­ tive way. within the metacognitive theory of emotional disorders, wells and matthews (2015) state that a psychological disorder results from an unhelpful thinking style called the cognitive attentional syndrome (cas). the cas incorporates worry/rumination, threat monitoring and unhelpful thought control strategies. according to the theory, not single thoughts, assumptions or beliefs create emotional turmoil, but the way a person deals with these thoughts: only if respective thoughts activate the cas, emotional and behavioral problems will follow. on this background one may assume that thoughts of suicide per se do not pose a great risk for suicidal behaviour (cf., mchugh et al., 2019), unless individuals engage in such thoughts in a repetitive manner. in future studies, the association between suicide-specific rumination and other variables of the metacognitive model should be investigated more closely. the results of the current study should be interpreted with consideration of the fol­ lowing limitations. first, the ptsq was developed for the current study and has only re­ cently been subjected to stringent psychometric evaluation (höller et al., in preparation). however, no direct comparison between the ptsq and the suicide rumination scale (srs; rogers & joiner, 2018a) was made. therefore, no conclusions with respect to the relationship between the two measures can be drawn, or determined whether one of the two measures is more valid in assessing suicide-specific rumination. second, rogers and joiner (2018a) included a large number of control variables (e.g., depression, anxiety, insomnia, agitation, emotion regulation, general rnt) in their study on suicide specific teismann, forkmann, michalak, & brailovskaia 9 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ rnt, whereas in the present study only age, gender, general rnt and current suicide ideation were included as control variables. future studies should therefore strive to in­ vestigate, whether suicide specific rnt – as assessed with the ptsq – also outperforms such a great number of suicide risk factors in predicting the presence of a lifetime suicide attempt. third, general rnt is understood as a trait (watkins & nolen-hoeksema, 2014) and both the ptsq and the srs capture suicide specific rnt in a trait-like manner. nev­ ertheless, it is unclear whether suicide specific rnt is indeed stable over time and across suicidal crises and/or whether it is (only) associated with more intense suicidal crises (cf., galynker, 2017). prospective studies with repeated measurements are needed. fourth, all of the constructs included in this study were measured exclusively via selfreport assessments. although it may be difficult to gather information regarding the frequency of particular thought patterns, participants may be prone to inaccuracy and uncertainty when responding to self-report items. finally, the use of a cross-sectional research design and a sample comprised of predominantly caucasians, limits the generalizability of the results and the discussion of temporal/causal relationships between study variables. this limitation is of specific importance considering the interpretation of the results of the mediation analysis: as all data were collected at a single measurement time-point and the outcome measure (i.e., lifetime suicide attempts) is retrospective, it might be more appropriate to frame the findings as indirect effects rather than as mediation effects. a replication of this study in treatment-seeking samples with prospective research designs would help to indicate whether the study results remain consistent in more at-risk populations. still, it is important to emphasize that all participants within the current study reported lifetime suicidal ideation, and in this sense are a group of clinical interest. not least therefore, the current study does exhibit potential clinical implications: first of all, it might be important to account for the presence of suicide-specific rumi­ nation in addition to other risk factors, when assessing individuals for suicide risk. fur­ thermore, suicide-specific rumination may be a potential target in treatment to reduce one’s suicidality. as such, (general) rumination has been shown to be malleable through treatments such as cognitive behavioral therapy (teismann & ehring, 2019) or mindful­ ness-based cognitive therapy (gu et al., 2015). therefore, it should be tested, whether suicide-specific rumination might be modifiable by similar interventions and techniques than general rumination. on the background of findings regarding the relevance of (suicide-specific) rnt in understanding suicidal behavior, respective studies seem highly warranted. should the current findings be confirmed in further studies, it also seems reasonable to integrate suicide-specific rumination as a relevant factor with respect to the transition from suicide ideation to suicidal behavior within the current models of suicide ideation/behavior (cf., o’connor & kirtley, 2018). repetitive thinking and suicide 10 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://www.psychopen.eu/ funding: no funding was received. acknowledgments: the authors would like to thank pierre schumacher and mandy funke for their support in the data collection. competing interests: the dataset reported here is not part of any published or currently in-press works. the authors have no conflict of interests to declare. s u p p l e m e n t a r y m a t e r i a l s perseverative thinking about suicide questionnaire (ptsq). the ptsq is modeled after the perseverative thinking questionnaire (ehring et al., 2011) and assesses with nine items suicide specific rumination (for access see index of supplementary materials below). index of supplementary materials teismann, t., forkmann, t., michalak, j., & brailovskaia, j. (2021). supplementary materials to "repetitive negative thinking about suicide: associations with lifetime suicide attempts" [questionnaire]. psychopen gold. https://doi.org/10.23668/psycharchives.5036 r e f e r e n c e s chen, h., cohen, p., & chen, s. (2010). how big is a big odds ratio? interpreting the magnitudes of odds ratios in epidemiological studies. communications in statistics – simulation and computation, 39(4), 860-864. https://doi.org/10.1080/03610911003650383 cohen, j. (1988). statistical power analysis for the behavioral sciences (2nd ed.). hillsdale, nj, usa: lawrence erlbaum. ehring, t., & watkins, e. r. (2008). repetitive negative thinking as a transdiagnostic process. international journal of cognitive therapy, 1, 192-205. https://doi.org/10.1521/ijct.2008.1.3.192 ehring, t., zetsche, u., weidacker, k., wahl, k., schönfeld, s., & ehlers, a. 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(2013). rumination, anxiety, depressive symptoms and subsequent depression in adolescents at risk for psychopathology: a longitudinal cohort study. bmc psychiatry, 13, article 250. https://doi.org/10.1186/1471-244x-13-250 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. repetitive thinking and suicide 14 clinical psychology in europe 2021, vol. 3(3), article e5579 https://doi.org/10.32872/cpe.5579 https://doi.org/10.1186/s12888-020-02875-8 https://doi.org/10.1026/0012-1924/a000269 https://doi.org/10.1037/0033-2909.134.2.163 https://doi.org/10.1037/a0035540 https://doi.org/10.1186/1471-244x-13-250 https://www.psychopen.eu/ repetitive thinking and suicide (introduction) method and materials participants and procedure measures statistical analyses results descriptive statistics, correlations and group differences prediction of lifetime suicide attempts mediation analysis discussion (additional information) funding acknowledgments competing interests supplementary materials references overcoming barriers and limitations – why this new journal is needed editorial overcoming barriers and limitations – why this new journal is needed winfried rief a, cornelia weise a [a] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2019, vol. 1(1), article e32600, https://doi.org/10.32872/cpe.v1i1.32600 published (vor): 2019-03-29 corresponding author: cornelia weise, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. e-mail: weise@uni-marburg.de highlights • introducing the new journal clinical psychology in europe (cpe). • overcoming artificial barriers by focusing on evidence instead of traditions. • bridging the gap from basic experimental to treatment-related research. • supporting open science recommendations. • covering a broad variety of research efforts. • full open access but no publication fees. we warmly welcome you to the reading of our newly founded journal clinical psychology in europe – cpe! most of us receive requests to submit a manuscript to some obscure new journal just about every day. and today you are holding another new journal in your hands and may – with good reason – be wondering whether it is really necessary to launch a new jour‐ nal given the numerous existing options for submissions. our resounding answer is: yes, we need this journal “clinical psychology in europe” (cpe). not because we feel the need to add another obscure new journal to the field, but because we are keen to have a journal that is committed to encouraging a modern and self-critical discussion in the scientific community, to have a journal that is open-minded about topics considered for publication, to have a journal that increases the visibility of our field of research and to have a journal that provides innovative ideas for future re‐ search in clinical psychology. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i1.32600&domain=pdf&date_stamp=2019-03-29 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ cpe aims to face several challenges in the field of clinical psychology: a first challenge stems from the past, when clinical psychology limited its power and potential to influence society with tensions and artificial barriers between traditions, es‐ pecially between traditions of psychotherapy (“schools”). to face this challenge, cpe is clearly committed to evidence-based treatments, inde‐ pendent of their traditional roots. we encourage all innovations that attempt to overcome these kinds of barriers, we aim to integrate different approaches, and to find a common language in clinical psychology. although science thrives on critical debates, we should aim to have these constructive debates inside our community – while acting as one pow‐ erful group for societal aims. secondly, it is all too often forgotten that clinical psychology is not limited to treat‐ ment. the fruitful exchange between basic approaches, mechanistic and experimental re‐ search, diagnostics and classification, epidemiology and interventional research is the ba‐ sic motor of our science. interventions without links to basic sciences are isolated appli‐ cations, but not serious fields of research. relating the different fields of clinical psychol‐ ogy to each other, but also with the progress of other areas such as neuroscience, emo‐ tion regulation, learning, social interaction, and many others, creates the cross-links that characterize top scientific fields. accordingly, in cpe we aim to provide a balanced ratio of articles reporting on basic, mechanistic, and experimental research in clinical psychology, research from associated areas, such as neuroscience, behavioral medicine, or health psychology and articles pre‐ senting treatment-related issues. our goal is to stimulate interdisciplinary exchange and understanding. a third critical challenge (not only for clinical psychology, but for science in general) is the risk of disseminating false positive results. clinical psychology, and in particular intervention research, is particularly prone to this threat. many psychotherapy research‐ ers are strongly identified with their favorite approaches and theories, and sometimes tend to disrespect one major rule of “good research practice”: distrust your own re‐ search, and cross-check every result critically before you attempt to publish it. this disre‐ spect is problematic as the dissemination of false positive results misleads other research‐ ers, deceives society, and leads to misallocation of resources. to face this challenge, cpe supports open science endeavors. we do not consider cur‐ rent proposals for open science as the final result of these discussions, but as a process during which we should try and evaluate different approaches to continuously improve the validity of published results. our supporting publisher “leibniz institute for psychol‐ ogy information (zpid)” provides several tools to improve open science, for example lit‐ erature databases, archives for data-sharing, repositories, support for study planning or pre-registration (https://www.leibniz-psychology.org/en/). fourth, it is our impression that there is extensive knowledge around, but this knowl‐ edge does not always reach the scientific community. given the pressure to 'publish or overcoming barriers and limitations 2 clinical psychology in europe 2019, vol.1(1), article e32600 https://doi.org/10.32872/cpe.v1i1.32600 https://www.leibniz-psychology.org/en/ https://www.psychopen.eu/ perish', many researchers focus on submitting empirical research articles. journals wel‐ come these manuscripts and only rarely allow for updates or general overviews. accord‐ ingly, there are limited opportunities for experts to share knowledge they have accumu‐ lated over several years of work in a specific field. to reflect the broad variety of research efforts, cpe provides the opportunity to sub‐ mit different types of articles. for empirical research, the typical research articles can be submitted. however, we also encourage submitting scientific updates on the current knowledge of a field in which experts can share their current summaries with all of us. the same holds true for the publication of other expertise or events, such as inaugural speeches or keynote lectures, which are characterized by thorough preparation. cpe can help to further disseminate this knowledge using the format of state-of-the-art over‐ views. to meet our goal of providing a platform of exchange, cpe further encourages au‐ thors to report latest developments (such as new technical applications or recently devel‐ oped questionnaires) as well as topics related to politics and education in the field of clini‐ cal psychology. for example, the description of different legal regulations for clinical psy‐ chology and psychological interventions might inform and stimulate the development of such regulations in different countries. and finally, we face a challenge in meeting the major societal aim of research: dis‐ seminate it for the benefit of others and let others make use of it. this is why journals exist and why we meet at conferences. however, many journals have developed a life of their own with financial benefit becoming more and more relevant. as we are convinced that the decision about publication should not depend on whether authors can afford to pay substantial article processing charges we are delighted that – thanks to the support of leibniz institute for psychology information – our aim of not charging any publica‐ tion costs for articles has become reality! we welcome your submissions at https://cpe.psychopen.eu and we are looking for‐ ward to collaborating with you! now enjoy reading the first issue of cpe and get in‐ spired. winfried rief, editor in chief, and cornelia weise, managing editor rief & weise 3 psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. www.leibniz-psychology.org https://cpe.psychopen.eu https://www.leibniz-psychology.org/ https://www.psychopen.eu/ a self-report measure of perfectionism: a confirmatory factor analysis of the swedish version of the clinical perfectionism questionnaire research articles a self-report measure of perfectionism: a confirmatory factor analysis of the swedish version of the clinical perfectionism questionnaire allison parks 1, jakob clason van de leur 2,3, marcus strååt 4,5, fredrik elfving 5, gerhard andersson 1,6, per carlbring 5, roz shafran 7, alexander rozental 1,3,7 [1] department of clinical neuroscience, karolinska institutet, stockholm, sweden. [2] pbm, stockholm, sweden. [3] department of psychology, uppsala university, uppsala, sweden. [4] prima barn och vuxenpsykiatri ab, stockholm, sweden. [5] department of psychology, stockholm university, stockholm, sweden. [6] department of behavioural sciences and learning, linköping university, linköping, sweden. [7] great ormond street institute of child health, university college london, london, united kingdom. clinical psychology in europe, 2021, vol. 3(4), article e4581, https://doi.org/10.32872/cpe.4581 received: 2020-10-19 • accepted: 2021-10-20 • published (vor): 2021-12-23 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: alexander rozental, department of psychology, uppsala university, von kramers allé 1a och 1c, 751 42 uppsala, sweden. phone: +46 73 693 79 48. e-mail: alexander.rozental@psyk.uu.se supplementary materials: materials [see index of supplementary materials] abstract background: perfectionism is often defined as the strive for achievement and high standards, but can also lead to negative consequences. in addition to affecting performance and interpersonal relationships, perfectionism can result in mental distress. a number of different self-report measures have been put forward to assess perfectionism. specifically intended for clinical practice and research, the clinical perfectionism questionnaire (cpq) was developed and is presently available in english and persian. to promote its use in additional contexts, the current study has translated and investigated the psychometric properties of the swedish version of the cpq. method: a confirmatory factor analysis was performed to examine the best fit with data, using a priori-models and a sample of treatment-seeking participants screened for eligibility to receive internet-based cognitive behavior therapy (n = 223). results: the results indicated a lack of fit with data. a two-factor structure without the two reversed items (2 and 8) exhibited the best fit, perfectionistic strivings and perfectionistic concerns, but still had poor structural validity. correlations with self-report measures of perfectionism, depression, anxiety, dysfunctional beliefs, self-criticism, quality of life, and self-compassion were this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4581&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0002-1019-0245 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ all in the expected directions. eight-week test-retest correlation was pearson r = .62, 95% confidence interval [.45, .74], using data from 72 participants in the wait-list control, and the internal consistency for the cpq, once removing the reversely scored items, was cronbach’s α = .72. conclusion: the cpq can be used as a self-report measure in swedish, but further research on its structural validity is needed. keywords perfectionism, swedish, psychometrics, clinical perfectionism questionnaire, confirmatory factor analysis highlights • the clinical perfectionism questionnaire is available in swedish. • two factors emerged: perfectionistic strivings and perfectionistic concerns. • eight-week test-retest correlation was pearson r = .62. • further research on its construct validity is needed. perfectionism can result in the refusal to accept any standard short of perfection and the relentless pursuit of achievements (egan et al., 2011). shafran et al. (2002) define this as the “overdependence of self-evaluation on the determined pursuit of personally demanding, self-imposed standards in at least one highly salient domain, despite adverse consequences.” (p. 778), noting that certain individuals become dependent on attaining high standards, experiencing distress when these are not met. a highly perfectionistic person is thought to derive its self-worth on success in one or a few domains, such as school or work, and to rely on highly inflexible behaviors, e.g., repeated checking, seeking reassurance, and comparing oneself to others (egan et al., 2011). this is also maintained by cognitive biases, such as dichotomous thinking (e.g., “either you succeed or you fail”). perfectionism can have a detrimental impact on interpersonal relationships, performance, and well-being (shafran et al., 2002). in a systematic review and meta-anal­ ysis, limburg et al. (2017) found moderate to strong correlations between self-rated perfectionism and many psychiatric disorders. also, egan et al. (2011) reviewed some of the issues a high degree of perfectionism might impose on treatment, e.g., achieving poorer outcomes for patients with depression and worse therapeutic alliance, suggesting that it constitutes a transdiagnostic process that may warrant clinical attention. to assess and determine the nature and severity of perfectionism, different forms of self-report measures have been developed (stoeber, 2018). among the first and most widespread are the frost multidimensional perfectionism scale (fmps; frost et al., 1990) and the multidimensional perfectionism scale (mps; hewitt & flett, 1990). both self-re­ port measures conceptualized perfectionism as a multidimensional construct, although being composed of somewhat different factors. regardless of what type of self-report measure is used, perfectionism is considered to involve two higher-order dimensions; the clinical perfectionism questionnaire in swedish 2 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ perfectionistic strivings, i.e., perfectionistic personal standards and a self-oriented striv­ ing for perfection, and perfectionistic concerns, i.e., concern over mistakes, perceived discrepancy between standards and performance, and the notion of being judged nega­ tively by others (stoeber, 2018). a criticism of the two self-report measures is their focus on issues that are a bit outside the scope of the two higher-order dimensions. this includes such subscales as organization on the fmps (i.e., need for order and neatness) and other-oriented perfec­ tionism on the mps (i.e., imposing unrealistic standards toward others), which have been recommended for removal (stoeber & otto, 2006). furthermore, it has been argued that many items are not associated with perfectionism at all, such as those belonging to the factors parental expectations and parental criticism on the fmps (frost et al., 1990), which can be seen as developmental antecedents (i.e., having parents that emphasize the need for performance and who are highly critical of their child) (limburg et al., 2017). in an attempt to overcome some of these issues, fairburn, cooper, and shafran (2003) developed the clinical perfectionism questionnaire (cpq), arguing that it measures behaviors and cognitions related to the clinically relevant aspects of perfectionism, e.g., “have you pushed yourself really hard to meet your goals” (item 1). in comparison to other self-report measures on perfectionism, it also prompts respondents to think about life domains relevant for their perfectionism and how perfectionism has affected them during the last month. furthermore, given the multidimensional nature of many self-report measure of perfectionism (six for the fmps and three for the mps), these might not be sensitive enough to detect change during treatment, suggesting that the cpq might be more clinically relevant. at present, the cpq has been administered in several clinical trials of perfectionism (e.g., rozental, shafran, et al., 2017; shafran et al., 2017; zetterberg et al., 2019), and a number of studies have also explored its psychometric properties in english (dickie et al., 2012; egan et al., 2016; stoeber & damian, 2014), persian (moloodi et al., 2017), and german (roth et al., 2021). overall, it seems to load on two factors, i.e., perfectionistic strivings and perfectionistic concerns, and the internal consistency, cronbach’s α, has been found to be within the acceptable range (.71-.82 for the full self-report measure), de­ pending on the study and sample. however, the results also indicate that its two reversed items can be removed to increase reliability, as is often the case with reversely scored statements (weijters et al., 2013). also, two other items have demonstrated cross-loadings (items 7 and 9) in some studies (egan et al., 2016; stoeber & damian, 2014), which could reflect the fact that the two higher-order dimensions are supposed to be correlated with each other (limburg et al., 2017), or indicate a more severe problem associated with the factorial structure of the cpq. further, in terms of its temporal stability, dickie et al. (2012) collected data from 142 undergraduate students and found a four-month test-retest correlation of r = .49-.67, depending on the factor investigated. as for its validity, the cpq has been found to be related to different self-report measures of perfectionism parks, van de leur, strååt et al. 3 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ and their respective subscales, e.g., concern over mistakes (r = .61) as well as personal standards (.47-.57) on the fmps, and the same goes for self-oriented perfectionism and socially prescribed perfectionism (.42-.59) on the mps, as shown, for example, in the studies by dickie et al. (2012) and stoeber and damian (2014). only one investigation assessed its relation with variables concerning psychiatric disorders (moloodi et al., 2017). here, items on the cpq belonging to the factor perfectionistic concerns were related to rumination (.49-.51) on the perfectionism inventory (hill et al., 2004), as well as depression (.44-.48), anxiety (.37-.43), and stress (.45-.51) on the dysfunctional attitudes scale (weissman & beck, 1978) (with higher correlations belonging to the clinical group, in comparison to the general population group). to promote its use in clinical practice and research in sweden, the cpq was transla­ ted into swedish as part of a series of clinical trials (rozental, magnusson, et al., 2017; zetterberg et al., 2019). however, no psychometric study of this translation has yet been reported, warranting an examination of its factorial structure, internal consistency, valid­ ity, and test-retest correlation. in addition, with the exceptions of moloodi et al. (2017) and prior et al. (2018), all attempts at examining the cpq have used exploratory factor analysis or principal component analysis. although being useful ways of investigating plausible factors or components among items, these methods should primarily be used when there is no available hypothesis regarding the underlying construct (hurley et al., 1997). seeing as there are presently several studies of the cpq in both english and persian, there is sufficient evidence to test a priori-models using confirmatory factor analysis (cfa). this method could help to explore not only the reliability of the swedish version but also to check the proposed two-factor structure using collected data, in line with the recommendations by stoeber and damian (2014). hence, the current study aims to investigate the psychometric properties of the cpq in swedish to facilitate its use in sweden, and to assess the best fitting factorial structure based on previous research. the data is derived from a treatment-seeking sample of participants that were recruit­ ed for a clinical trial of internet-based cognitive behavior therapy for perfectionism (rozental, shafran, et al., 2017). furthermore, internal consistency will also be explored, and convergent and divergent validity will be examined using self-report measures of perfectionism, depression, anxiety, dysfunctional beliefs, self-criticism, quality of life, and self-compassion. test-retest correlation will also be assessed using the wait-list control, i.e., participants who were assigned to a waiting-period of eight weeks in the clinical trial, as these are not subject to an intervention that might affect their scores. the clinical perfectionism questionnaire in swedish 4 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ m e t h o d participants participants were recruited through social media, the recruitment website www.stud­ ie.nu, posters set up at linköping university, stockholm university, and a number of health centers in linköping, a local public radio show, and a local newspaper. these advertisements declared that anyone who experienced severe problems of perfectionism and were interested in the study could register and fill out the self-report measures on the study’s website. inclusion criteria were as follows: being over the age of 18, fluent in swedish, and having severe problems of perfectionism. eligibility was determined using both self-report measures (i.e., the cpq and the fmps, subscales concern over mistakes and personal standards), and through a case management conference (where each case was reviewed and discussed together with an experienced clinician and researcher, ga). no cutoff was employed for any of the self-report measures, but each individuals’ scores were checked on a case-by-case basis. exclusion criteria included; pregnancy (given that it could have interfered with the completion of treatment), ongoing psychological treat­ ment, any change to psychotropic medication less than twelve weeks prior to entering the clinical trial, and the need for other or more extensive psychological treatment, such as when having anorexia nervosa or elevated suicide ideation, as assessed over the telephone using the mini-international neuropsychiatric interview (sheehan et al., 1998). other psychiatric disorders were allowed as long as perfectionism was deemed to be the primary concern. in total, 273 individuals registered on the study’s website, of which 223 (81.7%) completed all of the self-report measures and were included in the current psychometric study, regardless of whether they were included in the clinical trial or not. of those eligible for inclusion, 78 were randomized to a wait-list control and were used to estab­ lish the test-retest correlation of the cpq (eight weeks), with 72 (92.3%) completing the second round of assessments. for more detailed information concerning the screening procedure, see rozental, shafran, et al. (2017). although data in the current psychometric study are derived from the clinical trial, there are no overlaps in study design, statistical analyses, or the presentation of data or results. table 1 includes the sociodemographics of the participants. parks, van de leur, strååt et al. 5 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 http://www.studie.nu http://www.studie.nu https://www.psychopen.eu/ table 1 sociodemographic characteristics of the participants sociodemographics total sample (n = 223) women: n (%) 193 (86.5) age (years): m (sd) 34 (9.6) relationship status: n (%) single 63 (28.3) married/partner 154 (69.1) divorced/widowed 5 (2.2) answer missing 1 (0.4) children: n (%) yes, at home 74 (33.2) yes, not at home 10 (4.5) no 134 (60.1) answer missing 5 (2.2) pregnant: n (%) 2 (0.9) highest education level: n (%) elementary school 4 (1.8) high school 57 (25.6) university 156 (70.0) graduate school 6 (2.7) employment: n (%) unemployed 8 (3.6) student 57 (25.6) employed 141 (63.2) parent leave 6 (2.7) sick leave (> 3 months) 5 (2.2) other 5 (2.2) currently diagnosed with a psychiatric diagnosis: n (%) 24 (10.8) ongoing psychological treatment: n (%) 15 (6.7) regularly taking psychotropic medication: n (%) 39 (17.5) procedure individuals having registered their interest to participate completed a screening proc­ ess on a secure online platform (vlaescu et al., 2016), consisting of sociodemographic information and self-report measures. during the registration, individuals received an auto generated identification code, e.g., 1234abcd, guaranteeing their anonymity. prior to recruitment and data collection, ethics approval was granted by the regional ethical the clinical perfectionism questionnaire in swedish 6 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ board in linköping, sweden (dnr: 2015/419-31), and informed consent was obtained from all participants during the screening process. measures clinical perfectionism questionnaire the cpq includes the definition of perfectionism as put forward by shafran et al. (2002), followed by a yes/no question of whether the individual has tried to achieve high standards during the last month regardless of having succeeded at this, and what life domain(s) this pertains, e.g., performance at work (however, none of these parts are analyzed quantitatively). it is then followed by twelve items concerning clinically relevant aspects of perfectionism that are scored on a four-point likert-scale 1-4 (not at all to all of the time), with two reversed items (items 2 and 8), and employing a time-frame of one month. for more information regarding the factorial structure and validity of the cpq, please see the introduction. the swedish version of the cpq was developed in relation series of clinical trials (rozental, shafran, et al., 2017; zetterberg et al., 2019), with translation and back-transla­ tion being made by the researchers of the current study to ensure that nothing was lost in the process of translating the self-report measure. other self-report measures several self-report measures were also used in the current study to establish the conver­ gent and divergent validity of the cpq. the fmps was administered to establish the relationship with another self-report measure of perfectionism (frost et al., 1990). the fmps is rated on a five-point likert-scale 1-5, strongly disagree (1) to strongly agree (5), with 35 items covering the subscales concern over mistakes, personal standards, doubts about action, parental expectations, parental criticism, and organization. the fmps has been shown to correlate with other self-report measures of perfectionism and different symptoms of psychiatric disorders (e.g., purdon et al., 1999). with regard to internal consistencies, α ranges from adequate to excellent, .77-.93 (frost et al., 1990), see table 2 for this estimate for the fmps and the other self-report measures in the current study. the fmps does not include a predefined time-frame. moreover, the nine-item patient health questionnaire (phq-9; löwe et al., 2004) was distributed to evaluate the degree of depression and is scored on a four-point likert­ scale, not at all (0) to nearly every day (3). the phq-9 is often used as a screening tool for depressive symptoms, employs a time-frame of two weeks, has been validated against other self-report measures and clinical interviews of depression, and has an excellent in­ ternal consistency, .89 (löwe et al., 2004). the seven-item generalized anxiety disorder (gad-7; spitzer et al., 2006) determines the level of anxiety and worry and is scored on a four-point likert-scale, not at all (0) to nearly every day (3). the gad-7 is often used as parks, van de leur, strååt et al. 7 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ a screening tool for anxiety symptoms, employs a time-frame of two weeks, corresponds well with other self-report measures of anxiety and clinical interviews of generalized anxiety disorder, and has an excellent internal consistency, .92 (e.g., dear et al., 2011). the 40-item dysfunctional attitude scale, sometimes referred to as form a (as compared to the original version of 100-item) (das; weissman & beck, 1978) assesses various maladaptive beliefs, e.g., self-criticism. the das is scored on a seven-point likert-scale, strongly disagree (1) to strongly agree (7), is correlated with other self-report measures of depression (e.g., oliver & baumgart, 1985), and has an excellent internal consistency, .90 (cane et al., 1986). moreover, the 15-item subscale self-criticism was explored separately in the current study given its relationship with perfectionism (e.g., dunkley et al., 2009; imber et al., 1990). the das does not include a predefined time-frame. the 12-item table 2 range in scores, means, standard deviations, and internal consistencies of the self-report measures (n = 223) self-report measure range in scores m (sd) internal consistencies cronbach α cpq 12-48 38.3 (4.6) .68 psa 1-24 15.0 (2.7) .58 pca 1-20 17.0 (2.4) .69 fmps 35-175 97.9 (16.3) .89 pst. 35 28.3 (4.1) .69 cm 45 34.2 (6.6) .86 da 20 13.7 (3.3) .61 pc 20 9.5 (4.4) .86 pe 25 12.3 (5.5) .90 o 30 24.4 (4.4) .83 phq-9 0-27 10.3 (5.9) .85 gad-7 0-21 8.6 (5.3) .88 das-40 40-280 175 (31.7) .91 sc 15-105 63.1 (15.7) .90 bbq 0-96 41.8 (16.8) .71 scs-sf 12-60 26.1 (6.3) .79 note. cpq = clinical perfectionism questionnaire; ps = perfectionistic strivings; pc = perfectionistic concerns; fmps = frost multidimensional perfectionism scale; pst. = personal standards; cm = concern over mistakes; da = doubts about action; pc = parental criticism; pe = parental expectations; o = organization; phq-9 = patient health questionnaire; gad-7 = generalized anxiety disorder; das-40 = dysfunctional attitude scale; sc = self-criticism; bbq = brunnsviken brief quality of life scale; scs-sf = self-compassion scale short form. abased on the best fitting model in the current study, i.e., stoeber and damian (2014), without reversed items and with item 7 belonging to the factor perfectionistic concerns. the clinical perfectionism questionnaire in swedish 8 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ brunnsviken brief quality of life scale (bbq; lindner et al., 2016) explores the quality of life within six different areas, e.g., leisure and learning, and level of importance, e.g., “my leisure time is important to me”. the bbq is scored on a four-point scale from strongly disagree (1) to strongly agree (4). the bbq demonstrates good convergent and divergent validity, good classification ability, and has an adequate internal consistency, .76 (lindner et al., 2016). the bbq does not include a predefined time-frame. lastly, the twelve-item self-compassion scale short form (scs-sf) (as compared to the full self-report measure of 26 items) tests the degree of self-compassion and is scored on a five-point scale from almost never (1) to almost all of the time (5), range in scores 5-60. the scs-sf has been shown to be negatively correlated with self-report measures of symptoms of psychiatric disorders, and has a good internal consistency, .86 (raes et al., 2011). the scs-sf does not include a predefined time-frame. all of the self-report measures used in the current study have previously been translated and/or were available in swedish. for an overview of the means and standard deviations of all self-report measures used in the current study, see table 2. data analysis in order to investigate the factorial structure of the swedish version of the cpq and to relate the results to previous studies on the same self-report measure, cfa was used on the total sample (n = 223). in comparison to employing an exploratory factor analysis or principal component analysis, cfa allows the researcher to test one or several a priori-model(s), making it possible to assess the reliability of the cpq as well as to confirm or refute prior findings (brown, 2015), in this case with regard to its previously proposed two-factor structure. for comparison, a single factor model with and without the reversed items were also analyzed. model fit was subsequently examined using the likelihood-ratio χ2-test (p > .05), the tucker-lewis index (tli; > .95), the comparative fit index (cfi; > .95), the root mean square error of approximation (rmsea; < .06), with cutoffs for indices presented in parentheses (brown, 2015). given that the cpq violated assumptions of normality, weighted least squares was used as estimator. items with cross-loadings were added to the factor with the highest positive loading. internal consistencies were explored using cronbach’s α, and the convergent and divergent validity were investigated by examining the correlations between the manifest scale scores of the cpq and the other self-report measures administered in the current study. meanwhile, test-retest correlation was determined by studying the correlation on the cpq for the wait-list control (n = 78) between two points of measurement that were eight weeks apart. all analyses were performed in r studio 1.4.1717 (rstudio team, 2020). parks, van de leur, strååt et al. 9 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ r e s u l t s confirmatory factor analysis each a priori-model from the previous studies of the cpq were tested separately using cfa. however, none of them demonstrated an acceptable fit, as seen in table 3. with the exception of significant likelihood-ratio χ2-tests, the tli, cfi, and rmsea all exhibited indices that were below/above the cutoffs. similar results were obtained for a single factor model and the two models without the reversed items. table 3 goodness of fit indices for each priori-model from prior research on the clinical perfectionism questionnaire (n = 223) model χ2 df tli cfi rmsea 95% ci two-factor structure dickie et al. (2012) 101* 34 .59 .69 .09 .07, .12 factor 1: 1, 3, 6, 9, 10, 11 factor 2: 2, 4, 5, 12 stoeber and damian (2014)a 116* 49 .72 .79 .08 .06, .10 factor 1: 1, 3, 5, 6, 7, 8, 9, 10, 11 factor 2: 2, 4, 5, 7, 8, 9, 12 stoeber and damian (2014)a, without reversed items 76* 31 .73 .81 .08 .06, .11 factor 1: 1, 3, 5, 6, 7, 9, 10, 11 factor 2: 4, 5, 7, 9, 12 egan et al. (2016)b nac na na na na na factor 1: 1, 3, 6, 7, 8, 9, 10, 11 factor 2: 1, 2, 4, 5, 8, 12 moloodi et al. (2017)d 114* 43 .66 .74 .09 .07, .11 factor 1: 1, 3, 6, 7, 9, 10, 11 factor 2: 2, 4, 5, 12 single factor structure single factor 142* 54 .67 .73 .09 .07, .10 single factor without reversed items 91* 35 .70 .77 .09 .06, .11 note. likelihood-ratio χ2-test (p > .05), the tucker-lewis index (tli; > .95), the comparative fit index (cfi; > .95), the root mean square error of approximation (rmsea; < .06), cutoffs for indices presented in parenthe­ ses. df = degrees of freedom; ci = confidence interval. abased on the results reported for the first exploratory factor analysis. bbased on the results reported for study 1. cmodel did not converge. dbased on the results reported for the general population. *p < .05. the clinical perfectionism questionnaire in swedish 10 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ table 4 contains the factor loadings for each item using the model with the best fit in the current study, i.e., stoeber and damian (2014), without reversed items. factor 1 (items 1, 3, 6, 7, 9, 10, and 11) fits well with the first higher-order dimension of perfectionistic strivings, while factor 2 (items 4, 5, 7, 9, and 12) corresponds to the second, perfectionistic concerns. one item exhibited a significant cross-loading between factors, item 7, “have you judged yourself on the basis of your ability to achieve high standards?”. given its emphasis on negative evaluation, it was deemed more appropriate to include it in factor 2 (i.e., perfectionistic concerns). table 4 standardized factor loadings for each item using the best fitting a priori-model in the current study, i.e., stoeber and damian (2014), without reversed items (n = 223) items skewness factor 1: perfectionistic strivings factor 2: perfectionistic concerns 1. have you pushed yourself really hard to meet your goals? -0.67 .57* 3. have you been told that your standards are too high? -1.27 .55* 4. have you felt a failure as a person because you have not succeeded in meeting your goals? -1.30 .64* 5. have you been afraid that you might not reach your standards? -1.05 .07 .54* 6. have you raised your standards because you thought they were too easy? 0.04 .36* 7. have you judged yourself on the basis of your ability to achieve high standards? -0.98 .11* .53* 9. have you repeatedly checked how well you are doing at meeting your standards (for example, by comparing your performance with that of others)? -0.72 .16 .45* 10. do you think that other people would have thought of you as a ”perfectionist”? -0.42 .35* 11. have you kept trying to meet your standards, even if this has meant that you have missed out on things? -0.57 .63* 12. have you avoided any tests of your performance (at meeting your goals) in case you failed? -0.86 .49* *p < .05. parks, van de leur, strååt et al. 11 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ convergent and divergent validity the manifest scale scores of the cpq were correlated with the other self-report measures distributed to the participants (see table 5 for the correlation matrix, and table 6 and 7 in the online appendix, supplementary materials, for partial correlations controlling for each factor). overall, the cpq demonstrated moderate to large positive correlations with fmps (the full self-report measure) and the subscales personal standards and concern over mistakes, which are often used to examine levels of perfectionism in many clinical trials. meanwhile, the cpq exhibited small positive correlations with the rest of the sub­ scales, which are considered antecedents to, or, in the case of the subscale organization, unrelated to perfectionism. the cpq also exhibited moderate positive correlations with depression, anxiety, and self-criticism. furthermore, the cpq was negatively related to self-report measures of quality of life and self-compassion with correlations in the small to moderate range. table 5 correlations between the self-report measures (n = 223) selfreport measure cpq ps pc fmps pst. cm da pc pe o phq-9 gad-7 das-40 sc bbq scs-sf cpq – .84* .77* .49* .48* .46* .33* .23* .16* .26* .34* .41* .47* .44* -.20* -.38* ps – .41* .38* .45* .24* .24* .22* .17* .28* .23* .31* .31* .28* -.06 -.18* pc – .51* .35* .56* .37* .24* .16* .13 .43* .44* .54* .54* -.27* -.42* fmps – .66* .74* .48* .74* .71* .26* .27* .34* .55* .58* -.22* -.29* pst. – .48* .29* .22* .28* .39* .24* .32* .31* .30* -.07 -.20* cm – .38* .27* .19* .15* .33* .38* .70* .72* -.22* -.44* da – .13 .04 .18* .21* .33* .33* .37* -.17* -.10 pc – .82* .10 .10 .12 .26* .32* -.16* -.09 pe – .11 .02 .01 .14* .16* -.11 -.05 o – .07 .20* .04 .00* -.02 -.03 phq-9 – .72* .34* .36* -.28* -.26* gad-7 – .37* .36* -.28* -.30* das-40 – .92* -.28* -.51* sc – -.26* -.43* bbq – .33* scs-sf – note. cpq = clinical perfectionism questionnaire; ps = perfectionistic strivings; pc = perfectionistic concerns; fmps = frost multidimensional perfectionism scale; pst. = personal standards; cm = concern over mistakes; da = doubts about action; pc = parental criticism; pe = parental expectations; o = organization; phq-9 = patient health questionnaire; gad-7 = generalized anxiety disorder; das-40 = dysfunctional attitude scale; sc = self-criticism; bbq = brunnsviken brief quality of life scale; scs-sf = self-compassion scale short form. abased on the best fitting model in the current study, i.e., stoeber and damian (2014), without reversed items and with item 7 belonging to the factor perfectionistic concerns. *p < .05. the clinical perfectionism questionnaire in swedish 12 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ inspecting the two factors of the cpq more closely, both perfectionistic strivings and perfectionistic concerns show similar relationships with the other self-report measures when looking at the overall correlations. however, the partial correlation revealed that perfectionistic strivings (controlling for perfectionistic concerns) was primarily associ­ ated with the subscales perfectionistic standards and organization, while perfectionistic concerns (controlling for perfectionistic strivings) was most notably related to concern over mistakes and doubts about action. overall, perfectionistic concerns can also be distinguished by its stronger positive correlations to depression, anxiety, dysfunctional beliefs, self-criticism, and stronger negative correlations with quality of life and self-com­ passion, even after controlling for perfectionistic strivings. test-retest correlation of the 78 participants who were randomized to wait-list control, 72 (92.3%) completed the cpq at both measurement points. using this data, the eight-week test-retest corre­ lation was pearson r = .62, 95% confidence interval (ci) [.45, .74]. for perfectionistic standards, r = .49, 95% ci [.30, .65], and perfectionistic concerns, r = .65, 95% ci [.50, .77]. internal consistency internal consistencies for the cpq are shown in table 2. the reliability statistic for the full scale also indicated that it would increase if items 2 and 8 were removed (from .68 to .72), suggesting a somewhat improved reliability if the two reversely scored statements were to be excluded. with regard to the best fitting model, the reliability statistic was .58 for perfectionistic strivings and .69 for perfectionistic concerns. d i s c u s s i o n the current study explored the psychometric properties of the swedish version of the cpq. based on the results from the cfa, none of the a priori-models examined showed an acceptable fit. the single-factor model demonstrated poorest fit with data, refuting a unidimensional construct, as already noted in prior research of the self-report measure (dickie et al., 2012; egan et al., 2016; moloodi et al., 2017; stoeber & damian, 2014). this is in line with the theoretical notion as well as empirical findings of perfectionism being comprised of two higher-order dimensions, that is, perfectionistic strivings and perfectionistic concerns (stoeber, 2018). using the same single factor model without the two reversed items (2 and 8) increased the fit slightly, albeit still not being satisfactory. meanwhile, using the model proposed by stoeber and damian (2014), and excluding the two reversed items, resulted in the best fit in the current study, yet still without meeting cutoffs on the indices. of note is that one significant cross-loading was found; item 7, “have you judged yourself on the basis of your ability to achieve high standards?”. this parks, van de leur, strååt et al. 13 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ could indicate that there is an inherent problem with this item or that it challenges the proposed factorial structure of the cpq, that is, being related to both higher-order dimensions of perfectionism, i.e., setting high standards and being demanding of oneself (perfectionistic standards) and critically appraising one’s own behavior (perfectionistic concerns). in the current study, item 7 was included in latter factor, but the decision was data-driven rather than based on theory as there is no consensus in the literature on how to deal with this issue. judging by its wording, it could however be assumed that it relates to the core concept of perfectionism, as conceptualized by shafran et al. (2002), i.e., an overdependence of self-evaluation. this might be explored further by, for example, including additional items related to self-worth and investigating their loadings on either of the two factors. similarly, item 8, which is a reversed statement, demonstrated a negative correlation with one factor and positive correlation with the second. moreover, two additional, albeit not significant, cross-loadings were observed, items 5 and 9, “have you been afraid that you might not reach your standards?” and “have you repeatedly checked how well you are doing at meeting your standards (for example, by comparing your performance with that of others)?”. in the current study, these belonged to the factor perfectionistic concerns, but also taps into the concept of setting high standards (i.e., perfectionistic standards), perhaps explaining this finding. however, because there is no agreement on a theoretical concept behind the cpq with regard to what items belong to what factor, there is an inherent problem in examining different models. this makes it difficult to understand and manage cross-loadings as well as how to develop the self-report measure further, warranting a more collaborative approach to generating a theoretical concept of perfectionism and model testing. given the results from the cfa, a two-factor solution seems most reasonable. howev­ er, this still displayed a poor fit, suggesting that further research on its structural validity is needed. furthermore, a shorter version of the cpq with 10 items, excluding items 2 and 8, might be more useful to administer in the future, as has already been proposed by prior et al. (2018). the removal of these two reversed items improved the factorial structure, in line with stoeber and damian (2014), suggesting that the findings from the current study should not be a translational issue. still, there may be diagnostic reasons to retain reversely scored items, such as to preventing the risk of acquiescence bias. future research should explore the structural validity of the cpq in greater detail by employing larger samples and both clinical and non-clinical participants, as well as determining how to manage the more problematic items, i.e., 2, 7, and 8. meanwhile, the analysis of convergent and divergent validity shows that the cpq is positively correlated with the fmps, both for the full self-report measure and for the clinically most relevant subscales personal standards and concern over mistakes, as has been found previously in the literature (limburg et al., 2017). these estimates are similar, albeit a bit smaller than what has been found in other studies, such as .57 for personal standards and .61 for concern over mistakes (stoeber & damian, 2014). the the clinical perfectionism questionnaire in swedish 14 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ two factors of the cpq, perfectionistic strivings and perfectionistic concerns, also had somewhat different relationships with other variables, but all in the expected directions. when controlling for perfectionistic strivings, the correlations between the cpq and the fmps are stronger for the subscales concern over mistakes and doubts about action. meanwhile, when controlling for perfectionistic concerns, the cpq is more strongly related to the subscales personal standards and organization. these results were antici­ pated and corresponds to the findings by, for example, dickie et al. (2012). in addition, a high degree of perfectionism as assessed using the cpq, and in particular the factor perfectionistic concerns, seems to be associated with such issues as depression, anxiety, and self-criticism, while at the same time being linked to a lower quality of life and less of a compassionate stance towards yourself, confirming the results from moloodi et al. (2017). in terms of the test-retest correlation, the results for the wait-list control between the two points of measurement (i.e., eight weeks) was r = .62, which was slightly higher for perfectionistic concerns than perfectionistic strivings, r = .65 compared to .49. albeit in line with the estimates found by dickie et al. (2012), the correlation is still lower than many self-report measures used to assess symptoms of psychiatric disorders, e.g., the penn state worry questionnaire, r = .84 (pallesen et al., 2006). the reason and implication of this is unclear. on the one hand, it might be argued that the cpq is expected to exhibit greater temporal stability given its many trait-like features and the fact that no intervention was provided during the waiting period. on the other hand, it is not unlikely to see spontaneous remission and deterioration among participants in a wait-list control (e.g., rozental, magnusson, et al., 2017), as well as other external factors influencing their scores, such as being on holiday or not being exposed to triggers for their perfectionism at the second round of assessment, thereby affecting the test-retest correlation. another explanation may be that the cpq captures how cognitions and behaviors related to perfectionism fluctuates depending on situations the individual is exposed to, resulting in some variation in scores between assessments. additional research is required in order to get a better impression of the test-retest correlation of the cpq, preferably by using a normal population and a shorter time-frame, such as one or two weeks, as recommended by tingey et al. (1996). also, longitudinal studies could investigate the theoretical assumptions behind the test-retest correlation, such as factorial invariance and reliability index. the current study has a number of strengths as well as limitations that need to be addressed when reviewing the results. similar to prior et al. (2018), it used a clinical sample, in line with the intended use of the cpq in clinical settings. the average levels of perfectionism on the self-report measures were therefore high at screening, cpq 38.3 (sd = 4.6), and personal standards 28.3 (sd = 4.1) and concern over mistakes 34.2 (sd = 6.6) on the fmps, implying that they probably had quite severe problems before treatment. symptoms of depression and anxiety were also evident, for example phq-9 parks, van de leur, strååt et al. 15 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ 10.3 (sd = 5.9) and gad-7 8.6 (sd = 5.3), indicating slightly elevated levels of depression and anxiety. however, the inclusion of participants from a normal population would have been helpful to distinguish clinical from non-clinical perfectionism and should be pursued in future research. using a larger sample size and interviews with regard to the clinical implications of the participants’ perfectionism could also be used to assess classification accuracy. meanwhile, data was solely based on the responses at screening as part of being assessed for eligibility to participate in a clinical trial. this made it possible to explore convergent and divergent validity to a greater extent than before as other self-report measures were administered at the same time. yet, this recruitment method could be affected by self-presentation bias, that is, exaggerating one’s problems in order to be eligible for inclusion in treatment. an alternative would have been to administer the cpq to patients already in a clinical setting to confirm the results from the current study, e.g., eating disorders, which is advised in future psychometric studies of the self-report measure. similarly, participants included in the analyses were predom­ inantly in their 30’s, women (86.5%), having a university degree, and being employed, which might affect generalizability. although such sociodemographics are not uncom­ mon in treatment-seeking populations (vessey & howard, 1993), especially in terms of internet-based cognitive behavior therapy (lindner et al., 2015; titov et al., 2010), it does raise some questions concerning the self-report measure’s application across groups, e.g., age and gender, therefore research should try to include more diverse samples in upcoming studies. in addition, other aspects warranting further investigation is to determine the validity of the time-frame used in the instructions for the cpq, i.e., one month, perhaps by employing a longitudinal study design. on a different note, exploring rank order stability is also important, that is, how well the self-report measure functions for different symptom severity levels among individuals undergoing treatment. funding: this research was made possible thanks to a professor’s grant from linköping university to one of the authors (ga). all research at great ormond street hospital nhs foundation trust and ucl great ormond street institute of child health is made possible by the nihr great ormond street hospital biomedical research centre. the views expressed are those of the author(s) and not necessarily those of the nhs, the nihr, or the department of health. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have no conflict of interest to report. author note: the self-report measure evaluated in the current study, the clinical perfectionism questionnaire, is free to use in both english and swedish and can be located in the online appendix (see supplementary materials). the clinical perfectionism questionnaire in swedish 16 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • table 6: partial correlations between the self-report measures, controlling for perfectionistic strivings (n = 223) • table 7: partial correlations between the self-report measures, controlling for perfectionistic concerns (n = 223) • english and swedish translations of the clinical perfectionism questionnaire index of supplementary materials parks, a., van de leur, j. c., strååt, m., elfving, f., andersson, g., carlbring, p., shafran, r., & rozental, a. 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(2019). internetbased cognitive behavioral therapy of perfectionism: comparing regular therapist support and support upon request. internet interventions, 17, article 100237. https://doi.org/10.1016/j.invent.2019.02.001 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. the clinical perfectionism questionnaire in swedish 20 clinical psychology in europe 2021, vol. 3(4), article e4581 https://doi.org/10.32872/cpe.4581 https://doi.org/10.1016/j.paid.2014.01.003 https://doi.org/10.1207/s15327957pspr1004_2 https://doi.org/10.1080/10503309612331331638 https://doi.org/10.1371/journal.pone.0010885 https://doi.org/10.1037/0033-3204.30.4.546 https://doi.org/10.1016/j.invent.2016.09.006 https://doi.org/10.1037/a0032121 https://doi.org/10.1016/j.invent.2019.02.001 https://www.psychopen.eu/ the clinical perfectionism questionnaire in swedish (introduction) method participants procedure measures data analysis results confirmatory factor analysis convergent and divergent validity test-retest correlation internal consistency discussion (additional information) funding acknowledgments competing interests author note supplementary materials references the impact of an insecure asylum status on mental health of adult refugees in germany research articles the impact of an insecure asylum status on mental health of adult refugees in germany victoria sophie boettcher 1 , frank neuner 1 [1] department of clinical psychology and psychotherapy, bielefeld university, bielefeld, germany. clinical psychology in europe, 2022, vol. 4(1), article e6587, https://doi.org/10.32872/cpe.6587 received: 2021-04-18 • accepted: 2021-10-20 • published (vor): 2022-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: victoria sophie boettcher, department of clinical psychology and psychotherapy, bielefeld university, postbox 100131, 33501 bielefeld, germany. phone: +49 521 106-3890. e-mail: victoria.boettcher@unibielefeld.de supplementary materials: materials [see index of supplementary materials] abstract background: forcibly displaced people have a higher chance of developing post-traumatic stress disorder (ptsd) compared to people who have not experienced displacement. in addition to potentially traumatic events due to war, persecution, and flight, post-migration living stressors are an important influencing factor. among these, an insecure asylum status is one of the main stressors with which forcibly displaced people must cope. the aim of this study was to investigate the additive effect of an insecure asylum status on ptsd symptomatology in refugees, over and above the influence of other preand peri-migration factors, in particular potentially traumatic event types reported and duration of stay in germany. method: two overlapping convenience samples of 177 and 65 adult refugees that were assessed at different timepoints were interviewed by means of face-to-face interviews. interviews were conducted in either arabic, farsi, kurmancî, english, or german with the assistance of interpreters where necessary. besides residence status and potentially traumatic events experienced, mental distress was assessed via the refugee health screener-15 (rhs-15; study a) and the ptsd checklist for dsm-5 (pcl-5; study b). results: in both samples, an insecure asylum status explained a significant additional amount of variance of ptsd symptomatology, on top of traumatic events experienced and time since arrival in germany. conclusion: results suggest that refugees with an insecure asylum status are at higher risk for experiencing increased ptsd symptomatology. policy changes of asylum procedure in receiving countries could have a positive impact on refugees’ mental health. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6587&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0002-1524-8012 https://orcid.org/0000-0001-5427-3432 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords refugees, forcibly displaced people, mental health, post-traumatic stress disorder, insecure asylum status, postmigration living stressors highlights • prevalence rates of mental disorders are high among forcibly displaced people. • the impact of post-migration stressors on refugees’ mental health should not be disregarded. • as one of the possible post-migration stressors, asylum status is substantially associated with mental health. • changes to reception policies may be taken into account. b a c k g r o u n d at the end of 2019, 79.5 million people were forcibly displaced worldwide. over the course of the previous decades this number has increased consistently (unhcr, 2020). the high numbers pose serious challenges to the receiving countries, straining their capacity to provide housing, food, healthcare services, and education. as a result, during the last years, several potential receiving countries have adapted their reception policies regarding people seeking refuge (fazel, karunakara, & newnham, 2014; jakubowicz, 2016; li, liddell, & nickerson, 2016). as a consequence, in 2019 less than 40% of asylum seekers were formally recognized as refugees (unhcr, 2020). compared to non-refugees, those who have been forcibly displaced have a higher risk of mental disorders, most prominently post-traumatic stress disorder (ptsd) and depression (bozorgmehr et al., 2016; gäbel, ruf, schauer, odenwald, & neuner, 2006). studies demonstrated that mental disorders among refugees come along with a high burden. due to the symptoms, such as difficulty concentrating or sleeping problems, learning a new language, staying engaged in classes, or going to work on a regular basis can be much harder (elbert, wilker, schauer, & neuner, 2017). several studies have pointed out that post-migration stressors in the receiving coun­ tries have an impact on the onset and maintenance of psychological disorders (chu, keller, & rasmussen, 2013; li et al., 2016). asylum application procedure in germany one of the most salient post-migration stressors is an insecure residence permit that may leave refugees living in uncertainty and with restricted rights for months and even years (li et al., 2016). in germany, there are several different types of residence status for refugees (federal office for migration and refugees, 2019). the entitlement to asylum, according to article 16a para. 1 of the constitution (grundgesetz), and the refugee protection, according to section 3 subs. of the asylum act (asylg), involve similar insecure asylum status and mental health 2 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ implications for affected people’s lives. both comprise a residence permit for three years. access to the labor market is not restricted and the refugees are entitled to family reunification. moreover, in case people meet preconditions like german language skills, a permanent settlement permit after three or five years is possible. according to section 4 subs. 1 of the asylum act (asylg), subsidiary protection comprises a residence permit for one year, which can be repeatedly extended by two years. similar to the two other forms of protection stated above, receiving a settlement permit is possible but only after five years. access to the labor market is unrestricted as well. in contrast to the entitlement to asylum and the refugee protection, people with a subsidiary protection are not entitled to privileged family reunification. individuals holding one of these three types of permits have a right to move to their own homes with some regional restrictions and a comparable health care protection as the general population in germany. individuals who receive a national ban on deportation have a residence permit for at least one year, with possibility of extension. again, receiving a settlement permit is possible after five years. in contrast to the other forms of protection stated above, there are restrictions regarding the access to the labor market. the same holds for asylum seekers with pending applications. when an asylum application is turned down, the person has to leave germany in the near future. consequences of an insecure residence status for mental health in refugees during recent years, the potential influence of an insecure residence status on mental health in forcibly displaced people became increasingly apparent. research findings tend to show that insecure status is correlated with mental health symptoms (heeren et al., 2016; müller, zink, & koch, 2018; newnham, pearman, olinga-shannon, & nickerson, 2019). in a study by momartin et al. (2006), residing under a temporary permit to stay was found to be the greatest predictor of ptsd symptomatology even when having accounted for trauma experiences in the analyses. however, some studies have provided mixed results (schick et al., 2016; winkler, brandl, bretz, heinz, & schouler-ocak, 2019). schick et al. (2016) found that, while ptsd symptomatology was correlated with a sum-score of other post-migration stressors, there was no isolated influence of visa status. similarly, winkler et al. (2019) did not find a significant association between visa status and ptsd symptoms. however, among participants who fulfilled ptsd criteria, symptom intensity was increased with an insecure asylum status. as reported above, visa insecurity often comes with restrictions in daily life like limited access to health care services or limited rights (müller et al., 2018). these factors seem to increase the risk of mental disorders (chu et al., 2013) and complicate the proc­ ess of integrating into a new society because opportunities to do so are limited (müller et al., 2018). these findings are supported by previous research that found that mental boettcher & neuner 3 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ health improved following the granting of a residence permit (lamkaddem, essink-bot, deville, gerritsen, & stronks, 2015). next to visa status, the duration of stay in the host country (nickerson et al., 2019) that is highly associated with the duration of the asylum procedure (laban, gernaat, komproe, van der tweel, & de jong, 2005) may have an influence on mental health of refugees and people seeking asylum. in a study with refugees in australia, duration of stay was correlated with suicidal intent (nickerson et al., 2019). an association of duration of asylum procedure and anxiety disorders was found by laban et al. (2005). however, findings in the literature have been unable to confirm a consistent association, since other studies have found no effect (heeren et al., 2016; winkler et al., 2019). it may be conceivable that duration of stay assumes central importance only when it exceeds a threshold value. differentiating between different aspects of post-migration stressors, laban, komproe, gernaat, and de jong (2008) concluded that asylum seekers who had been in the netherlands for more than two years had several post-migration stressors to cope with, which might explain the association they made in earlier research (laban et al., 2005) regarding the length of stay in the receiving country with mental health. although the nature of the association between asylum seekers’ mental health and their length of stay in their host context remains uncertain, it is clear that forcibly displaced people often encounter significant stressors and have limited access to coping resources because of their preand peri-migration experiences, new living situation, and post-migration stressors. research has shown that the stressors experienced by people seeking asylum and recognized refugees can be divided in two categories (womersley, kloetzer, & goguikian ratcliff, 2017). the first category is associated with difficulties with housing and labor, which are reported by both groups. the second category is experienced more acutely by asylum seekers, who have reported uncertainty, lack of control, and insecurity. asylum seekers live under constant threat of being expelled from their relatively safe living environment (müller et al., 2018). uncertainty is one of the factors increasing the probability of continuing mental disorders (bogic et al., 2012; ryan, benson, & dooley, 2008) and personal control is lost (ryan, benson, & dooley, 2008). therefore, no complete security can be felt, which seems to be closely related with the development and maintenance of mental distress/ptsd. aim of the study this study seeks to investigate the effects of asylum status on ptsd symptomatology over and above the influence of potentially traumatic event types reported and length of stay in country of arrival in refugees living in germany. insecure asylum status and mental health 4 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ m e t h o d in this paper, two studies and the respective results are presented. study a and study b, including procedures and measures used, will be presented successively. the samples are overlapping and sample b is a detailed and more comprehensive re-assessment of a subset of sample a. all participants of study a who consented to a second interview were tried to be reached via telephone, email, or in person. participants in sample b participated in additional clinical face-to-face interviews by an expert interviewer that allowed to apply more detailed clinical scales some months after the first interview. sample study a. between february and august 2018 face-to-face interviews were conducted with 198 refugees (23.2% female, n = 46). the unselected convenience sample ranged from 18 to 75 years of age (m = 33.03, sd = 11.02). refugees were eligible to participate if they were at or above the age of majority, were living in north rhine-westphalia, had sufficient language skills to be able to conduct the interview in arabic, farsi, kurmancî (as these three languages were the most common ones on site at the time of the study), english or german, and their time since arrival in germany did not exceed six years. study b. between august 2018 and march 2019, refugees form study a were recon­ tacted and approached for interviews. out of these, 65 refugees (20.0% female, n = 13) participated, the remaining could not be contacted or were not available for a re-inter­ view. the participation rate of 32.8% may be explained by the fact that a substantial proportion of the participants of study a had no secure residence status and had possibly been forced to leave germany in the meantime. in general, most participants could be contacted successfully via telephone, email, or in person were consenting to take part in study b. participants ranged from 19 to 75 years of age (m = 34.50, sd = 12.13). procedures data collection was conducted within the framework of the research consortium “flüge– opportunities and challenges that global refugee migration presents for health care in germany” and was part of a larger study. the program was funded by the ministry of culture and science of the state of north rhine-westphalia, germany. thirteen para­ professional interviewers (12 male, 1 female) were trained as both interviewers and inter­ preters (9 arabic native speakers, 3 farsi native speakers, 4 kurmancî native speakers). data was collected in a region in the north-east of north rhine-westphalia, germany. interviews took place in shared accommodation facilities, private apartments, and on the bielefeld university campus. potential literacy problems were avoided by reading out all questions to participants. the respondents were free not to answer single questions without giving reasons. the ethical review board of bielefeld university granted appro­ boettcher & neuner 5 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ val for the study. to ensure the voluntariness of participation in an interview that may provoke distress in some individuals no compensation was provided for participation. study a. all material (informed consent forms, information letters, questionnaire) was translated by a professional translation agency and native speakers. blind back­ translations ensured correct translation. participants were identified through contact with social workers who have been working in the region and made contact with the shared accommodations. during informational events, initial interview appointments were arranged. further appointments were agreed on by asking people present in the accommodations and via snowball sampling. field teams consisted of two supervising re­ searchers and the necessary interviewers. the face-to-face interviews lasted on average 90 minutes (sd = 31.9). study b. informed consent forms and information letters were again translated and blind back translated. in the event that participants had previously provided their written consent and contact information, they were contacted via telephone, email, or home visits. face-to-face interviews were conducted by german speaking researchers with the assistance of interpreters where necessary. interviews lasted 116 minutes on average (sd = 48.2). participants were interviewed an average of six months after they had been interviewed for study a. measures study a. information regarding age, gender, citizenship, education, marital status, length of time since arrival in germany, and potentially traumatic event types was collected (see appendix a in the supplementary materials). in addition, mental distress and residence status were assessed (see detailed description below). study b. in addition to the questions assessed in the first interview, participants were asked to answer further questions regarding potentially traumatic event types and ptsd symptomatology. residence status was assessed again (see detailed description below). mental distress study a. the 15 item refugee health screener-15 (rhs-15; hollifield et al., 2013) assesses mental distress in refugees. the first 13 questions assess the presence of differ­ ent symptoms of depression, anxiety, and ptsd during the last month. question 14 measures the general coping capacities. answers are given on a 5-point likert scale (not at all – extremely). question 15 assesses how much suffering the participant experienced last week. responses to this item were reported on a scale of 0–10 on a “distress ther­ mometer”. effectiveness, validity, and reliability of the screening instrument have been demonstrated in various studies (hollifield et al., 2016; hollifield et al., 2013; kaltenbach, härdtner, hermenau, schauer, & elbert, 2017). in study a a cronbach's α of .87 was found. the cutoff value recommended by hollifield et al. (2013) is a sum-score of ≥ 12 regarding questions 1–14 and/or a score of ≥ 5 regarding the distress thermometer. insecure asylum status and mental health 6 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ the former cutoff is used in this study. regarding this cutoff, a sensitivity of = .81 and specificity of = .87 for ptsd was reported (hollifield et al., 2013). study b. the german version of the posttraumatic stress disorder checklist for dsm-5 (pcl-5; krüger-gottschalk et al., 2017) was used to assess ptsd symptomatology within the past month. the pcl-5 consists of 20 questions. answers were rated 0 (not at all) – 4 (extremely), which results in the highest possible score of 80. in the current sample, cronbach’s α was .86. good psychometric properties have been demonstrated in previous studies (krüger-gottschalk et al., 2017; wortmann et al., 2016). ibrahim, ertl, catani, ismail, and neuner (2018) used the translated checklist in displaced arab and kurdish populations and came up with a cut-off score of 23 to be the best balance between specificity and sensitivity in these populations. residence status the answers regarding the question assessing residence status were grouped in six categories (recognized as refugee, entitled to asylum, subsidiary protection, asylum appli­ cant with pending procedure, temporary suspension of deportation, demand to leave germany). the first three of the categories were classified as “secure residence status”. the latter three were classified as “insecure residence status”. data analysis statistical analyses were performed with ibm spss statistics version 27 for macos. due to ≥ 10% missing data in the rhs-15, 21 participants were excluded from study a. regarding cases with < 10% missing values on the rhs-15, values were set equal to 0. multiple linear regression analyses with two levels were carried out for both samples. in study a, the rhs sum-score to assess mental distress and in study b, the pcl-5 sum-score to assess ptsd symptomatology were used as dependent variables. both analyses accounted for age, gender (females coded as 0, males coded as 1), number of traumatic event types reported, and time (in month) since arrival in germany. the variables accounted for were entered in step one. the dummy coded residence status (secure residence status coded as 0, insecure residence status coded as 1) was added in the second step. for the analyses the alpha level was set at 0.05. r e s u l t s study a. the 177 participants (20.3%; n = 36 female) were, on average, 33 years old (sd = 11.21). with 42.4% (n = 75) the largest proportion of participants had a syrian citizenship, followed by 26.6% (n = 47) with an iraqi citizenship, and 9.0% (n = 16) with an afghan citizenship. the average time since arrival in germany was 28.5 months (sd = 9.96). an insecure residence status was reported by 30.5% (n = 61) of participants. rhs boettcher & neuner 7 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ mean sum-score (items 1–14 of the rhs-15) was 15.61 (sd = 10.92). a score above the cutoff (score ≥ 12) was reached by 54.8% (n = 97) of the participants. study b. the 65 participants (20.0%, n = 13 female) were, on average, 35 years old (sd = 12.13). the majority stated holding a syrian citizenship (58.5%, n = 38), followed by 23.1% (n = 15) with an iraqi citizenship. average time since arrival in germany was almost three years (m = 34.66 month; sd = 10.68). an insecure residence status was indicated by 15 participants (16.5%; see appendix a in the supplementary materials for all descriptive data). the mean score on the pcl-5 was 19.68 (sd = 14.58). using a suggested cut-off score of 23 for arabic and kurdish displaced populations (ibrahim et al., 2018), 25 participants (38.5%) met dsm-5 criteria for probable ptsd diagnosis. mental distress study a. participants who indicated having an insecure residence status had a higher rhs-15 sum-score (m = 20.52; sd = 11.53) compared to participants holding a secure residence status, m = 13.00; sd = 9.76; t(171) = −4.54, p < .001. study b. participants holding an insecure residence status reported an average score of 30.67 (sd = 15.98) on the pcl-5, whereas participants with a secure residence status scored 16.38 (sd = 12.52) on average, t(63) = −3.63, p = .001 (see appendix a in the supplementary materials for all descriptive data). residence status of the 177 participants in study a, four participants did not indicate their residence status, 61 indicated having a relatively secure residence status (34.5%). in study b, 23.0% of participants reported an insecure residence status (see table 1 for a detailed overview). table 1 descriptive statistics of participants’ residence status type residence status study a (n = 177) study b (n = 65) n % n % secure residence status recognized as refugee 42 23.7 6 9.2 entitled to asylum 35 19.8 24 36.9 subsidiary protection 35 19.8 20 30.8 insecure residence status; n (%) asylum applicant with pending procedure 38 21.5 6 9.2 temporary suspension of deportation 19 10.8 8 12.3 demand to leave germany 4 2.3 1 1.5 missing 4 2.3 0 0.0 note. % figures rounded to one decimal place. insecure asylum status and mental health 8 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ the impact of residence status on mental health–multiple regression analyses study a. variables added in the first step (age, gender, number of event types repor­ ted, time (in month) since arrival in germany) resulted in an r 2 of .12 (p < .001). the variables accounted for a significant amount of variance of mental distress variability. adding residence status in the second step explained an additional 7.7% of variance (∆r 2 = .08, p < .001). in the first step, age, gender, and number of traumatic event types experienced were significantly associated with the rhs sum-score. in the second step, gender, number of reported event types, and residence status were significantly associated with the rhs sum-score. an insecure residence status was associated with a higher rhs sum-score. overall, a significant regression equation was found, f(5, 161) = 7.82, p < .001. the final model accounted for 19.5% of the total variance in mental distress captured by the rhs-15 (see table 2 for exact values). table 2 hierarchical regression analysis of ptsd symptoms variable study a (rhs-15 sum-score as dependent variable)a study b (pcl-5 sum-score as dependent variable)b b [95% ci] p b [95% ci] p step 1 age 0.15 [0.00, 0.30] .046* 0.12 [-0.14, 0.39] .351 gender -5.47 [-9.61, -1.33] .010* -15.29 [-23.70, -6.88] .001* number traumatic event types reported 0.92 [0.45, 1.30] < .001* 1.02 [0.37, 1.68] .003* time since arrival in germanyc -.04 [-0.22, 0.14] .657 0.49 [0.17, 0.82] .004* step 2 age 0.14 [-0.01, 0.28] .059 0.16 [-0.08, 0.40] .187 gender -5.35 [-9.32, -1.38] .009* -16.33 [-24.09, -8.56] < .001* number traumatic event types reported 0.67 [0.20, 1.14] .005* 0.71 [0.09, 1.34] .026* time since arrival in germanya -0.04 [-0.21, 0.14] .640 0.45 [0.14, 0.75] .004* insecure residence status 6.65 [3.30, 10.00] < .001* 12.38 [5.13, 19.63] .001* ar 2 = .12 for step 1 (p < .001); ∆r2 = .08 for step 2 (p < .001). listwise deletion. n = 167. br 2 = .34 for step 1 (p < .001); ∆r 2 = .11 for step 2 (p = .001). listwise deletion. n = 64. cin month. *p ≤ .05. study b. variables added in the first step accounted for 34.4% of variance of ptsd symp­ tomatology (r 2 = .34, p < .001). by adding residence status in the second step additional 11.0% of variance of the pcl-5 sum-score was explained (∆r 2 = .11, p = .001). apart from age, all variables were significantly associated with the ptsd symptom variability in both steps of the regression analysis. a significant regression equation was found, boettcher & neuner 9 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ f(5, 58) = 9.64, p < .001. the final model accounted for approximately 45.4% of the total variance of ptsd symptomatology (see table 2 for exact values). d i s c u s s i o n impact of residence status on refugees’ mental health our study of forcibly displaced people found that people with an insecure asylum status are at higher risk for an increased ptsd symptomatology. these findings are in line with earlier research (heeren et al., 2016; müller et al., 2018; newnham et al., 2019). potential explanations for our results must include a consideration of the kind and amount of post-migration stressors experienced by the refugees. as described by womersley et al. (2017), people with an insecure asylum status often have a larger number of stressors than those with a more secure asylum status. female gender was accompanied with increased symptomatology scores (5.35 on the rhs-15 and 16.33 on the pcl-5). this finding is in line with earlier research reporting female gender as a predictor of ptsd symptomatology (mahmood, ibrahim, goessmann, ismail, & neuner, 2019; nickerson et al., 2019). as females did not report a significantly higher number of potentially traumatic event types, we assume that it may be the type of trauma rather than simply the number that is associated with an increased mental stress/ ptsd symptomatology score. moreover, other factors like perceived social support may play a role here. the fact that participants in our studies holding an insecure asylum sta­ tus reported having experienced a higher number of traumatic event types, on average, is in line with earlier studies as well (e.g., nickerson et al., 2019). for every additional event type reported, the rhs-15 and pcl-5 sum-scores increased by 0.67 in study a and 0.71 points in study b. participants with an insecure asylum status reached an rhs-15 sum-score 6.65 points higher than participants with a secure asylum status. the pcl-15 sum-score was 12.38 points higher for participants with an insecure status. duration of stay was only significant in study b. a possible explanation is that participants who took part in study b had spent on average six months longer in germany and thus had a longer exposure to post-migration stressors. furthermore, the different finding may be explained by the different questionnaires used in the studies. strength and limitations an advantage of having two different studies is the potential for participants to develop an increased level of trust with research staff by taking part in study b. this aspect was emphasized by statements of some of the participants describing a joy to meet again. by collecting all information through face-to-face interviews instead of (online) questionnaires, possible difficulties in comprehension could be resolved. insecure asylum status and mental health 10 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ our study is based on convenience samples that, although unselected, are far from representative of refugee populations in germany, which limits the generalizability of the findings. however, the fact that the same associations were found consistently across two measurements with different instruments supports validity of findings. data collection was cross-sectional in both studies. to be able to increase explanato­ ry power and investigate causation longitudinal studies are needed. even though the rhs-15 is a well-known screening tool with good reliability and validity scores, it is a screening tool with 15 items and does not allow a more detailed insight in a person’s mental health status or the diagnosis of potential mental health disorders. recommendations in line with previous research (chu et al., 2013), we found that asylum status as a post­ migration factor explains a significant amount of variance in ptsd symptomatology. it seems evident that post-migration conditions can interfere with recovery from traumatic experiences (heeren et al., 2014). people are best positioned to thrive when they experi­ ence a safe environment to be able to profit from available resources (ryan et al., 2008). further research on post-migration stressors could provide more insight in the potential influence of these stressors on ptsd symptomatology. moreover, including additional measures apart from rhs-15 and pcl-5 to investigate mental health status could offer an even more comprehensive insight in refugees’ mental health. lastly, investigating the possible confounding associations of citizenship with asylum status and mental distress may be insightful. however, to make reliable statements and draw conclusions, a larger sample size with a more balanced distribution of citizenships as well as residence status types will be needed. refugees need the opportunity to participate in everyday life. with a working per­ mit for integration, learning a new language, making socially supportive contacts, the ptsd rate decreases (hocking, kennedy, & sundram, 2015). policy changes regarding the asylum procedure in receiving countries could therefore have a positive impact on refugees’ mental health (porter & haslam, 2005). as long as asylum procedures cannot be substantially shortened, freedom of movement and access to the labor market should be provisionally granted. these changes may relieve at least some post-migration stressors. furthermore, the possible influence of an insecure asylum status on psychotherapy needs to be considered (chu et al., 2013). the additional stress might impede the thera­ peutic process. the increased risk of symptoms becoming chronic and the accompanying higher costs for the health care system could be bypassed by granting unconditional access to the health care system regardless of asylum procedure. knowing about the negative aspects of post-migration living stressors it might be also interesting to consider the opposite side, namely whether easing post-migration living conditions can promote recovery and growth. boettcher & neuner 11 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ conclusions it is not only the potentially traumatic events experienced before or during flight that have an impact on refugees’ mental health. in fact, conditions in the receiving countries contribute to psychological well-being. to be able to expect successful integration, op­ portunities for inclusion in everyday life need to be offered. changes in residence status policies may be one step in the right direction. apart from the people going through the established asylum procedure, forcibly displaced people who immigrated illegally should be kept in mind as well. healthcare services should not be hold back for people suffering from physical or mental illness regardless of asylum status. by providing refugees opportunities to be independent and active members of their communities, both they and society at large stand to benefit as refugees have a clearer path to realizing their potential. funding: the research reported was supported by the ministry of culture and science of the state of north rhinewestphalia; under grant 321-8.03.07-127600. the funding body had no influence on designing the study, collecting, analyzing interpreting the data, or writing the manuscript. acknowledgments: we sincerely thank all participants who made this research possible. we acknowledge support regarding data collection by the “flüge” research consortium and all of our interviewers. we sincerely thank justin preston for proofreading the manuscript. competing interests: there are no potential conflicts of interest in the professional or financial affiliations of any of the authors which may have biased the presentation of material in the paper. s u p p l e m e n t a r y m a t e r i a l s in the supplementary materials, a table with descriptive statistics of all relevant variables is displayed (for access see index of supplementary materials below). index of supplementary materials boettcher, v. s., & neuner, f. 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(2016). psychometric analysis of the ptsd checklist-5 (pcl-5) among treatmentseeking military service members. psychological assessment, 28(11), 1392–1403. https://doi.org/10.1037/pas0000260 boettcher & neuner 15 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://doi.org/10.5694/j.1326-5377.2006.tb00610.x https://doi.org/10.1007/s10903-017-0555-y https://doi.org/10.1007/s00038-019-01249-6 https://doi.org/10.1080/20008198.2019.1688129 https://doi.org/10.1001/jama.294.5.602 https://doi.org/10.1097/nmd.0b013e31815fa51c https://doi.org/10.3402/ejpt.v7.28057 https://www.unhcr.org/5ee200e37.pdf https://doi.org/10.1055/a-0806-3568 https://doi.org/10.1037/pas0000260 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. insecure asylum status and mental health 16 clinical psychology in europe 2022, vol. 4(1), article e6587 https://doi.org/10.32872/cpe.6587 https://www.psychopen.eu/ insecure asylum status and mental health background asylum application procedure in germany consequences of an insecure residence status for mental health in refugees aim of the study method sample procedures measures data analysis results mental distress residence status the impact of residence status on mental health–multiple regression analyses discussion impact of residence status on refugees’ mental health strength and limitations recommendations conclusions (additional information) funding acknowledgments competing interests supplementary materials references fear of becoming infected and fear of doing the wrong thing – cross-cultural adaptation and further validation of the multidimensional assessment of covid-19-related fears (mac-rf) research articles fear of becoming infected and fear of doing the wrong thing – cross-cultural adaptation and further validation of the multidimensional assessment of covid-19-related fears (mac-rf) branka bagarić 1 , nataša jokić-begić 2 [1] croatian association for behavioral-cognitive therapies (cabct), zagreb, croatia. [2] department of psychology, faculty of humanities and social sciences, university of zagreb, zagreb, croatia. clinical psychology in europe, 2022, vol. 4(1), article e6137, https://doi.org/10.32872/cpe.6137 received: 2021-02-11 • accepted: 2021-10-27 • published (vor): 2022-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: branka bagarić, croatian association for behavioral-cognitive therapies (cabct), šenoina 25, 10 000 zagreb, croatia. e-mail: branka.bagaric1@gmail.com supplementary materials: data [see index of supplementary materials] abstract background: with the covid-19 infection speeding around the world, many experience fear and anxiety. to detect those at risk of psychopathology and provide treatment, valid instruments are needed. the aim of this study was to cross-culturally validate the theory-based instrument multidimensional assessment of covid-19-related fears (mac-rf) in croatian and to further examine the scale’s validity by exploring its relationship with relevant constructs. method: a total of 477 participants completed an online survey during a rapid rise in new daily covid-19 cases in croatia and while new restrictions were being imposed. results: mac-rf had a stronger association with health anxiety, cyberchondria, and anxiety sensitivity compared to depression, attesting to its convergent and divergent validity. however, a 2-factor structure was revealed in this sample: fear of infection and fear of using an inadequate strategy in dealing with pandemic. fear of infection had a stronger association with health anxiety and covid-19 anxiety and was a better predictor of covid-19 related protective health behaviors. fear of choosing an inadequate strategy had a stronger association with cyberchondria, fear of consequences of the epidemic on mental health, as well as financial consequences, and loss of civil liberties. conclusion: fear of infection captures negative emotional states due to feared consequences on personal somatic health and the health of loved ones, while fear of choosing an inadequate this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6137&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0002-1786-0993 https://orcid.org/0000-0003-2597-535x https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ strategy in dealing with the pandemic reflects a metacognitive aspect. treatments may have to target both aspects of covid-19 related fear. keywords covid-19 fear, mac-rf, health anxiety, cyberchondria, scale validity highlights • mac-rf is a theory-based instrument for measuring covid-19 related fears. • mac-rf has two factors: fear of infection and fear of using an inadequate strategy in dealing with the pandemic. • first factor had a stronger association with heath anxiety and protective health behaviors. • second factor had a stronger association with cyberchondria and fear for mental health. with over 200 million people infected and over 4 million dead from covid-19 around the world, in addition to the social restrictions that affect our everyday life, the rise of fear, anxiety and distress is to be expected. although somatic health has the focus of attention, it has become evident that psychological consequences of the epidemic may be equally severe (e.g., kumar & nayar, 2021), but more difficult to detect. the development of instruments that measure psychopathology associated with covid-19 is an important step in identifying individuals at risk and developing treatments. during 2020, several measures focused on different aspects of negative psychological reactions to covid-19 pandemic emerged. the fear of covid-19 scale (fcv-19s; ahorsu et al., 2020) is a 7-item instrument measuring a single factor. the coronavirus anxiety scale (cas; lee, 2020) and covid-19 anxiety scale (cas5; lauri-korajlija & jokić-begić, 2020) are both 5-item scales, both measuring a single factor. the covid-19 anxiety syndrome scale (c-19ass; nikčević & spada, 2020) is a 9-item scale measuring two factors: perseveration and avoidance. the covid-19 phobia scale (c19p-s; arpaci et al., 2020) is a 20-item instrument measuring four factors: psychological, psycho-somatic, economic, and social. finally, the covid stress scales (css; taylor et al., 2020) is a 36-item instrument, measuring 5-factors: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and reassurance seeking, and traumatic stress symptoms about covid-19. considering differences in the breadth of focus of these scales, it is not surprising that different structures of the underlying construct have been reported. determining which aspects of psychological experience should be captured in such an instrument might be aided by a theoretical framework. this type of theory-based instrument has been recently developed – the multidimensional assessment of cov­ id-19-related fears (mac-rf). according to the model behind the mac-rf, as proposed covid-19 related fears 2 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ by schimmenti, billieux, and starcevic (2020), four mutually linked domains are involved in fear experiences during a pandemic: bodily, relational, cognitive, and behavioral. these domains are assumed to be organized in a dialectical structure. as such, the bodily domain involves 1) fear of the body and 2) fear for the body; the interpersonal domain involves 3) fear of others and 4) fear for others; the cognitive domain involves 5) fear of knowing and 6) fear of not knowing; and the behavioral domain involves 7) fear of action and 8) fear of inaction. the mac-rf appears to be a useful instrument in assessing pathological levels of fear during pandemics (schimmenti, starcevic, et al., 2020). however, more studies of its validity are needed. fear related to covid-19 is found to be associated with general psychopatholo­ gy, general anxiety, health anxiety and depression (ahorsu et al., 2020; schimmenti, starcevic, et al., 2020; taylor et al., 2020), functional impairment and dysfunctional coping (lee, 2020; nikčević & spada, 2020). several studies have suggested that anxiety sensitivity (fear of consequences of anxiety) and cyberchondria (excessive online search for health information followed by distress) might explain problematic responses to pandemic (hashemi et al., 2020; manning et al., 2021; mckay et al., 2020). specifically, it is suggested that because people with high anxiety sensitivity believe their physical sensations produced by anxiety to be harmful, they might experience more distress. those who are more distressed may be prone to searching for information about their health on the internet, resulting in even more distress due to the frightening information they encounter (hashemi et al., 2020). anxiety sensitivity may be associated with fear of and for the body, whereas cyberchondria may reflect the fear of knowing and not knowing, as proposed in schimmenti, billieux, and starcevic’s (2020) model. although the pandemic is a global crisis, there are differences in how a given country will respond to an outbreak in the type and duration of restrictions, in addition to economic, societal and cultural differences, which may affect how individuals experience and cope with pandemic. hence, the aim of this study was to: 1) cross-culturally validate the croatian version of the mac-rf; and 2) to further examine the scale validity by exploring its relationship with relevant constructs: health anxiety, anxiety sensitivity, cyberchondria, covid-19 safety behaviors, health care use and fear of different covid consequences. we predicted that the mac-rf would: 1) have a single-factor solution, as reported by the scale’s authors; 2) be associated with general psychopathology, as reported by the authors; 3) have a strong correlation with a previously validated measure of fear of covid-19 (concurrent validity); 4) have a stronger association with health anxiety, anxi­ ety sensitivity and cyberchondria as compared to depression (converged and divergent validity); and 5) have a positive association with covid-19 safety behaviors, health care utilization and fear of different covid consequences. the results of this study would inform the possibility of cross-cultural generalization of findings in the field. furthermore, this study may shed further light on possible bagarić & jokić-begić 3 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ predictors, mechanisms and consequences of fear of pandemic, and hence inform future experimental, longitudinal and intervention research. m e t h o d participants there were 477 participants in this study (an additional 25 participants filled out sociode­ mographic items only and were excluded from the data set), of which 74.8% were female. the mean age was 34.70 years (sd = 9.71; total range [tr] = 18-71). with respect to education, 25.99% were high school graduates, 10.27% held a bachelor’s degree, 53.46% held a master’s degree, and 10.27% held a phd. furthermore, 8.17% of participants were employed in the health care system and an additional 1.26% were trained in health sciences but were not employed in the health system. a total of 11.94% of participants reported suffering from a chronic condition, most commonly from thyroid diseases, asthma, allergies, depression, diabetes and anxiety. in regards to their experiences with covid-19, most participants reported personally knowing five (mode = 5; m = 7.05; tr = 0-200) people who tested positive for covid-19, 12.88% reported they themselves had tested positive for covid-19 at some point, and an additional 18.03% believed they had had covid-19 although this was not confirmed by a test. participants who tested positive for covid-19 on average estimated their symptoms to be mild (m = 32.04, sd = 22.90, tr = 0-83) and this experience to be only mildly uncomfortable (m = 34.63, sd = 27.88, tr = 0-100), although there was great variability in responses. instruments multidimensional assessment of covid-19-related fears (mac-rf) the mac-rf (schimmenti, starcevic, et al., 2020) is a newly developed 8-item measure of clinically relevant domains of fear during the covid-19 pandemic. items cover four domains of fear: bodily, relational, cognitive, and behavioral and are scored on a scale ranging from 0 (very unlike me) to 4 (very like me). authors reported a single-factor structure, satisfactory reliability (cronbach’s alpha = .84), whereas convergent validity was based on its positive correlation with overall psychopathology. cronbach’s α in this study was .72. covid-19 anxiety scale (cas5) the cas5 (lauri-korajlija & jokić-begić, 2020) is a recently developed 5-item instrument inspired by the swine flu anxiety scale (wheaton et al., 2012) that assesses worrying about covid, perceived likelihood of contracting the virus (oneself and others), per­ ceived severity of infection, and the degree to which a person believes covid is a more serious illness than the flu. each item is rated on a 5-point scale (1 = not at all; 5 = very covid-19 related fears 4 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ much). authors reported a cronbach’s alpha coefficient of 0.76 and 0.78. this is the only covid-19 distress scale that has been validated in the croatian language. cronbach’s α in this study was 0.74. dsm-5 self-rated level 1 cross-cutting symptom measure—adult (ccsm) the ccsm (apa, 2013) consists of 23 questions assessing 13 psychiatric domains: de­ pression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory problems, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. the respondent rates their experiences during the last two weeks on a scale ranging from 0 (none or not at all) to 4 (severe or nearly every day). the instrument has demonstrated good psychometric properties (narrow et al., 2013). cronbach’s α in this study was 0.89. short health anxiety inventory (shai) the shai (salkovskis et al., 2002) consists of 18 items measuring two factors: health anxiety (14 items) and fear of negative consequences of illness (4 items). it uses a multiple choice format with response options ranging from 0 to 3 (from no pathology to severe pathology; alberts et al., 2013). the instrument demonstrated good psychometric properties in both clinical and non-clinical samples (alberts et al., 2013). cronbach’s α in this study was 0.85 for the health anxiety factor and 0.86 for the full scale. short cyberchondria scale (scs) the scs (jokić-begić et al., 2019) consists of four items (e.g., after searching for health information, i feel frightened) rated on a 5-point likert scale. the scs has demonstrated satisfactory psychometric properties, has a unidimensional structure and measures the same latent construct as the significantly longer instrument developed by mcelroy and shevlin (2014); cyberchondria severity scale, (jokić-begić et al., 2019). cronbach’s α in this study was 0.80. anxiety sensitivity index – 3 (asi-3) the asi-3 (taylor et al., 2007) consists of 18 items measuring fear of anxiety and its consequences that are rated from 0 (very little) to 4 (very much). the asi has three subscales measuring the fear of physical (it scares me when i become short of breath), cognitive (when i feel “spacey” or spaced out i worry that i may be mentally ill) and social (when i tremble in the presence of others, i fear what people might think of me) aspects of anxiety. asi has demonstrated good psychometric properties. cronbach’s α in this study was 0.92. bagarić & jokić-begić 5 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ depression, anxiety and stress scale 21 (dass) the dass (lovibond & lovibond, 1993) is a short form of the original dass instrument and consist of 21 items measuring depression, anxiety, and stress during the last week, each rated on a scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). only the depression subscale was used in this study (dass-d), which consists of seven items describing dysphoria, hopelessness, lack of interest etc. (e.g., i couldn’t seem to experience any positive feeling at all). all three subscales demonstrated good psychometric properties in both clinical and non-clinical populations (parkitny & mcauley, 2010). cronbach’s α in this study was 0.92. covid safety behavior checklist (csbc) the csbc (lauri-korajlija & jokić-begić, 2020) consists of 13 items measuring safety be­ haviors that people engage in to avoid covid infection, such as thorough and frequent hand washing, avoiding people that appear ill, avoiding leaving home etc., each rated on a 5-point scale (1 = not at all; 5-very much). the csb was inspired by the ebola safety behavior checklist (blakey et al., 2015). cronbach’s α in this study was 0.86. health care use (hcu) hcu was measured using a single item where participants assess the number of doctor visits (both gp and specialists) they attended in the last two months. fear of covid-19 consequences (fccc) fccc was developed for the purposes of this study and consisted of six items covering fear of consequences on: physical health, mental health, loved ones’ health, financial loss, loss of civil liberties and disturbed relationships. respondents rated how much they feared each of these consequences from 1 (very little) to 5 (very much). procedure we followed the procedure for instrument cross-validation described in the literature (van widenfelt et al., 2005). the mac-rf was first translated into croatian by the two authors (professor in clinical psychology and a doctoral student in clinical psychology) and by another colleague (professor in biological psychology). all three versions were reviewed and compared and a final version was agreed upon. next, a bilingual professor in health psychology translated the final version back into english. small differences were discussed by all four psychologists and minor alterations were made. this revised version was assessed by another two colleagues: a psychotherapist with a phd in clinical psychology and a doctoral student in cognitive psychology. neither reviewer found any issues. finally, this version was completed and its content discussed by a small sample of laypersons known to the researchers, who found the items clear and easy to respond to. covid-19 related fears 6 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ data were collected via an online survey using the surveymonkey software. this survey consisted of the aforementioned instruments and several questions regarding sociodemographic data and experiences with covid-19 described in the “participants” section. the data collection period was limited to four weeks from the date the survey was published. data was collected during the second wave of the covid-19 pandemic in croatia (november and december 2020), when a steady rise in new daily cases was being registered and new restrictions were being introduced. the survey was advertised using social media (several open groups dealing with different topics), the website of a cbt counseling center in croatia and the authors’ personal contacts. this study was approved by the ethical committee of department of psychology, faculty of humanities and social sciences, university of zagreb (epop – 2021 – 005). data analyses analyses were performed using the lavaan r package (rosseel et al., 2017). to explore the underlying structure of the mac-rf, we performed confirmatory factor analyses. to determine the fit of the model, several goodness-of-fit criteria were used: the stand­ ard root mean square residual (srmr), the root mean square error of approximation (rmsea) with 90% confidence intervals, and the comparative fit index (cfi). a model is considered to have a good fit to the data if the srmr is close to or below 0.08, if rmsea is close to or below 0.06, (the upper limit of the 90% rmsea confidence interval should be below 0.10), and if cfi is close to or above 0.95 (brown, 2015; hu & bentler, 1999; kline, 2015). to explore scale’s reliability and validity, we calculated cronbach’s alpha and correlations with relevant measures. r e s u l t s descriptive data for the mac-rf items is presented in table 1. preliminary analysis because it was treated as a single question by the program, there were no missing data within the mac-rf matrix. single multivariate and nine univariate outliers were detected and subsequently omitted from the data set. no indications of collinearity were detected (maximum variance inflation factor value = 2.11; minimum tolerance value = .47). all items were non-normally distributed (kolmogorov-smirnov z = 4.16-8.52, all p values < .001). model generation we specified three alternative models: a single factor model suggested by the authors, a 4-factor model with each domain of fear bodily, relational, cognitive, and behavioral bagarić & jokić-begić 7 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ comprising its own factor, and a 2-factor model with fear of infection comprising one factor (items 1-4; fear for/of the body, fear of/for others) and fear of choosing an inadequate strategy in dealing with pandemic comprising the other factor (items 5-8; fear of knowing and not knowing, fear of action/inaction). confirmatory factor analyses due to non-normal data, the maximum likelihood estimation method with robust stand­ ard errors (mlr) was employed (brown, 2015). mlr is recommended for variables that have five or more categories (rhemtulla, brosseau-liard, & savalei, 2012). according to the proposed criteria (brown, 2015; hu & bentler, 1999), the good­ ness‐of‐fit indices for three tested models suggested that a single factor solution fits the data poorly, whereas 2and 4-factor solutions both provided a good fit to the data (table 2). since the difference in the fit of these two models was not statistically significant, χ2(5) = 4.08, p = 0.54, we preserved the more parsimonious 2-factor model. table 2 goodness of fit indices for the three tested cfa models of mac-rf (n = 477) model χ2 (df) p (χ2) srmr rmsea [90% ci] cfi 1-factor 204.13 (20) < .001 0.10 0.14 [0.12, 0.16] 0.78 2-factor 32.06 (19) .031 0.04 0.04 [0.01, 0.06] 0.99 4-factor 28.27 (14) .013 0.03 0.05 [0.02, 0.07] 0.98 note. srmr = standardized root mean square residual; rmsea = the root mean square error of approxima­ tion; cfi = comparative fit index. table 1 descriptive statistics for mac-rf items item and domain m (sd) tr skewness kurtosis 1. fear of the body 1.17 (1.13) 0-4 .643 -.612 2. fear for the body 1.60 (1.29) 0-4 .133 -1.326 3. fear of others 1.93 (1.29) 0-4 -.156 -1.271 4. fear for others 2.55 (1.24) 0-4 -.754 -.464 5. fear of knowing 1.82 (1.34) 0-4 -.009 -1.264 6. fear of not knowing 0.55 (0.86) 0-3 1.436 1.000 7. fear of action 0.80 (1.05) 0-4 1.110 .122 8. fear of inaction 1.05 (1.17) 0-4 .724 -.788 total score 11.48 (5.47) 0-27 .11 -.56 covid-19 related fears 8 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ all indicators had a meaningful saturation with their corresponding factor, apart from item 5 whose saturation was somewhat low (figure 1). a correlation of 0.40 (p < .001) between the two factors suggests that the mac-rf measures two related but clearly distinct aspects of covid fears; one describing fear of being infected with the virus, oneself or a person’s loved one, and the other describing fears related to choosing an inadequate strategy in dealing with the pandemic, including informing oneself too much or too little about the pandemic. figure 1 standardized parameter estimates of the accepted 2-factor model of the mac-rf (n = 477) note. all parameters are significant at p < .001. scale reliability and validity in accordance with the cfa results, two subscales for mac-rf were created. the cron­ bach’s alpha for mac-rf 1 is .77 and for the mac-rf 2 is .65. the correlation between the two subscales is r = 0.29, p <.001. to inspect associations with psychopathology, correlations between the mac-rf (subscales and total score) and the ccsm (domains and total scores) were calculated. as seen in table 3, the highest correlations were detected between the anxiety domain of the ccsm and mac-rf, falling in the range of a moderate correlation. other correlations were mostly small in magnitude or, in the case of suicidal ideation and psychosis, non-significant. to further explore the construct of fear of covid-19, we examined the associations between the two subscales of the mac-rf (and total score) and a similar measure of covid-19 anxiety (cas5), health anxiety (shai), cyberchondria (scs), three aspects of anxiety sensitivity (asi-3), depression (dass-d), protective health behaviors (hb) and health care utilization (hcu). bagarić & jokić-begić 9 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ table 3 correlations between the mac-rf and ccsm (n = 346) ccsm subscale mac-rf 1 2 total depression .23** .30** .33** anger .24** .27** .31** mania .01 .11* .07 anxiety .27** .40** .40** somatic symptoms .15** .24** .23** suicidal ideation -.02 .06 .02 psychosis -.02 .05 .02 sleep problems .12* .18** .18** memory problems .11* .15** .15** obsession/compulsion .08 .16** .14** dissociation .09 .18** .16** maladaptive personality .08 .20** .16** substance use .09 .10 .11* total score .20** .33** .32** note. ccsm = dsm-5 self-rated level 1 cross-cutting symptom measure—adult. mac-rf = multidimensional assessment of covid-19-related fears. *p < .01. **p < .001. as seen in table 4, the two aspects of fear of covid-19 measured by the mac-rf appear to have varying associations with a number of these constructs. for example, the cas5 captures only one aspect of fear of covid-19 – the fear of infection – and not the second aspect the fear of choosing the wrong strategy in coping with pandemic. this explains the fact that a correlation of only .58 was detected between the two measures. as expected, a stronger correlation was found between the mac-rf total score and health anxiety (.39) and cyberchondria (.44) than with depression (.28). fear of infection had a stronger correlation with health anxiety and fear of choosing the wrong strategy in coping with pandemic had a stronger correlation with cyberchondria and depression. with respect to anxiety sensitivity, a somewhat stronger correlation was found between the social domain of asi and the fear of infection subscale of the mac-rf, which includes the fear of others and for others. furthermore, protective health behaviors were strongly correlated with fear of infection (.64), but not with fear of choosing the wrong strategy in dealing with pandemic (.26). finally, neither aspect of fear of covid-19 correlated with the number of doctor visits in the previous two months. covid-19 related fears 10 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ table 4 correlations between mac-rf subscales and related constructs measure mac-rf 1 2 total n cas5 .65 .23 .58 477 shai .33 .29 .39 346 scs .32 .42 .44 321 asi physical .28 .31 .36 346 asi cognitive .20 .25 .27 346 asi social .36 .21 .29 346 dass-d .17 .29 .28 346 hb .64 .26 .58 346 hcu .04ns .05ns .06ns 346 note. mac-rf = multidimensional assessment of covid-19-related fears; cas5 = covid-19 anxiety scale; shai = short health anxiety inventory; scs = short cyberchondria scale; asi = anxiety sensitivity index; dass-d = depression, anxiety and stress scale 21; hb = protective health behaviors; hcu = health care use. all correlations are significant at p < .001 except correlations with hcu, which are all non-significant. with respect to the scs, participants who reported never searching for health information online were excluded from the analyses because including these participants would obscure the definition of cyberchondria at the low end. finally, correlations between the mac-rf subscales and fear of different types of conse­ quences related to covid-19 are presented in table 5. table 5 correlations between the mac-rf and fear of different types of consequences related to covid-19 feared consequences related to covid-19 m (sd) mac-rf 1 2 total physical health 2.70 (1.13) .49** .27** .49** mental health 2.74 (1.25) .27** .46** .44** loved ones health 3.64 (1.12) .47** .29** .48** financial loss 3.18 (1.21) .06 .22** .16** loss of civil liberties 3.10 (1.38) -.20** .18** -.05 disturbed relationships 3.07 (1.32) .02 .28** .16** note. mac-rf = multidimensional assessment of covid-19-related fears. *p < .01. **p < .001. bagarić & jokić-begić 11 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ the fear of infection subscale had a stronger correlation with the fear of consequences for one’s physical health and the health of loved ones and a small negative correlation with the fear of loss of civil liberties. conversely, fear of choosing inadequate strategy had a stronger correlation with the fear of consequences for mental health and was also positively correlated with fear of financial loss, loss of civil liberties and disrupted relationships with others. d i s c u s s i o n the aim of this study was to validate a theoretically based measure of covid-19 related fear – the mac-rf – in a croatian sample and to further explore its validity. in contrast to the 1-factor structure reported by the authors of the scale (schimmenti, starcevic, et al., 2020), a 2-factor structure was revealed in the croatian sample. with regards to the scale’s general properties, its association with general psychopathology as measured by the ccsm was similar to that reported by the authors. furthermore, the stronger associations between the mac-rf and health anxiety and cyberchondria than with depression found in this study further attest to its convergent and divergent validity and expands previous findings regarding the instrument. additionally, with respect to concurrent validity, we found a moderate to strong association between the mac-rf and a previously validated scale of covid anxiety (mac5). however, total scale reliability was lower in our study (.72; original study = .84). this might be the consequence of the 2-factor structure registered in this study. consid­ ering that each subscale has only four items, low cronbach’s alpha (.77 and .65) is not surprising. therefore, it would be more suitable to assess test-retest reliability. the two items from the cognitive domain showed the lowest factor saturations in both studies, suggesting that there may be issues with item formulation. furthermore, informing oneself about covid-19 may also be seen as an action (behavioral domain). finally, cognitive domain is maybe too narrowly defined since knowing and not knowing can be achieved through different means besides informing oneself in an explicit way; such as through talking vs. not talking about covid-19 or maybe even through ruminating about the information one has attained vs. suppressing it. the two mac-rf factors identified in this study are: fear of infection, which reflects emotional-interpersonal feature, and fear of choosing an inadequate strategy, which re­ flects cognitive-behavioral feature form the schimmenti, billieux, and starcevic’s model (2020). the two factors were only moderately associated (.40), suggesting that they measure two distinct aspects of covid-19 related fears. this is further confirmed by a somewhat different patterns of association that the two subscales shared with several relevant constructs. for example, fear of infection has a stronger correlation with health anxiety and covid-19 anxiety, suggesting that this factor captures negative emotional states related to covid-19 and primarily deals with feared consequences for one’s covid-19 related fears 12 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ somatic health and the health of others. this aspect of covid-19 fear also appears to be a much stronger predictor of safety behaviors. furthermore, this subscale is more strongly related to the social aspect of anxiety sensitivity, which may reflect the fear of embarrassment due to revealing covid-19 anxiety. on the other hand, fear of choosing an inadequate strategy when dealing with pandemic has a stronger association with cyberchondria, which is itself a dysfunctional strategy for dealing with health fears. according to a recently proposed metacognitive model of cyberchondria (fergus & spada, 2018), the vicious cycle of excessive online health information and distress is maintained due to conflicting metacognitive beliefs about this strategy: it is deemed helpful in protecting one’s somatic health, but harmful to one’s mental health. similarly, the second mac-rf subscale may reflect a metacogni­ tive aspect of covid-19 fear (beliefs about strategies for dealing with pandemic) that is dialectical in nature: fear of doing too much or too little, reading too much or too little. furthermore, this subscale shares the strongest correlation with the fear of consequences of pandemic for mental health. this finding, together with the dialectic nature of this subscale, may explain its weak correlation with safety behaviors. this subscale is also associated with the fear of disturbed relationships due to pandemic. besides dealing with evaluation of one’s knowledge and action in respect with covid-19, this subscale also deals with tolerating uncertainty so its association with this aspect needs to be explored in further studies. finally, an important aspect of this subscale is considering responsible social action as discussed in the schimmenti, billieux, and starcevic’s model (2020). although, we did not find correlation between this subscale and safety behaviors, it seems probable that only certain items or their combination is predictive of taking action. a lack of association between number of doctor’s visits with either of the mac-rf subscales may be explained by the fact that some people might avoid doctors due to the fear of contracting the coronavirus, while others may go “doctor shopping” to get reassurance. also, it should be noted that over 60% of the sample have not visited a doctor during the last two months. the different underlying structure of the mac-rf in our sample may suggest cultur­ al, social or economic differences, but might also be due to fact that the two studies were conducted in different epidemiological circumstances. in the original study (schimmenti, starcevic, et al., 2020), data was collected a month after restrictions were lifted, while our data was collected during a period in which new restrictions were being imposed and a significant growth in new cases was being registered. it is possible that there are differences in the definition of this construct depending on epidemiological circumstan­ ces. further studies should examine a bifactor structure for the mac-rf having in mind that both a single and two-factor structure may co-exist and may both have a meaningful interpretation as suggested for other psychopathology constructs (bornovalova et al., 2020). bagarić & jokić-begić 13 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ finally, the different instruments developed in this field capture different aspects of problematic psychological reactions to covid-19. while some emphasize emotional (lauri-korajlija & jokić-begić, 2020), behavioral (nikčević & spada, 2020) or physiolog­ ical (lee, 2020) aspects, others encompass a combination of emotional, physiological, cognitive and behavioral components (e.g., taylor et al., 2020; ahorsu et al., 2020). others even go beyond the fear of illness and include fear of economic consequences (arpaci et al., 2020). an instrument’s scope will certainly affect its associations with other relevant constructs: predictors, mediators and outcomes of fear. developing a theoretical approach to covid-19 related distress can help in achieving a consistent definition of this construct (or constructs), developing adequate measurement tools, integrating knowledge form different studies, and developing targeted interventions. this study supports the dialectical nature of covid-19 fears (schimmenti, billieux, & starcevic, 2020), since items describing opposing fears reflect a single construct, and attests to the complexity of human experiences in the time of a global health crisis. several strategies for addressing covid-19 anxiety have been suggested by the authors of mac-rf (schimmenti, billieux, & starcevic, 2020); practicing mindfulness to improve appraisal of the body and to adopt acceptance and self-compassion, delivering targeted interventions to foster attachment security, using strategies to improve emotion regu­ lation, and promoting responsibility. the results of this study further emphasize that treatment might need to focus not only on fear of becoming infected, but also on a metacognitive aspect that reflects conflicting beliefs about strategies used when dealing with the pandemic. using a combination of cognitive continuum and listing advantaging and disadvantages of extreme strategies (e.g., reading about covid too much or not at all), as a form of cognitive restructuring within cognitive-behavioral therapy, could help adopting appropriate intensity of health-related behaviors. it may also be necessary to modify metacognitive beliefs about strategies in dealing with pandemic and practice tolerating uncertainty which fuels covid-19 anxiety. the disadvantages of this study that place limits on its findings include: a non-repre­ sentative sample (certain groups are underrepresented), a self-selection bias (people more affected by covid-19 might have been more likely to participate) and the cross-sectional design (no causal associations can be claimed). conclusions this study suggests that the mac-rf might be a useful instrument in assessing cov­ id-19 fears. in a croatian sample and at a time of a rapid increase in daily cases, this instrument appears to measure two distinct, but related factors: fear of infection (emo­ tional aspect) and fear of choosing an inadequate strategy when dealing with pandemic (metacognitive aspect). further studies using the mac-rf across different cultures and different epidemiological circumstances are needed. covid-19 related fears 14 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://www.psychopen.eu/ funding: this research received no specific grant from any funding agency in the public, commercial, or not-forprofit sectors. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. ethics statement: this study was approved by the ethical committee of the department of psychology, faculty of humanities and social sciences, university of zagreb (epop – 2021 – 005). the study was conducted in accordance with the 1964 helsinki declaration and its later amendments or comparable ethical standards. data availability: for this article, a data set is freely available (bagarić & jokić-begić, 2022) s u p p l e m e n t a r y m a t e r i a l s the research data is collected in the validation study of multidimensional assessment of covid-19-related fears (mac-rf) – croatian version. a total of 477 participants completed the online survey during the covid-19 pandemic. for access see index of supplementary materials below. index of supplementary materials bagarić, b., & jokić-begić, n. 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(2005). translation and cross-cultural adaptation of assessment instruments used in psychological research with children and families. clinical child and family psychology review, 8(2), 135–147. https://doi.org/10.1007/s10567-005-4752-1 bagarić & jokić-begić 17 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://doi.org/10.1016/j.janxdis.2020.102233 https://doi.org/10.1176/appi.ajp.2012.12071000 https://doi.org/10.1016/j.psychres.2020.113322 https://doi.org/10.1016/s1836-9553(10)70030-8 https://doi.org/10.1037/a0029315 https://doi.org/10.1017/s0033291702005822 https://doi.org/10.3389/fpsyt.2020.00748 https://doi.org/10.1037/1040-3590.19.2.176 https://doi.org/10.1016/j.janxdis.2020.102232 https://doi.org/10.1007/s10567-005-4752-1 https://www.psychopen.eu/ wheaton, m. g., abramowitz, j. s., berman, n. c., fabricant, l. e., & olatunji, b. o. (2012). psychological predictors of anxiety in response to the h1n1 (swine flu) pandemic. cognitive therapy and research, 36(3), 210–218. https://doi.org/10.1007/s10608-011-9353-3 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. covid-19 related fears 18 clinical psychology in europe 2022, vol. 4(1), article e6137 https://doi.org/10.32872/cpe.6137 https://doi.org/10.1007/s10608-011-9353-3 https://www.psychopen.eu/ covid-19 related fears (introduction) method participants instruments procedure data analyses results preliminary analysis model generation confirmatory factor analyses scale reliability and validity discussion conclusions (additional information) funding acknowledgments competing interests ethics statement data availability supplementary materials references evaluation of the factor structure and psychometric properties of the german version of the clinical perfectionism questionnaire: the cpq-d research articles evaluation of the factor structure and psychometric properties of the german version of the clinical perfectionism questionnaire: the cpq-d isabel roth 1, barbara cludius 1 , sarah j. egan 2 , karina limburg 1 [1] department of psychology, lmu munich, munich, germany. [2] school of psychology and speech pathology, curtin university, perth, australia. clinical psychology in europe, 2021, vol. 3(2), article e3623, https://doi.org/10.32872/cpe.3623 received: 2020-04-27 • accepted: 2021-03-30 • published (vor): 2021-06-18 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: barbara cludius, department of clinical psychology and psychotherapy, lmu munich, leopoldstr. 13, 80802, munich, germany. +49 (0)89 2180 5590. e-mail: barbara.cludius@psy.lmu.de abstract background: the aim was to create a german version of the clinical perfectionism questionnaire (cpq-d) and to test its factor structure, reliability, and validity in a non-clinical population. method: we recruited n = 432 participants via an online panel. the factor structure of cpq-d was examined. the convergent, discriminative, and incremental validity was assessed in relation to the frost multidimensional perfectionism scale (fmps) and the positive and negative affect schedule (panas). results: exploratory factor analysis resulted in two factors. factor 1 represented the over evaluation of striving and factor 2 was associated to concern over mistakes. internal consistency was acceptable with ω = .81 for the total score, ω = .77 for factor 1, and ω = .73 for factor 2. convergent, discriminative, and incremental validity was demonstrated. important to note, item 12 should be used with caution since it showed low communality and a low item-total correlation and should therefore be further evaluated in future research. conclusion: the results indicate that the german translated version of the cpq has acceptable internal consistency, convergent, discriminative and incremental validity. future research should test the cpq-d scale further in clinical and non-clinical populations and assess a broader variety of scales to determine validity of the scale. keywords perfectionism, clinical perfectionism questionnaire, german version, validity, factor analysis this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3623&domain=pdf&date_stamp=2021-06-18 https://orcid.org/0000-0003-4814-1497 https://orcid.org/0000-0002-3715-4009 https://orcid.org/0000-0002-4061-8679 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • a german translation of the cpq was tested and validated in a large community sample. • the factor structure equals the english version, revealing two factors of clinical perfectionism. • the cpq-d proved to be a reliable and valid measure in a non-clinical sample. perfectionism is the tendency to set very high standards and to critically evaluate one’s own behaviour (frost, marten, lahart, & rosenblate, 1990). the construct of perfection­ ism is usually defined as multidimensional and mostly assessed with two multidimen­ sional perfectionism scales (fmps; frost et al., 1990; hmps; hewitt & flett, 1991). factor analyses of the two scales have consistently resulted in two factors: perfectionistic striv­ ings and perfectionistic concerns (stöber & otto, 2006). perfectionistic strivings refer to striving for high standards and perfectionistic concerns refer to concerns over mistakes and the belief others hold high standards of the individual. recent meta-analytic evi­ dence has demonstrated that both dimensions of perfectionism are linked to psychopa­ thology, particularly eating disorders, but also depression, anxiety and obsessive-compul­ sive disorder (limburg, watson, hagger, & egan, 2017). in order to focus on the clinically relevant aspects of perfectionism, shafran, cooper, and fairburn (2002) proposed a model of clinical perfectionism, defined as an overdependence of self-evaluation on meeting personally demanding, self-imposed standards, despite adverse consequences (shafran et al., 2002). thus, the multidimensional construct of perfectionism (including perfectionis­ tic strivings and concerns) differs from clinical perfectionism as the definition of clinical perfectionism puts a central emphasis on self-worth being dependent on meeting high standards. this emphasis is not present in the definition of perfectionistic strivings and concerns. shafran and colleagues (2002) developed a model which outlines a range of cognitive and behavioural processes which maintain clinical perfectionism. based on the clinical perfectionism model (shafran et al., 2002) cognitive behaviour therapy (cbt) interventions were developed to target clinical perfectionism as a transdiagnostic process which is a predisposing and maintaining process in a range of psychological disorders (egan, wade, & shafran, 2011). cbt for perfectionism has been demonstrated to result in transdiagnostic reductions in anxiety, depression and eating disorders (suh, sohn, kim, & lee, 2019). this approach to treat clinical perfectionism across disorders is in line with the current approach of process-based treatment (hofmann & hayes, 2019). in order to evaluate treatment efficacy, it is crucial to have a psychometrically sound scale assessing clinical perfectionism. therefore, fairburn, cooper, and shafran (2003) developed the clinical perfectionism questionnaire (cpq), consisting of 12 items that assess clinical perfectionism in the previous month. several studies have examined the validity and reliability of the cpq. the german version of the cpq 2 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ chang and sanna (2012) found the cpq was positively correlated with depression and anxiety, indicating convergent validity. the cpq further accounted for additional variance in depression and anxiety beyond the hmps (hewitt & flett, 1991), which demonstrated incremental validity (chang & sanna, 2012). dickie, surgenor, wilson, and mcdowall (2012) tested the cpq in a non-clinical sample. they excluded items 7 (“have you judged yourself on the basis of your ability to achieve high standards?”) and 8 (“have you done just enough to get by?”) due to low or negative correlations with all other items and low item-total correlations. a factor analysis of the remaining ten items resulted in two factors representing personal standards and concerns about failure with acceptable reliability (α = .71 for both factors; dickie et al., 2012). similar conclusions were drawn by stöber and damian (2014) who also excluded items 7 and 8 because of low correlations and crossloadings on the two factors they found. convergent validity was demonstrated by positive correlations with other perfectionism measures (stöber & damian, 2014). egan and colleagues (2016) tested the psychometric properties of the cpq including all 12 items in both a clinical eating disorder and community sample. their factor analysis also resulted in two factors representing similar constructs as previous studies. factor 1 comprised the overevaluation of striving, and convergent validity was indicated by a significant positive correlation (r = .64) with the fmps subscale personal standards. factor 2 was related to reacting to perceived failure, and convergent validity was demonstrated with self-criticism indicated by substantial and significant positive correlations with the fmps subscales concern over mistakes (r = .61) and doubts about actions (r = .56). further indicating convergent validity, the second factor of the cpq was correlated with the negative affect subscale of the positive and negative affect schedule (panas; watson, clark, & tellegen, 1988). discriminant validity of the cpq was shown because it could reliably discriminate between both participants with high and low negative affect as well as between the eating disorder sample and healthy controls. in terms of incremental validity, the fmps accounted for 23% of variance while the cpq accounted for an additional 11% of variance in the panas-na scores (egan et al., 2016). prior and colleagues (2018) also found in a clinical eating disorder sample a two factor structure using a bifactor approach, comprising of overevaluation of striving and concern over mistakes, in a 10 item version of the cpq excluding the two items found in previous research to be problematic. due to the focus of the cpq on clinical aspects of perfectionism relevant to treatment, the aim of this study was to develop a german version of the scale in order to extend access to and distribution of the cpq. this is important in further evaluating the efficacy of cbt for perfectionism in german speaking areas in clinical practice and research. in the present study a german translation of the cpq was developed and tested within a community sample in order to explore the factor structure and psychometric properties of the scale. since this is the first study on a german version, we used all 12 items instead of the reduced set of 10 items. we hypothesized that the german version (cpq-d) would consist of two factors roth, cludius, egan, & limburg 3 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ with a similar structure to the english version found in previous research (egan et al., 2016; prior et al., 2018) and that convergent, discriminant, and incremental validity would be demonstrated. m a t e r i a l s a n d m e t h o d s sample we used a community sample and recruited participants via the online panel psyweb (https://psyweb.uni-muenster.de). inclusion criteria were age above 18 years and self-re­ ported good german language abilities. since sample sizes of n = 200-300 are regarded suitable for a factor analysis even with lower communalities of the items, we aimed to recruit a minimum sample of n = 250 (bühner, 2011). measures to create the german version of the cpq (cpq-d), the original version of the cpq was first translated into german by the first author, then translated back to english and compared to the original version by the senior author. finally, a few linguistic changes were made by the first and the senior author. the original cpq (fairburn et al., 2003) is a self-report measure that assesses the core elements of clinical perfectionism (see table 2). the 12 items, of which items 2 and 8 are reverse-scored, are rated based on participants’ past 28 days on a 4-point likert scale from 1 (not at all) to 4 (all the time). total scores therefore range from 12 to 48 and a higher score indicates a higher level of clinical perfectionism. the german version of the frost multidimensional perfectionism scale (fmps; frost et al., 1990; stöber, 1995) was used to assess multidimensional perfectionism with six sub­ scales: personal standards (ps), concern over mistakes (cm), doubts about actions (da), parental expectations (pe), parental criticism (pc), and organisation (o) and a sum score. the fmps-d was chosen because its subscales personal standards and concern over mistakes are close to the definition of clinical perfectionism (egan et al., 2016; shafran et al., 2002). it consists of 35 items rated on 5-point likert scales from 1 (strongly disagree) to 5 (strongly agree). following recommendations of dunn, baguley, and brunsden (2014), mcdonald’s ω (mcdonald, 1999) was used instead of cronbach’s α to examine internal consistency. for the fmps it was acceptable with ω = .92 for concern over mistakes, ω = .84 for personal standards and ω = .76 for doubts about actions. the fmps score in our study comprised the subscales personal standards, doubts about actions, and concern over mistakes, following previous research examining the validity of the cpq (egan et al., 2016). we used the german version of the positive and negative affect schedule (panas; krohne, egloff, kohlmann, & tausch, 1996; watson et al., 1988) to measure positive and the german version of the cpq 4 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://psyweb.uni-muenster.de https://www.psychopen.eu/ negative affect over the past 28 days. the scale contains ten words describing pleasant and ten words describing unpleasant emotions, representing the subscales positive affect (pa) and negative affect (na), respectively. participants rate to what extent they had experienced each of the 20 emotions during the past weeks on a 5-point scale. the panas is valid (krohne et al., 1996) and in the present sample the internal consistency for the positive affect scale (panas-pa) was ω = .90 and for the negative affect scale (panas-na) was ω = .89. procedure the study was approved by the ethics committee of the faculty for psychology and educational science at the ludwig-maximilians university munich. participants provided informed consent and there was no identifying data. the online survey started with a short introduction after which participants were asked to complete the cpq-d, the fmps-d and the panas. finally, personal feedback regarding individual results on the fmps-d was provided. statistical analyses the free software r, version 3.5.1 (r core team, 2019), was used for all statistical anal­ yses. the following additional packages were necessary for the analyses: gparotation (bernaards & jennrich, 2005), boot (canty & ripley, 2017), semplot (epskamp, 2019), quantpsych (fletcher, 2012), polycor (fox, 2016), car (fox & weisberg, 2019), hmisc (harrell, 2019), mbess (kelley, 2019), ggm (marchetti et al., 2015), foreign (r core team, 2018), psych (revelle, 2018), corpcor (schafer et al., 2017), effsize (torchiano, 2018), ggplot2 (wickham, 2016). significance level for all tests was α=.05. after calculating de­ scriptive statistics, bartlett’s test was used to test for sphericity and kaiser-meyer-olkin test was applied to examine sampling adequacy. further, inter-item-correlations were calculated to investigate whether all 12 items could be included in the exploratory factor analysis (efa). afterwards and based on the results of the preceding tests, an efa was conducted for the cpq-d. the number of factors was determined with a scree plot and a parallel analysis. in the parallel analysis the eigenvalues of the empirical data were compared against the 95th percentile of eigenvalues generated from 1000 simulated analyses, corresponding in size and number of items. to not risk keeping too many or irrelevant factors, the conservative approach of using only the 95th percentile of the simulated eigenvalues was applied. factors with actual eigenvalues greater than those simulated eigenvalues were maintained (hayton, allen, & scarpello, 2004). again, mcdonald’s ω was used instead of cronbach’s α to examine internal con­ sistency of the factors (dunn et al., 2014; mcdonald, 1999). to test convergent and discriminative validity, correlations between the measures were calculated. substantial and significant positive correlations between the cpq-d, the fmps-d, and panas-na roth, cludius, egan, & limburg 5 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ were considered evidence for convergent validity. in terms of discriminant validity, small positive and/or negative correlations were expected between the cpq-d and panas-pa. correlation coefficients were interpreted according to the rule of thumb by cohen (1988), with 0.1≤|r|< 0.3 indicating small, 0.3≤|r|< 0.5 indicating moderate, and |r|> 0.5 indicating high correlations. to further test discriminant validity, we conducted t-tests to examine if participants with low negative affect differed from those with high negative affect in their cpq-d scores. effect sizes were assessed with cohen’s d and interpreted as small if 0.2≤|d|< 0.5, medium if 0.5≤|d|< 0.8, and high if |d|> 0.8 (cohen, 1988). finally, a hierarchical linear regression analysis predicting the panas-na score with the fmps-d and cpq-d scores as independent variables was conducted to check for incremental validity. r e s u l t s participants we collected data from 439 participants. data screening resulted in the exclusion of three datasets due to missing consent, two were excluded due to invalid age information, one due to voluntary withdrawal, and one due to insufficient knowledge of the german language. the final sample consisted of n = 432 participants. descriptive data of the sample along with means and standard deviations for the cpq-d, fmps-d, and panas are presented in table 1. the mean cpq-d total was m = 26.50 (sd = 5.70). factor structure and internal consistency inter-item correlations were mostly moderate, only items 8 and 12 had small correlations to other items (r < .30). the same items had small item-total correlations of r = .19 for item 8 and r = .20 for item 12. due to results of bartlett’s test, χ2(66) = 1253.53, p < .001, and kmo test (msa = .85) and since inter-item correlations were significant for all items, we decided to run the factor analysis for the complete set of items instead of excluding items 8 and 12. an exploratory factor analysis using maximum likelihood estimation with promax rotation resulted in two factors with simple structure. two factors were assumed based on the scree plot and parallel analysis. of note, the eigenvalue rule was not fulfilled with only one factor having an eigenvalue greater than one, but the eigenvalue criterion has been marked as too strict (jolliffe, 1972). eight items loaded on factor 1 and four items on factor 2. factor 1 explained 20% and factor 2 accounted for 15% of variance, factors were moderately correlated with r = .49. the factor structure along with communalities of the items is depicted in table 2. internal consistency was ω = .81 for the total score, ω = .77 for factor 1, and ω = .73 for factor 2. the german version of the cpq 6 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ table 1 sample characteristics, n = 432 variable m (sd) or n (%) age (years), m (sd) 49.53 (15.00) female, n (%) 251 (58.10) education, n (%) 9th grade or less 19 (4.40) 10th grade 62 (14.35) high school graduate 102 (23.61) university graduate 243 (56.25) other degree 6 (1.39) psychological diagnosis, n (%) 137 (31.71) psychotherapeutic and/or psychiatric treatment, n (%) yes, currently, n (%) 61 (14.12) yes, formerly, n (%) 162 (37.50) never, n (%) 233 (53.94) cpq-d total, m (sd) 26.50 (5.70) factor 1, m (sd) 18.21 (4.17) factor 2, m (sd) 8.29 (2.41) fmps-d total, m (sd) 98.84 (21.24) personal standards, m (sd) 21.64 (5.50) doubts about actions, m (sd) 9.99 (3.82) concern over mistakes, m (sd) 22.11 (8.43) parental expectations, m (sd) 11.98 (5.11) parental criticism, m (sd) 10.11 (4.61) organisation, m (sd) 23.02 (4.48) panas-na, m (sd) 20.61 (7.74) panas-pa, m (sd) 31.91 (7.39) note. cpq-d = clinical perfectionism questionnaire, german version; fmps-d = frost multidimensional perfectionism scale; panas-na = positive and negative affect schedule, negative affect subscale; panas-pa = positive and negative affect schedule, positive affect subscale. roth, cludius, egan, & limburg 7 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ ta b le 2 p ro m ax -r ot at ed f ac to r st ru ct ur e of t he c p q -d it em n o. it em c p q it em c p q -d f1 f2 h2 1 h av e yo u pu sh ed y ou rs el f re al ly h ar d to m ee t yo ur g oa ls ? h ab en s ie s ic h s eh r an ge st re n gt , u m i h re z ie le z u er re ic h en ? .4 8 .0 8 .2 7 3 h av e yo u be en t ol d th at y ou r st an da rd s ar e to o h ig h ? w ur de i h n en g es ag t, d as s ih re a n sp rü ch e zu h oc h s in d? .5 3 .1 2 .3 6 6 h av e yo u ra is ed y ou r st an da rd s be ca us e yo u th ou gh t th ey w er e to o ea sy ? h ab en s ie i h re a n sp rü ch e er h öh t, w ei l s ie d ac h te n s ie s ei en z u le ic h t zu e rr ei ch en ? .4 6 .0 0 .2 1 7 h av e yo u ju dg ed y ou rs el f on t h e ba si s of y ou r ab il it y to a ch ie ve h ig h s ta n da rd s? h ab en s ie s ic h s el bs t an h an d de ss en b eu rt ei lt , o b si e h oh e a n sp rü ch e er re ic h en k ön n en ? .5 8 .2 3 .5 1 8 h av e yo u do n e ju st e n ou gh t o ge t by ? (r ) h ab en s ie g er ad es o ge n ug g et an , u m ü be r di e r un de n z u ko m m en ? (r ) .4 2 -. 23 .1 4 9 h av e yo u re pe at ed ly c h ec ke d h ow w el l y ou a re d oi n g at m ee ti n g yo ur s ta n da rd s (f or e xa m pl e, b y co m pa ri n g yo ur pe rf or m an ce w it h t h at o f ot h er s) ? h ab en s ie w ie de rh ol t üb er pr üf t, w ie g ut s ie s ic h d ar in s ch la ge n , h oh e a n sp rü ch e zu e rr ei ch en ( zu m b ei sp ie l, in de m s ie i h re le is tu n g m it d er a n de re r ve rg li ch en )? .5 1 .2 0 .3 9 10 d o yo u th in k th at o th er p eo pl e w ou ld h av e th ou gh t of y ou a s a “p er fe ct io n is t” ? g la ub en s ie , d as s an de re l eu te s ie a ls „p er fe kt io n is t/ in “ be ze ic h n en w ür de n ? .6 2 -. 14 .3 2 11 h av e yo u ke pt t ry in g to m ee t yo ur s ta n da rd s, e ve n if t h is h as m ea n t th at y ou h av e m is se d ou t on t h in gs ? h ab en s ie a uc h d an n v er su ch t, i h re a n sp rü ch e zu e rr ei ch en , w en n s ie d ad ur ch a n de re d in ge v er sä um t h ab en ? .5 6 .0 5 .3 4 2 h av e yo u te n de d to f oc us o n w h at y ou h av e ac h ie ve d, ra th er t h an o n w h at y ou h av e n ot a ch ie ve d? ( r ) h ab en s ie s ic h e h er d ar au f fo ku ss ie rt w as s ie e rr ei ch t h ab en , a ls da ra uf , w as s ie n ic h t er re ic h t h ab en ? (r ) -. 03 .4 5 .1 9 4 h av e yo u fe lt a f ai lu re a s a pe rs on b ec au se y ou h av e n ot su cc ee de d at m ee ti n g yo ur g oa ls ? h ab en s ie s ic h w ie e in /e v er sa ge r/ in g ef üh lt , w en n e s ih n en n ic h t ge la n g, i h re z ie le z u er re ic h en ? .1 4 .7 6 .7 0 3 h av e yo u be en a fr ai d th at y ou m ig h t n ot r ea ch y ou r st an da rd s? h at te n s ie a n gs t, d as s si e ih re z ie le m ög li ch er w ei se n ic h t er re ic h en k ön n te n ? .1 4 .7 1 .6 1 12 h av e yo u av oi de d an y te st s of y ou r pe rf or m an ce ( at m ee ti n g yo ur g oa ls ) in c as e yo u fa il ed ? h ab en s ie je de a rt d er ü be rp rü fu n g ih re r le is tu n g ve rm ie de n , w ei l s ie b ei d er e rr ei ch un g ih re r z ie le v er sa gt h ab en k ön n te n ? -. 03 .3 5 .1 1 n ot e. f 1 = lo ad in gs o n f ac to r 1; f 2 = lo ad in gs o n f ac to r 2; h 2 = c om m un al it y; ( r ) = r ev er se -c od ed , l oa di n gs > 0 .3 a re p ri n te d in b ol d. r ep ri n t of o ri gi n al it em s w it h c ou rt es y of r oz s h af ra n . the german version of the cpq 8 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ construct validity pearson’s correlations between the measures are seen in table 3. table 3 pearson correlations and partial correlations of the scales scale cpq-d total factor 1 f1.f2 factor 2 f2.f1 fmps-d total .68*** [.63, .73] personal standards .60*** [.54, .66] .66*** [.60, .71] .62*** .29*** [.20, .38] -.02 concern over mistakes .67*** [.62, .72] .55*** [.48, .61] .37*** .61*** [.59, .70] .53*** doubts about actions .51*** [.44, .58] .35*** [.27, .43] .09 .65*** [.55, .67] .54*** panas-na .55*** [.48, .61] .40*** [.32, .48] .17*** .61*** [.55, .66] .52*** panas-pa -.11* [-.21, -.02] .07 [-.03, .16] -.39*** [-.46, -.30] note. cpq-d = clinical perfectionism questionnaire, german version; fmps = frost multidimensional perfec­ tionism scale; panas-na = positive and negative affect schedule, negative affect subscale; panas-pa = positive and negative affect schedule, positive affect subscale. values in brackets depict the 95% ci for the respective pearson correlation coefficient. f1.f2 = partial correlation of factor 1 controlled for factor 2, f2.f1 = partial correlation of factor 2 controlled for factor 1. *p < .05. **p < .01. ***p < .001. convergent validity the cpq-d total was highly correlated with the fmps-d total and the relevant subscales personal standards, concern over mistakes, and doubts about actions, and with panas­ na. factor 1 correlated with personal standards, but also concern over mistakes. when controlling for overlap with factor 2, the relationship was only moderate. factor 2 corre­ lated highly with concern over mistakes, doubts about actions, and panas-na and the relationship remained when controlling for factor 1. hence, the cpq-d demonstrated convergent validity. roth, cludius, egan, & limburg 9 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ discriminative validity as expected, correlations between cpq-d and both factors and panas-pa were small to negative. following egan and colleagues (2016), we classified participants with panas­ na scores of > 25 (75th percentile) as “high” (n = 114) and those with scores < 15 (25th percentile) as “low” (n = 133). an independent samples t-test revealed that those with higher panas-na scores had significantly higher scores on cpq-d total than those with low panas-na scores (“high” panas-na group: m = 31.18, sd = 5.42; “low” panas-na group: m = 23.14, sd = 4.44; t(218.51) = 12.61, p < .001). cohen’s d was large with d = 1.63 (95% ci [1.34, 1.92]). similar findings were evident for factor 1 and factor 2 (factor 1: “high” panas-na group: m = 20.75, sd = 4.01; “low” panas-na group: m = 16.38, sd = 3.60; t(226.94) = 8.84, p < .001, d = 1.14, 95% ci for d [.87, 1.41]; factor 2: “high” group: m = 10.43, sd = 2.26; “low” group: m = 6.77, sd = 1.62; t(201.23) = 14.40, p < .001, d = 1.88, 95% ci for d [1.58, 2.19]). incremental validity a multiple hierarchical linear regression model showed that the fmps-d accounted for 23.6% of variance in panas-na (p < .001) and that the cpq-d accounted for an additional 11% of variance (p < .001). upon inclusion of the cpq-d total in the regression model, the predictive value of the fmps-d reduced from β = .49 to β = .21, which could be due to the strong correlation of both variables (r = .68). the variance inflation factor of 1.86 confirmed that there was no multicollinearity between the predictors. hence, in the final model including fmps-d and cpq-d, the latter was a stronger predictor for negative affect than the fmps-d. d i s c u s s i o n consistent with previous studies on the original version of the cpq, the cpq-d consists of two factors, with the same eight items loading on factor 1 as the respective items in the english version and the same four items loading on factor 2 (dickie et al., 2012; egan et al., 2016; stöber & damian, 2014). the values of the loadings of the single items differ slightly between all sighted analyses, but never by more than 0.15 between the german and the english version (egan et al., 2016). similar to previous studies factor 1 represents primarily the over evaluation of striving whereas factor 2 assesses concern over mistakes (egan et al., 2016; prior et al., 2018). unlike the english version, the german version contains no cross loadings greater than 0.3 on both factors, which suggests that the german translation might discriminate more precisely between the two factors. internal consistency of the factors and the total score were acceptable. the amount of variance explained by both factors was 35%, a very low proportion considering recommendations that at least 60% of variance should be explained (hair et al., 2013). previous studies found diverging amounts of variance explained, with 47.9% (dickie et al., 2012), 45.9% the german version of the cpq 10 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ (stöber & damian, 2014), and 79% (egan et al., 2016). the low proportion we found could indicate that there is a third latent variable behind the construct of clinical perfectionism that could not be covered by the items. alternatively, formulation of the translated items may not be adequate so that they cannot sufficiently assess the two latent variables. prior and colleagues (2018) argued that a single, latent construct of clinical perfectionism could also explain the structure of the cpq in a clinical eating disorder sample, and it is possible that a unidimensional structure may be worth further investigating in future research. a noteworthy finding was that items 8 and 12 had both low communalities, indi­ cating small associations with both factors, and low item-total correlations, indicating that these items insufficiently represent the total scale. findings for item 8 (“have you done just enough to get by?”) can be interpreted in accordance with previous research finding this reverse scored item problematic (dickie et al., 2012; prior et al., 2018). this is supported by item 8 having relatively high loadings with opposite items on both factors, which means that participants with a high score on factor 1 (over evaluation of striving) seem to interpret item 8 in an opposite way to participants with high scores on factor 2 (concern over mistakes). this is likely due to the item being reverse scored and participants were reading the item incorrectly assuming it was similar to other items. future research on the german cpq should examine the 12-item version and a 10-item version of the scale with the reverse scored items removed. item 12 (“have you avoided any test of your performance (at meeting your goals) in case you failed?”) was not problematic in studies on the english version. they found that item 12 loaded on factor 2 between .37 and .71 and had corrected item total correlations (citc) of .24 or higher. in the german version the loading on factor 2 was slightly smaller, but more problematic were the low citc of .20 and the low communality of .11. this indicates that item 12 does not represent factor 2 well and does not contribute much to assessing the construct of clinical perfectionism. one reason could be that the german translation of item 12 may have been too complicated to be easily understood by participants. furthermore, avoidance of performance tests could be associated with other factors than perfectionism, for example test anxiety, a lack of motivation to be tested, or simply having no test situations available in everyday life. future research on the cpq-d should address this issue because the original content of item 12 (testing and evaluating one’s performance) is an important part of the definition of clinical perfectionism. in terms of validity, our results provided evidence for convergent validity, discrimina­ tive validity, and incremental validity. convergent validity was demonstrated by high correlations with the fmps-d and the negative affect subscale of the panas. factor 1 correlated highly with fmps-d subscales assessing the setting and evaluation of strivings while factor 2 correlated with scales measuring concerns about mistakes, concerns re­ garding meeting personal standards, and negative emotions. this supports the interpre­ tation of factor 1 representing perfectionistic strivings and factor 2 assessing emotional roth, cludius, egan, & limburg 11 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ consequences of failure. discriminative validity was shown by low correlations with the positive affect subscale of the panas and by the finding that the cpq-d could discriminate well between participants with high vs. low negative affect. finally, the cpq-d explained variance in negative affect beyond the proportion explained by the fmps-d, demonstrating incremental validity. strengths and limitations considering that we had similar findings compared to previous studies on the english version of the cpq in terms of factor structure and construct validity, it seems like trans­ lation of the measure was successful. also, it shows a simple structure which ensures interpretability. another strength is that we tested the cpq-d not only in a student sample, but in a community sample, of which nearly a third of the participants had a self­ reported diagnosed psychological disorder and 14% reported to be in psychotherapeutic and/or psychiatric treatment, indicating some generalisability towards clinical samples. however, there were some limitations. first, the community sample was recruited using an online panel. this method only reaches certain target groups. participants in our sample were on average 49.53 years old and highly educated, which decreases gener­ alisability of our results (e.g., our results may not apply to younger or people with lower education). future research should consider using test theory to explore item-person fit. second, we did not assess the number of specific psychological disorders, although it would be interesting to know whether there are diverging results for different disorders. third, we used a limited number of measures to assess construct and incremental validi­ ty. other measures assessing perfectionism and further constructs (e.g., depression, anxi­ ety, eating disorder symptoms, general well-being, personality traits) would have been valuable to examine validity more comprehensively. fourth, regarding translation of the measure, it would have been worthwhile to have the german version translated back to english by several people and to have the german scale evaluated by several clinicians. moreover, it should be considered in future research to use a cognitive interview to validate the german translation. finally, there are no “clinical” cut-offs or severity ranges for the cpq. instead, clinicians and researchers currently interpret the score on the basis of higher scores indicating greater clinical perfectionism. it would be useful for future research to determine severity ranges (e.g., mild, moderate, severe) to further enhance the clinical and research application of the scale. conclusion overall, we found evidence for the reliability and validity of the cpq-d, the factor structure is the same as in the english version (dickie et al., 2012; egan et al., 2016; prior et al., 2018; stöber & damian, 2014). therefore, the cpq-d can be used in a similar way to the english version. it would be useful for future research to examine if there the german version of the cpq 12 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://www.psychopen.eu/ are differences between clinical perfectionism across countries, for example, between the united kingdom (uk) where the cpq was developed, and germany. to date, cultural differences in the definition and perception of perfectionism have been found when comparing individualistic and collectivistic cultures, for example, caucasian and asian samples (nilsson, paul, lupini, & tatem, 1999; pietrabissa et al., 2020). as both germany and the uk are individualistic cultures which share common values (juslin, barradas, ovsiannikow, limmo, & thompson, 2016) we do not assume great cultural differences. however, future research should test this possible effect on the results. future studies should also examine the cpq-d in non-clinical and clinical populations in order to evalu­ ate whether the factor structure can be replicated and whether it is possible to explain more variance of the underlying construct than in the current study. additionally, they should use a wider variety of additional measures to test its validity. further, future research may wish to compare the cpq-d in its current version with a version that excludes items 8 and 12 due to their difficult properties. in summary, the cpq-d appears to be a valid and reliable measure to assess clinical perfectionism in a german speaking population. hence, it has the potential to be used as an efficient measure to assess the process of clinical perfectionism within the framework of process-based cbt (hofmann & hayes, 2019). funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s bernaards, c. a., & jennrich, r. i. 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(2016). ggplot2: elegant graphics for data analysis. new york, ny, usa: springer. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. the german version of the cpq 16 clinical psychology in europe 2021, vol. 3(2), article e3623 https://doi.org/10.32872/cpe.3623 https://cran.r-project.org/package=corpcor https://doi.org/10.1016/s0005-7967(01)00059-6 https://doi.org/10.1037/cou0000355 https://doi.org/10.1016/j.paid.2014.01.003 https://doi.org/10.1207/s15327957pspr1004_2 https://doi.org/10.5281/zenodo.1480624 https://doi.org/10.1037/0022-3514.54.6.1063 https://www.psychopen.eu/ the german version of the cpq (introduction) materials and methods sample measures procedure statistical analyses results participants factor structure and internal consistency construct validity discussion strengths and limitations conclusion (additional information) funding acknowledgments competing interests references qualitative approximations to causality: non-randomizable factors in clinical psychology scientific update and overview qualitative approximations to causality: nonrandomizable factors in clinical psychology michael höfler 1, sebastian trautmann 2, philipp kanske 1,3 [1] clinical psychology and behavioural neuroscience, institute of clinical psychology and psychotherapy, technische universität dresden, dresden, germany. [2] department of psychology, medical school, hamburg, germany. [3] max planck institute for human cognitive and brain sciences, leipzig, germany. clinical psychology in europe, 2021, vol. 3(2), article e3873, https://doi.org/10.32872/cpe.3873 received: 2020-06-14 • accepted: 2021-01-14 • published (vor): 2021-06-18 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: michael höfler, clinical psychology and behavioural neuroscience, institute of clinical psychology and psychotherapy, technische universität dresden, chemnitzer straße 46, 01187 dresden, germany. tel: +49 351 463 36921. e-mail: michael.hoefler@tu-dresden.de supplementary materials: materials [see index of supplementary materials] abstract background: causal quests in non-randomized studies are unavoidable just because research questions are beyond doubt causal (e.g., aetiology). large progress during the last decades has enriched the methodical toolbox. aims: summary papers mainly focus on quantitative and highly formal methods. with examples from clinical psychology, we show how qualitative approaches can inform on the necessity and feasibility of quantitative analysis and may yet sometimes approximate causal answers. results: qualitative use is hidden in some quantitative methods. for instance, it may yet suffice to know the direction of bias for a tentative causal conclusion. counterfactuals clarify what causal effects of changeable factors are, unravel what is required for a causal answer, but do not cover immutable causes like gender. directed acyclic graphs (dags) address causal effects in a broader sense, may give rise to quantitative estimation or indicate that this is premature. conclusion: no method is generally sufficient or necessary. any causal analysis must ground on qualification and should balance the harms of a false positive and a false negative conclusion in a specific context. keywords causality, causal considerations, counterfactuals, directed acyclic graphs this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3873&domain=pdf&date_stamp=2021-06-18 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • causal inference outside randomized, controlled experiments and trials is rare in clinical psychology, regardless of the rich methodology that has evolved in the last decades. • the attractiveness of these new formal tools distracts from their limits and expenditure, but considerable benefit is hidden in their qualitative use. • qualitative considerations may suffice to approximate causal answers. causal questions drive most scientific reasoning. this should entail plenty of causal analyses, but clinical psychology often avoids causality because the established gold standard, a randomized controlled experiment or trial (rct), is in many cases infeasible. although we cannot or should not manipulate variables such as gender, traumatic events, personality traits and other constructs, their effects on clinical outcomes must be investi­ gated to inform prevention, intervention, policies, theories and further research. t h e s p e c i f i c p r o b l e m o f c a u s a l i t y i n o b s e r v a t i o n a l s t u d i e s the methodological toolbox has been greatly expanded. it now offers approaches to causal answers in non-randomized studies (greenland, 2017). these new tools mainly address the specific problem of causality: without randomization, a binary factor x (group comparison, e.g., with and without a bipolar disorder diagnosis) and outcome y (e.g., amount of substance use) often have shared causes, z (e.g., parental mental health), that are out of experimental control and cause bias in an estimate of the average effect of x on y. in linear models and for just a single z, this bias is the product of the effect of z on x and y, meaning that it equals α1 * α2, where α1 denotes the effect of z on x, and α2 the effect of z on y (e.g., gelman & hill, 2007, chapter 9). this simple formula implies that a. bias occurs only if α1 ≠ 0 and α2 ≠ 0 b. the direction of bias just depends on the signs of α1 and α2. if they are equal, bias is upward, otherwise downward. c. bias is small if either is small these properties generalize to non-linear relations and any distributions of y and z and to multiple z that are independent or positively inter-related (groenwold, shofty, miočević, van smeden, & klugkist, 2018; pearl’s “adjustment formula” is the most general expression; pearl, 2009). we refer to the above as the basic confounding relation. experimental control and randomization together disconnect all confounders z from x and thus eliminate confounding bias. otherwise, x is just observed, and in life-sciences qualitative approximations to causality 2 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ like clinical psychology the number of natural causes of an x might be vast. the new methodical tools try to unravel the x-y relation in an imaginary world in which x (or y) was independent of z and thus simulate what changing (rather than observing) x would do with y (“do(x),” pearl, 2009). the new methods mimic what might be observed if x were changed, but unlike real-world change experiments where x is isolated, their use requires an explicit understanding of the relationships between variables z and x. likewise, during their elaboration it has been stressed that one must consider how an x is to be changed because this may make a large difference (greenland, 2005a). for example, just stopping drug use might even worsen an outcome if an intervention does not address factors like stress coping, a putative cause of drug use. in this sense, the new methods complement randomized experiments and rcts through the more explicit need to go beyond a single x, thus to move from “causal description” to “causal explanation” (johnson, russo, & schoonenboom, 2019). for other (non-specific) sources of bias like selection and measurement error that also effect the results of randomized studies, see the supplementary materials. instead of making use of the new methodological toolbox to approach causal answers in observational studies, clinical psychology was dominated by the “mantra” that “corre­ lation is not causation” (pearl & mackenzie, 2018, back of the book). for a historical account on how this stance has emerged through the statistical pioneer karl pearson, who had considered causality to equal perfect (deterministic) correlation, see pearl and mackenzie (2018). a i m o f t h i s p a p e r some papers have already introduced tools from the new methodical box in (clinical) psychology and summarized the meanwhile vast literature on them (dablander, 2020; marinescu, lawlor, & kording, 2018). however, these have mainly focussed on quanti­ tative approaches in a discipline where methodical causal thinking is new and, thus, requires qualitative guidance beforehand. one such instance is that psychology needs not only to overcome “retreating into the associational haven” (hernán, 2005), but also im­ munization against overconfidence (greenland, 2012) in novel methods. overconfidence mainly concerns the quantitative and highly formal methods, because the mathematical sophistication in these easily obstructs the sight for hidden assumptions and over-sim­ plification through translation into mathematics (greenland, 2012, 2017; vanderweele, 2016). costs of using these methods also include learning and conducting them (which is error-prone) and the further degrees of freedom in analysis through their use which promotes p-hacking. we argue that qualitative approaches as exemplified in this article are easier to access and invite more debate and refinement on them and should at least inform the decision of using a particular quantitative method. we focus on a few causal conceptions that we believe are most illustrative for causal quests: the above basic höfler, trautmann, & kanske 3 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ confounding relation (1), counterfactuals (2), popular qualitative considerations (3) and directed acyclic graphs (dags) (4). the following figure illustrates the scheme by which we describe how qualitative approaches may guide a causal quest. figure 1 scheme of qualitative approaches guiding causal quests note. these might be sufficient for overall causal answers, give rise to designing a new study and/or quantitative analysis, or suggest that such analysis is premature. the basic bias relation, counterfactuals and dags belong to the new toolbox of causal methods. q u a l i t a t i v e a p p r o a c h e s gender effects and the basic bias relation the effects of gender (biological sex) may play an important role for the development and maintenance of mental disorders. if they exist to considerable extent, they contribute to explaining the different aetiology of disorders that are more prevalent in females (e.g., internalizing disorders such as depression) and males (e.g., externalizing disorders such as substance use disorders). this is because gender may also affect many putative aetiological factors (e.g., response styles such as rumination; johnson & whisman, 2013; which, in turn, may influence the onset of disorders; emsley & dunn, 2012). qualitative approximations to causality 4 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ but is the causal wording “effect” warranted here? with the basic bias relation, we are equipped to ask: are there shared causes of gender and a disorder y? if it holds true that gender is largely random in the sense that it depends only on factors that do not also affect the disorder (scarpa, 2016, and references therein), then no confounding bias is expected. if such factors exist (e.g., environmental pollution; astolfi & zonta, 1999) but affect y only weakly, they may be neglected since the bias through them should be small. if bias from other sources is also negligible like selection and measurement, a causal conclusion seems informed. upward bias through confounders that affect x and y with the same sign in the presence of reliable associational results, the basic bias relation can be applied well beyond gender effects. if there is at most a weak association between an x and a y, and assuming that the common causes of x and y affect both positively or both negatively (and are unrelated or positively inter-related), bias should be upward. hence, the effect of x on y should be smaller than the association and, thus, be absolutely small (and probably negligible). for example, the relatively weak and often inconsistently reported association between anxiety and alcohol use might be explained by genetic and personality factors increasing the risk for both (schmidt, buckner, & keough, 2007). such risk increasing may frequently apply: psychopathology in parents, genetic factors, stable personality traits, stressful life events and prior mental disorders are factors that might all affect disorders positively and be positively inter-related (uher & zwicker, 2017). however, with a larger number of shared factors, the probability rises that some have negative relations, but if these are few and unlikely to dominate bias (because their effects on x and y are not very large as compared to those of the other factors), a researcher may still use the consideration. counterfactuals and a defendable assumption on them the above gender example brings up an important limitation yet in the standard “coun­ terfactual” definition of a causal effect. biological sex cannot be entirely changed (beyond transsexual transformation) or imagined to be changed, but social aspects of gender can (glymour & glymour, 2014). imagining a person under an alternative x condition is called counterfactual and defines an effect as the amount of change in y if x is changed from one value to another (if this equals zero, there is no effect). consider the putative effect of childhood trauma (ct) on depression (de). yet the idea of counterfactuals points out that “the effect” is imprecise since there are actually two counterfactuals and associated effects: a) trauma experience in individuals who actually do not experience trauma and b) trauma recovery in those who actually had experienced a trauma (but do not recover). just referring to höfler, trautmann, & kanske 5 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ “the effect” denotes the total effect, which means that we imagine both changes at once (pearl, 2009). such a summary appears pointless in clinical psychology, at least if one aims to keep aetiology and persistence/maintenance apart which seems important since in many cases, different factors seem to be involved in the onset versus the persistence of mental disorders (mclaughlin et al., 2011). the effect of experiencing a ct is, in principle, subject to a prevention rct, but such studies would be highly ineffective. this is because ct prevention will never succeed among all individuals and is unethical if the control group is deliberately exposed to ct although exposure (and associated harm) could have been prevented. the effect of recovery from a trauma on the other hand; i.e., of successful intervention, can in principle be investigated in an rct, but only with regard to specific consequences of ct. this not only heavily depends on what is meant with “consequences” (e.g., distress, symptom onset, incidence of a diagnosis) and the mode of intervention, it is confounded with the aim of investigating the recovery effect (greenland, 2005a). at least for onset, “target trials” (here prevention trials) may be an effective further tool to clarify what a counterfactual specifically means (vanderweele, 2016). a target trial is an ideal trial (or experiment) the data of which would provide the desired causal answer. it clarifies qualitatively what we would require, what we cannot do, but what we can anyway imagine (lewis, 1973; pearl, 2013), including the target population to infer on. for a conclusion on the existence of either effect, crude estimates of counterfactual depression rates (generally mean outcomes) among those with and without ct, respec­ tively, are necessary. if we know empirically that, say, 5% of those without ct develop depression later in life, and we assume that the experience of ct in all the observed individuals would have increased this rate (i.e., the counterfactual rate is >5%; probably few clinical psychologists would doubt this), the conclusion that ct experience increases the risk for depression is valid. likewise if, say, 10% of those with ct have depression later on, we may conclude that an intervention decreases the rate provided that we are willing to assume that the intervention would achieve a rate below 10%. this line of qualitative argument determines the “target quantity” (petersen & van der laan, 2014) one wishes to estimate. it may also trigger other considerations like substituting unknown counterfactual depression rates from other, “analogous” (hill, 1965) studies. for trauma experience, a sample of children traumatized by war may be used and for recovery, a sample of traumatized, untreated but resilient children. granger causality imagining counterfactual states of brains in neuroscience and neuroimaging research seems meaningful, but in associated longitudinal studies there is a shortcut to the specif­ ic causal problem of common causes hidden in the term “granger causality” (friston, moran, & seth, 2013). originally, the term states that, given “all the information in the qualitative approximations to causality 6 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ universe up to time t” (eichler & didelez, 2010), and provided that the prediction of y at time t + 1 is worse if an x at any time up to t is disregarded, then this prior x is a cause of y (granger, 1969). although equivalent with the counterfactual definition, granger causality has been frequently mistaken as only referring to observed x variables (eichler, 2012; eichler & didelez, 2010) or even just a time-series of a single x (marinescu et al., 2018). this downgrades the conception into a heuristic for practical use with the easily wrong qualitative suggestion that adjustment for common causes has been sufficient. researchers who use it must be aware of the basic bias relation indicating that they play into their own hands if they ignore unobserved common causes that effect x and y with the same sign. these may include variables that have occurred before study onset. generally, collecting big data like thousands of voxels in a brain scan is no substitute for thoughtful reflections on the processes beyond the data that any defendable causal analysis relies on (pearl & mackenzie, 2018). in the supplementary materials we briefly discuss other popular and, mostly long­ used approaches: multimethod evidence, mixed methods research and ruling out alterna­ tives. directed acyclic graphs so far, we have only addressed direction of bias but not when and how bias can be removed. in the supplementary materials, we revisit the example of the effect of ct on de to outline the qualitative answers that the qualitative method of dags provides, including the subsequent study design and analysis that a particular dag model may give rise to. the example uses a model with four common causes and causal relations among them. it reveals that adjustment for them is possible in subsequent quantitative analysis (whereby one shared cause does not require adjustment). importantly, dags may include effects of unchangeable factors like “socio-econom­ ical family status” in the example where the counterfactual conception of an effect does not apply. the conception, however, may be extended to include other actors than humans who could change an x (bollen & pearl, 2013). sometimes such an actor is difficult to name let alone to translate into a mathematical model, wherefore instances like “socio-economical family status” are more suited “to describe something as a cause” than to “reasonably define a quantitative causal effect estimand” (vanderweele, 2016). qualitative assumptions may make quantitative approaches seem premature in contrary to the above instance, a dag might reveal that bias can not be fully elim­ inated, or leave open whether an adjustment decreases or increases bias (morgan & winship, 2014, chapter 3). the practical utility of dags for quantitative analysis rises with fewer variables in them and the number of causal relations that can be assumed höfler, trautmann, & kanske 7 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ not to exist (greenland, 2017). however, setting up a dag model should reveal this. per se, a dag renders all associated assumptions transparent and invites for debate and refinement on them (the reader might ask herself if this happens with the figure in the supplementary materials). anyway, controversy on a model might be so large that grounding a study and quantitative analysis on it appears unwarranted (petersen & van der laan, 2014). also, if the number of potential common causes is large and there is no way to prioritize them for reducing bias, quantitative analysis seems premature. instead, more research is required beforehand to set up a defendable dag. an example is the effect of inter­ nalizing symptoms on substance use where common causes may include a variety of genetic, parental, childhood, personality and environmental factors, as well as all sorts of individual variables related to neurobiological, cognitive and emotional processes (pasche, 2012). c o n c l u s i o n s no method can fully cover all aspects of causality across research fields and specific applications, especially in a life science as complex as clinical psychology (greenland, 2017), and “there is no universal method of scientific inference” (gigerenzer & marewski, 2014). likewise, a causal query can never be fully objective, because it always involves assumptions beyond the data (greenland, 2005b). in sharp contrast, researchers tend to “mechanizing scientists’ inferences” (gigerenzer & marewski, 2014) and downgrade methods from tools for thoughtful cooperation between methodologists and substantive experts (höfler, venz, trautmann, & miller, 2018) into empty rituals (gigerenzer, 2018). in this article, we have outlined some qualitative approaches through which one may approach a crude causal answer on an average effect, plan a quantitative analysis or unravel that any analysis is currently infeasible. in fact, any causal quest must start with qualification because otherwise it would be just a mechanical exercise. the qualitative conceptions outlined here are meant as provisory heuristics that must not be ritualized but should be taken as invitations for refinement and adjustment to any particular application. above all, the two possible errors in causal conclusions should guide causal quests and the decision on whether the use of a highly formal method pays off (greenland, 2012): false positive and false negative. statistical decision theory provides the frame­ work to formalize the balance between false positive and false negative causal conclu­ sions. it states that the better decision is the one with the lower expected costs (dawid, 2012). thoughtful causal quests are essential for explaining why phenomena occur the way they do and in providing levers through which things could be changed, for instance, in preventing disorders and improving life. assessing causality is complex, demanding and qualitative approximations to causality 8 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://www.psychopen.eu/ ambivalent, but so is science. however, it makes use of the natural capacity of causal modelling which is deeply grounded in us human beings and structures how we view the world (pearl & mackenzie, 2018). funding: the authors have no funding to report. acknowledgments: we wish to thank konrad lehmann for the layout of the figure. competing interests: the authors have declared that no competing interests exist. s u p p l e m e n t a r y m a t e r i a l s the supplement provides additions to the paper, namely other sources of bias than confounding, and futher popular approaches to causality besides those from the new toolbox and granger causality. besides, it addresses the example of the effect of childhood trauma (factor x = ct) on depression (outcome y = de) using a dag (directed acyclic graph) model on common causes and subsequent study design and data analysis the model gives rise to (for access see index of supplementary materials below). index of supplementary materials höfler, m., trautmann, s., & kanske, p. 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(2017). etiology in psychiatry: embracing the reality of poly-geneenvironmental causation of mental illness. world psychiatry, 16(2), 121-129. https://doi.org/10.1002/wps.20436 höfler, trautmann, & kanske 11 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://doi.org/10.1186/s12874-018-0490-1 https://doi.org/10.1016/j.paid.2013.03.019 https://doi.org/10.1177/1558689817719610 https://doi.org/10.1038/s41562-018-0466-5 https://doi.org/10.1016/j.socscimed.2011.06.011 https://doi.org/10.1007/s11920-012-0264-0 https://doi.org/10.1111/cogs.12065 https://doi.org/10.1097/ede.0000000000000078 https://doi.org/10.3389/fpubh.2016.00102 https://doi.org/10.1177/0145445506297019 https://doi.org/10.1002/wps.20436 https://www.psychopen.eu/ vanderweele, t. j. (2016). commentary: on causes, causal inference, and potential outcomes. international journal of epidemiology, 45(6), 1809-1816. https://doi.org/10.1093/ije/dyw230 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. qualitative approximations to causality 12 clinical psychology in europe 2021, vol. 3(2), article e3873 https://doi.org/10.32872/cpe.3873 https://doi.org/10.1093/ije/dyw230 https://www.psychopen.eu/ qualitative approximations to causality (introduction) the specific problem of causality in observational studies aim of this paper qualitative approaches gender effects and the basic bias relation upward bias through confounders that affect x and y with the same sign counterfactuals and a defendable assumption on them granger causality directed acyclic graphs qualitative assumptions may make quantitative approaches seem premature conclusions (additional information) funding acknowledgments competing interests supplementary materials references the influence of alcohol on rumination and metacognitions in major depressive disorder research articles the influence of alcohol on rumination and metacognitions in major depressive disorder lana gawron 1 , anna pohl 1 , alexander l. gerlach 1 [1] institute of clinical psychology and psychotherapy, university of cologne, cologne, germany. clinical psychology in europe, 2022, vol. 4(4), article e5615, https://doi.org/10.32872/cpe.5615 received: 2021-01-30 • accepted: 2022-09-16 • published (vor): 2022-12-22 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: lana gawron, institute of clinical psychology and psychotherapy, pohligstraße 1, 50969 cologne, germany. e-mail: lana.gawron@uni-koeln.de supplementary materials: materials [see index of supplementary materials] abstract background and objectives: comorbidity between major depressive disorder (mdd) and alcohol use disorder (aud) is highly prevalent but reasons for this association are unclear. rumination may activate metacognitive beliefs that contribute to the development and maintenance of rumination and depression. negative metacognitions can further lead to other dysfunctional coping strategies (i.e., consumption of alcohol). we examined whether alcohol reduces (state) metacognitions, rumination and other disorder-specific processes in a group of individuals suffering from mdd. method: in an experiment with three randomized conditions we investigated whether the consumption of alcohol, placebo or no alcohol (orange juice) affects (meta-)cognitions, depressive symptoms and / or psychophysiological variables while participants ruminate. results: voluntary rumination increased self-reported sadness, tension and rumination, tensed facial muscles and increased heart rate, but did not affect (state) metacognitions and heart rate variability. the consumption of alcohol did not influence rumination, metacognitions, depressive or psychophysiological measures. limitations: we recruited a depressed population but excluded pathological alcohol use due to ethical considerations. conclusions: we found no evidence that alcohol consumption affects rumination, metacognitions and other disorder-specific processes in mdd. however, rumination had a negative effect on various depression-specific processes, although it did not activate (negative state) metacognitions. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5615&domain=pdf&date_stamp=2022-12-22 https://orcid.org/0000-0003-2664-5280 https://orcid.org/0000-0002-3761-5768 https://orcid.org/0000-0001-6794-5349 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords major depressive disorder, rumination, metacognitions, alcohol consumption, self-medication, alcohol use disorder highlights • the effect of alcohol on (meta-)cognitions, emotions, and psychophysiology was investigated with alcohol, placebo and a control group in mdd. • no group differences were found both before and after alcohol consumption. • induced rumination did not activate (state) metacognitions, but affected various depression-specific processes. • future studies could activate metacognitions by providing false feedback about the controllability of such processes. rumination, the repetitive negative thinking about past events, possible causes and consequences of negative emotions (nolen-hoeksema, 1991), contributes to the develop­ ment (e.g., huffziger et al., 2009) as well as maintenance and severity of depressive episodes (e.g., nolen-hoeksema et al., 2008). moreover, rumination has negative effects on somatic health, as illustrated by a number of psychophysiological changes such as decreased heart rate variability (hrv; e.g., ottaviani et al., 2015), increased heart rates (hr; ottaviani et al., 2016) and changes in muscular tension, e.g., in the corrugator emg (teasdale & rezin, 1978). according to the metacognitive model of rumination and depression (mcm), rumina­ tion is maintained by metacognitions reflecting on this type of perseverative thinking (papageorgiou & wells, 2003). negative thoughts or other triggers initially activate positive metacognitive beliefs about the usefulness of rumination (e.g., “in order to understand my feelings of depression, i need to ruminate about my problems.”), and mo­ tivate further rumination. however, rumination prevents effective problem solving and intensifies negative affect. as a result, negative metacognitive beliefs emerge regarding the uncontrollability and harmfulness of rumination and its social consequences (e.g., “i cannot stop myself from ruminating.”; “people will reject me if i ruminate.”), thereby in­ creasing the accessibility of negative and threatening information (e.g., negative thoughts or emotions), and thus exacerbating and maintaining depressive symptoms as well as promoting further rumination (papageorgiou & wells, 2004). both, clinical (e.g., papageorgiou & wells, 2003) and nonclinical studies (e.g., solem et al., 2016) have shown that metacognitive beliefs about rumination are significant for the onset (faissner et al., 2018; papageorgiou & wells, 2009) and maintenance (e.g., solem et al., 2016) of depressive states / depression. negative metacognitions may also promote the use of dysfunctional behavioral strat­ egies, such as the use of alcohol, to control or avoid recurrent negative thoughts. in the long term, however, these strategies may maintain negative metacognitions (cf. meta­ the influence of alcohol on cognitions in mdd 2 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ cognitive model of generalized anxiety disorder; wells, 2005; wells, 2011). although the mcm of generalized anxiety disorder focuses on worry and meta-worry, we assume that the assumptions regarding the use of other coping strategies can also be applied to the mcm for depression and rumination. thus, we take a step beyond the original model by postulating that alcohol use functions as a cross-model coping strategy that can reduce rumination (see, e.g., mollaahmetoglu et al., 2021) and possibly negative metacognitions (in the short term), making these thoughts and processes seem less uncontrollable and threatening. according to the appraisal disruption model, alcohol can disrupt the appraisal of threatening information (i.e., cognitions; sayette, 1993). more specifically, alcohol may interfere with the initial perception of stressful information by preventing negative memories and associated stressful concepts from being activated. moreover, cognitive abstraction capacity is supposed to be reduced by alcohol (sayette, 1993), which may also impede perseverative thinking and related metacognitions. finally, when intoxication precedes a stressor, it can buffer the stress by attenuating appraisal, thereby protecting the person drinking from fully experiencing the stressor (sayette, 2017). applied to the context here, negative thoughts and processes promoted by metacognitions can also be defined as a type of threatening information whose appraisal can be attenuated by alcohol consumption. furthermore, intoxication could prevent concepts associated with negative metacognitions, such as ruminative thoughts, from being activated, possibly leading to relief in terms of less threatening rumination or generally less aversive emo­ tional states. since this dysfunctional coping strategy is only helpful in the short term, alcohol may be consumed repeatedly in order to feel a facilitating effect (negative rein­ forcement). this could then lead to the development of a problematic drinking pattern or an alcohol use disorder (aud). empirical evidence suggests that these negative metacognitions are in particular associated with problematic alcohol use (e.g., spada et al., 2007). the higher the levels of maladaptive metacognitions are, the more likely alcohol is consumed in response to unpleasant aversive states (moneta, 2011). in line with this, rumination is associated with alcohol consumption (e.g., devynck et al., 2019) and with increased alcohol-related problems (e.g., willem et al., 2011). in a group of individuals with risky consumption, the direct effects of alcohol on rumination and mood were examined and it was found that alcohol reduced rumination directly and also indirectly by changing mood (mollaahmetoglu et al., 2021). apart from the study of mollaahmetoglu et al. (2021), most empirical evidence for the association of rumination, depressed mood and alcohol use (disorder) is correlative (e.g., heggeness et al., 2019). moreover, these relationships have mostly been examined in analogue samples (e.g., bravo et al., 2018), and metacognitions have been assessed as a trait variable (e.g., faissner et al., 2018; papageorgiou & wells, 2009). however, it has been argued that mimicking typical problematic situations may also provoke the gawron, pohl, & gerlach 3 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ presence of state-dependent metacognitive beliefs about perseverative cognitions as well as their consequences, especially in clinical populations (andor et al., 2008). consistent with this, negative metacognitions following worrying, so negative state metacognitions, were more pronounced in patients with generalized anxiety disorder compared with control participants when they received feedback that indicated arousal while being asked to relax (andor et al., 2008). in light of previous findings, we believe it is important to examine the direct effects of alcohol consumption on perseverative cognitions, such as rumination, and negative state metacognitions in an experimental setting: indeed, if it is shown that people with depression can alter cognitive processes with the help of alcohol, this could provide a significant clue to the mechanisms underlying the high comorbidity of major depressive disorder (mdd) and aud (e.g., brière et al., 2014), with, for example, odds ratios between 2.0 (kessler et al., 1997) and 3.8 (grant & harford, 1995). namely, depression-related cognitive / ruminative and metacognitive processes that appear uncontrollable and threatening may erroneously appear controllable and less threatening after alcohol consumption, which may be relieving in the short term, thus promoting further consumption and the development of aud. to our knowledge, no study has yet examined the direct effects of alcohol on neg­ ative (meta)cognitions and depression in a clinically depressed sample. our aim was therefore to examine these effects on rumination and metacognition in mdd. we specif­ ically focused on (negative) state metacognitions (cf. andor et al., 2008). the negative appraisal of these state metacognitions may be interrupted by alcohol consumption and consequently appear less threatening (cf. sayette, 1993). for a holistic understanding of the effects of alcohol on disorder-specific processes, we also wanted to investigate the influence of alcohol on emotional states and psychophysiology (heart rate, heart rate variability, muscle tension). according to some studies, alcohol can lead to an increase in heart rate (weise et al., 1986), a reduction in hrv (koskinen et al., 1994), and a decrease in muscle tension (stockwell et al., 1982). our hypotheses were as follows: given that rumination has an unfavorable impact on negative affect and psychophysiology (see, e.g., ottaviani et al., 2016), we hypothesized that (h1) induced rumination has a negative effect on sadness, tension, and on the extent of rumination itself, as well as on psychophysiological processes. we also hypothesized that (h2) alcohol consumption reduces rumination, (h3) alcohol consumption reduces negative state metacognitions about rumination that, according to the mcm of rumi­ nation and depression, should be triggered by induced rumination, and (h4) alcohol consumption reduces negative emotions such as sadness and experienced muscle tension intensified by rumination. finally, in addition to rumination, alcohol consumption may also affect psychophysiology, although the direction of the effect in mdd is still unclear. we assumed an increase in hr and a decrease in hrv and muscle tension in individuals with depression (h5). the influence of alcohol on cognitions in mdd 4 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ m e t h o d recruitment participants were recruited online (e.g., via facebook), with publicly distributed leaflets, posters and at the outpatient treatment center for psychotherapy. all participants re­ ceived a compensation of 8.50 euros per hour and were offered counselling. exclusion criteria were current or past substance use disorder or aud, complete abstinence of alcohol, gad, current use of psychoactive medication, liver damage, current or past psy­ chotic episodes, and pregnancy. gad was excluded to ensure that the main problem with repetitive negative content was rumination and not worrying. all participants signed an informed consent. the ethics committee of the german psychological association approved this study (ss 042017). participants sixty-five participants (46 women) diagnosed with current mdd using a structured clinical interview (see procedure) completed the study. thirty-nine participants (40.5%) were diagnosed with additional comorbid disorders. twenty-seven suffered from anxiety disorders (41.5%), ten from posttraumatic stress disorder (15.4%), three from obsessive compulsive disorder (4.6%), three from an eating disorder (4.6%), and five from somat­ ic symptom disorders (7.7%). sociodemographic data is presented in table 1. further characteristics can be found in table a1 (supplementary materials). power analyses according to g*power 3 (faul et al., 2007) indicated a required sample size of at least 54 participants, expecting a medium effect size f = .25 for the analysis of a repeated measures anova (within-between interaction) at an alpha level of .05 and 95% power (cf. andor et al., 2008; stevens et al., 2017). procedure participants were telephone screened and then received information about the experi­ ment. they had to agree to participate in the study irrespective of whether they would receive alcohol or not. participants with depressive symptoms were invited for a 2 h diagnostic session using the german version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, 4th version (scid-i; wittchen et al., 1997). a trained clinical psychologist conducted the interviews. participants with mdd then completed several questionnaires (see baseline questionnaires) and were invi­ ted for a laboratory session. at this point, participants were fully randomized to three conditions (see drinking procedure). at the beginning of the laboratory session, electro­ des for physiological measurement were attached and participants estimated their blood alcohol level (bal). then the bal was measured. a three-minute resting period (first baseline) and an additional three-minute task (schandry, 1981) followed, which will not gawron, pohl, & gerlach 5 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ be reported here. then, a drinking phase of 15 minutes drinking and a five-minute break allowing for absorption of the alcohol followed. participants again estimated their bal and it was also measured. after a second three-minute resting period (second baseline), participants estimated their level of rumination, sadness and tension, and completed the state metacognitions questionnaire (mcq-state; andor et al., 2008). the rumination induction procedure (a variant of the worry induction procedure; borkovec & inz, 1990) followed. participants were asked to write down three topics they regularly ruminated about and were to choose the currently most troubling one. they were then instructed to ruminate about this topic “like they normally did”. after ruminating for three minutes (rumination episode), participants reported their rumination, sadness and tension again table 1 demographic data of all participants separated by group variable ac (n = 22) pc (n = 22) oc (n = 21) mean age (sd) 33.6 (11.5) 30.2 (11.8) 30.7 (12.9) sex, n (%) women 15 (68.2) 16 (72.7) 15 (71.4) men 7 (31.8) 6 (27.3) 6 (28.6) education, n (%) o level 4 (18.2) 16 (72.7) 1 (4.8) specialized a level 1 (4.5) 3 (13.6) 6 (23.8) a level 15 (68.2) 3 (13.6) 15 (71.4) still attending school 2 (9.1) – – family status, n (%) unmarried 17 (77.3) 20 (90.9) 17 (81.0) married – living together 1 (4.5) 1 (4.5) 3 (14.3) divorced 3 (13.6) 1 (4.5) – registered civil partners – – 1 (4.8) widowed 1 (4.5) – – treatment, n (%) current outpatient treatment 4 (18.2) 2 (9.1) 4 (19.0) past outpatient treatment 16 (72.7) 15 (68.2) 12 (57.1) past psychiatric inpatient treatment 7 (31.8) 7 (31.8) 5 (23.9) past antidepressant medication 5 (22.6) 7 (31.8) 8 (38.1) note. ac = alcohol condition; pc = placebo condition; oc = control / orange juice condition. o level = ordinary level high school certificate; a level = advanced level high school certificate. the groups did not differ significantly. the influence of alcohol on cognitions in mdd 6 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ and completed the mcq-state. they were instructed to ruminate for another minute and then asked to relax for three minutes (relaxation episode). following the relaxation, participants completed the self-reports and mcq-state a third time as well as the wbsi, tcq-r and cas-i (see questionnaires used during the experiment). in the end, they estimated their bal and the bal was measured one last time. after the experiment, participants were debriefed. the procedure is visualized in figure 1. figure 1 procedure note. timing and overview of the two sessions. the blood alcohol level (bal) was measured at the beginning, after the phase of drinking and at the end of the experiment. self-reports (sr) and mcq-state were assessed at three time points: before rumination, after rumination and after relaxation. an overview of all baseline questionnaires and all questionnaires used during the experiment can be found in section measurements. ac = alcohol condition (n = 22); pc = placebo condition (n = 22); oc = control condition / orange juice (n = 21). bals = participants' estimated bal before each measurement of bal; bal-m = measured breath alcohol level. sr = self-reports, i.e., estimated levels of sadness, rumination, and tension. mcq-state = two subscales of the metacognitions questionnaire, german version. hr = heart rate; hrv = heart rate variability; emg = facial electromyography. gawron, pohl, & gerlach 7 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ drinking procedure all participants were asked to eat a light meal, specified in a handout, four hours prior to the experiment and to forego food and drinks containing caffeine from then on. they were requested to abstain from alcohol 24 hours prior to the experiment. participants in the control condition (oc) were told that they would receive orange juice. participants in the alcohol (ac) and placebo condition (pc) were both given the information that they would receive alcohol and that they would have to be picked up or wait until their bal decreased below 0.3 ‰. all participants were tested at 4:00 pm. female participants in the ac or pc were pregnancy tested. none of the participants tested positive. finally, height and weight were measured. participants in the ac consumed a drink of 1:2 vodka and orange juice. following a modified version of the widmark formula, participant’s sex, weight, height and age was used to estimate the necessary amount of alcohol to reach a blood alcohol level of about 0.6 ‰ (gerlach et al., 2006). the nonalcoholic beverage in the oc and pc was orange juice in comparable drinking quantity. in the pc, immediately before serving the beverages, a few milliliters of vodka were dropped on the orange juice and applied along the rims using a pipette (stevens et al., 2014). participants received three glasses with equal amounts of chilled beverage, each to be finished within five minutes. after drinking, participants waited five minutes. breath alcohol concentration was assessed by breathalyzer with an accuracy of +/ 0.03 mg/l (dräger, alcotest, 7410 plus). in the pc, the first measurement used a standard breathalyzer to ensure a bal of zero. then, a rigged breathalyzer with identical built was used giving a false feedback of 0.6 ‰ and then 0.7 ‰ bal. measurements baseline questionnaires alcohol use disorder identification test (audit) — the audit (dybek et al., 2006) is a brief screening scale developed by the world health organization (who) for early detection of problematic drinking. the original as well as the german version includes 10 questions regarding alcohol consumption, dependency symptoms and alcohol related problems. for each question, one of five statements related to alcohol use in the past year can be selected on a 5-point likert-type scale ranging from 0 (“never”) to 4 (e.g., “daily or almost daily”). cronbach’s α = .76. simplified beck depression inventory (bdi-s) — the bdi-s (schmitt et al., 2003) assesses current depressive symptoms with 20 items on a 6-point likert-type scale ranging from 0 (“never”) to 5 (“almost always”), for example, “i feel sad.”. cronbach’s α = .87. the influence of alcohol on cognitions in mdd 8 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ metacognitions questionnaire 30 (mcq-30) — the german version of the mcq-30 (arndt et al., 2011; a shortened version of the original metacognitions questionnaire; cartwright-hatton & wells, 1997) is used to assess thoughts and beliefs (metacognitions) about worry. the questionnaire consists of five subscales (positive worry beliefs, beliefs about uncontrollability and danger, metacognitive efficiency, general negative beliefs, cognitive self-consciousness) assessed by 30 items (e.g., “not being able to control my thoughts is a sign of weakness.”). items/statements can be rated on 5-point likert-type scales ranging from 1 (“not agree”) to 4 (“agree very much”). cronbach’s α = .84. penn state worry questionnaire (pswq) — the german version of the pswq (stöber, 1995) is a 16-item questionnaire assessing intensity, excessiveness and uncon­ trollability of worry (e.g., “i worry all the time.”) on a 5-point likert-type scale ranging from 1 (“not at all typical of me”) to 5 (“very typical of me”). cronbach’s α = .89. response styles questionnaire (rsq) — the german version of the rsq (kühner & weber, 1999) assesses people’s cognitive and behavioral strategies to cope with depressed mood with 32 items on 4-point likert-type scales ranging from 1 (“almost never”) to 4 (“almost always”). the rsq consists of the subscales rumination with 21 items (e.g., “when i am sad, i think about how sad i feel.”) and distraction with 11 items (e.g., “when i am sad, i go to my favorite place to get my mind off my feelings.”). cronbach’s α = .69. questionnaires used during the experiment assessment of state metacognitions (mcq-state) — since state-dependent changes in metacognitions can be assessed using the mcq (cf. andor et al., 2008), two subscales of the mcq-30 (beliefs about uncontrollability and danger, general negative beliefs) were adapted to the experiential situation. an example is “my ruminating could make me go mad.”. cronbach’s α = .97. rumination score (rs) — the levels of sadness, tension and rumination were assessed on one rating scale each, ranging from zero (“absolutely not”) to 100 (“extremely so”) and then averaged. cronbach’s α = .83. white bear suppression inventory (wbsi) — the german version of the wbsi (fehm et al., 2000) measures thought suppression with 15 items (e.g., “there are things i prefer not to think about.”) on a 5-point likert-type scale ranging from 1 (“strongly disagree”) to 5 (“strongly agree”). cronbach’s α = .85. thought control questionnaire (tcq) — the german version of the tcq (fehm & hoyer, 2004) is a 30-item self-report measure assessing rumination, intrusive and unwanted thoughts. items can be rated on 4-point likert-type scales ranging from 1 (“never”) to 4 (“almost always”). cronbach’s α = .67. gawron, pohl, & gerlach 9 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ cognitive attentional syndrome-inventory (cas-i) — the german version of the cas-i (wells, 2011) assesses maladaptive coping strategies (e.g., worrying, avoidance, use of alcohol/drugs) for dealing with negative thoughts, and negative and positive metacog­ nitive beliefs. in total, the cas-i consists of four questions. the first three questions are answered using a scale from 0 (“not at all”) to 8 (“all the time”) and refer to how much dealing with problems or worries about problems was done in the past week and how it was dealt with. the fourth question refers to positive and negative metacognitions, answered using a scale from 0 (“i do not believe in this belief at all.”) to 100 (“i am absolutely convinced that this belief is true.”). cronbach’s α = .75. psychophysiological data recording, sampling and analysis psychophysiological data (heart rate, respiration and facial muscle tension) were recor­ ded using the varioport (becker meditec, karlsruhe, germany). ecg was recorded at 512 hz sample rate from three electrodes. the active electrodes were placed on the lowest left rib and on the right collarbone. ground was affixed to the left collarbone. respiration was assessed with a respiratory belt (128 hz sample rate). facial electromyography (emg) was recorded in mv at 256 hz sample rate over the corrugator supercilii on the left side of the face with two electrodes (tiga-med, germany ltd.). the emg signal was preprocessed using an infinite impulse response high pass filter at 10 hz. it was notch filtered at 50 hz with a width of 3 hz and rectified and smoothed using a two-step low pass filter with eight point moving average. for hrv, the root mean square successive differences (rmssd) was calculated (cf. task force of the european society of cardiology and the north american society of pacing and electrophysiology, 1996; bertsch et al., 2012). mean values were computed for each experimental 3-minute episode (baseline 2, rumination, relaxation). data analysis group differences concerning sociodemographic characteristics and self-reported bal were tested using an anova1 and bonferroni-corrected post-hoc tests. group differ­ ences concerning psychopathological variables (questionnaires) were analyzed using a manova. a pearson correlation was performed between problematic alcohol consump­ tion (audit) and the level of alcohol as a coping strategy (cas-i). to test our hy­ potheses, we conducted several repeated measures anovas2 with bonferroni-corrected post-hoc tests. each anova was analyzed by group (alcohol, placebo, orange juice). 1) initial exploratory analyses revealed a few outliers. however, there was no relevant change in the pattern of results when including vs. excluding outliers. thus, results from the complete data set are reported. deviations from the original data set are indicated in the data analysis (e.g., mcq-state ratings). 2) the assumption of normality (anova) or the equality of variances (repeated measures anovas) was not met. since the f-test is relatively robust for violation of assumption (finch, 2005; tabachnick & fidell, 2007), the anova the influence of alcohol on cognitions in mdd 10 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ to test h1 (rumination increases sadness, tension, rumination, and worsens psycho­ physiology) the measurement time points of all variables from “second baseline” to “rumination” were examined. h2 (alcohol reduces rumination) and h4 (alcohol reduces sadness and tension intensified by rumination) were tested in one model: for this, rs over time were analyzed. to test h3 (alcohol reduces negative state metacognitions), metacognitions ratings (mcq-state) were analyzed. to test h5 (alcohol influences psy­ chophysiology), emg, hr and hrv over time were analyzed. in case sphericity was violated, the greenhouse–geisser adjustment was used. r e s u l t s manipulation check coping strategies the correlation of audit and cas-i was significant (r = .46, p < .001). the most frequently used coping strategy was “to control emotions” (m = 6.0, sd = 2.0), followed by “the attempt not to think about anything” (m = 5.2, sd = 2.2), “to avoid situations” (m = 2.8, sd = 2.5), “to control symptoms” (m = 4.2, sd = 2.2), “to seek reassurance” (m = 3.5, sd = 2.3). the least used strategy was “to consume alcohol or drugs” (m = 2.5, sd = 2.0). self-reported alcohol level and measured blood alcohol level compared to baseline, in both ac and pc self-estimated alcohol levels (in ‰) were higher after drinking (mac = 0.6, sd = 0.2, mpc = 0.2, sd = 0.1) and after finishing the experiment (mac = 0.7, sd = 0.2, mpc = 0.4, sd = 0.2). the manipulation in the pc can be considered successful: 20 of 22 participants believed that they had been given alcohol. two subjects (pcs) were excluded because their self-estimated bal was 0.0 ‰ at all measurement points and then assigned to the control condition for subsequent analyses. in the ac, the measured bal was 0.8 ‰ (sd = 0.2) after the drinking period and 0.7 ‰ (sd = 0.2) at the end of the experiment (see figure 2). and the repeated measures anovas were nevertheless conducted and results reported. because the number of subjects varied across the variables, no repeated measures manova could be calculated for the self-reports or for the biodata. instead, several repeated measures anovas were conducted with bonferroni-corrected post-hoc tests. gawron, pohl, & gerlach 11 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ figure 2 blood alcohol level note. measured and estimated bal. data points represent values before and after the drinking procedure and at the end of the experiment; error bars depict 95% ci. ac = alcohol condition (n = 22); pc = placebo condition (n = 20). bal = measured breath alcohol level in ac; bal-self = participants' estimated bal before each measurement of bal. control condition is not included. rumination induction procedure (h1, h5) self-report: an initial univariate anova revealed no significant group differences in the self-reports (f(2, 62) = .86, p = .427) and mcq-state-ratings3 (f(2, 42) = .26, p = .772) before rumination induction. after rumination, rs were significantly higher (see table 2 and figure 3), whereas mcq-state-ratings did not change (see table 2). psychophysiological measures: an initial univariate anova4 revealed no significant group differences in hr (f(2, 61) = .37, p = .690), hrv (f(2, 61) = 1.46, p = .240) or emg (f(2, 58) = .36, p = .702) before rumination. hr and emg increased significantly with rumination. regarding hrv, there was no significant change in rmssd during rumination or relaxation (see table 2 and figures 4, 5). 3) since the first measuring time of the mcq-ratings was subsequently integrated into the experiment, the repeated measures anova was conducted with only n = 45. 4) regarding emg, three subjects (pc) were excluded from further analyses because they were identified as outliers in at least four of five relevant time intervals. another subject was excluded because the recording of biodata failed. see table a3 (supplementary materials) for an overview of all participants per condition. the influence of alcohol on cognitions in mdd 12 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ figure 3 results over time separated by group: a) rumination score note. data points represent the mean values before, after the rumination induction and after relaxation; error bars depict 95% ci. estimates of depression (sadness, rumination, tension) were rated on a scale from 0 to 100. figure 4 results over time separated by group: b) heart rate note. data points represent the mean values of three time intervals: during second baseline, rumination and relaxation; error bars depict 95% ci. gawron, pohl, & gerlach 13 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ figure 5 results over time separated by group: c) emg note. data points represent the mean values of three time intervals: during second baseline, rumination and relaxation; error bars depict 95% ci. repeated measures anovas (h2-h5) anovas revealed a significant main effect of time for rs (f(1.52, 94.38) = 16.45, p < .001, ηp = .21), hr (f(2, 122) = 14.12, p < .001, ηp = .19), and emg (f(2, 116) = 5.41, p = .006, ηp = .09). from “second baseline” (t1) to “rumination episode” (t2) there was a significant increase in rs, hr and emg. from t2 to “relaxation” (t3) there was a significant decrease in rs (see figure 3). from t2 to t3 there was no significant change in hr and emg (see figures 4, 5). no significant effect for group and no interaction effect for time × group was found in any variable (see table 2 and a2, supplementary materials, for all significant and nonsignificant effects, table a3, supplementary materials for mean values). the influence of alcohol on cognitions in mdd 14 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ table 2 repeated measures anovas results effects / measures f df p ηp2 time rs 16.45 1.52, 94.38 < .001 .21 mcq-state .32 2, 84 ns .01 hr 14.12 2, 122 < .001 .19 hrv 1.57 1.50, 91.26 ns .03 emg 5.41 2, 116 .006 .09 group rs .57 2, 62 ns .02 mcq-state .31 2, 42 ns .02 hr .32 2, 61 ns .01 hrv 1.08 2, 61 ns .03 emg .74 2, 58 ns .03 time × group rs .38 3.05, 94.38 ns .01 mcq-state .15 4, 84 ns .01 hr .56 4, 122 ns .02 hrv 1.69 2.99, 91.26 ns .05 emg .37 4, 116 ns .01 note. rs = rumination score; mcq-state = state version of the metacognitions questionnaire; hr = heart rate, beats per minute (bpm); hrv = heart rate variability, rmssd; emg = facial electromyography, absolute emg values (uv). ns = nonsignificant. d i s c u s s i o n we directly studied if alcohol affects disorder-specific processes in individuals suffering from mdd. in particular, we wanted to understand whether and how alcohol affects rumination and state metacognitions about rumination. in addition, we were interested in determining the extent to which rumination negatively affects other disorder-specific processes, such as intensifying sadness, and in terms of the mcm, is associated with negative metacognitions. the rumination induction was successful: self-reported levels for rumination, tension, and sadness increased, as did hr and muscle tension. however, hrv and state metacog­ nitions did not change. we were able to successfully establish a placebo condition (i.e., induce the belief of having consumed alcohol) in almost all participants. in addition, participants who reported higher alcohol consumption were more likely to report using alcohol for coping. yet, alcohol use was the least reported coping strategy for aversive states in our sample. gawron, pohl, & gerlach 15 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ in contrast to our first hypothesis, we did not find an increase in negative state metacognitions after rumination. it is possible that the type and implementation of the rumination induction procedure influenced our result. the procedure was originally developed for the induction of worry (borkovec & inz, 1990). given, however, that worry and rumination are often transdiagnostically conceptualized as two forms of perseverative negative cognitions (e.g., mcevoy et al., 2013), the procedure for inducing rumination should have been sufficient to induce metacognitions about rumination, just as inducing worry was sufficient to induce metacognitions about worry (andor et al., 2008). yet, andor and colleagues (2008) studied individuals with generalized anxiety disorder whose negative (trait) metacognitions are more pronounced than in individuals with mdd (sun et al., 2017). participants in the andor study received false arousal feedback during the relaxation phase, making it more likely to experience worry and relaxation as uncontrollable. in other words, it was directly suggested to the participants in this study that their condition was not controllable. it is likely that both the type of disorder and the type of manipulation influenced the intensification of metacognitions. one approach for future studies might be to examine both state and trait metacognitions in relation to rumination and depressive symptomatology and to directly induce a sense of uncontrollability to participants. however, another consideration against the background of the mcm is conceivable. in the andor study as well as in our experiment, negative metacognitions were measured via two subscales of the mcq-30. these scales assess the uncontrollability and danger of worry (reworded to rumination in our study), but not negative metacognitions with regard to social consequences of rumination, which, in terms of the mcm, are also typical for the perpetuation of depression. after successful induction, we did not find more pronounced metacognitions in terms of uncontrollability and danger, but we might have found changes in terms of metacognitions related to the social consequences of rumination. one way to measure both types of negative metacognitive beliefs about rumination would have been to include the negative beliefs about rumination scale (nbrs; papageorgiou & wells, 2001) in our experiment. in this way, we would have been even closer to the original model and the respective measurement methods (cf. papageorgiou & wells, 2003). also, it is possible that negative metacognitions do not need to be reinforced in certain situations to have a negative effect on perseverative thinking. it may be suffi­ cient that these assumptions exist in the first place to maintain depressive states (e.g., papageorgiou & wells, 2009). if negative (state) metacognitions cannot be intensified even with the use of other experimental procedures, we nonetheless consider it advisable to reassess the long-term effects of negative metacognitions on the development of depression in a vulnerable group of participants. this would allow to further investigate the extent to which negative metacognitions are causal in the development and mainte­ nance of depression. the influence of alcohol on cognitions in mdd 16 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ contrary to our hypotheses (h2-h5), we could neither show that alcohol consump­ tion reduced experienced rumination, sadness, or muscle tension, nor that it reduced state metacognitions about rumination. the three groups did not differ regarding their rs nor in their ratings of metacognitions. there were also no differences between groups in terms of psychophysiological data. alcohol did not change the negative effect of rumination on psychophysiological variables, nor did it increase physiological reactivity. thus, surprisingly, we did not find evidence of alcohol effects on any process potentially relevant for the formation and maintenance of depression. conger (1956) suggested that alcohol may be used because it reduces muscular ten­ sion. however, alcohol did not reduce muscle tension nor change other measures of arousal. whereas conger’s notion can be found in many textbooks, the pharmacological (stress-reducing) effects of alcohol have only rarely been illustrated. according to a review of studies in social anxiety, for example, alcohol expectancy effects were more likely to be responsible for a reduction of aversive states such as anxiety than alcohol’s pharmacological properties (battista et al., 2010). thus, people who consume alcohol and expect a stress and tension-relieving effect, may experience such an effect regardless of pharmacological effects. such positive alcohol expectancies should have been evident in both the ac and pc in comparison to the oc. yet, in both self-reports and emg the numerically highest values (indicating distress) were found in the pc. since conger's hypothesis refers mainly to anxiety-provoking situations, it should be noted that these assumptions may not apply in situations where other emotions, such as depression or sadness, are prominent. or possibly, individuals might assume that alcohol is a helpful strategy, but notice when drinking that the strategy proves unsuccessful. significant positive correlations have previously been found between metacognitions and alcohol consumption as well as between anxiety, depression and alcohol consump­ tion (spada et al., 2007). the consumption of alcohol can therefore be regarded as a conscious strategy for dealing with aversive states (quitkin et al., 1972). in the ac, however, alcohol consumption did not result in feeling less emotionally distressed than in the other two groups. thus, we found no evidence that alcohol consumption reduces rumination, state metacognitions, or sadness in depressed individuals. interestingly, our findings are consistent with those of a recent study on social anxiety, in which alcohol consumption had no attenuating effect on negative (post-event) rumination (hagen et al., 2020), although consumption reduced (social) anxiety (stevens et al., 2014). mollaahmetoglu and colleagues (2021) found that alcohol had an effect on ruminative thoughts and mood at a low dose (about 0.2 mg/l) but not at a high dose (about 0.6 mg/l). it is therefore worth considering whether the desirable effects of alcohol in our study would also have been observed if we had used a lower dose. a promising approach for further studies could be to examine alcohol effects on rumination, metacognitions and depressive mood depending on the dose administered. also, the question arises to what extent the model assumptions on alcohol effects (for a review see sayette, 2017), gawron, pohl, & gerlach 17 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ which were investigated in the context of anxiety (disorders), can be transferred to other disorders and / or other emotional states, such as depression. it should be noted, however, that according to sayette’s model (1993), appraisal disruption is expected only at higher levels of alcohol (i.e., at an amount of alcohol sufficient to cause cognitive im­ pairment), and that we based our hypotheses on this model. nonetheless, if alcohol may not be the usual choice for our participants, e.g., to control unpleasant cognitions, state metacognitions or emotions, it simply may not have this effect in the present sample due to selection bias. in order to ensure that alcohol is a preferred coping strategy, it would have been necessary to pre-screen, for example with the cas-i (wells, 2011). regarding the effects of alcohol consumption on (meta-)cognitive, emotional, and psychophysiological processes and its function in coping with depression, it can be stated that further research is needed to investigate these relationships in more detail. limitations one limitation of our study relates to the sample size, due to which only moderate effects could be detected. however, compared to the results of other clinical studies dealing with the effects of alcohol (e.g., in social anxiety disorder), the sample size we recruited can be considered sufficient (cf. stevens et al., 2017). another limitation relates to our procedure, which can be considered rather exploratory, as the direct effect of alcohol on state metacognitions has not been investigated before and therefore we could only assume that alcohol consumption may prevent negative state metacognitions from being appraised as threatening (cf. sayette, 1993). in addition, it would have been helpful to assess the expected effects of alcohol on rumination or metacognitions before or during the experiment to include trait and actual expectancies of alcoholic effects into statistical analyses. a final limitation relates to the assessment of rumination. here, for example, a rumination-related questionnaire with better psychometric properties may have been more suitable, (e.g., the brief state rumination inventory; marchetti et al., 2018). conclusions to our knowledge, this was the first study to directly examine the association between aud and by assessing the effects of alcohol on rumination and state metacognitions in a sample of clinically depressed individuals. we did not find that alcohol reduced rumination, state metacognitions about rumination, or depressive symptoms. thus, our results suggest that previous models of alcohol effects from the domain of anxiety disorders (e.g., sayette, 1993) may not be easily transferable to the domain of depressive disorders. consistent with the findings of previous studies (see, e.g., nolen-hoeksema et al., 2008; ottaviani et al., 2016), we were able to show that rumination negatively affects disorder-specific processes in mdd. surprisingly, rumination did not elicit negative met­ the influence of alcohol on cognitions in mdd 18 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://www.psychopen.eu/ acognitions about the uncontrollability and danger of rumination, although this would have been expected in terms of the mcm. however, due to the novelty of this research approach, further studies are needed to further test existing models / theories linking depression and alcohol. for example, this could include studies with individuals who drink more and use alcohol more regularly for coping, with a modified paradigm, i.e., with other forms of rumination induction, with manipulated arousal feedback, or with a lower dose of administered alcohol, and / or with other (physiological) measurement methods. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. author note: this study was part of the first author’s doctoral thesis (gawron, 2022), which focused on the function of cognitive processes to explain the association of alcohol (consumption) and depression. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include the descriptive statistics of all questionnaires used, the results of the bonferroni-corrected post-hoc tests for repeated measures anovas, and the means of all measures across the three measurement time points (for access see index of supplementary materials below). index of supplementary materials gawron, l., pohl, a., & gerlach, a. l. 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(1997). scid-i: structured clinical interview for dsm–iv. hogrefe. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. the influence of alcohol on cognitions in mdd 24 clinical psychology in europe 2022, vol. 4(4), article e5615 https://doi.org/10.32872/cpe.5615 https://doi.org/10.1016/j.paid.2010.12.020 https://www.psychopen.eu/ the influence of alcohol on cognitions in mdd (introduction) method recruitment participants procedure drinking procedure measurements psychophysiological data recording, sampling and analysis data analysis results manipulation check repeated measures anovas (h2-h5) discussion limitations conclusions (additional information) funding acknowledgments competing interests author note supplementary materials references open-label placebo effects on psychological and physical well-being: a conceptual replication study research articles open-label placebo effects on psychological and physical well-being: a conceptual replication study anne-kathrin bräscher 1 , ioanna-evangelia ferti 1, michael witthöft 1 [1] department of clinical psychology, psychotherapy, and experimental psychopathology, johannes gutenberg university of mainz, mainz, germany. clinical psychology in europe, 2022, vol. 4(4), article e7679, https://doi.org/10.32872/cpe.7679 received: 2021-10-18 • accepted: 2022-01-19 • published (vor): 2022-12-22 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: anne-kathrin bräscher, department for clinical psychology, psychotherapy, and experimental psychopathology, johannes gutenberg-university of mainz, wallstr. 3, 55099 mainz, germany. phone: +49 6131 3939209. e-mail: abraesch@uni-mainz.de supplementary materials: materials [see index of supplementary materials] abstract background: contrary to traditional placebos, open-label placebos (olp) abstain from deception, i.e., participants are openly informed to receive an inert substance. studies in clinical and healthy samples evidence the efficacy of olps. this study aims to conceptually replicate and expand findings of a recent olp study in healthy participants while implementing a within-subject design and daily instead of retrospective assessments. additionally, the effect of a brand name on the medicine container is tested and possible predictors of the olp effects are explored. method: healthy participants (n = 75) received olp and no placebo for 5 days each (randomized sequence) and answered daily questionnaires on sleep quality, bodily symptoms, mental wellbeing, and psychological distress. the medicine container of half the participants had a brand name, the remaining did not. different personality traits and situational factors were assessed. results: mental and physical well-being did not differ between olp and control phase, i.e., overall, no olp effect emerged. contrast analysis indicated that an olp effect emerged for sleep quality and psychological distress when no brand name was present. further, an olp effect emerged in persons with higher expectations for bodily symptoms (r = .23, p = .046) and psychological distress (r = .24, p = .037). conclusions: methodological differences to the original study are discussed as an explanation for the failure to induce overall olp effects. future studies should continue to replicate previous findings and determine the exact conditions of successful implementation of olp effects in healthy as well as clinical samples. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7679&domain=pdf&date_stamp=2022-12-22 https://orcid.org/0000-0002-2621-5689 https://orcid.org/0000-0002-4928-4222 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords open-label placebo (olp) effect, expectation, brand name, personality traits, healthy sample highlights • the attempt to replicate an open-label placebo effect on well-being in healthy participants failed. • possibly, differences in the design and time-points of assessments explain the negative findings. • presence of a brand name on the medicine container and possible moderators were tested. due to deception, the application of traditional placebos (i.e., “interventions that, owing to their intrinsic properties, are ineffective for a particular condition or symptom(s), but which may be (…) administered (…) with the aim of eliciting placebo effects”, p. 18, blease & annoni, 2019) in patient care can go along with ethical and legal problems as well as with a loss of trust in the therapist-patient relationship (bundesärztekammer, 2010; miller et al., 2005). open-label placebos (olp) might solve these issues since patients are openly informed about the placebo treatment, rendering deception unneces­ sary. numerous studies evidence the efficacy of olp in different clinical contexts and two meta-analyses indicate large effect sizes (charlesworth et al., 2017; von wernsdorff et al., 2021). studies in healthy participants have been conducted less frequently, although they can 1) help to shed light on underlying mechanisms of olp effects that remain unclear to this point and 2) target primary endpoints as the improvement of well-being and physical or cognitive performance (kleine-borgmann et al., 2021; saito et al., 2020). along these lines, some studies in healthy samples explored olp effects in experimental­ ly induced pain (disley et al., 2021; kube et al., 2020; locher et al., 2017; schafer et al., 2015; schneider et al., 2020; wei et al., 2018). few studies focused on areas other than pain perception (el brihi et al., 2019; guevarra et al., 2020; kleine-borgmann et al., 2021). especially, el brihi and colleagues (2019) showed that the intake of placebo pills on five subsequent days compared to not taking placebo pills can reduce psychological distress and bodily symptoms and increase mental well-being and sleep quality in healthy partici­ pants. while the dose (i.e., taking one vs. four pills each day) did not influence the olp effects, positive expectations and adherence were significant predictors. the primary aim of the present study was to conceptually replicate the findings of el brihi et al. (2019) on physical and mental well-being in healthy participants. as a stricter test of the olp effect, a within-subject design was implemented (i.e., all participants pass through a control phase without taking placebos and a placebo phase), since a control group that does not receive olps might be disappointed and thus artificially boost olp open-label placebo effects on well-being 2 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ effects. further, instead of a singular retrospective assessment of relevant constructs, assessments were collected daily to avoid potential memory biases. knowledge on situational and personality factors that moderate olp effects is scarce. dispositional optimism has shown to be associated with deceptive but not open-label placebo effects (locher et al., 2019). yet, studies on the impact of personality factors are rare even in the investigation of deceptive placebo effects, and results tend to be inconsistent (kern et al., 2020). beyond that, evidence shows the influence of aspects like price, appearance, branding, and labeling on deceptive placebos (meissner & linde, 2018), but studies in this realm focusing on olp effects are missing. expanding the conceptual replication, we aimed to additionally explore whether the presence of a brand name on the medicine container would influence the olp effect, as suggested by el brihi and colleagues (2019), who did not vary the brand name (“placibax”) in the original study. we hypothesized that healthy participants would show olp effects in physical and mental well-being, which would be further enhanced when the medicine container is equipped with a brand name instead of no label. further, we exploratively assessed a range of different psychological and situational factors to potentially identify predictors of the olp effect. m e t h o d sample participants were recruited by notes on campus, social media, and e-mail distribution lists, already indicating that the study investigated the influence of placebos on well-be­ ing. in total n = 75 participants (n = 49 females, 65.3%; m = 32.00, sd = 12.75 years) were included in the study (for exclusion criteria and further information cf. appendix a, supplementary materials). all participants gave their written informed consent before commencing the study. all procedures were approved by the local ethics committee (2019-jgu-psychek-001). experimental procedure in the first part of the study, participants came to the lab and filled in several psycho­ metric questionnaires and a questionnaire on demographic information via the online platform soscisurvey (leiner, 2018). suggestibility was assessed with the creative imagi­ nation scale (cf. below). subsequently, participants watched a 10-minute animated video (generated with videoscribe; cf. appendix b, supplementary materials, for the narrative), addressing the four key aspects that are always communicated in olp studies (kaptchuk, 2018): remove the stigma of placebo effects; automatic nature of placebo responses; no requirement to believe; taking the pills is critical. the video also stressed that studies have shown beneficial effects on psychological and bodily well-being in healthy persons. bräscher, ferti, & witthöft 3 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ after that, participant’s questions were answered and expected effects on sleep quality, bodily symptoms, mental well-being, and psychological distress were assessed using a scale from 0 (“i do not expect any effect at all”) to 10 (“i expect a very strong effect”), respectively. finally, participants received a closed envelope containing an amber glass with five placebo pills. half of the amber glasses (n = 37) had a label inscribed with “pharmacebo”, the other half of the amber glasses (n = 38) did not have a label (random­ ized; cf. figure 1). the experimenter was blind to the kind of amber glass, which the participant received. further, participants were informed when they should start taking the placebo pills. figure 1 picture of the medicine container note. medicine container with and without a label (left) and display of the label with the brand name (“pharmacebo”), including information on the size and weight of the pills as well as the expiration date. the second part of the study always started on the monday following the lab appoint­ ment, to avoid interference with weekend days. participants either started with the placebo phase and were instructed to take a placebo every morning for five consecutive days (monday to friday) and then switch to the control phase (again from monday to friday), or they started with the control phase and switched to the placebo phase the week after. the order of placebo and control phase was randomized (random.org). during those ten days, participants received an e-mail every evening containing the link to questionnaires they were asked to fill in to assess the olp effects as well as a question on adherence (“did you take the placebo pill at least 6 hours ago?” yes/no). on the last day of the placebo phase, they were additionally asked how many placebo pills they had to spare. further, on the day before the start of the placebo phase, the expected effects on all outcome measures were assessed again, using the expectancy scale. open-label placebo effects on well-being 4 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ outcome measures the following questionnaires were filled in daily. the instructions were changed where necessary to refer to the current day (instead of a longer period). warwick-edinburgh mental well-being scale the questionnaire (tennant et al., 2007; german version, lang & bachinger, 2017) con­ tains 14 items and assesses general mental well-being (range [14-70]). it has shown good internal consistency (α = .89 to .91), content, convergent, and discriminant validity. the retest reliability is high (r = 0.83, tennant et al., 2007). the german version has shown good validity and reliability, as well (lang & bachinger, 2017). internal consistency in the current study ranged between α = .91 and α = .96. profile of mood state (poms) the questionnaire (mcnair et al., 1971; german short version, dalbert, 1992) assesses the current mood through 19 items. within the present work, the subscales sorrow, hope­ lessness, fatigue, and positive mood (reversely coded) are summoned to build the scale psychological distress (16 items; range [16-112]). the internal consistency is high and ranges between α = .83 and .94 for the different subscales (dalbert, 1992). the internal consistency of the scale psychological distress in the current study ranged between α = .93 and α = .96. subjective health complaints (shc) the shc lists 29 bodily symptoms, which can be rated on an intensity scale from 0 (not at all) to 3 (severe) (rang [0-87]). it has acceptable to good internal consistency (α = .75 to .82, eriksen et al., 1999) and is associated with healthcare utilization (filipkowski et al., 2010). the items have been translated by the authors. internal consistency in the current study ranged between α = .70 and α = .80. groningen sleep quality scale (gsqs) this questionnaire (leppämäki et al., 2003; mulder-hajonides van der meulen et al., 1980) contains 15 items, which can be answered with yes and no, assessing sleep quality of the previous night. larger scores indicate poorer sleep [range 0-14]. internal consis­ tency was α = .88 in a sample of depressed patients (current study: α between .15 and .55). measures of psychological factors during the lab appointment, participants filled in the following questionnaires to as­ sess different traits and psychological factors: state-trait inventory (stai-t), neo-five factor inventory, somatosensory amplification scale, patient health questionnaire-15 bräscher, ferti, & witthöft 5 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ (phq-15), questionnaire on attitudes towards complementary medical treatment (qa­ cam). further information on the questionnaires can be found in appendix c, supplementary materials. creative imagination scale (cis) the cis (wilson & barber, 1978) assesses suggestibility using standardized descriptions of ten different situations on visual, auditive, kinesthetic, and olfactory perceptions. while the experimenter reads out the descriptions, the participant is asked to imagine the situation and afterward evaluate inasmuch their imagination matched the real expe­ rience using one item for each of the ten situations. the internal consistency in the current study was α = .89. statistical analysis changes between the first and second assessment in expected olp effects were tested using the wilcoxon-signed-rank-test due to non-normally distributed data. considering sleep quality, bodily symptoms, mental well-being, and psychological distress, respective­ ly, as outcome variables, mixed 2x5x2-anovas were performed to assess the olp-effect (within-factor “condition”) and the influence of time (within-factor “day”) as well as brand name (between-factor “brand name”). since the order of the phases (placebo intake or control phase in week one) did not significantly influence the results, this factor was not included in the reported analyses. holm-corrected post hoc-tests were applied were appropriate. contrast analyses were calculated to test the hypothesis that olp effects were larger with a brand name. as measures of effect size, η2 (η2 ≥ 0.01 small; η2 ≥ 0.06 medium; η2 ≥ 0.14 large) and cohen’s d (d ≥ 0.30 small, d ≥ 0.50 medium, d ≥ 0.80 large) are specified. as explorative analyses, to identify potential predictors of the olp effect, pearson correlations between psychological factors and the outcome measures (i.e., the difference between the average score during placebo and control phase) were calculated (r ≥ |.10| small; r ≥ |.30| medium, r ≥ |.50| large). the alpha level was set to 5%. analyses were calculated with jasp version 0.14.1 (jasp team, 2020). r e s u l t s expectation and adherence adherence (i.e., intake of the placebos as instructed) was excellent. in only two instances, participants reported to have forgotten the intake once, which was confirmed by the question at the end of the olp phase (“how many pills do you have to spare?”). expected effects of the olp effects were in the medium to low range of the scale and significantly decreased from the first to the second assessment (see table 1). open-label placebo effects on well-being 6 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ table 1 expected open-label placebo effects outcome expectation after manipulation expectation before placebo phase test statistic for differences between both assessments m sd m sd w p rrb sleep quality 3.41 2.99 2.82 2.85 427.5 .040 0.33 bodily symptoms 3.73 2.95 2.88 2.76 928.00 < .001 0.58 mental well-being 4.41 3.12 3.34 2.95 1039.50 < .001 0.63 psychological distress 3.77 3.01 2.86 2.84 874.00 .008 0.43 note. expectations assessed at the first assessment directly after the open-label placebo manipulation and at the second assessment the day before the first intake of the open-label placebo and difference test. open-label placebo effects concerning sleep quality, placebo and control week did not differ significantly and this did not change over the five days, i.e., overall, no olp effect emerged (see table 2). neither the main effect of day nor that of brand name were significant. a significant interaction effect between condition and brand name emerged (see figure 2), but post hoc-tests were non-significant (all ps > .190). contrary to the hypothesis, the contrast analysis showed that the difference between scores of the placebo versus the no treat­ ment week was larger when no brand name was present, t(73) = -2.42, p = .009, indicating that a medicine container without a brand label led to an olp effect but a medicine container without a brand label did not. with regards to bodily symptoms, placebo and control week did not differ significant­ ly (see table 2). a significant interaction effect between condition and day emerged (see figure 2), but post hoc-tests were non-significant (all p > .240). the five days differed significantly for reported bodily symptoms and post-hoc tests indicated that bodily symptoms decreased when comparing day 1 to day 5, t(74) = 4.11, p < .001, d = 0.48, remaining post hoc-tests all p > .056. bodily symptoms did not differ significantly depending on the presence of a brand name and no significant interaction emerged between brand name and condition. the contrast analysis did not point to a differential effect depending on the presence of a brand name, t(73) = -0.03, p = .490. placebo and control week did not differ significantly concerning mental well-being (see table 1, figure 2) and this did not change over the five days, i.e., no overall olp effect emerged. neither the main effect of day nor of label, nor the interaction effect between label and condition reached significance. the contrast analysis did not point to a differential effect depending on the presence of a brand name, t(73) = -0.94, p = .175. for psychological distress, similarly, placebo and control week did not differ signifi­ cantly (see table 2, figure 2) and no significant interaction effect between condition and day emerged. no main effect of day and label reached significance. the interaction bräscher, ferti, & witthöft 7 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ effect between brand name and condition just reached significance, but post hoc-tests were non-significant (all ps > .561). contrary to the hypothesis, the contrast analysis indicated that the difference between scores of the placebo versus the no treatment week was larger without the brand name, t(73) = -1.99, p = .025, indicating that a medicine container without a brand label led to an olp effect but a medicine container without a brand label did not. figure 2 open-label placebo effects note. average scores of psychological distress, mental well-being, bodily symptoms, and sleep quality across five days each in the olp (white) and control condition (black). error bars represent the standard error. open-label placebo effects on well-being 8 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ identification of predictors expectation assessed the day before the placebo intake (2nd assessment) significantly cor­ related with the difference between scores taken in the placebo versus the no treatment week for the outcome measures bodily symptoms (r = .23, p = .046) and psychological distress (r = .24, p = .037), respectively. the effect sizes of the remaining correlations with other psychological factors were partly in the small range but did not reach significance (suppl. table 1 in appendix c, supplementary materials). table 2 results of anovas for the respective outcome measures outcome / factor df f p effect size η2 sleep quality condition 1 0.43 .512 < .001 day of the week 4 2.18 .071 .010 condition x day 3.48 2.32 .066 .008 label 1 0.95 .334 .004 condition x label 1 5.85 .018 .007 bodily symptoms condition 1 1.60 .210 .002 day of the week 3.46 4.61 .002 .006 condition x day 3.32 2.68 .042 .004 label 1 < 0.01 .979 < .001 condition x label 1 < 0.01 .979 < .001 mental well-being condition 1 0.13 .716 < .001 day of the week 3.27 1.21 .306 .002 condition x day 3.68 0.99 .408 .001 label 1 0.10 .749 .001 condition x label 1 0.89 .349 < .001 psychological distress condition 1 0.16 .693 < .001 day of the week 3.51 2.50 .051 .003 condition x day 3.68 0.71 .572 .001 label 1 0.01 .910 .001 condition x label 1 3.96 .050 .001 bräscher, ferti, & witthöft 9 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ d i s c u s s i o n this study aimed to conceptually replicate findings of a previous experiment (el brihi et al., 2019) that demonstrated small to medium olp effects (d = 0.28-0.50) on mental and physical well-being in healthy participants. using a within-subject design and daily assessed sleep quality, bodily symptoms, mental well-being, and psychological distress, overall no significant olp effect emerged in the present study. other than hypothesized, a brand name on the medicine container hindered olp effects in sleep quality and psychological distress. explorative analyses hinted at expectation as a possible predictor of the olp effects in bodily symptoms and psychological distress. several reasons might explain the failure to replicate the results of the original study. general issues refer to possible differences in the populations investigated (e.g., language, country, ethnicity, etc.). it is also possible that floor or ceiling effects prevented the development of olp effects in this healthy sample, yet a comparison to normative values is hardly possible due to altered instructions (referring to the last day instead or a week or else). further, the present study partly used other outcome measures than the original study (poms, gsqs). the two most important differences to the original study refer to the design of the studies and the time points of assessment. employing a within-subjects design has the advantage that every participant serves as their control group, i.e., no random differences will confound the effects of interest. this is especially important since concerns regarding the control group in olp studies have been voiced (blease et al., 2020). it can be speculated that the control group in the original study was less motivated or did not pay as much attention to the symptoms in question as the group that received placebos because they were neither reminded to attend to possible effects by taking a pill nor by filling in daily questionnaires, which might have artificially boosted olp effects. regarding the time points of assessment, the present study assessed symptoms daily, while the original study assessed symptoms once after five days of placebo intake or control phase. this retrospective assessment might have led to an overestimated olp effect due to memory biases (ebner-priemer & trull, 2009). another potential reason for the non-existent olp effects might be the mode of presen­ tation of the information concerning olp effects to the participants. to standardize this aspect of the study, participants watched an animated video that conveyed the relevant information. in other olp studies, this information is given in a conversation between the experimenter and the participant. research indicates that (open-label) placebo effects benefit from trustworthy, friendly and empathetic treatment providers (gaab et al., 2019; kube et al., 2021). possibly, the therapeutic alliance between treatment provider and participant was adversely affected by implementation of the video instead of personal communication in the present study. feasibly, participants in our study were not as attentive or engaged or the video just was less convincing than a personal conversation. along these lines, expected olp effects were somewhat lower in our study (range of m = 3.4 and m = 4.4) compared to the original study (m = 4.9). interestingly, a recent study open-label placebo effects on well-being 10 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ (kube et al., 2021) failed to find olp effects in allergic rhinitis when information on olp was conveyed in an online setting. this result emphasizes the importance of the mode of presentation. although many previous studies evidence olp effects in clinical (carvalho et al., 2016; charlesworth et al., 2017; von wernsdorff et al., 2021) as well as healthy samples, including those on mental and physical well-being (el brihi et al., 2019; guevarra et al., 2020; kleine-borgmann et al., 2021), some studies were only partly successful (context of itch, meeuwis et al., 2019; meeuwis et al., 2018) or failed to induce olp effects, e.g., in chronic back pain (ikemoto et al., 2020), nausea (barnes et al., 2019), wound healing (mathur et al., 2018), and allergic rhinitis (kube et al., 2021). future studies should find out, whether olp effects can be reliably induced in healthy participants and which conditions are key. we hypothesized that a brand name on the medicine container would increase the olp effect because usually medication is labeled and in deceptive placebos, brand names lead to larger effects (meissner & linde, 2018). however, contrary to that, the difference in scores between placebo and control week tended to be increased when no brand name was present for two of the outcome measures, namely psychological distress and sleep quality, while the presence of a brand name did not influence the effects of the two re­ maining outcome measures. possibly, when reading the label “pharmacebo”, participants were reminded that they are about to take a placebo, which might have counteracted conditioned effects based on previous experiences with medication. it would be worth­ while to replicate the present findings and to investigate the effect of a brand name that does not hint at the placebo context in future studies. several possible predictors of olp effects were explored. suggestibility, neuroticism, extraversion, openness, conscientiousness, habitual anxiety, somatization, somatosensory amplification, and a positive attitude towards cam or conventional medicine were not significantly associated with the difference in scores of the placebo and control week. these findings are similar to those of a study on experimental heat pain in healthy participants that did not find associations of the olp effect with optimism, pessimism, openness, locus of control, and positive attitudes towards cam (locher et al., 2019). interestingly, relevant traits in the context of deceptive placebo effects do not necessarily play a role in olp effects (cf. optimism, locher et al., 2019). thus, more research is needed to identify facilitating personality traits of olp effects, should they exist. in line with our assumptions, expectations were a significant predictor for the olp effects in bodily symptoms and psychological distress. results of previous studies concerning the role of expectations are inconsistent; whereas some studies showed a relationship between olp effect and measures of expectation (el brihi et al., 2019, not for sleep quality, however; kleine-borgmann et al., 2021) other did not (guevarra et al., 2020; kube et al., 2021). possibly, the time point of assessment of the expectations is an important aspect to consider. in the present study, participants expressed higher expect­ bräscher, ferti, & witthöft 11 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://www.psychopen.eu/ ations directly after the information about olp effects and expectations significantly decreased in the second assessment before the placebo phase. yet, only expectations of the second assessment were significantly associated with the olp effects. therefore, possibilities should be explored that keep expectations stable for a longer period of time, for example sending patients written information on the open-label placebo effect to boost expectations right before the intake of the placebos. some limitations need to be mentioned for the present study. the animated video was meant to increase standardization when giving participants information about olp effects. it would have been helpful to validate the animated video in a pilot study, test whether the information was conveyed as desired and whether alliance would be affected. since the placebo and control phases of the study took place in the field instead of in a controlled lab environment, we cannot be sure whether participants took the placebos as prescribed. yet, this approach has higher ecological validity than most olp studies that comprise healthy participants, as it closely resembles realistic conditions (i.e., taking medication at home). further, besides asking about the intake of the placebo pills daily, we confirmed the participants’ statements by asking how many pills they had to spare at the end of the study. the employed brand name “pharmacebo” might have not been optimally chosen, since it includes the term “pharma” and thus could be misleading. yet, the results do not support this notion as participants whose medicine container did not have a label tended to benefit better from the placebos. it would be helpful to investigate the impact of different brand names and their connotations in a future study. finally, analyses were based solely on self-report data. assessing objective data, for example with the help of fitness watches tracking sleep parameters, could be a beneficial addition. to conclude, open-label placebo effects are a promising phenomenon that has the potential to improve patient care while respecting patients’ autonomy. similar to other recent investigations, this study failed to find overall olp effects in mental and physical well-being in healthy participants. it will be important to continue replicating previous findings and to determine the exact conditions of successful implementation of olp effects in healthy as well as clinical samples. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @annekbraescher, @witthoef open-label placebo effects on well-being 12 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://twitter.com/annekbraescher https://twitter.com/witthoef https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary material contains further information on the sample, the manualized narrative provided in the animated video, further information on questionnaires assessed, and a supplemen­ tary table with correlations of the difference between scores taken in the placebo versus the no treatment week of the outcome measures with psychological factors (for access see index of supplementary materials below). index of supplementary materials bräscher, a., ferti, i., & witthöft, m. (2022). supplementary materials to "open-label placebo effects on psychological and physical well-being: a conceptual replication study" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.12173 r e f e r e n c e s barnes, k., yu, a., josupeit, j., & colagiuri, b. (2019). deceptive but not open label placebos attenuate motion-induced nausea. journal of psychosomatic research, 125, article 109808. https://doi.org/10.1016/j.jpsychores.2019.109808 blease, c. r., & annoni, m. (2019). overcoming disagreement: a roadmap for placebo studies. biology & philosophy, 34(2), article 18. https://doi.org/10.1007/s10539-019-9671-5 blease, c. r., bernstein, m. h., & locher, c. (2020). open-label placebo clinical trials: is it the rationale, the interaction or the pill? bmj evidence-based medicine, 25(5), 159–165. https://doi.org/10.1136/bmjebm-2019-111209 bundesärztekammer. 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(1978). the creative imagination scale as a measure of hypnotic responsiveness: applications to experimental and clinical hypnosis. the american journal of clinical hypnosis, 20(4), 235–249. https://doi.org/10.1080/00029157.1978.10403940 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. open-label placebo effects on well-being 16 clinical psychology in europe 2022, vol. 4(4), article e7679 https://doi.org/10.32872/cpe.7679 https://doi.org/10.1097/aln.0000000000003076 https://doi.org/10.1186/1477-7525-5-63 https://doi.org/10.1038/s41598-021-83148-6 https://doi.org/10.1155/2018/8459429 https://doi.org/10.1080/00029157.1978.10403940 https://www.psychopen.eu/ open-label placebo effects on well-being (introduction) method sample experimental procedure outcome measures measures of psychological factors statistical analysis results expectation and adherence open-label placebo effects identification of predictors discussion (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references “same same or adapted?” therapists’ feedback on the implementation of trauma-focused cognitive behavioral therapy with unaccompanied young refugees latest developments “same same or adapted?” therapists’ feedback on the implementation of trauma-focused cognitive behavioral therapy with unaccompanied young refugees johanna unterhitzenberger 1 , sophia haberstumpf 2, rita rosner 1, elisa pfeiffer 3 [1] department of psychology, catholic university eichstätt-ingolstadt, eichstätt, germany. [2] center for mental health, department of psychiatry, psychosomatics and psychotherapy, university hospital würzburg, würzburg, germany. [3] clinic for child and adolescent psychiatry/psychotherapy, ulm university, ulm, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e5431, https://doi.org/10.32872/cpe.5431 received: 2020-12-11 • accepted: 2021-06-29 • published (vor): 2021-11-23 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: johanna unterhitzenberger, catholic university eichstätt-ingolstadt, department of psychology, ostenstr. 26, d-85072 eichstätt, germany. phone: +49 8421 9321733. e-mail: johanna.unterhitzenberger@ku.de related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: materials [see index of supplementary materials] abstract background: rates of trauma exposure and posttraumatic stress disorder (ptsd) are high among refugee youth. although there is a vast evidence base on effective trauma-focused interventions for children and adolescents, there is only limited understanding of how to adapt these interventions for oftentimes severely traumatized young refugees. this study aims to investigate adaptations undertaken during trauma-focused cognitive behavioral therapy (tf-cbt) in a pilot study with unaccompanied refugee minors (urms). method: written answers on five questions given by n = 9 therapists on n = 16 tf-cbt cases were analysed qualitatively using mayring’s content analysis. the questions were on (1) additional techniques used in the sessions, (2) obstacles to tf-cbt treatment, (3) cultural factors considered and most helpful components for (4) patient and (5) therapist. the categories were built inductively and analysed descriptively. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5431&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0002-7417-8747 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ results: in addition to the regular tf-cbt components, added content mostly concerned the socalled “crisis of the week”, meaning a more lengthy discussion of struggles and concerns in their daily lives. few obstacles in treatment were reported, and little cultural factors had to be considered. the implementation of a trauma narrative and the agenda provided by the manual were frequently reported as helpful. conclusion: the results of this study indicate that the manualized evidence-based treatment tfcbt can be used in the culturally heterogeneous population of urms with minor adaptations. these findings can contribute to future research as well as clinical practice with urms. keywords tf-cbt, cultural adaptation, refugee, therapist, adolescent highlights • tf-cbt is a promising treatment for ptsd in traumatized refugee minors. • necessary adaptations for this target group have not been analysed so far. • therapists reported only a few “on the fly” adaptations during a pilot study on tfcbt. unaccompanied refugee minors (urms) constitute a vulnerable population, firstly due to their various traumatic experiences before, during and after their flight (reed et al., 2012; steel et al., 2017), and secondly in terms of severe post-migration stressors (keles et al., 2018) on their arrival in the host country. it comes as no surprise that the prevalence rates of traumaand stress-related mental health conditions are higher among urms compared to youth without a migration background, immigrant samples (betancourt et al., 2017) or accompanied refugee minors (bean et al., 2007). a recent meta-analysis on mental illness among refugee minors revealed that 23% report posttraumatic stress disorder (ptsd) (blackmore et al., 2020). current treatment guidelines for treating trauma-related disorders, especially ptsd, recommend trauma-focused cognitive behavioral approaches (international society for traumatic stress studies [istss], 2019; rosner et al., 2019) for traumatized children and adolescents. in this context, trauma-focused cognitive behavioral therapy (tf-cbt, e.g. the specific manual by cohen et al., 2017) has been identified as a gold standard treatment for children and adolescents with ptsd across guidelines and meta-analyses (gutermann et al., 2016). experts claim, however, that yet child trauma guidelines focus too little on children’s cultural background and possible adaptations (alisic et al., 2020). most evidence-based treatments for ptsd were developed in western societies. they were then increasingly widely implemented and found to be effective in samples with cultures outside of western societies (ennis et al., 2020). only a very small number of interventions have been specifically developed and tailored to the needs of urms, for example the trauma-focused group intervention “mein weg” (english “my way”) therapists’ feedback on tf-cbt with refugees 2 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ (pfeiffer et al., 2018), which is based on tf-cbt but re-modeled into a group-based low-level intervention for refugees in child welfare programs. the development of this intervention adopted a theory-driven approach for cultural adaptation (heim & kohrt, 2019). the theory-driven changes focused mostly on delivery in a group format (e.g. additional group discussions), the language barrier (e.g. changes in materials) and the inclusion of flight and migration specific content (flight route as part of narrative). more commonly, evidence-based trauma-focused treatments are adapted to cultural char­ acteristics of study populations in a data-driven, so-called “bottom-up” approach. these approaches are especially favorable if the question is whether there is a good fit between the evidence-based treatment itself and the new target group, and whether cultural adaptations are necessary to some or all aspects of that specific therapy. a recent review (ennis et al., 2020) systematically reviewed research articles on cultural adaptations in trauma-focused cbt approaches with children and adults. the results highlight the complexity of cross-cultural adaptations of psychotherapy due to several reasons such as heterogeneous sources of information (e.g. stakeholders, thera­ pists or patients), the usage of different frameworks for cultural adaptations (if used at all) and different levels of efficacy evaluation. seven out of the 17 included studies were on cultural adaptations in tf-cbt. they either implemented the treatment with immigrant samples in western countries (e.g. schottelkorb et al., 2012) or delivered the treatment abroad in the cultural context of the country itself (drc: mcmullen et al., 2013; jordan: damra et al., 2014; zambia: murray et al., 2013; tanzania: o’donnell et al., 2014). one study involved local therapists (murray et al., 2013) as main source of information for assessing potentially necessary changes to the treatment protocol during treatment delivery, while others used focus groups, surveys, or expert panels ahead of treatment implementation. the most often used source in the studies described in the review by ennis et al. (2020), which focused on data-driven approaches, were (local) therapists as they might function as a direct mediator between high adherence in the implementation of the manual on the one hand and the individual needs of their patients on the other hand. there are only two studies on cultural adaptations to the tf-cbt protocol delivered to refugee minors (schottelkorb et al., 2012; unterhitzenberger et al., 2019). the refugee population might throw up specific challenges as it represents a heterogeneous popula­ tion that originates from different countries and cultures. consequently, this makes an oftentimes preferred “one size fits all” approach even more challenging. the authors of both studies gave only a brief description of marginal changes to the protocol (e.g. translation when needed, tailored psychoeducation, more sessions on trauma narrative). this leaves a gap in the literature on the need for cultural adaptations in tf-cbt for this vulnerable cohort. especially so-called “on the fly” adaptations of experienced therapists (heim & kohrt, 2019) might be crucial to increasing understanding of necessary adapta­ tions to evidence-based trauma-focused treatments such as tf-cbt for urms. unterhitzenberger, haberstumpf, rosner, & pfeiffer 3 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ in our recent pilot study (unterhitzenberger et al., 2019) on tf-cbt with urms, we implemented the tf-cbt protocol without prior theory-driven adaptations. the aim was to evaluate the feasibility of tf-cbt for this specific target group. therapists were instructed to provide the treatment according to the manual, however, also to implement and document any “on the fly” adaptations they made in order to successfully treat the refugee patient. the present study, which was part this pilot study (unterhitzenberger et al., 2019), aims to increase knowledge on how to adapt tf-cbt to the specific needs of urms by examining therapists’ self-reported cultural adaptations in implementing tf-cbt with urms in a qualitative study design. m e t h o d this study is part of a recently published pilot study conducted in germany between march 2015 and july 2017. for details on the procedure please refer to the main publica­ tion (unterhitzenberger et al., 2019). the participants treated in this pilot study were 26 male urms (mage = 17.1; sd = 1.0; range 15-19) who had been in germany for an average of 9.8 months (sd = 3.9) and who originated from eight different countries in the middle east and africa. 22 of them completed treatment. uncontrolled effect sizes were high for ptsd symptoms at post (d = 1.08) and follow-up assessments (d = 1.23). participants a total of 9 therapists were taken into account for this analysis. please see table 1 for the description of participants’ characteristics. therapists responded to the survey for a total of 16 treatment cases. unfortunately, we do not have therapist feedback on all the cases treated, as the questionnaire was put together during the ongoing pilot study. all therapists participated in a tf-cbt training by a certified trainer and received biweekly supervision. in addition, one of the manual developers offered case consultation calls once a month. during the project, an expert in psychotherapy with refugees and torture survivors ran a half-day training session attended by all therapists. therapists’ feedback on tf-cbt with refugees 4 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ table 1 sociodemographic characteristics of the participating therapists (n = 9) characteristic age m (sd) 35 (9.5) range 29 – 60 gender n (%) female 8 (88.9) cbt therapist n (%) 9 (100) licensed 6 (66.7) in training 3 (33.3) child and adolescent therapist 1 (11.1) adult therapist with additional training for children 8 (88.9) clinical experience n (%) 1 to 5 treated cases 2 (25.0) 11 to 20 treated cases 1 (12.5) 21 to 50 treated cases 1 (12.5) > 50 treated cases 4 (50.0) tf-cbt cases treated m (sd) 5.5 (2.99) range 0 – 20 note. cbt = cognitive behavioral therapy; tf-cbt = trauma-focused cognitive behavioral therapy; m = mean; sd = standard deviation. intervention the tf-cbt treatment protocol followed the manual by cohen et al. (2017). it consists of nine treatment modules on psychoeducation and parenting skills, relaxation, affec­ tive modulation, cognitive processing, trauma narrative and cognitive processing ii, in vivo exposure, conjoint child/caregiver session, and enhancing safety and future skills. standard tf-cbt involves twelve 90-minute sessions with the child and the caregiver. usually, the caregiver is a parent, however, for children and adolescents housed in child welfare facilities (like urms) these are professionals, for instance, social workers. the amount of caregiver involvement depends on the child’s age. according to the manual developers, tf-cbt is flexible and culturally sensitive (cohen et al., 2017). in this pilot study, treatment fidelity was relatively high (62-82%) (unterhitzenberger et al., 2019). the mean treatment dose was 15 sessions. an interpreter was present in 55% of treatment cases. data collection after each session, therapists filled out a session checklist for the tf-cbt module addressed in the respective session to report on treatment adherence. after the respon­ unterhitzenberger, haberstumpf, rosner, & pfeiffer 5 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ ses to the components (yes/no), one item “additional content or techniques” was to be answered openly that was analyzed for this article (question 1). furthermore, we conducted a survey among therapists. they were given a questionnaire for each study case at the same day they had completed it. the questionnaire consisted of four lik­ ert-scaled questions and eleven questions on each treatment case. it included questions on the complexity of the disorder, therapeutic relationship, therapist’s satisfaction, help­ ful components and obstacles as well as cultural considerations. for the purpose of this study, we present responses from the following four questions that we deemed to be helpful regarding (cultural) adaptations: “which component(s) constituted an obstacle in treatment?” (question 2), “did you consider cultural factors in this treatment case? if so, which ones?” (question 3); “which tf-cbt component(s) helped the patient most?” (question 4); “which tf-cbt component(s) was/were especially helpful for you in treat­ ment?” (question 5). data analysis the answers were analyzed according to mayring’s qualitative content analysis (mayring, 2000). we conducted categories in a structured manner. a key component of this process is the coding manual (for an overview see supplementary material). the coding manual is developed in three steps: the definition of categories, the derivation of examples from the text, and the addition of rules for coding when necessary. categories were built inductively, meaning they were derived from the material rather than from a theoretical concept. the coding was done by sh, any uncertainties regarding the coding and coding manual were discussed with ju. the categories were then analyzed quantitatively by percentage of naming. this approach seemed suitable, as many answers were very short or only bullet points. categories were built separately for each question so there is a coding manual for each question. for question 1, 242 session checklists were analyzed. for questions 2 to 5, we analyzed 16 questionnaires from 16 treatment cases. percentages represent how often one category was named by the answers analyzed for the respective question. percentages represent data from one question and all categories for the respective question are reported except for question 1, where we report only categories with percentages ≥ 4. r e s u l t s additional content or techniques in 150 out of the 242 checklists, the therapists named 172 additional contents or techni­ ques. we coded them in 21 subcategories. the categories named most often were “crisis of the week” (12.2%), psychoeducation (11.3%), cognitive processing and trauma narrative therapists’ feedback on tf-cbt with refugees 6 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ (each 11.1%). these were followed by relaxation (4.7%), treatment course, grief, and affective modulation (4.1% respectively). obstacles in treatment five therapists named obstacles regarding tf-cbt for six cases. eleven responses cate­ gorized in six categories showed the following challenges in implementing tf-cbt: relaxation (36.4%), cognitive processing i and tf-cbt components ahead of trauma narrative (each 18.2%), affective modulation, work sheets and linguistic problems (each 9.1%). cultural factors in treatment nine therapists gave 14 responses that indicate consideration of cultural factors that were assigned to eleven categories: using pride, religion, and metaphors (each 14.3%), simplify language, using strength and respect, culture-specific grief rituals, combination of psychological and somatic complaints, information on the culture-specific image of women, handling of aggressive behavior, culture-specific adaptation of treatment rela­ tionship and handling of general cultural controversies (each 7.1%). for six cases, thera­ pists did not describe any cultural considerations. three of the participants indicated that they possibly did but were not aware of it or did not explicitly do so. most helpful for patient twenty-six responses for 15 treatment cases were given regarding the most helpful tf­ cbt components for the patient: trauma narrative (53.9%), cognitive processing (19.2%), psychoeducation, relaxation, conjoint session with patient and caregiver (each 7.7%) and affective modulation (3.9%). most helpful for therapist eight therapists responded to the question about what was most helpful for their work derived from tf-cbt in 22 responses for 13 treatment cases: having an agenda (22.7%), trauma narrative and psychoeducation (each 18.2%), cognitive processing (13.6%), intervi­ sion with other tf-cbt therapists (9.1%) and affective modulation, conjoint session, grief modules, and expectation of treatment success (each 4.6%). d i s c u s s i o n this is the first study to investigate “on the fly” adaptations by practitioners implement­ ing tf-cbt with an especially vulnerable and diverse population. as one of the first studies, we present qualitative findings from therapists’ adaptations during tf-cbt, unterhitzenberger, haberstumpf, rosner, & pfeiffer 7 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ which is a valuable addition to the research field. the overall results suggest that the implementation of tf-cbt is feasible without a tremendous amount of adaptation. in line with other studies on cultural adaptations to trauma-focused treatments, therapists also made changes in the conceptualization of the trauma’s effects such as spiritual approaches (ennis et al., 2020), and tailored materials and language (e.g. usage of meta­ phors) to the target group. the additional content or techniques described were mostly tf-cbt components. consequently, therapists had to repeat some components in later sessions (like psycho­ education before starting the trauma narrative) or brought components forward that were supposed to be carried out later (like affective modulation in the first session to enable some self-efficacy in dealing with ptsd symptoms). this is an approach that is typical for tf-cbt, which is meant to be flexible in the use of its components (cohen et al., 2017). it is not surprising that dealing with the ‘crisis of the week’ was the content added most often. in addition to their trauma history, urms have to deal with daily stressors and post-migration stressors (keles et al., 2018) such as an unsecure asylum status, discrimination, or language and cultural barriers in the acculturation process. therefore, we recommend that enhanced problem management related to post-migration stressors should be added as an additional component in tf-cbt (‘crisis of the week’) for this population. there were reports of obstacles related to tf-cbt in only one third of cases. lan­ guage was named as the only problem in treatment, the other responses referred to components of little help for the respective treatment case. relaxation was named most often. we recommend, however, to retain this content as part of the treatment as it is considered to be an important part of stabilization ahead of the trauma confrontation and suitable for use across different cultures. the cultural adaptations named by the therapists were rather diverse. looking at the data, we can see that most adaptations named were techniques that we would use irregularly throughout treatment, like the meaning of pride, strength or respect that can be included in the cognitive work, trauma narrative or future safety. the use of pride or respect and culture-specific grief rituals could be discussed in the tf-cbt training in order to enable therapists to deliver culturally sensitive treatment for urms. this specific content might not be necessary for all urms in treatment though, which means that therapists need to evaluate the inclusion of such culture-specific rituals and concepts for each individual patient independently. therapists need to be trained to maintain a balance between cultural considerations and an overestimation of cultural aspects as this might lower manual adherence. in addition, suitable metaphors should be provided for different modules. even though trauma confrontation with asylum seekers is discussed in a controver­ sial manner in the literature (ter heide et al., 2016), the therapists named the trauma narrative as the most helpful component for their patients. the factor named most therapists’ feedback on tf-cbt with refugees 8 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ helpful for therapists was “having an agenda” which is not a tf-cbt component, but a characteristic of manualized cbt approaches. the agenda for every session seems especially helpful when the “crisis of the week” is a very dominant part of the treatment sessions. there are several limitations which might limit the generalizability of the findings. unfortunately, question 3 about cultural adaptations was phrased as a closed, two-step­ ped question (“did you consider cultural factors in this treatment case? if so, which ones?”). this might have forced a “yes” or “no” answer and might therefore have biased the results. furthermore, we were not able to calculate interrater reliability scores for the coding of categories. in addition, there was a lack of objective ratings (e.g. independent raters of videos from treatment sessions). lastly, we did not assess the therapists’ cultural competence or prior experience in transcultural work. therefore, we cannot rule out that the level of cultural knowledge influenced the actual cultural adaptations. conclusion the present study enhances our knowledge about the implementation of tf-cbt for a culturally diverse sample such as urms in germany. nonetheless, urms face numerous individual and structural barriers to receiving mental health care interventions tailored to their needs. within the project “better care – improving mental health care for unaccompanied young refugees through a stepped-care approach” (rosner et al., 2020) we will implement tf-cbt according to the knowledge gained from the present study. furthermore, the recommendations discussed can contribute to the implementation of tf-cbt in culturally diverse groups in future research and clinical practice and might help practitioners to overcome barriers in treating young refugees. funding: participant incentives in the pilot study were financed by profor+, a funding programme run by the catholic university of eichstätt-ingolstadt. the better care trial is funded by the german ministry of education and research (01ef1802a-b). acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. s u p p l e m e n t a r y m a t e r i a l s the supplementary material contains examples from the coding manual for the questions regard­ ing additional techniques, obstacles to treatment and cultural adaptations (for access see index of supplementary materials below). unterhitzenberger, haberstumpf, rosner, & pfeiffer 9 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://www.psychopen.eu/ index of supplementary materials unterhitzenberger, j., haberstumpf, s., rosner, r., & pfeiffer, e. 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(2012). treatment for childhood refugee trauma: a randomized, controlled trial. international journal of play therapy, 21(2), 57-73. https://doi.org/10.1037/a0027430 unterhitzenberger, haberstumpf, rosner, & pfeiffer 11 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://istss.org/getattachment/treating-trauma/new-istss-prevention-and-treatment-guidelines/istss_preventiontreatmentguidelines_fnl-march-19-2019.pdf.aspx https://istss.org/getattachment/treating-trauma/new-istss-prevention-and-treatment-guidelines/istss_preventiontreatmentguidelines_fnl-march-19-2019.pdf.aspx https://doi.org/10.1177/0165025416658136 https://doi.org/10.17169/fqs-1.2.1089 https://doi.org/10.1111/jcpp.12094 https://doi.org/10.1016/j.chiabu.2013.04.017 https://doi.org/10.1002/jts.21970 https://doi.org/10.1111/jcpp.12908 https://doi.org/10.1016/s0140-6736(11)60050-0 https://doi.org/10.1186/s13063-020-04922-x https://doi.org/10.1037/a0027430 https://www.psychopen.eu/ steel, j. l., dunlavy, a. c., harding, c. e., & theorell, t. (2017). the psychological consequences of pre-emigration trauma and post-migration stress in refugees and immigrants from africa. journal of immigrant and minority health, 19(3), 523-532. https://doi.org/10.1007/s10903-016-0478-z ter heide, f. j. j., mooren, t. m., & kleber, r. j. (2016). complex ptsd and phased treatment in refugees: a debate piece. european journal of psychotraumatology, 7(1), article 28687. https://doi.org/10.3402/ejpt.v7.28687 unterhitzenberger, j., wintersohl, s., lang, m., könig, j., & rosner, r. (2019). providing manualized individual trauma-focused cbt to unaccompanied refugee minors with uncertain residence status: a pilot study. child and adolescent psychiatry and mental health, 13, article 22. https://doi.org/10.1186/s13034-019-0282-3 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. therapists’ feedback on tf-cbt with refugees 12 clinical psychology in europe 2021, vol. 3(special issue), article e5431 https://doi.org/10.32872/cpe.5431 https://doi.org/10.1007/s10903-016-0478-z https://doi.org/10.3402/ejpt.v7.28687 https://doi.org/10.1186/s13034-019-0282-3 https://www.psychopen.eu/ therapists’ feedback on tf-cbt with refugees (introduction) method participants intervention data collection data analysis results additional content or techniques obstacles in treatment cultural factors in treatment most helpful for patient most helpful for therapist discussion conclusion (additional information) funding acknowledgments competing interests supplementary materials references burnout subtypes: psychological characteristics, standardized diagnoses and symptoms course to identify aftercare needs research articles burnout subtypes: psychological characteristics, standardized diagnoses and symptoms course to identify aftercare needs gianandrea pallich 1,2 , martin grosse holtforth 3,4, barbara hochstrasser 1 [1] center for psychiatry and psychotherapy, private hospital meiringen, meiringen, switzerland. [2] department of clinical psychology and psychotherapy, university of zurich, zurich, switzerland. [3] department of clinical psychology & psychotherapy, university of bern, bern, switzerland. [4] psychosomatic medicine, department of neurology, inselspital, bern university hospital, university of bern, bern, switzerland. clinical psychology in europe, 2021, vol. 3(3), article e3819, https://doi.org/10.32872/cpe.3819 received: 2020-06-04 • accepted: 2021-05-09 • published (vor): 2021-09-30 handling editor: martin hautzinger, university of tübingen, tübingen, germany corresponding author: gianandrea pallich, university of zurich, department of psychology, binzmühlestrasse 14, box 1, 8050 zurich, switzerland. e-mail: g.pallich@psychologie.uzh.ch supplementary materials: materials [see index of supplementary materials] abstract background: to better understand individual differences between burnout inpatients and improve individually tailored treatments in a psychiatric hospital, cluster analysis based on a number of self-report measures was used to investigate psychosocial characteristics of 96 participants. method: group membership was analyzed regarding associations with standardized measures of psychiatric and personality disorders. moreover, symptom levels of burnout, depression, and general mental health were used to characterize the groups and to observe differential trajectories at admission, discharge, and follow-up. results: as in previous research, we identified four subtypes that differed in comorbidity, psychological characteristics and treatment outcome. this calls for tailored interventions for the more vulnerable patients. conclusion: the replicated and enriched characterization of burnout inpatients can help to optimally meet the differential needs of burnout patients. keywords depression, burnout, aftercare needs, diagnoses, symptoms, cluster analysis, subtypes this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3819&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0002-0673-4879 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • four burnout subtypes were found: functional, dysfunctional, straightforward pragmatist, and unhappy altruist. • psychosocial characteristics and symptom levels at admission, discharge, and followup were described to better characterize the subtypes. • the replicated and enriched characterization of burnout inpatients improves individually tailored treatments. the importance of burnout the term burnout was introduced to the scientific discussion of psychological ailments in the 1970s by freudenberger as a label of a negative affective state after having been ex­ posed to continued work-related stress experiences (freudenberger, 1974). later, maslach and colleagues (maslach & jackson, 1981) embossed the concept of burnout, recognizing emotional exhaustion, depersonalization, and a reduced sense of personal accomplish­ ment with a sense of a diminished level of performance to be the key dimensions of this phenomenon. criticisms of this definition notwithstanding, the related questionnaire, the maslach burnout inventory (mbi), has become the gold standard in research and literature (burisch, 2014). since then, the phenomenon of burnout has been described in more than 60 different professions and professional subgroups (kaschka, korczak, & broich, 2011), showing a prevalence of burnout varying between 3.5% and 50% (nil et al., 2010). not surprisingly, the conception and improvement of the clinical treatment of burnout inpatients have also become an important research focus (hochstrasser, von bardeleben, ruckstuhl, & soyka, 2008). long-term effects of an inpatient treatment program for burnout due to the heterogeneity and multifactorial etiology of burnout, a multimodal and individual treatment has been shown to be warranted (hochstrasser et al., 2008; schwarzkopf, conrad, straus, porschke, & von, 2016). yet, the majority of studies on burnout interventions have not been performed with clinical samples, but in groups of volunteers who exhibited a level of burnout allowing them to maintain active engage­ ment at work (ahola et al., 2017; awa et al., 2010; van der klink et al., 2001). patients with burnout who need inpatient care are those who are more afflicted, i.e., those who suffer from clinical burnout. despite the importance of an adequate and effective inpatient treatment for burnout, to date, only few studies have examined the shortor long-term effects of inpatient treatment programs for burnout (elkuch et al., 2010; perski et al., 2017; schwarzkopf et al., 2016). a previous study (elkuch et al., 2010) examining a multimodal inpatient treatment at a private psychiatric hospital has found evidence of positive effects. treatment included cognitive-behavioral individual and group psy­ chotherapy, various relaxation techniques, body therapy, physical exercise, and psycho­ burnout subtypes 2 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ pharmacological treatment. however, one limitation of the previous study was that assessments were performed only at admission and at follow-up, but not at discharge. moreover, it has to be considered that the potential long-term effects of the inpatient treatment program and its sustainability may develop in the period between discharge and follow-up. thus, assessing patients at admission, discharge, and at follow-up allows the examination of the short-term effects and the unfolding process of long-term effects more accurately. the expected results promise to yield valuable information serving the ongoing optimization of the future inpatient treatment of burnout. the importance of characterizing patients discharged from inpatient treatment for burnout identifying burnout patients’ subtypes is crucial to tailoring treatment to patient charac­ teristics and thereby improving burnout treatment. at an empirical level, some studies have identified subjects with burnout symptoms as one of several types of respondents in the workforce. schaarschmidt and fischer (2001) used self-report data on personal experiences with work-related stress and typical coping behaviors using the avem questionnaire (work-related behavior and experience patterns; german: arbeitsbezo­ genes verhaltensund erlebensmuster; schaarschmidt & fischer, 1996) to empirically categorize subjects in the workforce. the avem assesses stress experiences and coping behaviors in three domains and 11 subscales of six items each: work commitment, resist­ ance to stress/emotions, and subjective well-being (schaarschmidt & fischer, 2001). the domains and subscales were identified by factor analyses of responses of 1598 subjects of diverse professions, and the avem has been subsequently used in various studies (schulz et al., 2011; voltmer et al., 2007, 2010, 2011). in the original study, schaarschmidt and fischer (2001) empirically identified four types of subjects based on scores in the 11 subscales: healthy (pattern g), unambitious (pattern s), overexertion (risk pattern a), and burnout (risk pattern b). in a recent study based on a sample of 1766 health care employees, leiter and maslach (2016) proposed five empirical profiles emerging from latent profile analyses of their dimensions of burnout (i.e., emotional exhaustion, depersonalization, and a reduced sense of personal accomplishment): burnout (high on all three dimensions), engagement (low on all three), overextended (high on exhaustion only), disengaged (high on cynicism only), and ineffective (high on inefficacy only). at a theoretical level, montero-marin and colleagues (montero-marín et al., 2009) proposed a three-partite classification of burnout patients based on a general proposal by farber (1991): frenetic (involved and ambitious subjects who sacrifice their health and personal lives for their jobs); under-challenged (indifferent and bored workers who fail to find personal development in their job); and worn-out (subjects who feel they have little control over results and that their efforts go unacknowledged). haberthür and colleagues (haberthür et al., 2009) empirically classified burnout inpatients using self-report data on various interpersonal and intrapersonal aspects of functioning, such pallich, grosse holtforth, & hochstrasser 3 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ as social support, interpersonal problems, coping styles, emotion regulation, and motiva­ tional incongruence. the authors identified four groups by cluster analyses: functional, dysfunctional, straightforward pragmatist, and unhappy altruist. for the current study, data were collected in the same private hospital and the same treatment unit as in the haberthür et al. study. to our knowledge, the results of haberthür et al.’s study (haberthür et al., 2009) have not been replicated yet. the study did not assess standardized clinical diagnoses of psychiatric disorders and personality disorders, or comorbid somatic diagnoses, nor did it assess outcome at discharge. the present study attempts to overcome these limitations and to replicate the former empirical classification of burnout inpatients to allow practitioners to tailor individual treatments to improve treatment outcomes. the self-reported person characteristics ex­ amined in haberthür et al.’s study were motivational incongruence (motive satisfaction), interpersonal problems, social support, regulation of emotions, and coping styles. in the current study, the self-report measures used for clustering were the same as those used by haberthür and colleagues, with the addition of as a self-report screening tool for personality dysfunction. refining the clinical assessment methodology, structured interviews for psychiatric diagnosis and personality disorder were conducted. at admis­ sion, discharge, and follow-up, we assessed levels of depression, general symptoms and burnout. a i m s the aims of this study are: 1. to constructively replicate and improve a previously empirically derived description and categorization of burnout inpatients in an analogous treatment setting according to psychosocial parameters; 2. to characterize the patients and patient groups according to psychiatric diagnostic criteria; 3. to observe how group membership corresponds to different levels of psychological symptoms (depression and burnout) and general mental health at admission, discharge, and follow-up. m a t e r i a l a n d m e t h o d sample, treatment, and recruitment the present study was approved by the ethics committee of the canton bern (switzer­ land) and was conducted in the private hospital meiringen. the sample comprised 96 inpatients of a specialized burnout ward. the therapeutic program includes individual psychotherapy, group therapy, relaxation techniques, body therapy, massages, sports activities and fitness instructions, psychopharmacotherapy, and selected interventions from complementary medicine (e.g., traditional chinese medicine). a detailed description of the treatment program can be found in hochstrasser et al. (2008). burnout subtypes 4 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ the specialized burnout ward admits only patients being referred by a physician, having a burnout syndrome that arose primarily in the context of the work environment, and with a diagnostically confirmed burnout syndrome at admission evaluated in a clini­ cal interview before admission. in this context, it is important to note that in the icd-10, burnout is not considered to qualify as an independent psychiatric disorder but is listed as a syndrome being associated with difficulties pertaining to life circumstances (i.e., icd-10, z.73.0). an association of burnout with mental disorders, especially depression, has often been described, such that a recent overview on the overlap between depres­ sion and burnout postulated that clinical burnout corresponds to an atypical depression (bianchi et al., 2015). consequently, various comorbid primary psychiatric diagnoses according to icd-10, chapter f, were given on the basis of a clinical interview and in accordance with the patients’ symptomatic presentation at admission. to be included, patients had to be at least 18 years old. patients were excluded if they exhibited current alcohol or drug addictions (if not stopped at admission), inability to participate in the treatment (e.g., due to psychological disorders or dementia), insufficient knowledge of the german language, or acute suicidality or psychotic symptoms. between february 2017 and december 2017, a total of 173 inpatients were asked to participate in the study, a total of 113 inpatients gave their consent, and, due to missing data in cluster-relevant questionnaires, a total of 96 individuals, n = 96, f = 33 (34.4%), m = 63 (65.6%), were included in the analyses. instruments during the first week after admission, participants completed paper-pencil versions of different questionnaires and participated in two clinical interviews (mini-dips and scid-ii) (fydrich et al., 1997; margraf, 2013) administered by the study psychologist. the discharge assessment was done in the last week of their stay, and the follow-up assess­ ment was administered three months after discharge via paper-pencil questionnaires sent by mail with a pre-paid return envelope. as in haberthür et al. (2009), psychological characteristics were measured using the following self-report instruments: first, a short version of the incongruence question­ naire (german: inkongruenzfragebogen, k-ink; grosse holtforth & grawe, 2003) was used to assess the degree of insufficient motivational satisfaction (approach incongru­ ence and avoidance incongruence). the german 32-item short version of the inventory for interpersonal problems was used to assess problematic interpersonal behaviors (iip­ sc; soldz, budman, demby, & merry, 1995; german: grosse holtforth, 2005). the 32 items are an equivalent subset of the german iip (iip-d; horowitz, strauss, & kordy, 2000). to measure the subjective appraisal of received or anticipated social support from persons in the social environment, the german short version of the questionnaire of social support was used (german: fragebogen zur sozialen unterstützung, f-sozu-k-22; fydrich, sommer, & brähler, 2007). to evaluate different ways of coping with stressful pallich, grosse holtforth, & hochstrasser 5 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ situations (task-oriented, emotion-oriented, avoidance-oriented), the german version of the coping inventory for stressful situations (ciss; kälin, 1995) was used. the ques­ tionnaire for the self-evaluation of emotional competency (german: fragebogen zur selbsteinschätzung emotionaler kompetenzen, sek; berking & znoj, 2008) was used to measure deficits and resources in emotion regulation with the following scales: attention, awareness of bodily sensations, clarity, understanding, regulation, acceptance, resilience, self-support, and goal-oriented readiness to confront. the scale scores can be summar­ ized by a total score. as mentioned before, previous studies did not assess personality and personality dysfunctions. to fill this gap, we added the inventory of personality or­ ganization (ipo-16; zimmermann et al., 2013) for clustering purposes. the 16-item short version of the inventory of personality organization (ipo-16) is a self-report measure assessing the severity of personality dysfunction. the level of symptoms and problems were assessed using the beck depression inventory (bdi; hautzinger et al., 1995), a brief version of the symptom checklist scl-90 (scl-9; klaghofer & brähler, 2001) and the maslach burnout inventory – human services survey (mbi-hss; maslach et al., 1997). the bdi is a self-report instrument assessing the degree of depressive symptomatology. the brief version of the symptom checklist assesses the general level of symptoms in one scale (hautzinger et al., 1995). the mbi-hss is considered the gold standard for burnout assessment and measures burnout in three dimensions (emotional exhaustion, depersonalization, and a sense of reduced personal effectiveness) (maslach et al., 1997). data analytical approach / statistical analysis all statistical analyses were performed using the spss program (version 23.0) and jamovi (version 0.8.6.0) (an interface program based on r). in a first step, a hierarchical cluster analysis (ward’s method) was performed to determine the appropriate number of clus­ ters. euclidean distance, which does not weigh outliers as strongly as the quadrated euclidean distance, was used. according to these criteria, a cluster solution of four groups was considered optimal. the following questionnaires and scales were used for clustering: the incongruence questionnaire (k-ink; approach and avoidance incongruence), the inventory for inter­ personal problems (iip-sc/iip-d; dominance and affiliation dimensions), the question­ naire of social support (f-sozu-k-22; general score), the self-report measure for the assessment of emotion regulation skills (sek; general score); the coping inventory for stressful situations (ciss; task-oriented coping, emotion-oriented coping, avoidance-ori­ ented coping) and the inventory of personality organization (ipo-16; general score). the number of clusters, i.e., four, corresponds to the number of clusters proposed by elkuch et al. (2010). on the basis of the solutions suggested by the hierarchical cluster analysis, we further calculated confirmatory k-means cluster analyses for four cluster solutions. to exclude bias resulting from differing scaling of the various variables, all burnout subtypes 6 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ cluster analyses were performed using z-standardized values. consequently, the values of the resulting groups were z-standardized and are presented as norm-related z-standar­ dized values (see figure 1). descriptive statistics were used to describe the frequencies of different clinical diagnoses and personality disorder diagnoses (see table 1). figure 1 z-standardized levels of psychological characteristics used for the formation of the four groups and duration of hospital stay (no grouping characteristic) bdi, scl-9, and mbi-hss were used to further characterize the groups (but not as factors to identify the groups) and to observe longitudinal development of symptoms. to evaluate differences in symptom levels among the resulting groups, we calculated a repeated measure analysis of variance (anova) (see figure 2). r e s u l t s sample description a total of 96 patients were included in the analyses. the mean age at admission was 48.02 years (sd = 8.78; 27.44 – 62.79 years). 33 (34.4%) of the participants were female, 63 (65.6%) were male. 50 married, 14 divorced, 25 singles, 3 separated, 1 widowed, and 1 unknown. the mean duration of the hospital stay was 57.31 days (sd = 16.04; 9 – 94 days). all the participants received medication during clinical stay. the duration between the time of discharge from the hospital and the follow-up assessment was 3 months. at follow-up, 14.6% participants were unemployed, 10.4% were fully employed, 33.3% were working part-time, 2.1% were working in their own household, 1.0% was in training for a different job, 3.1% were in a rehabilitation program, 6.3% were receiving a pension (i.e. an amount of money paid regularly by a government or company to somebody who has retired from work) or a disability pension (i.e. a form of pension given to those people who are permanently or temporarily unable to work due to a disability), and the employment status of 29.1% was unknown. in comparison to before the impatient stay, 6.3% were unemployed, 49.0% were fully employed, 20.8% were working part-time, pallich, grosse holtforth, & hochstrasser 7 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ table 1 main psychiatric diagnoses, presence of an additional psychiatric diagnosis, presence of an additional somatic diagnosis, and personality disorders for the four groups at admission total sample functionals dysfunctionals straightforward pragmatists unhappy altruists main psychiatric diagnoses (mini-dips) f31.x (bipolar disorder) 5.21% (n = 5) 5.88% (n = 1) 15.79% (n = 3) 0.00% (n = 0) 2.70% (n = 1) f32.x (major depressive disorder, single episode) 34.37% (n = 33) 17.65% (n = 3) 15.79% (n = 3) 43.48% (n = 10) 45.95% (n = 17) f33.x (major depressive disorder, recurrent) 46.87% (n = 45) 47.05% (n = 8) 57.90% (n = 11) 39.13% (n = 9) 45.95% (n = 17) f43.x (reaction to severe stress, and adjustment disorders) 6.25% (n = 6) 11.76% (n = 2) 5.26% (n = 1) 13.04% (n = 3) 0.00% (n = 0) missing 7.29% (n = 7) 17.65% (n = 3) 5.26% (n = 1) 4.35% (n = 1) 5.40% (n = 2) presence of comorbid psychiatric diagnoses (mini-dips) 33.33% (n = 32) 23.52% (n = 4) 42.08% (n = 8) 24.21% (n = 6) 37.80% (n = 14) presence of comorbid somatic diagnoses 33.33% (n = 32) 35.28% (n = 6) 31.56% (n = 6) 21.75% (n = 5) 40.50% (n = 15) avoidant personality disorder (pd) & obsessivecompulsive pd (possibly comorbid with additional pd) 6.25% (n = 6) 0.00% (n = 0) 21.05% (n = 4) 4.35% (n = 1) 1.70% (n = 1) avoidant pd (possibly comorbid with additional pd) 4.17% (n = 4) 5.88% (n = 1) 5.26% (n = 1) 0.00% (n = 0) 5.41% (n = 2) obsessive-compulsive pd (possibly comorbid with an additional pd) 23.96% (n = 23) 5.88% (n = 1) 21.05% (n = 4) 34.78% (n = 8) 27% (n = 10) other pd 5.21% (n = 5) 5.88% (n = 1) 10.52% (n = 2) 4.35% (n = 1) 1.70% (n = 1) no pd 60.42 (n = 58) 82.35% (n = 14) 42.11% (n = 8) 56.52% (n = 13) 62.16% (n = 23) burnout subtypes 8 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ 1.0% was working in their own household, none was in training, in a rehabilitation program, or receiving a pension / disability pension, and the employment status of 22.9% participants was unknown. psychosocial characteristics generally, the group labels are intended to be maximally comprehensive summaries of the respective characteristics. with the current sample and measures, we found that the obtained clusters corresponded closely to the previous grouping by haberthür et al. (2009), so that we decided to keep the previous labels: (a) functional, (b) dysfunctional, (c) straightforward pragmatist, and (d) unhappy altruist. functionals participants categorized in this group, n = 17, f = 3 (17.6%), m = 14 (82.4%), experienced little avoidance incongruence (z = -1.43) and approach incongruence (z = -1.36). the figure 2 repeated anovas for the four groups (functionals, dysfunctionals, straightforward pragmatists and unhappy altruists) at intake, discharge and follow-up for bdi and scl and at intake and follow-up for the three dimensions of mbi (emotional exhaustion, depersonalization and sense of reduced personal effectiveness) pallich, grosse holtforth, & hochstrasser 9 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ patients mentioned few interpersonal problems (z = -1.32) and having good social sup­ port (z = 0.43). in addition, they reported good emotional competences (z = 1.13). the functionals group used many task-oriented (z = 0.87) but just a few emotion-oriented (z = -1.45) coping strategies. they reported having little personality dysfunctions (z = -1.10). in general, they had a shorter stay in the hospital (z = -1.35). most of the participant in the group of functionals had an f33.x (i.e., major depres­ sive disorder, recurrent) diagnosis (n = 8, 47.05%), three (17.65%) had an f32.x (i.e., major depressive disorder, single episode) diagnoses, two (11.76%) an f43.x (i.e., reaction to severe stress, and adjustment disorders diagnoses) and one (5.88%) an f31.x (i.e., bipolar disorder) diagnoses. a total of four (23.52%) had a secondary psychiatric diagnosis (e.g., f10.1, f40.2, f41.0, f42.2). six participants (35.29%) of this group additionally had one or more somatic diagnoses (e.g., e78.0, g44.0, g44.2, h95.1, i10.90, i10.91, r05, r73.1, z61, z62, z73). for three participants it was not possible to use the mini-dips for assessing standardized diagnoses. most of the participants categorized in the group of the functionals showed no personality disorder (82.35%, n = 14). dysfunctionals compared to the other three groups, participants categorized in the group of dysfunc­ tionals, n = 19, f = 7 (36.8%), m = 12 (63.2%), showed the highest average approach incongruence (z = 0.87) as well as avoidance incongruence (z = 0.91). they showed strong interpersonal problems (z = 1.07). additionally, they reported least social support (z = -1.17), generally insufficient emotional competence (z = -0.43) and mainly emotional coping (z = 0.80) and little task-oriented (z = -1.19) and avoidance-oriented (z = -1.08) coping strategies. in addition, they reported many personality dysfunctions (z = 1.32). in general, they had a longer stay in the hospital (z = 1.06). most of the participants in this group had an f33.x diagnosis (n = 11, 57.90%), three (15.79%) had an f32.x diagnosis, three (15.79%) an f31.x diagnosis and one (5.26%) an f43.x diagnosis. a total of eight (42.12%) had a secondary psychiatric diagnosis (e.g., f13.2, f40.2, f41.0, f41.1, f42.1, f43.1, f50.5). six participants (31.59%) of this group additionally had one or more somatic diagnoses (e.g., a49.8, e03.9, e14.91, e78.5, g40.9, g43.9, g47.0, g47.39, i10.9, j45.0, m54.4, n48.0). one participant was not diagnosed systematically with mini-dips. the dysfunctionals showed the highest association with a combination of avoidant and obsessive-compulsive personality disorders (21.05%, n = 4), and a high percentage had an obsessive-compulsive personality disorder (21.05%, n = 4) or other personality disorders (10.52%, n = 2). burnout subtypes 10 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ straightforward pragmatists on average, this group, n = 23, f = 13 (56.5%), m = 10 (43.5%), showed more avoidance incongruence (z = 0.25) than approach incongruence (z = -0.13). generally, they reported a low level of interpersonal problems (z = -0.06). this group reported having good social support (z = 1.14). they generally had good emotional competences (z = 0.45). they reported using emotional coping (z = 0.46) and task-oriented coping (z = 0.78) at similar levels. this group showed average personality dysfunction (z = 0.00). the hospital stay was a little higher than average (z = 0.18). most of the participants in this group had an f32.x diagnosis (n = 10, 43.48%), nine (39.13%) had an f33.x diagnosis, three (13.04%) an f31.x diagnosis and none (0.00%) an f41.x diagnosis. a total of six (26.09%) had a secondary psychiatric diagnosis (e.g., f40.0, f40.2, f41.0, f44.4, f50.3). five participants (21.74%) of this group additionally had one or more somatic diagnoses (e.g., e66.99, g35.9, g43.9, g47.31, h93.1, i10.90, i49.8). for one participant it was not possible to use the mini-dips for assessing standardized diagnoses. the group of the straightforward pragmatists showed the highest prevalence of obsessive-compulsive personality disorder compared to the other groups. unhappy altruists the members of this group, n = 37, f = 10 (27.0%), m = 27 (73.0%), showed higher average approach incongruence (z = 0.62) than avoidance incongruence (z = 0.27). overall, they tended to show above-average scores in interpersonal problems (z = 0.31). additionally, they reported bad social support (z = -0.40). furthermore, this group showed an emotion­ al competence below the average (z = -1.16). the members of this group primarily used emotion-oriented coping strategies (z = 0.19) and few task-oriented coping strategies (z = -0.46). this group showed little personality dysfunction (z = 0.22). the hospital stay was a little longer than average (z = 0.10). seventeen participants (45.95%) of this group had an f32.x diagnosis. seventeen participants 45.95%) had an f33.x diagnosis, and one participant (2.70%) had an f31.x diagnosis. no participants were diagnosed with f43.x in this group. a total of fourteen patients in this group (37.83%) had a secondary psychiatric diagnosis (e.g., f10.1, f13.2, f40.1, f40.2, f41.0, f44.2, f61.0). fifteen participants (40.54%) had one or more somatic diagnoses in addition (e.g., d17.3, e11.90, e78.0, g25.0, g25.81, g43.0, g43.9, g47.1, g47.31, h93.1, h93.3, i10.90, k91.1, m17.9, m19.91, m53.0). for two participants it was not possible to use the mini-dips for assessing standardized diagnoses. the group of the unhappy altruists, similar to the group of the straightforward pragmatists, showed a higher percentage of obsessive-compulsive personality disorder compared to the other groups. pallich, grosse holtforth, & hochstrasser 11 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ symptom course in groups of burnout patients data were analyzed using repeated measures anovas for depression, general symp­ toms, and burnout with a within-subjects factor (admission, discharge, follow-up) and a between-subject factor of subtypes (functional, dysfunctional, straightforward pragma­ tist, and unhappy altruist). for missing values, list-wise deletion of cases was applied. for the three mbi dimensions, there were just two measured time points (admission and follow-up). only for the repeated measures anova for depression, the mauchly’s test indicated that the assumption of sphericity had been violated, therefore degrees of freedom were corrected using greenhouse-geisser estimates of sphericity (ε = 0.876). for the interested reader we report mean, median, standard deviation and range for bdi, scl and mbi for the four groups (i.e. functional, dysfunctional, straightforward pragmatist and unhappy altruist) in the supplementary material depression (beck depression inventory, bdi) a repeated measures anova (see figure 2) with a greenhouse-geisser correction showed that mean depression scores differed significantly between time points, f(1.75, 127.86) = 117.55, p < .001, ηp2 = .617, and between groups, f(3, 73) = 4.46, p < .01, ηp2 = .158. the interaction between time and groups was also significant, f(5.25, 127.86) = 2.51, p < .05, ηp2 = .093. post hoc tests revealed that the depression scores for the functionals group was the lowest and differed highly significantly from those of all other groups regarding (p < .001). for the remaining groups, depressive symptoms were higher at admission, all at similar and non-significantly different levels. at discharge, levels of depressive symptoms did not differ significantly between the four groups. however, at follow-up, the average depression levels of the functional and dysfunctional groups differed significantly (p < .05), and also a significant difference between functionals and unhappy altruists (p < .05) was found. all patient groups showed a significant decrease of depressive symptoms from admission to discharge (p < .05). whereas functionals, straightforward pragmatists, and unhappy altruists reported no significant increase of depressive symptoms between discharge and follow-up, the dysfunctionals showed a significant increase of depressive symptoms (p < .05). general symptoms (brief symptom checklist, scl) a repeated measures anova (see figure 2) showed that the mean general symptoms scores differed significantly between time points, f(2, 154) = 53.23, p < .001, ηp2 = .409, and between groups, f(3, 77) = 7.24, p < .001, ηp2 = .220. the interaction between time and groups was also significant, f(6, 154) = 2.60, p < .05, ηp2 = .092. the functionals had the lowest symptom level, and the dysfunctionals the highest at admission, discharge, and follow-up. straightforward pragmatists and unhappy altruists showed similar levels of general symptoms, with levels being lower than those of dysfunctionals but higher compared to the functional group at all three measurement points. post hoc tests burnout subtypes 12 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ revealed that at admission, the functionals differed highly significantly regarding the general symptoms from the dysfunctional and straightforward pragmatists (p < .01) and significantly from the unhappy altruists (p < .05). the group of dysfunctionals differed highly significantly from the group of unhappy altruists (p < .01) and significantly from the group of straightforward pragmatists (p < .05). regarding general symptoms at discharge, no significant differences could be found between the four groups. at follow-up dysfunctionals differed from all other groups (p < .05). all groups showed a significant decrease of symptoms between admission and discharge (p < .05). whereas dysfunctionals and straightforward pragmatists showed significant increases of symp­ toms between discharge and follow-up (p < .05), this was not the case for the functionals and the unhappy altruists. burnout (maslach burnout inventory, mbi) a repeated measures anova for the dimension of emotional exhaustion showed a sig­ nificant difference between admission and follow-up, f(1, 71) = 56.87, p < .001, ηp2 = .445, and between groups, f(3, 71) = 3.10, p < .05, ηp2 = .116. the interaction between time and groups was not significant. post hoc tests revealed that regarding emotional exhaustion, all groups showed a significant (p < .01) decrease between admission and follow-up. functionals and dysfunctionals showed a significantly different level of emotional ex­ haustion at admission (p < .01). a second repeated measures anova for mbi for the dimension of depersonalization showed a significant difference between admission and follow-up, f(1, 71) = 11.83, p < .001, ηp2 = .143, and between groups, f(3, 71) = 4.54, p < .01, ηp2 = .161. the interaction between time and groups was not significant. post hoc tests showed that functionals dif­ fered from dysfunctionals and unhappy altruists significantly concerning depersonali­ zation at admission (p < .05). additionally, dysfunctionals differend from straightforward pragmatists (p < .05). dysfunctionals’ and unhappy altruists’ level of depersonalization decreased significantly (p < .05) between admission and follow-up. a last repeated measures anova for the third mbi dimension, the sense of reduced personal effectiveness, showed a significant difference between admission and follow-up, f(1, 71) = 4.61, p < .05, ηp2 = .061, and no significant difference between groups. the interaction between time and groups was not significant. in a post hoc analysis, unhappy altruists reported, as the only group, a significant (p < .05) improvement in the sense of reduced personal effectiveness. d i s c u s s i o n in the present study, we set out to reproduce the results and improve the previous descriptions of burnout inpatients of haberthür and colleagues (2009). first, a cluster analysis was used to group burnout patients. second, we characterized the burnout pallich, grosse holtforth, & hochstrasser 13 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ patients according to psychosocial parameters. additionally, the groups were described regarding their residual symptoms at admission, discharge, and follow-up. finally, we described the psychiatric, somatic, and personality disorder diagnoses of the sample. four groups were identified based on clustering (i.e., functional, dysfunctional, straight­ forward pragmatist, and unhappy altruist). the functional group was characterized by low levels of motivational incongru­ ence, interpersonal problems, emotion-oriented coping, and personality dysfunction and showed good social support, emotional regulation, and mainly task-oriented and avoid­ ance-oriented coping. the members of the dysfunctional group had an almost reversed profile showing high levels for incongruence, interpersonal problems, emotion-oriented coping, and personality dysfunction in addition to low social support, emotional reg­ ulation, taskand avoidance-oriented coping. the other two groups (straightforward pragmatists and unhappy altruists) did not show characteristically extreme values in the above-mentioned variables. straightforward pragmatists reported good social support, emotional competences, and using all three coping strategies. unhappy altruists repor­ ted levels of incongruence and interpersonal problems a little above average, low social support, and emotional competences as well as stronger use of emotion-oriented than task-oriented or avoidance-oriented coping strategies. all psychosocial characteristics of the functional group could be reproduced without exception as described by haberthür and colleagues (2009). the group of the dysfunc­ tionals had similar psychosocial parameters as found in the previous study, with the exception of task-oriented coping that was found to be low instead of average. for the other groups (i.e., straightforward pragmatists and unhappy altruists), we found similar psychosocial parameters as in the previous study. only the emotional competence of the straightforward pragmatists was found to be high and not average, and reported levels of emotional competence and social support of the unhappy altruists were found to be low instead of average. above and beyond replicating the description by psychosocial parameters, also psy­ chiatric, somatic, and personality disorder diagnoses were assessed for the four subtypes of burnout patients. the standardized assessment of psychiatric diagnoses showed most of the participants of the groups of functionals and dysfunctionals having a recurrent major depressive disorder. furthermore, most of the participants in the group of the straightforward pragmatists had a single major depressive disorder. finally, the partic­ ipants of the group of the unhappy altruists had the same frequency of recurrent major depressive disorder and single major depressive disorder. interestingly, all groups showed some comorbidity of somatic diagnoses. around one third of the functionals and dysfunctionals had, in addition to psychiatric diagnoses, also a somatic diagnosis, whereas around one quarter of the group of the straightforward pragmatists had a somatic diagnosis. finally, 40.50% of the unhappy altruists had a diagnosis of a somatic disorder. burnout subtypes 14 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ in previous studies, a high level of overlap between burnout and depression sympto­ matology was found in all groups of burnout patients, to the point that it has been suggested that clinical burnout may rather be a form of depression (bianchi et al., 2015). the dgppn (berger et al., 2012) proposed to consider depression as a common consequence of prolonged burnout. yet, the temporal relationship between burnout and depression remains unclear (ahola & hakanen, 2007). in order to require inpatient care, burnout patients are likely to be more strongly affected and more impaired regarding daily functioning, which might bias the sample we examined towards those with a depressive disorder or other mental disorders. functionals showed almost no personality disorders, dysfunctionals had a higher prevalence of personality disorders (especially avoidant pd in combination with obses­ sive-compulsive pd and obsessive-compulsive pd), and both straightforward pragma­ tists and unhappy altruists showed a high prevalence of obsessive-compulsive pd. the results of the ipo-16, assessing the severity of personality dysfunction, seem to confirm these findings, indicating similar personality dysfunctions as found through scid-ii for the four groups (very low for functionals, very high for dysfunctionals, average for straightforward pragmatists, and low for unhappy altruists). these findings could be relevant for planning tailored treatments for burnout patients considering that treatment of personality disorder is a major goal of psychotherapy interventions for all groups except the functionals. symptom level at admission, discharge, and follow-up was assessed for the four groups using the bdi, the scl, and the mbi. generally, all four groups improved signif­ icantly between admission and discharge regarding depressive symptoms and overall symptom level. dysfunctionals showed an increase of depressive symptoms between discharge and follow-up. dysfunctionals and straightforward pragmatists showed a sig­ nificant increase of general symptoms between discharge and follow-up. this worsening should be considered for discharge planning for the group of straightforward pragma­ tists and even more so for the dysfunctionals. particularly for dysfunctionals, increased attention to discharge planning and more intensive support after leaving the clinic seems indicated. practical implications this study suggests that it is of great importance to attend to the relevant psychological characteristics of burnout patients, and that applying our categorization early in the process could improve the success of treatment and discharge planning. this may be done by clinical judgment or, if available, also by using structured assessment tools. de­ pending on burnout group membership, the needs of inpatients are likely to be different. as indicated by group label, functionals generally show more benign characteristics and are more likely to improve during the inpatient treatment, an effect that appears sus­ tained during follow-up. under the perspective of optimal resource allocation, frequent pallich, grosse holtforth, & hochstrasser 15 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ monitoring of patients’ mental health might suffice to meet their needs for care after discharge. in contrast, our data suggest that the group of dysfunctionals may need the most in­ tensive inpatient treatment and well-organized psychosocial aftercare. our data suggest that increasing the level of a patient’s motivational satisfaction needs to be an important treatment goal, and the identification of the individual sources of motivational incongru­ ence will help to select targeted interventions. also, due to strong interpersonal prob­ lems, lower levels of perceived social support, and insufficient emotional competence, assertiveness training (rakos, 1991), activation of the patient’s social network (perry & pescosolido, 2015; pescosolido & levy, 2002; smith & christakis, 2008), as well as training of emotional skills (berking, 2015; cherniss, 2000; pallich et al., 2020) might be suitable interventions. the enhancement of a task-oriented coping style and related skills may be an important target for longer-term treatment of this group. whereas straightforward pragmatists showed rather unproblematic profiles at admis­ sion with regard to psychological characteristics, they showed significant increases of symptoms between discharge and follow-up. for this reason, assessment during inpatient treatment should exceed patient self-reports to not miss relevant stressors that patients might not be able or willing to report. in addition, the formulation of crisis-response plans may be indicated, as well as close symptom monitoring after discharge. finally, also unhappy altruists, who show interpersonal problems above the average, bad social support, and emotional competence below the average, could profit from as­ sertiveness training (rakos, 1991) and a training of emotional competence (berking, 2015; cherniss, 2000; pallich et al., 2020). this group, who showed higher levels of approach incongruence and avoidance incongruence, indicating dissatisfaction of motives, should be analyzed more deeply during treatment. targeted interventions may be selected after recognizing individual sources of motivational incongruence to increase the level of patients` motivational satisfaction. finally, especially for the group of unhappy altruists, who show the highest rate of comorbid somatic diagnoses, it is suggested to consider specific interventions and treatment for somatic problems. additionally, an assessment of personality disorders (fydrich et al., 1997) seems indi­ cated particularly for straightforward pragmatists and unhappy altruists, who generally show a high percentage of comorbidity with personality disorder diagnoses. during the inpatient stay and after discharge, a long-lasting psychotherapeutic treatment with a focus on personality disorder should be implemented (sachse, 2013). especially strategies for avoidant and obsessive-compulsive personality disorders could play an important role (sachse, 2013). the present findings should be considered in light of some methodological limita­ tions. first, the sample was relatively small and recruited in only one clinic, and sample sizes of the groups resulting from cluster analysis differed considerably (n = 17 to n = 37). second, because of the heuristic nature of this study, we omitted corrections of burnout subtypes 16 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ the significance levels for multiple testing (e.g., bonferroni). additionally, the intervals between assessments were different across the sample as the length of inpatient stay varied. this may have affected symptom scores at discharge and follow-up. furthermore, follow-up data were collected only three months after discharge and the patient sample consists of patients of an inpatient ward of one psychiatric hospital in one country and is therefore not representative for the population of burnout patients. future research should replicate the classification of former patients in different, larger, and more diverse samples. an additional follow-up later in time could be more informative regarding relapse and promote the development of tailored interventions for the different groups. following up inpatients months or even years after discharge could provide further information about potential difficulties patients may encounter in the long run regarding the course of symptoms and especially relapse risk for different groups. additionally, different and tailored intervention programs for acute treatment and maintenance care for the different burnout types should be developed and tested. those programs should focus on the individual needs and the tailored therapeutic interventions of the different groups, as mentioned above. we assume that observing such a differentiated treatment approach will increase the probability of an effective and long-lasting successful treatment outcome. further long-term data collection will allow evaluating the effects of more tailored programs on the basis of assessed burnout subtypes in service of further optimizing the acute treatment and aftercare of burnout patients. the development of tailored treatment programs for the different subtypes of burnout patients and their long-term evaluation will be an important next step to optimize the acute treatment and aftercare of burnout patients. conclusion to the best of our knowledge, this is the first study to constructively replicate and improve the attempt to categorize burnout inpatients of haberthür and colleagues (2009). overall, we were able to replicate and improve the characterization of the four different groups: functional, dysfunctional, straightforward pragmatist, and unhappy altruist. additionally, we described psychiatric, somatic, and personality disorder diagnoses. we further showed the symptoms course in the four groups of burnout patients. these findings support the proposition that burnout is a heterogeneous phenomenon. for clini­ cians it is necessary to consider these different characteristics of burnout inpatients in order to assure an individually tailored treatment program and corresponding discharge and aftercare planning. future research should focus on tailored treatment programs depending on different subtypes of burnout patients. pallich, grosse holtforth, & hochstrasser 17 clinical psychology in europe 2021, vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ funding: the project was funded by the private hospital meiringen. the private hospital meiringen was not involved in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. acknowledgments: we thank dr. roberto la marca from the university of zürich who provided expertise that greatly assisted the research, julia ricciardi for her support in the data collection, petra wehrli for her supervised support in data entry and analyses, and the participating patients for their cooperation. competing interests: gianandrea pallich and barbara hochstrasser worked at the burnout ward of the private hospital meiringen. martin grosse holtforth declares that he has no conflict of interest. s u p p l e m e n t a r y m a t e r i a l s in the supplementary materials we report mean, median, standard deviation and range for bdi, scl and mbi for the four groups (i.e. functional, dysfunctional, straightforward pragmatist and unhappy altruist) (for access see index of supplementary materials below). index of supplementary materials pallich, g., grosse holtforth, m., & hochstrasser, b. 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vol. 3(3), article e3819 https://doi.org/10.32872/cpe.3819 https://www.psychopen.eu/ burnout subtypes (introduction) the importance of burnout long-term effects of an inpatient treatment program for burnout the importance of characterizing patients discharged from inpatient treatment for burnout aims material and method sample, treatment, and recruitment instruments data analytical approach / statistical analysis results sample description psychosocial characteristics symptom course in groups of burnout patients discussion practical implications conclusion (additional information) funding acknowledgments competing interests supplementary materials references implicit attitudes toward psychotherapy and explicit barriers to accessing psychotherapy in youths and parent–youth dyads research articles implicit attitudes toward psychotherapy and explicit barriers to accessing psychotherapy in youths and parent–youth dyads simone pfeiffer 1 , ashley huffer 1, anna feil 1, tina in-albon 1 [1] department of clinical child and adolescent psychology and psychotherapy, university of koblenz-landau, landau, germany. clinical psychology in europe, 2022, vol. 4(3), article e7375, https://doi.org/10.32872/cpe.7375 received: 2021-08-23 • accepted: 2022-06-14 • published (vor): 2022-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: simone pfeiffer, clinical child and adolescent psychology and psychotherapy, university of koblenz-landau, ostbahnstraße 12, 76829 landau, germany. phone: +49 6341 280 35615. e-mail: pfeiffer-s@unilandau.de abstract background: few studies have investigated implicit and explicit attitudes toward psychotherapy in youths (study 1), although information about attitudes would improve interventions that aim to decrease barriers to accessing psychotherapy including parents (study 2), who facilitate the helpseeking process of youths. method: the study 1 sample comprised 96 youths (14–21 years) and the study 2 sample 38 parent–youth dyads. differences in implicit attitudes regarding psychotherapy and a medical treatment were measured with the implicit association test, and psychotherapy knowledge and self-reported barriers to psychotherapy were assessed with questionnaires. the actor-partner interdependence model was used to test the dyadic effects of implicit attitudes on explicit attitudes in parents and youths. results: we did not find evidence for an implicit bias toward psychotherapy compared to a medical treatment, neither in youths, nor in parents. self-reported barriers were a predictor for lower help-seeking intentions. deficits in psychotherapy knowledge were more relevant in younger participants. having a prior or current experience with psychotherapy and having a friend or family member with a prior or current experience with psychotherapy were predictors for better psychotherapy knowledge, but was not for lower barriers to accessing psychotherapy. partner effects (degree to which the individual’s implicit attitudes are associated with explicit attitudes of the other dyad’s member) were not found. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7375&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0002-6866-8221 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: specific deficits in psychotherapy knowledge should be addressed in interventions to lower barriers accessing psychotherapy. parents should be included in interventions as a valuable resource to support youths in seeking psychotherapy for mental disorders. keywords implicit association test, psychotherapy, barriers, mental disorders, stigma, youths highlights • implicit attitudes toward psychotherapy were comparable with attitudes toward a medical treatment. • youths reported explicit barriers to accessing psychotherapy and exhibited deficits in psychotherapy knowledge. • interventions aiming to reduce barriers to accessing psychotherapy should address specific knowledge deficits in youths. • parents should be included in interventions as a valuable resource to support youths in seeking psychotherapy for mental health problems. stigmatizing attitudes toward people with mental disorders as a barrier of help-seeking have been widely studied (aguirre velasco et al., 2020; gulliver et al., 2010; radez et al., 2021), however, there is a lack of studies investigating attitudes toward mental health care, especially psychotherapy, in youths. in their mental illness stigma framework, fox and colleagues (2018) distinguish between experienced stigma and internalized stigma as a consequence of self-disclosure and anticipated stigma toward psychotherapy (the extent to which a person with a mental disorder expects to be the target of stereotypes, prejudice, or discrimination in the future), which is the focus of our study. in adult samples, negative attitudes toward mental health care use, especially the presence of stigma, low perceived efficacy of treatments, or the desire to handle the problem on their own, are the most common barriers to seek treatment for mental disorders (andrade et al., 2014; mojtabai et al., 2011; van voorhees et al., 2006). when asked specifically about psychotherapy, adults have reported mainly positive attitudes (petrowski et al., 2014) yet also that they would be ashamed if neighbors and friends knew about the use of psychotherapy (albani et al., 2013). most of those studies use explicit measures to assess attitudes toward mental health care, implicit measures however can elicit more spontaneous responses than explicit measures, whereas explicit measures are related to deliberative decisions about the con­ formation or rejection of attitudes. there is evidence that the assessment of implicit and explicit attitudes are distinct measures with a rather weak relationship and the need to consider (negative) attitudes as a multifaceted construct (brauer et al., 2000). the combination of implicit and explicit measures to assess barriers toward psychotherapy might be promising in capturing the complexity of attitudes toward psychotherapy. implicit and explicit attitudes toward psychotherapy 2 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ studies investigating implicit attitudes toward mental disorders using the implicit association test (iat) found that adults reported a more negative implicit attitude to­ ward people with mental disorders than toward people with a physical illness (gonzálezsanguino et al., 2020; teachman et al., 2006). o’driscoll et al. (2012) found higher stigmatization for a vignette describing an individual with depression compared to an individual with attention-deficit/hyperactivity disorder in boys, but not in girls. in a sample of young adults, depression was associated with more implicit, but not explicit, negative attitudes compared to a physical illness (monteith & pettit, 2011). little is known about the effects of implicit attitudes toward psychotherapy with regard to low treatment rates for mental disorders in youths and negative attitudes toward people with mental disorders. negative attitudes are influenced by gender, age, and personal experience with men­ tal disorders and help seeking. in men compared to women, there is evidence of lower help-seeking intentions for mental health problems (addis & mahalik, 2003; oliver et al., 2005; petrowski et al., 2014) and less mental health knowledge (farrer et al., 2008). boys compared to girls have reported higher mental health stigma and less willingness to use mental health services (calear et al., 2011; chandra & minkovitz, 2006; gonzalez et al., 2005). further, there is evidence that higher age is associated with higher mental health knowledge and a less stigmatizing attitude (farrer et al., 2008; swords et al., 2011) and more acceptance of peers with mental disorders (swords et al., 2011). a prior experience with a mental disorder or psychotherapy, or familiarity with someone who has a mental disorder, which is associated with less stigmatizing attitudes in children, youths, and adults (bellanca & pote, 2013; griffiths et al., 2008; sandhu et al., 2019) may be seen as protective factors for stigmatizing attitudes. the identification of possible risk factors (e.g., gender, specific age group) might enable to develop ageor gendertailored interventions to reduce barriers toward psychotherapy or interventions, which include contact to a person with a prior experience of psychotherapy. parental role in attitudes toward psychotherapy children and youths often prefer informal sources of help for mental disorders, such as parents (rickwood et al., 2005). when assessing attitudes toward psychotherapy in youths, it is important to include parental attitudes, as they are important key gatekeep­ ers to mental health care access and as they also report negative attitudes toward mental health care (reardon et al., 2017). despite youths’ growing autonomy, their decision to seek professional help for mental health problems is highly influenced by their parents (gulliver et al., 2012; rickwood et al., 2005; ryan et al., 2015), who are often the first to recognize mental health problems in their children and the need for help. in their model for a parent-mediated pathway to mental health services for adolescents, logan and king (2001) emphasized the important role of parent’s attitudes toward mental health care in the help-seeking process of their child. pfeiffer, huffer, feil, & in-albon 3 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ youths’ willingness to seek help is higher when they think their parents support the use of mental health services (chandra & minkovitz, 2006; wahlin & deane, 2012) and lower when they think their parents would be ashamed of them because of their mental health problems (moses, 2009). little is known about whether youths report similar attitudes toward mental health to those of their parents. there is evidence that youths seem to agree with their parents’ evaluation of the helpfulness of mental health services (jorm & wright, 2007) but that parents and youth differ in their knowledge and explicit attitudes toward mental disorders, with youths showing higher stigma scores and less mental health knowledge compared to their parents (lorona & miller-perrin, 2016). there is, however, a lack of research evaluating implicit and explicit attitudes toward psychotherapy and their relationship which each other in parent–youth dyads. aims of the study in study 1, the first aim was to compare implicit attitudes toward psychotherapy with attitudes toward a medical treatment using the iat (greenwald et al., 1998). we decided to contrast psychotherapy with a medical treatment to control for attitudes that are generally associated with help-seeking behavior for (mental) health problems (e.g., being confronted with symptoms of [psycho]pathology). in this study, we were particularly interested if attitudes differ about consulting a pediatrician or general practitioner for health-related symptoms versus a psychotherapist for mental health problems. the second aim was to assess explicit barriers to accessing psychotherapy as well as psy­ chotherapy knowledge in youths and their influence on help-seeking intentions, for which we used a self-report questionnaire. we hypothesized that higher positive implicit attitudes toward psychotherapy compared to a medical treatment, higher psychotherapy knowledge, and lower explicit barriers to accessing psychotherapy would be associated with higher help-seeking intentions. as there are gender and age differences in attitudes toward mental health care, we evaluated if male participants reported more negative attitudes toward psychotherapy than female participants and if negative attitudes toward psychotherapy decrease with age. the analysis of differences between different educa­ tion levels were analyzed exploratively. we further expected fewer barriers to accessing psychotherapy and better psychotherapy knowledge in participants with a prior or current experience with psychotherapy and in those who had a friend or family member involved in psychotherapy. in study 2, we investigated parents and youths’ implicit and explicit attitudes (barriers) toward psychotherapy and their relationship considering the dyadic structure of the data. implicit and explicit attitudes toward psychotherapy 4 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ s t u d y 1 method participants a total of 96 youths between the age of 14 and 21 years participated in this study (m = 18.4 years, sd = 2.1). in this sample, 68% self-identified as female and 32% as male. in terms of education, 69% attended a secondary school, 21% a university, and 10% a voca­ tional school. nineteen percent had a prior or current experience with psychotherapy and 72% rated the experience as positive. in all, 72% were familiar with someone having sought or seeking psychotherapy and 78% rated that person’s experience as positive. participants were recruited online via social media and in local secondary schools. the inclusion criterion to participate in the study was being between 14 and 21 years of age. we chose the age of 14 years because youth can participate in studies without a written parental consent and 21 years as this is the age limit for child and adolescent psychotherapy in germany. measures implicit association test (iat) — the iat (greenwald et al., 1998) is a computerized dichotomous categorization task measuring association strengths between concepts and attributes. the outcome measure is response time (milliseconds), with shorter latencies indicating stronger automatic associations of concepts with the stimulus group. the key iat assumption is that participants show faster reaction times when stimuli are paired in ways that are consistent versus inconsistent with well-learned automatic associations, that is, implicit biases. the iat is a relative assessment; that is, evaluations of one group are compared with evaluations of a second group (greenwald et al., 1998). regarding the concepts, psychotherapy and a medical treatment were compared using words as stimuli. psychotherapy was primed with words psychotherapist, psycho­ therapist’s practice, psychological conversation, psychology, and children’s and adolescents’ psychotherapist; medical treatment was primed with general practitioner, general practi­ tioner’s practice, medical exam, medicine, and pediatrician. we chose positive and negative attributes associated with psychotherapy (maier et al., 2014). positive attributes were pro­ fessional, effective, trustworthy, competent, and meaningful and negative attributes were unprofessional, ineffective, untrustworthy, incompetent, and meaningless. the categoriza­ tion of concepts and attributes was checked in advance with four youths that correctly assigned the priming words to the concepts and the attributes. in our pilot study, we evaluated time-differences for concepts and attributes and did not find differences between the concept “medical treatment” and “psychotherapy”, t(8)= 0.87, p = .38 or between the attributes “positive” and “negative”, t(8)= 0.29, p = .77. the iat was constructed with online-survey software, a valid and reliable approach (carpenter et al., 2019) using sosci-survey (leiner, 2019). the iat consists of seven pfeiffer, huffer, feil, & in-albon 5 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ “blocks” (sets of trials) and in each block, participants see a stimulus (word) on the screen. stimuli represent concepts (medical treatment or psychotherapy) or attributes (positive negative). when stimuli appear, the participant “sorts” the stimulus as rapidly as possible by pressing with either their left or right hands on the keyboard (the “e” an “i” keys). the sides with which one should press are indicated in the upper left and right corners of the screen. if the target word was a member of the category listed on the left side of the screen, the participants were to respond with the e key. if the target word was a member of the category listed on the right side of the screen, the participants were to respond with the i key. a correct response was required before continuing to the next slide and response latencies were recorded from the presentation of the stimulus to the correct response. the initial pairing of concepts and attributes was counterbalanced across participants. the interstimulus interval was 300 ms. block 1 is used to practice the two categories; participants distinguished between the target categories of medical treatment and psychotherapy. the priming words were presented in a random order and were distinguished by designated keys on the left or right side of the keyboard (e.g., left for medical treatment, right for psychotherapy). block 2 is used to practice the attributes (positive vs. negative); participants distinguished positive attributes from negative attributes presented on the screen. block 3 is the first pairing of categories and attributes; participants distinguished between medical treatment and positive attributes versus psychotherapy and negative attributes by pressing the designated keys. block 4 repeats the block 3 pairings. in block 5, responses to the positive attributes and negative attributes are reversed. both blocks 6 and 7 are test blocks that consist of the second category and attribute pairing; participants distinguished between medical treatment and negative attributes versus psychotherapy and positive attributes. the order in which each pairing was presented and associated with the key on the right or left side of the keyboard (blocks 3 and 4 vs. blocks 6 and 7) was randomized. barriers to accessing psychotherapy — to assess explicit barriers to accessing psy­ chotherapy, we developed a self-report questionnaire. first, we conducted a literature review on attitudes toward psychotherapy, from which we drew 13 statements (table 1). in a pilot study, youths (n = 9) rated the comprehensibility of the statements on a 6-point likert scale (1 = totally disagree, 6 = totally agree). to explore the factor structure, the 13 items were subjected to an exploratory analysis with oblique rotation. the kaiser–mey­ er–olkin (kmo) measure verified the sampling adequacy for the analysis (kmo = 0.85). bartlett’s test of sphericity, χ2(78) = 406.72, p < .001, indicated that the correlation struc­ ture was adequate for factor analysis. a maximum likelihood factor analysis with a cutoff point of .40 and kaiser’s criterion of eigenvalues greater than 1 yielded a one-factor solution as the best fit for the data, with the root mean square of residuals = 0.06, the root mean square error of approximation = 0.08, and the tucker–lewis index = 0.96, an acceptable value considering it is over 0.9. one item (“i would prefer other treatment implicit and explicit attitudes toward psychotherapy 6 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ options than psychotherapy”) did not load on the factor and was excluded from further analyses. internal consistency was good with mcdonald’s omega = 0.88. help-seeking intention and familiarity with psychotherapy — we asked partici­ pants to rate their anticipated probability of initiating psychotherapy in the event of serious mental health problems (0–100%) and to indicate if they had current or past experience with psychotherapy themselves, and if they had a friend or family member who had current or past experience with psychotherapy. they also rated whether the experience (or reported experience) was positive (1) or negative (0) using a dichotomous item. the items were taken from a previous study (pfeiffer & in-albon, 2022). psychotherapy knowledge — we assessed psychotherapy knowledge with a self-de­ veloped questionnaire with 11 statements based on a literature search (e.g., knowledge about the professional confidentiality, the nonpsychoanalytical setting, multifactorial causes of mental disorders), which are listed in table 3. six licensed psychotherapists rated the statements for correctness and we made adjustments in two steps. first, we used fleiss’s kappa to measure interrater reliability. we found κ = 1 (perfect agreement) for nine of the items and lower kappas for item 1 (κ = .5) and item 5 (κ = .33). these two items were then revised and rated again, resulting in perfect interrater agreement of κ = 1 for all items. participants were asked to indicate if the statements were true or false or to indicate that they did not know the answer (“i don’t know”). before conducting the pilot-study, we conducted a pretest with four youths who rated the statements for sufficient feasibility, which lead to the revision of one item because of the use of professional jargon. procedure the local ethics committee approved the study (reference number: lek_262). parents and youths were informed about the content and aims of the study. written consent in accordance with the declaration of helsinki from parents and youths was mandatory for participants. we conducted a pilot study in advance with n = 9 youths to test the feasibility of the study design. parents and youths received a link and a qr code to participate in the online study. study duration was 20-25 minutes. researcher were available to answer questions during the study. participants did not receive compensation. data processing and statistical analyses statistical analyses were conducted with r (version 4.03). for the evaluation of implicit attitudes, we used the improved d score (greenwald et al., 2003), which measures the strength and direction of the implicit association. we included all participants who pfeiffer, huffer, feil, & in-albon 7 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ completed the study. reaction times faster than 300ms and slower than 10 seconds were excluded from further evaluation (n = 1). positive improved d scores suggest a stronger association between medical treatment and positive attributes than psychotherapy and negative attributes. negative d scores suggest that the association between psychotherapy and positive attributes is higher compared to medical treatment and negative attributes. for psychotherapy knowledge, we calculated the total score using the number of correct answers (correct answer = 1; wrong answer or “i don’t know” = 0). exploratively, we examined if implicit attitudes toward psychotherapy and barriers to accessing psy­ chotherapy as well as psychotherapy knowledge varied with gender, age, or education using a multivariate analysis of variance and multiple regression analysis. an apriori power analysis was conducted with g*power (faul et al., 2007). for the manova a sample size of n = 84 is necessary to detect a small effect, f2 = 0.10, 1-ß = 0.95, α = 0.05. for the multiple regression analysis, a sample size of n = 70 is necessary to detect a small effect, f 2 = 0.10, 1-ß = 0.95, α = 0.05. multiple regressions were calculated to determine if implicit attitudes toward psychotherapy and barriers to accessing psychotherapy as well as psychotherapy knowledge predict higher help-seeking intentions. multiple regressions were also calculated to determine if a prior or current experience with psychotherapy or familiarity with someone seeking psychotherapy predicts fewer negative implicit attitudes toward psychotherapy, fewer barriers to accessing psychotherapy, and better psychotherapy knowledge. we used dummy variables with 1= prior or current experi­ ence and 0= the absence of a prior or current experience. results iat we did not find evidence for a stronger association neither for positive nor for negative attributes with psychotherapy compared to a medical treatment with an improved d score of m = 0.09 (sd = 0.41). barriers to accessing psychotherapy the descriptive statistics regarding explicit barriers to accessing psychotherapy indicate an overall moderate agreement with barriers (table 1). help-seeking intention and familiarity with psychotherapy the intention to seek psychotherapy in the event of mental health problems had a median of 60% (range 0–100%). multiple linear regressions indicated an overall effect for implicit attitudes, explicit barriers and psychotherapy-knowledge as predictors for helpseeking intentions, r 2 = .23, f(3, 91) = 8.91, p < .001, with a significant effect in explicit barriers to accessing psychotherapy as predictor for lower help-seeking intention, b = implicit and explicit attitudes toward psychotherapy 8 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ -1.20, ß = -0.45, ci 95% [-1.71, -0.69], se_b = 0.25, t(91) = -4.72, p < .001, whereas implicit attitudes, b = -0.43, ci 95% [-0.63, 1.49], ß = 0.08, se_b = 0.53, t(91) = 0.81, p =.42 and psychotherapy knowledge, b = 0.07, ci 95% [-0.11, 0.26], ß = 0.08, se_ b = 0.09, t(91) = 0.82, p = .41 were not associated with higher or lower help-seeking intentions. table 1 barriers to accessing psychotherapy in study 1 (youths) and study 2 (youth–parent dyads) item study 1 youths study 2 youths study 2 parents m (sd) m (sd) m (sd) 1. i would be afraid that psychotherapy would make my problems worse. 2.45 (1.18) 2.79 (1.42) 2.34 (1.28) 2. i would be concerned that my problems would not be treated confidentially. 3.03 (1.57) 2.29 (1.35) 2.26 (1.37) 3. i would think that starting psychotherapy costs money and is too expensive. 2.57 (1.50) 2.71 (1.56) 2.21 (1.18) 4. i would be afraid that the psychotherapist would judge me or think something bad about me. 2.50 (1.47) 2.05 (1.14) 1.63 (0.91) 5. i would be afraid that the psychotherapist would admit me to a psychiatric facility against my will. 3.23 (1.48) 2.84 (1.41) 2.26 (1.18) 6. i would think a psychotherapist doesn’t understand my problems. 2.95 (1.37) 3.45 (1.78) 3.63 (1.75) 7. i had negative previous experiences with psychologists/psychotherapists. 2.94 (1.51) 2.26 (1.41) 1.74 (0.95) 8. my parents/my environment would not support me in starting psychotherapy. 2.90 (1.41) 2.16 (1.20) 4.55 (1.35) 9. i would be concerned that starting psychotherapy would say something bad about my family. 3.28 (1.55) 2.58 (1.18) 2.34 (1.02) 10. i would be afraid of not knowing what happens during psychotherapy. 3.39 (1.52) 2.45 (1.25) 2.39 (1.20) 11. i would be afraid to talk about my problems with a psychotherapist. 3.06 (1.41) 3.05 (1.45) 3.05 (1.63) 12. i wouldn’t think psychotherapy would help. 2.58 (1.47) 3.47 (1.61) 4.34 (1.65) total score 2.60 (0.88) 2.67 (0.84) 2.94 (0.49) note. items were rated on a 6-point likert scale (1 = totally disagree, 6 = totally agree). multiple regression analysis were conducted to investigate if a prior or current experi­ ence of psychotherapy or familiarity with a person seeking psychotherapy are predictors of levels in implicit attitudes (model 1), r 2 = .00, f(2, 92) = 1.08, p = 0.34, barriers toward psychotherapy (model 2), r 2 = .00, f(2, 93) = 0.48, p = 0.61, and psychotherapy knowledge (model 3), r 2 = .22, f(2, 93) = 14.21, p < .001, and are reported in table 2. pfeiffer, huffer, feil, & in-albon 9 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ table 2 results from multiple regression analysis for prior or current experience of psychotherapy and familiarity with people seeking psychotherapy as predictors for implicit attitudes (model 1), explicit barriers (model 2), and psychotherapy knowledge (model 3) estimates b se beta (β) t p model 1 (implicit attitudes) intercept 0.14 0.08 0.00 1.75 .08 experience_pt 0.15 0.71 -0.14 -1.35 .18 familiarity -0.04 0.09 -0.04 -0.42 .67 model 2 (explicit attitudes] intercept 2.70 0.17 0.00 15.65 < .001 experience_pt -0.20 0.23 -0.09 -0.85 0.40 familiarity -0.08 0.20 -0.04 -0.38 0.70 model 3 (psychotherapy knowledge) intercept 4.33 0.43 0.00 9.98 < .001 experience_pt 2.00 0.59 0.31 3.40 < .001 familiarity 1.87 0.51 0.33 3.66 < .001 note. experience_pt = prior or current experience with psychotherapy. psychotherapy knowledge participants’ psychotherapy knowledge is reported in table 3. age, gender, and education differences in implicit attitudes, explicit barriers, and psychotherapy knowledge contrary to our expectations, we did not find gender differences, f(3, 93) = 2.09, p = .13, or differences between education levels, f(3, 93) = 0.15 p = .87, in implicit attitudes toward psychotherapy, explicit barriers to accessing psychotherapy, or psychotherapy knowledge as a result of a manova. we conducted a single predictor regression analysis to examine if age is associated with implicit attitudes, explicit barriers, and psychotherapy knowledge and found a significant overall effect, r 2 = .12, f(3, 91) = 3.99, p < .001. higher age was associated with higher psychotherapy knowledge, b = 0.29, ci 95% [0.12, 0.47], ß = 0.35, se_b = 0.09, t(91) = 3.42, p < .001, however age was not a predictor for implicit attitudes, b = 0.32, ci 95% [-0.68, 1.32], ß = 0.06, se_b = 0.50, t(91) = 0.63, p = .53, or explicit barriers seeking psychotherapy, b = 0.31, ci 95% [-0.17, 0.79], ß = 0.13, se_b = 0.24, t(91) = 1.30, p = .20. implicit and explicit attitudes toward psychotherapy 10 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ s t u d y 2 method participants in study 2, 38 parent–youth dyads participated. the youths (mage = 18.5 years, sd = 2.0, range: 14–21) had not participated in study 1. here, 68% identified themselves as female. in terms of education, 37% attended a secondary school, 57% a university, 6% a vocational school. the parent sample had an age range of 38–62 years (m = 49.6 b, sd = 5.7) and 76% identified themselves as female. twenty-nine percent had a prior or current experience table 3 percentages of correct, incorrect, and “i don’t know” answers for psychotherapy knowledge items item correct answer (%) incorrect answer (%) i don’t know (%) 1. the costs of psychotherapy are usually covered by health insurance. 47 13 41 2. during psychotherapy, the patient is usually lying on a couch. 77 5 18 3. in a psychotherapy patients take an active part in the decision making concerning the psychotherapy process. 58 7 34 4. mental illnesses often manifest as physical symptoms, e.g., abdominal pain and headaches. 67 14 20 5. over 40% of all people meet the criteria of a mental disorder during their lifetime. 49 7 44 6. the origin of mental disorders is exclusively genetic. 81 4 15 7. the effectiveness of psychotherapy is proven by scientific studies. 53 6 41 8. from the age of 15, i am allowed to start psychotherapy without the consent of my parents. 17 6 77 9. a psychotherapist is allowed to speak with my parents about the content of my psychotherapy without my consent. 72 7 21 10. health insurance pays for trial sessions to find out if i want to work with the therapist. 34 5 60 11. a therapist helps me become an expert on my own problems. 50 11 39 note. percentages do not sum up to 100% due to rounding. pfeiffer, huffer, feil, & in-albon 11 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ with psychotherapy and 64% of them rated the experience as positive. seventy-nine percent were familiar with people having sought or seeking psychotherapy, with 77% rating the reported experience as positive. measures the iat and explicit barriers measure were identical to those in study 1. regarding help seeking, youths were asked if they thought they would receive support from their parents, and parents were asked if they would seek support from their close network. procedure the procedure was identical to that in study 1. parents and youths were asked to create the same code to assign the parent-youth dyad. data processing and statistical analysis statistical analyses were conducted with r (version 4.03). the data treatment was iden­ tical to study 1. three participants were excluded from further analysis because their codes did not match with a corresponded code. descriptive statistics and welch sample t-tests for implicit attitudes and barriers toward psychotherapy between youths and parents were calculated. considering the dyadic structure of the data we conducted an actor-partner-interde­ pendence model (apim) using the lavaan package for structural equation modelling (sem). apims are useful for exploring the dynamic interplay between relational partners, in our case parents and youths (kenny, kashy, & cook, 2006). this model is based on the fact that the scores within the same dyad are not independent but instead are more similar than the scores of two individuals, who are not in the same dyad. the apim is useful to determine how parameters (explicit and implicit attitudes) among youth and parent are influenced by not only internal factors but also factors related to the other member of the dyad. structural equation modeling simultaneously examines both paths in the apim: two actor effects (i.e., each person’s implicit attitudes regressed on his or her own explicit attitudes) and two partner effects (i.e., each person’s implicit attitudes regressed on the other person’s explicit attitudes). results consistent with the results of study 1, we did not find evidence for a stronger association neither for positive nor for negative attributes with psychotherapy compared to a medi­ cal treatment with an improved d score of m = 0.04 (sd = 0.47) for youths and m = 0.12 (sd = 0.51). means and standard deviations for barriers toward psychotherapy are reported in table 2. analyzing mean scores, parents and youths did differ in explicit attitudes, t(44) = 2.88, p = .01, but not in their implicit attitudes, t(73) = 0.70, p = .46. implicit and explicit attitudes toward psychotherapy 12 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ the results of the apim analysis for explicit attitudes and implicit attitudes are set out in figure 1. the goodness of fit measures were good with χ2(n = 38, 6) = 18.68, p = .01, cfi = 1.00, tli = 1.00, rmsea = 0.00, srmr = 0.00 with except for the chi-square test, which is however sensitive to sample size. the actor effect for youths was significant with implicit attitudes being a predictor for explicit attitudes in youths, which has not been the case for the parent sample. there was no evidence for a partner effect. figure 1 path diagram of the actor-partner-interdependence model (apim) with implicit attitudes being a predictor for explicit attitudes implicit attitudes youth explicit attitudes youth implicit attitudes parent explicit attitudes parenta2-0.10 (0.08), p= 0.31 ci 95% [-0.30, -0.16] a1 0.97 (0.25), p<.001 ci 95% [0.42, -1.56] p21 0.01 (0.09), p= 0.90, ci 95% [-0.13, -0.12]) p12 0.03 (0.23), p= 0.87, ci 95% [-0.47 -0.36]) c1 0.03 (0.04), p= 0.46, ci 95% [-0.05 -0.10]) c2 0.05 (0.03), p= 0.08, ci 95% [-0.01 -0.11]) e1 e2 note. a1, a2 = actor effect; p12, p21 = partner effect; c1 = covariance of implicit attitudes between parent and youth; c2 = residual non-independence of explicit attitudes. ***p < .001. g e n e r a l d i s c u s s i o n in contrast to the higher stigmatization of mental disorders when compared to physical illnesses (gonzález-sanguino et al., 2020; teachman et al., 2006), psychotherapy was not more stigmatized when evaluating implicit attitudes in comparison to a medical treatment. this result is in line with findings of mainly positive explicit attitudes toward psychotherapy in a general nonclinical adult sample (petrowski et al., 2014). the youth sample in the present study did, however, agree with explicit specific barriers to access­ ing psychotherapy, probably reflecting more negative attitudes when confronted with pfeiffer, huffer, feil, & in-albon 13 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ the idea of actual help seeking instead of psychotherapy in general, which is consistent with findings in adults (albani et al., 2013). higher barriers to accessing psychotherapy were also, as expected, associated with lower help-seeking intentions, which is consistent with findings in adult samples regarding attitudes toward mental health care (andrade et al., 2014; mojtabai et al., 2002; van voorhees et al., 2006). regarding psychotherapy knowledge, the results were mixed (see table 2) revealing deficits in psychotherapyknowledge. interventions aiming to increase mental health knowledge should include information about the setting and general framework of psychotherapy to facilitate the decision to access it. in our sample, higher psychotherapy knowledge was not associated with higher help-seeking intentions, but the interpretation of the results is limited by the high number of youths indicating knowledge deficits. we did not find gender differences for implicit attitudes toward psychotherapy, ex­ plicit barriers to accessing psychotherapy, or psychotherapy knowledge. in contrast to other studies that found gender differences for mental health knowledge and attitudes toward mental health care use (chandra & minkovitz, 2006; gonzalez et al., 2005), we focused specifically on psychotherapy, which might represent a different construct from mental health care in general that includes treatment in inpatient settings and psychopharmacotherapy. overall, there are few studies evaluating gender differences in this field of research in youths. the results indicate less psychotherapy knowledge in younger youths compared to participants with older youths, which is consistent with other findings (farrer et al., 2008; swords et al., 2011). barriers to accessing psychotherapy seemed to increase with age and were associated with lower help-seeking intentions. more research is necessary to determine age-related factors to improve interventions aiming to lower barriers to accessing psychotherapy in specific age groups. having a prior or current experience with psychotherapy and being familiar with someone with a prior or current experience with psychotherapy were predictors for higher psychotherapy-knowledge, but surprisingly not with fewer implicit and explicit attitudes toward psychotherapy. however, the interpretation of this result is limited, as we had only a small sample of those seeking psychotherapy and a lack of further information (e.g., number of sessions). when we analyzed the data from parent–youth dyads, we found evidence of similar implicit attitudes toward psychotherapy. comparable with study 1, psychotherapy was not more highly stigmatized than medical treatment in youths as well as in parents. the dyadic analyses for implicit and explicit attitudes based on the apim revealed an actor effect for youths with implicit attitudes being a predictor for explicit attitudes, meaning that higher improved-d scores (a stronger association between medical treatment and positive attributes than psychotherapy and negative attributes) were predictors for more negative explicit attitudes. this might be evidence for a higher congruency in youths implicit and explicit attitudes, whereas parents’ explicit attitudes were not predicted by implicit and explicit attitudes toward psychotherapy 14 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ their implicit attitudes. we did not find partner effects for parents’ implicit attitudes being a predictor for youths’ explicit attitudes and vice versa. the covariance between youths and parent implicit and explicit attitudes were also non-significant. to sum up, parental explicit and implicit attitudes toward psychotherapy seem to be independent from youths` explicit and implicit attitudes with youths reporting less explicit barriers than parents. this might be due to a higher awareness of mental disorders and their treatment by exposure to interventions (e.g., in schools) aiming to increase mental health knowledge and decrease stigmatizing attitudes toward people with mental disorders (reavley & jorm, 2012). these results also indicate that interventions aiming to decrease barriers of help-seeking for mental disorders are well invested in youths who build their attitudes more and more independently of their parent’s attitudes when transitioning into adulthood. however, these results also emphasize the need to include parents in interventions to lower barriers to seeking psychotherapy, as they play an important role in supporting their children during the professional help-seeking process (logan & king, 2001). lowering barriers to accessing psychotherapy in parents might increase recogni­ tion of their child’s need for help and encourage them to search for professional help in the event of mental health problems. in conclusion, the results suggest that interventions or campaigns promoting a positive image of psychotherapy might be less relevant than intervention focusing on the reduction of specific barriers toward psychotherapy and deficits in psychotherapy-knowledge. there is evidence that parents should be included in interventions as a valuable resource to support youths in the help-seeking process for a mental disorder. limitations there are some limitations with regard to the use of the iat to assess implicit attitudes toward psychotherapy (see meissner et al., 2019). we did not assess whether a negative evaluation of psychotherapy predicts actual help-seeking behavior, as we assessed only help-seeking intentions. we also chose to contrast psychotherapy with a medical treat­ ment, assessing the relative strength of the associations with the attributes. for this reason, we do not know if psychotherapy is perceived as positive, negative or neutral, the only knowledge we have is that psychotherapy is not perceived more negatively com­ pared to a medical treatment. future studies might choose different implicit measures, for example, a single iat (teige-mocigemba et al., 2008) to evaluate the association of psychotherapy with attributes independent of a reference to a medical treatment. the age differences might also pose problems as older participants may have very different needs and knowledge compared to younger participants. the gatekeeper role accessing mental health treatment might vary with age and further analyses are neces­ sary to determine to which extend parents are still important gatekeeper for youths in their transition to adulthood. although youths in emerging adulthood get more and more autonomous, parents still play an important role in their life might be an important pfeiffer, huffer, feil, & in-albon 15 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://www.psychopen.eu/ source to discuss sensitive topics (jiang et al., 2017), for example mental health problems and treatment use. in the parent sample, we had higher participation of mothers (76%) compared to fathers. the sample size was low for dyadic data analysis with an insuffi­ cient power of 0.7 to detect an actor effect in youths and a power of 0.05 to detect a partner effect for parents, whereas the power was good with 0.8 to detect an actor effect in parents and 1.00 to detect a partner effect in youths. therefore, analysis should be conducted with a larger sample size. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s addis, m. e., & mahalik, j. r. 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(2012). discrepancies between parentand adolescent-perceived problem severity and influences on help seeking from mental health services. the australian and new zealand journal of psychiatry, 46(6), 553–560. https://doi.org/10.1177/0004867412441929 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. implicit and explicit attitudes toward psychotherapy 20 clinical psychology in europe 2022, vol. 4(3), article e7375 https://doi.org/10.32872/cpe.7375 https://doi.org/10.1007/s00127-006-0091-x https://doi.org/10.1177/0004867412441929 https://www.psychopen.eu/ implicit and explicit attitudes toward psychotherapy (introduction) parental role in attitudes toward psychotherapy aims of the study study 1 method results study 2 method results general discussion limitations (additional information) funding acknowledgments competing interests references external locus of control but not self-esteem predicts increasing social anxiety among bullied children research articles external locus of control but not self-esteem predicts increasing social anxiety among bullied children belinda graham 1,2 , lucy bowes 1 , anke ehlers 1,2 [1] department of experimental psychology, university of oxford, oxford, united kingdom. [2] oxford health nhs foundation trust, oxford, united kingdom. clinical psychology in europe, 2022, vol. 4(2), article e3809, https://doi.org/10.32872/cpe.3809 received: 2020-06-01 • accepted: 2022-01-20 • published (vor): 2022-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: belinda graham, oxford centre for anxiety disorders and trauma, department of experimental psychology, the old rectory, paradise square, ox1 1tw, u.k. e-mail: belinda.graham@psy.ox.ac.uk abstract background: elevated social anxiety is more likely among bullied children than those who have not been bullied but it is not inevitable and may be influenced by cognitive factors. lower selfesteem and more external locus of control are associated with bullying and social anxiety but the impact of these factors over time among bullied children is less clear. method: children from the uk avon longitudinal study of parents and children (alspac) reported bullying experiences at age 8 (n = 6,704) and were categorized according to level of bullying exposure. the impact of self-esteem and locus of control on social anxiety was assessed up to age 13 across the bullying exposure groups using multi-group latent growth curve analysis. complete data was available for 3,333 participants. results: more external locus of control was associated with a steeper increase in social anxiety among severely bullied children [b = .249, p = .025]. although self-esteem at age 8 was associated with existing social anxiety it did not predict later increases in social anxiety. conclusion: these results indicate that beliefs about lack of personal control among severely bullied children may contribute to increasing social anxiety over time. exploring related cognitions may be helpful in this potentially vulnerable group. keywords alspac, bullying, social anxiety, locus of control this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3809&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0002-3073-617x https://orcid.org/0000-0001-5645-3875 https://orcid.org/0000-0002-8742-0192 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • childhood bullying increases risk of social anxiety. • for severely bullied children this risk is exacerbated by external locus of control. • exploring beliefs around lack of personal control may be helpful. social anxiety is characterised by excessive fears of coming across badly or being judged harshly by others in social situations (american psychiatric association, 2013; world health organisation, 1992) and can lead to avoidance and poorer performance in school, work, and relationships (e.g., stein & kean, 2000; van ameringen et al., 2003). it is a chronic treatable condition (bruce et al., 2005) that is maintained by unhelpful cognitions (clark & wells, 1995). childhood bullying increases the risk of developing social anxiety (arseneault, 2018; pontillo et al., 2019) with higher risk conferred by more frequent exposure (copeland et al., 2013) but not all bullied children are socially anxious and identifying subgroups at risk may inform prevention and intervention. previous crosssectional research has identified locus of control (reknes et al., 2019) and self-esteem (wu et al., 2021) as modifiers of the relationship between bullying and mental health outcomes. in this longitudinal study, we evaluate the impact of locus of control and self-esteem on social anxiety over time among children with different levels of bullying exposure. better understanding factors that contribute to the unfolding of social anxiety symptoms in young people over time could inform targeted and developmentally appro­ priate approaches to treatment. bullying is generally understood to include aggressive interpersonal acts that are in­ tentional, repeated, and include a power imbalance between the victim and the aggressor (olweus, 1994). prevalence rates vary according to the measure of bullying used, setting and child age. one survey found rates of 8.7-14.4% for frequent bullying and 26.8-38.1% for occasional bullying over a 10-year period in england (chester et al., 2015). bullying experiences are classified as overt events like hitting, threatening or name calling, and relational events that use social power to inflict hurt by excluding, ignoring, gossiping or telling lies behind someone’s back. experiences like these can be socially traumatic (wild & clark, 2011) and contribute to the onset and maintenance of anxiety disorders (norton & abbott, 2017) including social anxiety (hackmann et al., 2000). of note, problematic social anxiety commonly arises during adolescence, with rates of onset peaking around age 13 (kessler et al., 2005). among adults with anxiety disorders, those suffering with social anxiety are particularly likely to report having been bullied or teased when they were younger (mccabe et al., 2003, 2010). increased risk of elevated long-term anxiety af­ ter bullying is evident from retrospective studies (gladstone et al., 2006) and prospective data (copeland et al., 2013; gladstone et al., 2006; sourander et al., 2007; stapinski et al., 2014). therefore, it is well established that bullying increases risk of social anxiety. however, mechanisms are less well understood. locus of control and social anxiety in bullied children 2 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ locus of control (nowicki & duke, 1974) refers to the extent to which someone believes the outcomes of events or behaviours to be under personal control (internal) or down to luck or chance (external). internal locus of control is associated with better wellbeing while external locus of control is associated with negative outcomes such as depression (zhang et al., 2014) and higher levels of ptsd, for example among survivors of combat (karstoft et al., 2015) and children exposed to stressful political life events (hallis & slone, 1999). it is possible that these outcomes are driven by associations with thinking and coping styles, such that internality is associated with positive thinking and help-seeking, while externality is associated with avoidance and helplessness (reknes et al., 2019). research has shown that adolescents who are victims of bullying generally have a more external locus of control compared with peers not involved in bullying (radliff et al., 2016) and among severely bullied adolescents those with more external locus of control also had higher risk of psychotic symptoms (fisher et al., 2013). of note, reknes et al. (2019) suggested that externality may contribute to a diminished sense of personal responsibility that is actually protective for adult victims of workplace bullying, as they may more readily attribute negative experiences externally. this may suggest a reduced risk of negative outcomes for bullied children who have a more external locus of control. however, no longitudinal studies have specifically investigated locus of control as a mechanism driving social anxiety among bullied children. low self-esteem refers to an unfavourable attitude towards the self (rosenberg, 1979) and may be informed by negative social interactions including experiences of bullying that are internalised (van geel et al., 2018). cross-sectional studies show that lower self-esteem is associated with bullying (brito & marluce, 2013; o’moore & kirkham, 2001) and cyberbullying (patchin & hinduja, 2010) but cannot speak to the direction of the effect, such that although bullying may contribute to reducing self-esteem it is also possible that children with lower self-esteem are more likely to be targeted (van geel et al., 2018). wu et al. (2021) found that self-esteem explained some of the cross-sec­ tional relationship between bullying and social anxiety among adolescents, but did not investigate causation due to the study design. in this study we investigate longitudinally whether lower self-esteem increases the risk of social anxiety among children who are bullied. cognitive models suggest that negative beliefs maintain social anxiety (clark & wells, 1995) and ptsd (ehlers & clark, 2000). for social anxiety, beliefs are commonly connected in meaning to past experiences of humiliation or rejection (wild et al., 2007) and include themes of personal capacity to perform adequately and appear acceptable to other people (e.g., “i am inadequate”). for ptsd, beliefs are commonly connected with the traumatic event and its sequelae and include themes about loss of control in terms of personal reactions (e.g., “i cannot handle stress”) and the environment more broadly (e.g., “the world is completely dangerous”). of note, these maintaining cognitions related to self and past or future events are not limited to explicit thoughts, but rather include imagery graham, bowes, & ehlers 3 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ and “felt sense” that is highly emotional (ehlers et al., 2004; hackmann et al., 2000). beliefs consistent with external locus of control and low self-esteem may be fruitful targets for cognitive interventions with bullied children if these factors negatively impact anxiety trajectories in this group. the current study assessed the moderating effects of locus of control and self-esteem on social anxiety among children using a three-wave longitudinal design over five-years, from age 7.5 to 13. the goal of this study was to assess whether externality of locus of control and self-esteem at age 8 influence the trajectory of social anxiety among children up to the age of 13, and whether the impact of these cognitive factors differs depending on bullying exposure. therefore, this study hypothesized that (1) social anxiety will increase from age 7.5 to 13; (2) children exposed to more severe peer victimisation will have higher initial social anxiety and steeper increase in social anxiety over time; (3) lower self-esteem, and (4) more external locus of control will predict higher initial social anxiety and steeper increase over time for those with more severe victimization experiences. m e t h o d this sample was drawn from the avon longitudinal study of parents and children (alspac) which is a large prospective observational study of health and development in children. pregnant women resident in avon, uk during 1991-2 were invited to take part in the study. of 14,541 pregnancies initially enrolled, there was a total of 14,676 foetuses, resulting in 14,062 live births and 13,988 children who were alive at 1 year of age. when the oldest children were approximately 7 years of age, an attempt was made to bolster the initial sample with eligible cases who had failed to join the study originally. the number of new pregnancies not in the initial sample (known as phase i enrolment) is 913 (456, 262 and 195 recruited during phases ii, iii and iv respectively). the phases of enrolment are described in more detail in the cohort profile paper and its update (boyd et al., 2013; fraser et al., 2013). the total sample size is therefore 15,454 pregnancies, resulting in 15,589 foetuses, of whom 14,901 were alive at 1 year of age. this includes multiple births. participant flowchart shown in figure 1. informed consent for the use of data collected via questionnaires and clinics was obtained from participants following the recommendations of the alspac ethics and law committee at the time. please note that the study website contains details of all the data that is available through a fully searchable data dictionary and variable search tool (http://www.bristol.ac.uk/alspac/re­ searchers/our-data/). this project proposal received approval from alspac executive committee [b2804]. locus of control and social anxiety in bullied children 4 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 http://www.bristol.ac.uk/alspac/researchers/our-data/ http://www.bristol.ac.uk/alspac/researchers/our-data/ https://www.psychopen.eu/ figure 1 participant flowchart attended clinic at age 8 (i.e., eligible for this study), n = 7,278 complete information on all variables, n = 3,333 data available on peer victimisation at age 8, n = 6,704 complete information on bullying and social anxiety, n = 4,175 missing data on social anxiety, n = 2,529 enrolled in phases i, ii, iii, iv, n = 14,676 fetuses excluded, n = 7,679: died, n = 92 untraceable, n = 627 withdrawn, n = 505 multiple birth, n = 404 did not attend clinic at age 8, n = 6,069 miscarriages and still births, n = 614 fetuses liveborn children, n = 14,062 additional enrolments, n = 913 missing data on peer victimisation age 8, n = 574 missing data on one or more covariatesa, n = 842 aprior emotional problems (strengths and difficulties questionnaire), locus of control (nowicki-strickland internal-external scale), self-esteem (harter’s self-perception profile for children). data available at www.bristol.ac.uk/alspac/researchers/cohort-profile/ participants in total 7,278 participants attended clinic assessment at age 8 making them eligible for this study. of these, 6,704 provided data on bullying exposure, of whom 2,529 were missing data on social anxiety at one or more time points and 842 were missing data on one or more covariates. complete data was therefore available for 3,333 cases. the current sample includes singleton births only to reduce within family confounds. measures peer victimisation a modified version of the bullying and friendship interview (wolke et al., 2001) was used to determine the frequency that children had experienced nine different types of re­ lational and overt peer victimisation involving other children at school or to/from school in the past six months. specifically, four relational behaviours (others wouldn’t play with them to upset them, been made to do things didn’t want to do, had lies/nasty things said about them, had games spoilt) and five overt behaviours (had personal belongings taken, been threatened/blackmailed, been hit/beaten up, been tricked in a nasty way, graham, bowes, & ehlers 5 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ been called bad/nasty names). for each type, participants responded “no”, “yes sometimes” (less than four times), “yes repeatedly” (four or more times), or “yes very frequently” (at least once per week). fisher et al. (2013) established an index of bullying severity in the same sample comprising three levels of bullying severity at age 8, such that children who reported exposure to both overt and relational victimization at least 4 times each or at least once per week were classed as severely bullied, those who had experienced only one of these types at this frequency were classed as occasionally bullied, and all remaining children were classified as not bullied. internal reliability was acceptable (α = 0.73). locus of control an adapted version of the nowicki-strickland internal-external scale (nowicki & duke, 1974) suitable for use with children was completed during in-person assessment at age 8 years, comprising 12 items answered yes/no. a sum score was calculated (range 0-12), with higher scores indicating more external locus of control and lower scores indicating more internal locus of control. self-esteem the global self-worth subscale of harter’s self perception profile for children (harter, 1985) was completed during in-person assessments at age 8 years, comprising 6 items each split into two components reflecting high and low self-esteem (e.g., some children are often unhappy with themselves, other children are pretty pleased with themselves). each component was rated as “sort of true for me” or “really true for me” to produce a four-point scale for each item. a sum score was calculated (range 6 – 24), with higher scores indicating higher self-esteem. internal reliability was acceptable (α = 0.73). prior emotional problems parents rated their child’s emotional wellbeing using the relevant subscale from the strengths and difficulties questionnaire at age 6.75 years. a sum score was calculated (range 0 – 10) with higher scores indicating more emotional difficulties. this variable was included as a covariate in the model. social anxiety parents rated their child’s fear of new people, lots of people, and eating, speaking, reading, or writing in front of others over the last month as either “no”, “a little”, “a lot”, using the development and well-being assessment (goodman et al., 2000) six-item social fears subscale (dawba-sf) at age 7.5, 10, and 13. a total score was calculated (range 0 – 12), with higher scores indicating more severe social anxiety. internal reliability was good (α = 0.77 – 0.80). locus of control and social anxiety in bullied children 6 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ analytic approach first, the pattern of growth in social anxiety over time was modelled using a first-order latent growth curve model (lgcm), specifying initial severity (intercept) and shape of change (slope) using a repeated measure sum score of severity of social anxiety (dawba-sf). data was collected at three time points so linear shape was assumed and loadings for time were fixed at 0 (baseline, age 7.5), 2 (age 10), and 5 (age 13) in order to allow interpretation of the intercept as severity at age 7.5 and slope as linear change over time (hypothesis 1). intercepts and slopes were allowed to vary between individuals. good model fit was assessed using recommended indices (hooper et al., 2008), namely standardized root mean square residual (srmr) below 0.08, root mean square error of approximation (rmsea) below 0.05, comparative fit index (cfi) above 0.95, and tucker-lewis index (tli) above 0.90. models were run in mplus using the mlr estimator (maximum likelihood estimation with robust standard errors) to minimize bias associated with missing data from study attrition and to account for non-normality of observations. chi-square significance was not used to assess model fit as it is unreliable in large samples and is not estimated when using mlr. all measures were assumed to be influenced by random measurement error. second, to test the hypothesis that trajectory of social anxiety differs by level of exposure to victimisation (hypothesis 2), exposure to victimisation was tested as a predictor of social anxiety overall, and in addition initial level and slope was compared between not bullied (n = 4,037), occasionally bullied (n = 1,955), and severely bullied (n = 712) groups in a multi-group lgcm grouped by exposure to victimisation. presence of additional variance in social anxiety trajectory was also assessed within each victimi­ sation exposure group, with and without adjustment for prior emotional problems. third, to test the contribution of cognitive predictors (hypothesis 3, 4) locus of control and self-esteem were entered into the model to determine their ability to explain variance in initial level and slope in the full sample, in each bullying exposure group, and between bullying exposure groups (see figure 2). univariate anova suggested no evidence of a differential relationship between bully­ ing and social anxiety according to sex so analyses were conducted on the group as a whole. data was inspected in spss27 and analysed in mplus 8. graham, bowes, & ehlers 7 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ figure 2 diagram of multigroup latent growth curve model, grouped by bullying severity (“not”, “occasionally”, “severely”) prior emotional difficulties (age 6) locus of control (age 8) self-esteem (age 8) social anxiety (age 7.5) social anxiety (age 10) social anxiety (age 13) social anxiety intercept social anxiety slope r e s u l t s sample characteristics enrollment and participation flowchart is shown in figure 1. at age 8, over a third of participants (n = 2,667, 39.8%) reported exposure to either relational or overt victimiza­ tion at least four times over the last six months, and of these over a quarter (n = 712, 26.7%) experienced both types and were classified as severely bullied. severity of bullying exposure at age 8 was not associated with level of social anxiety but was associated with lower self-esteem and more external locus of control. those exposed to bullying also had higher prior emotional difficulties compared to those not exposed to bullying. characteristics are shown in table 1. missing data among the sample with data on bullying at age 8, missing data on social anxiety at age 13 was more likely among those who were severely bullied, χ2(2, n = 6,704) = 9.89, p = .007 and those whose parents had a lower socio-economic status, χ2(1, n = 5,601) = 29.84, p < .001. missingness did not differ by sex, χ2(1, n = 6,704) = 0.241, ns. locus of control and social anxiety in bullied children 8 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ trajectory of social anxiety a single linear growth curve model of social anxiety over time had a good fit for the data, cfi = .992, tli = .977, srmr = .010, rmsea = .037, 90% ci [0.018, 0.060]. across the sample, the social anxiety variable was highly positively skewed but mean levels increased slightly from age 7.5 (range 0 – 12, m = 0.83, sd = 1.51), to age 10 (range 0 – 12, m = 0.91, sd = 1.60), to age 13 (range 0 – 11, m = 1.15, sd = 1.79), confirmed by small but significant positive slope (m = 0.07, se = .005, p < .001). there was also significant variability in social anxiety intercept (m = 1.27, se = .090, p < .001) and slope (m = 0.55, se = .008, p < .001) indicating individual differences around the mean trajectory. model fit improved when level of prior emotional difficulties, which are expected to be associated with social anxiety at age 7.5, was included in the model, cfi = .996, tli = .987, srmr = .009, rmsea = .024, 90% ci [0.010, 0.040]. prior emotional difficulties predicted initial social anxiety (m = 0.39, se = .021, p < .001) but did not impact on the rate of subsequent change in social anxiety over time (m = -0.02, se = .030, ns). table 1 sample characteristics by severity of bullying victimisation at age 8 variable severity of bullying at age 8, m (sd) or n (%) not bullied (n = 4,037) occasional (n = 1,955) severe (n = 712) f, χ2 gender female (n, %) 2,136 (52.9) 910 (46.5) 341 (47.9) 17.68a social anxiety age 7.5 0.83 (1.50) 0.81 (1.44) 0.86 (1.67) 0.31 (ns) age 10 0.89 (1.57) 0.92 (1.62) 1.01 (1.76) 1.49 (ns) age 13 1.12 (1.75) 1.17 (1.80) 1.32 (1.97) 3.23a self-esteem 19.67 (3.18) 18.98 (3.51) 18.02 (3.72) 80.14b locus of control 5.71 (2.05) 6.21 (2.00) 6.67 (2.12) 78.69b prior emotional difficulties 1.43 (1.58) 1.57 (1.74) 1.59 (1.71) 5.06c note. self-reported severity of bullying victimisation using bullying and friendship interview and categorized following fisher et al. (2013); social anxiety = dawba social fears subscale (range 0 – 12; higher is more social anxiety); self-esteem = harter’s self perception profile for children: shortened form (range 6 – 24; higher is better self-esteem); external locus of control = nowicki-strickland internal external scale (range 0 – 12; higher is more external); prior emotional difficulties = relevant subscale from strengths and difficulties questionnaire age 6.75 (range 0 – 10; higher is more emotional difficulties). significant group difference between, a. “not bullied” and “severe”, p < .05, b. all groups, p < .01, c. “not bullied” and both bullied groups (p < .05). graham, bowes, & ehlers 9 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ trajectories of social anxiety by severity of bullying exposure when severity of bullying exposure at age 8 was added as a predictor of overall social anxiety trajectory alongside prior emotional problems, the expected effect of bullying on social anxiety was shown, such that higher bullying exposure at age 8 predicted a slightly steeper increase in social anxiety over time (m = 0.06, se = 0.02, p = .014). however, bullying exposure at age 8 was not associated with concurrent social anxiety (m = -0.01, se = 0.02, ns). in order to test the impact of cognitive factors on social anxiety in the context of differing bullying exposure, the sample was split following fisher et al. (2013) into three groups of bullying severity, namely “not bullied”, “occasional”, and “severe”. model fit for this grouped model was good, cfi = .995, tli = .986, srmr = .011, rmsea = .025, 90% ci [0.007, 0.042]. all three groups had significant positive slope indicating increasing social anxiety over time (“not bullied”: m = .063, se = 0.01, p < .001; “occasional”: m = .075, se = .01, p < .001; “severe”: m = .102, se = .02, p < .001) but hypothesis 2 was not supported as there were no significant differences in mean initial social anxiety severity or mean slope between bullying exposure groups. see figure 3. of note, there was significant variance in slope within each group indicating that other factors are responsible for explaining individual differences in trajectory. figure 3 estimated mean social anxiety (age 7.5 – 13) grouped by bullying exposure at age 8 0 0,2 0,4 0,6 0,8 1 1,2 1,4 1,6 age 7.5 age 10 age 13 se ve ri ty o f so ci al a n xi et y not bullied occasionally bullied severely bullied note. grouped by self-reported level of bullying victimisation in bullying and friendship interview. social anxiety assessed at three time points (age 7.5, 10, 13) using dawba social fears subscale (range 0 – 12; higher is more social anxiety). at age 10, group differences in social anxiety are not significant. at age 13, social anxiety was significantly higher in the severe group compared with the not bullied group (p = .013) but not the occasionally bullied group (p = .090). locus of control and social anxiety in bullied children 10 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ cognitive predictors of social anxiety by severity of bullying exposure the final model including hypothesized predictors (locus of control, self-esteem, and prior emotional difficulties) had good model fit, cfi = .995, tli = .986, srmr = .010, rmsea = .019, 90% ci [0.004, 0.032]. contrary to hypothesis 3, lower self-esteem at age 8 was not independently associated with concurrent social anxiety or rate of change in social anxiety over time in any group. in contrast, while more external locus of control at age 8 was not associated with concurrent social anxiety in any group, it predicted a moderate increase in anxiety in the severely bullied group (b = .167, p = .011) with smaller effects for those who were never bullied (b = .095, p = .005) and occasionally bullied (b = .097, ns). prior emotional problems strongly predicted social anxiety at age 7.5 in all groups but did not impact the rate of change in social anxiety over time. see table 2. table 2 predictors of social anxiety trajectory from age 7.5 to 13 grouped by age 8 bullying exposure trajectory components and predictors not bullied, n = 4,037 occasional, n = 1,955 severe, n = 712 coefficient (se) p coefficient (se) p coefficient (se) p intercept (social anxiety age 7.5) 0.816 (.024) 0.810 (.035) 0.846 (.066) predictors of intercept self-esteem -0.041 (.023) ns -0.059 (.034) ns 0.009 (.055) ns locus of control 0.039 (.024) ns 0.038 (.034) ns 0.075 (.049) ns prior emotional problems 0.393 (.026) < .001 0.412 (.043) < .001 0.344 (.063) < .001 slope (social anxiety over time) 0.057 (.007) 0.073 (.010) 0.102 (.018) predictors of slope self-esteem -0.021 (.033) ns 0.027 (.048) ns -0.031 (.069) ns locus of control 0.095 (.034) < .05 0.097 (.051) ns 0.167 (.065) < .05 prior emotional problems -0.033 (.040) ns -0.013 (.057) ns -0.008 (.081) ns intercept x slope -0.061 (.023) -0.067 (.035) -0.081 (.070) note. cells contain unstandardized coefficients for intercept and slope estimated without predictors, standar­ dized coefficients for predictors, with standard errors (se) and probabilities (p; two-tailed). social anxiety = dawba social fears subscale; self-esteem = harter’s self perception profile for children: shortened form; locus of control = nowicki-strickland internal external scale; prior emotional problems = mother report relevant subscale from strengths and difficulties questionnaire. d i s c u s s i o n children who were bullied at age 8 were more likely to have a more external locus of control than other children and higher externality among severely bullied children was associated with steeper increases in social anxiety up to the age of 13. of note, graham, bowes, & ehlers 11 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ exposure to bullying at age 8 was not associated with existing social anxiety at age 7.5 but was associated with subsequent increases social anxiety, and this increase was larger for those with external locus of control. this pattern was not observed in relation to self-esteem. this suggests that external locus of control in early childhood could be a risk factor for later anxiety among severely bullied children and is a potential target for intervention. external locus of control describes a tendency to consider events and experiences as outside personal control. in this sample, the effect of externality on negative outcomes was small overall but larger in the severely bullied group, such that external locus of control was associated with steeper increases in social anxiety for severely bullied children. beliefs around bullying that are consistent with external locus of control may include thoughts such as, “being picked on is inevitable”, or “others will always target me”. evidence from personal experiences that contradict these types of beliefs related to bullying may be accessible for those who are not bullied or bullied occasionally. in contrast, beliefs about lack of control over a threatening and unpredictable social environment may be strengthened by repeated confirmatory evidence for children who are severely bullied and therefore more likely to persist. in line with existing literature suggesting that external locus of control is a risk factor for psychopathology (hallis & slone, 1999; karstoft et al., 2015; zhang et al., 2014), there was some indication of a dose response relationship between external locus of control and social anxiety, but with only minimal effects among children who were never or occasionally bullied. reknes et al. (2019) suggested that external beliefs were protective against general psychological strain for adult victims of workplace bullying, enhancing acceptance and enabling external attribution of negative experiences towards negative characteristics of the perpetrator or bad luck instead of taking personal blame. however, the current study suggests that while external control beliefs do not confer additional risk of social anxiety for occasionally bullied children there is an additional risk for severely bullied children. for children who are severely bullied and have a tendency towards externality, promoting personal control beliefs may be one route towards encouraging more constructive coping strategies. the cognitive model of social anxiety disorder (clark & wells, 1995) posits that those suffering with social anxiety hold unhelpful beliefs about their ability to perform well in social situations that, when triggered in a social situation, lead to increased self-consciousness and self-monitoring. in an effort to mitigate the perceived risks, the person then engages in “safety-seeking” behaviors that are intended to keep them safe (e.g. looking down and avoiding eye contact). however, these behaviors can also have unintended consequences (e.g. looking unfriendly or disinterested) which negatively impact the social interaction. therefore, it is possible that excessive perception of threat may persist even in the absence of an ongoing objectively threatening environment and that perceiving threat may encourage children to act in ways that could inadvertently locus of control and social anxiety in bullied children 12 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ increase likelihood of ongoing bullying. in this analysis, social anxiety at age 7.5 was not associated with higher bullying exposure at age 8, so it is not necessarily the case that more fearful children were being targeted or perceived that they were being targeted. however, appraisals associated with external locus of control may contribute to excessive perceptions of ongoing social threat and to passive or unhelpful forms of coping that contribute to increasing social anxiety over time. it is interesting to note that early self-esteem did not influence the trajectory of social anxiety to age 13 among any bullying exposure group. as such, it is possible that early cognitive processes related to self-esteem could be less important in terms of predicting future anxiety (sowislo & orth, 2013) despite evidence of cooccurrence (lee & hankin, 2009). in fact, these results support cross-sectional associations between bullying, self-esteem and social anxiety (gómez-ortiz et al., 2018; núñez et al., 2021) but our findings suggest that children who are bullied and have low self-esteem are not necessarily at increased risk of social anxiety over time. similarly, although our analyses showed the expected association between prior emotional problems and social anxiety at age 7.5, there was no ongoing impact of early emotional problems on increasing social anxiety over time. this indicates that early emotional problems and self-esteem may be less important indicators of ongoing adjustment compared with external locus of control, a feature that has been largely overlooked in this domain but which may be an important clinical target for assessment and intervention. this study has important clinical implications. it is notable that long-term anxiety as­ sociated with bullying can persist even in the absence of current threat, that is, even after bullying has stopped. cognitive theories of anxiety after stressful experiences (clark & wells, 1995; ehlers & clark, 2000) suggest that cycles develop between unhelpful beliefs, particular memory characteristics, and behavioral and cognitive coping strategies to maintain anxiety. maladaptive beliefs associated with bullying may contribute to social anxiety that increases over time and children who have been bullied may be supported with cognitive behavioural approaches (pontillo et al., 2019). this study suggests that particularly among children who have been severely bullied, beliefs associated with external locus of control may be relevant to maintaining and exacerbating social anxiety. more specific investigation of these beliefs could inform targeted and developmentally appropriate approaches to treatment among young people. in addition, these findings underline the importance of repeated measurement of social anxiety during adolescence in order to recognize differential trajectories of change. it appears that the differentiated trajectories in social anxiety were not visible prior to age 10 and rather became apparent first between age 10 and 13. this underscores the importance of developmental models of psychopathology that can be linked to a developmental clinical approach. some limitations in this study should be kept in mind. the sample suffered from attrition but this is common in prospective studies of this duration. although higher exposure to bullying was associated with dropout, this would have if anything likely graham, bowes, & ehlers 13 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ attenuated findings rather than increased them, such that effect sizes may have been greater if these participants had been retained. small effect sizes indicate that substantial variance in the model remains unexplained, perhaps due to cognitive or social factors that were not measured, or due to biological or genetic factors. observed effects between bullying and social anxiety accounted for early internalizing problems, but these were measured after starting school (age 6), so the possibility that very early bullying trig­ gered anxiety cannot be ruled out. it is also possible that past or ongoing bullying may negatively impact self-esteem later, but this is not measured in this study. of note, the locus of control and self-esteem measures used in this study were not developed within the cognitive model framework but can provide a useful proxy for the meaning of the constructs within this model. future research should assess whether the observed effect of external locus of control on social anxiety is indeed replicated for cognitions that are consistent with this construct and tailored to perceptions of bullying experiences. overall, it is well known that bullying contributes to increased risk of anxiety among children. it is also known that this is a critical developmental stage for increasing social anxiety symptoms and onset of social anxiety disorder, a mental health problem with severe consequences which once chronic rarely abates in the absence of specific interventions. it is also widely recognized that cognitive factors are central to the onset and maintenance of anxiety disorders including social anxiety. the present study aimed to understand the impact of specific cognitive factors, namely locus of control and self-esteem, on trajectories of social anxiety among children aged 8 to 13. results suggest that children who are severely bullied at age 8 are particularly at risk of increasing social anxiety if they also hold an external locus of control. however, self-esteem does not appear to have the same moderating effect. it is possible that beliefs consistent with external locus of control contribute to further reduced perception of control over the environment in the context of bullying, which leads to more passive or ineffective coping strategies. the results of this study offer new insight into potentially modifiable factors that increase risk of social anxiety among bullied children and suggest that external control beliefs could be useful targets for cognitive interventions. locus of control and social anxiety in bullied children 14 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://www.psychopen.eu/ funding: the uk medical research council and wellcome trust [217065/z/19/z] and the university of bristol provide core support for alspac. a comprehensive list of grants funding is available on the alspac website (http://www.bristol.ac.uk/alspac/external/documents/grant-acknowledgements.pdf). this publication is the work of the authors belinda graham, anke ehlers and lucy bowes who serve as guarantors for the contents of this paper. their work was supported by the wellcome trust [205156, 200796], the nihr biomedical research centre at oxford university hospitals nhs trust, and the nihr oxford health biomedical research centre. also, the academy of medical sciences springboard award and nihr public health program for bullying intervention. acknowledgments: we are extremely grateful to all the families who took part in this study, the midwives for their help in recruiting them, and the whole alspac team, which includes interviewers, computer and laboratory technicians, clerical workers, research scientists, volunteers, managers, receptionists and nurses. competing interests: the authors have declared that no competing interests exist. twitter accounts: @drbelindagraham data availability: conditions for accessing and using alspac data are described on the study website http://www.bristol.ac.uk/alspac/researchers/access/ r e f e r e n c e s american psychiatric association. 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(2014). a longitudinal study of posttraumatic stress disorder symptoms and its relationship with coping skill and locus of control in adolescents after an earthquake in china. plos one, 9, article e88263. https://doi.org/10.1371/journal.pone.0088263 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. graham, bowes, & ehlers 19 clinical psychology in europe 2022, vol. 4(2), article e3809 https://doi.org/10.32872/cpe.3809 https://doi.org/10.1371/journal.pone.0088263 https://www.psychopen.eu/ locus of control and social anxiety in bullied children (introduction) method participants measures analytic approach results sample characteristics missing data trajectory of social anxiety trajectories of social anxiety by severity of bullying exposure cognitive predictors of social anxiety by severity of bullying exposure discussion (additional information) funding acknowledgments competing interests twitter accounts data availability references description of a culture-sensitive, low-threshold psychoeducation intervention for asylum seekers (tea garden) latest developments description of a culture-sensitive, low-threshold psychoeducation intervention for asylum seekers (tea garden) ricarda mewes 1 § , julia giesebrecht 2 §, cornelia weise 2 , freyja grupp 2 [1] outpatient unit for research, teaching and practice, faculty of psychology, university of vienna, vienna, austria. [2] division of clinical psychology and psychotherapy, department of psychology, university of marburg, marburg, germany. §these authors contributed equally to this work. clinical psychology in europe, 2021, vol. 3(special issue), article e4577, https://doi.org/10.32872/cpe.4577 received: 2020-10-19 • accepted: 2021-05-17 • published (vor): 2021-11-23 handling editor: eva heim, university of lausanne, lausanne, switzerland corresponding author: ricarda mewes, outpatient unit for research, teaching, and practice, faculty of psychology, university of vienna, renngasse 6-8, vienna, 1010, austria. e-mail: ricarda.nater-mewes@univie.ac.at related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: materials [see index of supplementary materials] abstract background: asylum seekers often suffer from high levels of mental distress. however, as a result of a lack of knowledge about mental health and health care, as well as cultural and language barriers, the utilization of mental health care in western host countries is often difficult for these individuals. reducing these barriers may thus be a crucial first step towards appropriate mental health care. previous research showed that psychoeducation may be helpful in this regard. method: the current manuscript describes a short, low-threshold and transdiagnostic intervention named ‘tea garden (tg)’. the tg aims to increase specific knowledge about mental health problems and available treatments, and may improve psychological resilience and self-care. in this manuscript, we specifically focus on culturally sensitive facets, following the framework proposed by heim and colleagues (2021, https://doi.org/10.32872/cpe.6351), and lessons learned from three independent pilot evaluations (ns = 31; 61; 20). results: the tg was found to be feasible and quantitative results showed that it was helpful for male and female asylum seekers from different countries of origin (e.g., afghanistan, syria, this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4577&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0002-4724-9597 https://orcid.org/0000-0001-5216-1031 https://orcid.org/0000-0001-9855-4658 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ pakistan, iraq) and with different educational levels. interestingly, even asylum seekers who had already been in germany or austria for three or more years benefited from the tg. conclusion: the tg specifically aims to be culture-sensitive rather than culture-specific, to be transdiagnostic rather than focused on specific mental disorders, and to be suitable for asylum seekers who are still in the insecure process of applying for asylum. it may also be helpful for distressed asylum seekers who do not fulfill the criteria for a mental disorder, and for healthy asylum seekers who could use the knowledge gained in the tg to help others. keywords asylum seekers, culture-sensitive, knowledge, mental health (care), psychoeducation, transdiagnostic highlights • there is a lack of short, low-threshold, and culture-sensitive interventions for asylum seekers. • a transdiagnostic intervention, named ‘tea garden’ (tg), is described and findings of pilot evaluations are reported. • the tg aims to increase knowledge about mental health (care), and improve resilience and self-care. • the tg was found to be helpful for refugees from different origins and with different educational levels. the prevalence of mental disorders in refugees and asylum seekers1 is high, as they have frequently experienced different kinds of hardship and traumatic situations (blackmore et al., 2020; henkelmann et al., 2020). even when asylum seekers have arrived in a safe host country, factors such as a lengthy asylum procedure, fear of deportation, or ethnic discrimination pose a risk for the aggravation or new manifestation of mental health problems (gleeson et al., 2020). despite high levels of mental distress, access to mental health treatment for asylum seekers is limited (björkenstam et al., 2020; führer et al., 2020). this is mainly a result of barriers such as a general lack of knowledge about mental disorders and mental health care, but is also caused by limited access to health care systems in host countries, cultural understanding and stigmatization of mental disorders and mental health care, and language barriers (grupp et al., 2019; mårtensson et al., 2020). systematic reviews have revealed that psychoeducation improves specific knowledge about mental disorders (e.g., about possible causes, typical symptoms of a disorder, 1) 'an asylum seeker' is defined as a person who is seeking international protection and whose claim for asylum has not yet been finalized. if protection is granted according to the 1951 refugee convention, the person is recognized as a 'refugee'. accordingly, all refugees were initially asylum seekers. many of the studies cited investigated both asylum seekers and refugees. because of the current study's focus, we primarily use the term 'asylum seekers' and speak of refugees only if they are specifically addressed. description and feasibility of the tea garden 2 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ factors influencing the symptoms) and psychosocial functioning, including coping with symptoms, and reduces distress for people suffering from mental disorders (barnicot et al., 2020; tursi et al., 2013). colom (2011, p. 339) defines psychoeducation “as a patient’s empowering training targeted at promoting awareness and proactivity, providing tools to manage, cope and live with a chronic condition …, and changing behaviours and attitudes related to the condition.” consequently, psychoeducation may be an effective intervention to improve the mental health knowledge and to enable an initial mental health improvement of different cultural groups of asylum seekers in western host coun­ tries. such a psychoeducation intervention should be adapted to a degree that allows its use in different cultural groups (i.e., being culture-sensitive; e.g., see the suggestions on cultural adapted cognitive behavioral therapy by hinton et al., 2012) rather than focused on one specific culture or group (i.e., culture-specific; e.g., see the examples and recommendations for specific cultural/ethnic groups by smith et al., 2011). however, this type of psychoeducation for asylum seekers is lacking. therefore, we developed a short, culture-sensitive intervention, named tea garden (tg). we chose this name because a tea garden is a familiar concept for many migrants from different regions of origin and is often associated with a positive situation. we wanted to avoid difficult names or labels (e.g. psychotherapy or psychological) that could discourage interested persons as a result of a lack of knowledge about psychotherapy and psychological interventions or a possi­ ble fear of stigmatization. our focus was on reducing distress and increasing knowledge about the development of mental disorders, resources to cope with mental distress, and interventions, that were assumed to be of particular relevance for asylum seekers. in line with betsch and colleagues, we aimed for a “deliberate and evidence-informed adaptation of health communication to the recipients’ cultural background in order to increase knowledge and improve preparation for medical decision making and to enhance the persuasiveness of messages in health promotion” (betsch et al., 2016, p. 813). we did not limit culture to the nationality or a set of habits and beliefs, but also account for the particular sociodemographic, legal, and living situation of asylum seekers (e.g., napier et al., 2014). our main aim (i) in this paper is to describe the tg with a specific focus on culturally sensitive facets, following the framework proposed by heim and colleagues (2021, this issue). additionally, we provide summarized findings (ii) from pilot evaluation studies with regard to the acceptability and feasibility of the tg, as well as lessons learned. d e s c r i p t i o n o f t h e t e a g a r d e n ( t g ) the tg was developed as part of the project ‘psychotherapeutic first aid for asylum seekers living in hesse’ funded by the european refugee fund, eff-12-775 (mewes et al., 2015). the aim of the tg is threefold: (1) to increase knowledge about mental disor­ ders most relevant for asylum seekers, psychological and psychiatric treatments, mental mewes, giesebrecht, weise, & grupp 3 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ health care in the resettlement country, and the special access conditions for asylum seekers in this regard; (2) to reduce stigmatization of mental disorders and mental health care, and thereby increase openness to psychotherapy and psychiatric treatments; and (3) to strengthen psychological resources and achieve first reduction of mental distress. team of developers the developing team comprised members from different countries of origin and different cultural backgrounds (e.g., persian, arabic, kurdish, turkish), some of them with a refugee background, psychotherapists working with asylum seekers, and researchers in the field of intercultural psychology. target population the target group for the tg consists of asylum seekers who have recently arrived in a host country (e.g., max. 18 months), are still in the process of applying for asylum, and may suddenly be transferred to other cities or federal states during their asylum procedure. participants may be mentally distressed or suffer from a mental disorder, but this is not mandatory for participation. the tg is transdiagnostic and may even be helpful for healthy asylum seekers who could use the knowledge gained in the tg to help others. general implementation of the tg with the aid of interpreters, the tg is provided in a group format to provide help to several asylum seekers simultaneously. the tg consists of four modules (a-d): module a) establishing trust and confidence; module b) symptoms of mental disorders; module c) resources and self-care, and module d) treatment options. these modules are inter­ actively presented in two 90-minute sessions delivered one week apart in groups of approximately six participants (detailed information can be found in the german manual, mewes et al., 2015). this schedule is considered short enough to reach many target clients, but long enough to provide the required information in a relaxing and interactive manner. a group setting is applied to enhance social support and mutual exchange, and to take into account the mainly collectivistic background of the main groups of asylum seekers (in western host countries) as well as shared pre-, peri-, and postmigration expe­ riences (kananian et al., 2017; kira et al., 2012). these benefits are assumed to outweigh possible disadvantages, such as reservations to participate in a group (e.g., worries about confidentiality and being stigmatized), the limited consideration of individual problems, and the therapists’ necessity to closely monitor not only the content but also the group process (kira et al., 2012). description and feasibility of the tea garden 4 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ tea and food are offered to promote a relaxing and welcoming atmosphere. in addi­ tion, the tg uses images/ illustrations, symbols (e.g., rope, flowers, stones, spinning top) and familiar metaphors in order to facilitate communication and to adapt to different educational levels. its material is free of written language or complicated figures, and operates best in genderand language-homogenous groups of five to seven participants. components and contents of the intervention based on a literature review and our own work (hinton et al., 2012; reich et al., 2015) as well as advice from experienced psychotherapists in the field, we included several treatment components in order to foster confidence and therapy motivation, and thus to increase the usefulness of the tg. with regard to specific components, i.e. components that have specific relevance for the aims of the tg, we focused on psychoeducation (e.g., explaining that traumatic events can cause symptoms, explaining the concept of psychotherapy), strengthening resources (e.g., introducing possible resources, initiating exchange about useful strategies for coping and how to implement them in the daily life), giving hope (e.g., by explaining that symptoms can improve with the right care), and reducing stigmatization (e.g., by initiating exchange about problems and by emphasizing that persons with mental problems are not ‘mad’). in addition, we included several unspecific components that should support the implementation of the tg (but do not specifically relate to the aims of the tg) such as guiding through the sessions (e.g., by outlining the structure of the sessions and monitoring the time), normalizing (e.g., by explaining that experiencing symptoms such as worries and flashbacks after traumatic events is normal), discussing advantages of and barriers to treatments (e.g., by asking for the participants’ views on psychopharmacological treatments, by explaining how to get a psychotherapy and addressing possible barriers), monitoring the distress level of participants (e.g., by working with two therapists and a limited number of participants, one therapist can watch out for signs of distress), and interrupting participants when narratives become too personal/ distress becomes too high (this is part of a set of group rules which are introduced at the first session). moreover, in-session techniques such as behavioral experiments (relaxation) and exchange between group participants were included to this end. in order to consider relevant target syndromes, needs, and concepts of distress (lewis­ fernández & kirmayer, 2019) of our target group, the following contents were included in the tg: i. explanatory models, etiological assumptions. based on a literature review (e.g., liedl et al., 2010), we used a body-mind metaphor for the description of a traumatic event and the care and healing related to this event (i.e., the mind can be wounded by traumatic events; this wound is similar to a wound on the hand after a cut; wounds mewes, giesebrecht, weise, & grupp 5 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ in the mind may cause symptoms; and the wound must be nursed and will then heal, leaving a scar). ii. symptom patterns and socially acceptable terms for expressing distress. the higher relevance of bodily symptoms in many groups of immigrants in western host countries and culture-specific symptoms such as 'burning liver' or 'pulling hair' was accounted for by explicitly introducing these symptoms (among others) with drawings as part of a module about symptoms (module b). this decision was based on a literature review (e.g., hinton et al., 2012; rometsch et al., 2020) and experiences from the team of developers. culturally salient resources. as many groups of asylum seekers in western host countries highly value religion and faith, and have strong ties within the ‘extended family’, these potential resources were introduced as part of the module on resources and self-care (module c). this decision was based on a literature review, our own scientific work (e.g., grupp et al., 2019), and advice from the team of developers. suggested outcome measure in line with trials offering psychoeducation interventions for persons with serious men­ tal illnesses (e.g., zhao et al., 2015), the primary outcome for evaluations of the tg should be changes in specific knowledge with regard to mental health (please see the appendix in the supplementary materials for suggestions on measures of the other aims of the tg). moreover, the feasibility and acceptability of the tg should be assessed, e.g., the atmosphere, the comprehensibility, and the communication, as well as the personal benefit, relief, and perceptions of resources. for the three pilot studies reported below, a questionnaire developed by our work group was used (demir et al., 2016). this questionnaire assessed self-reported knowledge on 1) symptoms of mental disorders, 2) resilience and coping strategies, and 3) mental health care offered in the country. to facilitate assessment in illiterate and low-educated participants, we aimed for easy language and used smileys to indicate negative to posi­ tive response or low to high agreement and a right-angled triangle symbol to indicate increase in knowledge (range 1 = not at all to 5 = very much; the higher the value the more positive the assessment), respectively. moreover, feedback on the personal benefits, and suggestions for improvement, could be given using free text. f i n d i n g s f r o m f i r s t e v a l u a t i o n s o f t h e t e a g a r d e n a n d l e s s o n s l e a r n e d three independent pilot evaluations were conducted with a focus on acceptance, feasi­ bility, first hints of possible effectiveness, as well as lessons learned (mainly based on anecdotal reports of the researchers, and the therapists who conducted the tgs, and description and feasibility of the tea garden 6 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ written and verbal feedback of participants). two pilot evaluations were conducted in germany (bogdanski et al., 2019; demir et al., 2016) and one in austria. most participants came from syria, afghanistan, pakistan, or iraq. more detailed information is provided in the appendix (see supplementary materials). by reason of the low-threshold character of the tg, participants in the pilot evaluations were not screened for mental disorders. the outcome assessments were conducted after each tg session and were supported by interpreters when necessary. after the tg, participants reported increased knowledge about mental health care, psychotherapy and self-help options, relief for general distress, improved perceptions of resources, and high overall satisfaction with the program. lessons learned: i. to facilitate recruitment, potential participants needed to be educated in detail about the program, and it was necessary to establish trust, be patient, and build a network of contact persons. ii. the outcome assessment was too complex and unfamiliar for some participants, and was simplified by only using smileys. iii. some participants erroneously expected to learn about asylum procedures. therefore, flyers and invitations should be phrased very clearly and highlight the content of the tg. iv. even asylum seekers with longer durations of stay (e.g. three years and more) appreciated the tg. v. the illustrations used in the tg were complemented by new illustrations in order to enhance the variety of shown human appearances and the fit for different groups of asylum seekers. vi. the larger the size of the group the more likely conflicts between participants may emerge. we thus suggest to limit the number of participants to eight. d i s c u s s i o n in contrast to other interventions, the tg specifically aims to be culture-sensitive rath­ er than culture-specific, to be transdiagnostic rather than focusing on specific mental disorders, and to be suitable for asylum seekers who are still in the insecure process of applying for asylum. the three independent pilot evaluations demonstrated the feasi­ bility of the tg and its acceptance with regard to different countries of origin, spoken languages, educational levels, and durations of stay in the host countries. moreover, they provided us with important lessons for the future recruitment of potential participants, appropriate designs for the outcome assessment, the materials used, and the recommen­ ded group size. in general, our findings suggest that the tg may be a useful first step to improve mental health care for asylum seekers. however, the generalizability and explanatory power of the presented results is limited by the single-group designs, and the lack of pre-post comparisons as well as follow-up assessments that would provide mewes, giesebrecht, weise, & grupp 7 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://www.psychopen.eu/ information about the sustainability of possible benefits. these limitations will now be tackled by the multicenter randomized controlled trial ‘efficacy of low-threshold, culturally sensitive group psychoeducation in asylum seekers’ (lope; drks00020564), where the participants will be randomized to either the tg or a waitlist control group and changes in knowledge will be assessed preand postintervention as well as two and six months later. following the example of other projects that successfully used brief psychological interventions to reduce the treatment gap for common mental disorders in affected groups, such as the friendship bench project in zimbabwe (chibanda et al., 2016) or the self-help plus project in uganda (tol et al., 2020), the tg might best be implemented via psychologists working in asylum facilities, trained and supervised social workers or even lay facilitators, depending on the local means and structures. by being culture-sensitive and very low-threshold, the tg considers the high diversity of asylum seekers living in western host countries (e.g., with regard to their countries of origin, their ethnicity, religion, education level, asylum status, distress level, etc.) and avoids the discrimination of specific (often particularly marginalized) groups. the tg may, thus, be considered as a broadly applicable first-line mental health intervention. funding: parts of this study were funded by the european refugee fund (eff-12-775). the lope study is funded by the german ministry of education and research (01ef1804b). acknowledgments: we thank mag.a vesna maric medjugorac (caritas vienna) for supporting the pilot evaluation 3. competing interests: cornelia weise is one of the editors-in-chief of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. twitter accounts: @corneliaweise s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain suggestions for the measures of the aims two and three of the tea garden and more detailed information about findings from the first evaluations of the tea garden and lessons learned (incl. two tables) (for access see index of supplementary materials below). index of supplementary materials mewes, r., giesebrecht, j., weise, c., & grupp, f. (2021). supplementary materials to "description of a culture-sensitive, low-threshold psychoeducation intervention for asylum seekers (tea garden)" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.5030 description and feasibility of the tea garden 8 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://twitter.com/corneliaweise https://doi.org/10.23668/psycharchives.5030 https://www.psychopen.eu/ r e f e r e n c e s barnicot, k., michael, c., trione, e., lang, s., saunders, t., sharp, m., & crawford, m. j. (2020). psychological interventions for acute psychiatric inpatients with schizophrenia-spectrum disorders: a systematic review and meta-analysis. clinical psychology review, 82, article 101929. https://doi.org/10.1016/j.cpr.2020.101929 betsch, c., bohm, r., airhihenbuwa, c. o., butler, r., chapman, g. b., haase, n., . . . uskul, a. k. (2016). improving medical decision making and health promotion through culture-sensitive health communication: an agenda for science and practice. medical decision making, 36(7), 811-833. https://doi.org/10.1177/0272989x15600434 björkenstam, e., helgesson, m., norredam, m., sijbrandij, m., de montgomery, c. j., & mittendorfer-rutz, e. (2020). differences in psychiatric care utilization between refugees, nonrefugee migrants and swedish-born youth. psychological medicine. advance online publication. https://doi.org/10.1017/s0033291720003190 blackmore, r., boyle, j. a., fazel, m., ranasinha, s., gray, k. m., fitzgerald, g., . . . gibson-helm, m. (2020). the prevalence of mental illness in refugees and asylum seekers: a systematic review and meta-analysis. plos medicine, 17(9), article e1003337. https://doi.org/10.1371/journal.pmed.1003337 bogdanski, c., ghazal makki, s., hermann, a., mewes, r., diringer-seither, a., & stark, r. (2019). evaluation des „gesundheits-teegarten“ – eine psychoedukative gesprächsgruppe mit geflüchteten [evaluation of the health teagarden – a psychoeducative discussion group with refugees]. gesundheitswesen, 81(3), article 265. https://doi.org/10.1055/s-0039-1679354 chibanda, d., weiss, h. a., verhey, r., simms, v., munjoma, r., rusakaniko, s., . . . araya, r. (2016). effect of a primary care-based psychological intervention on symptoms of common mental disorders in zimbabwe: a randomized clinical trial. journal of the american medical association, 316(24), 2618-2626. https://doi.org/10.1001/jama.2016.19102 colom, f. (2011). keeping therapies simple: psychoeducation in the prevention of relapse in affective disorders. the british journal of psychiatry, 198(5), 338-340. https://doi.org/10.1192/bjp.bp.110.090209 demir, s., reich, h., & mewes, r. 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(2015). motivation for psychotherapy and illness beliefs in turkish immigrant inpatients in germany: results of a cultural comparison study. journal of racial and ethnic health disparities, 2(1), 112-123. https://doi.org/10.1007/s40615-014-0054-y description and feasibility of the tea garden 10 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://doi.org/10.1080/20008198.2019.1684225 https://doi.org/10.32872/cpe.6351 https://doi.org/10.1192/bjo.2020.54 https://doi.org/10.1177/1363461512441595 https://doi.org/10.1080/20008198.2017.1390362 https://doi.org/10.1521/ijgp.2012.62.1.69 https://doi.org/10.1177/1363461519861795 https://doi.org/10.1186/s12889-020-09163-w https://doi.org/10.1016/s0140-6736(14)61603-2 https://doi.org/10.1007/s40615-014-0054-y https://www.psychopen.eu/ rometsch, c., denkinger, j. k., engelhardt, m., windthorst, p., graf, j., gibbons, n., . . . junne, f. (2020). pain, somatic complaints, and subjective concepts of illness in traumatized female refugees who experienced extreme violence by the “islamic state” (is). journal of psychosomatic research, 130, article 109931. https://doi.org/10.1016/j.jpsychores.2020.109931 smith, t. b., rodriguez, m. d., & bernal, g. (2011). culture. journal of clinical psychology, 67(2), 166-175. https://doi.org/10.1002/jclp.20757 tol, w. a., leku, m. r., lakin, d. p., carswell, k., augustinavicius, j., adaku, a., . . . van ommeren, m. (2020). guided self-help to reduce psychological distress in south sudanese female refugees in uganda: a cluster randomised trial. the lancet: global health, 8(2), e254-e263. https://doi.org/10.1016/s2214-109x(19)30504-2 tursi, m. f., baes, c., camacho, f. r., tofoli, s. m., & juruena, m. f. (2013). effectiveness of psychoeducation for depression: a systematic review. the australian and new zealand journal of psychiatry, 47(11), 1019-1031. https://doi.org/10.1177/0004867413491154 zhao, s., sampson, s., xia, j., & jayaram, m. b. (2015). psychoeducation (brief) for people with serious mental illness. cochrane database of systematic reviews, 4, article cd010823. https://doi.org/10.1002/14651858.cd010823.pub2 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. mewes, giesebrecht, weise, & grupp 11 clinical psychology in europe 2021, vol. 3(special issue), article e4577 https://doi.org/10.32872/cpe.4577 https://doi.org/10.1016/j.jpsychores.2020.109931 https://doi.org/10.1002/jclp.20757 https://doi.org/10.1016/s2214-109x(19)30504-2 https://doi.org/10.1177/0004867413491154 https://doi.org/10.1002/14651858.cd010823.pub2 https://www.psychopen.eu/ description and feasibility of the tea garden (introduction) description of the tea garden (tg) team of developers target population general implementation of the tg components and contents of the intervention suggested outcome measure findings from first evaluations of the tea garden and lessons learned discussion (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references reporting cultural adaptation in psychological trials – the recapt criteria latest developments reporting cultural adaptation in psychological trials – the recapt criteria eva heim 1,2 , ricarda mewes 3, jinane abi ramia 4,5, heide glaesmer 6, brian hall 7, melissa harper shehadeh 7, burçin ünlü 8, schahryar kananian 9, brandon a. kohrt 10, franziska lechner-meichsner 9, annett lotzin 11, marie rose moro 12, rahmeth radjack 12, alicia salamanca-sanabria 13, daisy r. singla 14,15,16, annabelle starck 9, gesine sturm 17, wietse tol 18, cornelia weise 19, christine knaevelsrud 20 [1] institute of psychology, university of lausanne, lausanne, switzerland. [2] department of psychology, university of zürich, zürich, switzerland. [3] outpatient unit for research, teaching and practice, faculty of psychology, university of vienna, vienna, austria. [4] national mental health programme – ministry of public health, beirut, lebanon. [5] department of clinical, neuroand developmental psychology, amsterdam public health research institute, vrije universiteit amsterdam, amsterdam, the netherlands. [6] department of medical psychology and medical sociology, university of leipzig, leipzig, germany. [7] global public health, new york university shanghai, shanghai, china. [8] psyq, parnassia psychiatric institute, the hague, the netherlands. [9] department of clinical psychology and psychotherapy, goethe university frankfurt, frankfurt, germany. [10] department of psychiatry and behavioral sciences, george washington university, washington, dc, usa. [11] department of psychiatry and psychotherapy, university medical center hamburg-eppendorf, hamburg, germany. [12] inserm, hôpital cochin, ap-hp, paris university, paris, france. [13] future health technologies, singapore-eth centre, campus for research excellence and technological enterprise (create), singapore, singapore. [14] campbell family mental health research institute, toronto, canada. [15] department of psychiatry, temerty faculty of medicine, university of toronto, toronto, canada. [16] lunenfeld tanenbaum research institute, toronto, canada. [17] laboratoire cliniques psychopathologique et interculturelle lcpi ea 4591, université toulouse ii jean jaurès, toulouse, france. [18] section for global health, department of public health, university of copenhagen, copenhagen, denmark. [19] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. [20] department of education and psychology, freie universität berlin, berlin, germany. clinical psychology in europe, 2021, vol. 3(special issue), article e6351, https://doi.org/10.32872/cpe.6351 received: 2021-03-18 • accepted: 2021-08-18 • published (vor): 2021-11-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: eva heim, university of lausanne, institute of psychology, géopolis, bureau 4114, 1015 lausanne, switzerland. e-mail: eva.heim@unil.ch this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6351&domain=pdf&date_stamp=2021-11-23 https://orcid.org/0000-0001-7434-7451 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: materials [see index of supplementary materials] abstract background: there is a lack of empirical evidence on the level of cultural adaptation required for psychological interventions developed in western, educated, industrialized, rich, and democratic (weird) societies to be effective for the treatment of common mental disorders among culturally and ethnically diverse groups. this lack of evidence is partly due to insufficient documentation of cultural adaptation in psychological trials. standardised documentation is needed in order to enhance empirical and meta-analytic evidence. process: a “task force for cultural adaptation of mental health interventions for refugees” was established to harmonise and document the cultural adaptation process across several randomised controlled trials testing psychological interventions for mental health among refugee populations in germany. based on the collected experiences, a sub-group of the task force developed the reporting criteria presented in this paper. thereafter, an online survey with international experts in cultural adaptation of psychological interventions was conducted, including two rounds of feedback. results: the consolidation process resulted in eleven reporting criteria to guide and document the process of cultural adaptation of psychological interventions in clinical trials. a template for documenting this process is provided. the eleven criteria are structured along a) set-up; b) formative research methods; c) intervention adaptation; d) measuring outcomes and implementation. conclusions: reporting on cultural adaptation more consistently in future psychological trials will hopefully improve the quality of evidence and contribute to examining the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability. keywords cultural adaptation, reporting criteria, randomised controlled trials, common mental disorders, psychological interventions reporting cultural adaptation in psychological trials (recapt-criteria) 2 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ highlights • adaptation starts with defining the target population along cultural and sociodemographic criteria. • literature review and formative research are used to define target symptoms, syndromes, needs, and context. • using a standardized documentation system to structure the adaptation process is recommended. • documentation includes results of formative research and adaptation of treatment elements. psychotherapies developed in western, educated, industrialized, rich, and democratic (weird; henrich et al., 2010) societies may not or only partly be relevant to cultural groups or ethnic minorities who differ from the former in terms of cultural values, norms, or illness concepts. evidence indicates that cultural adaptation of psychological interventions for the treatment of common mental disorders increases their acceptabili­ ty and efficacy (benish et al., 2011; chowdhary et al., 2014; hall et al., 2016; harper shehadeh et al., 2016). there is a large variety of target populations, psychological interventions and settings where cultural adaptation is applied, from low-intensity inter­ ventions in humanitarian settings (perera et al., 2020) to higher-intensity interventions through the internet (knaevelsrud et al., 2015) or face-to-face (hinton et al., 2012), to mention only a few. most cultural adaptation studies use a top-down approach, in which existing psychological interventions developed for one cultural group are adapted for another one. few studies use a bottom-up approach to develop new interventions based on culturally specific symptoms or syndromes (hall et al., 2016; hwang, 2006). so far, there are no standard criteria for documenting bottom-up and top-down cultural adaptations in clinical trials testing psychological interventions (in short: psy­ chological trials). a more detailed standard documentation is key to obtain more reliable information regarding the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability. in this paper, we suggest a set of reporting criteria for this purpose. first, we outline the theoretical and empirical background. thereafter, the reporting criteria are introduced. more detailed information on the background, the development of the reporting criteria, and the use of these criteria, can be found in appendix a (see supplementary materials). b a c k g r o u n d in the lancet commission on culture and health, culture is defined as follows: “culture, then, can be thought of as a set of practices and behaviours defined by customs, habits, language, and geography that groups of individuals share” (napier et al., 2014, p. 1609). heim, mewes, abi ramia et al. 3 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ in appendix a (supplementary materials), we provide additional definitions of culture. these definitions highlight that culture refers to shared systems of understanding and engaging with the world, which extends beyond language and ethnicity to include polit­ ical, economic, environmental, and other contexts that shape these patterns of shared experience. for instance, this means that translation from english into spanish is unlikely to be sufficient to address the needs of residents of barcelona, venezuelan refugees in co­ lombia, and first generation salvadoreans immigrated to the united states. conversely, because culture is strongly tied to context, many of the adaptations done for syrian refugees in urban host communities in jordan may be helpful for venezuelan refugees in urban host communities in colombia, despite the language of adaptation being entirely different. cultural adaptation, therefore, refers to enabling an intervention to produce its desired psychological effect with a particular group in a specific context. several frameworks for cultural adaptation of evidence-based interventions exist (e.g., applied mental health research [amhr] group at johns hopkins university, 2013; gonzález castro et al., 2010; perera et al., 2020), all of which have been developed mainly for clinical practice. these frameworks have in common that they use stage models which include assessment, selection of the intervention (components), adaptation, pilot­ ing, and implementation. such stage models provide guidance on the process of cultural adaptation (i.e., how to adapt). with regard to content of cultural adaptation (i.e., what to adapt), several frameworks exist, which are described more in detail in appendix a (supplementary materials). empirical evidence from experimental studies is needed to show differential effects of different kinds of adaptations (heim et al., 2020). using a standardised documentation system, such as proposed in this paper, is key to meta-analytic evidence that is based on high quality of research. to achieve this aim, it is vital to structure reports on cultural adaptations, and to enhance transparency on what was culturally adapted in psychological trials. t h e o r e t i c a l f r a m e w o r k heim and kohrt (2019) propose a new framework of cultural adaptation that is based on evidence from cultural clinical psychology and psychotherapy research (see the sec­ tion on cultural adaptation frameworks in appendix a, supplementary materials). the authors suggest using cultural concepts of distress (ccd) as the starting point for cultural adaptation. the term ccd has been introduced into the diagnostic and statistical man­ ual of mental disorders, fifth edition (dsm-5, american psychiatric association, 2013) to describe culturally shaped mental health-related phenomena. ccd encompass idioms of distress (nichter, 1981, 2010), cultural explanations (bhui & bhugra, 2002), and cultural reporting cultural adaptation in psychological trials (recapt-criteria) 4 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ syndromes (kaiser & jo weaver, 2019). evidence shows that ccd differ from diagnostic categories in dsm and the international classification of diseases (kohrt et al., 2014). heim and kohrt (2019) further suggest using a taxonomy of treatment components proposed by singla et al. (2017) to structure the cultural adaptation and reporting proc­ ess. different taxonomies to dismantle components of psychological interventions have been proposed in literature, e.g., for behaviour change interventions (michie et al., 2013) or for interventions for children and adolescents (chorpita & daleiden, 2009). based on such blueprints, singla et al. (2017) proposed a taxonomy to distil the components of psy­ chological interventions for the treatment of common mental disorders (i.e., depression, anxiety, and stress-related mental health issues) in lowand middle-income countries. this taxonomy consists of specific and nonspecific elements, and therapeutic techniques. elements are therapeutic activities or strategies (e.g., problem solving), whereas techni­ ques are skills that the therapist implements during a session (e.g., role-playing). specific elements are grounded in specific psychological mechanisms (i.e., behavioural, cognitive, emotional, and interpersonal elements), and nonspecific elements are routed in common factors of psychological interventions (cuijpers et al., 2019; wampold, 2007). aside from elements and techniques, which refer to what is provided in treatment, singla et al. (2017) describe the how (e.g., delivery format), who (e.g., non-specialists), and where (i.e., setting) of psychological interventions. in cultural adaptation, treatment aspects that are related to how content is transmitted, include, e.g., the consideration of different dialects in translation or culture-specific aspects in illustrations that are not directly related to therapeutic elements (e.g., abi ramia et al., 2018). in accordance with resnicow et al. (1999), these are considered as adaptations of the surface (heim & kohrt, 2019). p r o c e s s f o r d e v e l o p i n g t h e r e p o r t i n g c r i t e r i a the reporting cultural adaptation in psychological trials (recapt) criteria were devel­ oped by a “task force for cultural adaptation of mental health interventions for refugees” in germany. the aim of this task force was to harmonise and document the cultural adaptation process across eleven randomised controlled trials testing psychological in­ terventions among refugees in germany (heim & knaevelsrud, 2021, this issue). the task force developed a first set of criteria. thereafter, an expert survey was conducted to seek consensus among international experts in the field of cultural adaptation and global mental health. twenty-four international experts were invited, of which eleven responded to our survey and provided feedback on the reporting criteria. a second round of feedback was implemented, where the experts provided their comments on the revised criteria. for more details, please refer to appendix a (supplementary materials). the expert survey is provided in appendix b (supplementary materials). heim, mewes, abi ramia et al. 5 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ r e p o r t i n g c r i t e r i a in the following, we propose eleven reporting criteria for future psychological trials with different cultural and ethnic groups. based on the theoretical and empirical consid­ erations outlined above, the reporting criteria for bottom-up and top-down cultural adap­ tation in psychological trials are structured along the following categories: a) set-up; b) formative research methods; c) intervention adaptation; d) measuring outcomes and implementation. an overview of the eleven criteria is shown in box 1. the last category, measuring outcomes, is kept short, as this is addressed in specific literature (e.g., leong et al., 2019). however, because measuring outcomes is an integral part of randomised controlled trials, we decided to include it as part of the reporting criteria. box 1 reporting cultural adaptation in psychological trials (recapt): overview of criteria a. set-up criterion 1: definition of the target population criterion 2: team and roles criterion 3: documentation and monitoring system criterion 4: documentation of adaptations during trial (“on the fly”) b. formative research criterion 5: formative research methods criterion 6: target symptoms, syndromes, needs, and context c. intervention adaptation criterion 7: specific treatment elements criterion 8: nonspecific elements and therapeutic techniques criterion 9: surface adaptations d. measuring outcomes and implementation criterion 10: questionnaires and clinical interviews criterion 11: implementation measures we recommend reporting on these criteria, regardless of whether they were implemen­ ted or not. these reporting criteria can also be used as a guideline for planning the process of cultural adaptation of an existing intervention (top-down), or the considera­ tion of cultural aspects in the development of new interventions (bottom-up) to be tested in psychological trials. the sequence of the reporting criteria is not fixed, as the process is often iterative; however, we put the sequence in what we considered to be a helpful order (e.g., establishing a documentation system early in the process). for reasons of reporting cultural adaptation in psychological trials (recapt-criteria) 6 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ word count, the description of each criterion is kept short. more detailed information can be found in the appendix a (supplementary materials). if possible, we recommend publishing a separate paper on formative research and cultural adaptation alongside the regular papers of a psychological trial (i.e., protocol and outcome paper), as it has been done in several studies (e.g., abi ramia et al., 2018). a separate paper allows researchers to provide detailed information on the decision-mak­ ing process and the different adaptations that were implemented. if it is not possible to publish a separate paper on the formative research and cultural adaptation, it is still recommendable to report on the most important aspects in the protocol or results paper. a reporting form that can be used for future trials is presented in the supplementary materials). for reasons of transparency and replicability, we recommend adding the documentation and monitoring sheet as supplementary material to published papers. the template is structured along the reporting criteria. a) set-up cultural adaptation of psychological interventions is a complex process which most often includes several stages. once a psychological trial is completed and results are about to be published, it may be difficult or impossible to reconstruct all the decisions that were made during the cultural adaptation process. for this reason, it is advisable to continuously document this process, and to be explicit about the people involved in decision-making. criterion 1: definition of the target population as described above, culture is a complex construct that cannot be reduced to ethnic groups or race. many different socio-demographic factors may contribute to one’s “cul­ ture”, such as language, religion, age, migration background, refugee status, gender identity, sexual orientation, and socio-economic status, among others (gonzález castro et al., 2010; sue & sue, 2015). there is large variety with regard to values and norms within geographically or demographically defined groups (e.g., fischer & schwartz, 2011; resnicow et al., 1999), and people may adopt different “cultural identities” in different contexts (lehman et al., 2004). therefore, the first step in cultural adaptation is to clearly define the “unit of analysis”, i.e., the target population in the psychological trial (gonzález castro et al., 2010). the definition and operationalisation of this unit of analysis should be done along the most important criteria that may have an impact on participants’ cultural identity and their psychopathology (betancourt & lópez, 1993). the unit of analysis may not always be limited to one particular ethnic, language, or even cultural group, i.e., psychological interventions can be culture-sensitive rather than culture-specific. culture-sensitive interventions may target diverse groups, e.g., migrant populations in high-income countries, and be sensitive to cultural aspects in general rather than adapted heim, mewes, abi ramia et al. 7 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ to specific features of one particular group (e.g., lotzin et al., 2021, this issue; mewes et al., 2021, this issue). criterion 2: team and roles several guidelines for qualitative research (e.g., malterud, 2001; tong et al., 2007) consis­ tently recommend providing information on the personal characteristics of the research­ ers involved in qualitative studies (e.g., occupation, gender, training and qualifications), as well as information about preconceptions, which represent previous experiences, pre-study beliefs, and motivation. in this sense, we recommend shortly describing the team that was involved in the cultural adaptation process, as well as their roles during the formative research phase and in the decision-making process. criterion 3: documentation and monitoring system documentation is key for transparency and replicability of clinical trials in general, and therefore also for the cultural adaptation process. when documenting the process of cultural adaptation, we suggest providing as much information as possible on ccd, on other relevant aspects in the target population (e.g., specific needs), on the foundations for decisions that were made (e.g., data gathered through focus group discussions), and on the strength of evidence to support such decisions. cultural adaptation most often starts with formative research (see below). in forma­ tive research, relevant information on the target population is gathered, and representa­ tives of the target population are asked about the relevance and acceptability of the intervention. during this process, many suggestions for changing and adapting parts of the intervention may be made. some of these suggestions may be absolutely essential, for instance because of ethical considerations, because not doing them may cause harm (e.g., stigmatization, hurting feelings of subgroups), or foster higher attrition rates. moreover, a strong evidence-base might be a good indicator for the need of an adaptation. on the other hand, there may be changes that are “nice-to-have”, or even controversial, especially if they are based on personal preferences or taste (e.g., shala et al., 2020). criterion 4: documentation of adaptations during trials (“on the fly”) in most running trials, some level of adaptation may happen “on the fly”, especially when working with diverse ethnic and cultural groups, for whom we have less empiri­ cal evidence on psychological interventions (unterhitzenberger et al., 2021, this issue). as an example, if a misunderstanding in psychoeducation is discovered, it might be necessary to adapt the wording and, if needed, provide standard translations of such psychoeducation to interpreters for the rest of the trial. one may argue that ideally, such difficulties are discovered in pilot trials that are done exactly for this purpose. however, it is still possible that important information is revealed in the course of running trials, reporting cultural adaptation in psychological trials (recapt-criteria) 8 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ and documentation and transparency with regard to such “on-the-fly” adaptations may be relevant for a better understanding of trial results and implementation. in this line of thinking, chambers and norton (2016) challenge the assumption of a linear, static process from intervention development (and adaptation) to pilot testing, randomised controlled trial, and implementation. in this linear view that is still prevail­ ing in literature, deviances from manuals are considered to be problematic, as they may threaten treatment fidelity and thus, effectiveness of the intervention. in their publication entitled “the adaptome advancing the science of intervention adaptation”, chambers and norton (2016) aim to capture “positive deviance (e.g., where adaptation leads to better outcomes compared to the original trials) as well as circumstances in which program drift was deleterious to intervention effectiveness” (p. 127). thus, cham­ bers and colleagues make a case for documenting deviances from originally defined protocols: “by augmenting trial data with practice-based evidence, we can understand much more about what works for whom” (chambers et al., 2013, p. 6). using a stand­ ard documentation system (recapt template, supplementary materials) will enhance transparency on adaptations that were made during trials. b) formative research formative research includes the iterative process of gathering relevant information be­ fore starting a trial. the process of formative research is ideally reported in a consistent and transparent manner, to ensure replicability and valid interpretation of results. the recapt criteria include the methods of formative research on the one hand, and the results of this process on the other hand. criterion 5: formative research methods formative research is an iterative process using multiple qualitative and quantitative methods. in the following, we provide suggestions on how to implement this process, thus, on how to adapt. in the supplementary materials, we provide a template for documenting the cultural adaptation process. formative research methods (i.e., literature review, qualitative, quantitative, and mixed methods) can be flexibly used until a level of saturation is reached. results of this process should highlight the description of the target population’s main characteristics, their most salient symptoms or syndromes and needs, and the feedback gathered on the intervention during the process of cultural adap­ tation. although there is no “standard procedure” for top-down or bottom-up cultural adaptation, we suggest reporting on these different stages of formative research. formative research normally starts with a literature review. thereafter, researchers may conclude that available evidence on their target population is insufficient for cul­ tural adaptation. qualitative and/or quantitative information on the target population (i.e., main characteristics, symptoms, syndromes, needs) should be gathered where no or insufficient evidence is available, including mixed methods approaches (shala et al., heim, mewes, abi ramia et al. 9 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ 2020; singla et al., 2014). quantitative methods include symptoms scales, surveys, or other questionnaires used to describe the target population. qualitative methods include in-depth interviews with key informants, focus groups, free-list interviews, pile sorting, among others (cork et al., 2019; keys et al., 2012). we recommend using the consolidated criteria for reporting qualitative research (coreq, tong et al., 2007), a 32-items checklist for explicit and comprehensive reporting of qualitative studies. it includes participant selection (i.e., selection, method of approach, sample size, reasons for refusing); the setting for data collection (e.g., home, clinic); the method of data collection (i.e., interview guide, recording, duration), and the analysis methods (i.e., how themes were derived from the data). once data on the target population is gathered and compiled, interventions are adapted in a bottom-up or top-down approach. this process is accompanied by formative research, as well. and iterative process of adaptation, validation, and piloting is recom­ mended (e.g., shala et al., 2020). regardless of the methods chosen in the process of cultural adaptation, documentation is key. criterion 6: target symptoms, syndromes, needs, and context this criterion describes the most relevant aspects to consider in cultural adaptation. as outlined above, heim and kohrt (2019) suggest using ccd as the pivotal point for cultural adaptation. ccd are distinct from diagnostic categories such as depression, or post-traumatic stress, but in many cases share symptoms with these disorders (e.g., haroz et al., 2017; rasmussen et al., 2014). examples of ccd in literature are spirit possession in uganda and zimbabwe (ertl et al., 2011; patel et al., 1995), dhat in india (i.e., semen loss in urine; gautham et al., 2008), hwa-byung in korea (i.e., fire/projection of [accumulated] anger into the body; min & suh, 2010), or khyâl attacks (i.e., wind attacks) in cambodia (hinton et al., 2010). evidence shows that ccd are often associated with symptoms of psychological distress and mental disorders in general. however, it would be erroneous to conclude that ccd are just variations of the same (universal) underlying constructs across cultural groups. in their systematic review on ccd, kohrt et al. (2014) argue that higher methodological rigour is needed to better understand potential associations and distinctions between ccd and diagnostic categories developed in western countries. we recommend using an ethnopsychological model to frame the understanding and use of ccds (keys et al., 2012; kohrt & hruschka, 2010). other relevant topics for cultural adaptation may include specific needs in the target population, mental health related stigma, as well as contextual variables such as differen­ tial exposure to social determinants of mental health, and access to health systems, and mental health resources (hook et al., 2021). an example of such a contextual variable is ongoing armed conflict, which requires specific contextual adaptation of psychological interventions (castro-camacho et al., 2019). reporting cultural adaptation in psychological trials (recapt-criteria) 10 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ c) intervention in clinical and empirical literature, cultural adaptation of psychological interventions most often implicitly refers to the top-down approach, in which existing psychological interventions developed for one cultural group are adapted for another one (hall et al., 2016; hwang, 2006). there is little evidence on psychological interventions adapted in a bottom-up approach to address culture-specific symptoms and syndromes. one might argue that the development of new interventions does not fall under “adaptation”. we counter this argument by stating that psychological interventions for the treatment of distress and mental disorders are a “western” concept by themselves, as is the empirical evaluation of such interventions through randomised controlled trials. therefore, the present reporting criteria are applicable not only for trials testing cultur­ ally adapted versions of existing interventions, but also newly developed interventions and intervention components that aim to target specific factors among culturally diverse groups. psychological interventions and trials to evaluate them share a common set of fea­ tures, which have been classified by singla et al. (2017) into four categories: who (i.e., provider); what (i.e., treatment components); where (i.e., treatment setting); and how (i.e., training, supervision, treatment delivery). treatment components can be distilled into i) specific elements that are based on theoretical psychological models; ii) nonspe­ cific elements that are commonly shared by interventions of different theoretical back­ grounds; and iii) therapeutic techniques that aim to transmit specific and nonspecific elements (see theoretical framework above). this taxonomy provides a helpful grid to support the cultural adaptation of intervention, as it specifies the different levels of an intervention. other frameworks (e.g., bernal et al., 1995; bernal & sáez-santiago, 2006) have listed elements for cultural adaptation without putting them into a functional relationship. accordingly, we structured our reporting criteria along the taxonomy by singla et al. (2017). the template provided in the supplementary materials can be used for documenting cultural and contextual adaptations, evidence to support each decision, and suggestions from the research team. criterion 7: specific treatment elements most psychological trials have used manuals or protocols as unit of analysis (chorpita & daleiden, 2009). manuals most often focus on one particular diagnosis and use a series of elements for the treatment of this disorder (e.g., psychoeducation, exposition, cognitive restructuring, relapse prevention) for their treatment. transdiagnostic inter­ ventions combine treatment elements to address a broader symptom spectrum instead of one particular diagnosis, with promising effect sizes (newby et al., 2013). as an example, the common elements treatment approach (ceta, murray et al., 2014), ap­ plies evidence-based treatment elements depending on the specific symptomatology of heim, mewes, abi ramia et al. 11 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ the patient. other examples are problem management plus (pm+, dawson et al., 2015) developed by world health organization (who), or the unified protocol for emotional disorders (barlow et al., 2004). as mentioned in the theoretical framework (see above), single treatment components can be distilled from such manuals, and several authors advocate reporting on treatment components (rather than manuals) in randomised controlled trials. in the process of cultural adaptation, this distillation may be even more relevant. in psychological trials with diverse ethnic and cultural groups, it may be important to provide some empirically or theoretically based rationale for the selection, omission or adaptation of each of the specific treatment elements. in addition, explicit decisions to leave specific elements unchanged should be reported, as well (böttche et al., 2021, this issue). the mental health cultural adaptation and contextualization for implementation (mhcaci) procedure begins with identification of the mechanisms of action as the first step in order to inform the literature review, formative work, and other steps (sangraula et al., 2021). the literature review and formative work can be used to determine which specific treatment elements and other mechanisms of action will best fit with the culture and context. alternatively, the literature review and formative work can be used to select which type of intervention will fit best and is mostly likely to undergo successful adap­ tation. if the ccd, community needs, and context are clearly defined, this will inform which interventions would not require heavy adaptation for implementation, which is especially important when rapid deployment is needed such as during humanitarian emergencies. criterion 8: nonspecific elements and therapeutic techniques nonspecific elements refer to components that are universal to all treatments, also known as “common factors” (cuijpers et al., 2019; wampold, 2007). one important common factor is the provision of a convincing treatment rationale. psychological inter­ ventions ideally provide explanations that differ from the patient’s views, but that are not too discrepant from the patient’s intuitive assumptions as to be rejected (wampold, 2007). this suggests trying to find common ground between the treatment’s hypothe­ sized mechanism of action (including both specific and nonspecific elements) and the patient’s explanatory model. for treatment adherence and compliance, it is vital that patients understand and to some point share the rationale behind the treatment. the treatment rationale is ideally dovetailed with cultural explanations and idioms of distress that are part of ccd (hwang, 2006; rathod et al., 2019). ccd may include beliefs and assumptions that require to be challenged when providing the treatment rationale. in addition, it may be relevant to consider culture-specific notions of stigma, and the way how mental health-related stigma threatens the life domains that “matter most” (yang et al., 2014) to members of a specific cultural group (e.g., marriage, employment, social networks). intervention adaptation should include consideration of "what matters reporting cultural adaptation in psychological trials (recapt-criteria) 12 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ most" because this will influence stigma and motivation of those delivering the inter­ vention (kohrt, turner, et al., 2020). documentation of how adaptations address what matters most further demonstrates the rigor of the approach. we also recommend to report on the reflections that have guided the choice, omis­ sion, or adaptation of therapeutic techniques, such as role-playing, goal setting, or home­ work (singla et al., 2017). criterion 9: surface adaptations surface structure adaptations aim to enhance acceptability of an intervention through matching materials, channels and settings to the target population (resnicow et al., 1999). such surface adaptations correspond to the how and where in the taxonomy suggested by singla et al. (2017). there is much evidence on such surface adaptations of psychological interventions (chowdhary et al., 2014; chu & leino, 2017; harper shehadeh et al., 2016). cultural and contextual factors may determine the channels through which the treat­ ment components are provided, e.g. group-based as opposed to individual treatment (epping‐jordan et al., 2016; sangraula et al., 2018; verdeli et al., 2003), or internet-based interventions (naslund et al., 2017) that are increasingly tested and applied among diverse ethnic and cultural groups. reporting should include considerations that have been made with regard to such different modes of delivery. interventions (both self-help and face-to-face) may include materials such as texts, illustrations, case examples, flyers, audio files, videos, etc. standards exist for the transla­ tion of assessments and materials (e.g., van ommeren et al., 1999). several studies report that it is often difficult to draw the line between translation and adaptation, as these two are closely intertwined (ramaiya et al., 2017; shala et al., 2020). for pragmatic reasons, it is often not possible to document all the decisions that were made during the process of translation and language editing, especially if the decisions are merely questions of style or grammar. however, some decisions might be relevant to be documented in the cultural adaptation monitoring sheet. as an example, metaphors are often culture-specific and cannot be translated literally (rechsteiner et al., 2020). it might therefore make sense to report on how specific metaphors in the intervention were translated or adapted. d) measuring outcomes and implementation as outlined above, there is considerable cultural variation in symptom expression. in clinical trials testing psychological interventions among diverse ethnic and cultural groups, it is important to account for this cultural validation by using validated instru­ ments. heim, mewes, abi ramia et al. 13 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ criterion 10: questionnaires and clinical interviews when conducting clinical trials with culturally diverse populations, it is vital to provide information on the extent to which outcome measures (i.e., questionnaires and clinical interviews) were translated, (culturally) adapted, and validated. there are standard criteria for the translation, adaptation, and validation of ques­ tionnaires. as an example, wild et al. (2005) and van ommeren et al. (1999) provided principles of good practice for the translation and cultural adaptation process for pa­ tient-reported outcomes. in addition, standard psychometric methods for the cross-cul­ tural validation of questionnaires and measurement invariance have been developed (e.g., byrne et al., 1989; chen, 2008; milfont & fischer, 2010; vandenberg & lance, 2000). several standard questionnaires have been used for application among diverse cultural and ethnic groups, e.g., the patient health questionnaire (kroenke & spitzer, 2002), the generalised anxiety disorder scale (spitzer et al., 2006), the posttraumatic diagnostic scale (foa et al., 1997), the general health questionnaire (goldberg, 1972), or the who disability assessment scale (ustun et al., 2010), to mention only a few. the validity of questionnaires can be enhanced by incorporating ccd, and par­ ticularly idioms of distress. another option is the use of client-generated outcome measures, such as the psychological outcome profiles instrument (psychlops, ashworth et al., 2004), which has been validated in several countries (e.g., czachowski et al., 2011; héðinsson et al., 2013). another client-generated outcome measure is the personal questionnaire (elliott et al., 2016). most trials use self-report questionnaires as their primary outcome measure. clinical interviews are of course more labour-intensive, but the diagnostic accuracy might be higher (ferrari et al., 2013), especially among diverse cultural and ethnic groups. if the planned outcome measure for the psychological trial is a clinical interview (e.g., the structured clinical interview for dsm-5, scid-5-cv; first et al., 2016), it is rec­ ommended to integrate a culture-sensitive interview, such as the cultural formulation interview in dsm-5 (american psychiatric association, 2013). training interviewers in culture-sensitive assessments is important, in order to avoid misdiagnosis. and it is relevant to report on interviewer training and interrater reliability with regard to cultural competence. criteria 11: implementation measures in addition to measuring outcomes, the implementation process should be documented, as well. without documenting implementation, it is difficult to determine if an unsuc­ cessful intervention is due to the intervention not being effective or lack of fidelity when delivering the intervention (jordans & kohrt, 2020; kohrt, el chammay, et al., 2020). moreover, assessing implementation is vital to determine that the cultural adaptations were actually enacted in delivery of the intervention. criterion 11 refers to the who and how criteria in the taxonomy by singla et al. (2017). reporting cultural adaptation in psychological trials (recapt-criteria) 14 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ in addition to fidelity, competency of providers is important to evaluate. competency tools now exist that can be modified based by the culture and context for a psychological intervention (kohrt, schafer, et al., 2020); these address both competency in nonspecific treatment factors (kohrt et al., 2015) and culturally adapted competencies in treatment specific factors, such as for pm+ (pedersen et al., in press). quality rating currently there are no standards for ranking of cultural adaptation quality. we propose for preliminary use that cultural adaptation studies that only report on 4 or fewer of the criteria be consider ‘low quality’ of reporting. studies that are 5-8 criteria be identified as ‘moderate quality’ of reporting. finally, studies that clearly document 9-11 criteria be considered ‘high quality’. these rankings are subject to change as more documentation occurs on adaptation and further research is conducted about what aspects of adaptation matter most for successfully alleviating suffering across cultures and context around the world. c o n c l u d i n g r e m a r k s in this paper, we propose a set of reporting criteria for cultural adaptation in clinical trials which test psychological interventions among diverse cultural and ethnic groups. although these reporting criteria were primarily developed for treatments of common mental disorders, they may be used also for other kinds of interventions, such as preven­ tion or mental health promotion. the suggested set of criteria was compiled based on the authors’ experiences and cur­ rent literature. although not exhaustive, the criteria are comprehensive and may be used for top-down and bottom-up cultural adaptation (hall et al., 2016; hwang, 2006). they can be used to guide the process of cultural adaptation, as well as for documentation. that said, it is likely that not all of these criteria are relevant for all trials conducted in this field of research. in this sense, the use and the sequence can be adapted flexibly to the needs of researchers. a template for documenting the process and results of cultural adaptation can be found in the supplementary materials. reporting on cultural adaptation more consistently in future psychological trials will hopefully improve the quality of evidence and contribute to examining the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability. heim, mewes, abi ramia et al. 15 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://www.psychopen.eu/ funding: the project that led to the development of the reporting criteria and the paper was funded by the german federal ministry of education and research (nr 01ef1806h). acknowledgments: we would like to thank dr. kenneth carswell for his valuable contributions to the manuscript. competing interests: eva heim and cornelia weise are both guest editors of this special issue of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • appendices – appendix a provides additional information on definitions of culture, cultural adaptation literature, the process for developing the recapt criteria, and detailed information on each criterion. – appendix b shows the expert survey used for developing the recapt criteria. • recapt template a template for documenting the cultural adaptation process that was developed by the “task force for cultural adaptation of mental health interventions for refugees”. a documented version for better understanding is provided, along with an empty template in word format that can be used for future studies. index of supplementary materials heim, e., mewes, r., abi ramia, j., glaesmer, h., hall, b., harper shehadeh, m., ünlü, b., kananian, s., kohrt, b. a., lechner-meichsner, f., lotzin, a., moro, m. r., radjack, r., salamanca-sanabria, a., singla, d. r., starck, a., sturm, g., tol, w., weise, c., & knaevelsrud, c. 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(2014). recent advances in crosscultural measurement in psychiatric epidemiology: utilizing ‘what matters most’ to identify reporting cultural adaptation in psychological trials (recapt-criteria) 24 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://doi.org/10.1146/annurev-clinpsy-032816-045217 https://doi.org/10.1016/j.jad.2014.07.017 https://doi.org/10.1001/archinte.166.10.1092 https://doi.org/10.1093/intqhc/mzm042 https://doi.org/10.32872/cpe.5431 https://apps.who.int/iris/handle/10665/43974 https://doi.org/10.1177/109442810031002 https://doi.org/10.1177/136346159903600304 https://doi.org/10.1037/0003-066x.62.8.857 https://doi.org/10.1111/j.1524-4733.2005.04054.x https://www.psychopen.eu/ culture-specific aspects of stigma. international journal of epidemiology, 43(2), 494-510. https://doi.org/10.1093/ije/dyu039 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. heim, mewes, abi ramia et al. 25 clinical psychology in europe 2021, vol. 3(special issue), article e6351 https://doi.org/10.32872/cpe.6351 https://doi.org/10.1093/ije/dyu039 https://www.psychopen.eu/ reporting cultural adaptation in psychological trials (recapt-criteria) (introduction) background theoretical framework process for developing the reporting criteria reporting criteria a) set-up b) formative research c) intervention d) measuring outcomes and implementation quality rating concluding remarks (additional information) funding acknowledgments competing interests supplementary materials references explaining the efficacy of an internet-based behavioral activation intervention for major depression: a mechanistic study of a randomized-controlled trial research articles explaining the efficacy of an internet-based behavioral activation intervention for major depression: a mechanistic study of a randomized-controlled trial zhongfang fu 1, huibert burger 2, retha arjadi 3,4, maaike h. nauta 4, claudi l. h. bockting 1,5 [1] department of psychiatry, amsterdam university medical centers, location amc, university of amsterdam, amsterdam, the netherlands. [2] department of general practice and elderly care medicine, university medical center groningen, university of groningen, groningen, the netherlands. [3] faculty of psychology, atma jaya catholic university of indonesia, jakarta, indonesia. [4] department of clinical psychology and experimental psychopathology, university of groningen, groningen, the netherlands. [5] centre for urban mental health, university of amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2021, vol. 3(3), article e5467, https://doi.org/10.32872/cpe.5467 received: 2020-12-20 • accepted: 2021-08-16 • published (vor): 2021-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: claudi l. h. bockting, meibergdreef 5, 1105 az amsterdam, the netherlands. e-mail: c.l.bockting@amsterdamumc.nl supplementary materials: materials [see index of supplementary materials] abstract background: behavioral activation is an effective treatment for depression that is theorized to facilitate structured increases in enjoyable activities that increase opportunities for contact with positive reinforcement; to date, however, only few mechanistic studies focused on a standalone intervention. method: interventions using internet-based behavioral activation or psychoeducation were compared based on data from a randomized-controlled trial of 313 patients with major depressive disorder. activation level and depression were measured fortnightly (baseline, weeks 2, 4, 6, 8, 10), using the patient health questionnaire-9 and the behavioral activation for depression scale-short form, respectively. analysis was performed to determine if a change in activation level mediated treatment efficacy. results: latent growth modeling showed that internet-based behavioral activation treatment significantly reduced depressive symptoms from baseline to the end of treatment (standardized coefficient = −.13, p = .017) by increasing the rate of growth in the activation level (mediated effect this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5467&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0002-9220-9244 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ estimate = −.17, 95% ci [−.27, −.07]. results from mixed effects and simplex models showed that it took 4 weeks before mediation occurred (i.e., a significant change in activation that led to a reduction in depressive symptoms). conclusion: activation level likely mediated the therapeutic effect of behavioral activation on depression in our intervention. this finding may be of significant value to clinicians and depressed individuals who should anticipate a 4-week window before seeing a prominent change in activation level and a 6-week window before depressive symptomatology reduces. future research must consolidate our findings on how behavioral activation works and when mediation occurs. keywords psychological interventions, working mechanisms, behavioral activation, depression, internet-based intervention, lay counselors highlights • activation level mediates depression outcomes in an 8-week internet-based behavioral intervention. • internet-based behavioral activation appeared to work by changing the level of activation at week 4 and reducing depressive symptoms over the next 2 weeks. • internet-based treatment requires patience and perseverance from clinicians and patients. background depression is a prevalent and disabling mental health condition characterized by sadness and lack of interest (american psychiatry association, 2015). behavioral activation is well-established as an effective treatment (cuijpers, van straten, & warmerdam, 2007; stein, carl, cuijpers, karyotaki, & smits, 2021) and as a standalone therapy in relevant clinical guidelines (national collaborating centre for mental health [uk], 2010). it is also considered a cost-effective therapy that can be delivered easily and disseminated in a range of formats (arjadi et al., 2018; carlbring et al., 2013). however, more research is needed to clarify uncertainties about how behavioral activation exerts its clinical effects (janssen et al., 2020). rooted in behavioral frameworks, the theory underpinning behavioral activation con­ ceptualizes depression as the result of low levels of (response-contingent) positive rein­ forcement: the consequences of environmental interaction that increase the likelihood of a given behavior (ferster, 1973, 1981; lazarus, 1972; lewinsohn, 1974). the theory posits that a lack of this positive reinforcement can result in decreased behavioral activation or withdrawal from the environment, which precipitates depression (manos, kanter, & busch, 2010). therefore, actively engaging in behavioral activation can help to break the negative cycle of depression by promoting meaningful and adaptive engagement in life (martell, dimidjian, & herman-dunn, 2013). this strong theoretical basis allows for mechanism of behavioral activation intervention 2 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ changes in levels of activation and avoidance (i.e., the activation level) to be evaluated as the hypothesized mediator of change in depressive symptoms during treatment (curry & meyer, 2016). however, two research gaps remain. first, contrasting starkly with research into cognitive processes, there is limited empirical evidence of activation level as a potential mediator (lemmens, müller, arntz, & huibers, 2016; moreno-peral et al., 2020). second, mediators have rarely been examined in randomized-controlled trials (rcts) of behavioral activation as a standalone treatment (janssen et al., 2020). further study is needed to correct this lack of mechanistic research into mediation processes. most research into behavioral activation has investigated it as a component of cog­ nitive behavior therapy (e.g., van luenen, kraaij, spinhoven, wilderjans, & garnefski, 2019), for which the underlying theoretical assumption differs, suggesting instead that behavioral change helps to improve symptoms through cognitive restructuring. to date, ten studies have examined activation level for the treatment of depression (dimidjian et al., 2017; forand et al., 2018; gaynor & harris, 2008; nasrin, rimes, reinecke, rinck, & barnhofer, 2017; richards et al., 2017; rovner et al., 2014; santos et al., 2019; silverstein et al., 2018; van luenen et al., 2019; weidberg, gonzález-roz, garcía-fernández, & secades-villa, 2021). among these, four investigated a standalone behavioral activation intervention, producing inconsistent results, and none assessed both depression and activation during treatment, precluding mediation analyses. the inconsistent findings likely result from clinical heterogeneity and a failure to meet specific methodological requirements, such as using an rct design, examining variables of interest longitudinal­ ly to assess temporal ordering, and being sufficiently large to ensure robust statistical analyses (curran et al., 2010; kazdin, 2007; lemmens et al., 2016). studies assessing the activation level as a mediator of depression treatment have not complied with all these requirements (janssen et al., 2020), with some adopting small samples (e.g., <40 per trial arm) (gaynor & harris, 2008) and others using too few repeat observations (e.g., <3) (richards et al., 2017; weidberg et al., 2021) or no control group (e.g., santos et al., 2019). thus, adequately powered trials of standalone behavioral activation interventions for depression are needed to clarify the extent to which the activation level mediates treatment outcomes. our group has previously conducted an rct for an internet-based intervention in­ volving a large sample of patients with major depressive disorder treated by behavioral activation under the guidance of lay counselors (intervention) compared with psycho­ education (controls) (arjadi et al., 2018). in that study, we concluded that, after 10 weeks, patients in the intervention group reported significantly fewer depressive symptoms (effect size, 0.24) and had a 50% higher chance of remission than those in the control group. crucially, this study complied fully with the methodological requirements of mechanistic research into mediation processes. in the present study, we therefore aimed to use data from that study to demonstrate that the activation level mediates the relation­ ship between treatment with behavioral activation and improved depression. this was fu, burger, arjadi et al. 3 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ considered achievable if we could demonstrate two criteria (kazdin, 2007; mackinnon, 2008). first, that the treatment condition correlated with changes in the activation level, which in turn, correlated with changes in depressive symptoms and was conditional on treatment allocation (criterion 1). second, that the change in activation level produced the change in depressive symptoms, and not vice versa (i.e., temporal ordering; criteri­ on 2). m a t e r i a l s a n d m e t h o d design this study reports on a post-hoc analysis of an earlier two-group rct of an inter­ net-based behavioral activation program for patients with major depressive disorders (n = 313). details of the original rct are reported elsewhere (arjadi et al., 2018). all assessments were completed on the qualtrics survey platform and administered at baseline and every 2 weeks thereafter up to the main post-treatment evaluation at week 10 (endpoint), with follow-up at 12 and 24 weeks after baseline. for the purposes of the current study, depression and activation level were examined fortnightly at baseline and at weeks 2, 4, 6, 8, and 10. participants and randomization in total, 313 participants were included and randomized into the treatment (n = 159) and control (n = 154) groups (see arjadi et al., 2018, for a detailed flowchart). the baseline characteristics we comparable in each group, as presented in table 1, indicating successful randomization. participants were recruited via online self-referral. eligible participants were aged ≥16 years, scored ≥10 on the patient health questionnaire-9 (phq-9), and had a principal diagnosis of major depressive disorder or persistent de­ pressive disorder defined according to the diagnostic and statistical manual of mental disorders, fifth edition. diagnosis was by semi-structured diagnostic interview (scid-5) (first et al., 2015). participants with current substance use disorder, current or previous manic or hypomanic episodes, psychotic disorder, or acute suicidality were excluded, as were those receiving psychological interventions. eligible participants were allocated (1:1) by a research assistant in a random permuted block design stratified by sex and depression severity (score 10–14 or ≥15 on the phq-9) via a web-based program. current depressive episodes and post-traumatic stress disorder were assessed by clinical diagnostic interview conducted by trained clinical interviewers who were required to hold at least a bachelor’s degree in psychology. mechanism of behavioral activation intervention 4 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ table 1 descriptive statistics of baseline demographic characteristics demographic information gaf (n = 159)a pe (n = 154)a age (m, sd) 24.5 (4.9) 24.5 (5.2) sex female 128 125 male 31 29 current ptsd yes 22 30 no 137 124 education above bachelor 89 81 others 70 73 living area urban 93 96 others 67 58 socioeconomic class low 32 27 middle 98 100 high 29 27 ethnicity java 69 64 tionghoa 30 18 sunda 21 22 others 39 40 anote that all patients were in a depressive episode. abbreviations: gaf = guided act-and-feel-indonesia; pe = psychoeducation; ptsd = post-traumatic stress disor­ der; sd = standard deviation. treatments intervention group: guided act-and-feel-indonesia (gaf-id) participants in the intervention group received an internet-based behavioral activation intervention (the gaf-id) supported by lay counselors. the intervention program was adapted from an online intervention for behavioral activation based on lewinsohn’s (1974) theory of depression. the original program was published in dutch (doe en voel; bockting & van valen, 2015) and was translated to bahasa indonesian. the gaf-id program was delivered using an online platform in eight structured modules delivered weekly. each module was expected to be completed online in 30–45 minutes. the inter­ vention group was guided and supported by lay counselors who were supervised by fu, burger, arjadi et al. 5 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ a licensed clinical psychologist. a detailed description of the guidance and support is available elsewhere (arjadi et al., 2018). control group: online psychoeducation participants in the control group were given access to another online platform from which they could find basic psychoeducation on depression and brief tips on coping with depression in general. this information was distilled from the psychoeducation module of the gaf-id program, but no guidance or support was provided. measures demographic information was collected at baseline, including age, gender, ethnicity, education (above bachelor/other), living area (urban/other), and socioeconomic class. the latter was determined by monthly expenditure in indonesian rupiah (idr): low, <1 million; middle, 1–5 million; and high, >5 million. in addition, the phq-9 and behavioral activation for depression scale-short form (bads-sf) were completed fortnightly. patient health questionnaire-9 item version the phq-9 is a 9-item self-report questionnaire in which participants rate how they felt during the previous two weeks (e.g., “feeling tired or having little energy”). each question is scored 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). sum scores range from 0 to 27, with higher scores representing higher levels of depression. the phq-9 has acceptable validity and reliability (carroll et al., 2020), and the cronbach’s alphas in the current study ranged from .78 to .87 at the different assessments. behavioral activation for depression scale-short form the bads-sf is a 9-item self-report questionnaire that measures changes in activation and avoidance in the previous week (e.g., “there were certain things i needed to do that i didn’t do”). each question is scored 0 to 6 (0 = not at all, 6 = completely). items 1, 6, 7, and 8 are reverse-coded. sum scores can range from 0 to 54, with higher scores representing higher activation. the validity and reliability of bads-sf have been established (manos, kanter, & luo, 2011), and the cronbach’s alphas in the current study ranged from .78 to .88 at different assessments. data analysis mixed effects model to compare mean depression and activation levels mixed effects models were used to inspect how treatment influenced activation level and depression at each time point. baseline and follow-up measures were treated as response variables. missing values were imputed by multiple imputation, including treatment mechanism of behavioral activation intervention 6 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ allocation and all phq-9 and bads-sf assessments in the predictor matrix. given that the functional form of the mean responses during treatment can be difficult to anticipate, time was specified as a class effect in an unstructured manner. the contrasts between treatment groups at each time point were obtained by comparing the least squares means of the variables of interest. mixed effect analyses were conducted using the nlme r package (pinheiro, bates, debroy, sarkar, & r core team, 2020), and for multiple imputations, we used the mice r package (van buuren & groothuis-oudshoorn, 2011). mediation analyses using latent growth and simplex mediation models mediation analyses were based on latent growth models to address criterion 1 (mackinnon, cheong, & pirlott, 2012) and simplex mediation models to address criterion 2 (goldsmith et al., 2018) in a structural equation model framework. we refer to the path estimating the relationship between treatment allocation (t) and activation level (m) as the a path and refer to the path between activation level and depression (y) as the b path. the direct effect from treatment allocation to depression is noted as the c path, after accounting for m as c′. the product of a × b coefficients method was used to indicate the indirect effect (goldsmith et al., 2018). coefficients were provided based on a completely standardized solution, and the confidence intervals of a × b were estimated by bootstrapping (1,000 times). a mediated effect was deemed statistically significant if the 95% confidence interval (95% ci) did not cross zero. latent growth model analyses were performed in three steps to model the rela­ tionship between treatment and the growth trajectories of activation and depression (cheong, mackinnon, & khoo, 2003). first, to investigate the shape of the growth trajec­ tories for depression and activation, unconditional growth models were built. second, to examine if the growth rates of depression and activation differed by treatment con­ dition, two conditional models were constructed with the treatment conditions. third, to assess the indirect effect of treatment allocation on the outcome, via the mediator (activation level), we combined the two conditional growth models into a parallel process growth model. in this, the path coefficients (a, b, c, and c′) of the mediation model were estimated and the contributions of baseline characteristics as covariates were examined (e.g., sex, ethnicity, urban/rural, socioeconomic status, post-traumatic stress disorder, and education level). a simplex mediation model was then adopted to determine if there was temporal ordering. this was achieved by evaluating whether a prior activation level was associ­ ated with the level of depression at a subsequent measurement. we specified models as either a lagged b path (activation affects depression at adjacent time points) or a contemporaneous b path (activation affects depression at the same time point). we added treatment allocation as a time-invariant antecedent variable to predict depression and activation level at each time point. autoregressive and cross-lagged effects were constrained to be equal over time (goldsmith et al., 2018). to assess the timing of the fu, burger, arjadi et al. 7 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ potential mediation process, a paths were freely estimated. in addition, to evaluate the extent to which prior depression influenced the subsequent activation level, we reversed the position of depression and activation level in a supplementary analysis (see supple­ mentary materials). the time-specific indirect effect was estimated using a series of product terms to indicate the possible timing of the putative mediator taking effect. figure 1 shows an example simplex model with lagged b paths: for the third time point, depression y3 (i.e., week 4 depression), one indirect effect of treatment could be t→ m2 →y3. calculation was performed as a2 × b23, where the subscripts indicated direction (e.g., the coefficient a2 was the effect to activation at point 2, and b23 was the effect from activation at point 2 to depression at point 3, and all b paths were considered equal). a significant result could suggest a lagged mediation effect from week 2 activation (m2) to week 4 depression (y3). the overall indirect effect in the model for y3 was the sum of all time-specific indirect effects estimated by the products of the parameters that estimated the paths between t and y3 and passed through the mediator. coefficient a at baseline (i.e., a1) was fixed at zero because treatment had not been implemented at this time. figure 1 example diagram of simplex models for mediation with contemporaneous b paths (right side) and lagged b paths (left side) with depression at third timepoint (week 6) as outcome note. abbreviations: a2 = parameter estimated coefficient from treatment to week 4 behavioral activation; b = parameter estimated coefficient from mediator to outcome; b0 = parameter estimated coefficient from baseline mediator to week 2 depression; ba, behavioral activation; bads(1, 2, 3, 4, 5, 6) = behavioral activation of depression scale-short form (baseline and 2, 4, 6, 8, 10 weeks, respectively); c′2, c′3 = parameter estimated coefficient from treatment to week 4, 6 depression after controlled for intermediate behavioral activation; phq(1, 2, 3, 4, 5, 6) = patient health questionnaire-9 items (baseline and 2, 4, 6, 8, 10 weeks, respectively). data were assumed to be missing at random or completely at random (graham, 2009), so we used a full-information maximum likelihood estimation in the structural equation mechanism of behavioral activation intervention 8 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ modeling analysis. participants who had at least one measurement for depression were retained in the model and analysis performed on an intention-to-treat basis. model fit was assessed by the comparative fit index (cfi), tucker–lewis index (tli), root mean squared error of approximation (rmsea), and standardized root mean square residual (srmr). we used established guidelines of acceptable fit, requiring that the cfi and tli should exceed 0.90–0.95, that the rmsea should not exceed 0.06–0.10, and that the srmr should not exceed 0.08. all structural equation modeling analyses were performed in mplus 8.3 (muthén & muthén, 2019). r e s u l t s a full overview of the levels of activation and depression at each measurement is presented in table 2. table 2 means and standard deviations of phq-9 and bad-sf for each group at each assessment measure gaf-id pe missing means sd missing means sd depression (phq-9) week 0 (baseline) 0 17.92 5.39 0 18.01 5.05 week 2 21 12.04 6.05 2 12.81 5.97 week 4 33 10.53 6.04 10 11.33 6.01 week 6 31 9.79 5.80 8 11.18 5.85 week 8 43 9.07 6.22 11 10.48 6.12 week 10 (endpoint) 39 8.50 5.75 9 10.83 6.21 behavioral activation (bads-sf) week 0 (baseline) 0 16.67 6.72 0 16.38 6.29 week 2 21 19.59 6.75 2 18.68 6.64 week 4 33 23.22 7.32 10 19.93 6.87 week 6 31 24.11 7.94 8 20.57 7.61 week 8 43 24.93 8.06 11 22.22 7.72 week 10 (endpoint) 39 24.12 7.37 9 20.73 7.45 note. abbreviations: bads-sf = behavioral activation for depression scale – short form; gaf = guided act­ and-feel-indonesia; pe = psychoeducation; phq-9 = patient health questionnaire-9; sd = standard deviation. each fortnightly assessment was completed by at least 83% of the sample, but 17.5% of all data points were missing in the gaf-id group versus 4.3% in the control group. participants in both groups had at least 4 data points (83.6% for the gaf-id group and 95.4% for the control group). the main reasons for dropout at week 10 were “no time” fu, burger, arjadi et al. 9 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ (18 in the gaf-id group) and “no improvement” (12 in gaf-id group and 6 in the control group). mixed effects model: differences of depression and activation level treatment allocation had significant effects on depression (p < .001) and activation (p < .001) across all included time points. as shown in table 3, the mean differences in activation and depression increased over time between the treatment and control groups, reaching statistical significance from week 4 (assessment 3) for activation and week 6 (assessment 4) for depression. table 3 means difference of depression and activation between treatment and control groups over time (unstructured time model) time point lsmd se 95% ci p value behavioral activation (bads-sf) week 0 (baseline) 0.30 0.74 [−0.77, 1.36] .688 week 2 0.70 0.77 [−0.46, 1.87] .360 week 4 3.47 0.94 [1.72, 5.21] < .001 week 6 3.41 1.01 [1.39, 5.42] .002 week 8 2.86 0.96 [1.05, 4.63] .004 week 10 (endpoint) 3.36 0.89 [1.82, 4.91] < .001 depression (phq-9) week 0 (baseline) −0.08 0.59 [−0.77, 0.60] .890 week 2 −0.61 0.69 [−1.55, 0.33] .379 week 4 −0.97 0.72 [−1.97, 0.04] .178 week 6 −1.41 0.68 [−2.31, −0.50] .039 week 8 −1.76 0.74 [−0.68, −2.84] .019 week 10 (endpoint) −2.59 0.71 [−3.56, −1.61] < .001 note. abbreviations: bads-sf = behavioral activation for depression scale-short form; ci = confidence interval; lsmd = least squares mean difference; pe = psychoeducation; phq-9 = patient health questionnaire-9; se = standard error. latent growth model for mediation unconditional growth model model fit indices, as shown in table 4, were acceptable. the rmsea for the model of depression was higher than that of activation level, suggesting that the variance in depression could be explained by a potential covariate (e.g., treatment). mechanism of behavioral activation intervention 10 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ table 4 fit indices of latent growth models model cfi tli rmsea (90%ci) srmr depression (unconditional model) 0.96 0.94 0.11 [0.08, 0.14] 0.07 treatment–depression 0.96 0.94 0.09 [0.07, 0.12] 0.06 ba (unconditional model) 0.99 0.99 0.04 [0, 0.08] 0.04 treatment–ba 0.99 0.99 0.04 [0, 0.07] 0.04 treatment–ba–depression 0.97 0.96 0.05 [0.04, 0.07] 0.05 note. abbreviations: ba = behavioral activation; cfi = comparative fit index; ci = confidence interval; rmsea = root mean squared error of approximation; srmr = standardized root mean square residual; tli = tucker–lewis index. conditional growth models: the effect of treatment the fitness of both conditional models appeared acceptable (table 4). the gaf-id group showed a larger increase in activation (standardized coefficient = .27, p < .001) and a larg­ er reduction in depression compared with the control group (standardized coefficient = −.13, p = .017). this confirmed that treatment was efficacious in producing a difference in trajectories between the treatment and control groups. parallel process growth models: the mediation effect model fit of the parallel process growth model was acceptable (figure 2). factor loadings of the slope growth factor indicating the predicted trajectory of depression and activa­ tion are presented in table 5. table 5 growth factor loadings for intercept and slope factors in the parallel latent growth models for depression and activation level time point depression (phq-9) behavioral activation (bads-sf) intercept slope intercept slope week 0 (baseline) 1 0 1 0 week 2 1 0.65 1 0.42 week 4 1 0.85 1 0.84 week 6 1 0.93 1 1.00 week 8 1 1.01 1 1.17 week 10 (endpoint) 1 1.00 1 1.00 note. abbreviations: bads-sf = behavioral activation for depression scale-short form; phq-9 = patient health questionnaire-9. fu, burger, arjadi et al. 11 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ consistent with the plotted growth trajectory for depression based on data for the whole sample (see figure 3a), there was a sharp decrease (0.65 unit) in depressive symptoms from the second week. the reduction in depression continued, reaching a trough at week 8 that persisted to week 10 (endpoint). a slightly different pattern was observed for the trajectory of the activation level. as shown in figure 3b and table 5, activation increased by 0.42 units after the second week of treatment, peaking at week 8 before decreasing slightly at week 10 (endpoint). figure 2 parallel process latent growth model of depression and activation level conditioned on treatment groups note. rectangles denote observed variables, and ellipses denote latent variables. bolded arrows indicated the significant prediction from treatment to growth of activation, growth of activation to growth of depression. dashed arrow indicated the insignificant prediction from treatment to growth of depression. abbreviations: bads(1, 2, 3, 4, 5, 6) = behavioral activation of depression scale-short form (baseline and 2, 4, 6, 8, 10 weeks, respectively); i.dep = intercept growth factor of depression; i.ba = intercept growth factor of behavioral activation; phq(1, 2, 3, 4, 5, 6) = patient health questionnaire-9 items (baseline and 2, 4, 6, 8, 10 weeks, respectively); s.ba = slope growth factor of behavioral activation; s.dep = slope growth factor of depression. mechanism of behavioral activation intervention 12 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ figure 3a trajectories of depression (phq-9) across measurements in treatment (gaf) and control (pe) groups note. gaf = guided act and feel treatment; pe = psychoeducation. figure 3b trajectories of activation (bads-sf) across measurements in treatment (gaf) and control (pe) groups note. gaf = guided act and feel treatment; pe = psychoeducation. fu, burger, arjadi et al. 13 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ treatment condition (gaf-id or control) was significantly associated with the slope factor of activation level (path a, standardized coefficient = 0.28, p < .001), which in turn was associated with the slope factor of depression (path b, standardized coefficient = −0.60, p < .001). after accounting for the growth trajectory of the activation level, the prediction that treatment affected depression was no longer significant (path c′, standar­ dized coefficient = 0.03, p = .483). table 6 shows that the estimated mediated effect (a × b product) was standardized as −0.17, 95% ci [−0.27, −0.07], p = .001. after adding the baseline characteristics as covariates, model fit was similar, cfi = 0.97, tli = 0.96, rmsea = 0.04, 90% ci [0.03, 0.05], and srmr = 0.05. the estimated mediated effect in this model was similar to that in the model without baseline characteristics as covariates, standardized estimate = −0.15, 95% ci [−0.25, −0.08], p < .001. table 6 regression coefficients of mediational parallel process growth models model standard coefficient se p value conditional models treatment–depression −0.13 0.06 .017 treatment– ba 0.27 0.06 < .001 parallel process model treatment–ba (a path) 0.28 0.06 < .001 ba–depression (b path) −0.60 0.08 < .001 treatment–depression (c′ path) 0.03 0.05 .483 a × b product −0.17 0.05 .001 note. abbreviations: ba = behavioral activation; se = standard error. time-specific mediation effect in the simplex models for the simplex models with activation level as a mediator, fit indices with a contempo­ raneous b path were adequate, cfi = 0.96, tli = 0.95, rmsea = 0.06, 90% ci [0.05, 0.08], and srmr = 0.07. table 7a shows that the contemporaneous indirect effect reached significance from week 6. table 7b summarizes the results with only significant lagged indirect paths, showing that the paths all passed through m3 (i.e., activation level at week 4) to influence either contemporary depression or subsequent mediators (mn), and ultimately, later depression. fit indices of the simplex mediation model with the lagged b path were adequate, cfi = 0.95, tli = 0.94, rmsea = 0.07, 90% ci [0.06, 0.08], and srmr = 0.08. as shown in table 7b, the indirect effect reached significance from week 6 onwards. as with the contemporaneous b paths, m3 was the only mediator to be passed through during the treatment. mechanism of behavioral activation intervention 14 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ table 7a simplex model with contemporaneous b paths for activation level as a mediator simplex for mediation with contemporaneous b path se p 95% ci time-specific outcome / significant paths and effect of treatment standardized estimate ll ul week 2 depression (y2) total effect −0.05 0.05 .320 −0.17 0.06 indirect effect −0.01 0.01 .379 −0.03 0.01 week 4 depression (y3) total effect −0.08 0.06 .189 −0.20 0.05 indirect effect −0.09 0.04 .035 −0.19 −0.001 t→m3→y3 −0.04 0.02 .006 −0.08 −0.01 week 6 depression (y4) total effect −0.13 0.06 .028 −0.25 −0.004 indirect effect −0.12 0.05 .016 −0.22 −0.01 t→m3→y3→y4 −0.03 0.01 .005 −0.06 −0.01 t→m3→m4→y4 −0.04 0.02 .006 −0.08 −0.02 week 8 depression (y5) total effect −0.15 0.06 .012 −0.27 −0.02 indirect effect −0.14 0.05 .003 −0.25 −0.04 t→m3→y3→y4→y5 −0.02 0.01 .004 −0.04 −0.01 t→m3→m4→y4→y5 −0.03 0.01 .004 −0.05 −0.01 t→m3→m4→m5→y5 −0.04 0.01 .005 −0.07 −0.01 week 10 depression (endpoint, y6) total effect −0.22 0.06 < .001 −0.34 −0.09 indirect effect −0.16 0.05 .001 −0.26 −0.06 t→m3→y3→y4→y5→y6 −0.02 0.01 .004 −0.03 −0.01 t→m3→m4→y4→y5→y6 −0.02 0.01 .004 −0.03 −0.01 t→m3→m4→m5→y5→y6 −0.03 0.01 .004 −0.05 −0.01 t→m3→m4→m5→m6→y6 −0.04 0.01 .005 −0.06 −0.01 note. only significant paths are shown to save space. abbreviations: m3, m4, m5 = mediator measurements (taken at weeks 4, 6, and 8, respectively); se = standard error; t = treatment allocation (treatment group = 1, control group = 0); y2, y3, y4, y5, y6 = outcome measurements (taken at weeks 2, 4, 6, 8, and 10, respectively). fu, burger, arjadi et al. 15 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ table 7b simplex model with lagged b paths for activation level as a mediator simplex model for mediation with lagged b path se p 95% ci time-specific outcome / significant paths and effect of treatment standardized estimate ll ul week 4 depression (y3) total effect −0.08 0.06 .187 −0.21 0.05 indirect effect −0.05 0.05 .269 −0.15 0.03 week 6 depression (y4) total effect −0.13 0.06 .025 −0.25 −0.01 indirect effect −0.11 0.05 .033 −0.22 0.001 t→m3→y4 −0.04 0.02 .01 −0.07 −0.01 week 8 depression (y5) total effect −0.16 0.06 .01 −0.28 −0.02 indirect effect −0.15 0.05 .003 −0.26 −0.04 t→m3→y4→y5 −0.03 0.01 .008 −0.05 −0.01 t→m3→m4→y5 −0.04 0.02 .01 −0.07 −0.01 week 10 depression (endpoint,y6) total effect −0.22 0.06 < .001 −0.35 −0.09 indirect effect −0.15 0.05 .002 −0.26 −0.04 t→m3→y4→y5→y6 −0.02 0.01 .007 −0.04 −0.01 t→m3→m4→y5→y6 −0.03 0.01 .008 −0.05 −0.01 t→m3→m4→m5→y6 −0.04 0.01 .009 −0.07 −0.01 note. only significant paths are shown to save space. abbreviations: m3, m4, m5 = mediator measurements (taken at weeks 4, 6, and 8, respectively); se = standard error; t = treatment allocation (treatment group = 1, control group = 0); y2, y3, y4, y5, y6 = outcome measurements (taken at weeks 2, 4, 6, 8, and 10, respectively). for the simplex models with depression as a mediator, the fit indices were acceptable for both contemporary b paths, cfi = 0.97, tli = 0.95, rmsea = 0.06, 90% ci [0.05–0.08], srmr = 0.06, and lagged b paths, cfi = 0.95, tli = 0.93, rmsea = 0.07, 90% ci [0.06– 0.09], srmr = 0.08. none of the significant indirect effect from treatment allocation to activation level at each time point passed through depression, indicating that our intervention works though the impact of activation on depression rather than the other way around. more detailed results are provided in the supplementary materials. mechanism of behavioral activation intervention 16 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ d i s c u s s i o n in this study of data from a large rct, we provide evidence that activation level un­ derpinned the clinical response to a guided internet-based intervention for depression. during the 8-week treatment period, we showed that (1) our treatment improved activa­ tion levels from week 4 and reduced depressive symptoms from week 6, and (2) the activation level acted as a mediator for the change in depressive symptoms. these findings support the theory that a change in depression is contingent on a change in activation level (e.g., lewinsohn, 1974). we first confirmed that statistically significant associations existed between treatment allocation, activation, and depression level that were not affected by controlling for baseline characteristics. we further sup­ ported this by demonstrating temporal order, evidencing that the significant increase in activation level at week 4 preceded the significant decrease in depressive symptoms at week 6. this was strengthened by the lack of a “reverse” effect of depression on the activation level when conditioned on treatment. together, these findings strongly suggest that the hypothesized mediation process occurred around week 4. our findings are consistent with those of similar randomized studies (e.g., dimidjian et al., 2017; nasrin et al., 2017; santos et al., 2017), but conflict with those presented else­ where. for example, richards et al. (2017) observed no mediation effect of activation level in a large rct comparing behavioral activation and cognitive behavioral therapy, nor did rovner et al. (2014), when they compared behavioral activation and supportive therapy to prevent depression in older adults. there are a couple of plausible explanations for these incongruencies. first, different control conditions were used, with inactive control groups in the first two (waitlist control or usual obstetric care; similar to ours) (dimidjian et al., 2017; nasrin et al., 2017) and active control groups in the latter two (richards et al., 2017; rovner et al., 2014). second, measurements were taken at different times, with previous studies assessing mediation either immediately (dimidjian et al., 2017; nasrin et al., 2017) or 4 to 6 months (richards et al., 2017; rovner et al., 2014) after completing the intervention. delaying measurements in this way is less likely to capture significant changes caused by the mediator during treatment. two studies have used interventions for depression in which the activation level was examined as a putative mediator, and among these, our findings agree with one and disagree with another. in the research by van luenen et al. (2019) who adopted a similar intervention timeframe (eight sessions completed in 8–10 weeks), it was concluded that the investigated mediation occurred between weeks 3 and 5. however, this was not apparent in the research by forand et al. (2018) in another 10-week internet-based trial of cognitive behavioral therapy for depression, who found that the change in activation from baseline to week 3 did not predict the subsequent change in depression. this inconsistency could be attributed to the fact that forand et al. (2018) included another potential mediator (cognitive skills) in their mediation model. if activation level were a proximal process that led to another mediation process, controlling for this specific fu, burger, arjadi et al. 17 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ factor may fail to reveal the activation level as a mediator. it could also be that mediation occurred after week 3 of the intervention; therefore, a test based on earlier change will not have captured the required period. nevertheless, although the weight of evidence may be shifting, these inconsistencies point to a requirement for more evidence to confirm the mediational role of activation level. regarding missing data, more was missing in the intervention group (17.5%) than in the control group (4.3%). this was presumably because the gaf-id intervention deman­ ded greater effort to accomplish and because some participants could not afford the time. alternatively, sending the fortnightly measurements via email separately to monitoring within the intervention may have led to some participants erroneously believing that they had already completed the questionnaires. our results help to clarify how internet-based and lay-counselor-guided behavioral activation treatments work. clinicians can use this new knowledge to prepare patients with depression for a 4to 6-week lag before a major change occurs in their activation level, and subsequently, their symptoms of depression improve. this may encourage depressed individuals to persevere with treatment when they encounter difficulties in­ creasing activity levels in the first phase of treatment. clinicians and patients alike can be reassured that persistence with therapy will reduce depressive symptoms and lead to recovery. the present study has several strengths. first, we used data from a well-powered rct to ensure that the effect estimates from treatment allocation to activation level and depression could be readily and precisely interpreted as causal. the sample size calcula­ ted for the rct was ample for the current mediation analysis, for which a sample size of at least 100 with at least three repeated observations per individual was considered appropriate (curran et al., 2010). second, the fortnightly measures added precision and the low dropout rate (0.20%) contributed to both precision and low risk of bias. third, we adopted latent growth and simplex mediation modeling to estimate, as precisely as possible, the association between the mediator and depression while controlling for the within-participant change. according to criteria set by lemmens et al. (2016), our work constitutes a high-quality mediation study. some limitations also warrant discussion. notably, the mediator–outcome relation­ ship could still have been confounded by a third unmeasured variable (e.g., cognition). in addition, we only included a single mediator in our model, limiting us to identifying activation as the mediator. other working mechanisms correlated with activation level may have mediated part its effect, such as a change in cognition that may have preceded the reduction in depressive symptomatology. aside from using the scid-5 to assess unipolar depressive disorder before and after treatment, measurements in the rct relied on self-reporting every 2 weeks. thus, the assessments of activation level may not have been objective and may have missed a more nuanced dynamic (folke et al., 2015). moreover, lay counselors had no role in assessment of the participants and the effect of mechanism of behavioral activation intervention 18 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://www.psychopen.eu/ change in activation level on depression outcomes was also not assessed by lay counse­ lors and fully independently conducted from these counselors. therefore, although some bias can never be fully excluded, it is unlikely bias explained the outcomes. future research must seek to replicate our findings with different control groups. it should have a more temporally sensitive design (e.g., experience sampling method), more objective measures of activation, and include other variables (e.g., cognitive varia­ bles). such research may also benefit from experimental manipulation of mediator levels (e.g., component analysis) (emmelkamp et al., 2014) and micro-trials using experimental designs, such as rcts with temporally sensitive designs (brouwer et al., 2020; slofstra et al., 2018), to reach firm (causal) conclusions (lorenzo-luaces, lemmens, keefe, cuijpers, & bockting, 2021). conclusion this study provides evidence that a change in activation level underpinned the effects of a guided internet-based intervention using behavioral activation to treat depression. in a large-scale rct, it took 4 and 6 weeks to change activation levels and depressive symptoms, respectively. more studies are still required to support these findings and optimize treatment strategies. funding: this work was supported by the indonesia endowment fund for education (lembaga pengelola dana pendidikan), ministry of finance, republic of indonesia (no. 790/lpdp/2013) and by a chinese scholarship council grant (no. 201606040157). the funding sources had no role in the design or execution of the research. acknowledgments: dr robert sykes (www.doctored.org.uk) provided technical editing services for the final drafts of this manuscript. competing interests: mhn reports grants from the indonesia endowment fund for education (awarded to ra for a phd at the university of groningen) during the study, development, and translation of the cognitive behavioral therapy treatment manuals, including a blended internet-based treatment program unrelated to the current project, for which she receives no direct payments. mhn also reports travel expenses, some subsistence, and speaker honoraria for lectures and clinical training workshops paid for by mental health centers. clhb developed the intervention used in this study but has received no direct payment. she reports grants from the indonesia endowment fund for education (awarded to ra for a phd at the university of groningen) during the study, is a member of the dutch multidisciplinary guideline for anxiety and depression (non-remunerated), a co-editor of plos one and european psychology (non-remunerated), and a member of the scientific board in the dutch national statutory insured package, for which she receives an honorarium. she has received honoraria for keynote addresses at the european association for behavioral and cognitive therapies, the european psychiatry association, and the european conference association, as well as for clinical training workshops (paid by mental health centers). she also receives book royalties. all other authors declare no competing interests. ra reports grants from the indonesia endowment fund for education (awarded to complete a phd program at the university of groningen, during which data collection took place for the current study). zf and hb have no conflicts of interest to declare. fu, burger, arjadi et al. 19 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 http://www.doctored.org.uk https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s detailed results for the mediation examination in simplex models with depression as mediator were provided in the supplementary materials (for access see index of supplementary materials below). index of supplementary materials fu, z., burger, h., arjadi, r., nauta, m. h., & bockting, c. l. h. 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(2021). activation level as a mediator between behavioral activation, sex, and depression among treatment-seeking smokers. addictive behaviors, 114, article 106715. https://doi.org/10.1016/j.addbeh.2020.106715 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. mechanism of behavioral activation intervention 24 clinical psychology in europe 2021, vol. 3(3), article e5467 https://doi.org/10.32872/cpe.5467 https://doi.org/10.1016/j.addbeh.2020.106715 https://www.psychopen.eu/ mechanism of behavioral activation intervention (introduction) background materials and method design participants and randomization treatments measures data analysis results mixed effects model: differences of depression and activation level latent growth model for mediation time-specific mediation effect in the simplex models discussion conclusion (additional information) funding acknowledgments competing interests supplementary materials references indirect prevention and treatment of depression: an emerging paradigm? scientific update and overview indirect prevention and treatment of depression: an emerging paradigm? pim cuijpers 1 [1] department of clinical, neuro and developmental psychology, amsterdam public health research institute, vrije universiteit amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2021, vol. 3(4), article e6847, https://doi.org/10.32872/cpe.6847 received: 2021-06-01 • accepted: 2021-08-18 • published (vor): 2021-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: pim cuijpers, department of clinical, neuro and developmental psychology, amsterdam public health research institute, vrije universiteit amsterdam, van der boechorststraat 7-9, 1081 bt amsterdam, the netherlands. e-mail: p.cuijpers@vu.nl abstract background: although depression is one of the main public health challenges of our time, the uptake of interventions aimed at the prevention and treatment is low to modest. new approaches are needed to reduce the disease burden of depression. method: indirect prevention and treatment may be one method to increase uptake of services. indirect interventions aim at problems related to depression but with lower stigma and prevent or treat depression indirectly. this paper describes the approach, the empirical support and limitations. results: a growing number of studies focus on indirect prevention and treatment. several studies have examining the possibilities to prevent and treat depression through interventions aimed at insomnia. several other studies focus on indirect interventions aimed at for example stress and perfectionism. digital ‘suites’ of interventions may focus on daily problems of for example students or the workplace and offer a broad range of indirect interventions in specific settings. conclusion: indirect prevention and treatment may be a new approach to increase uptake and reduce the disease burden of depression. keywords depression, disease burden, indirect treatment, stigma, prevention this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6847&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0001-5497-2743 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • effective treatments and preventive interventions are available for depression but uptake is low. • indirect prevention and treatment focus on problems related to depression. • uptake of indirect interventions is higher because they focus on daily problems. • indirect interventions may provide a new paradigm for prevention and treatment. depressive disorders are highly prevalent (alonso et al., 2004; kessler & bromet, 2013), have a high incidence (waraich et al., 2004), and are associated with a substantial loss of quality of life for patients and their relatives (saarni et al., 2007; vos et al., 2016), increased mortality rates (cuijpers et al., 2014), high levels of service use, and enormous economic costs (greenberg et al., 2003; smit et al., 2006). major depression is currently ranked fourth worldwide in disease burden, and it is expected to rank first in high-income countries by the year 2030 (mathers & loncar, 2006). there is no doubt that depression is one of the most important public health challenges in the coming decades (cuijpers et al., 2012). one of the main problems that limits the impact of attempts to reduce the burden of disease of depression is the low uptake of treatments. this uptake is low in the general population, with rates that are often lower than 30%, even in high income countries (chisholm et al., 2016). in some specific groups, such as adolescents, young adults, older adults and minority groups, the number of those seeking help is even considerably lower. for example, one study found that the uptake in college students in high income countries was only 30% for those with a 12-month depressive disorder (bruffaerts et al., 2019). the low uptake of treatment is related to several factors, such as lack of financial resources and availability of clinicians. this is an important reason why the uptake of services is low in low– and middle-income countries, where hardly any infrastructure for mental health care exists, too few trained clinicians are available and insufficient resources are available to pay for these services. however, also in high-income settings the uptake is low because of the stigma related to depression, being unaware that exist­ ing problems are indeed depression, lack of time and the preference of many patients to manage their problems on their own or with friends and family. the uptake of preventive services is even lower. in one study we estimated that about 1% of those meeting criteria for participation in indicated prevention actually participated, even when offered free or almost free of charge (cuijpers et al., 2010). reasons are comparable to those mentioned earlier for the low uptake of treatments and include stigma, and preference to solve problems her/himself instead of seeking help (cuijpers et al., 2010). another limiting factor in the reduction of the disease burden of depression is that interventions aimed at the prevention and treatment of depression are effective, but indirect prevention and treatment of depression: an emerging paradigm? 2 clinical psychology in europe 2021, vol. 3(4), article e6847 https://doi.org/10.32872/cpe.6847 https://www.psychopen.eu/ their effects are modest. the impact of interventions can be seen as the product of the uptake and the effects, and when both the uptake and the effects are small, the impact is also small. meta-analyses of psychological and pharmacological treatments usually find that the interventions improve outcomes in about 20 to 25% of patients, compared to control conditions (cipriani et al., 2018; cuijpers et al., 2021b). that means that most patients either improve regardless of treatment or do not respond to them (cuijpers, 2018). preventive interventions are also effective and can reduce the risk of developing a depressive disorder in the coming year with about 20% (cuijpers et al., 2021a), but despite these positive effects the majority of high-risk participants still develop a disorder. together with the low uptake of these services, it should not come as a surprise that the prevalence of depressive disorders has not been reduced over the past decades, despite the availability of services for prevention and treatment (ferrari et al., 2013). t h e i n d i r e c t a p p r o a c h t o p r e v e n t i o n a n d t r e a t m e n t conventional methods to increase help-seeking rates include universal mental health awareness campaigns (salerno, 2016; yamaguchi et al., 2013), gatekeeper training (lipson et al., 2014) and specific interventions aimed at improving help-seeking behaviours (ebert et al., 2019). an alternative method to increase uptake is what could be called “indirect” prevention and treatment. the basic idea of these “indirect” interventions is that they focus on problems related to depression, but not directly on depression itself. at the same time the participants learn techniques which not only directly affect the problem, but also have an effect on depression or may prevent future depressive symptoms or disorders. for example, people with insomnia and depression receive an intervention aimed at insomnia, but also learn skills to manage their mood. insomnia is less stigmatising than depression to talk about or to seek treatment for, and if the inter­ vention aimed at insomnia is also effective in reducing depression, then the participant is still successfully “treated” for depression in an indirect way. the same idea can be applied to prevention. if someone with insomnia has subthres­ hold depression but no diagnosis for a depressive disorder, this person meets criteria for participation in an indicated prevention program. an intervention aimed at insomnia for this person could be considered as indicated prevention and has the potential to prevent the onset of depressive disorders in an indirect way. again, participation in an intervention on insomnia is probably less stigmatising as an intervention to prevent a depressive disorder. cuijpers 3 clinical psychology in europe 2021, vol. 3(4), article e6847 https://doi.org/10.32872/cpe.6847 https://www.psychopen.eu/ r e s e a r c h o n t h e i n d i r e c t a p p r o a c h a growing number of studies is focusing on this strategy. for example, recent studies have shown that cognitive behaviour therapy for insomnia in patients with both insom­ nia and depression, reduces not only insomnia but also depression (van der zweerde et al., 2019). the effect sizes found for such interventions on depressive symptomatology are comparable to those of ‘regular’ treatment of depression. this is true even though the interventions are not directly aimed at depression, and the stigma to participate in inter­ ventions for insomnia is lower than interventions for depression. the generic cognitive behavioural strategies that participants learn for handling insomnia, are in many ways comparable to those that are used in cognitive behavioural therapies for depression. or it could be the case that improvement of insomnia is the first step to escape from a vicious circle of mood problems. other research has used the same principle as a preventive strategy. for example, one study found that participants with insomnia and subthreshold depression who receive cognitive behaviour therapy for insomnia had a smaller chance to develop major depression at follow-up (christensen et al., 2016). but this principle of ‘indirect’ prevention and treatment of depression is not limi­ ted to insomnia. one recent study examined the effects of an intervention aimed at perinatal women scoring high on perfectionism, with depression and anxiety as an outcome (lowndes et al., 2019). this study found that the intervention significantly reduced perfectionism, and path analyses demonstrated a significant indirect effect of the intervention on depression and anxiety. another study showed that a considerable part of the participants in interventions aimed at ‘stress management’ also suffer from depression, and that the effects of this stress management training on depression were considerable and comparable to the effects of psychological treatments of depression in general (weisel et al., 2018). interventions aimed at problems like perfectionism, procrastination, and low self-esteem have also been found to have considerable effects on depression in those suffering from depression at baseline (cuijpers et al., 2021). there is much research on interventions for such common psychological problems and for many high-risk groups, but not with a focus on indirect prevention and treatment of depression. one could argue that this approach is very similar to selective prevention. selective prevention is aimed at people who have an increased risk to develop a depressive disorder. selective interventions are for example aimed at children of depressed parents (clarke et al., 2001), pregnant women with an increased risk for postpartum depression (phipps et al., 2013; zlotnick et al., 2016), dementia caregivers (cheng et al., 2020) or patients with general medical disorders (rovner et al., 2014). interventions aimed at these high-risk groups may support participants in coping with their problems but may at the same time prevent or reduce existing depressive symptomatology. however, these studies usually first have the intention to support participants with their problems and have depression only as secondary outcome. they are hardly ever designed as indirect indirect prevention and treatment of depression: an emerging paradigm? 4 clinical psychology in europe 2021, vol. 3(4), article e6847 https://doi.org/10.32872/cpe.6847 https://www.psychopen.eu/ treatment or prevention of depression in the sense that they report the number of depressed participants at baseline and the effects of the intervention on depression in these participants. “ s u i t s ” o f i n d i r e c t i n t e r v e n t i o n s f o r s p e c i f i c s e t t i n g s one important development in recent years may help in disseminating indirect interven­ tions. internet-based cognitive behavioural interventions have been developed for many different disorders, problems and target groups. because they can be easily adapted and broadly disseminated it could be possible to develop ‘suites’ of multiple interventions for problems with relatively low stigma that are related to depression. for example, it could be possible to develop a suite of interventions for college students on procrastina­ tion, perfectionism, low self-esteem, test-anxiety, stress, worry, and any other common problem that is brought forward by students themselves. or a suite of interventions for employees in large companies on stress, conflict resolution, assertiveness, time man­ agement and problem-solving. comparable suites could be developed for high-school students, perinatal women, or specific groups of patients in general hospitals. because such interventions are scalable and not expensive after first development, they could be offered to full populations, but are in fact meant to be early interventions for depression and potentially other common mental disorders. c h a l l e n g e s a n d l i m i t a t i o n s it is possible that indirect interventions can be an option for mild depression, but not for moderate and severe depression. however, not every person with severe depression gets treatment, and it is very well possible that they are willing to participate in these ‘indirect’ interventions. it is an empirical question whether indirect treatments in these patients are still better than the current practice of not providing treatment at all if the patient cannot be motivated to get treatment. how other clinical issues, such as suicidality and comorbidity, should be handled is also not yet clear. if patients partici­ pate in interventions that are not directly aimed at depression, who will take care of suicide risks and correct diagnoses? in order to avoid risks in these domains extended baseline assessment could be needed for these indirect interventions. it is also uncertain whether such an approach would indeed lead to higher uptake rates of services. will interventions aimed at reducing insomnia, perfectionism or stress lead indeed to better outcomes then just offering mental health services? these are empirical question that have to be answered with future research, but at ‘face value’ they can lead to a higher uptake, especially when they are offered as ‘suits’ of interventions. cuijpers 5 clinical psychology in europe 2021, vol. 3(4), article e6847 https://doi.org/10.32872/cpe.6847 https://www.psychopen.eu/ c o n c l u s i o n depression is a highly heterogeneous condition with largely varying symptoms patterns and associations with other variables. this heterogeneity is typically seen as problematic and hampering progress in our understanding and management of depression. but it may also offer new possibilities for indirect prevention and treatment. a growing number of studies focuses on problems related to depression, and interventions focus not directly on depression itself, but participants learn techniques that not only affect such problems di­ rectly, but also depression. this may offer new possibilities to get effective interventions to people who usually do not get treatment for depression. much research is needed to examine whether this is possible, feasible and effective, but the first findings are hopeful. maybe we are witnessing the start of a new paradigm in the prevention and treatment of depression. funding: the author has no funding to report. acknowledgments: the author has no additional (i.e., non-financial) support to report. competing interests: the author has declared that no competing interests exist. twitter accounts: @pimcuijpers r e f e r e n c e s alonso, j., ferrer, m., gandek, b., ware, j. e., jr., aaronson, n. k., mosconi, p., rasmussen, n. k., bullinger, m., fukuhara, s., kaasa, s., leplège, a., & iqola project group. 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(2016). randomized controlled trial to prevent postpartum depression in mothers on public assistance. journal of affective disorders, 189, 263-268. https://doi.org/10.1016/j.jad.2015.09.059 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. cuijpers 9 clinical psychology in europe 2021, vol. 3(4), article e6847 https://doi.org/10.32872/cpe.6847 https://doi.org/10.1111/josh.12461 https://doi.org/10.1017/s0033291718001149 https://doi.org/10.1016/s0140-6736(16)31678-6 https://doi.org/10.1177/070674370404900208 https://doi.org/10.2196/jmir.9387 https://doi.org/10.1097/nmd.0b013e31829480df https://doi.org/10.1016/j.jad.2015.09.059 https://www.psychopen.eu/ indirect prevention and treatment of depression: an emerging paradigm? (introduction) the indirect approach to prevention and treatment research on the indirect approach “suits” of indirect interventions for specific settings challenges and limitations conclusion (additional information) funding acknowledgments competing interests twitter accounts references shifting our perspective for the future of assessment and intervention science editorial shifting our perspective for the future of assessment and intervention science maria karekla a [a] department of psychology, university of cyprus, nicosia, cyprus. clinical psychology in europe, 2021, vol. 3(1), article e6197, https://doi.org/10.32872/cpe.6197 published (vor): 2021-03-10 corresponding author: maria karekla, 1 panepistimiou avenue, 2109 aglantzia, nicosia, cyprus. e-mail: mkarekla@ucy.ac.cy a big chunk of my early years in graduate school was spent learning about psychopa­ thology and the diagnostic systems that categorize these. we learned about prevalence, contributing factors, how to assess and differentially diagnose individuals with psycho­ pathological problems. when i started my clinical work, i was shocked to encounter that the reality of clinical practice was far from the information i learned in my psy­ chopathology courses. almost all clients, would not fit properly under one diagnosis, comorbidity was the norm, and i discovered that assigning a diagnosis was not par­ ticularly helpful for my case conceptualizations and choice of treatment. since those days, even though i have seen hundreds of patients, i am still looking for the classic book example of a panic patient. as for depression, it is fascinating to me that i can give the same diagnosis to a patient who presents with loss of appetite, low energy, excessive sleepiness, and catatonic-like symptoms, as to a patient who presents with concentration difficulties, increased appetite, difficulty sleeping, and restlessness. how does our training in a topographical approach to psychological suffering with the search for syndromes (collection of signs and symptoms) prepare us for clinical practice and ef­ fective intervention? what are our diagnostic systems useful for? interestingly, even the task force on dsm-5 (american psychiatric association, 2013) acknowledges the shortfall of this approach in “uncovering etiologies”, recommending intervention strategies, and have gone as far as to propose that a “paradigm shift may need to occur” (kupfer, first, & regier, 2002). beyond assessment and diagnosis, in the realm of treatment, psychological interven­ tion training is driven by theories, traditions, or schools of thought (e.g., cognitive-be­ havioral, humanistic, psychodynamic). in training and education, we focus on teaching students’ tools, techniques, and approaches, almost like cookbooks, ignoring that the this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6197&domain=pdf&date_stamp=2021-03-10 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ reality of practice or even cooking, is far from the strict following of a specific mech­ anistically applied set of tools. inflexible and strict devotion to a particular approach has hindered scientifically based development of psychotherapy, has propagated bias and impeded progress and communication among therapists, and has prevented the investigation of common mechanisms that may drive therapeutic changes in individuals who suffer and seek services (hofmann, 2020; rief, 2021). going back to the reality of human suffering, if we examine the world health organizations’ top 10 diseases causing the most deaths worldwide (who, 2020a, 2020b), we will notice that these include heart disease, stroke, chronic obstructive pulmonary disease, respiratory infections, neonatal conditions, lung-related cancers, alzheimer’s and dementia, diarrheal diseases, diabetes, and kidney diseases. what is common among all these top killers? common to all these are maladaptive health-related behaviors, dysfunctional coping, and behaving and all can be aided with the realm of the work we do as clinical psychologistsbehavior change. yet, despite important scientific advances, current treatments are hindered by these dysfunctional behaviors and clinicians' inability to help patients overcome them. therefore, a change of perspective is needed on how we approach human suffering, and under what circumstances, how and where we intervene. one such new perspective shift came from the national institute of health (nimh, 2021) rdoc framework. this approach aimed to examine psychopathology as dysregu­ lation of particular neurobiological and behavioral systems, including affective valence systems, cognitive systems, social systems, attachment processes, and arousal systems (cuthbert, 2014). the goal is to translate progress in behavioral and neuroscience to improve understanding of psychopathology and develop new and tailored treatments. it remains to be seen whether this framework will prove helpful in remedying the problems posed above. another recent development comes from hofmann and hayes (2019, p. 47), who are extending the question posed by gordon paul in 1969 and ask: “what core biopsychosocial processes should be targeted with this client given this goal, in this situation, and how can they most efficiently and effectively be changed?”. with this question and their new conceptual developments of a process-based approach couched within the umbrella of evolutionary science, they raise a different claim (see hayes, hofmann, & ciarrochi, 2020). in this approach, assessment procedures and therapy can and should be linked via mechanisms of action implicated in the maintenance and treatment of suffering and the promotion of well-being. research from my laboratory and others around the world are presently attempting to establish necessary parameters so as to be able to result in directly linking mecha­ nisms of action (change processes via which psychotherapeutic change can occur) with intervention choices and outcomes in an iterative, bottom-up manner. we recently pro­ posed that a successful coupling of assessment and treatment depends on the basic core mechanisms of action identified and measured (gloster & karekla, 2020). such candidate mechanisms need to: 1) be malleable and amenable to experimental manipulation, 2) editorial 2 clinical psychology in europe 2021, vol.3(1), article e6197 https://doi.org/10.32872/cpe.6197 https://www.psychopen.eu/ demonstrate robustness across contexts, 3) be tested across time ideographically, and 4) be tested across multiple levels of analysis (e.g., biological, genetic, psychophysiological, and behavioral). adopting such a multi-method, multi-level perspective in the explora­ tion of mechanisms of action can move us towards functional process-based alternatives to approaching human suffering. when this is couched within a coherent theory such as that of evolutionary science (see hayes, hofmann, & ciarrochi, 2020), we may be able to achieve meaningful progress towards our aim of better serving the humans who suffer and seek our services. i hope that as a field we will shift our perspective to a more functional, contextualistic, and process-based approach for the future of our assessment and intervention science. funding: the author has no funding to report. competing interests: the author has declared that no competing interests exist. acknowledgments: the author has no support to report. r e f e r e n c e s american psychiatric association. (2013). diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596 cuthbert, b. n. (2014). the rdoc framework: facilitating transition from icd/dsm to dimensional approaches that integrate neuroscience and psychopathology. world psychiatry, 13(1), 28-35. https://doi.org/10.1002/wps.20087 gloster, a. t., & karekla, m. (2020). a multi-level, multi-method approach to testing and refining intervention targets. in s. hayes & s. g. hofmann (eds.), beyond the dsm: toward a processbased alternative for diagnosis and mental health treatment (pp. 226-249). oakland, ca, usa: context press/new harbinger publications. hayes, s. c., hofmann, s. g., & ciarrochi, j. (2020). creating an alternative to syndromal diagnosis: needed features of processes of change and the models that organize them. in s. c. hayes & s. g. hofmann (eds.), beyond the dsm: toward a process-based alternative for diagnosis and mental health treatment (pp. 1–22) oakland, ca, usa: context press/new harbinger publications. hofmann, s. g. (2020). imagine there are no therapy brands, it isn’t hard to do. psychotherapy research, 30(3), 297-299. https://doi.org/10.1080/10503307.2019.1630781 hofmann, s. g., & hayes, s. c. (2019). the future of intervention science: process-based therapy. clinical psychological science, 7(1), 37-50. https://doi.org/10.1177/2167702618772296 kupfer, d. j., first, m. b., & regier, d. a. (2002). introduction. in d. j. kupfer, m. b. first, & d. a. regier (eds.), a research agenda for dsm-v (pp. xv–xxiii). washington, dc, usa: american psychiatric association. karekla 3 clinical psychology in europe 2021, vol.3(1), article e6197 https://doi.org/10.32872/cpe.6197 https://doi.org/10.1176/appi.books.9780890425596 https://doi.org/10.1002/wps.20087 https://doi.org/10.1080/10503307.2019.1630781 https://doi.org/10.1177/2167702618772296 https://www.psychopen.eu/ national institute of mental health. (2021, february 21). research domain criteria (rdoc). retrieved from https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/index.shtml paul, g. l. (1969). behavior modification research: design and tactics. in c. m. franks (ed.), behavior therapy: appraisal and status (pp. 29–62). new york, ny, usa: mcgraw-hill. rief, w. (2021). moving from tradition-based to competence-based psychotherapy. evidence-based mental health. advance online publication. https://doi.org/10.1136/ebmental-2020-300219 world health organization. (2020a). the top 10 causes of death. retrieved february 21, 2021 from https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death world health organization. (2020b). who reveals leading causes of death and disability worldwide: 2000-2019. retrieved february 21, 2021 from https://www.who.int/news/item/09-12-2020-who-reveals-leading-causes-of-death-anddisability-worldwide-2000-2019 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. editorial 4 clinical psychology in europe 2021, vol.3(1), article e6197 https://doi.org/10.32872/cpe.6197 https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/index.shtml https://doi.org/10.1136/ebmental-2020-300219 https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death https://www.who.int/news/item/09-12-2020-who-reveals-leading-causes-of-death-and-disability-worldwide-2000-2019 https://www.who.int/news/item/09-12-2020-who-reveals-leading-causes-of-death-and-disability-worldwide-2000-2019 https://www.psychopen.eu/ correction of abeditehrani, h., dijk, c., sahragard toghchi, m., & arntz, a. (2020). integrating cognitive behavioral group therapy and psychodrama for social anxiety disorder: an intervention description and an uncontrolled pilot trial correction correction of abeditehrani, h., dijk, c., sahragard toghchi, m., & arntz, a. (2020). integrating cognitive behavioral group therapy and psychodrama for social anxiety disorder: an intervention description and an uncontrolled pilot trial clinical psychology in europe, 2021, vol. 3(4), article e7727, https://doi.org/10.32872/cpe.7727 published (vor): 2021-12-23 correction note to: abeditehrani, h., dijk, c., sahragard toghchi, m., & arntz, a. (2021). integrating cognitive behavioral group therapy and psychodrama for social anxiety disorder: an intervention description and an uncontrolled pilot trial. clinical psychology in europe, 2(1), article e2693. https://doi.org/10.32872/cpe.v2i1.2693 in the originally published version of the above mentioned article, there was a typo­ graphical error in table 4. in the second row ("lsas"), an incorrect value in the "p" column was provided (.19). instead, the correct data for "lsas" under the "p" column is: .019. this change has no effect on the conclusions drawn in the article as the authors had already explained correctly that there was a significant decrease (p = .019) in social anxiety symptoms assessed with the lsas. the corrected table can be found below (see table 4). the authors apologize for any inconveniences caused. table 4 pretest and posttest comparison for the cbpt intervention scale pre post t (4) m difference [ci 99%] cohen’s d hedges’ gm sd m sd ll ul p bfne 35.60 7.02 28.40 4.10 2.86 -4.39 18.79 .046 1.03 0.82 lsas 99.40 16.99 58.40 24.81 3.82 -8.44 90.44 .019 2.41 1.93 sads 14.40 5.64 11.80 7.73 1.31 -6.56 11.76 .261 0.46 0.37 pas 133.20 13.88 131.60 17.21 0.20 -34.67 37.87 .849 -0.12 -0.09 opq 56.20 23.18 35.80 16.63 3.22 -8.74 49.54 .032 0.88 0.70 this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7727&domain=pdf&date_stamp=2021-12-23 https://doi.org/10.32872/cpe.v2i1.2693 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ scale pre post t (4) m difference [ci 99%] cohen’s d hedges’ gm sd m sd ll ul p ocq 64.80 23.47 47.00 26.67 5.95 4.03 31.57 .004 0.76 0.61 bdi 19.60 5.86 12.60 8.20 2.03 -8.82 22.82 .111 1.19 0.96 qoli 29.40 21.31 36.00 25.17 -0.88 -41.13 27.93 .429 0.31 0.25 note. observed means (m) and standard deviations (sd) for the pre and post assessment points; results of t-test analyses (t, p-value) and effect sizes cohen’s d and hedges’ g. bfne = brief fear of negative evaluation; lsas = liebowitz social anxiety scale; sads = social avoidance and distress scale; pas = personal attitude scale-ii; opq = social cost and probability by the outcome probability questionnaire; ocq = outcome cost questionnaire; bdi = beck depression inventory; qoli = quality of life inventory. cohen’s d was estimated as d = (mean pre-post change)/(pretest sd). hedges’ g was calculated as follows: g = j*d, with d = cohen’s d; j = (1 – 3/(4*df-1)); df = n-1. the sign of the effect size was chosen so that a positive effect size indicates improvement and negative effect size represents worsening. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. correction of abeditehrani, h., dijk, c., toghchi, m. s., & arntz, a. (2020) 2 clinical psychology in europe 2021, vol. 3(4), article e7727 https://doi.org/10.32872/cpe.7727 https://www.psychopen.eu/ imagery rescripting versus cognitive restructuring for social anxiety: treatment effects and working mechanisms research articles imagery rescripting versus cognitive restructuring for social anxiety: treatment effects and working mechanisms miriam strohm 1, marena siegesleitner 1, anna e. kunze 1 , thomas ehring 1 , charlotte e. wittekind 1 [1] department of psychology, lmu munich, munich, germany. clinical psychology in europe, 2021, vol. 3(3), article e5303, https://doi.org/10.32872/cpe.5303 received: 2020-11-29 • accepted: 2021-07-16 • published (vor): 2021-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: charlotte e. wittekind, department of psychology, lmu munich, leopoldstraße 13, 80802 munich, germany. tel.: +49 (0)89 2180 5196. e-mail: charlotte.wittekind@psy.lmu.de supplementary materials: materials [see index of supplementary materials] abstract background: negative mental images in social anxiety are often linked to memories of distressing social experiences. imagery rescripting (imrs) has been found to be a promising intervention to target aversive memories, but mechanisms underlying imrs are largely unknown. the present study aimed (a) to investigate the effects of imrs compared to cognitive restructuring (cr) on social anxiety symptoms and (b) to extend previous research by examining whether imrs works by fostering reappraisal of negative emotional self-beliefs. method: highly socially anxious individuals (n = 77) were randomly allocated to imrs, cr, or no intervention control (nic). a speech task was performed at baseline and at 1-week follow-up. results: only cr significantly reduced social anxiety symptoms from baseline to follow-up. decreases in negative appraisals and emotional distress in response to the speech task did not differ between conditions. regarding working mechanisms, imrs led to stronger increases in positive emotions than cr and nic. both cr and imrs yielded short-term reductions in emotionally anchored idiosyncratic self-beliefs, but cr was superior to imrs at follow-up. conclusions: the present study provides evidence for the efficacy of a single-session of cr for social anxiety symptoms. as one specific version of imrs was applied, it is conceivable that other or optimized versions of imrs might be more effective. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5303&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0002-7021-6144 https://orcid.org/0000-0001-9502-6868 https://orcid.org/0000-0002-5841-0067 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords imagery rescripting, cognitive restructuring, social anxiety, mental imagery, working mechanisms, autobiographical memories highlights • cr was more effective than imrs and no intervention to reduce social anxiety symptoms. • cr more effectively reduced dysfunctional beliefs. • imrs led to strongest increase of positive emotions. cognitive models of social anxiety disorder (sad) suggest that negative mental images of the self are a key maintaining factor of the disorder (clark & wells, 1995; hofmann, 2007; rapee & heimberg, 1997). image content is often linked to former aversive social experi­ ences (hackmann et al., 2000). therefore, specifically targeting these aversive memories during treatment might improve therapeutic outcomes (norton & abbott, 2017; wild & clark, 2011). imagery rescripting (imrs) is an imagery-based intervention for aversive memories that has increasingly been incorporated in cognitive behavioral therapy (cbt) for sad (e.g., mcevoy et al., 2020; mcevoy & saulsman, 2014; wild & clark, 2011). during imrs, patients are instructed to visualize an aversive memory and to change it in imagination according to their emotional needs. imrs aims to update the meaning of memories thereby reducing associated negative (self-)images, beliefs, and emotions (arntz, 2012). imrs may be an efficacious treatment for different disorders including sad (morina et al., 2017). several studies have found that one session of imrs significantly improved social anxiety symptoms (lee & kwon, 2013; wild et al., 2007, 2008), also when delivered as a stand-alone intervention and without prior cognitive restructuring (cr; nilsson et al., 2012; norton & abbott, 2016; reimer & moscovitch, 2015). while imrs yields promis­ ing treatment results, a better understanding of its underlying working mechanisms is needed to eventually optimize treatment efficacy. it has been proposed that imrs might work by changing the idiosyncratic meaning of aversive experiences (arntz, 2012) and, more specifically, by leading to emotionally anchored reappraisal of core beliefs (nilsson et al., 2012; norton & abbott, 2016; wild et al., 2008). during imrs, positive meanings are offered in the form of images. based on evidence that mental imagery elicits stronger emotions than verbal thinking (holmes & mathews, 2010), it is conceivable that generating images with alternative meanings during imrs is associated with stronger emotional activation than questioning maladap­ tive beliefs verbally (holmes et al., 2009). consequently, alternative meanings offered in the form of images might be more emotionally anchored, more believable, and more likely to lead to changes in behavior than meanings exclusively generated as verbal representations (holmes & mathews, 2010). this assumption is in line with the idea that imrs vs. cognitive restructuring in social anxiety 2 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ one can distinguish between different levels of meaning representations (e.g., barnard & teasdale, 1991; but see power & dalgleish, 1999). according to the model of interacting cognitive subsystems (ics; barnard & teasdale, 1991), intellectual beliefs (propositional level) can be distinguished from emotional beliefs (implicational level). intellectual beliefs are described as knowing something “with the head”, whereas emotional beliefs corre­ spond to an implicit sense of knowing “with the heart” or “having a gut feeling” (barnard & teasdale, 1991). cognitive treatments can be expected to change beliefs primarily on a propositional level. imrs as an experientially oriented intervention invokes different sensory modalities thereby addressing the implicational meaning level, which is sugges­ ted to be necessary to then change emotional beliefs (see arntz, 2012; wild et al., 2008). although emotionally anchored reappraisal (i.e., changing emotional beliefs) has often been discussed as a mechanism underlying imrs, empirical evidence is largely missing. one study with a sample of bulimia nervosa patients has investigated effects of imrs on emotional vs. intellectual beliefs (cooper et al., 2007). imrs was found to be more effective than a control intervention in reducing emotional self-beliefs. a recent study investigated the effects of imrs (vs. imaginal exposure [ie] and supportive counselling [sc]) on memory processes in patients with social anxiety disorder (romano et al., 2020). there were no differences between conditions regarding memory appraisal, but a higher proportion of patients receiving imrs updated their negative core belief compared to sc (no differences emerged compared to ie). given the limited number of studies on working mechanisms of imrs, the aim of the present study was to investigate whether imrs works by reducing maladaptive emotional beliefs. the present study aimed to (1) investigate the effects of stand-alone imrs and cr on social anxiety symptoms, and (2) extend previous research by exploring mechanisms underlying imrs. our procedure was based on the study by norton and abbott (2016). highly socially anxious individuals were randomly allocated to either one session of imrs, one session of cr, or a no-intervention control condition (nic). outcomes were assessed at baseline and at 1-week follow-up. a speech task was included to examine intervention effects to a social stressor. in line with previous findings, we hypothesized that imrs and cr would yield greater decreases in social anxiety symptoms than nic. we expected imrs and cr to reduce negative appraisals and emotional responses (sub­ jective arousal and distress) to the speech task more strongly than nic. regarding mechanisms, we hypothesized that imrs would lead to stronger emotional activation than cr. while we expected both imrs and cr to decrease the maladaptive intellectual self-beliefs, we assumed that imrs would yield stronger reductions of maladaptive emo­ tional self-beliefs. we additionally explored the relationship between the hypothesized mechanisms and symptomatic change. strohm, siegesleitner, kunze et al. 3 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ m e t h o d participants highly socially anxious individuals were recruited via advertisements on university cam­ pus and social media. to be included, participants had to score ≥ 30 (clinical cut-off) on the german version of the social interaction anxiety scale (sias; stangier et al., 1999). results of a sample-size calculation (two-tailed, α = .05, power = .80, run with g*power 3.1; faul et al., 2007) with medium to large effect sizes (d = .70; morina et al., 2017) showed that a sample size of 76 was required to detect significant differences between active treatments (imrs + cr) versus nic. during the first session, eligible participants were administered the mini interna­ tional neuropsychiatric interview (m.i.n.i. 5.0.0; sheehan et al., 1998; german version: ackenheil et al., 1999) to screen for exclusion criteria: (1) current diagnosis of major depressive disorder, (2) current and/or lifetime diagnosis of posttraumatic stress disor­ der/psychotic disorder/bipolar disorder, (3) substance dependence during the past 12 months, (4) acute suicidal tendencies. further exclusion criteria were: (5) age < 18 or > 35 years, (6) current psychological treatment, (7) pregnancy, (8) severe physical illness. the restricted age range was applied to obtain a more homogenous sample regarding age. participants had to meet the following inclusion criteria: (1) negative mental self-im­ age(s) in feared social situations, (2) aversive social experience related to the image, and (3) maladaptive self-belief (see section "imagery interview"). a total of 96 participants attended session 1 of whom 16 had to be excluded (n = 10 current/lifetime diagnosis of mental disorders specified above; n = 4 no negative mental self-image; n = 2 no maladaptive self-belief). three participants did not attend the follow-up session, leaving a final sample of 77 participants (81% female; age: m = 22.46, sd = 3.88). all participants gave written informed consent and were reimbursed by receiving partial course credit or 20€. the study was approved by the research ethics committee of the faculty of psychology and educational sciences at lmu munich. clinical interviews the m.i.n.i. (sheehan et al., 1998; german version: ackenheil et al., 1999) was ad­ ministered to assess current diagnoses according to dsm-iv (american psychiatric association [apa], 2000). additionally, the sad module of the structured clinical inter­ view for dsm-iv (scid-i; first et al., 2002; german version: wittchen et al., 1997) was administered. imagery interview the imagery interview was based on the waterloo images and memories interview (wimi; moscovitch et al., 2011) and on the interview used by norton and abbott (2016). imrs vs. cognitive restructuring in social anxiety 4 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ the semi-structured interview assessed negative self-imagery, aversive memories, and maladaptive self-beliefs. participants were asked to define their most anxiety-provoking social situation and to imagine themselves being in such a situation. they were instruc­ ted to become aware of whether there was a mental image that comes to their mind in this kind of situation and to describe the mental image in detail. participants were then asked when they first felt the way they did in the image and to visualize and describe the respective event. this was used to determine whether there was an early aversive memory related to the mental image. in order to specify the idiosyncratic self-belief derived from the negative mental image and the aversive memory, participants were asked: “what do the image and the memory tell about you as a person?”. participants were instructed to summarize the meaning in form of a short statement. speech task in order to measure reactions to a social stressor, participants were asked to give a 3 min video-recorded impromptu speech (norton & abbott, 2016) on a given political topic in both sessions (the order of two topics was counterbalanced). symptom measures the 20-item sias (mattick & clarke, 1998; german version: stangier et al., 1999) was used to assess social interaction anxiety during the past seven days on a 5-point scale (0 = not at all to 4 = extremely). the 12-item brief fear of negative evaluation scale-re­ vised (bfne-r; carleton et al., 2006; german version: reichenberger et al., 2016) was administered to measure fear of negative evaluation by others on a 5-point scale (1 = not at all characteristic of me to 5 = extremely characteristic of me). in order to test for baseline group differences in depressive symptoms, the patient health questionnaire-9 item (phq-9; krönke et al., 2001; german version: löwe et al., 2002) was administered. speech task measures in order to verify the relevance of the speech task as a stressor we asked participants to indicate how anxious they had felt or would have felt when giving a speech/presentation during the last week (0 = not at all anxious to 3 = extremely anxious). the probability and consequences questionnaire (pcq; rapee & abbott, 2007) asks participants to rate their appraisal of the likelihood (7 items) and cost (7 items) of negative evaluation of their speech on a 5-point scale (0 = not at all likely/bad to 4 = extremely likely/bad). subjective­ ly experienced levels of distress were assessed using subjective units of distress (sud, 0 = not at all distressed to 100 = extremely distressed). self-assessment manikins (sam; bradley & lang, 1994) were used to assess self-reported physiological arousal (1 = very calm to 9 = very aroused). strohm, siegesleitner, kunze et al. 5 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ measures of underlying mechanisms emotional activation the positive and negative affect schedule-extended (panas-x; watson & clark, 1994; german version: grühn et al., 2010) was administered to assess changes in positive and negative emotions from preto post-intervention. participants were instructed to indicate how they felt at this very moment. we included the general dimensions “positive affect” (pa) and “negative affect” (na) as well as the subscales “fear”, “hostility”, “guilt”, “sadness”, “joviality”, “self-assurance”, and “attentiveness”. scales range from 1 (very slightly or not at all) to 5 (extremely). intellectual and emotional beliefs the maladaptive self-belief was identified during the imagery interview. participants were asked to rate intellectually and emotionally how much they felt that this belief was true (see cooper et al., 2007). for the intellectual rating, participants were asked to indicate how much they would rationally agree to their belief (0 = i do not agree at all to 100 = i completely agree). for the emotional rating, participants were asked how much they felt the belief was true, regardless of what they were thinking rationally (0 = feels not true at all to 100 = feels completely true). interventions imagery rescripting the imrs procedure was based on protocols by arntz and weertman (1999) and wild and clark (2011). stage 1 of imrs started with participants closing their eyes and vividly imagining the aversive memory from the perspective of their younger-self. participants were instructed to describe the situation in the first person, present tense, and to include all sensory modalities. stage 2 of imrs was initiated by instructing participants to imag­ ine the scene from the perspective of their current adult-self who is witnessing the events as a bystander. participants were asked to describe what they see is happening to their younger-self and were then encouraged to intervene in any way they wished. when the adult-self felt fully satisfied, stage 3 was initiated by asking participants to relive the memory again from the perspective of their younger-self, experiencing the in­ terventions of their adult-self. additionally, the younger-self was encouraged to express further unmet needs. the imrs procedure was concluded by asking participants to dwell on the final positive image. as we wanted to elucidate the underlying mechanisms of imrs (vs. cr) on symptom change, we used “pure” interventions and tested imrs in isolation. consequently, imrs was not preceded by cognitive restructuring and we did not explicitly refer to the maladaptive self-belief during imrs. the mean duration of imrs was 22.35 min (sd = 6.20). imrs vs. cognitive restructuring in social anxiety 6 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ cognitive restructuring the cr procedure was based on the protocol by wild and clark (2011). participants were first asked to outline evidence for their maladaptive self-belief and were then encouraged to challenge the self-belief by collecting evidence against it. to support this process we asked participants to consider alternative explanations for their experiences (including the early aversive memory), and to think of experiences contradicting the self-belief. all evidence for and against the negative self-belief was written down on a worksheet. finally, participants were instructed to rephrase the original self-belief into a more helpful statement. the mean duration of cr was 23.74 min (sd = 4.40). no-intervention control condition participants in nic were provided neutral magazines and were instructed to wait for 30 min in the laboratory. they were asked not to use any electronic device. procedure the study comprised two sessions, which were one week apart. two experimenters carried out different parts of the procedure so that the speech task and intervention were not administered by the same experimenter. during session 1, experimenter 1 administered the clinical interviews and baseline measurements (t0: sociodemograph­ ic data, sias, bfne-r, public speaking anxiety, suis, erq), followed by pre-speech measures (sud, sam, pcq) and the speech task. experimenter 2 then conducted the imagery interview and administered pre-treatment questionnaires (t1: intellectual and emotional belief, panas-x). then, participants were randomly allocated to imrs (n = 25), cr (n = 27), or nic (n = 25). the allocation sequence was computer-generated and experimenter 2 was blinded until the beginning of the interventions, experimenter 1 was blinded during the entire study. immediately after the interventions or the waiting period, participants completed post-treatment measures (t2: intellectual and emotional belief, panas-x). during session 2, which took place one week later, experimenter 1 administered the follow-up questionnaire (t3: sias, bfne-r, intellectual and emotional belief) and the second speech task, again including speech task measures administered prior to the speech task (sud, sam, pcq). finally, participants were fully debriefed. statistical analyses a series of 2(time) x 3(condition) repeated measures anovas were carried out for so­ cial anxiety symptoms (t0; t3), for speech task measures (pre-speech1; pre-speech2), and for positive and negative emotions (t1; t2). to follow up significant interactions, planned contrasts on change scores were conducted (imrs+cr vs. nic; imrs vs. cr). effects on intellectual and emotional self-beliefs were tested with 3(time) x 3(condition) repeated measures anovas. significant interactions were followed up using planned contrasts strohm, siegesleitner, kunze et al. 7 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ (imrs+cr vs. nic; imrs vs. cr). for imrs, pearson correlations were computed between mechanisms and symptomatic change. a significance level of α = .05 (two-tailed) was used for all analyses. partial eta squared (ηp2) or cohen’s d were used as effect sizes. r e s u l t s participant characteristics and baseline comparisons no significant baseline differences between conditions emerged (see table 1). mean age at time of the aversive event was 12.86 years (sd = 4.55; range 3-27), with significant differences between groups1 (imrs: m = 13.88, sd = 4.90; cr: m = 13.76, sd = 4.60; nic: m = 10.88, sd = 3.55), f(2, 74) = 3.78, p = .027. table 1 demographic variables and pre-treatment characteristics demographics and pretreatment characteristics overall sample (n = 77) imrs (n = 25) cr (n = 27) nic (n = 25) statistics demographics gender (female/male), n 62/15 21/4 20/7 21/4 χ2(2) = 1.10, p = .577 age in years, m (sd) 22.36 (3.88) 22.64 (3.82) 22.59 (3.92) 21.84 (4.01) f(2,74) = 0.33, p = .718 social anxiety symptoms, m (sd) sias 40.29 (12.55) 40.84 (13.21) 37.93 (12.06) 42.28 (12.49) f(2,74) = 0.81, p = .447 bfne-r 40.48 (10.39) 40.20 (11.00) 39.44 (10.36) 41.88 (10.07) f(2,74) = 0.36, p = .696 sad criteria met, n (%) 21 (27) 8 (32) 8 (30) 5 (20) χ2(2) = 1.02, p = .599 comorbidity (yes/no), n 7/70 3/22 3/24 1/24 generalized anxiety disorder, n 2 0 1 1 dysthymia 3 1 2 0 anorexia nervosa 1 1 0 0 bulimia nervosa 1 1 0 0 public speaking anxiety, m (sd) 1.94 (0.85) 1.92 (0.95) 1.93 (0.96) 1.96 (0.61) f(2,74) = 0.02, p = .984 note. imrs = imagery rescripting; cr = cognitive restructuring; nic = no-intervention control; sias = social interaction anxiety scale; bfne-r = brief fear of negative evaluation scale-revised; sad = social anxiety disorder. 1) we tested whether age of the aversive memory (i.e., time that had passed since the event) had an influence on our main symptomatic outcomes. however, results remained unchanged when including age of the memory as a covariate. note that age of the aversive memory was not significantly different in the two active treatment conditions (imrs and cr). imrs vs. cognitive restructuring in social anxiety 8 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ social anxiety symptoms social interaction anxiety for sias scores (see figure 1), there was no main effect of condition, f(2, 74) = 1.97, p = .147, ηp2 = .05, but a significant effect of time, f(1, 74) = 17.94, p < .001, ηp2 = .20, and a significant interaction, f(2, 74) = 3.22, p = .046, ηp2 = .08. planned contrasts revealed no difference between the active treatment groups compared to nic in reducing social interaction anxiety, t(74) = 1.05, p = .298, d = 0.26. however, cr led to stronger decreases than imrs, t(74) = 2.29, p = .025, d = 0.64. figure 1 effects of imrs vs. cr vs. nic on (a) social interaction anxiety (sias), and (b) fear of negative evaluation (bfner) note. error bars represent sem. fear of negative evaluation results for bfne-r revealed a significant main effect of time, f(1, 74) = 5.70, p = .020, ηp2 = .07, but neither a significant effect of condition, f(2, 74) = 1.09, p = .342, ηp2 = .03, nor a significant interaction, f(2, 74) = 2.90, p = .061, ηp2 = .07., see figure 1. speech task measures for both subscales of the pcq2, there were significant main effects of time, fs(1, 71) > 9.74, ps < .003, ηp2s ≥ .12, but no significant interactions, fs(2, 71) < 2.28, ps > .110, ηp2s ≤ .06. the main effect of condition was significant for probability, f(2, 71) = 3.13, p = .050, ηp2 = .08, but not for cost of negative evaluation, f(2, 71) = 1.13, p = .330, ηp2 = .03. imrs and cr did not yield significantly greater reductions of appraisals of negative evaluation than nic (see table 2). for distress (sud), a significant effect of time emerged, f(1, 70) = 17.41, p < .001, ηp2 = .20, but neither the main effect of condition nor the interaction were significant, fs(2, 70) < 2.12, ps > .128, ηp2s < .06 (see table 2). 2) in some participants, speech-related questionnaires were erroneously not administered (pcq: n = 3; sud: n = 4; sam: n = 2) and these participants were excluded from the respective analyses. strohm, siegesleitner, kunze et al. 9 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ results for arousal (sam) revealed a significant effect of time, f(1, 72) = 11.35, p = .001, ηp2 = .14, but neither a significant main effect of condition nor a significant interaction, fs(2, 72) < 1.05, p > .354, ηp2 < .03 (see table 2). table 2 means and standard deviations for speech task measures before (speech 1) and after (speech 2) intervention: means (sd) group speech 1 speech 2 m (sd) m (sd) negative evaluation: probabilitya imrs 15.46 (4.25) 14.79 (4.66) cr 13.04 (5.62) 10.27 (5.45) nic 14.25 (5.93) 13.33 (5.93) negative evaluation: costa imrs 13.50 (5.87) 12.25 (6.10) cr 12.46 (6.71) 9.27 (4.64) nic 13.79 (5.98) 12.29 (6.52) distress (sud)b imrs 66.50 (29.77) 57.42 (27.33) cr 75.12 (22.01) 55.35 (28.42) nic 72.17 (23.10) 65.65 (24.33) arousal (sam)c imrs 6.67 (1.61) 5.79 (1.35) cr 6.62 (1.50) 5.65 (1.67) nic 6.28 (1.67) 6.00 (1.61) note. imrs = imagery rescripting; cr = cognitive restructuring; nic = no-intervention control; sud = subjective units of distress; sam = self-assessment manikins. an = 74. bn = 73. cn = 75. mechanisms activation of positive and negative emotions for panas-pa and na (see table 3) there were significant effects of time, fs(1, 74) > 35.10, ps < .001, ηp2s ≥ .32, but no significant effects of condition, fs(2, 74) < 2.17, ps > .121, ηp2s ≤ .06. no significant interaction was found for panas-na, f(2, 74) = 0.57, p = .570, ηp2 = .02. a significant interaction emerged for panas-pa, f(2, 74) = 9.29, p < .001, ηp2 = .20. planned contrasts revealed that active treatments increased positive emotions more strongly than nic (mdiff = -0.52, sd = 4.48), t(60.89) = 3.97, p < .001, d = 0.97, with imrs (mdiff = -7.36, sd = 6.81) leading to stronger increases than cr (mdiff = imrs vs. cognitive restructuring in social anxiety 10 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ -3.52, sd = 5.35), t(45.54) = 2.25, p = .029, d = 0.62. results for the remaining subscales of panas-x are provided in the supplementary materials (table s1). table 3 symptom measures and mechanism variables before the interventions (t0/t1), after the interventions (t2) and at follow-up (t3): means (sd) group t0/t1 t2 t3 m (sd) m (sd) m (sd) panas-pa imrs 23.12 (5.20) 30.48 (8.21) cr 22.89 (6.79) 26.41 (7.12) nic 22.92 (6.13) 23.44 (6.89) panas-na imrs 19.04 (6.77) 13.92 (3.64) cr 18.19 (6.29) 14.41 (5.37) nic 18.60 (5.58) 13.48 (3.12) intellectual belief imrs 51.60 (27.53) 39.40 (26.91) 48.80 (26.55) cr 64.74 (29.83) 40.37 (25.79) 42.52 (29.49) nic 57.8 (33.32) 55.48 (32.32) 57.24 (29.63) emotional belief imrs 90.40 (10.88) 62.52 (19.71) 73.80 (18.10) cr 84.07 (16.82) 56.11 (29.00) 52.78 (27.92) nic 83.08 (20.92) 81.36 (21.90) 79.60 (20.74) note. imrs = imagery rescripting; cr = cognitive restructuring; nic = no-intervention control; sias = social interaction anxiety scale; bfne-r = brief fear of negative evaluation scale-revised; panas = positive and negative affect schedule; pa = positive affect; na = negative affect. intellectual and emotional beliefs to check whether participants were able to distinguish between the intellectual and the emotional belief, a correlation between the two measures was computed. the moderate correlation of rs = .387, p = .001, suggests that the two measures have some overlap but are not identical. for intellectual beliefs, there was no significant effect of condition, f(2, 74) = 1.00, p = .373, ηp2 = .03, but a significant effect of time and a significant interaction, fs(1.81, 134.19 / 3.63, 134.19) > 6.12, ps < .001, ηp2s ≥ .14 (see table 3). planned contrasts revealed that active treatments led to stronger reductions in intellectual beliefs from preto post-intervention than nic, t(55.43) = 4.58, p < .001, d = 1.12, and from pre to follow-up, t(74) = 2.13, p = .036, d = 0.52. cr led to stronger reductions than imrs from preto post-intervention, t(35.93) = 2.03, p = .050, d = 0.49, and from pre to follow-up, t(74) = 3.04, p = .003, d = 0.84. strohm, siegesleitner, kunze et al. 11 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ for emotional beliefs, there were significant effects of time and condition, fs(2, 148/2, 74) > 5.37, ps ≤ .006, ηp2s ≥ .13, and a significant interaction, f(4, 148) = 13.94, p < .001, ηp2 = .27. planned contrasts revealed that the active treatments reduced emotional beliefs more strongly than nic from preto post-intervention, t(60.66) = 8.51, p < .001, d = 2.07, and from pre to follow-up, t(69.14) = 5.62, p < .001, d = 1.37. cr and imrs decreased emotional beliefs from preto post-intervention equally effective, t(49.78) = -0.16, p = .878, d = 0.04, but cr led to stronger reductions than imrs from pre to follow-up, t(48.13) = 2.67, p = .010, d = 0.74. correlations between mechanisms and symptomatic change within the imrs group, symptomatic change was not significantly correlated with changes in emotions (pa x sias: r = -.08; pa x bfne-r: r = .26; na x sias: r = -.35; na x bfne-r: r = .11; ps ≥ .085) nor with pre-post changes in emotional beliefs and symptomatic change (sias: r = -.39; bfne-r: r = -.15; all ps ≥ .055). the same non-signif­ icant pattern emerged in the cr group (pa x sias: r = -.25; pa x bfne: r = .07; na x sias: r = -.13; na x bfne: r = -.12; rational belief x sias: r = .14; rational belief x bfne: r = .09, ps ≥ .217). d i s c u s s i o n the present study examined the effects of single-session imrs vs. cr for socially anxious individuals compared to nic. effects on social anxiety symptoms contrary to hypothesis, we found that one session of cognitive restructuring (cr) is more effective than one session of imagery rescripting (imrs) and no intervention con­ trol (nic) in reducing social interaction anxiety. no significant differences between groups emerged for fear of negative evaluation. when confronted with the speech task, participants in all conditions demonstrated equal reductions in distress, arousal, and negative appraisals suggesting that if cr and imrs are administered as very brief interventions no beneficial effects emerge over and above mere exposure to the speech. the speech task represents a strength of the study, but our findings suggest that the speech task may be susceptible to exposure effects, thereby reducing its ability to capture between-group differences in anxiety across time. taken together, we could not replicate previous findings regarding the effects of the interventions on responses to a social stres­ sor (norton & abbott, 2016). our findings support previous evidence that one session of cr exerts positive effects on social anxiety symptoms (e.g., norton & abbott, 2016; shikatani et al., 2014). contrary to expectations, we were not able to replicate earlier findings on the benefits of stand-alone imrs (nilsson et al., 2012; norton & abbott, 2016; imrs vs. cognitive restructuring in social anxiety 12 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ reimer & moscovitch, 2015) on social anxiety symptoms. this result is surprising given the similarities between studies (i.e., one session of imrs, no cognitive preparation); however, a sub-clinical sample was included in our study whereas participants were diagnosed with sad in previous research (nilsson et al., 2012; norton & abbott, 2016; reimer & moscovitch, 2015). although the severity of self-reported interaction anxiety in our study was comparable to previous studies (ø40 [this study]; ø37 [nilsson et al, 2012]; ø44 [norton & abbott, 2016]), the low rate of diagnoses in the present sample could indicate that the impairment caused by the social anxiety symptoms was not sufficient to fulfill diagnostic criteria and that participants are able to cope with their negative mental images. as our imrs procedure closely followed the procedure of norton and abbott (2016), it seems rather unlikely that procedural differences explain the inconsistent findings. alternatively, imrs as used in this study might need to be optimized. first, imrs might not have been optimally delivered (e.g., insufficient reactivation of emotions or the hot­ spot; short duration of imrs [ø 22min in the present study]). second, we do not know to what extent participants were able to put themselves in their younger self´s perspective. third, in order to ensure internal validity we used a highly standardized imrs protocol whereas other studies administered imrs in a more individualized way and with a more active therapist/ experimenter (e.g., norton & abbott, 2016). fourth, participants were instructed to introduce changes themselves in the present study. finally, as dysfunctional self-beliefs were not explicitly addressed during imrs it cannot be ruled out that the rescripting did not show a good enough match with the dysfunctional self-beliefs in the sense of providing corrective information and experiences to modify this belief. this may provide another explanation why imrs was not associated with long-term effects in our study. therefore, as the imrs protocol used in the present study represents only one specific implementation of imrs, it is conceivable that other versions of imrs might have yielded more stable effects. for example, in accordance with the protocol by wild and clark (2011), a combination of imrs with cr (lee & kwon, 2013; wild et al., 2008) might yield more stable treatment effects. different imrs techniques have been applied in both research and clinical practice; however, it remains an open question how imrs is best realized (e.g., with or without cognitive preparation; active vs. passive role of patient/therapist), therefore, future research is clearly needed to identify the most effective implementation of imrs. mechanisms underlying imagery rescripting in line with our hypothesis and with previous evidence (holmes & mathews, 2010), a single session of imrs led to stronger increases of positive emotions than cr and nic. in contrast, negative emotions significantly decreased across time with no differences between conditions. imrs and cr more strongly reduced maladaptive intellectual and emotional beliefs from preto post-intervention compared to nic, but only for cr strohm, siegesleitner, kunze et al. 13 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ reductions remained stable across time. in imrs, neither changes in positive emotions nor in emotional beliefs correlated with symptomatic outcomes. although our results indicate that brief imrs led to beneficial (short-term) effects, it remains to be tested whether the aforementioned mechanisms play a role in producing symptomatic change, as imrs did not yield improvements on symptom measures in the present study. moreover, our results challenge the notion that emotionally anchored reappraisal is a mechanism specific to imrs. in fact, brief cr seems to be more effective in targeting maladaptive emotional beliefs in the longer-term, counter to the theoretical idea that cognitive treatment strategies primarily change intellectual meaning levels (i.e., propositional level). however, after a single session of cr mean levels of emotional beliefs were still high at follow-up and more systematic research is needed to test whether emotional beliefs can be further reduced with multiple treatment sessions. limitations imrs and cr were delivered as very brief interventions within a non-therapeutic setting. thus, the interventions deviate from treatment as used in clinical practice limiting its generalizability. however, laboratory-based studies in healthy or subclinical samples are a valuable means to investigate mechanisms involved in psychological treatments under highly controlled and standardized conditions (e.g., van den hout et al., 2017). although we inquired about the meaning of the mental image, we did not assess how distressing and how relevant the image was regarding participants´ social anxiety symptoms. the distress/impairment caused by the image should be inquired in future studies as it is conceivable that only the modification of distressing images might be associated with long-term effects on social anxiety symptoms. moreover, it remains unclear whether participants adhered to the imrs instructions and how distressed they were during imrs as distress during imrs was not assessed. therefore, we cannot verify the correct implementation of imrs and that emotional activation was sufficient. emotional beliefs were rated on a one-item vas, which might reduce reliability. conclusion the present study compared the effects of imrs vs. cr as stand-alone single-session interventions in socially anxious individuals and aimed to examine mechanisms underly­ ing symptomatic change. results indicate that a single session of cr effectively reduces social anxiety symptoms. the present study raises the question how imrs for socially anxious individuals should optimally be implemented in order to yield symptomatic change. we propose that more individualized imrs protocols, higher treatment intensity, cognitive preparation, and/or directly targeting dysfunctional self-beliefs might be neces­ sary to yield therapeutic effects. imrs vs. cognitive restructuring in social anxiety 14 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ funding: this research did not receive any grant funding from the public, commercial, or not-for-profit sectors. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: all authors declare that they have no conflict of interest. ethics statement: all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. the study was approved by the research ethics committee of the faculty of psychology and educational sciences at lmu munich (67_strohm_b). author note: this paper was part of miriam strohm´s ph.d. project (strohm, 2019). s u p p l e m e n t a r y m a t e r i a l s the supplementary material contains a table containing the means and standard deviations of the positive and negative emotions as well as the results of the statistical analyses (for access see index of supplementary materials below). index of supplementary materials strohm, m., siegesleitner, m., kunze, a. e., ehring, t., & wittekind, c. e. 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(1994). manual for the positive and negative affect schedule – expanded form. ames, ia, usa: university of iowa. wild, j., & clark, d. m. (2011). imagery rescripting of early traumatic memories in social phobia. cognitive and behavioral practice, 18, 433-443. https://doi.org/10.1016/j.cbpra.2011.03.002 wild, j., hackmann, a., & clark, d. m. (2007). when the present visits the past: updating traumatic memories in social phobia. journal of behavior therapy and experimental psychiatry, 38, 386-401. https://doi.org/10.1016/j.jbtep.2007.07.003 wild, j., hackmann, a., & clark, d. m. (2008). rescripting early memories linked to negative images in social phobia: a pilot study. behavior therapy, 39, 47-56. https://doi.org/10.1016/j.beth.2007.04.003 wittchen, h.-u., zaudig, m., & fydrich, t. (1997). skid – strukturiertes klinisches interview für dsm-iv: achse i und ii. göttingen, germany: hogrefe. imrs vs. cognitive restructuring in social anxiety 18 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://doi.org/10.1026/0012-1924/a000148 https://doi.org/10.1016/j.brat.2015.10.007 https://doi.org/10.1016/j.janxdis.2019.102169 https://doi.org/10.1016/j.janxdis.2014.05.012 https://doi.org/10.1026//0084-5345.28.1.28 https://edoc.ub.uni-muenchen.de/25436/1/strohm_miriam.pdf https://doi.org/10.5127/pr.045115 https://doi.org/10.1016/j.cbpra.2011.03.002 https://doi.org/10.1016/j.jbtep.2007.07.003 https://doi.org/10.1016/j.beth.2007.04.003 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. strohm, siegesleitner, kunze et al. 19 clinical psychology in europe 2021, vol. 3(3), article e5303 https://doi.org/10.32872/cpe.5303 https://www.psychopen.eu/ imrs vs. cognitive restructuring in social anxiety (introduction) method participants clinical interviews imagery interview speech task symptom measures speech task measures measures of underlying mechanisms interventions procedure statistical analyses results participant characteristics and baseline comparisons social anxiety symptoms speech task measures mechanisms discussion effects on social anxiety symptoms mechanisms underlying imagery rescripting limitations conclusion (additional information) funding acknowledgments competing interests ethics statement author note supplementary materials references sex differences in the outcome of expressive writing in parents of children with leukaemia research articles sex differences in the outcome of expressive writing in parents of children with leukaemia dorte mølgaard christiansen 1 , maria luisa martino 2 , ask elklit 1 , maria francesca freda 2 [1] national center of psychotraumatology, institute of psychology, university of southern denmark, odense, denmark. [2] department of humanistic studies, federico ii university, naples, italy. clinical psychology in europe, 2022, vol. 4(1), article e5533, https://doi.org/10.32872/cpe.5533 received: 2020-12-31 • accepted: 2021-10-03 • published (vor): 2022-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: dorte mølgaard christiansen, university of southern denmark, campusvej 55, 5230 odense m, denmark. e-mail: dochristiansen@health.sdu.dk abstract background: sex differences are widely reported in clinical psychology but are rarely examined in interventions. method: this mixed-method explorative study examined sex differences in 13 mothers and 10 fathers of children in the off-therapy phase of acute lymphoblastic leukaemia. parents underwent an expressive writing intervention using the guided written disclosure protocol (gwdp). results: mothers had more negative mood profiles than fathers but improved more during the intervention. conclusion: though preliminary, our findings highlight the importance of sex as a potential moderator of intervention and treatment outcome that could be of great clinical significance. keywords sex differences, gender differences, expressive writing therapy, mood states, childhood leukaemia, parental stress highlights • parents of children in remission from cancer can benefit from expressive writing. • expressive writing can improve mood states. • mothers may benefit more than fathers. • more research on gender differences in outcomes is needed. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5533&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0003-0650-3031 https://orcid.org/0000-0003-1906-9369 https://orcid.org/0000-0002-8469-7372 https://orcid.org/0000-0002-2529-2279 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ when a child falls severely ill, it affects the whole family and parental stress levels remain increased even after successful treatment (hile et al., 2014). how the parents cope with the shared trauma and burden of that illness is essential to the health of the family as a whole (morris et al., 2012). one study reported that parental stress was the strongest correlate of functional impairment in children at least 2 years following treatment for leukemia/lymphoma (hile et al., 2014). consequently, decreasing the stress and symptom levels of parents of children who have undergone treatment for serious illnesses is likely to benefit the whole family. however, parents receive little attention from hospital personnel and healthcare researchers beyond the first initial shock associated with the child’s diagnosis and treatment. inspired by the field of linguistics, pennebaker et al. (2010) theorised that words used in a written narrative reflect the writer’s state of mind and could be used to track changes in the meaning attributed to an event (pennebaker et al., 2010; tausczik & pennebaker, 2010). building on these principles, expressive writing was designed to be used as an element in therapy or as an independent intervention to promote mean­ ing-making and integrate traumatic content into a personal narrative (de luca picione et al., 2017; de luca picione et al., 2018; martino & freda, 2016; martino et al., 2013). one such expressive writing intervention, the guided written disclosure protocol (gwdp) has been used to reduce distress, anxiety, and ptsd symptoms in parents of children with cancer, whereas results for depression have been less promising (cafaro et al., 2019; dicé et al., 2018; duncan & gidron, 1999; duncan et al., 1998; gidron et al., 2002; martino et al., 2019; martino et al., 2013). this protocol is designed to help participants build an increasingly complex and coherent narrative by building on themes of meaning-making, insight, emotion-regulation, mastery and self-efficacy (baikie & wilhelm, 2005). one factor that likely affects how parents respond to different interventions is sex, but research remains scarce (christiansen, 2015, 2017; ogrodniczuk, 2006). research on sex differences in the outcomes of different interventions is often limited by small sample sizes (especially few male participants), yet effect sizes are rarely reported. furthermore, moderation effects are rarely based on a priori hypotheses. possibly as a consequence of poor statistical power, few studies have reported significant sex differences. nonetheless, there are indications that women generally benefit more from psychotherapy than men (christiansen, 2015, 2017; ogrodniczuk, 2006; wade et al., 2016), especially interventions focusing on verbal processing of traumatic content (christiansen, 2017). little focus has been given to potential sex differences in outcome of expressive writing. one meta-anal­ ysis found that percentage of male participants was positively associated with effect size across 13 studies. however, this effect was not found for psychological outcomes. furthermore, as trauma type was not controlled, it may be that women were more likely to write about more toxic exposures, such as sexual trauma, which is more common among women (christiansen, 2017). other studies have generally failed to report sex differences in the effects of expressive writing (pennebaker & chung, 2011), though this sex differences in expressive writing 2 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ may be at least partly due to low statistical power. to the best of our knowledge, no studies have examined whether references to emotion and cognition predict treatment outcome in both men and women. knowledge on sex differences in how parents respond to different interventions may help improve outcomes for both individual parents and their family, not least the children whose functioning is often very dependent on the psychological health of their parents (morris et al., 2012). in the present study we examined how a brief intervention of expressive writing affects the mood states of parents whose children were in the off­ therapy all phase (i.e. remission of malignant cells; interruption of radio/chemotherapy; ca. 2 years post diagnosis). we chose to focus on this phase because parents whose children were not in remission would likely be too focused on the current threat to their child to fully benefit from the intervention, yet this phase remains an extremely vulnerable period within which families begin to return to “normal” life, yet parents still feel vulnerable and may need help processing the trauma (martino et al., 2013). the present study was a pilot study implementing an expressive writing protocol in a group of parents in a very sensitive period following a serious threat to their children. the purpose was to examine sex as a moderator of the impact of expressive writing on mood states over time. we expected mothers to benefit more from the intervention than fathers. m e t h o d participants participants included 10 fathers and 13 mothers whose children were at the beginning of the off-therapy remission phase being treated for acute lymphoblastic leukemia at one of italy’s leading facilities for children with neoplastic illness. the mean age was 41.5 years (sd = 5.01) for fathers and 38.2 years (sd = 5.6) for mothers. the children undergoing treatment were four boys (m = 4.25 years, sd = 0.5) and nine girls (m = 6.77 years, sd = 3.3). procedure the sample was consecutive with parents being identified from medical reports. recruit­ ment occurred through phone calls or at the hospital. parents were contacted one day after their child was confirmed to be in remission. exclusion criteria were ongoing thera­ py/interventions for symptoms related to dealing with their child’s illness. participation was voluntary and confidential based on informed written consent, and the study was approved by the hospital’s ethics committee. the gwdp protocol was used in the present studies because of the above mentioned positive results in parents of children with cancer. writing sessions lasted 30 minutes and christiansen, martino, elklit, & freda 3 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ were conducted individually in a quiet room of the hospital with only the psychologist researcher present. in the first session parents were asked to describe events as they occurred and developed over time. in the second session (10-15 days later) parents were invited to express the emotions accompanying these same events. in the final session (10-15 days later) parents were instructed to envision their future, compare their present and past feelings, consider the effects the experience has had on them, and describe how they expect to cope with future adversities. following the intervention parents were assessed for need of continued psychological support. one mother was offered and accepted additional meetings with a psychologist at the hospital. the study originally included a control group of 23 parents not undergoing a writing intervention who were invited to participate during the subsequent year. however, as the two groups differed significantly on the main outcome measure at t1, prior to inter­ vention, we unfortunately had to exclude the control group, as it would be impossible to conclude whether any potential differences between the groups were caused by the intervention or by other factors. out of a total of 20 couples whose children were diag­ nosed during 2007, seven couples and an additional three fathers declined participation, thus leaving us with 10 parental dyads and three mothers without participating partners. participants were assessed prior to the intervention (t1), 10-15 days post-intervention (t2) and at follow-up (40-45 days post-intervention (t3). measure the profile of mood states (poms) is a self-report questionnaire assessing specific affective states during the past week (mcnair et al., 1971). the test consists of 58 ad­ jectives belonging to six factors: tension–anxiety, depression–dejection, anger–hostility, vigor–activity, fatigue–inertia, and confusion–bewilderment. items are rated on a 5-point likert scale ranging from 0 (not at all) to 4 (extremely). the poms scale revealed accept­ able reliability across all three measurements (cronbach’s α > .96) and across five of the six subscales (cronbach’s α > .81). cronbach’s α was consistently low for the vigor-activ­ ity subscale and an inter-item correlation matrix revealed internal inconsistencies. thus, this subscale was excluded from all analyses. a measure of change in poms scores was calculated for later analyses (t3 scores – t1 scores) with negative scores indicating an improvement in mood states. data analyses the low number of participants (n = 23) limited the type and power of statistical analyses. therefore, the results must be considered preliminary. a significance level of p < .05 was used but to better guide future research, high and medium effect sizes are also reported regardless of statistical significance level. a t-test was also used to examine sex differences in changes in poms total and subscale scores between assessments. effect sex differences in expressive writing 4 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ sizes were calculated using cohen’s d with values of 0.2, 0.5, and 0.8 used as guidelines for small, medium, and large effect sizes, respectively. the main effect of time was examined along with the main effect of sex and the interaction effect between time and sex in a mixed methods within-between subjects anova. effect sizes were calculated using partial eta squared (ηp2) with values of .01, .06, and .14 used as guidelines for small, medium, and large effect sizes, respectively. due to the way in which data was collected and stored, it was not possible to conduct paired analysis based on parental dyads. thus, analyses of sex differences fail to take into account that paired parents affect each other and share both the child and the circumstances surrounding that child’s illness and treatment. r e s u l t s the mixed methods anova for mothers and fathers across all three measurements is shown in table 1a, 1b, and 1c. in accordance with the t-tests, significant large main effects of sex were found for poms total score, f(1, 21) = 7.77; p < .05; ηp2 = .27, and all subscale scores, ηp2 > .20; p < .05), except for depression-dejection (p = .07; ηp2 = .14; see table 1a). no significant main effect was found for time on poms total score despite a relatively large effect size (ηp2 = .17; see table 1b). there was, however, a significant main effect on tension-anxiety (wilk’s lambda = .70, f(2, 20) = 4.26, p < .05, ηp2 = .30). the main effects for time on the remaining subscales were all medium though non-significant (.08 < ηp2 < .20). all effect sizes indicated a decrease in poms levels from pre-treatment to follow-up. finally, the interaction effects between sex and time were all non-significant, though all except for the depression-dejection subscale had effect sizes that can be considered medium-to-large (.06 < ηp2 < .17; please see table 1c). table 1a anova: between-subjects effect – sex poms subscale f p pe 2 total 7.77 < .05 .270 tension-anxiety 7.52 < .05 .264 depression-dejection 3.63 .07 .147 anger-hostility 5.45 < .05 .206 fatigue-inertia 8.90 < .01 .298 confusion-bewilderment 21.10 < .001 .501 note. poms: profile of mood states. christiansen, martino, elklit, & freda 5 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ table 1b anova: multivariate tests – time poms subscale wilk’s λ f p pe 2 total .828 2.07 ns. .172 tension-anxiety .701 4.26 < .05 .299 depression-dejection .915 0.93 ns. .085 anger-hostility .900 1.12 ns. .100 fatigue-inertia .806 2.41 ns. .194 confusion-bewilderment .912 0.96 ns. .088 note. poms: profile of mood states. table 1c anova: multivariate tests – time * sex poms subscale wilk’s λ f p pe 2 total .887 1.28 ns. .113 tension-anxiety .835 1.97 ns. .165 depression-dejection .960 0.41 ns. .040 anger-hostility .898 1.14 ns. .102 fatigue-inertia .869 1.50 ns. .131 confusion-bewilderment .934 0.71 ns. .066 note. poms: profile of mood states. post-hoc t-tests examining the moderation effects (please see table 2) revealed that mothers reported a higher average decrease in poms scores (m = -20.46, sd = 54.43) compared to fathers (m = -6.20, sd = 8.04) from t1 to t3, though the effect size was small and non-significant (cohen’s d = .37). the main decrease in poms levels in mothers occurred during the intervention (m = -21.54) with little additional change occurring afterwards (m = -1.08; see table 2). this difference was much smaller in fathers (m = -4.7 vs. m = -1.5). though independent t-tests examining sex differences in the decrease in poms scores at each step were non-significant, a large effect size was found comparing the decrease in poms scores during the intervention (d = .54) but not subsequently (d = .23). these sex differences were not significant for any of the subscales and could only be considered medium for the tension-anxiety subscale (d = 0.70). most participants (78%) experienced some decrease in their poms scores over the course of writing. however, 10.0% of fathers and 30.8% of mothers reported some increase in poms scores from t1 to t3. sex differences in expressive writing 6 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ table 2 poms total and subscale scores at baseline and over time poms total score m (sd) t p dall f m poms total scores poms total t1 52.61 (39.15) 27.80 (25.02) 71.69 (37.86) 3.16 < .05 1.37 poms total t2 38.39 (34.41) 23.10 (22.43) 50.15 (38.06) 1.99 .060 0.87 poms total t3 38.35 (38.64) 21.60 (20.06) 51.23 (44.97) 2.12 < .05 0.85 change from t1 to t3 poms total -14.26 (41.17) -6.20 (8.04) -20.46 (54.43) 0.93 ns. 0.37 tension-anxiety -4.91 (8.05) -2.00 (3.56) -7.15 (9.84) 1.75 ns. 0.70 depression-dejection -3.52 (14.21) -1.90 (1.79) -4.77 (19.08) 0.54 ns. 0.21 anger-hostility -2.22 (9.26) -1.00 (2.05) -3.15 (12.32) 0.62 ns. 0.24 fatigue-inertia -2.43 (6.06) -1.40 (1.35) -3.23 (8.02) 0.81 ns. 0.32 confusion-bewilderment -1.17 (5.16) 0.10 (1.29) -2.15 (6.72) 1.18 ns. 0.47 note. f = fathers; m = mothers. t, p, and cohen’s d all relate to sex differences. poms = profile of mood state. t1: prior to therapy; t2: at the end of therapy: t3: at follow-up. d i s c u s s i o n as the present study was a pilot study, the most relevant finding was that the implemen­ tation of the emotional writing procedure in this clinical setting was successful. that significant sex differences were found despite low statistical power highlights the impor­ tance of taking sex into account in intervention studies. several of the non-significant effects could be considered moderate or even strong, indicating that type ii error due to small sample size may have disguised further significant findings. mothers reported sig­ nificantly more negative mood states than fathers. it is possible that mothers were more negatively affected by their child’s illness, as indicated by prior research (christiansen, 2017; clarke et al., 2009). another possibility is that these findings may just reflect sex differences in everyday mood. although there was no significant main effect of time, the effect size was quite large for poms total scores, and medium-to-large effect sizes were found for all five poms subscales. without a control group, it is unknown whether the apparent improvements in mood profiles were caused by the intervention or simply by the passing of time. however, mothers showed a much steeper decline in symptom scores from t1 to t2 than from t2 to t3. this decline was larger in mothers than in fathers during the intervention, whereas there was no difference between the two sexes in changes in mood states occurring from the end of the intervention until follow-up. this may suggest that, at christiansen, martino, elklit, & freda 7 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ least in mothers, some of the changes were caused by the writing intervention. accord­ ingly, although the interaction between time and sex was statistically non-significant, the medium-to-large effect sizes found for both poms total score and all but one of the subscale scores suggests that future studies may reveal women to benefit more from expressive writing interventions than men. though preliminary, our findings highlight the importance of including sex as a moderator in treatment studies. though not shown here, analyses using the linguistic inquiry and word count software (liwc) (pennebaker et al., 2007; freitag et al., 2011; freda & martino, 2015) found that mothers focused more on affect during writing sessions than fathers, includ­ ing both positive and negative emotions (analyses may be obtained from corresponding author). this is in accordance with findings from prior studies (newman et al., 2008; thomson & murachver, 2001). ogrodniczuk (2006) suggested that women’s willingness to self-disclose and express emotion make them better patients and help them benefit more from therapy. perhaps the socialization processes that cause women to share emotional content with others more easily than men make them more prepared to benefit from interventions focusing on emotional processing. another possibility is that women’s stronger inclination to seek treatment (christiansen, 2015; ogrodniczuk, 2006) makes them generally more prepared than men to put in the effort needed for it to be successful. though the present study was not based on a treatment-seeking sample, mothers were more likely than fathers to agree to participate, so a similar phenomenon may be present in this sample. whereas it is possible that mothers’s scores simply declined more because they were higher from the beginning, thus leaving more room for improvement, this would also be the case from the end of treatment to follow-up where no additional change occurred. this may suggest that the decrease was in fact caused by the writing intervention, but due to the unfortunate exclusion of the control group, there is no way of knowing for sure. finally, it is important to note that four of the mothers and one father experienced an increase in symptoms over the course of the writing intervention. thus, whereas mothers on average benefitted more, they also appear more likely to get worse over time. as the poms measure was not directly linked to the child’s illness and only assessed mood states during the past weeks, the increased poms scores may have been caused by new chronic or temporary stressors, independently of the intervention. however, such findings does serve as a reminder that when evaluating the benefits of any intervention, we must focus both on overall gains and on potential detrimental individual effects. sex differences in intervention outcomes is of great importance to both scientists and clinicians, and implementing these into treatment and intervention designs may increase the benefits of these for both men and women presenting with a variety of symptoms, thus reducing the great societal and personal costs associated with ineffective interventions (christiansen, 2017; donner & lowry, 2013). knowledge about both sex and gender and how they influence intervention outcomes should be implemented in sex differences in expressive writing 8 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://www.psychopen.eu/ research on different types of psychotherapy to a much greater degree than what is cur­ rently being done (bekker & van mens-verhulst, 2007; christiansen, 2015; christiansen & berke, 2020; christiansen & elklit, 2012). whereas the results of the present study are preliminary and cannot in and of themselves be used as evidence of sex differences in the therapeutic effects of expressive writing and emotional processing in general, it is our great hope that it may increase focus on the importance of considering sex differences in the impact of psychotherapy and psychological interventions. in terms of clinical implications, taking sex differences into account when designing and selecting interventions for parents of critically ill children may help reduce symptom levels for both mothers and fathers and in turn improve quality of life for the whole family. strengths and limitations beyond showing the feasibility of such an intervention in a sensible clinical environ­ ment, the primary strength of this study is the specific focus on sex as a potential moderator of intervention outcome. however, the fact that the study was not originally designed with this in mind, thus failing to ensure sufficient power for detecting signifi­ cant effects, severely limits the conclusions. the exclusion of the control group due to significant pre-treatment differences in poms scores severely limits the results, as we were not able to conclude whether the reductions in poms scores over time were in fact caused by the intervention. further, low sample size of this pilot trial only allows cautious interpretation of results. finally, the inability to match mothers and fathers into parental dyads forced us to treat the two sexes as independent groups, thereby making our results vulnerable to certain biases, such as parents affecting the symptom levels of their partners and both parents being affected by how their child copes with the illness along with other shared circumstances and stressors. funding: this research received no specific grant from any funding agency in the public, commercial, or not-forprofit sectors. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s baikie, k. a., & wilhelm, k. 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(2016). gender difference in outcomes following trauma-focused interventions for posttraumatic stress disorder: systematic review and meta-analysis. psychological trauma: theory, research, practice, and policy, 8(3), 356–364. https://doi.org/10.1037/tra0000110 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. sex differences in expressive writing 12 clinical psychology in europe 2022, vol. 4(1), article e5533 https://doi.org/10.32872/cpe.5533 https://doi.org/10.1037/tra0000110 https://www.psychopen.eu/ sex differences in expressive writing (introduction) method participants procedure measure data analyses results discussion strengths and limitations (additional information) funding acknowledgments competing interests references dysfunctional cognition in individuals with an increased risk for mania research articles dysfunctional cognition in individuals with an increased risk for mania raphaela ulrich a, thomas d. meyer b, sylke andreas ac, claudia lex d [a] department of psychology, university of klagenfurt, klagenfurt, austria. [b] faillace department of psychiatry and behavioral sciences, mcgovern school of medicine, university of texas hsc, houston, tx, usa. [c] department of psychology, university witten/herdecke, witten, germany. [d] department of psychiatry, villach general hospital, villach, austria. clinical psychology in europe, 2021, vol. 3(1), article e3733, https://doi.org/10.32872/cpe.3733 received: 2020-05-19 • accepted: 2021-01-17 • published (vor): 2021-03-10 handling editor: tania lincoln, university of hamburg, hamburg, germany corresponding author: claudia lex, department of psychiatry, villach general hospital, nikolaigasse 43, 9500 villach, austria. phone: (43) 4242-208-0. e-mail: clex@iit.edu abstract background: there is still a lack of knowledge about attitudes and cognitions that are related to bipolar disorder. theoretically, it was proposed that exaggerated beliefs about the self, relationships, the need for excitement, and goal-related activities might lead to mania in vulnerable individuals, however, the few studies that examined this hypothesis provided mixed results. one of the unresolved issues is if such a cognitive style is associated with current mood symptoms or with different stages of the illness, i.e. at-risk versus diagnosed bipolar disorder. therefore, the present study aimed at evaluating depression and mania-related cognitive style in individuals at-risk for mania. method: in an online survey, we collected data of 255 students of the university of klagenfurt, austria. all participants completed the hypomanic personality scale (hps), the cognition checklist for mania – revised (ccl-m-r), the dysfunctional attitude scale (das), the beck depression inventory (bdi), and the internal state scale (iss). results: in a hierarchical regression, hps was positively related to scores of all subscales of the ccl-m-r. the hps did not significantly predict scores of the das. current manic and depressive symptoms significantly contributed to the models. conclusion: the present results suggest that a trait-like risk for mania is associated with maniarelated but not depression-related cognitions. keywords bipolar disorder, hypomania, hypomanic personality, dysfunctional attitudes, cognition, vulnerability this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.3733&domain=pdf&date_stamp=2021-03-10 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • individuals at-risk for mania show mania-specific rather than depression-specific thinking patters. • current subclinical mood symptoms are related to mood-congruent attitudes and cognitions. bipolar spectrum disorders, which include bipolar i, bipolar ii, and subthreshold bipolar disorder, affect about 2.4% of the population worldwide (merikangas et al., 2011) and can be highly disabling. compared to other psychiatric illnesses, bipolar disorder (bd) is the fifth leading cause of years lived with disability (ferrari et al., 2016), it is associated with social disruption (e.g., depp et al., 2010) and an increased risk of suicide (e.g., nordentoft et al., 2011). psychological treatments for bd combined with pharmacological strategies yielded better outcomes than pharmacological treatment alone (miklowitz et al., 2007). for example, structured psychological treatments, such as cognitive behavioral therapy (cbt) seem to be effective (chiang et al., 2017), but this effect might be specific for depressive symptoms (oud et al., 2016). one reason for this result might be that cognitive behavioral interventions for bd stem from cbt that was originally developed in the context of major depression (lam et al., 2010), and usually psychotherapy does not focus on decreasing activation, changing self-confident thoughts or lowering elevated mood. in addition, there is still relatively little knowledge about cognition specifically related to bd and mania. one of the few cognitive theories specifically developed for bd was proposed by beck et al. (2006). they state that individuals possess schemata defined as underlying cognitive structures for organizing perceptions of the world. these schemata can be detected by asking people about their beliefs and attitudes. if a negatively biased schema is activated by a stressful life event, the individual might develop even more negative thoughts and subsequently experience depressive symptoms. for example, an underlying belief “i am incompetent” can be represented in the conscious thought “i can’t do it” when asked to handle a difficult situation, which then might lead to an increase in de­ pressive symptoms (beck & haigh, 2014). parallel, a different set of dysfunctional beliefs might lead to manic episodes. these mania-specific cognitions relate to exaggerated be­ liefs about self-worth, to grandiose beliefs about interpersonal relationships, to erroneous beliefs about needing excitement caused by high-risk situations, and unrealistic beliefs about having high energy levels for undertaking goal-driven activities (beck et al., 2006; newman et al., 2002). to tap into mania-related dysfunctional beliefs beck et al. (2006) developed the cognition checklist for mania – revised (ccl-m-r) that comprises four subscales, i.e. ‘myself’, ‘relationship’, ‘pleasure/excitement’, and ‘activity’. based on beck’s model, all four dimensions of the ccl-m-r should be elevated in manic states. however, the cognition and risk for mania 2 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ few studies conducted so far have yielded mixed results. beck et al. (2006) found that currently manic patients indeed reported more mania-related cognition with regards to ‘myself’, ‘relationship’, and ‘activity’ compared to patients in depressed and mixed states, whereas another study found that only the ‘pleasure/excitement’ subscore was related to manic symptoms (fulford et al., 2009). in addition, it is unclear whether this specific set of cognitions is associated exclusively with manic states or if they persist in other bipolar states as well, e.g., remission or prodromal. while two studies mentioned before concluded that certain mania-related cognitions were linked only to acute manic states (beck et al., 2006; fulford et al., 2009; ruggero et al., 2015) showed that individuals with a history or current diagnosis of bd reported elevated levels of mania-related cognitions, irrespective of current symptoms. also, mania-related cognitions might be present and prevalent in different stages of the disorder, i.e. at-risk stages or symptomatic bd (fulford et al., 2009). for example, beliefs relating to self-confidence in the ccl-m-r were increased in individuals at risk for bd but not in those diagnosed with bd. in contrast, cognitions relating to interpersonal problems were increased in individuals diagnosed with bd but not in those at high risk for bd. a few more studies examined depression-related cognition in bd. in this context, one of the most wildly used instruments is the dysfunctional attitude scale (das; weisman, 1979). however, the results of the studies that used the das were mixed. some studies found no differences in overall dysfunctional attitudes between healthy controls and in­ dividuals diagnosed with remitted bd (alatiq et al., 2010; lex et al., 2008; lex et al., 2011; mansell et al., 2011). other studies found elevated das scores in patients with remitted bd relative to healthy control groups (hollon et al., 1986; jones et al., 2005; scott et al., 2000; tosun et al., 2015). however, dysfunctional attitudes refer to different areas, for example, achievement, dependency, and goal attainment. since mania involves increased goal-directed activity (american psychiatric association, 2013) some researchers argued that it would be essential to focus on assessing beliefs relating to goal attainment. in line with this, lam et al. (2004) found evidence that dysfunctional attitudes related to goal attainment were indeed more pronounced in individuals with bd compared to unipolar depression. however, this was not found in all studies (e.g., jabben et al., 2012). despite the recent increased efforts to understand cognitive processes in bd, studies are still sparse and their results are mixed. for example, it still remains unclear whether these dysfunctional cognitions are tied to depressive or (hypo)manic states of bd or if they are part of the underlying diathesis of bd. one possibility to examine this question would be to assess these cognitions among individuals at-risk for mania. risk for bd can be defined via a genetic vulnerability (ruggero et al., 2015) or via a constitutional pre­ disposition. hyperthymic temperament represents such a constitutional predisposition for mania and can be assessed by the hypomanic personality scale (hps; eckblad & chapman, 1986) because there is evidence that people scoring high on the hps are more ulrich, meyer, andreas, & lex 3 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ likely to develop symptoms of bd over time (blechert & meyer, 2005; kwapil et al., 2000; walsh et al., 2015). therefore, the present study aimed at examining, if mania related cognition depicted by the ccl-m-r were even present in at-risk states or if they were rather tied to acute manic symptoms. also, we were interested if core beliefs related to goal attainment were associated with at-risk states for mania. therefore, we hypothesized that risk for mania predicted mania-related cognition assessed with the ccl-m-r and the das subscale ‘goal attainment’. we also expected that current manic symptoms were associated with mania-related cognition. we, however, did not expect such a relation for depression-spe­ cific cognition, i.e. das-subscales ‘dependency’ and ‘achievement’. m e t h o d participants and procedure at first, we contacted all students at the university of klagenfurt, austria, via their cam­ pus e-mail addresses. the e-mail contained general information on the study and a link to “lime survey”. “lime survey” is a web application to conduct online surveys. if the students decided to participate, the provided informed consent, filled out the question­ naires, and provided demographic data. we also asked if they had been in psychotherapy before, because some psychological approaches might potentially alter cognitions related to mood symptoms. the participants remained anonymous and could leave the survey and delete their data at any time. at the end, the participants could optionally disclose their mail address to obtain course credit (n = 68). in total, we obtained data from 255 students. most participants were female (80%) and had never been in psychotherapy before (63.5%). the demographic data is displayed in table 1. measurements hypomanic personality scale (hps) the hps (eckblad & chapman, 1986) is a self-rating scale and includes 48 true-false items covering emotions (e.g., “i frequently get into moods where i feel very speeded-up and irritable”), behavior (e.g., “at social gatherings, i am usually the ‘life of the party’”), and energy level, (e.g., “there have often been times when i had such an excess of energy that i felt little need to sleep at night”) one feels at most times of his/her life. it assesses hyperthymic temperament, was used in clinical and non-clinical samples before, and is predictive of bipolar disorder and (hypo)manic symptoms (blechert & meyer, 2005; kwapil et al., 2000; walsh et al., 2015). in the present study, we used the total score to operationalize a constitutional risk to develop mania. scores can range between 0 and 48, and individuals scoring above 26 are considered at high risk for mania (meyer & baur, 2009). the german version (meyer et al., 2000) showed an internal consistency of α = .89. cognition and risk for mania 4 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ hyperthymic temperament was a stable trait over time (rtt = .87 [2 years]; hofmann & meyer, 2006). in the present sample the reliability was adequate (cronbach’s α = .87), and 34 participants were considered at high risk for mania (hps > 26). cognition checklist for mania – revised (ccl-m-r) the ccl-m-r (beck et al., 2006; goldberg et al., 2008) includes 29-items assessing beliefs associated with mania one had had during the past two days and has been used in clinical and non-clinical samples (fulford et al., 2009). the questionnaire contains four subscales. the ‘myself’ subscale contains 7 items and assesses cognition related to the self (e.g., “i am the best”), the ‘relationship’ subscale contains 7 items and assesses interpersonal issues (e.g., “i love everyone”), the ‘pleasure/excitement’ scale contains 9 items exploring excitement seeking (e.g., “it is ok to take risks”), and the ‘activity’ subscale comprises 6 items and assesses goal-driven activities (e.g., “i have got to get the job done while i can”). a ‘thwarting’ subscale can be derived from the ‘relationship’ scale by summing two items (“i could accomplish great things, if people did not get in my way” and “other people stand between me and my goals”; fulford et al., 2009). inde­ table 1 characteristics of the sample (n = 255) variable m sd minimum maximum age 28.27 9.56 18 65 hps 16.28 8.25 1 42 bdi 10.25 9.36 0 48 act 142.88 95.22 0 466 ccl-m-r myself 8.42 4.12 1 19 relation 4.05 2.92 0 14 pleasure/ excitement 9.87 4.00 0 20 activity 7.80 3.39 0 18 thwarting 0.90 1.38 0 6 total 30.14 11.12 1 60 das goal attainment 20.27 4.82 3 35 dependency 8.27 4.84 0 22 achievement 9.80 6.60 0 29 total 60.58 18.03 20 117 note. act = internal state scale activation subscore; bdi = beck depression inventory; ccl-m-r = cognition checklist mania; das-24 = dysfunctional attitude scale; hps = hypomanic personality scale. ulrich, meyer, andreas, & lex 5 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ pendent back-translation was used by two of the authors (r. u. and c. l.) and a native english speaker to obtain a german version of the ccl-m-r. internal consistencies in the present study were adequate (total ccl-m-r score: cronbach’s α = .89, ‘myself’: α = .80, ‘relationship’: α = .64, ‘pleasure/excitement’: α = .83, ‘activity’: α = .70) and comparable to the english version (beck et al., 2006; ruggero et al., 2015). dysfunctional attitude scale (das-24) the das (weisman, 1979; german version: hautzinger et al., 1985) is designed to assess depression-specific beliefs that individuals have about themselves, others, and their envi­ ronments most of the time. although the das has been widely applied in clinical sam­ ples, it is also used with analogue samples (e.g., perez & rohan, 2021). lam et al. (2004) used a 24-items das version in their study from which 3 factors could be derived: ‘goal attainment’ (6 items e.g., “i ought to be able to solve problems quickly”), ‘dependency’ (4 items, e.g., “if others dislike you, you cannot be happy”, and ‘achievement’ (5 items, e.g., “people who have good ideas are more worthy”). these subscales showed good internal consistency. in the present study, we adapted the german das in order to parallel the das-24 by lam et al. (2004). we obtained cronbach α = .83 for the total score, for ‘goal attainment’ α = .44, for ‘dependency’ α = .65, and for ‘achievement’ α = .80. beck depression inventory (bdi) the bdi (beck et al., 1961; german version: hautzinger et al., 1995) measures the severity of self-reported depression during the past 2 weeks and is used in clinical and non-clini­ cal samples (richter et al., 1998). it consists of 21 items and each item is scored on a 4-point scale, e.g. “0 i do not feel sad; 1 i feel sad; 2 i am sad all the time and i can't snap out of it, 3 i am so sad and unhappy that i can't stand it”. scores can range from 0 to 63, and higher scores indicate more severe depressive symptoms. in the present study, we used the validated german version that has comparable psychometric properties to the english version (hautzinger et al., 1995). internal state scale (iss) the iss (bauer et al., 1991, 2000; german version: meyer & hautzinger, 2004) is a self-report measure that consists of 16 items that are rated on a visual analogue scale (0 – “not at all” to 100 – “totally”) incorporating 4 subscales (activation, well being, perceived conflict, depression index). the activation subscale (act) contains 5 items. it reflects self-reports of manic symptoms within the last 24 hours by assessing behavioral and formal cognitive activation (e.g. “i feel overactive”, “my thoughts are going fast”). it correlates positively with selfand expert ratings of mania (bauer et al., 1991, 2000) and has been used in clinical and non-clinical samples (e.g., kelly et al., 2016). cognition and risk for mania 6 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ statistical analysis to examine if high risk for mania predicted depressionand mania-specific cognition we calculated hierarchical regression analyses using ibm spss statistics for macintosh, version 25.0. scores of the ccl-r-m and das-24 were used as dependent variables. all analyses controlled for age and gender in block 1, for current manic and depressive symptoms in block 2, and for a prior history of psychotherapy in block 3. scores of the hps were entered in block 4 after accounting for the other variables of interest. prior to interpreting the models, the relevant assumptions for linear regressions and potential biases were examined. first, the visual inspection of all scatter plots depicturing ‘standard residuals’ vs. ‘standard predicted value’ revealed no specific pattern, hence the assumptions of linearity and heteroscedasticity were met. second, the correlations between the predictors were low (all r < |.5|), and the multicollinearity statistics (i.e., tolerance and vif) were all within the tolerable limits (field, 2009). third, histograms and p-p plots showed that the standard residuals were normally distributed. forth, the assumption of independent errors was met because all durbin-watson results were close to 2 (between 1.83 and 2.14). finally, we identified the presence and significance of outliers by looking at the standard residuals, the mahalanobis distance and the leverage effect (i.e., cook’s distance). cases with standard residuals values below -2 and above 2 were defined as outliers. however, the proportion of identified outliers was less than 5% in all analyses and was, therefore, tolerated (field, 2009). in order to examine this issue in more detail, we also looked at the mahalanobis distance. eleven cases were defined as outliers because their values of the mahalanobis distance were above 22.59 (for the cut-off value see stevens, 1984). however, the leverage effects of these 11 cases were small (i.e., cook’s distance < 1); therefore, the cases were not deleted from the analyses (field, 2009, p. 309). r e s u l t s first, the final overall models including all predictors for mania-related cognitions (ccl­ m-r) are reported. the final overall model for the composite ccl-m-r score was signifi­ cant f(6, 248) = 23.96, p < .001. also, the final overall models for the specific dimensions of the ccl-m-r were significant: ‘myself’ f(6, 248) = 22.56, p < .001, ‘relationship’ f(6, 248) = 18.05, p < .001, ‘pleasure/excitement’ f(6, 248) = 14.52, p < .001, and ‘activity’ f(6, 248) = 15.40, p < .001. looking at the δr 2, it became evident that bdi, act, and hps scores significantly increased the explained variance in all five models (table 2). ulrich, meyer, andreas, & lex 7 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ ta b le 2 fi na l m od el ( st ep 4 ) of t he h ie ra rc hi ca l r eg re ss io n a na ly se s fo r c og ni ti on r el at ed t o m an ia p re di ct or c c lm -r t ot al c c lm -r m ys el f c c lm -r r el at io n sh ip c c lm -r p le as ur e/ e xc it em en t c c lm -r a ct iv it y b se b β b se b β b se b β b se b β b se b β b lo ck 1 se x 2. 02 1. 45 0. 07 0. 45 0. 54 0. 04 0. 94 0. 40 0. 13 * 0. 06 0. 56 0. 01 0. 56 0. 47 0. 07 a ge 0. 06 0. 06 0. 05 0. 00 0. 02 0. 00 0. 02 0. 02 0. 08 -0 .0 1 0. 02 -0 .0 2 0. 04 0. 02 0. 12 * b lo ck 2 b d i -0 .1 1 0. 06 -0 .0 9 -0 .1 7 0. 02 -0 .3 9* ** 0. 12 0. 02 0. 37 ** * 0. 01 0. 02 0. 01 -0 .0 6 0. 02 -0 .1 7* * a c t 0. 03 0. 01 0. 22 ** * 0. 01 0. 00 0. 14 ** 0. 00 0. 00 0. 05 0. 01 0. 00 0. 20 ** * 0. 01 0. 00 0. 26 ** * b lo ck 3 t h er ap y 0. 00 0. 00 -0 .0 1 0. 00 0. 00 0. 00 0. 00 0. 00 -0 .0 5 0. 00 0. 00 -0 .0 6 0. 00 0. 00 0. 08 b lo ck 4 h p s 0. 65 0. 08 0. 48 ** * 0. 23 0. 03 0. 46 ** * 0. 10 0. 02 0. 28 ** * 0. 18 0. 03 0. 36 ** * 0. 14 0. 03 0. 35 ** * n ot e. c c lm -r t ot al : r 2 = .0 1 fo r b lo ck 1 ; δ r 2 = .1 8* ** f or b lo ck 2 ; δ r 2 = .0 1 fo r b lo ck 3 ; δ r 2 = .1 7* ** f or b lo ck 4 ; c c lm -r m ys el f: r 2 = .0 1 fo r b lo ck 1 ; δ r 2 = .1 9* ** fo r b lo ck 2 ; δ r 2 = .0 0 fo r b lo ck 3 ; δ r 2 = .1 5* ** f or b lo ck 4 ; c c lm -r r el at io n sh ip : r 2 = .0 3* f or b lo ck 1 ; δ r 2 = .2 1* ** f or b lo ck 2 ; δ r 2 = .0 1 fo r b lo ck 3 ; δ r 2 = .0 5* ** fo r b lo ck 4 ; c c lm -r p le as ur e/ e xc it em en t: r 2 = .0 1 fo r b lo ck 1 ; δ r 2 = .1 4* ** f or b lo ck 2 ; δ r 2 = .0 1 fo r b lo ck 3 ; δ r 2 = .1 0* ** f or b lo ck 4 ; c c lm -r a ct iv it y: r 2 = .0 2 fo r b lo ck 1 ; δ r 2 = .1 6* ** f or b lo ck 2 ; δ r 2 = .0 0 fo r b lo ck 3 ; δ r 2 = .0 9* ** f or b lo ck 4 . a c t = i n te rn al s ta te s ca le a ct iv at io n s ub sc or e; b d i = b ec k d ep re ss io n i n ve n to ry ; c c lm -r = c og n it io n c h ec kl is t m an ia ; h p s = h yp om an ic p er so n al it y sc al e; t h er ap y = p ri or p sy ch ot h er ap y. *p < .0 5. * *p < .0 1. * ** p < .0 01 . cognition and risk for mania 8 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ more specifically, act positively predicted cognition related to ‘myself’ (β = 0.14), ‘pleasure/excitement’ (β = 0.20), and ‘activity’ (β = 0.26), bdi positively predicted cogni­ tion related to ‘relationship’ (β = 0.37), and hps scores positively predicted all ccl-m-r dimensions as well as the total ccl-m-r score. an exploratory hierarchical regression model for the thwarting subscale was also significant, f(6, 248) = 10.63, p < .001 (final model). specifically, bdi (β = 0.40, p < .001) and hps scores (β = 0.16, p = .01) predicted thwarting. next, the final overall models including all predictors for depression-related cognitions (das-24) are reported. the final overall model for the composite das-24, f(6, 248) = 18.30, p < .001, as well as the final overall models for the specific dimensions of the das-24 were significant: ‘achievement’ f(6, 248) = 15.20, p < .001, ‘dependency’ f(6, 248) = 13.63, p < .001, ‘goal attainment’ f(6, 248) = 4.52, p < .001. the bdi significantly predicted attitudes related to ‘achievement’ (β = 0.45), ‘dependency’ (β = 0.46) and the total das-24 score (β = 0.49). the act (β = 0.20) and sex (β = 0.17) significantly predicted ‘goal attainment’. the hps score could not increase the explained variance in any of the regression models (table 3). table 3 final model (step 4) of the hierarchical regression analyses for cognition related to depression predictor das-24 total das-24 achievement das-24 dependency das-24 goal attainment b seb β b seb β b seb β b seb β block 1 sex 3.98 2.45 0.09 1.66 0.92 0.10 0.13 0.69 0.01 2.06 0.75 0.17** age -0.02 0.10 -0.01 0.02 0.04 0.03 0.00 0.03 -0.01 0.03 0.03 0.06 block 2 bdi 0.95 0.11 0.49*** 0.32 0.04 0.45*** 0.24 0.03 0.46*** 0.03 0.03 0.05 act 0.02 0.01 0.11 0.01 0.00 0.11 0.00 0.00 0.04 0.01 0.00 0.20** block 3 therapy 0.00 0.00 0.00 0.00 0.00 -0.03 0.00 0.00 0.04 0.00 0.00 -0.03 block 4 hps 0.13 0.13 0.06 0.06 0.05 0.07 0.05 0.04 0.08 0.04 0.04 0.06 note. das-24 total: r 2 = .02* for block 1; δr 2 = .28*** for block 2; δr 2 = .00 for block 3; δr 2 = .01 for block 4; das-24 achievement: r 2 = .02 for block 1; δr 2 = .24*** for block 2; δr 2 = .00 for block 3; δr 2 = .01 for block 4; das-24 dependency: r 2 = .01 for block 1; δr 2 = .23*** for block 2; δr 2 = .00 for block 3; δr 2 = .01 for block 4; das-24 goal attainment: r 2 = .03** for block 1; δr 2 = .06*** for block 2; δr 2 = .00 for block 3; δr 2 = .01 for block 4. *p < .05. **p < .01. ***p < .001. ulrich, meyer, andreas, & lex 9 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ d i s c u s s i o n the present study examined the relation between an increased risk for mania, current mood symptoms and cognition specifically related to depression and mania. the risk for mania was assessed with the hps. in line with our hypotheses, risk for mania significantly predicted mania-specific but not depression-specific cognitions. however, while we had expected that risk for mania would be specifically related to one aspect of dysfunctional attitudes, i.e., ‘goal attainment’, this was not the case. current manic and depressive mood also contributed significantly to the regression models. the association between high risk for mania and elevated levels of mania-specific cognition was proposed by beck and his colleagues (2006) as a logical extension of the original theory of depression (beck et al., 1979). in line with this theory, we found that the ccl-m-r total score as well as all subscores were associated with increased vulnerability for mania. beck et al. (2006) also found evidence for their theory regarding most types of mania-specific cognition, however, they failed to find elevated scores on the ccl-m-r subscale ‘pleasure/excitement’. as they point out, they tested inpatients who had few opportunities to engage in exciting, high risk behavior while admitted to the hospital. in contrast, our sample consisted of university students who had much more chances for potentially risky behavior to fulfill their need for excitement. this is consistent with fulford et al. (2009) who also found that hps scores were related to a modified ‘pleasure/excitement’ score of the ccl-m-r in a college student sample. the ccl-m-r assesses mania-specific beliefs and although it explicitly asks to focus on the last days, it might capture more long-standing beliefs and attitudes about the self, the interaction with others, the engagement of high risk behavior to feel excitement, and the attainment of high goals. this would explain why an indicator of vulnerability for bd would be related to these beliefs, even after accounting for current symptoms. in contrast, ruggero et al. (2015) found no difference in ccl-m-r scores between indi­ viduals at-risk for mania and those with no elevated risk. there are several differences between the studies. we used continuous scaling, whereas ruggero et al. (2015) used be­ tween group differences, i.e. high-risk group vs. low risk group, which could reduce the variance in the predictor group. in addition, their sample was much smaller and might have lower power.1 finally, contrary to ruggero et al. (2015), we assessed current mood symptoms and found associations to the ccl-m-r, therefore, not differentiating between current symptoms and vulnerability could also affect the results. finally, it might be that the ccl-m-r and the hps show some construct overlap. although designed to tap into emotion, behavior, and energy levels, some items of the hps might also assess cognition, e.g. “i expect that someday i will succeed in several different professions”.2 1) we thank an anonymous reviewer for these comments. 2) see footnote 1. cognition and risk for mania 10 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ the same study found that the hypomanic attitudes and positive prediction invento­ ry (happi; mansell, 2006) differentiated between individuals at-risk and those with no elevated risk. the happi assesses hypomania-specific positive and negative appraisals relating to high and low activation internal states, e.g., an emotion one feels in a specific situation (e.g., kelly et al., 2017). given the few studies, it remains unclear whether cognition relating to internal states as measured by the happi or cognition potentially relating to more long-standing cognitive factors as measured by the ccl-m-r is more relevant for at-risk stages in bd. furthermore, the way risk for bd is defined might be essential, as well. in the present study, we focused specifically on risk for mania by assessing temperamental traits (e.g., blechert & meyer, 2005; kwapil et al., 2000), whereas ruggero et al. (2015) defined the risk for bd genetically (offspring of parents diagnosed with bd). speculatively, individuals scoring high on the hps who might never have been exposed to actual bd might be less familiar with its presentation and more likely to endorse items on the ccl-m-r than individuals whose parents have expressed such mania-related attitudes and beliefs while being (hypo)manic. internal processes, such as appraisals might be less shared with others even if they influence actual behaviors. or perhaps, offspring of parents with bd might have been exposed to challenging situations due to their parent’s disorder during their childhood and therefore be more cautious to endorse, for example, grandiose statements or behaviors that are considered risky as asked in the ccl-m-r. in the present study, risk for mania did not predict cognitions related to goal attain­ ment as measured with the das. although lam et al. (2004) found that the ‘goal attainment’ subscale of the das differentiated between patients with remitted bd and patients with remitted unipolar depression, most previous studies found little evidence for increased scores on the ‘goal attainment’ subscale of the das in remitted bd (e.g., alatiq et al., 2010; lex et al., 2008). this is interesting because there is evidence that a dysregulation of goal-directed behavior and goal striving is an important aspect in bd (alloy et al., 2012; urošević et al., 2008) and life events relating to goal attainment caused increases in manic symptoms (johnson et al., 2000, 2008; tharp et al., 2016). subsequent­ ly, it would make sense that individuals at-risk for mania endorse exaggerated believes about goal attainment. in the present study risk for mania predicted elevated scores on the ‘activity’ subscale of the ccl-m-r but not on the ‘goal attainment’ subscale of the das. one possible reason for this could be that the items of the das ‘goal attainment’ subscale are worded more generally, e.g. “i should be happy all the time”, while the items on the ccl-m-r ‘activity’ scale are targeted at more specific events, e.g., “i have new goals”. additionally, there is evidence that dysfunctional attitudes might be latent outside of acute mood episodes and must be activated before individuals endorse them (babakhani & startup, 2012) or are state-dependent (alloy et al., 1999; hollon et al., 1986; lex et al., 2008, 2011; reilly-harrington et al., 1999; scott et al., 2000). we actually found an association between current manic symptoms and the das subscale ‘goal at­ ulrich, meyer, andreas, & lex 11 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ tainment’. although one has to keep in mind that the reliability for the ‘goal attainment’ subscale was low, this result suggests that manic mood, rather than risk for mania, might be more closely related to dysfunctional attitudes related to goal attainment. we also found that current subthreshold manic symptoms predicted the mania-rela­ ted cognition, even though to a lesser degree than the risk for mania. this is consistent with previous studies (fulford et al., 2009). however, our data also revealed an unexpec­ ted association between current depressed mood and the ccl-m-r subscale ‘relation­ ship’. this is in conflict to previous evidence and to the theoretical background (beck et al., 2006; fulford et al., 2009). it might be that some of the items of the ‘relationship’ scale might relate to depressed mood, e.g., “people treat me like i am sick” and “they do not understand me”. however, even if only those two items of the ‘relationship’ scale were extracted, that focus on interpersonal behavior most relevant in bd, namely being thwarted by others in the attainment of goals (fulford et al., 2009), we still found that the level of depression was a significant predictor. the present study focused on risk and cognitions associated with mania. however, in most cases bd also includes depressive mood episodes. based on our results we cannot explain how depressive symptoms might arise, which could be a limitation of the present study. in terms of methodical limitations, first, our data was collected online. this approach bears some disadvantages, e.g., limited control regarding the test setting (wright, 2005). however, there is evidence that paper-and-pencil and internet data col­ lection methods are equivalent (weigold et al., 2013). second, our participants were not asked if they had been diagnosed with an affective or any other psychiatric illness before or if they were experiencing an acute illness episode at the time of their participation. however, in order to control for psychological problems we asked them if they had ever been in psychological therapy and found no relation to mania-specific cognition. third, we had a mainly female non-clinical sample that might not be representative of people developing bd. however, several reviews emphasize the relevance of analogous samples to understanding clinical phenomena (abramowitz et al., 2014; ehring et al., 2011). at last, we used a hierarchical regression design in a cross-sectional approach because we aimed at examining a directional association. it might be that this approach missed longitudinal developments and changes of our target variables. despite these limitations, the present study showed that risk for mania was associ­ ated with mania-specific dysfunctional cognition. this finding points toward the impor­ tance to identify mania-specific cognitions in early or at-risk states of bd in order to help individuals to question and modify these cognitions to potentially prevent more severe symptoms. future studies should assess mania-specific beliefs in different phases of bd in order to examine the relation between mania-specific cognitions and current mood, perhaps even looking at specific symptoms, such as elated versus irritable mania. also, longitudinal studies are highly awaited in order to test if dysfunctional cognitions cognition and risk for mania 12 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://www.psychopen.eu/ increase the risk of acute bipolar episodes or if they interact with life events or other factors (e.g., lex et al., 2017). funding: the authors have no funding to report. competing interests: the authors have declared that no competing interests exist. acknowledgments: we would like to thank markus emperger for technical support and nikki la rosa for proofreading the final version of the manuscript. ethics approval: all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. informed consent: informed consent was obtained from all individual participants included in the studies. animal rights: this article does not contain any studies with animals performed by any of the authors. r e f e r e n c e s abramowitz, j. s., fabricant, l. e., taylor, s., deacon, b. j., mckay, d., & storch, e. a. 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(2005). researching internet-based populations: advantages and disadvantages of online survey research, online questionnaire authoring software packages, and web survey services. journal of computer-mediated communication, 10(3), article jcmc1034. https://doi.org/10.1111/j.1083-6101.2005.tb00259.x clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. cognition and risk for mania 18 clinical psychology in europe 2021, vol.3(1), article e3733 https://doi.org/10.32872/cpe.3733 https://doi.org/10.1111/j.1083-6101.2005.tb00259.x https://www.psychopen.eu/ cognition and risk for mania (introduction) method participants and procedure measurements results discussion (additional information) funding competing interests acknowledgments ethics approval informed consent animal rights references further specifying the cognitive model of depression: situational expectations and global cognitions as predictors of depressive symptoms research article further specifying the cognitive model of depression: situational expectations and global cognitions as predictors of depressive symptoms tobias kube ab, philipp herzog a, charlotte m. michalak a, julia a. glombiewski ab, bettina k. doering ac, winfried rief a [a] department of clinical psychology and psychotherapy, philipps-university of marburg, marburg, germany. [b] department of clinical psychology and psychotherapy, university of koblenz-landau, landau, germany. [c] department of psychology, catholic university eichstätt-ingolstadt, ingolstadt, germany. clinical psychology in europe, 2019, vol. 1(4), article e33548, https://doi.org/10.32872/cpe.v1i4.33548 received: 2019-01-31 • accepted: 2019-04-16 • published (vor): 2019-12-17 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: tobias kube, department of clinical psychology and psychotherapy, philipps-university of marburg, gutenbergstraße 18, d-35032 marburg, germany. e-mail: tobias.kube@uni-marburg.de abstract objectives: the cognitive model of depression assumes that depressive symptoms are influenced by dysfunctional cognitions. to further specify this model, the present study aimed to examine the influence of different types of cognitions on depressive symptoms, i.e., situational expectations and global cognitions. it was hypothesized that situational expectations predict depressive symptoms beyond global cognitions. design: the present study examined a clinical (n = 91) and a healthy sample (n = 80) using longitudinal data with a baseline assessment and a follow-up five months later. although the study was not designed as an interventional trial, participants from the clinical study received nonmanualized cognitive-behavioral treatment after the baseline assessment. methods: we examined situational expectations, intermediate beliefs, dispositional optimism, and generalized expectancies for negative mood regulation as predictors of depressive symptoms. hypotheses were tested using multiple hierarchical linear regression analyses. results: results indicate that, although there were significant correlations between the cognitive factors and depressive symptoms, in both samples neither global cognitions, nor situational expectations significantly predicted depressive symptoms at the five-month follow-up. conclusions: the present study could, contrary to the hypotheses, not provide evidence for a significant impact of cognitive vulnerabilities on depressive symptoms, presumably due to high drop-out rates at follow-up. limitations of the study and directions for future research are critically discussed. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.v1i4.33548&domain=pdf&date_stamp=2019-12-17 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords expectation, expectancy, depression, cognitive model, behavioral experiment highlights • situational and global cognitions were examined as predictors of depressive symptoms. • in a healthy and a clinical sample, cognitive factors were correlated with depressive symptoms. • however, in both samples depressive symptoms at follow-up were not predicted by cognitive factors. since beck’s early studies from the 1960s (beck, 1963, 1964), numerous studies have pro‐ vided evidence for cognitive vulnerabilities among people suffering from major depres‐ sive disorder (mdd) (mathews & macleod, 2005; scher, ingram, & segal, 2005; wenze, gunthert, & forand, 2010). in particular, it has been assumed that people suffering from mdd have dysfunctional cognitions such as negative automatic thoughts, intermediate beliefs and dysfunctional core beliefs. these cognitions are supposed to influence the de‐ velopment and maintenance of depressive symptoms (beck, rush, shaw, & emery, 1979). this cognitive model of depression has significantly influenced research on depression for decades and has promoted the development of cognitive-behavioral treatment. re‐ cently, however, it has been argued that the concept of “cognition” in the traditional cog‐ nitive model might be too broad and could benefit from further specification (rief & joormann, 2019). in fact, the precise influence of different types of cognitions on depres‐ sive symptoms has rarely been studied directly up to now. therefore, the present study aimed to examine the influence of different types of cognitions that differ in their gener‐ alizability vs. specificity and the extent to which they relate to future events or experien‐ ces. on a temporal level, cognitions can be related either to the past, the present or the future. the subgroup of cognitions that relates to future events or experiences is referred to as expectations (kirsch, 1985; olson, roese, & zanna, 1996). more specifically, expecta‐ tions may relate both to the probability of occurrence of a particular event or experience and to the consequences thereof; this can be conscious or unconscious (laferton, kube, salzmann, auer, & shedden mora, 2017). while human beings are quite trained in coping with momentary unpleasant feelings, such as pain or sadness, this dramatically changes if people expect these unpleasant conditions to last forever, or to be repeated frequently in the future (rief & joormann, 2019). therefore, rief and joormann have argued that ex‐ pectations regarding the stability of future experiences may have considerable impact on human well-being. in line with this notion, several studies have shown that negative fu‐ ture expectations influence the development of depressive symptoms (horwitz, berona, expectations as predictors of depressive symptoms 2 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ czyz, yeguez, & king, 2017; strunk, lopez, & derubeis, 2006; vilhauer et al., 2012). this is consistent with beck’s ‘cognitive triad’ (beck et al., 1979). the impact of negative ex‐ pectations on future well-being is also supported by research on ‘affective forecasting’ (wilson & gilbert, 2003). according to this literature, dysphoric people tend to be biased in predicting future emotional states towards the overestimation of negative emotional reactions to future events (hoerger, quirk, chapman, & duberstein, 2012; marroquín & nolen-hoeksema, 2015). according to laferton et al. (2017), expectations can vary in their degree of specificity vs. generalizability. situation-specific expectations (also referred to as ‘situational expect‐ ations’) such as, “when i ask someone for help, i will be rejected”, represent predictions of specific events or experiences in a particular situation. in contrast, generalized or glob‐ al expectations can apply to various areas of life (e.g., “i hardly ever expect things to go my way”). relatedly, due to their “if-then” structure, situational expectations might be more easily amenable to an empirical test of their validity compared to global expecta‐ tions, e.g., through behavioral experiments. with reference to the cognitive model of de‐ pression (beck et al., 1979), it has been hypothesized that situational expectations may constitute an important link between global beliefs, such as intermediate beliefs and dis‐ positional optimism, and depressive symptoms. this hypothesis could recently be con‐ firmed: the effects of both intermediate beliefs and dispositional optimism on depressive symptoms were mediated via situational expectations (kube et al., 2018a, 2018b). to add to this line of research, the present study used longitudinal data of both healthy and de‐ pressed people to compare the predictive values of situational vs. more global cognitions in the context of depressive symptoms. in the current work, three constructs were used as indicators for generalized cogni‐ tions. these three constructs were chosen because they have often been studied in de‐ pression research, and because there are well validated measurement tools to assess them. first, we considered dispositional optimism, arguably the most prominent concept of generalized expectations (laferton et al., 2017). dispositional optimism has been de‐ fined as ‘the tendency to believe that one will generally experience good vs. bad out‐ comes in life’ (scheier & carver, 1985). previous research has consistently linked opti‐ mism to depression (korn, sharot, walter, heekeren, & dolan, 2014; strunk et al., 2006; thimm, holte, brennen, & wang, 2013). dispositional optimism can be assessed with the life orientation test, the most recent form of which was presented by scheier, carver, and bridges (1994). second, another construct reflecting rather generalized expectations has been introduced by catanzaro and mearns (1990): they focused on generalized ex‐ pectancies for negative mood regulation, and defined this construct as ‘the generalized expectancy that some behavior or cognition will alleviate a negative mood state’. similar to dispositional optimism, these expectancies, assessed with the generalized expectan‐ cies for negative mood regulation scale (catanzaro & mearns, 1990), have been found to be associated with depressive symptoms (backenstrass et al., 2006). third, we considered kube, herzog, michalak et al. 3 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ intermediate beliefs, a central construct of the traditional cognitive model reflecting global attitudes and assumptions regarding oneself and life in general. intermediate be‐ liefs can be measured using the dysfunctional attitudes scale (oliver & baumgart, 1985). it has been shown that intermediate beliefs predict the development of depressive symp‐ toms (alloy, abramson, whitehouse, & hogan, 2006; jarrett et al., 2012), and are associ‐ ated with the severity of depressive symptoms in both healthy and clinical samples (burns & spangler, 2001). importantly, although the dysfunctional attitudes scale in‐ cludes items that do partly measure expectations of future events or experiences, it also comprises a considerable amount of items assessing more general attitudes without a clear focus on the future. therefore, it cannot completely be regarded as a measure of expectations. besides these generalized cognitions, the current study focused on situation-specific dysfunctional expectations in depression. to assess this relatively new construct, the de‐ pressive expectations scale has been developed (kube, d'astolfo, glombiewski, doering, & rief, 2017). using a consequent “if-then” structure, this scale assesses situational ex‐ pectations for different areas of personal and interpersonal life, such as expectations con‐ cerning social rejection, social support, mood regulation, and personal performance (see appendix 1 for some sample items). the scale has been developed from a clinical point of view, with the aim of developing a tool that could be helpful in planning psychothera‐ peutic interventions to evaluate the validity of patients' expectations through behavioral experiments. aims and hypotheses the primary aim of the study was to examine situational expectations and more global cognitions as predictors of depressive symptoms. dispositional optimism, generalized ex‐ pectancies for negative mood regulation, and intermediate beliefs represent dysfunction‐ al cognitions and have therefore conceptual similarities with situational expectations. further, since all of these constructs reflect a negative view of an individual on different areas of personal and interpersonal life, they may only slightly differ with regards to their contents. they do differ, however, in terms of their situational specificity vs. gener‐ alizability: dispositional optimism, generalized expectancies for negative mood regula‐ tion, and intermediate beliefs represent more global cognitions while situational expecta‐ tions are characterized by a higher level of situational specificity. we argue that due to this clear situational focus, situational expectations may predict depressive symptoms be‐ yond global cognitions; situational expectations reflect specific predictions of everyday events, and therefore the actual occurrence of anticipated negative events (or the nonoccurrence of anticipated positive events) may result in negative emotions such as disap‐ pointment or frustration, thus providing the breeding ground for symptoms of depres‐ sion. global cognitions, however, are often more abstract and less closely linked to every‐ day experiences, so that they are less often perceived as confirmed or disconfirmed and expectations as predictors of depressive symptoms 4 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ thus less obviously related to depression. in particular, it was hypothesized that situa‐ tional expectations at baseline predict the later severity of depressive symptoms at fol‐ low-up independently from the aforementioned more global cognitions in both a healthy and a clinical sample. m e t h o d this study was part of a larger research project. recently, first data from this project us‐ ing a clinical sample have recently been published (kube et al., 2018b). the present study used the same clinical sample as the previous article. while the previous article analyzed only cross-sectional data, the present study reports the longitudinal data. additionally, the present study reports data from a healthy sample, which have not previously been published. participants and procedure healthy sample healthy individuals were recruited via mailing lists and postings at public spaces. inclu‐ sion criteria for the healthy sample were: absence of a currently diagnosed mental disor‐ der (self-report), age of at least 18 years, and sufficient knowledge of the german lan‐ guage (self-evaluation of the participants). at baseline, 80 healthy people participated in the study and completed the questionnaires online via the commercial survey platform unipark®. five months after the first measurement, participants were contacted by the study coordinator via email, and they were asked to complete the questionnaires from the follow-up measure. the follow-up questionnaires were completed by 47 participants (completion rate: 58.8%). the main reason for not completing the follow-up in the healthy sample was that participants could not be contacted again due to changes in their email address (the healthy sample consisted mainly of students, and most participants used their university e-mail address, which were no longer available if they had left the university in the meantime). participants who completed the entire study did not signifi‐ cantly differ from those who completed only the baseline assessment (all p values > .05; detailed statistical data can be found in the appendix 2). clinical sample participants were recruited at two inpatient hospitals (n = 53 and n = 18) and one outpa‐ tient clinic (n = 24) in germany. the following inclusion criteria were used: current diag‐ nosis of mdd according to icd-10, age of at least 18 years, sufficient knowledge of the german language (self-evaluation of the participants). in the outpatient clinic, partici‐ pants were diagnosed using the scid interview by clinical psychologists who were ap‐ propriately trained in this interview (wittchen, zaudig, & fydrich, 1997). in the inpatient kube, herzog, michalak et al. 5 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ hospitals, participants were also diagnosed by trained clinical psychologists using semistructured interviews based on scid; these semi-structured interviews were, however, short-forms of the scid and not validated in previous studies. if patients were interested in participating in the study, they received detailed study information and gave written informed consent. next, participants could complete the paper-pencil questionnaires on their own. of note, in order to control for effects of later treatment (e.g. psychotherapy), participants could only participate in the study during the first two weeks after their in‐ take at the hospital or in diagnostic phase before the beginning of the outpatient therapy, respectively. though the study was not an interventional trial, all participants from the clinical sample received non-manualized individual cognitive-behavioral treatment after the baseline assessment. five months after completing the first questionnaire, patients from the inpatient clin‐ ics were sent the second questionnaire via postal service and completed it at home. par‐ ticipants from the outpatient clinic received the questionnaires by their therapists or the study coordinator. completed follow-up questionnaires were sent back to the study coor‐ dinator, which was done by 52 persons (completion rate: 54.7%). the reasons for not com‐ pleting the follow-up assessment in the clinical sample included: participants could not be contacted again; participants were not willing to complete questionnaires again; al‐ though the participants initially agreed to complete the follow-up questionnaires, they did not return the questionnaires in the end. completers did not significantly differ from non-completers (all p values > .05; detailed statistical data can be found in the appendix 2). data collection lasted from may 2016 to november 2017. for 14 participants, there were difficulties in contacting them since their contact data had changed or were incor‐ rect. therefore, the period of five months for the follow-up measure could not be ensured for these participants, resulting in a follow-up measure six to fourteen months after the first measurement. for both samples, the questionnaire used at the follow-up was shorter than the one used at the first measurement, and included only the measure of situational expectations and depressive symptoms in order to decrease the anticipated drop-out rate due to addi‐ tional strains. to give an incentive for participation, participants had the chance to win gift vouchers for a popular bookshop. the study was approved by local ethics committee (reference number 2016-04k) and has been conducted in accordance with ethical stand‐ ards as laid down in the 1964 declaration of helsinki and its later amendments. all par‐ ticipants gave written informed consent and all procedures were in accordance with the ethical guidelines of the german psychological society. expectations as predictors of depressive symptoms 6 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ measures situation-specific dysfunctional expectations (sdes) we used the depressive expectations scale (des) to assess situation-specific dysfunc‐ tional expectations. the des is a 25-item scale that was developed by kube et al. (2017) to measure mdd-specific expectations. the construction principle was, according to the method of domain sampling (nunnally, 1978), to use common dysfunctional core beliefs (e.g., “i am not likable”) to deduce situation-specific predictions thereof (e.g., “when i try to make new acquaintances, i will get to know kind people” (inverted)). the majority of the items are formulated in such a way that at the beginning of each sentence a certain everyday situation is presented, and the participants’ task is to indicate what behavioral, emotional, or cognitive consequences they expect to occur in this situation (see some ex‐ amples in appendix 1). specifically, participants are asked to assess on a five-point likert scale to what extent each of the possible completions would apply to them personally. importantly, the completions can refer to both the likelihood of occurrence of a particular event or its emotional consequences; the main purpose of item development was simply to formulate a specific prediction that could be tested in a behavioral experiment. since depression has been linked to both lack of positive expectations (horwitz et al., 2017) and overly negative expectations (strunk et al., 2006), it was important for us to balance posi‐ tively and negatively worded items. originally, 75 items had been developed, and item reduction was performed in an on‐ line survey (n = 175), as described in detail in kube et al. (2017). it resulted in a 25-item version of the des, and a factor analysis revealed four factors: expectations of social re‐ jection, social support, personal performance, and negative mood regulation. high sum scores of the des reflect a greater endorsement of dysfunctional expectations. in three previous studies, the des has shown good psychometric properties (kube et al., 2017, 2018a, 2018b). specifically, internal consistency ranged in previous studies between α = .87 and α = .93; one-year retest reliability was r = 0.430; correlations with measures of depressive symptoms were high (correlation with the phq 9: r = .754, correlation with the bdi-ii: r = .572 and r = .527, respectively). in the current study, internal consistency for the clinical sample was α = .89 at the first measurement (for the healthy sample: α = .89) and α = .92 at follow-up (for the healthy sample: α = .94). five-months retest reli‐ ability was r = .509 for the clinical sample, and for the healthy sample r = .693. after a previous study examined the factorial structure of the des using a convenience sample (kube et al., 2017), we performed an exploratory factor analysis to analyze the factor structure using the clinical sample from the present study. the results of this factor anal‐ ysis revealed in general a similar factor structure as in the previous study, with the ex‐ ception that an additional fifth factor was found, labelled ‘approval by others’. the meth‐ ods, results, and discussion of this factor analysis can be found in the supplementary ma‐ terials. kube, herzog, michalak et al. 7 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ dispositional optimism we assessed dispositional optimism with the german version of the life orientation test revised (lot-r), originally developed by (scheier et al., 1994) and translated into ger‐ man by glaesmer et al. (2012). the lot-r is a 10-item self-report scale, of which four items are distractor items and excluded when computing the sum scores. the items are rated on a five-point likert scale. high values indicate positive outcome expectations. the lot-r has been shown to have good reliability and validity (glaesmer et al., 2012; reilley, geers, lindsay, deronde, & dember, 2005; scheier et al., 1994). for the clinical sample from the present study, internal consistency of the lot-r was α = .80, and for the healthy sample it was α = .73. generalized expectancies for negative mood regulation we used the generalized expectancies for negative mood regulation (nmr) scale (backenstrass et al., 2006; catanzaro & mearns, 1990) to examine incremental validity of the des over this existing measure, since the nmr scale also assesses one specific aspect of mdd-specific expectations (i.e. generalized expectancies for negative mood regula‐ tion). the nmr scale includes 30 items, and is rated using a five-point likert scale. high values reflect positive expectations. the nmr scale has been shown to be associated with depressive symptoms, and there is evidence for good reliability of this scale (backenstrass et al., 2006). in the current study, internal consistency for the clinical sample was α = .90 (for the healthy sample: α = .89). intermediate beliefs intermediate beliefs were assessed using a shortened version of the dysfunctional atti‐ tudes scale (das), originally developed by weissman and beck (1978) and translated into german by hautzinger, joormann, and keller (2005). the 26-item version of this scale is based on those items which have consistently been shown to belong to the dimensions “performance evaluation” and “approval by others” (cane, olinger, gotlib, & kuiper, 1986; joormann, 2004; prenoveau et al., 2009). previous studies have revealed good relia‐ bility and validity of the das (joormann, 2004; nelson, stern, & cicchetti, 1992). internal consistency for the clinical sample was α = .92 (for the healthy sample: α = .88). depressive symptoms we assessed depressive symptoms with the beck depression inventory-ii (beck, steer, ball, & ranieri, 1996). this well-established 21-item scale assesses somatic, cognitive and affective symptoms of depression (ranging from 0 to 63) with higher scores reflecting more severe symptoms of depression. the bdi-ii has shown good psychometric proper‐ ties (beck et al., 1996). expectations as predictors of depressive symptoms 8 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ sociodemographic variables socio-demographic variables were assessed in a self-report questionnaire including age, sex, education, and employment status. statistical analyses data screening was conducted according to the recommendations by tabachnick and fidell (2014). for four participants from the clinical sample, more than 40% of all data were missing. according to tabachnick and fidell (2014), these participants were exclu‐ ded. univariate outliers were inspected via standardized values of measured variables and their histograms (kline, 2005). according to cohen, cohen, west, and aiken (2003) and stevens (2002), multivariate outliers were examined via mahalanobis distance and cook’s distance. data from the participants who completed the follow-up questionnaire (52 participants from the clinical sample and 47 participants from the healthy sample) were used to perform a multiple linear hierarchical regression for the two samples, sepa‐ rately, according to the suggestions made by tabachnick and fidell (2014). the mcar test (little, 1988) yielded non-significant results in the respective samples, indicating that the values were missing completely at random. missing values were estimated using the expectation maximization procedure according to tabachnick and fidell (2014). a multi‐ variate analysis of variance (manova) examined differences between the healthy and the clinical sample. assumptions of multiple hierarchical linear regression analysis were carefully exam‐ ined. regression analysis was performed with the bdi-ii sum scores at follow-up as de‐ pendent variables. baseline bdi-ii sum scores were included as predictors in the first block. lot-r sum scores, nmr sum scores, and das sum scores from the first measure‐ ment were entered as predictors in the second block. baseline des sum scores were en‐ tered in the third block. importantly, although the aforementioned constructs des, lot-r, nmr expectancies and das represent dysfunctional cognitions, there was no multi-collinearity between the predictors, indicated by the variance inflation factor (all values < 10). in the results of the regression analyses, the standardized beta coefficients (β) are reported. type-1 error levels were set at 5%. all analyses were conducted with ibm spss statistics version 25. r e s u l t s sample characteristics healthy sample the mean participant sum score in the bdi-ii at baseline was 10.10 (sd = 9.07) indicating minimum levels of depression (beck et al., 1996). at follow-up, mean sum score in the bdi-ii was 8.57 (sd = 10.24), indicating the absence of clinically relevant symptoms of kube, herzog, michalak et al. 9 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ depression. bdi-ii sum scores at baseline ranged from 0 to 50, and eleven participants re‐ ported at least moderate levels of depression (bdi-ii ≥ 20), of which five participants completed the follow-up questionnaire. at follow-up, bdi sum scores ranged from 0 to 46, and four participants reported a sum score ≥ 20. as will be shown below, the results of the main analysis are strongly influenced by whether or not the five participants who reported elevated levels of depression at baseline and completed the follow-up are inclu‐ ded in the analysis. a paired samples t-test indicated that depressive symptoms in the healthy sample did not significantly change from baseline to follow-up, t(46) = 1.054, p = .297, d = 0.188. sim‐ ilarly, des sum scores did not change from baseline (m = 49.45; sd = 12.21) to follow-up (m = 49.06; sd = 15.96), t(46) = 0.227, p = .821, d = 0.032. sample characteristics regarding socio-demographic variables are presented in table 1. table 1 sociodemographic sample characteristics variable clinical sample (n = 91) healthy sample (n = 80) age in years, m (sd) 40.8 (13.2) 23.05 (5.32) sex, n (%)a male 28 (31.5) 20 (25.0) female 61 (68.5) 60 (75.0) educational level, n (%)b no educational degree 1 (1.2) 0 primary education 41 (47.7) 3 (3.8) secondary education 16 (18.6) 57 (71.3) higher education 28 (32.6) 20 (25.0) employment status, n (%)c full-time working 15 (17.2) 16 (20.0) part-time working 6 (6.9) 10 (12.5) in training 12 (13.8) 49 (61.3) unemployed 9 (10.3) 5 (6.3) disabled 14 (16.1) 0 be off sick 24 (27.6) 0 pensioners 5 (5.7) 0 homemaker 2 (2.3) 0 a2 missing values in the clinical sample; b5 missing values in the clinical sample; c4 missing values in the clinical sample. clinical sample in our sample, 36.7% of the participants were diagnosed with a major depressive episode, 55.7% with a recurrent depressive disorder, 3.8% with a bipolar disorder, and 3.8% with a expectations as predictors of depressive symptoms 10 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ “double depression” (dysthymia plus current depressive episode). about a quarter of all participants (24.7%) had at least one comorbid mental disorder with anxiety disorders be‐ ing most frequent (13.5%). the mean bdi-ii sum score at baseline was 28.7 (sd = 9.18) indicating severe levels of depression (beck et al., 1996). at the follow-up, the mean bdiii score was 19.25 (sd = 11.02) indicating moderate levels of depression. a paired samples t-test indicated that depressive symptoms significantly decreased from baseline to followup, t(50) = 5.205, p < .001, d = 0.922, reflecting a large effect according to cohen (1988). sdes also significantly changed from baseline (m = 68.71; sd = 13.25) to follow-up (m = 61.40; sd = 15.42), t(50) = 3.583, p = .001, d = 0.551, reflecting a medium effect according to cohen (1988). all sample characteristics regarding sociodemographic variables can be found in table 1. differences between samples a manova indicated significant differences between the two samples (clinical vs. healthy) at baseline, f(5, 165) = 73.315, p < .001, ηp2 = .690. participants from the healthy sample had significantly fewer depressive symptoms, f(1, 169) = 175.818, p < .001, ηp2 = .510, less pronounced situation-specific dysfunctional expectations, f(1, 169) = 68.775, p < .001, ηp2 = .289, and less pronounced generalized expectancies for negative mood regulation, f(1, 169) = 51.518, p < .001, ηp2 = .234. they were also more optimistic, f(1, 169) = 93.246, p < .001, ηp2 = .356, and significantly younger than those from the clini‐ cal sample, f(1, 113) = 124.846, p < .001; ηp2 = .425. frequency analyses revealed that par‐ ticipants from the two samples did not differ on sex distribution, χ2 = .865, p = .352. how‐ ever, healthy participants had significantly higher educational degrees, χ2 = 59.371, p < .001, and had, unlike the clinical sample, predominantly a student status, χ2 = 69.446, p < .001. main analysis: prediction of depressive symptoms using data from both samples, correlational analyses revealed significant inter-correla‐ tions of the scales used in this study, which can be found in table 2. table 2 correlational analyses from the healthy and clinical sample at baseline sample / variable bdi des nmr lot-r das healthy sample bdi .608** -.550** -.486** .289* des -.745** -.690** .512** nmr .685** -.490** lot-r -.371* das kube, herzog, michalak et al. 11 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ sample / variable bdi des nmr lot-r das clinical sample bdi .641** -.520** -.522** .534** des -.672** -.561** .634** nmr .497** -.468** lot-r -.535** das note. bdi = beck’s depression inventory ii; des = depressive expectations scale; nmr = generalized expect‐ ancies for negative mood regulation scale; lot-r = life orientation test revised; das = dysfunctional atti‐ tudes scale. *p < .05. **p < .001. healthy sample for the bdi-ii sum scores from the follow-up as dependent variable, the baseline levels of depression explained 10.9% of the variance, and had significant effects (β = .331; p = .023). the second set of predictors added another 14.7% of the explained variance which did not reach significance (p = .054); none of the predictors had significant effects. including the des sum scores as predictors in the third block added another 5.6% of the variance, which was not significant either (p = .074). the results of the regression analysis for the healthy sample can be found in table 3. when excluding the aforementioned five participants with elevated levels of depression, the pattern of results changed considerably. neither bdi sum scores at baseline (∆r 2 = .057; p = .127), nor the sum scores of the lot-r, das, nmr (∆r 2 = .011; p = .934), nor the sum scores of the des at baseline (∆r 2 = .001; p = .874) predicted depressive symptoms five months later. the overall explained variance was only 6.9%. clinical sample using the bdi-ii sum scores from the follow-up as dependent variables, the baseline bdiii sum scores explained 14.9% of the variance, p = .005; β = .387. the second set of predic‐ tors added another 7.2% of the variance (p = .240). in this step, none of the predictors had significant effects. when including the des sum scores in the third block, another 6.0% of the variance could be explained (p = .057). though there was a trend indicating the im‐ portance of des sum scores (β = .420; p = .057), none of the predictors in this step had significant effects. results of the multiple hierarchical linear regression analysis are pre‐ sented in table 3. expectations as predictors of depressive symptoms 12 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ table 3 prediction of depressive symptoms in the healthy sample (n = 47) and the clinical sample (n = 52) samples / predictors criterion: bdi-ii t2 β r 2 r 2 adj. ∆r 2 ∆f model healthy sample block 1 .109 .090 .109* 5.523* bdi-ii t1 .331* block 2 .256 .185 .147 2.766 bdi-ii t1 .103 das t1 .051 nmr t1 -.172 lot-r t1 -.281 block 3 .313 .229 .056 3.366 bdi-ii t1 .031 das t1 .026 nmr t1 -.003 lot-r t1 -.089 des t1 .455 clinical sample block 1 .149 .132 .145* 8.784* bdi-ii t1 .387* block 2 .221 .155 .072 1.450 bdi-ii t1 .256 das t1 .182 nmr t1 .162 lot-r t1 -.217 block 3 .281 .203 .060 3.804 bdi-ii t1 .173 das t1 .019 nmr t1 .332 lot-r t1 -.232 des t1 .420 note. t1 = baseline assessment; t2 = follow-up assessment; bdi-ii = beck depression inventory ii; des = de‐ pressive expectations scale; das = dysfunctional attitudes scale; nmr = generalized expectancies for nega‐ tive mood regulation scale; lot-r = life orientation test revised. *p < .05. kube, herzog, michalak et al. 13 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ d i s c u s s i o n the aim of the present study was to examine situational expectations and more global cognitive vulnerabilities (i.e., dispositional optimism, generalized expectancies for nega‐ tive mood regulation and intermediate beliefs) as predictors of depressive symptoms in a longitudinal design. in doing so, we aimed to provide a contribution to a further specifi‐ cation of the cognitive model of depression (beck et al., 1979) by directly comparing the predictive values of negative global cognitions, which have been well studied in depres‐ sion (horwitz et al., 2017; strunk et al., 2006), and situational expectations, which have recently received increasing attention (rief et al., 2015). the results of the regression analyses indicate that for the healthy sample, none of the cognitive variables, whether global or situational, had significant effects on depressive symptoms five months later. there were only non-significant trends regarding the additionally explained variance when entering global cognitions (p = .054) and situational expectations (p = .074) as pre‐ dictors. these trends, however, completely disappeared when excluding five participants who reported elevated levels of depression at baseline, presumably due to the thus re‐ duced variance. in the clinical sample the effects of all cognitive variables on depressive symptoms did not reach significance either. there was merely a trend indicating the pre‐ dictive value of situational expectations above global cognitions (p = .054). thus, the present study failed to provide evidence for the significance of cognitive factors as pre‐ dictors of depressive symptoms. this is in contradiction with previous studies indicating the importance of both global (czyz, horwitz, & king, 2016; horwitz et al., 2017; strunk et al., 2006) and situational ex‐ pectations (kube et al., 2018b). further, it is inconsistent with findings from studies ex‐ amining cognitions other than expectations as predictors of depressive symptoms, such as dysfunctional attitudes (alloy et al., 2006; burns & spangler, 2001; jarrett et al., 2012). arguably, the absence of significant findings in the present study is, at least in the clini‐ cal sample, most likely due to the low attendance rate at follow-up. indeed, a post-hoc power analysis indicated that the power for, e.g., detecting an incrementally significant effect of situational expectations in the clinical sample was only 43%. in view of the ex‐ tremely low explained variance when considering the healthy sample without partici‐ pants with elevated depressive symptoms, the results of the healthy sample can best be interpreted in such a way that cognitive factors seem to have no influence whatsoever on depressive symptoms as long as there is low variability in depressive symptoms. the non-significant results of the current study could possibly be seen as an opportu‐ nity to shift the focus away from the effects of cognitions themselves on depressive symptoms to their change in the further investigation of the cognitive model of depres‐ sion. an excellent overview of directions for future research in this regard has been pro‐ posed by lorenzo-luaces, german, and derubeis (2015). in line with this notion, a series of recent studies has shown that depression is related to the absence of an optimistic bias in updating beliefs about the future (korn et al., 2014) and inflexibility in adjusting nega‐ expectations as predictors of depressive symptoms 14 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ tive interpretations after novel positive information (everaert, bronstein, cannon, & joormann, 2018). these findings are also in line with neurophysiological studies indicat‐ ing that depression is associated with difficulty in processing unexpected events (“predic‐ tion errors”) (garrett et al., 2014; gradin et al., 2011). limitations first and foremost, the results of the regression analyses have to be interpreted with cau‐ tion due to the small sample sizes at follow-up. given that the cognitive variables failed to reach significance in predicting depressive symptoms in the clinical sample, it is par‐ ticularly important to further explore the trend regarding the importance of situational expectations as a predictor in future studies. moreover, the small sample size at follow-up could account for the null findings regarding the influence of negative global cognitions on depressive symptoms. therefore, future studies should aim to examine the predictive values of these variables using larger samples, ideally also including more sophisticated diagnostic procedures incl. the determination of interrater-reliability. second, it has to be noted that the two samples considerably differed on sociodemographic variables. there‐ fore, it is difficult to draw inferences from the comparison of the samples. third, given the three different clinical subsamples, multilevel methods could be considered a more sophisticated approach of analysis. however, according to a simulation study on suffi‐ cient sample sizes for multilevel analyses (maas & hox, 2005), the sample size of the present study would have been at high risk of leading to biased estimates of the secondlevel standard errors, which is why we refrained from it. fourth, as the bdi-ii is a selfreport questionnaire for the measurement of depressive symptom severity, it might be useful in future studies to additionally use e.g. the hamilton depression rating scale (hamilton, 1960) as an observer-rated assessment. fifth, for some participants from the clinical sample, the follow-up interval was longer than five months, possibly resulting in additional variability among all participants regarding the prediction of depressive symp‐ toms. sixth, since all participants from the clinical sample received psychotherapeutic treatment between the two assessments, the prediction of depressive symptoms was pos‐ sibly influenced by the effects of later treatment. since the present study was not de‐ signed as an interventional study, it could not unravel specific mechanisms that may have impacted change in depressive symptoms. in sum, the current study aimed to further specify the cognitive model of depression by directly comparing the influence of global cognitions and situational expectations on depressive symptoms. in a healthy sample and a clinical sample, the present study found neither evidence of a significant influence of global cognitions nor of situational expecta‐ tions on depressive symptoms at follow-up. given the high drop-outs at follow-up, future studies should aim to investigate larger samples in order to examine the influence of dif‐ ferent cognitions on depressive symptoms. special attention might also be paid in future kube, herzog, michalak et al. 15 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ studies to changes in dysfunctional cognitions and their influence on symptoms, which could be analyzed using structural equation modeling. funding: the authors have no funding to report. competing interests: winfried rief is editor-in-chief of clinical psychology in europe but played no editorial role for this particular article. acknowledgments: the authors have no support to report. s u p p l e m e n t a r y m a t e r i a l s the methods, results, and discussion of the exploratory factor analysis for this study are provided in the supplementary materials (for access, see index of supplementary materials below). index of supplementary materials kube, t., herzog, p., michalak, c. m., glombiewski, j. a., doering, b. k., & rief, w. (2019). supplementary materials to "further specifying the cognitive model of depression: situational expectations and global cognitions as predictors of depressive symptoms". psychopen. https://doi.org/10.23668/psycharchives.2655 r e f e r e n c e s alloy, l. b., abramson, l. y., whitehouse, w. g., & hogan, m. e. (2006). prospective incidence of first onsets and recurrences of depression in individuals at high and low cognitive risk for depression. journal of abnormal psychology, 115(1), 145-156. https://doi.org/10.1037/0021-843x.115.1.145 backenstrass, m., schwarz, t., fiedler, p., joest, k., reck, c., mundt, c., & kronmueller, k. t. (2006). negative mood regulation expectancies, self-efficacy beliefs, and locus of control orientation: moderators or mediators of change in the treatment of depression? psychotherapy research, 16(2), 250-258. https://doi.org/10.1080/10503300500485474 beck, a. t. 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(1997). structured clinical interview for dsm-iv. göttingen, germany: hogrefe. a p p e n d i c e s appendix 1: sample items of the des • expectations regarding social rejection: e.g., “when i ask someone for help, i will be rejected” • expectations regarding social support: e.g., “when i talk to someone about my problems, i will feel better afterwards” (inverted) • expectations regarding mood regulation: e.g., “when i’m feeling guilty, i will feel better when i lie down in my bed” • expectations regarding personal performance: e.g., “when i have to get an important task done, i will fail at it” appendix 2: completer analyses participants from the healthy sample who completed the entire study did not significantly differ from those healthy people who completed only the baseline assessment in baseline depressive symptoms, f(1, 78) = 0.066, p = .798; ηp2 = .001; situational expectations, f(1, 78) = 2.811, p = .098; ηp2 = .035; dispositional optimism, f(1, 78) = 3.164, p = .079; ηp2 = .039; intermediate beliefs, f(1, 78) = 0.683, p = .411; ηp2 = .009; expectancies for negative mood regulation, f(1, 78) = 0.476, p = .492; expectations as predictors of depressive symptoms 20 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://doi.org/10.1016/j.brat.2005.07.001 https://doi.org/10.3389/fpsyg.2013.00470 https://doi.org/10.1111/j.1755-5949.2011.00235.x https://doi.org/10.1007/s10608-010-9299-x https://doi.org/10.1016/s0065-2601(03)01006-2 https://www.psychopen.eu/ ηp2 = .006; age, f(1, 78) = 0.105, p = .746; ηp2 = .001; sex, χ2(1) = 2.080, p = .149; education, χ2(2) = 0.560, p = .756; or employment status, χ2(3) = 2.674, p = .445. similarly, in the clinical sample completers did not significantly differ from non-completers in baseline depressive symptoms, f(1, 89) = 2.384, p = .126; ηp2 = .026; situational expectations, f(1, 89) = 0.126, p = .723; ηp2 = .001; dispositional optimism, f(1, 89) = 0.598, p = .442; ηp2 = .007; inter‐ mediate beliefs, f(1, 89) = 0.058, p = .810; ηp2 = .001; expectancies for negative mood regulation, f(1, 89) = 0.050, p = .823; ηp2 = .001; age, f(1, 89) = 3.702, p = .058; ηp2 = .040; primary diagnosis, χ2(3) = 4.095, p = .251; comorbid diagnosis, χ2(7) = 4.195, p = .757; sex, χ2(1) = 1.975, p = .160; education, χ2(5) = 6.715, p = .243; or employment status, χ2(7) = 3.738, p = .809. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology information (zpid), germany. kube, herzog, michalak et al. 21 clinical psychology in europe 2019, vol.1(4), article e33548 https://doi.org/10.32872/cpe.v1i4.33548 https://www.psychopen.eu/ expectations as predictors of depressive symptoms (introduction) aims and hypotheses method participants and procedure measures statistical analyses results sample characteristics main analysis: prediction of depressive symptoms discussion limitations (additional information) funding competing interests acknowledgments supplementary materials references appendices appendix 1: sample items of the des appendix 2: completer analyses lifetime trauma history and cognitive functioning in major depression and their role for cognitive-behavioral therapy outcome research articles lifetime trauma history and cognitive functioning in major depression and their role for cognitivebehavioral therapy outcome lena schindler 1 , tobias stalder 2 , clemens kirschbaum 1, franziska plessow 3 , sabine schönfeld 1,4, jürgen hoyer 5 , sebastian trautmann 5,6 , kerstin weidner 7, susann steudte-schmiedgen 1,7 [1] faculty of psychology, technische universität dresden, dresden, germany. [2] department erziehungswissenschaften und psychologie, universität siegen, siegen, germany. [3] neuroendocrine unit, department of medicine, massachusetts general hospital and harvard medical school, boston, ma, usa. [4] department of psychology, lund university, lund, sweden. [5] institute of clinical psychology and psychotherapy, technische universität dresden, dresden, germany. [6] department of psychology, medical school hamburg, hamburg, germany. [7] department of psychotherapy and psychosomatic medicine, medical faculty carl gustav carus, technische universität dresden, dresden, germany. clinical psychology in europe, 2021, vol. 3(3), article e4105, https://doi.org/10.32872/cpe.4105 received: 2020-07-27 • accepted: 2021-06-03 • published (vor): 2021-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: susann steudte-schmiedgen, department of psychotherapy and psychosomatic medicine, medical faculty carl gustav carus, technische universität dresden, fetscherstraße 74, 01307 dresden, germany. tel.: +49 351 458 3634. e-mail: susann.schmiedgen@tu-dresden.de supplementary materials: materials [see index of supplementary materials] abstract background: while cognitive-behavioral therapy (cbt) is the gold-standard psychological treatment for major depression (md), non-response and lacking stability of treatment gains are persistent issues. potential factors influencing treatment outcome might be lifetime trauma history and possibly associated primarily prefrontal-cortexand hippocampus-dependent cognitive alterations. method: we investigated md and healthy control participants with (md+t+, n = 37; md-t+, n = 39) and without lifetime trauma history (md+t-, n = 26; md-t-, n = 45) regarding working memory, interference susceptibility, conflict adaptation, and autobiographical memory specificity. further, md+t+ (n = 21) and md+tgroups (n = 16) were re-examined after 25 cbt sessions, with md-tindividuals (n = 34) invited in parallel in order to explore the stability of cognitive this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4105&domain=pdf&date_stamp=2021-09-30 https://orcid.org/0000-0002-8355-1603 https://orcid.org/0000-0001-7558-1274 https://orcid.org/0000-0002-9721-7817 https://orcid.org/0000-0002-1697-6732 https://orcid.org/0000-0002-8976-3244 https://orcid.org/0000-0002-1171-7133 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ alterations and the predictive value of lifetime trauma history, cognitive functioning, and their interaction for treatment outcome. results: on a cross-sectional level, md+t+ showed the highest conflict adaptation, but md+tthe lowest autobiographical memory specificity, while no group differences emerged for working memory and interference susceptibility. clinical improvement did not differ between groups and cognitive functioning remained stable over cbt. further, only a singular predictive association of forward digit span, but no other facets of baseline cognitive functioning, lifetime trauma history, or their interaction with treatment outcome emerged. discussion: these results indicate differential roles of lifetime trauma history and psychopathology for cognitive functioning in md, and add to the emerging literature on considering cognitive, next to clinical remission as a relevant treatment outcome. keywords major depression, lifetime trauma history, working memory, interference susceptibility, conflict adaptation, autobiographical memory, cognitive-behavioral therapy highlights • conflict adaptation was highest in md with lifetime trauma history. • autobiographical memory specificity was lowest in md without lifetime trauma history. • no differential treatment response was found in md with and without lifetime trauma history. • there were no changes of cognitive functioning over cbt, irrespective of lifetime trauma history. • only singular predictive value of cognitive functioning for cbt success emerged. meta-analyses suggest cognitive-behavioral therapy (cbt) as the gold-standard psycho­ logical treatment for major depression (md; e.g., barth et al., 2013; cuijpers et al., 2014), a condition characterized by depressed mood and loss of motivation together with behav­ ioral alterations such as reduced activity and disturbed sleep (diagnostic and statistical manual of disorders – fifth edition; american psychiatric association, 2013). however, a substantial patient subgroup fails to achieve clinically significant symptom improvement, with non-response and dropout rates of approximately 34% and 25%, respectively (for meta-analytic data, see cuijpers et al., 2014; hans & hiller, 2013). this highlights the need to enhance our understanding of factors associated with psychopathology and treatment outcome, allowing an optimization of cbt effects and reduction of dropout rates. here, trauma history is frequently discussed, defined as exposure to actual or threatened death, serious injury, or sexual violence (american psychiatric association, 2013). particularly for childhood trauma in md, associations with poorer therapy re­ sponse, longer remission time, and greater need for additional medication are relatively well-researched (for review and meta-analytic data, see nanni et al., 2012; nemeroff, lifetime trauma and cognitive functioning in md 2 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ 2016; teicher & samson, 2013). notably, lifetime trauma, including childhood, adulthood, or both types of trauma, has been far less well studied, except for one study suggesting negative associations of both childhood and adulthood adversity with therapy outcome in md (miniati et al., 2010). importantly, lifetime trauma history is assumed to co-occur with neurobiological (e.g., kolassa & elbert, 2007; sherin & nemeroff, 2011) and cognitive alterations (e.g., vasterling & arditte hall, 2018). however, data on this and its influence on therapy success in the context of md and trauma is sparse. in particular, primarily prefrontal-cor­ texand hippocampus-dependent functioning have received attention (mcintyre et al., 2013; rock et al., 2014; snyder, 2013; snyder & hankin, 2019). regarding the former, of importance might be working memory (wm) as a facet of executive functioning (ef) rel­ evant for temporal maintenance (usually assessed by the repetition of a list of numbers) and manipulation (usually assessed by the repetition of a list of numbers in a backward fashion) of content necessary for current tasks (diamond, 2013). accumulating evidence suggests impaired wm in patients with md (for reviews, see snyder, 2013; snyder & hankin, 2019). further, one study reported childhood trauma to predict performance in a compound wm score of information maintenance and manipulation in both patients with md and healthy controls (saleh et al., 2017), but another found no wm differences with respect to information maintenance or manipulation in patients with md with or without childhood trauma (dannehl et al., 2017). an ef domain considered to be even more impaired in md (e.g., snyder, 2013; snyder & hankin, 2019) is the ability to suppress irrelevant and/or interfering response tendencies while pursuing mentally represented goals (i.e., inhibitory control, diamond, 2013). typically, this is studied via the well-known simon task (simon, 1990), where the inhibition of a response following a task-irrelevant visual stimulus is necessary as a different response is required. the resulting additional performance costs (i.e., slower reaction times [rts] and/or increased percentages of error [pes]) compared to trials with matching automatic and required tendencies comprise the so-called simon effect as a measure of interference susceptibility (simon, 1990). after response conflicts, inhibitory control is typically increased, leading to a decreased impact of task-irrelevant informa­ tion compared to trials not following conflicts. the resulting difference in the simon effect is termed conflict adaptation (botvinick et al., 2001). in md, particularly this con­ flict adaptation according to task demands is suggested to be increased (van steenbergen et al., 2012). notably, previous work from our group revealed similar findings for patients with posttraumatic stress disorder (ptsd) and, albeit less clearly, trauma-exposed con­ trols (schindler et al., 2020; steudte-schmiedgen et al., 2014), encouraging research on the interaction of trauma and md. of note, there is an abundance of studies suggesting not only ef, but also mainly hippocampally-driven overgeneral memory retrieval (ogm) to be a central correlate of md (for meta-analytic data, see, e.g., sumner et al., 2010). this increased recall of over­ schindler, stalder, kirschbaum et al. 3 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ general (e.g., “i am happy when meeting friends”) instead of specific autobiographical memories (e.g., “i was happy on july 8 when i met friends”; williams et al., 2007) is also prevalent in ptsd, with trauma history a potential shared mechanism (moore & zoellner, 2007; ono et al., 2016; sumner et al., 2010; williams et al., 2007). however, previous contrasting of trauma-exposed and non-exposed individuals with md (notably, again only focusing on childhood trauma) provided mixed results, with one study finding ogm only in trauma-exposed (aglan et al., 2010) and another only in non-exposed individuals (kuyken et al., 2006). next to these cross-sectional findings of certain alterations of ef and autobiographi­ cal memory domains, and the possible mediating role of trauma history in md, it is plausible to assume that such alterations show significant change over psychotherapy. however, the vast majority of studies could not detect any changes of the cognitive alter­ ations described above over psychotherapy/combined psychoand pharmacotherapy (for wm, see, e.g., beblo et al., 1999; lahr et al., 2007; for inhibitory control, see, e.g., schmid & hammar, 2013; but ajilchi et al., 2016; for ogm, see, e.g., peeters et al., 2002). thus, a current meta-analysis (bernhardt et al., 2019) rather support the suggestions from previous reviews (e.g., bernhardt et al., 2019; köhler et al., 2015; moore & zoellner, 2007; snyder & hankin, 2019) of high stability of such alterations even after clinical remission, with improvements not exceeding task-specific practice effects. while previous data on cognitive markers as predictors for clinical outcome in the context of pharmacotherapy is promising (groves et al., 2018), research on cbt is outstanding, except for initial studies suggesting a predictive value of enhanced autobiographical memory specificity (sumner et al., 2010), but not interference susceptibility (goodkind et al., 2016). however, while lifetime trauma history is assumed to be associated with both therapy outcome (e.g., nemeroff, 2016; teicher & samson, 2013) and cognitive alterations (e.g., vasterling & arditte hall, 2018) in md, a combined investigation is still pending. hence, the aim of the current study was to examine (i) lifetime trauma history and (ii) facets of cognitive functioning (i.e., wm, interference susceptibility, conflict adaptation, and ogm) as well as (iii) their interaction in the context of md symptomatology and therapy success. due to the inconclusive literature on the interplay of lifetime trauma history and md for cognitive functioning, our first step was to study respective baseline alterations in md and healthy control participants with (md+t+, n = 37; md-t+, n = 39)1 and without lifetime trauma history (md+t-, n = 26; md-t-, n = 45). specifically, we aimed to (1) investigate whether the previously found effect of lifetime trauma history on conflict adaptation (schindler et al., 2020; steudte-schmiedgen et al., 2014) is also visible in md and (2) shed light on the conflicting evidence regarding ogm (aglan 1) md+t+ = patients with md with lifetime trauma history; md+t= patients with md without lifetime trauma history; md-t+ = patients without md with lifetime trauma history; md-t= patients without md and without lifetime trauma history. lifetime trauma and cognitive functioning in md 4 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ et al., 2010; kuyken et al., 2006). further, we assessed clinical and cognitive treatment outcome under consideration of lifetime trauma history by re-examining patients with md with (md+t+, n = 21) and without lifetime trauma history (md+t-, n = 16) after 25 cbt sessions. in order to account for practice effects, non-traumatized healthy con­ trol individuals (md-t-, n = 34) were re-invited in parallel. here, we hypothesized (3) poorer treatment outcome for md+t+ than for md+tindividuals. based on recent meta-analytic evidence (bernhardt et al., 2019), we aimed to examine whether we could confirm the finding of (4) no changes of cognitive functioning over cbt, irrespective of lifetime trauma history, also for the tasks studied here. on a last note, we aimed to (5) exploratorily study the predictive value of cognitive functioning for cbt outcome. m e t h o d participants and procedures recruitment was conducted within the outpatient unit of the institute of clinical psy­ chology and psychotherapy of the technische universität dresden, as well as via flyers and local advertisements. individuals were included in the study if they were aged between 18 and 65 years, not pregnant (women), and did not report any severe physical diseases (e.g., cancer, encephalopathy) over the past five years. further exclusion criteria concerned hair-related and endocrine factors due to biomarker analyses reported else­ where (e.g., glucocorticoid medication; steudte et al., 2013; steudte-schmiedgen et al., 2014). the presence of md and any other dsm-iv (american psychiatric association, 2007) mental disorders was assessed using the standardized munich composite inter­ national diagnostic interview (dia-x/m-cidi; wittchen & pfister, 1997) conducted by therapists of the outpatient unit or trained research team members and confirmed by an experienced clinical psychologist. twenty-eight participants from the md groups showed psychiatric comorbidities within the last 12 months (one: n = 15, two: n = 8, three or more: n = 5). those encompassed specific (n = 12) or social phobia (n = 13), somatoform disorders (n = 6), panic disorder with or without agoraphobia (n = 8), generalized anxiety (n = 3), obsessive-compulsive (n = 2), adjustment (n = 2), or eating disorders (n = 1). an assignment to the md groups was based on a current primary 12-month md diagnosis and no 12-month diagnosis of substance abuse or dependence (except for nicotine) or any lifetime diagnoses of psychosis, severe depressive disorder with psychot­ ic symptoms, or bipolar disorder. notably, individuals meeting the lifetime diagnostic criteria for ptsd were also excluded from the study, in order to allow insights into the role of lifetime trauma exposure per se for cognitive functioning in md. participants were included in the control group if they did not report any lifetime mental disorders accord­ ing to the dia-x/m-cidi stem questions and the mini international neuropsychiatric interview (m.i.n.i.; sheehan et al., 1998). participants were further classified as exposed or schindler, stalder, kirschbaum et al. 5 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ non-exposed to lifetime trauma based on the posttraumatic stress diagnostic scale (pds; ehlers, steil, winter, & foa, 1996). for an allocation to the t+ groups, both the “objective” a1 (“actual or threatened death or serious injury or a threat to the physical integrity of oneself or others”) and the “subjective” a2 criterion (“intense fear, helplessness or horror”) had to be met, following the dsm-iv requirements that qualify life events as traumatic (american psychiatric association, 2007). the control groups are the same as in the parallel study on patients with ptsd (schindler et al., 2020). for further participant characteristics, see table 1 and supplementary materials (type of lifetime trauma history). cbt for md groups was conducted within the outpatient unit based on established manuals (hautzinger, 1998, 2008) and supervised by experienced therapists. after 25 sessions, md+t+ and md+tpatients were re-invited for clinical and cognitive testing, with md-tparticipants being contacted in a parallel fashion (no difference regarding months between assessments: m = 13.5, sd = 3.86; m = 11.56, sd = 4.03; and m = 14.76, sd = 6.97, respectively; f(2, 68) = 1.78, p = .177, ηp2 = .05). among the 63 patients with md examined at baseline, 6 (9.5%) were only interested in the cross-sectional study, 16 (25.4%) dropped out of cbt, and 41 (65.1%) completed therapy. between those who dropped out of cbt and those who did not, no differences emerged regarding pre-treatment clinical variables (all ps ≥ .219). all participants had provided written informed consent before study inclusion. the study protocol was approved by the ethics committee of the technische universität dresden (ek 65022010) and conducted in accordance with the declaration of helsinki. clinical and psychological measures self-developed questionnaires were applied for socio-demographic (age, sex, education status) and health-related variables (smoking, chronic physical diseases, regular medica­ tion intake). depressive symptoms over the previous two weeks were assessed via the beck depression inventory-ii (bdi-ii, hautzinger et al., 2006). the pds (ehlers et al., 1996) provided insights into the presence or absence of lifetime trauma history and the severity of symptoms associated with posttraumatic stress according to dsm-iv criteria. the trauma history questionnaire (thq, maercker, 2002) provided an overview over number and frequency of potentially traumatic events fulfilling the dsm-iv a1, but not a2 criterion (hooper et al., 2011). furthermore, to obtain information on the severity of childhood maltreatment (irrespective of fulfilling dsm-iv a criteria), the childhood trauma questionnaire (ctq, gast et al., 2001) was used. at follow-up, patients with md additionally received the revised version of the questionnaire of changes in experi­ ence and behavior (veränderungsfragebogen des erlebens und verhaltens vev-r; zielke & kopf-mehnert, 2001). this allowed a classification of patient-evaluated therapy effects via 42 items of opposite polarity (e.g., “compared with the time prior to initiation of lifetime trauma and cognitive functioning in md 6 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ ta b le 1 b as el in e d em og ra ph ic , h ea lt hr el at ed , a nd c li ni ca l c ha ra ct er is ti cs o f p at ie nt s w it h m aj or d ep re ss io n w it h (m d + t+ ) an d w it ho ut ( m d + t) as w el l a s c on tr ol s w it h (m d -t + ) an d w it ho ut ( m d -t -) l if et im e t ra um a h is to ry p ar ti ci pa n ts ’ c h ar ac te ri st ic s m d +t + (n = 3 7) m d +t (n = 2 6) m d -t + (n = 3 9) m d -t (n = 4 5) te st s ta ti st ic p d em og ra ph ic s a ge ( m , s d ) 37 .5 9 (1 1. 91 ) 39 .2 7 (1 1. 8) 41 .4 6 (1 2. 82 ) 35 .3 1 (1 3. 8) f( 3, 1 43 ) = 1 .7 1 .1 67 fe m al e se x (% ) 27 ( 73 ) 17 ( 65 .4 ) 32 ( 82 .1 ) 38 ( 84 .4 ) χ 32 = 4 .3 4 .2 27 h ig h es t ed uc at io n al s ta tu s χ 1 22 = 2 2. 26 .0 35 a ca de m ic d eg re e (% ) 7 (1 8. 9) 2 (8 )a 16 ( 41 ) 11 ( 24 .4 ) p ro fe ss io n al t ra in in g/ co lle ge d eg re e (% ) 10 ( 27 ) 12 ( 48 )a 13 ( 33 .3 ) 15 ( 33 .3 ) a le ve l ( % ) 13 ( 35 .1 ) 5 (2 0) a 7 (1 7. 9) 16 ( 35 .6 ) h ig h s ch oo l d ip lo m a/ lo w er ( % ) 7 (1 8. 9) 6 (2 4) a 3 (7 .7 ) 3 (6 .7 ) sm ok in g (% ) 8 (2 1. 6) 11 ( 42 .3 ) 4 (1 0. 3) 10 ( 22 .2 ) χ 32 = 9 .2 4 .0 26 p h ys ic al d is ea se ( % ) 19 ( 51 .4 ) 11 ( 42 .3 ) 17 ( 43 .6 ) 12 ( 26 .7 ) χ 32 = 5 .5 8 .1 34 r eg ul ar m ed ic at io n ( % ) 21 ( 56 .8 ) 16 ( 61 .5 ) 11 ( 28 .2 ) 8 (1 7. 8) χ 32 = 2 1. 02 < .0 01 p sy ch ia tr ic ( % )b 16 ( 43 .2 ) 12 ( 46 .2 ) 0 0 n on -p sy ch ia tr ic ( % ) 10 ( 27 ) 8 (3 0. 8) 11 ( 28 .2 ) 8 (1 7. 8) pd s sc or e (m , s d ) 12 .4 ( 11 .4 5) n .a . 4. 56 ( 6. 18 ) n .a . t 5 4. 72 = 3 .6 8 .0 01 th q n um be r of a 1 tr au m at ic e ve n ts ( m , s d ) 4. 3 (2 .5 ) 2. 81 ( 2. 08 ) 4. 21 ( 3. 17 ) 1. 33 ( 1. 21 ) f( 3, 1 43 ) = 1 4. 87 < .0 01 i th q f re qu en cy o f a 1 tr au m at ic e ve n ts ( m , s d ) 7. 33 ( 6. 71 )c 6. 12 ( 5. 1) 7. 26 ( 8. 42 ) 2. 64 ( 3. 79 ) f( 3, 1 43 ) = 5 .2 5 .0 02 ii c tq s co re (m , s d ) 39 .5 9 (1 0. 48 ) 37 .4 5 (1 0. 83 ) 37 .9 4 (1 3) 29 .0 2 (4 .8 7) f( 3, 1 43 ) = 9 .4 3 < .0 01 ii i bd iii s co re (m , s d ) 20 .7 8 (9 .1 1) 22 .1 5 (8 .7 5) 5. 1 (6 .8 ) 4. 52 ( 0. 67 ) f( 3, 1 43 ) = 6 6. 66 < .0 01 iv n ot e. p d s = p os tt ra um at ic s tr es s d ia gn os ti c sc al e; t h q = t ra um a h is to ry q ue st io n n ai re ; c t q = c h il dh oo d t ra um a q ue st io n n ai re ; b d iii = b ec k d ep re ss io n in ve n to ry -i i. a r ef er s to n = 2 5. b in cl ud ed a n ti de pr es sa n ts ( n = 2 7) , a n ti co n vu ls iv es ( n = 3 ), n eu ro le pt ic s (n = 2 ), se da ti ve s (n = 2 ). c r ef er s to n = 3 6. i m d + t + = m d -t + > m d -t (p s < .0 01 ), w it h m d + t in b et w ee n . i i m d + t + = m d -t + > m d -t (p s ≤ .0 06 ), w it h m d + t in b et w ee n . i ii m d + t + = m d -t + = m d -t + > m d -t (p s ≤ .0 05 ). iv m d + t + = m d + t -> m d -t + = m d -t (p s ≤ .0 01 ). schindler, stalder, kirschbaum et al. 7 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ therapy, i feel more relaxed/no change/more tense.”) into three categories (i.e., symptom improvement, no change, and worsening). cognitive tasks wm was examined using the wechsler memory scale digit span task (wechsler, 1997). participants repeated a series of numbers read out loud by the experimenter in a forward (information maintenance) or backward fashion (information manipulation). interference susceptibility and conflict adaptation were assessed by a number version of the simon task (fischer et al., 2008). in brief, participants categorized the numbers 1 to 9, except 5, as smaller or larger than five by pressing a left (alt) or right (alt gr) key on a qwertz keyboard with their left or right index finger, respectively. although task-irrelevant, stimulus location automatically facilitates the pressing of the corresponding response button, either in accordance, or in conflict with the required action, resulting in compati­ ble and incompatible trials, respectively. the resulting difference in rts and pes compri­ ses the simon, and the typical reduction of interference susceptibility after conflict trials the conflict adaptation effect (botvinick et al., 2004; simon, 1990). participants completed a 16-trial practice, followed by three 64-trial test blocks, resulting in 192 test trials (for further details, see schindler et al., 2020; steudte-schmiedgen et al., 2014). indices for interference susceptibility (i – c) and conflict adaptation [(ci – cc) – (ii – ic)] (lowercase letters: compatibility of the previous, uppercase letters: compatibility of the current trial, larger values indicating more pronounced effects) were calculated (van steenbergen et al., 2010). autobiographical memory specificity was assessed via the standardized autobio­ graphical memory test (williams & broadbent, 1986). participants were instructed to read words out loud (practice phase: three neutral words, testing phase: five positive and five negative words in a pseudo-randomized order, starting with a positive word and alternating valence) and briefly describe a related specific autobiographical memory. the words were randomly chosen from a word pool from a previous study (schönfeld & ehlers, 2006) matched for word frequency, emotionality, imagery, and pleasantness (apart from positive words rated as more pleasant than negative ones; hager & hasselhorn, 1994), with different sets used at baseline and follow-up. answers were tape-recorded, transcribed and coded by trained research assistants. as an outcome variable, the number of specific memories was used, defined as having happened at a particular place and time more than one week ago and having lasted for one day or less. if no answer was provided within 30 seconds, the trial was considered an omission. for assessing inter-rater-reliability, a second, independent rater re-assessed a random sample (10%) of the tape-recorded sequences, resulting in κ = .76 for the baseline and κ = .82 for the follow-up assessment. lifetime trauma and cognitive functioning in md 8 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ statistical analyses analyses were conducted via spss for windows, version 25 (ibm, armonk, ny), r (r core team, 2017), and stata 15.1 (statacorp llc, 2017). cross-sectional group comparisons were carried out via univariate analyses of variance (anovas; continuous variables) and χ2 contingency tables (dichotomous variables). for the simon task, the first trial of each block (1.6%), posterror trials (3%), target repetitions (11.3%), and, for rt analyses, error trials (3%) were excluded. amt data from one md+tand one md-t participant were missing. for longitudinal analyses, as a first step, participants from the md+t+, md+t-, and md-tgroups with available longitudinal data were re-examined regarding baseline demographic and clinical differences. simon task data from one md+t+ and three md-t participants, and amt data from one md+tand two md-tparticipants were missing. again, the first trial of each block (1.6%), posterror trials (baseline: 2.8%, follow-up: 2.7%), target repetitions (baseline: 11.5%, follow-up: 10.9%) and, for rt analyses, error trials (baseline: 2.8%, follow-up: 2.7%) were excluded. repeated-measures anovas with time [2, baseline vs. follow-up] as within-subject and group [3, md+t+ vs. md+tvs. md-t-] as between-subject factor were applied to assess clinical and cognitive changes over cbt. exploratory linear/logistic regression analyses were conducted for examining the pre­ dictive value of lifetime trauma history (pds; yes/no) for changes of depressive symptom severity (bdi-ii) and dropout from care as core outcome measures, respectively. due to the small sample size for the longitudinal analyses, and the high correlations between depressiveness (bdi-ii) and the subjectively evaluated therapy effects (vev-r, r = -.66, p < .001) at the follow-up assessment, we decided to omit the vev-r from the predictive analyses. for the bdi-ii, a change score was computed by subtracting baseline from follow-up values, and baseline values were included as a covariate to the regression analyses. as a second step, baseline cognitive performance (centered around the mean to avoid multicollinearity issues), and, as a third, the interaction of lifetime trauma history (yes/no) and baseline cognitive performance were added to the model. whenever hypothesis testing referred to one major cognitive domain (i.e., ef and learning/memory) and were not exploratory in nature, holm-bonferroni correction (holm, 1979) for family-wise error (fwer) per respective domain was applied. as the assumptions of conventional glms (anova, linear regression) are frequently violated in psychological data possibly leading to poor power and inaccurate effect sizes (field & wilcox, 2017), we repeated hypothesis testing using robust regressions. these drop glm assumptions by using a robust sandwich estimation of standard errors, down-weight­ ing observations with large residuals, and omitting outlying residuals (royall, 1986). predictive analyses were repeated using mixed-effects regressions with random intercept parameter addressing regression to the mean, which can otherwise yield biased results (oberg & mahoney, 2007). however, due to the higher prevalence and familiarity of schindler, stalder, kirschbaum et al. 9 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ conventional glms in the field, whenever both analyses yielded the same results, con­ ventional glms were reported. r e s u l t s sample characteristics, clinical symptomatology, and baseline cognitive functioning the groups were well-matched regarding age, sex, and physical diseases (all ps ≥ .134, see table 1). however, group differences emerged for educational status (χ122 = 22.26, p = .035) and smoking (χ32 = 9.24, p = .026). furthermore, both clinical groups reported higher medication intake than the non-clinical ones (χ32 = 21.02, p < .001), mainly driven by psychiatric medication. however, including these variables as covariates did not change the cross-sectional results. for depressive symptom severity (bdi-ii), both md+t and md+t+ individuals reported higher levels than the control groups (all ps ≤ .001), with post-hoc analyses indicating no difference between them. for number and frequen­ cy of dsm-iv a1 traumatic events, both md+t+ and md-t+ scored higher than md-t individuals, with md+tindividuals in between (thq, all ps ≤ .006). for the severity of childhood maltreatment, both md+ groups as well as the md-t+ participants scored higher than the md-tgroup (ctq, all ps ≤ .005). no group differences emerged for forward, backward, and overall digit span (all ps ≥ .283, see table 2). for the simon task, groups differed regarding conflict adaptation of median rts with a medium effect size, f(3, 143) = 3.23, p = .024, ηp2 = .063, 90% ci [0, .12], see figure 1), with higher levels in md+t+ compared to md-tindividuals (p = .017) and no other differences (all ps ≥ .43). neither for conflict adaptation of mean pes, nor for interference susceptibility did group differences emerge (all ps ≥ .424). regarding ogm, for positive and negative words and the overall score, md+tparticipants scored lower than both md-t+ and md-tones with, again, medium effect sizes (all ps ≤ .002), and no other differences (all ps ≥ .118). while ogm results remained stable after holm-bonferroni correction for fwer, the group difference for conflict adaptation of median rts lost statistical significance (p = .168). applying robust regressions did not considerably change the results, except for the difference between md-t+ and md-tparticipants regarding conflict adaptation of median rts and the interference effect of median rts emerging as non-significant trends, β = -15.2, 95% ci [-30.7, 0.2], p = .053 and β = -11.5, 95% ci [-24.2, 1.2], p = .076). lifetime trauma and cognitive functioning in md 10 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ ta b le 2 b as el in e w or ki ng m em or y in t he d ig it s pa n ta sk , i nt er fe re nc e an d c on fl ic t a da pt at io n e ff ec ts o f m ea ns o f m ed ia n r ea ct io n t im es ( r ts ) an d p er ce nt ag e of e rr or s (p e ) in th e si m on t as k, a nd a ut ob io gr ap hi ca l m em or y sp ec if ic it y in t he a ut ob io gr ap hi ca l m em or y te st ( a m t ) of p at ie nt s w it h m aj or d ep re ss io n w it h (m d + t+ ) an d w it ho ut (m d + t) as w el l a s c on tr ol s w it h (m d -t + ) an d w it ho ut ( m d -t -) l if et im e t ra um a h is to ry fa ce t of c og n it iv e fu n ct io n in g m d +t + (n = 3 7) m d +t (n = 2 6) m d -t + (n = 3 9) m d -t (n = 4 5) te st s ta ti st ic p η p2 90 % c i [l l, ul ] a dj us te d p (h ol m b on fe rr on i co rr ec ti on ) d ig it s pa n t ot al 17 .5 7 (3 .5 2) 17 .7 7 (3 .8 2) 17 .3 3 (3 .7 4) 18 .6 2 (3 .0 3) f( 3, 1 43 ) = 1 .1 .3 51 .0 23 [ 0, .0 6] 1 fo rw ar d 9. 84 ( 1. 94 ) 9. 81 ( 1. 98 ) 9. 72 ( 1. 75 ) 10 .1 3 (1 .7 ) f( 3, 1 43 ) = 0 .4 1 .7 46 .0 09 [ 0, .0 3] 1 b ac kw ar d 7. 73 ( 2. 06 ) 7. 96 ( 2. 36 ) 7. 62 ( 2. 4) 8. 49 ( 2. 14 ) f( 3, 1 43 ) = 1 .2 8 .2 83 .0 26 [ 0, .0 7] 1 si m on t as k : r t in te rf er en ce e ff ec t 27 .3 2 (2 9. 05 ) 24 .8 8 (2 8. 2) 31 .8 7 (2 8. 54 ) 21 .9 9 (2 4. 81 ) f( 3, 1 43 ) = 0 .9 4 .4 24 .0 19 [ 0, .0 5] 1 c on fl ic t ad ap ta ti on e ff ec t 68 .9 3 (4 2. 42 ) 51 .1 5 (4 4. 22 ) 57 .7 4 (3 9. 49 ) 43 .1 4 (2 8. 83 ) f( 3, 1 43 ) = 3 .2 3 .0 24 i .0 63 [ 0, .1 2] .1 68 si m on t as k : p e in te rf er en ce e ff ec t 1. 83 ( 3. 39 ) 1. 73 ( 3. 57 ) 2. 05 ( 4. 48 ) 1. 32 ( 3. 57 ) f( 3, 1 43 ) = 0 .2 7 .8 46 .0 06 [ 0, .0 2] 1 c on fl ic t ad ap ta ti on e ff ec t 5. 23 ( 5. 88 ) 5 (5 .7 9) 5. 26 ( 7. 12 ) 4. 6 (6 .4 2) f( 3, 1 43 ) = 0 .1 .9 62 .0 02 [ 0, 0 ] 1 a m t n um be r of s pe ci fi c m em or ie s t ot al 5. 68 ( 2. 72 ) 4. 36 ( 2. 46 )a 6. 69 ( 2. 18 ) 6. 73 ( 1. 86 )b f( 3, 1 41 ) = 7 .1 6 < .0 01 ii .1 32 [ .0 5, .2 1] < .0 01 p os it iv e cu es 2. 92 ( 1. 44 ) 2. 4 (1 .3 5) a 3. 49 ( 1. 36 ) 3. 57 ( 1. 23 )b f( 3, 1 41 ) = 5 .2 .0 02 ii i .1 [ .0 2, .1 7] .0 02 n eg at iv e cu es 2. 76 ( 1. 54 ) 1. 96 ( 1. 34 )a 3. 21 ( 1. 2) 3. 16 ( 1. 16 )b f( 3, 1 41 ) = 5 .7 2 .0 01 iv .1 1 [. 03 , . 18 ] .0 02 n ot e. d at a ar e pr es en te d as m ( sd ). c i = c on fi de n ce in te rv al ; l l = lo w er le ve l; u l = u pp er le ve l; r t = m ed ia n r ea ct io n t im es ; p e = p er ce n ta ge s of e rr or . a r ef er s to n = 2 5. b re fe rs t o n = 4 4. i m d + t + > m d -t (p = .0 17 ). ii m d + t < m d -t + = m d -t (p s ≤ .0 01 ). ii i m d + t < m d -t + = m d -t (p s ≤ .0 11 ). iv m d + t < m d -t + = m d -t (p s ≤ .0 02 ). schindler, stalder, kirschbaum et al. 11 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ figure 1 mean (± sem) (a) conflict adaptation of median rts (simon task) and (b) specificity of autobiographical memory (autobiographical memory test) of patients with major depression with (md+t+) and without (md+t-) as well as controls with (md-t+) and without (md-t-) lifetime trauma history at baseline note. *p < .05, †p < .10, dotted lines indicate differentiating results between general linear and robust models. clinical and cognitive treatment outcome under consideration of lifetime trauma history md+t+ (n = 21), md+t(n = 16), and md-tparticipants (n = 34) available for longitudi­ nal analyses did not differ regarding baseline demographic/health-related characteristics (all ps ≥ .136, see supplementary materials), except for higher medication intake in both md groups (χ22 = 13.9, p = .001). however, including it as a covariate did not affect the longitudinal results. md+t+ individuals reported a higher number of dsm-iv a1 traumatic events (thq) than md+tones, which, in turn, reported more than md-t individuals (all ps ≤ .036). with respect to their frequency (thq), as well as for childhood maltreatment severity (ctq), both md+ groups scored higher than the md-tone (all ps ≤ .035 and all ps ≤ .002, respectively). notably, while cbt led to substantial clinical improvements, md+t+ and md+t individuals did not differ regarding depressive symptom changes (bdi-ii), subjectively evaluated therapy effects (vev-r), and percentage of dropouts (all ps ≥ .605, see table 3). furthermore, no cognitive improvements over cbt in the clinical groups emerged (all ps ≥ .272, see table 3). however, for digit span, medium-to-large time effects indicated better performance at follow-up over all groups (all ps ≤ .009). robust regressions yielded similar results. regression analyses on the predictive value of lifetime trauma history (yes/no) for therapy outcome (bdi-ii changes of depressive symptom severity and dropout status, lifetime trauma and cognitive functioning in md 12 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ ta b le 3 c li ni ca l i m pr ov em en t an d c ha ng es i n w or ki ng m em or y in t he d ig it s pa n ta sk , i nt er fe re nc e an d c on fl ic t a da pt at io n e ff ec ts o f m ea ns o f m ed ia n r ea ct io n t im es ( r ts ) an d p er ce nt ag e of e rr or s (p e ) in t he s im on t as k, a nd a ut ob io gr ap hi ca l m em or y sp ec if ic it y in t he a ut ob io gr ap hi ca l m em or y te st ( a m t ) b et w ee n b as el in e an d fo ll ow -u p a ss es sm en t in p at ie nt s w it h m aj or d ep re ss io n w it h (m d + t+ ) an d w it ho ut ( m d + t) as w el l a s c on tr ol s w it ho ut ( m d -t -) l if et im e t ra um a h is to ry p ar ti ci pa n ts ’ c h ar ac te ri st ic s m d +t + (n = 2 1) m d +t (n = 1 6) m d -t (n = 3 4) te st s ta ti st ic p η p2 90 % c i [l l, ul ] a dj us te d p (h ol m -b on fe rr on i c or re ct io n ) t 1 t 2 t 1 t 2 t 1 t 2 bd iii s co re (m , s d ) 21 .6 7 (7 .7 2) 12 .1 4 (9 .5 2) 23 .1 2 (8 .8 3) 11 .2 5 (8 .1 9) 3. 97 ( 4. 76 ) 4. 59 ( 5. 3) f 2 , 6 8 = 2 3. 54 a, b < .0 01 i .4 09 [ .2 5, .5 2] bd iii c h an ge s co re (m , s d ) -9 .5 2 (8 .4 8) -1 1. 88 ( 7. 69 ) 0. 62 ( 5. 32 ) v ev -r s ym pt om im pr ov em en t (% ) 16 ( 76 .2 ) 13 ( 86 .7 ) n .a . χ 22 = 1 .0 1 .6 05 n .a . d ro po ut s (% ) 9 (2 9) 7 (2 6. 9) n .a . χ 22 = 0 .3 1 1. 00 n .a . d ig it s pa n t ot al 18 .5 7 (3 .1 6) 19 .8 1 (4 .0 9) 18 .1 3 (3 .5 7) 18 .9 4 (3 .0 9) 18 .5 9 (3 .2 ) 20 .3 8 (3 .5 4) f 2 , 6 8 = 0 .7 7a .4 7 .0 22 [ 0, .0 9] 1 fo rw ar d 10 .1 ( 1. 73 ) 10 .8 1 (2 .2 1) 9. 81 ( 1. 8) 9. 94 ( 1. 39 ) 10 ( 1. 67 ) 10 .9 4 (1 .9 8) f 2 , 6 8 = 1 .1 7a .3 18 .0 33 [ 0, .1 1] 1 b ac kw ar d 8. 48 ( 1. 94 ) 9 (2 .1 5) 8. 31 ( 2. 3) 9 (2 .0 3) 8. 59 ( 2. 29 ) 9. 44 ( 2. 21 ) f 2 , 6 8 = 0 .1 8a .8 33 .0 05 [ 0, .0 4] 1 si m on t as k : r t in te rf er en ce e ff ec t 26 .4 8 (2 9. 66 )b 20 .0 5 (2 6. 93 )b 20 .3 8 (2 7. 09 ) 15 .7 8 (2 3. 59 ) 20 .7 1 (2 5. 65 )c 24 .4 8 (2 4. 12 )c f 2 , 6 4 = 1 .3 3a .2 72 .0 4 [0 , . 12 ] 1 c on fl ic t ad ap ta ti on e ff ec t 66 .6 ( 29 .9 5) b 60 .1 ( 31 .4 )b 54 .8 8 (5 0. 85 ) 65 .8 4 (3 5. 65 ) 41 .0 2 (2 3. 4) c 50 .3 2 (3 7. 03 )c f 2 , 6 4 = 0 .9 6a .3 87 .0 29 [ 0, .1 ] 1 si m on t as k : p e in te rf er en ce e ff ec t 2. 24 ( 1. 84 )b 1. 55 ( 3. 27 )b 1 (3 .3 5) 1. 45 ( 2. 58 ) 1. 31 ( 4. 05 )c 2. 41 ( 2. 76 )c f 2 , 6 4 = 1 .2 3a .2 99 .0 37 [ 0, .1 2] 1 c on fl ic t ad ap ta ti on e ff ec t 4. 76 ( 5. 49 )b 4. 22 ( 6. 16 )b 4. 4 (5 .7 5) 4. 24 ( 5. 12 ) 5 (6 .2 6) c 3. 32 ( 6. 2) c f 2 , 6 4 = 0 .2 5a .7 8 .0 08 [ 0, .0 5] 1 a m t n um be r of s pe ci fi c m em or ie s t ot al 6. 05 ( 2. 71 ) 6. 67 ( 2. 31 ) 4. 47 ( 2. 13 )d 4. 53 ( 2. 23 )d 6. 75 ( 2) e 6. 25 ( 2. 24 )e f 2 , 6 5 = 1 .2 1a .3 05 .0 36 [ 0, .1 1] p os it iv e cu es 3. 1 (1 .3 8) 3. 29 ( 1. 31 ) 2. 47 ( 1. 3) d 2. 4 (1 .3 )d 3. 63 ( 1. 29 )e 3. 19 ( 1. 42 )e f 2 , 6 5 = 1 .2 a .3 08 .0 36 [ 0, .1 1] n eg at iv e cu es 2. 95 ( 1. 47 ) 3. 38 ( 1. 32 ) 2 (1 .1 3) d 2. 13 ( 1. 13 )d 3. 12 ( 1. 24 )e 3. 06 ( 1. 16 )e f 2 , 6 5 = 0 .6 4a .5 29 .0 19 [ 0, .0 8] n ot e. d at a is p re se n te d as m ( sd ). c i = c on fi de n ce in te rv al ; l l = lo w er le ve l; u l = u pp er le ve l; b d iii = b ec k d ep re ss io n i n ve n to ry -i i; r t = m ed ia n r ea ct io n t im es ; p e = p er ce n ta ge s of e rr or . a g ro up x t im e in te ra ct io n . b re fe rs t o n = 2 0. c r ef er s to n = 3 1. d re fe rs t o n = 1 5. e r ef er s to n = 3 2. i m d + t + = m d + t > m d -t (p < .0 01 ). schindler, stalder, kirschbaum et al. 13 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ respectively) yielded no associations (all ps ≥ .391). when, in a second step, adding respective facets of baseline cognitive functioning, more pronounced reductions of de­ pressive symptom severity (bdi-ii) emerged with smaller forward digit span, b = 1.48, 95% ci [0.07; 2.90], p = .041), while for all other measures of cognitive functioning, no predictive value emerged (all ps ≥ .059). adding, in a third step, interaction terms of lifetime trauma history (yes/no) and baseline cognitive functioning did not predict cbt outcome regarding bdi-ii and dropout status (all ps ≥ .058). notably, robust regressions led to similar results. d i s c u s s i o n the aim of the study was to assess associations of (i) lifetime trauma history according to the dsm-iv (american psychiatric association, 2007) and (ii) facets of cognitive func­ tioning (i.e., wm, interference susceptibility, conflict adaptation, and ogm) as well as (iii) their interaction with cbt outcome among patients with md. at baseline, more pronounced conflict adaptation emerged in individuals with md and lifetime trauma history in contrast to non-exposed healthy controls, while autobiographical memory was found to be primarily affected in md without lifetime trauma history compared to both control groups. notably, individuals with md with and without lifetime trauma history did not differ regarding treatment outcome, and the cognitive parameters proved stable over cbt. exploratory analyses suggested no direct or interacting association of lifetime trauma history, and only a tentative one of forward digit span, but no other aspects of cognitive functioning with treatment outcome. baseline cognitive functioning on a cross-sectional level, the results support the role of lifetime trauma history for cognitive functioning in md. while no differences emerged for interference susceptibil­ ity and wm, md+t+ patients showed higher conflict adaptation of median rts than md-tparticipants, with md+tand md-t+ in between. this corresponds with previous findings from our group of more pronounced conflict adaptation in traumatized individ­ uals with and possibly also without ptsd (schindler et al., 2020; steudte-schmiedgen et al., 2014). however, as there also are suggested associations of conflict adaptation and depressive symptom severity (van steenbergen et al., 2012), albeit without considering trauma history, further studies are desirable. interestingly, autobiographical memory yielded contrasting findings: md+tpatients showed more pronounced ogm compared to the healthy control groups, corresponding with our previous findings of ogm in ptsd, but not trauma exposure per se (schindler et al., 2020), and suggestions from reviews and meta-analyses (moore & zoellner, 2007; ono et al., 2016; sumner et al., 2010; williams et al., 2007). further, it supports the findings of lifetime trauma and cognitive functioning in md 14 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ kuyken, howell, and dalgleish (2006) of ogm only in md without (childhood) trauma history, but not those of aglan et al. (2010) of ogm in md with history of csa. in sum, neither the results for conflict adaptation, nor those for ogm speak for a mere additive effect of trauma and md on cognitive functioning, but rather for complex patterns with different impacts on different processes, and, potentially, different implications for clinical practice. clinical and cognitive treatment outcome under consideration of lifetime trauma history in contrast to several previous studies particularly on childhood trauma (reviewed in nemeroff, 2016; teicher & samson, 2013), our data suggest cbt to be equally effective in individuals with md with and without the history of at least one traumatic event according to the dsm-iv. several aspects may contribute to this divergence. firstly, it is plausible that lifetime trauma, as examined in this study, does exert different effects than childhood trauma. importantly, in our study, md+t+ and md+tgroups reported equal ctq childhood maltreatment severity, and it is conceivable that this may have contributed to lacking group differences with respect to cbt effectiveness. notably, also with respect to the thq, the md+t+ and the md+tgroups did only differ on a descriptive level. however, it is important to consider that this instrument refers to the number and frequency of potentially traumatic events, for which the presence of the complete dsm-iv criteria are not checked. in order to better understand the role of childhood and adulthood trauma for cbt effectiveness, studies explicitly contrasting individuals with md (i) without lifetime trauma, (ii) with exclusively childhood, and (iii) with exclusively adulthood trauma as defined by the current diagnostic criteria are necessary. furthermore, treatment differences might have played a role. most prominent­ ly, the majority of studies reporting similar therapy outcome for md with and without (particularly childhood) trauma history had applied combined psychotherapy and antide­ pressant medication (lewis et al., 2010; miniati et al., 2010; nemeroff et al., 2003; but asarnow et al., 2009), as was the case for approximately half of our sample. further, we cannot rule out whether, in our study, trauma status had led to slight individual treatment adaptations by the responsible therapists. this might, for instance, have led to combined modifications of trauma-related and -unrelated automatic thought patterns, or the encouraging of restarting activities avoided after the trauma during behavioral interventions within the context of the utilized cbt manuals (hautzinger, 1998, 2008). thus, future studies applying more strictly manualized cbt and investigating larger md groups with and without medication intake are required. additionally, the results corroborate previous findings of cognitive alterations in md being highly stable over cbt (reviewed in köhler et al., 2015; moore & zoellner, 2007; snyder & hankin, 2019), and of this to be irrespective of trauma history. while wm im­ proved from baseline to follow-up, this is presumably attributable to practice/habituation schindler, stalder, kirschbaum et al. 15 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ effects, as it also concerned md-tindividuals. as cognitive impairments are assumed to be associated with worse psychosocial functioning and increased relapse risk in md (rock et al., 2014), the continuous finding of this to not be adequately addressed by cbt shows the necessity to strive for “cognitive”, next to clinical remission in md (bernhardt et al., 2019; bortolato et al., 2016). for example, this might be achieved by directly targeting cognitive functioning during md-centered cbt. while research on ef training in md is still in its infancy (for a meta-analysis, see, e.g., motter et al., 2016), there are promising results that ogm, as well as md symptomatology itself may be influenced by interventions directly focusing on autobiographical recall, albeit with long-term stability still questionable (for a meta-analysis, see barry, sze, & raes, 2019). the exploratory predictive analyses on lifetime trauma history and cognitive func­ tioning for cbt do not provide clear results from which robust next steps could be derived. what can be clearly stated as of now is that there, again, was no evidence for a relevant role of lifetime trauma history. further, only a singular association with cognitive parameters emerged, suggesting smaller wm to be associated with more pro­ nounced depressiveness-related cbt effects. in sum, this pattern, albeit stemming from a very small sample size, supports the findings of goodkind et al. (2016) on interference susceptibility, but stands at variance with those of sumner et al. (2010) suggesting a predictive role of autobiographical memory specificity in md. future studies are needed to follow up on autobiographical memory in this context, or investigate whether other cognitive markers might be more suitable to predict clinical outcome after standardized psychotherapeutic/pharmacological treatment (e.g., groves et al., 2018) with or without taking trauma history into account. strengths, limitations, and outlook one central strength of the study is the naturalistic, highly ecologically valid study design. while the inclusion of a waiting control group of md+t+/md+tpatients not receiving cbt was impossible for ethical reasons, the fact that a healthy control group was studied longitudinally alongside the md individuals is a further major strength, as it allowed the separation of cbt-associated and mere practice effects on cognitive functioning. however, limitations resulting from the naturalistic design are the heteroge­ neous manifestations of psychopathology and medication and the group differences in educational status and smoking. further limitations include the lack of an objective, ob­ server-rated outcome of depressiveness (e.g., the hamilton rating scale for depression; hamilton, 1960), as well as the small sample sizes and the thus reduced statistical power for detecting especially interactive relationships. however, the fact that the vast major­ ity of associations were confirmed in robust analyses corroborates the validity of the findings. finally, behavioral tasks established in cognitive psychology, such as the ones used in our study, are characterized by task impurity, which describes the impossibility of assessing “pure” cognitive processes without simultaneously eliciting others (miyake lifetime trauma and cognitive functioning in md 16 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ et al., 2000; e.g., scott et al., 2015). in order to maximize transparency in data reporting, we chose to report subscale scores of the cognitive tasks for which different properties are discussed (botvinick et al., 2004; wechsler, 1997; williams & broadbent, 1986). in ad­ dition, we acknowledge that for any of the assessed tasks, additional cognitive processes such as processing speed, attention, and motivation – while not directly studied – are inevitably involved. conclusions in conclusion, the study is the first to examine lifetime trauma history, cognitive func­ tioning, and their interaction in the context of cbt in patients with md. on a cross-sec­ tional level, conflict adaptation and autobiographical memory specificity emerged to be differentially affected in md with and without lifetime trauma history. contrary to previous research on childhood trauma, we found no evidence for a differential treatment response in patients with md with and without lifetime trauma history as defined by the dsm-iv. further, the cognitive parameters were stable over cbt, and only a singular predictive association of forward digit span, but no other facets of baseline cognitive functioning, lifetime trauma history, or their interaction with treatment out­ come emerged. these insights into the interaction between lifetime trauma history and cognitive functioning provide unique extensions for research on md psychopathology and treatment and underline the relevance of “cognitive” remission (bernhardt et al., 2019; bortolato et al., 2016). for achieving this aim, further research is required to allow more profound, neuroscience-informed diagnostic processes and personalized, multi-mo­ dal treatment approaches depending on patients’ individual manifestation of cognitive functioning (de raedt, 2020). schindler, stalder, kirschbaum et al. 17 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://www.psychopen.eu/ funding: this work was supported by the german research foundation (dfg; grant nos. sta 1213/5-1 to t.s. and j.h. and sfb 940/1 project no. b5 to f.p. and c.k). l.s. was supported by the german academic scholarship foundation. s.s.-s. was funded by a habilitation fellowship for women from the faculty of medicine carl gustav carus, technische universität dresden. acknowledgments: the authors would like to thank elisabeth cohors-fresenborg, fanny weber, anna-katharina richter, juliane kant, inger-sophie hellerhoff, kristin werzner, the staff of the outpatient unit, and the members of the endocrinology laboratory of the department of psychology at the technische universität dresden for their great help in conducting this research. competing interests: all authors have no conflicts of interest to disclose. author contributions: lena schindler: formal analysis, data curation, writingoriginal draft preparation, visualization. tobias stalder: conceptualization, writingreview & editing, funding acquisition. clemens kirschbaum: resources, writingreview & editing. franziska plessow: conceptualization, methodology, writing review & editing. sabine schönfeld: conceptualization, methodology, writingreview & editing. jürgen hoyer: resources, writingreview & editing, funding acquisition. sebastian trautmann: formal analysis, writingreview & editing. kerstin weidner: writingreview & editing. susann steudte-schmiedgen: conceptualization, methodology, investigation, formal analysis, writingreview & editing, supervision s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • supplement 1 (lifetime trauma history and mental disorder comorbidities) • supplement 2 (baseline demographic, health-related, and clinical characteristics of patients with major depression with (md+t+) and without (md+t-) as well as controls without (md-t-) lifetime trauma history available for longitudinal analyses) index of supplementary materials schindler, l., stalder, t., kirschbaum, c., plessow, f., schönfeld, s., hoyer, j., trautmann, s., weidner, k., & steudte-schmiedgen, s. 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(2001). der vev-r-2001: entwicklung und testtheoretische reanalyse der revidierten form des veränderungsfragebogens des erlebens und verhaltens (vev). praxis klinische verhaltensmedizin und rehabilitation, 53, 7-19. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. lifetime trauma and cognitive functioning in md 24 clinical psychology in europe 2021, vol. 3(3), article e4105 https://doi.org/10.32872/cpe.4105 https://doi.org/10.1176/appi.ajp.2013.12070957 https://doi.org/10.1177/0956797610385951 https://doi.org/10.3758/s13415-011-0078-2 https://doi.org/10.1007/s11920-018-0964-1 https://doi.org/10.1037/0033-2909.133.1.122 https://doi.org/10.1037/0021-843x.95.2.144 https://www.psychopen.eu/ lifetime trauma and cognitive functioning in md (introduction) method participants and procedures clinical and psychological measures cognitive tasks statistical analyses results sample characteristics, clinical symptomatology, and baseline cognitive functioning clinical and cognitive treatment outcome under consideration of lifetime trauma history discussion baseline cognitive functioning clinical and cognitive treatment outcome under consideration of lifetime trauma history strengths, limitations, and outlook conclusions (additional information) funding acknowledgments competing interests author contributions supplementary materials references blended delivery of imagery rescripting for childhood ptsd: a case study during the covid-19 pandemic research articles blended delivery of imagery rescripting for childhood ptsd: a case study during the covid-19 pandemic nathan bachrach 1,2,3 , sanja giesen 2, arnoud arntz 4 [1] department of medical and clinical psychology, tilburg university, tilburg, the netherlands. [2] ggz oost brabant, boekel, the netherlands. [3] rino zuid, eindhoven, the netherlands. [4] department of clinical psychology, university of amsterdam, amsterdam, the netherlands. clinical psychology in europe, 2022, vol. 4(3), article e7815, https://doi.org/10.32872/cpe.7815 received: 2021-11-12 • accepted: 2022-02-21 • published (vor): 2022-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: nathan bachrach, warandelaan 2, 5037 ab tilburg, the netherlands. e-mail: n.bachrach@tilburguniversity.edu abstract background: despite the growing evidence that trauma-focused treatments can be applied as first-line approaches for individuals with childhood trauma-related ptsd (ch-ptsd), many therapists are still reluctant to provide trauma-focused treatments as a first-choice intervention for individuals with ch-ptsd, especially by telehealth. the current manuscript will therefore give an overview of the evidence for the effectiveness of trauma-focused therapies for individuals with chptsd, the delivery of trauma-focused treatments via telehealth, and a case example on how a specific form of trauma focused therapy: imagery rescripting (imrs) can be applied by telehealth. method: this article presents a clinical illustration of a blended telehealth trajectory of imagery rescripting (imrs) ch-ptsd delivered during the covid-19 pandemic. results: the presented case shows that imrs can be safely and effectively performed by telehealth for ch-ptsd, no stabilization phase was needed and only seven sessions were needed to drastically reduce ch-ptsd and depressive symptoms, and to increase quality of life. conclusion: this case report shows the effectiveness of imrs by telehealth for ch-ptsd, which gives hope and additional possibilities to reach out to patients with ch-ptds. telehealth treatment might have some of advantages for specific patients, especially, but certainly not only, during the pandemic. keywords imagery rescripting, ptsd, telehealth, childhood trauma-related ptsd this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7815&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0002-0746-2692 https://orcid.org/0000-0002-7992-2272 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • imrs is an effective and highly acceptable procedure for both patients as therapists and seems a very good option for treating ch-ptsd effectively. • in the presented case only seven sessions were needed to reduce ch-ptsd and depressive symptoms drastically, and increase quality of life. • the delivery of imrs by telehealth did not have a negative impact on the effectiveness, quality and patient satisfaction; which is in line with systematic reviews on effectiveness of psychological telehealth treatments for ptsd (not imrs and not specifically ch-ptsd). meta-analytic reviews and practice guidelines recommend trauma-focused cognitive behavior therapy (tf-cbt) and eye movement desensitization and reprocessing (emdr) as first-line treatments for ptsd (lewis et al., 2020). despite the growing evidence that trauma-focused treatments can be applied as first-line approaches for individuals with childhood trauma-related ptsd (ch-ptsd), many therapists are still reluctant to provide trauma-focused treatments as a first-choice intervention for individ­ uals with ch-ptsd, especially by telehealth (wild et al., 2020). the current manuscript will therefore give an overview of the evidence for the effectiveness of trauma-focused therapies for individuals with ch-ptsd, the delivery of trauma-focused treatments via telehealth, and a case example on how a specific form of trauma focused therapy: imagery rescripting (imrs) can be applied by telehealth. individuals with ch-ptsd are characterized by more complex ptsd symptoms, such as emotional regulation problems, interpersonal difficulties and impaired self-concept (ehring et al., 2014; messman-moore & bhuptani, 2017). there is a limited number of studies investigating trauma-focused treatment among ch-ptsd patients (ehring et al., 2014). a meta-analysis of psychological treatments for ch-ptsd (ehring et al., 2014) found evidence that patients with ch-ptsd can be treated safely with trauma-focused therapies, and that these treatments are effective (moderate to high effect sizes) in reducing ptsd symptoms as well as related symptoms, such as depression, anxiety and dissociation. furthermore, recent randomized controlled studies show that direct applications of trauma-focused therapies such as prolonged exposure, emdr, and image­ ry rescripting are very effective and can be performed safely with ch-ptsd patients (boterhoven de haan et al., 2020; oprel et al., 2021). these studies found large effect sizes for reducing ptsd symptoms as well as other symptoms such as depression, dissociation and trauma related cognitions with trauma-focused treatments in ch-ptsd patients, with notably low dropout rates (7%) for emdr and imrs compared to prolonged expo­ sure and intensified prolonged exposure (27% and 29%) and low rates of serious adverse events (boterhoven de haan et al., 2020; oprel et al., 2021). imrs as a stand-alone treatment for ch-ptsd has been studied far less compared to other first line ptsd treatments such as emdr, prolonged exposure, cognitive process­ blended delivery of imrs 2 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ ing therapy and tf-cbt. recent findings show that imrs is a very effective procedure and is highly acceptable for both patients as therapists (boterhoven de haan et al., 2020; boterhoven de haan et al., 2021; morina et al., 2017; raabe et al., 2015). very large treat­ ment effects on the clinician administered ptsd scale for dsm-5 between baseline and one-year follow-up (i.e., pre-post d = 2.26 for imrs and d = 1.88 for emdr) were found in a recent rct in which emdr was compared to imrs. moreover, the drop-out rates were low, at 7.7%, suggesting that the treatments were well tolerated by participants (boterhoven de haan et al., 2020). no differences in effectiveness and dropout between emdr and imrs for ch-ptsd, were found. however, imrs was superior for those with comorbid depression, which is highly prevalent in ptsd patients (70% in the irem sample) (assmann et al., 2021). to date, cost effectiveness studies in imrs have not yet been performed. imrs might be potentially more cost-effective than emdr, because of lower training costs and shorter sessions (60 vs 90 minutes). it is also still not clear how session frequency impacts the effectiveness of ptsd treatments, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for which patient (wibbelink et al., 2021). imrs uses a different method compared to prolonged exposure and emdr, therefore, imrs might additionally work for patients who do not benefit from other ptsd treatments. research shows that imrs compared to prolonged exposure leads to less dropout (arntz et al., 2007) is experienced as less distressing (siegesleitner et al., 2019) and is more effective regarding anger control, hostility and guilt. imrs might therefore be indicated especially for a specific group of patients who experience difficulties in these areas and ptsd patients with comorbid depression (assmann et al., 2021; bosch & arntz, 2021). in imrs for ptsd, patients are asked to vividly recall a traumatic experience where­ after patients are asked to imagine that an intervention takes place that changes the course of the original memory into an image in which the needs of the patient are fulfilled (arntz, 2012; arntz & weertman, 1999). in imrs several therapeutic steps are used to modify the content of traumatic memories into new positive images in order to change the meaning of the trauma memory representation, by adding new and corrective information about the meaning of the event. imrs is thought to reevaluate unconditioned stimuli and thereby reduce conditioned stimuli-elicited affects (arntz, 2012). this is done by adding new information into the memory representation of the unconditioned stimuli; by for instance adding information on the needs of little children and taking care of the patients’ needs in the traumatic event. imrs for ptsd is performed in phases. in the first phase, which usually has a duration of six sessions, patients are asked to close their eyes and imagine a concrete negative traumatic experience as vividly as possible, until enough emotional arousal is achieved usually around a specific traumatic moment in the memory representation. prolonged exposure to the most traumatic aspect of the memory is not necessary, the therapist enters the image when arousal levels are still manageable for the patient. the therapist rescripts the image by establishing safety for the child, bachrach, giesen, & arntz 3 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ and in the following steps, further needs of the child are taken care of, and the child's emotions are validated. the perpetrator is confronted and hold accountable for their ac­ tions and responsibility and, if necessary, helped to do better in the future or to punished and/or eliminated so he/she cannot cause any harm. in the second phase of treatment, usually after 6 sessions, after trauma-memory activation (from the child perspective), imrs is performed in three steps (1) patients are asked to imagine the image as an adult in order to experience what they feel, think and are inclined to do from their present adult perspective. (2) thereafter they are stimulated to intervene in the image and do whatever they think is needed for their own little child. (3) patients are subsequently asked to experience the interventions by their adult self again from the perspective of the child in order to experience how it feels when needs are fulfilled (arntz & weertman, 1999). a recent study investigated the perspectives of patients and therapists regarding the elements of change in imrs. patients mention, caring for the child by the therapist when the therapist rescripts the traumatic event, speaking up to the perpetrator, the positive connection they had with the therapist and the encouragement they received from him or her as important elements of change (bosch & arntz, 2021). delivering imrs by telehealth (e.g., delivering psychological therapy remotely via video teleconferencing) to patients with ptsd poses challenges to both therapist and patients (paulik et al., 2021). the need for remote delivery of psychological treatments increased drastically due to the covid-19 pandemic, because of closure of outpatient facilities, travel restrictions, and home confinement. up to date, the study of delivery of imrs via telehealth has been limited to a few cases (paulik et al., 2021). however, several systematic reviews on effectiveness of psychological telehealth treatments for various disorders including ptsd (not imrs and not specifically ch-ptsd) have been performed, which in general show that the effectiveness, drop-out rates, quality and patient satisfaction, is comparable to face-toface therapies (berryhill et al., 2019; bolton & dorstyn, 2015; finkelstein et al., 2006; simpson, 2009; sunjaya et al., 2020; varker et al., 2019). despite this ample evidence to support the use of telehealth therapy for mental health conditions, therapists and patients however may be hesitant to perform telehealth therapies targeting memories of traumatic experiences. paulik and colleagues (2021) describe key clinical considerations and recommendations for delivering imrs by telehealth: the importance to consider the context (living condition, level of privacy during therapy, levels of covid-19 restrictions, voluntariness of choice for telehealth) perceived and real safety (being physically safe and having a safe place to perform imrs); practical (travelling time, preparation structure of sessions, camera position, exhaustion levels of therapist, quiet environment) and technological issues (stable connection, type of device) therapeutic alliance (reduced level of eye contact, more difficult observation of body language); depth of emotional processing (stimulating visualization and emotion­ ally connect to the image); and dissociation (strategies to stop dissociation). imrs might be more easily adapted to telehealth delivery than other trauma-focused methods such blended delivery of imrs 4 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ as emdr because imrs does not require dual stimulation tasks, and during rescripting patients have their eyes closed and are not focused on the therapist. imrs also does not require the provision of materials in the sessions, such as handouts for completion of homework (paulik et al., 2021). in the following a case illustration is given of the application imrs protocol by telehealth. c a s e i l l u s t r a t i o n presenting problem and client description the case report is presented with permission of the patient, for privacy reasons several changes were made to the report (e.g. names, dates). larry is a 42-year-old divorced, unemployed man, who was referred by the assertive community treatment team (act) to the trauma department of a mental health care center in the netherlands for treatment of ch-ptsd. act is a service-delivery treatment model that provides comprehensive, locally based treatment to people with serious and persistent mental illnesses (drukker et al., 2011). during the assessment phase the following dsm-5 classification was made based on the following semi-structured clinical interviews: scid-5-p (first et al., 2015); scid-5-cv (first et al., 2016) and caps-5 (weathers et al., 2018): antisocial personality disorder with schizoidand borderline personality traits; depression, adhd and chronic childhood ch-ptsd. he suffers from low self-esteem, difficulties in aggression regula­ tion, and difficulties with maintaining intimate relationships. he feels detached from others, is hyperalert, worries a lot and can be impulsive, experiences nightmares and sleeping problems. larry functioned on the fringes of society for several years, but has recently found a volunteer job and now lives independently. he has a limited social network because of his distrust of others. larry grew up in a family in which he did not feel safe and connected. larry was the middle child of three. larry has few memories of his childhood and mentions that he was a hyperactive and difficult child. he felt unwanted as a child and had an emotionally detached father who worked a lot and a gentle mother who was a housewife. she died in a car accident caused by a drunken driver when larry was 6 years old. larry was not allowed to attend the funeral because his father did not let him attend it. after his mother passed away, his brother, grandparents, and friends looked after larry when larry’s dad attended work. larry was sexually abused by the father of a befriended family, who baby-sat larry, from his seventh till tenth year of age. at school larry experienced concentration and behavioral problems and regularly got into fights. there was very little support and attention for him at home. he went to technical secondary vocational education. he quit school after getting beaten up by a group of boys at age sixteen. he met his wife at age eighteen, they married after she got pregnant. larry once forced his wife to have sex after which she filed a divorce. she left him with their child, bachrach, giesen, & arntz 5 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ which was three years old at that time. after the divorce, larry did not see his daughter anymore. larry held numerous jobs and often experienced conflicts at work. he got addicted to gambling and into serious debts, he lost his house and lived on the street for three years. during this stressful period, he experienced several psychotic episodes; the first around age of thirty-two. because of the psychotic experiences larry sought mental help and his general practitioner referred him to a act team. the act team helped him to reduce psychotic problems, depressive complaints and helped him to live independently again. he found volunteer work and restored contact with one brother and one friend. his psychotic symptoms were resolved and he succeeded in living independently again. he now lives a tranquil and isolated life, with which he seemed satisfied. larry drank about five beers a day and smoked weed occasionally; he received anti-psychotic-, anti-depressants-, anti-adhdand sleep medication. he was referred for trauma therapy by the act team and was offered to take part in the irem-freq study. the irem-freq study design is registered in ntr7153 and approved by the ethics committee of the university amsterdam. the design manuscript of the study was sub­ mitted recently (wibbelink et al., 2021). larry was randomly allocated to the two times a week imrs condition, 90 minutes per session with a maximum of 12 sessions. in the irem-freq imrs protocol the therapist rescripts the traumatic situation in the first six sessions, from the seventh session till twelfth session the patient as his current self-rescripts the traumatic event (boterhoven de haan et al., 2020). due to the pandemic, the face-to-face sessions had to be stopped, and treatment was continued online. because of methodological considerations, the study participants that could not be treated visà-vis were excluded from the irem-freq study (see wibbelink et al., 2021, and trial registration). therefore, the case of larry could be separately presented. larry was a friendly, quiet, reserved but cooperative man who made the impression to be at ease living an isolated life. the therapist felt sympathy and empathy for him. larry did not show any aggressiveness to the therapist, nor did he evoke any negative or intense countertransference emotions. course of treatment the first two sessions were delivered face-to-face, after which the covid-pandemic led to delivering the treatment online. in the first session trauma processing does not takes place. in this session the therapist got acquainted with larry and explained the rational of imrs. the therapist and larry made a list of traumas that larry wanted to address. this list included trauma’s that contributed to the ptsd diagnosis as well as traumas that did not qualify for the a-criterion of ptsd in the dsm-5 definition of ptsd. the list is considered to be flexible, the patient can add trauma’s during treatment and/or can change the order in which traumas are addressed. in the first session a trial imrs intervention with a mildly negative memory, preferable before age of 12, is provided to blended delivery of imrs 6 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ let patients become familiar with imrs. in larry’s case this was getting beaten up at school. larry’s list of traumas included the following themes: • sexual abuse at age seven till ten years of age • death of his mother at the age of six • getting beaten up by a group of boys at age 16 • being threatened by a motorcycle gang at age 40 • aggressive behavior against and sexual abuse of his ex-wife at age 22 in the second session, the first active imrs session, the loss of his mother due to a car accident was processed. larry was not allowed to see his mother after the accident and to attend the funeral. larry therefore was not able to properly take part in his mother’s farewell. his family members didn’t talk about her death after the funeral. therapist: please close your eyes larry, i would like you to speak in the present tense and the i-form as if the situation which we will process is happening right now. please go back to the situation where your mother died. where are you? what is happening? larry: i see my mom; she is crushed in the car (crying). i’m overwhelmed and feel sad. therapist: what do you need? larry: i’m so lonely. somebody should comfort me. therapist: i’m here. oh larry, this must be so sad for you. it is okay to cry, losing your mommy is a great loss. i’ll take care of you. let me comfort you. i’ll put my arms around you. is there anything else you need? larry: i feel calmer now. therapist: and the drunk driver, is something needed towards him? larry: yes! he gets away with it. he should be punished. therapist: okay, i’m still there, i’ll confront this driver. how can you be so irresponsible? do you realize what you have done? you just killed a mother of this friendly little boy who needs his mother. and how dare you to just leave the scene of the accident and just drive through. this is a crime; you belong in jail! police officer please incarcerate this man. larry: i see them taking him away. bachrach, giesen, & arntz 7 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ therapist: what would you like to happen now? larry: i want to see my mom and tell her that i love her. i want to say goodbye. in the rescripting larry felt very lonely and in need of support and comfort. he felt relieved to get comforted in the rescripting and experienced a reduction of feelings of revenge towards the drunken driver. because of the covid-19 pandemic and the government restrictions of the lockdown larry was not able to attend physical appointments. larry was therefore asked if he would like to continue the imrs by telehealth, to which he agreed. in the following session the use of telehealth by secured video call was set up, because the sound of the video call was of poor quality the audio of the videocall was delivered by phone. the third imrs session was performed via telehealth. notably larry was very much at ease at his own home, he was drinking coffee, smoked cigarettes and spontaneous­ ly interrupted the sessions by going to the toilet and was distracted by his cat who walked on his keyboard. these behaviors are not uncommon when delivering therapy by telehealth (paulik et al., 2021). practical agreements such as quiet environment without distractions should be made, preferably in advance, in order to perform imrs successfully by telehealth. the therapist and larry therefore discussed how larry could best profit from the telehealth sessions. they agreed on larry attending telehealth sessions similar to the face-to-face sessions (e.g. no distraction, drinks and toilet visits, the imrs proce­ dure could thereafter proceed in exactly the similar manner as to face-to-face imrs. after these ground rules were set, therapist and larry carried on with the imrs procedure and succeeded to process the most important index trauma the sexual abuse. the (index) trauma that they worked on was memory of the first time that the sexual abuse took place. this was a situation in a car in which he had to perform oral sex the abuse always took place in this car; therefore, this situation was exemplary of the majority of the sexually abuse experiences. in the rescripting larry felt very anxious and in need of protection. therapist: i step into the image, do you see me? i take you out of the car immediately, come and stay behind me larry. i lock the car, he cannot get out anymore. what are you doing? you are damaging larry, that is very bad and mean. i brought police officers with me. arrest this man! he is abusing larry. incarcerate this filthy man! what do you see larry? larry: i see him being taken away. therapist: what else do you need? larry: i feel shaky and anxious. what happens when they let him go? blended delivery of imrs 8 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ therapist: i’ll tell the police to lock him up forever. he will not be able to hurt you anymore. you are safe now larry. is there anything else you need? larry: i feel lonely and sad. delivering safety to larry was followed by condolement. larry wished his dad would comfort and help him. in the rescripting it became clear that larry’s father was not able to comfort larry, he neglected larry. the therapist therefore confronted larry’s dad that it is his task as a parent to take care for larry and provided safety and comfort to little larry. thereafter, therapist continued rescripting by giving comfort to little larry. little larry was explained that he was not guilty of the abuse, but the perpetrator was, and that the man who abused him misused the vulnerability of larry and should be punished for his actions. the therapist reassures little larry that if needed the therapist would be there for larry, therapist: every time you’ll need me, i’ll be there for you. at the end of the rescripting larry wants to play soccer with a friend. larry feels happier and less guilty at this point. in the 4th session (second telehealth session) larry wanted to address his own sexual­ ly aggressive behavior towards his ex-wife, which led to a divorce and loss of contact with his child. the hotspot in this situation was his sexually behavior in their bedroom. therapist: okay larry, i’m here. what do you need right now? larry: i feel so bad, i want to stop myself. because larry explicitly wanted to take action himself, the therapist decided to violate the imrs protocol by letting adult larry rescript the situation (fourth session instead of seventh session), assuming that it would be more powerful and effective when larry would address his own aggressive behavior. therapist: what does adult larry want tell to the twenty-two-yearold larry, go ahead tell him. larry: you fool, stop immediately. you should never do this; this is so wrong. get out, you are destroying your life and that of your family. therapist: how does the twenty-two-year-old larry react? larry: he startles, he’s ashamed so badly (crying). therapist: what else would you like to do? larry: i want to tell my wife i’m sorry. therapist: okay, tell her as current larry what you want to say, go ahead. bachrach, giesen, & arntz 9 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ in the rescripting, current larry acknowledges to his ex-wife that he has a deep remorse. therapist: is there anything else you feel like doing? larry: i want to tell my daughter how sorry i am. that i’ve been wrong. i don’t want to take the father role in her life. but i want her to know i miss her. therapist: go ahead larry. current larry apologizes to his current daughter in the rescripting. after that he feels the need for comfort because of all his losses, the therapist offers this to him in the image by giving him a hug and by validating his feelings and speaking out comforting words. he feels relieved afterwards. in the 5th session (third via telehealth) larry addresses a situation in which he was beaten up by a group of boys. the sudden confrontation appeared to be the most traumatic point of the memory of this situation. little larry felt in need of safety and wanted to escape the boys. therapist: i want you to know that it is not your fault. this must have been very scary for you. they should be ashamed that they’re threatening you and beat you up while they’re with so many. how do you feel now? what do you need? larry: i’m very angry. they should be punished. they should experience the same as what they did to me. therapist: you guys are so bloody mean; you should feel ashamed of yourselves. i’ll hit you and kick you wherever i can. if you’ll do this again, you’ll meet me once again. how do they react? did i punish them enough or is more needed? larry: i don’t know. it feels bad to see them beaten up. i rather have the police take them into custody, let them be scared. therapist: very well, we rewind the film. therapist: you have no right to be so cruel to this boy. i have brought police officers with me. police officers take care of this scum, make sure they’ll never harm larry again and to inform their parents about their gratuitous violence. once larry felt safe he felt that the boys needed to be punished for their deeds and he wanted to be sure that they would never harm him again. the therapist informed the police who took the boys into custody. blended delivery of imrs 10 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ therapist: does it feel okay for you now, or are you in need of something else? larry: it is okay, i feel calm now. therapist: shall we do something nice? larry: let’s play soccer. therapist: let’s go to the square and have some fun. feel the sun, smell the grass. enjoy playing soccer for a while…… open your eyes and return to the here and now. larry felt relieved and at ease after the imrs. in the 6th session larry chose a situation in which he was threatened by a motorcycle gang whereby he felt very unsafe for several days. at the start of the threats, he didn’t dare to go to sleep for days which resulted in sleep deprivation and subsequently a psychotic episode. the most traumatic moment of the memory in this situation was the moment he was told that he was dating a former girlfriend of a member of the motor cycle gang and he realizes he is in trouble. in the rescripting larry feels anxious and is in need of safety. therapist rescripts the situation by rescuing larry by taking him out of the situation. after larry is safe, he wants to be sure they’ll never harm him again. the motor gang is incarcerated by the police and they get locked up. larry feels relieved and at ease after the rescripting. from the 7th session (fifth telehealth session), following the protocol, the patient rescripts the traumatic event as his current self and therapist coaches the adult-self when necessary, to do what is needed. at the start of the session larry shares that he no longer feels anxious when he hears the sounds of motor bikes. in this session larry wants to address the sexual abuse because it is still bothering him, the same traumatic situation in which larry got abused again was processed for a second time. at first larry was asked to step into the situation as little larry. the most traumatic aspect of the memory of the situation was the moment at which the sexual abuse was going to take place. therapist: what do you need right now? larry: i want to get out of the car, i want to get away. therapist: okay, keep your eyes closed and step into the situation as adult larry. what is happening? what do you see? larry: i see little larry, he is so scared. it makes me angry. therapist: what would you like to do right now? bachrach, giesen, & arntz 11 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ larry: i want to beat the man up and to have the police lock him up forever. he is not allowed to abuse little larry. therapist: okay. go ahead, do what you want to do. adult larry confronts the abuser. larry: i tell him he is not worth living, that he is really disgusting and that everybody should know what he has done, you’re a fucking loser. i beat the hell out of him. therapist: how does little larry react? larry: he feels that justice is done. he is peaceful now. therapist: larry what inclination do you have now? larry: i want to tell little larry that he can’t help it, he is innocent and a good boy. i am always there for him. therapist: very well, just say that directly to little larry. larry: [speaks directly to little larry] therapist: is there anything else that’s needs to be done? larry: no, it is okay now. therapist: what about your father, does he need to know? larry: maybe. i don’t know, we can try. therapist: let’s go to your father, what do you want to tell him? larry: i tell him what happened. therapist: how does your father react? larry: he startles. he feels uncomfortable. he doesn’t know how to react. therapist: is there anything else you want to tell him? larry: you should have been more careful, and looked after little larry; he needs you to be there for him. therapist: how does little larry react? blended delivery of imrs 12 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ larry: he is sad. he needs a hug. my father is never going to give him that. therapist: is there anything you can do for little larry? larry: i’ll hug him till he is calm. when adult larry feels satisfied the therapist tells larry: ok, keep your eyes shut. go back to the situation, but now as little larry and start the film from beginning and tell me what happens when adult larry intervenes? in the end the therapist asks little larry: what would you want to happen right now? little larry: it feels awkward that my father doesn’t know how to react. i want adult larry to tell it is not my fault. therapist: go ahead, ask adult larry what you need. what does adult larry do? little larry: he tells me i’m a good boy, that it is not my fault that father is clumsy. a father shouldn’t be that neglective but should be giving his son attention and see his need for comfort after having lost his mother and after what he went through during the abuse. he tells me that father is not capable of giving that to me. he gives me a hug. after which they leave the house to play soccer together, they have fun and the little larry feels relaxed. in the eight session (sixth telehealth session) larry states that he is no longer expe­ riencing nightmares and flashbacks and feels that he has progressed enormously in treatment; he does not have any situations anymore which he wants to address. larry also feels at ease that there currently is no contact with his daughter and grandchildren, he feels resignation about this situation. larry wished that he received imrs much earlier in his life. after ptsd treatment, larry was able to reduce his antidepressant (90%) and sleep medication (50%). larry was inclined to stop with the act treatment which he received for several years. therapy outcome and prognosis larry was considered an early completer because he only needed seven out of twelve sessions. therapy outcome and prognosis for larry, were very good. the follow-up as­ sessment of self-reported and clinician administered ptsd symptoms, quality of life, gen­ eral psychiatric symptoms and trauma related cognitions about self and others showed dramatic, significant and clinical improvements (see table 1). the prognosis of larry is expected to be very good based on the follow up results after 1 year. bachrach, giesen, & arntz 13 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ table 1 results on outcome measures at baseline, after completion of imrs and follow up measure baseline after completion of imrs 1 year follow up clinician administered ptsd scale for dsm-5 (weathers et al., 2018) 33 9 3 pcl-5 index trauma (weathers et al., 2013) 51 10 15 pcl-5 other traumatic events 51 9 15 whodas 2.0 (üstün et al., 2010) 47.92 16.67 12.50 symptom check list-90 hostility (derogatis & unger, 2010) 6 6 6 ptci (foa et al., 1999) negative cognitions about self 4.48 2.14 1.86 negative cognitions about world 5.57 2.86 1.71 self-blame 5.40 2.40 4.40 euroqol eq-5d-5l quality of life vas (busschbach et al., 2016). average of general dutch population age group 40-49 = .85, sd = .20) 0.43 0.77 0.85 beck depression inventory bdi-ii (beck et al., 1996). 28 6 7 happiness (abdel-khalek, 2006). fairly unhappy fairly happy entirely happy d i s c u s s i o n larry’s case is unfortunately exemplary for patients with ch-ptsd in which underdiag­ nosis and undertreatment is common. ptsd is often not diagnosed; only 2% to 11% of the patients with ptsd actually have their diagnosis noted in the medical record in primary care and 18-35% in mental health care centers (kantor et al., 2017; meltzer et al., 2012). unfortunately, less than half of the patients with ptsd diagnosed, or even fewer, actually receive treatment for ptsd (kantor et al., 2017; meltzer et al., 2012). this creates a major risk for escalation of clinical disorders (such as psychosis in larry’s case), chronicity and long treatments, poor quality of life and high societal costs. early detection and treatment of ptsd urgently is needed in order to counter these negative effects. imrs has proven to be an effective and highly acceptable procedure for both patients as therapists and seems a very good option for treating ch-ptsd effectively (boterhoven de haan et al., 2020; morina et al., 2017; raabe et al., 2015). in larry’s case, blended delivery of imrs 14 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ which at forehand seemed to be a very complex case, only seven sessions were needed to reduce ptsd and depressive symptoms drastically, and increase his quality of life. by just following the treatment protocol, the application of imrs could be performed by telehealth in a regular manner in quiet a complex case. this is in line with research previous findings which show that trauma focused therapy (e.g., emdr and imaginal exposure) is effective, safe, and feasible in patients with ptsd and complex symptoms such as severe psychotic disorder (van den berg et al., 2015). the delivery of imrs by tel­ ehealth did not seem to have a negative impact on the effectiveness, quality and patient satisfaction; which is in line with systematic reviews on effectiveness of psychological telehealth treatments for ptsd (not imrs and not specifically ch-ptsd) (berryhill et al., 2019; bolton & dorstyn, 2015; finkelstein et al., 2006; simpson, 2009; sunjaya et al., 2020; varker et al., 2019). in larry’s case the delivery of imrs by telehealth proceeded similar to face-to-face sessions. it might have helped that the initial start of the trajectory was face-to-face due to which patient and therapist got acquainted before switching to telehealth. larry’s context might be favorably to telehealth, he had had a good internet connection, lived by himself –privacy was guaranteed and was motivated to continue treatment by telehealth. it however might be helpful if basic agreements on how imrs by telehealth is delivered and in which manner patients can take care for privacy, quiet en­ vironment, good stable internet connection, focus during sessions and how to deal with possible dissociation, were discussed in advance (paulik et al., 2021). it is important to investigate the effectiveness of delivering imrs by telehealth in an adequately designed and powered study. furthermore, it is unlikely that telehealth is applicable to all patients; some patients might respond better to face-to-face imrs compared to imrs delivered by telehealth. it is important to investigate patient and context characteristics in order to improve treatment selection. it is important to note that application of telehealth and effectivity of telehealth might also depend on therapists' attitudes towards telehealth applications. therapists might be reluctant to perform ptsd treatments online, which might interfere with outcomes and extensive application of telehealth. however, several systematic reviews on effectiveness of psychological telehealth treatments for various disorders including ptsd show that the effectiveness, drop-out rates, quality and patient satisfaction, is comparable to face-to-face therapies (berryhill et al., 2019; bolton & dorstyn, 2015; finkelstein et al., 2006; simpson, 2009; sunjaya et al., 2020; varker, brand et al., 2019). which might indicate that this reluctance and attitudes towards telehealth might not be justified. in conclusion, larry’s case illustrates that imrs can be safely and effectively performed by telehealth for ch-ptsd, no stabilization phase was needed and only seven sessions were needed to drastically reduce ch-ptsd and depressive symptoms, and to increase quality of life. this gives hope and additional possibilities to reach out to patients with ch-ptds due to the fact that telehealth might have some of advantages for patients, especially, but certainly not only, during the pandemic. this bachrach, giesen, & arntz 15 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://www.psychopen.eu/ patient group is so often undertreated for their ptsd, this case report shows that the reluctance for direct ptsd treatment through telehealth is not rightfully. funding: the authors have no funding to report. acknowledgments: we thank research assistant melissa kir and phd student sophie rameckers for the data collection and data processing. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s abdel-khalek, a. m. 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(2020). treating posttraumatic stress disorder remotely with cognitive therapy for ptsd. european journal of psychotraumatology, 11(1), article 1785818. https://doi.org/10.1080/20008198.2020.1785818 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. bachrach, giesen, & arntz 19 clinical psychology in europe 2022, vol. 4(3), article e7815 https://doi.org/10.32872/cpe.7815 https://doi.org/10.1037/pas0000486 https://www.ptsd.va.gov https://doi.org/10.1186/s13063-021-05712-9 https://doi.org/10.1080/20008198.2020.1785818 https://www.psychopen.eu/ blended delivery of imrs (introduction) case illustration presenting problem and client description course of treatment therapy outcome and prognosis discussion (additional information) funding acknowledgments competing interests references ambassadors of clinical psychology and psychological treatment letter to the editor, commentary ambassadors of clinical psychology and psychological treatment claudi bockting 1 , winfried rief 2 [1] department of psychiatry, amsterdam university medical centers, location amc, university of amsterdam, amsterdam, the netherlands. [2] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2022, vol. 4(1), article e8545, https://doi.org/10.32872/cpe.8545 published (vor): 2022-03-31 corresponding author: winfried rief, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, gutenbergstrasse 18, 35032 marburg, germany. e-mail: rief@unimarburg.de the european association of clinical psychology and psychological treatment (ea­ clipt) board has decided to nominate ambassadors of clinical psychology and psycho­ logical treatment. ambassadors are selected according to their achievements for our field, but also according to the perspectives for further fostering the visibility and impact of clinical psychology. the typical profile of our ambassadors is the high quality of translational research. ambassadors commit to show their support for the association and its mission. we are proud that two extremely well-known colleagues confirmed to become am­ bassadors for eaclipt: paul emmelkamp and peter fonagy, and they will be introduced in this issue. we are extending this list and will announce it in future issues of cpe, and we promise to consider gender and diversity issues. congratulations to paul emmelkamp and to peter fonagy, and to all of us because we have tremendous personalities in our group. claudi bockting (president of eaclipt) winfried rief (editor of cpe) this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8545&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0002-9220-9244 https://orcid.org/0000-0002-7019-2250 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. ambassadors of clinical psychology and psychological treatment 2 clinical psychology in europe 2022, vol. 4(1), article e8545 https://doi.org/10.32872/cpe.8545 https://www.psychopen.eu/ the cultural supplement: a new method for assessing culturally relevant prolonged grief disorder symptoms latest developments the cultural supplement: a new method for assessing culturally relevant prolonged grief disorder symptoms clare killikelly 1,2 , andreas maercker 1 [1] department of psychology, university of zürich, zurich, switzerland. [2] department of psychiatry, university of british columbia, vancouver, canada. clinical psychology in europe, 2023, vol. 5(1), article e7655, https://doi.org/10.32872/cpe.7655 received: 2022-03-02 • accepted: 2022-11-14 • published (vor): 2023-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: clare killikelly, department of psychology, university of zurich, binzmuehlestrasse 14/17, ch-8050 zurich, switzerland. e-mail: c.killikelly@psychologie.uzh.ch abstract background: the new diagnosis of prolonged grief disorder (pgd) is both an opportunity and a challenge for researchers, clinicians, and bereaved individuals. the latest definition of pgd includes a refreshing and novel feature: the cultural caveat, i.e., clinicians must determine that the grief presentation is more severe and of longer duration than would be expected by an individual’s culture and context. currently, there are no guidelines on how to operationalize the cultural caveat in mental health care settings. method: to respond to this important demand we have developed, piloted, and tested the cultural supplement module of the international prolonged grief disorder scale (ipgds). the cultural supplement aims to provide clinicians with a catalogue of culturally relevant symptoms of grief that indicate probable pgd alongside a simple framework for cultural adaptation for use in specific clinical settings. results: in this short report we outline the rationale and aim of the cultural supplement and provide a summary of our latest validation studies of the ipgds with bereaved german-speaking, chinese and swiss migrant individuals. we also provide a step-by-step framework for adaptation of the cultural supplement that clinicians and researchers may use when working with different cultural groups. conclusion: to date, this is the first pgd questionnaire based on the icd-11, and the first to include a cultural supplement that can be adapted to different contexts and groups. this cultural supplement will provide clinicians and researchers an easy-to-use assessment tool with the aim to improve the global applicability of the icd-11 pgd definition. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7655&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0003-2661-4521 https://orcid.org/0000-0001-6925-3266 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords prolonged grief disorder, icd-11, international prolonged grief disorder scale, cultural adaptation highlights • we explore the role of culture and the new diagnosis of prolonged grief disorder. • we provide the framework for a new method of cultural adaptation for a grief assessment measure. • we summarize new research using this new method in different cultural groups around the world. • we provide key recommendations for clinical practice. p r o l o n g e d g r i e f d i s o r d e r in 2022 the latest revision of the icd-11 was implemented in clinical and research set­ tings around the world. prolonged grief disorder (pgd) is a new mental health disorder included in the icd-11. the inclusion of grief as a mental disorder has been hailed as both an opportunity and a challenge for researchers, clinicians, and patients (bryant, 2014; killikelly & maercker, 2017; stelzer, zhou, merzhvynska, et al., 2020; stroebe et al., 2008). in the latest iteration of the icd-11 the who outlined a new remit for the structure and content for disorder definitions. a strong emphasis on clinical utility and global applicability was prioritized over further delineation of accessory symptoms and subtypes (keeley et al., 2016). this led to the inclusion of refreshing new features in the diagnostic definition of pgd. the cultural caveat purports that for a diagnosis to be assigned, the symptoms of pgd must be more intense, more severe and of longer dura­ tion than would normally be expected for the individuals’ cultural or religious context. this is an exciting and novel feature for a diagnostic definition. it holds the promise of a more inclusive, globally applicable classification system, that may improve diagnostic accuracy, therapeutic rapport and treatment outcomes (aggarwal, 2013). however, the icd-11 falls short of providing clear guidance on how to operationalize the cultural caveat. questions remain about how to differentiate symptoms of ‘normal’ bereavement in different contexts (e.g., child loss, unnatural violent loss, ambiguous loss) alongside ‘disordered’ symptoms in different cultures around the world. historically the fields of culture, psychology, and psychiatry have only recently intersected to develop models and frameworks to explore the contribution of culture to psychopathology. earlier in the history of psychiatry, it had been largely assumed that the symptoms of disorder expressed in north american and european populations were representative globally. recent research has confirmed that the symptom content and structure, duration, chronicity and response to treatment can be highly dependent on culture (kohrt et al., 2014; nichter, 1981). this relativist view of disorder purports that the boundary between normal and abnormal is a social judgment or a social/cultural cultural supplement of the ipgds 2 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ norm and that the definition of abnormal will change depending on particular culture norms (canino & alegría, 2008). there are several examples of how disordered grief may manifest differently in different cultures. unique culturally bound symptoms of pgd have been identified worldwide (killikelly et al., 2018; rosenblatt, 2008). for example, in traumatically bereaved kurdish refugees one common expression of severe grief was to imitate the behaviours of the deceased (hall et al., 2014), 52% of cambodia refugees reported dreams of the deceased and this was associated with elevated pgd symptoms (hinton et al., 2013), in japan bereaved individuals will control their grief at funerals as they do not want to make others uncomfortable (killikelly et al., 2022). on the other hand, the universalist approach (or pan cultural approach) suggests that mental disorders have core symptoms of internal disorder however these symptoms may manifest differently in different contexts (canino et al., 1997). a famous study on experiences of grief around the world examined the expression of emotion after bereavement in 78 cultures (rosenblatt et al., 1976). they concluded that it is a basic human characteristic to react with emotions towards bereavement and for the majority of societies these emotions included crying, overt anger, and fear. in an early study comparing dutch and slovenian spouses who lost their partner due to unnatural causes it was found that there were more similarities than differences between cultures (cleiren et al., 1996). although in slovenian people symptoms of depression were slightly higher the overall pattern was very similar. there is a gap in the research field, as currently there are no up to date studies that directly compare symptoms of pgd across cultures, particularly the latest icd-11 definition of pgd. additionally, there are no culturally adapted questionnaires or measures of prolonged grief disorder. it is therefore difficult to ascertain if pgd symptoms follow a relativist or universalist trend, especially without adequate assessment measures. new research is consistently demonstrating the importance in cultural adaptation of mental health assessment interviews and questionnaires (hall et al., 2016). however cur­ rently, there is discourse and debate in the field over the level of cultural adaptation that is required to successfully evaluate mental disorders in cultures outside of europe and north america (harper shehadeh et al., 2016; heim & kohrt, 2019). there are currently two broad approaches to the development or adaptation of culturally sensitive mental health tools. the etic approach refers to a questionnaire or intervention developed out­ side of the culture whereas the emic approach refers to a questionnaire or intervention developed from within a culture (triandis & marin, 1983). both of these approaches have been used in the cultural clinical psychology field to varying degrees (heim et al., 2017; killikelly et al., 2018; rasmussen et al., 2014) and with conflicting results. some clinicians and researchers argue that the etic approach is enough to provide a clear and valid understanding of disorder, while others argue that the evaluation must stem from within the culture in order to be valid (aggarwal et al., 2014; berry, 1969). currently there is a dearth of both etic or emic approaches to assessment in the field of prolonged grief killikelly & maercker 3 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ diagnosis, assessment and treatment. here we consider both the emic and etic approach in a new combined pgd assessment methodology. i p g d s a n d c u l t u r a l s u p p l e m e n t the international prolonged grief disorder scale (ipgds) is a two-part assessment ques­ tionnaire. this questionnaire is unique as it includes both emic and etic methodology within one questionnaire. the first part is the ‘standard scale’; a 14-item scale developed directly from the latest narrative definition of pgd from the icd-11. this represents the etic approach. it contains two core items (longing or yearning for the deceased, preoccupation with the deceased), accessory items including examples of emotional pain, time and impairment criteria and the cultural caveat. the standard scale can be used to determine a preliminary diagnosis of pgd and is a clinical diagnostic tool. the second part of the ipgds is the cultural supplement and uses an emic approach. the cultural supplement was developed from focus groups and key informant interviews from health care professionals and bereaved individuals from a range of cultural backgrounds. the aim was to collect a catalogue of possible pgd symptoms that may be culturally relevant above and beyond the standard icd-11 items (table 1). the cultural supplement is intended to provide a more in-depth assessment of possible pgd symptoms that may improve treatment decision making with clinical guidance. for example, recently a novel study of bereaved balinese family members revealed a probable caseness of 0% for pgd, 1% for posttraumatic stress disorder and 2% for depression. these findings are striking as usually rates of pgd are expected to be at least around 1% and more commonly less than 10% of the population. the authors conclude that there are perhaps aspects of the balinese culture that protect individuals from developing mental health disorders (djelantik et al., 2021). however, another explanation could be that the scale used to measure pgd was not culturally adapted from within the population and instead only used at etic approach. therefore, the scale may not have captured pgd symptoms that are most distressing or representative in this population. it was recently suggested that pgd assessment across cultures would benefit from the inclusion of both etic and emic methods within an assessment tool, such as provided by the ipgds (kokou-kpolou, 2021). below is a summary of our research exploring the development and first applica­ tions of this combined methodology using both the etic ‘standard scale’ and the emic cultural supplement of the ipgds in different cultural groups. cultural supplement of the ipgds 4 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ table 1 ipgds cultural supplement items: developing a catalogue culturally relevant of grief symptoms cultural supplement item germanspeaking sample chinese sample arabic migrant sample i experience strong physical problems since the loss (e.g., headache, problems with appetite). i would do anything to feel close to the deceased (e.g., visit their grave everyday, sleep next to their picture). if i could, would do anything to feel close to the deceased (e.g., visit their grave everyday, sleep next to their picture). (slightly reworded item) since the loss my behavior has changed drastically in an unhealthy direction (e.g., excessive alcohol consumption). the loss shattered my trust in life or faith in god/a higher spiritual power. the loss shattered my beliefs (i.e. my understanding of how the world should work, spiritual beliefs, religious beliefs). it is impossible for me to focus. my grief is so intense that i feel stuck in grief. i just can’t seem to fall back into a rhythm. i feel paralyzed and disconnected, (e.g., as if i am not in my own body). i have no energy or desire to engage in activities. this life holds no meaning since the death. i want to die to be with the deceased. i don’t feel close to other people or feel no satisfaction when being around others. i feel like i have completely lost control. i feel like i have completely lost control over my life or over myself. i am searching for the deceased with the hope to find him/her. killikelly & maercker 5 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ cultural supplement item germanspeaking sample chinese sample arabic migrant sample i constantly look back upon the past relationship. i feel so helpless since i lost him/her. i feel he/she is beside me. i cry loudly when i think of the loss. i can’t trust others since the loss. i feel disconnected from the new society i live in (e.g. the country i move to). without a funeral (body, or other burial ritual) i cannot move on with my life. tbc not knowing what happened to them is the worst part. tbc i would rather know they are dead then face this uncertainty. tbc if i were in my home country i would have more support for my grief. tbc i feel so overwhelmed with grief that i cannot deal with all the changes in my new country. tbc there are so many things to worry about in my new country that i never have time to grieve. tbc when i talk about the loss no one understands me. tbc i am grieving for multiple loved ones at the same time. tbc note. the first column represents the items of the ipgds cultural supplement. the subsequent columns indicate from which cultural group the item was developed and validated. the items with tbc indicate that these need to be validated in a large sample. the cultural supplement emerged from a bottom-up qualitative approach. items were developed from key informant interviews with german-speaking and chinese-speaking health care workers (killikelly et al., 2020; stelzer, höltge, et al., 2020; stelzer, zhou, cultural supplement of the ipgds 6 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ merzhvynska, et al., 2020), bereaved migrants and refugees (killikelly et al., 2021) and japanese health care professionals (killikelly et al., 2022). currently there are several versions of the cultural supplement that are being validated in different cultural groups. the chinese version has been psychometrically validated in a sample of n = 325 chinese bereaved (killikelly et al., 2020), the migrant cultural supplement (for bereaved migrant individuals living in a host country) has recently been validated in 121 bereaved migrants (in preparation). a japanese version and a version for arabic speaking refugees experi­ encing ambiguous loss are currently under development. s u m m a r y o f r e c e n t f i n d i n g s f r o m t h e i m p l e m e n t a t i o n o f i p g d s c u l t u r a l s u p p l e m e n t below we outlined how the cultural supplement of the ipgds has been used to explore culturally relevant symptoms in different cultural groups. to date the cultural supple­ ment has been used in two main ways 1) to compare and contrast a wide range of possible pgd symptoms between different cultural groups 2) to identify new culturally relevant symptoms of pgd within a cultural group or context. the earliest results from the implementation of the cultural supplement in the chinese bereaved sample show the value of the supplement. firstly, an item specific analysis revealed that certain items were endorsed more strongly in the chinese sample when compared to the german speaking sample. for example, the most strongly endorsed item in the chinese sample was item 15 (i constantly look back upon the past relationship) whereas for the german speaking sample it was item 17 (i feel he/she is beside me). additionally overall scores on the cultural supplement were higher in the chinese sample than the german speaking sample, possibly indicating the items were more culturally relevant for the chinese sample, as expected (killikelly et al., 2020). our recent study explored pgd in germanspeaking and chinese samples using a network analysis. we confirmed the presence of a core network of pgd symptoms consisting of yearning and emotional distress in both swiss and chinese participants (stelzer, höltge, et al., 2020). however, when culturally relevant items were included in the network this improved the predictability of the network for the chinese sample only, possibly indicating that the cultural supplement yielded a better fit. important network differences also revealed a strong connection between item 11 (wish to die to be with the deceased) and item 14 (searching for the deceased) for chinese participants that was not found for german-speaking participants. we concluded that separation distress is a particularly relevant therapeutic target for chinese participants. in our latest study, 121 migrants to switzerland completed the standard scale of the ipgds and the culturally adapted ‘migrant version’ of the cultural supplement. this version of the cultural supplement was developed from focus groups and interviews with syrian migrants. new items were developed based on these interviews (e.g., item 4: the killikelly & maercker 7 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ loss shattered my beliefs (i.e., my understanding on how the world should work, spiritual beliefs, religious beliefs), item 13: i feel like i have completely lost control over my life or over myself and item: 19 i feel disconnected from the new society i live in (e.g. the country i moved to). each of these items must be answered in response to the loss of a loved one. to reduce the item list of the cultural supplement, a preliminary analysis of the response rates to each item revealed that the most endorsed items included item 4 and item 19. this potentially indicates that the inclusion of these culturally relevant items improved the sensitivity of the migrant version of the cultural supplement. r e c o m m e n d e d m e t h o d s f o r a d a p t a t i o n o f t h e c u l t u r a l s u p p l e m e n t researchers and clinicians might be interested in developing a cultural supplement for the ipgds based on their own community and context. in line with this we propose the following steps for adaptation (see figure 1). figure 1 step by step method for cultural adaptation of the ipgds cultural supplement 1. item development step 1: identification of domain and item generation step 2: translation (who guidelines): forward translation + expert panel + back translation  focus groups (fgs) fg 1 = 6-10 health care workers fg 2 = 6-10 bereavement professionals note. meeting with cultural brokers, expert judges (clinicians)  discussion of the questions and evaluation of each item to determine whether they fit and represent the domain of interest or not (boateng et al., 2018) 2. scale pretesting step 3: content validity step 4: pre-testing of questions  6 cognitive interviews (cis) with bereaved note. “think-aloud” and “probing” methods (beatty & willis, 2007) with target users to evaluate sources of response error in the questionnaire (beatty & willis, 2007) 3. piloting and validation step 5: pilot study step 6: psychometric validation  pilot study with at least n = 20 target users note. feedback on feasibility, acceptability, useability  psychometric validation with n = 200 target users cultural supplement of the ipgds 8 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ however, first, in cross cultural research there are two important methodological caveats that should be transparently and forthrightly presented, particularly when comparing symptoms of mental disorder between different groups. first, the researchers definition of cultural group should be clearly stated and defined. cultural group can be defined in different terms with a focus on different features (ryder et al., 2011). in our research we define cultural group specifically in terms of the features that may intersect with mental disorder and pgd: a group of people who share a common language, regional history, beliefs, patterns of behaviour and values (national center for cultural competence, 2001). this should be measured transparently and systematically through a simple ques­ tionnaire. brief questions of cultural group and identity could be asked for example: what is your country of origin? which culture influences you the most? how connected do you feel to western culture? (killikelly et al., 2020). second, the effect of unmatched groups should be clearly presented to highlight any possible confounding factors. when possible, cultural groups should be matched in terms of characteristics that might affect the severity of pgd symptoms. for example, loss related characteristics should be similar across groups (e.g., relationship to the deceased, type of loss (natural or unnatural), time since loss). demographic characteristics such as age, gender, and co-morbid mental health disorders should also be clearly documented. the first step in the development of a new cultural supplement questionnaire is item development. a wide range of possible symptom items are gathered from cultural brokers or key experts such as clinicians or researchers that belong to the cultural group of interest and have key clinical knowledge. for example, ‘free listing’ is a technique used to elicit a large number of possible symptoms (kumar, 1989; world health organisation, 2012). focus groups may then reduce the number of items to the most highly endorsed and relevant. these items are then translated into the language of the group under study following the who’s recommended translation process. the second step is scale pretest­ ing (boateng et al., 2018). the content validity of newly suggested symptoms can then be established via cognitive interviews with a representative sample of bereaved individuals (e.g., gender, age, type of loss, duration of loss all represented). for information on how to conduct cognitive interviews including the think aloud and probing technique see (abi ramia et al., 2018; drennan, 2003; prince, 2008). the aim of this step is to ensure that the format and nature of the questions are clear, concise and valid. finally, the new questions should be piloted in a small sample of intended users. this can be followed by a larger scale psychometric validation study whereby standard psychometric properties of the scale (validity and reliability) are established (see killikelly et al., 2020). it should be noted that the cultural supplement should be used alongside the ‘stand­ ard scale’ i.e., the 14 items of the icd-11 pgd definition. this is particularly impor­ tant when establishing cross cultural prevalence rates, differences and similarities of symptom structure or establishing methodologically robust comparisons across different groups and contexts. the ‘standard scale’ provides the icd-11 pgd symptom list and killikelly & maercker 9 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ could be used in clinical samples for diagnosis. this assumes the universalist approach to mental disorders. the cultural supplement can add to this list for purposes of exploring alternative pgd symptoms and supporting treatment planning. for example, somatic symptoms are not included in the icd-11 pgd definition, however several different cultural groups have strongly endorsed physical symptoms following bereavement. after assessing with the ipgds, a clinician may then offer interventions and techniques to alleviate somatic symptoms if these are most distressing symptoms indicated. these somatic symptoms may not be discovered without the wide range of questions covered by the cultural supplement. i m p l i c a t i o n s a n d f u t u r e r e s e a r c h since 2022 the new icd-11 is used worldwide in clinics and research settings. research­ ers are presented with a unique opportunity to document the impact of the inclusion of a new mental health disorder, pgd on patient experience and clinical outcomes. additionally, the inclusion of the cultural caveat presents several challenges and op­ portunities. we invite clinicians and researchers to consider using the ipgds and the cultural supplement in their clinical and research settings to add to the growing database of literature exploring prolonged grief disorder in different cultural contexts. there are many questions that remain unanswered about the relationship and importance of culture and mental disorder. one outstanding research question concerns the etiology of prolonged grief disorder and its’ location on the universalist versus relativist spectrum. the development and testing of additional cultural supplements in different cultural groups worldwide could help identify which prolonged grief disorder symptoms are universal and which are culturally relative. one hypothesis could be that core symptoms of prolonged grief disorder are universal for example yearning and preoccupation with the deceased, while supplementary symptoms and examples of emotional distress may vary depending on cultural group. although currently we recommend assigning a pgd diagnosis following the guidance of the ipgds standard scale and the icd-11 pgd defi­ nition, treatment planning may be enhanced with a person-specific approach. therefore, the cultural supplement may be a valuable tool to improve clinician-patient relationship and treatment decision making. it is important to note that the cultural supplement is subject to some key limitations. for example, the definition of culture will be specific to the research group, the research question and the sampling method. researchers and clinicians should provide thorough and transparent information on how they selected participants and the sampling method used to determine the cultural group or context. additionally, it will be important to clearly document loss related variables, such as the type of loss, time since loss and the nature of the loss (sudden, violent etc.) as this may have a significant impact on the nature and severity of pgd symptoms particularly in different cultural contexts (djelantik et al., 2020). in conclusion, the inclusion of pgd as cultural supplement of the ipgds 10 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://www.psychopen.eu/ a mental health disorder opens the door for further robust, systematic research on the relationship between grief and culture. funding: the authors have no funding to report. acknowledgments: we would like to thank the participants for taking the time to complete our research surveys. we would like to thank the following master’s students for their work on this research programme: alexandra reymond, olivia gabban, lea-martina christen, hanzhang xie. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s abi ramia, j. a., shehadeh, m. h., kheir, w., zoghbi, e., watts, s., heim, e., & el chammay, r. 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(2020). clinical utility and global applicability of prolonged grief disorder in the icd-11 from the perspective of chinese and german-speaking health care professionals. psychopathology, 53(1), 8–22. https://doi.org/10.1159/000505074 stroebe, m. s., hansson, r. o., schut, h., & stroebe, w. (2008). bereavement research: contemporary perspectives. in m. stroebe, r. o. hansson, h. schut, & w. stroebe (eds.), handbook of bereavement research and practice: advances in theory and intervention (pp. 3–27). american psychological association. triandis, h. c., & marin, g. (1983). etic plus emic versus pseudoetic. journal of cross-cultural psychology, 14(4), 489–500. https://doi.org/10.1177/0022002183014004007 world health organisation. (2012). who | assessing mental health and psychosocial needs and resources. http://www.who.int/about/licensing/copyright_form/en/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. cultural supplement of the ipgds 14 clinical psychology in europe 2023, vol. 5(1), article e7655 https://doi.org/10.32872/cpe.7655 https://doi.org/10.1111/j.1751-9004.2011.00404.x https://doi.org/10.1016/j.comppsych.2020.152211 https://doi.org/10.3389/fpsyg.2019.02982 https://doi.org/10.1159/000505074 https://doi.org/10.1177/0022002183014004007 http://www.who.int/about/licensing/copyright_form/en/ https://www.psychopen.eu/ cultural supplement of the ipgds prolonged grief disorder ipgds and cultural supplement summary of recent findings from the implementation of ipgds cultural supplement recommended methods for adaptation of the cultural supplement implications and future research (additional information) funding acknowledgments competing interests references from formative research to cultural adaptation of a face-to-face and internet-based cognitive-behavioural intervention for arabic-speaking refugees in germany latest developments from formative research to cultural adaptation of a face-to-face and internet-based cognitive-behavioural intervention for arabic-speaking refugees in germany maria böttche 1,2, christina kampisiou 1, nadine stammel 1,2, rayan el-haj-mohamad 1, carina heeke 1, sebastian burchert 1, eva heim 3,4, birgit wagner 5, babette renneberg 6, johanna böttcher 7, heide glaesmer 8, euphrosyne gouzoulis-mayfrank 9, jürgen zielasek 9, alexander konnopka 10, laura murray 11, christine knaevelsrud 1 [1] clinical-psychological intervention, freie universität berlin, berlin, germany. [2] center überleben, berlin, germany. [3] department of psychology, university of zurich, zurich, switzerland. [4] institute of psychology, university of lausanne, lausanne, switzerland. [5] clinical psychology & psychotherapy, medical school berlin, berlin, germany. [6] clinical psychology and psychotherapy, freie universität berlin, berlin, germany. [7] clinical psychology and psychotherapy, psychologische hochschule berlin, berlin, germany. [8] medical psychology and medical sociology, university of leipzig, leipzig, germany. [9] lvr-institute for healthcare research, cologne, germany. [10] health economics and health services research, university medical center hamburg-eppendorf, hamburg, germany. [11] johns hopkins university, baltimore, md, usa. clinical psychology in europe, 2021, vol. 3(special issue), article e4623, https://doi.org/10.32872/cpe.4623 received: 2020-10-30 • accepted: 2021-06-17 • published (vor): 2021-11-23 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: maria böttche, clinical-psychological intervention, freie universität berlin, habelschwerdter allee 45, 14195 berlin, germany. tel +49 30 838 58883. e-mail: maria.boettche@fu-berlin.de related: this article is part of the cpe special issue “cultural adaptation of psychological interventions”, guest editors: eva heim & cornelia weise, clinical psychology in europe, 3(special issue), https://doi.org/ 10.32872/10.32872/cpe.v3.si supplementary materials: materials [see index of supplementary materials] abstract background: this study aims to provide a transparent and replicable documentation approach for the cultural adaptation of a cognitive-behavioural transdiagnostic intervention (common elements treatment approach, ceta) for arabic-speaking refugees with common mental disorders in germany. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4623&domain=pdf&date_stamp=2021-11-23 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ method: a mixed-methods approach was used, including literature review, interviews, expert decisions and questionnaires, in order to adapt the original ceta as well as an internet-based guided version (eceta). the process of cultural adaptation was based on a conceptual framework and was facilitated by an adaptation monitoring form as well as guidelines which facilitate the reporting of cultural adaptation in psychological trials (recapt). results: consistent with this form and the guidelines, the decision-making process of adaptation proved to be coherent and stringent. all specific ceta treatment components seem to be suitable for the treatment of arabic-speaking refugees in germany. adaptations were made to three different elements: 1) cultural concepts of distress: a culturally appropriate explanatory model of symptoms was added; socially accepted terms for expressing symptoms (for eceta only) and assessing suicidal ideation were adapted; 2) treatment components: no adaptations for theoretically/empirically based components of the intervention, two adaptations for elements used by the therapist to engage the patient or implement the intervention (nonspecific elements), seven adaptations for skills implemented during sessions (therapeutic techniques; two for eceta only) and 3) treatment delivery: 21 surface adaptations (10 for eceta only), two eceta-only adaptations regarding the format. conclusion: the conceptual framework and the recapt guidelines simplify, standardise and clarify the cultural adaptation process. keywords cultural adaptation, transdiagnostic, refugees, decision-making process highlights • the framework and the guidelines allow for a reproducible and systematic cultural adaptation. • the flexible and simple format of the original ceta manual requires mainly surface adaptations. • eceta requires additional adaptations compared to the face-to-face version. arabic-speaking refugees from the mena (middle east and north africa) region have constituted the largest group of refugees in germany in recent years (federal office for migration and refugees, 2020). epidemiological studies on the mental health of asylum seekers and refugees indicate high prevalence rates of mental disorders, especially for posttraumatic stress disorder (ptsd) and depression (nesterko et al., 2020; turrini et al., 2017). despite the need for psychological treatment among refugees, only a minority utilise specialised mental health care services. göpffarth and bauhoff (2017) reported that refu­ gees in germany have six psychotherapist contacts per 1,000 health-insured persons, compared to 20 contacts for non-refugee persons. reasons for this treatment gap lie in structural barriers (e.g. difficult to access the health system, post-migration difficulties, from formative research to cultural adaptation 2 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ regional lack of trained therapists, long waiting lists) and cohort-specific characteristics (e.g. language, fear of stigmatisation, comorbid disorders), but are also due to a general lack of psychotherapeutic treatments for culturally diverse groups (colucci et al., 2015; sijbrandij, 2018). transdiagnostic approaches seem to be especially promising for the treatment of a wide range of psychological symptoms, as they can be effectively applied for different and comorbid disorders (newby et al., 2015; reinholt & krogh, 2014). a prominent evidence-based transdiagnostic approach for war-torn populations is ceta (common elements treatment approach; murray et al., 2014, supplement 1: modules and content). ceta has proven to be effective in reducing common mental health problems in cultur­ ally diverse settings in lowand middle-income countries (e.g. zambia: kane et al., 2017; iraq: weiss et al., 2015). it addresses symptoms of depression, anxiety, substance use and trauma-related disorders, and follows a tailored approach, i.e. element selection, sequencing and dosage vary depending on symptom presentation. ceta might also be a promising approach to reduce the treatment gap for refugees in european countries. additionally, an internet-based format would enable a wider reach, since it does not depend on geography (e.g. lack of trauma therapists in the local area), and communi­ cation between client and counsellor can be asynchronous. an internet-based version could also overcome the fear of stigmatisation due to the visual anonymity of the online format. as many refugees in high-income countries use the internet (gillespie et al., 2016), internet-based interventions are easily accessible for refugee populations. in order to tailor mental health interventions to the context and needs of diverse cultural groups, there has been an increasing focus on culture-sensitive interventions. meta-analyses generally indicate a superiority of culturally adapted interventions for the respective target group over non-adapted interventions (hall et al., 2016; harper shehadeh et al., 2016), although it should be noted that most adaptations did not follow a systematic procedure, thus limiting the ability to compare and replicate their findings. to overcome this weakness, a conceptual framework for cultural adaptation of inter­ ventions for common mental disorders was developed (heim & kohrt, 2019). this frame­ work consists of three main elements: 1) cultural concepts of distress, including cultural explanations, cultural syndromes, idioms of distress; 2) treatment components, compris­ ing specific and unspecific elements and therapeutic techniques; and 3) treatment deliv­ ery including delivery format, surface adaptation and setting. specific elements refer to interventions that are based on theoretical assumptions, such as behavioural or cog­ nitive approaches; unspecific treatment elements are the common factors such as the therapeutic relationship or providing a meaningful treatment rationale; and therapeutic techniques refer to exercises and other interventions that are undertaken to transmit the therapeutic components, such as role plays or homework (singla et al., 2017). in addition, the framework by heim and kohrt (2019) includes “surface adaptations”, which refer to matching materials and illustrations to the target population (resnicow et al., böttche, kampisiou, stammel et al. 3 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ 1999). this framework has been extended and translated into a set of reporting criteria for the cultural adaptation of psychological interventions (heim et al., 2021, this issue; supplement 2). in conclusion, some of the existing barriers to psychological treatment provision for refugees in europe might be addressed by culturally adapted and transdiagnostic interventions with different delivery formats. thus, the aim of the present study was to conduct a culture-sensitive adaptation of a cognitive-behavioural transdiagnostic in­ tervention (ceta) for arabic-speaking refugees with common mental health disorders in germany in a transparent and replicable manner, based on the framework (heim & kohrt, 2019) and the guidelines of reporting cultural adaptation in psychological trials (recapt, heim et al., 2021, this issue). the study focuses on the decision-making proc­ ess, i.e., the process from assessing cultural concepts of distress to adapting treatment components. the adaptation was conducted both for the original face-to-face context and for an internet-based context (eceta). m e t h o d procedures and participants the process of cultural adaptation in this study used the recapt guidelines (heim et al., 2021, this issue), and consists of six steps (details on the procedures followed and the study participants are presented in supplement 2, recapt guidelines; supplement 3, adaptation monitoring form, and supplement 4, consolidated criteria for reporting qualitative research [coreq] checklist): first, in a workshop with the ceta developers as well as in discussions of the research team, all interventional components (e.g. treatment components, therapeutic techniques, expressions) were identified in the treatment manual and included in the free list and key informant interviews in step 3. second, a literature review was conducted regarding existing cultural concepts of distress among arabic-speaking persons in the mena region (e.g. idioms of distress, cultural explanations). third, semi-structured interviews and focus groups were conducted to discuss cul­ tural concepts of distress and treatment components with arabic-speaking refugees/mi­ grants and mental health experts. participants included i) arabic-speaking potential users without a medical and/or psychosocial background (au, arabic users; n = 20); ii) arabic-speaking mental health professionals with a migration and refugee background (ap, arabic professionals; n = 11); iii) mental health experts working with refugees in different institutions in germany (he, health experts; n = 6). additionally, two focus groups of arabic-speaking mental health professionals (male and female) discussed in­ consistent results of the interviews (fg, n = 7). the structure of the interviews and focus from formative research to cultural adaptation 4 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ groups was based on module 1 of the established manual for design, implementation, monitoring, and evaluation of mental health and psychosocial assistance programs for trauma survivors in low resource countries (applied mental health research group, 2013). the interviews were carried out on the basis of semi-structured interviews. each type of interview contains different, non-overlapping closed and open-ended questions. in addition to the interviews, potential users (au, n = 20) and arabic-speaking profes­ sionals (ap, n = 11) also completed the “barts explanatory model inventory-checklist” (bemi-c), which assesses cultural concepts of distress (rüdell et al., 2009). fourth, all adaptations and examinations were listed and summarised in a monitoring form (supplement 3, heim et al., 2021, this issue). fifth, final agreements on the adapted version were made with the help of four independent arabic-speaking experts, who evaluated the suggested adaptations based on the aforementioned steps (supplement 3). sixth, any differences between the preliminary adapted version and the experts’ suggestions were discussed within the research team and a final decision was made (supplement 3). data collection after receiving information about the study, participants signed an informed consent form prior to participating in the interviews/focus groups. all forms were provided in arabic. the interviews (au, ap) and the fg were conducted by arabic-speaking trained interviewers. all interviews/fgs were audio-recorded, and the recordings were summar­ ised and translated into german. an interview id was assigned by the first author, who kept an encrypted digital document with the identifying keys. basic non-identifying information about the respondents was collected (age, gender). interviews were conducted in berlin and cottbus, germany, between december 2019 and may 2020. final agreements (step 6 in procedures and participants) were made between july and september 2020. all participants (table 1 for more details) received an incentive for their participation (20-40 euros). the ethics committee of the freie universität berlin (germany) gave approval for this study (008/2020). data analysis the data were analysed using content analysis, i.e. transcripts of the communication were evaluated and prepared for the adaptation process (rädiker & kuckartz, 2019) with the help of maxqda 2018 (verbi software, 2018). all responses from the au, ap and he interviews were listed and coded. no prior coding framework existed. a coding system was developed inductively for all three forms of interviews. codes represented the themes provided in responses to the open-ended questions and were summarised quantitatively (e.g. 18 out of 20 au interviewees named sport as a positive activity: sport böttche, kampisiou, stammel et al. 5 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ n = 18/20). the frequency of the answers can be interpreted as an indicator of their importance (applied mental health research group, 2013). each group received different questions, so the second number always indicates the interview group (n/20 = au, n/6 = he, n/11 = ap). all data were analysed at the individual level, with the exception of data from the fgs, which were analysed at the group level. findings of the fgs aimed to complement or contrast findings from au, ap and he interviews. the themes that arose from the coded framework were presented to the four arabic-speaking experts and finalised by the research team. quantitative data from bemi-c were analysed using the spss software, version 26 (ibm corporation, 2018). r e s u l t s decision-making and expert reviews for the decision-making process, the monitoring form (supplement 3) was used. here, all preliminary and final adaptations in the process were written down and discussed. first, two one-day workshops of the research group (see supplement 2) took place in berlin, germany, to discuss and evaluate the results of the fl and ki interviews. these results were prepared by mb (first author) and a psychology student (re). during the workshop, the prepared results and suggestions were read by all participants (written in the monitoring form). there was either agreement with the adaptation or further suggestions were made. table 1 sample description of participants of the formative research (step 3) interviews/focus group sample size age in years m (sd) age range sample size age in years m (sd) age range free list interview (arabic users) total 20 30.10 (8.86) 23-57 men 15 27.40 (3.94) 23-39 women 5 38.20 (14.46) 24-57 key informant interview (arabic professionals) key informant interview (health experts) total 11 30.78 (5.36) 23-37 6 47.83 (12.81) 32-68 men 5 31.80 (5.63) 23-37 2 45.50 (12.02) 37-54 women 6 29.50 (5.51) 24-36 4 49.00 (14.83) 32-68 focus group i focus group ii men 3 28.33 (4.73) 23-32 – – – women – – – 4 27.75 (3.50) 24-32 note. sd = standard deviation. from formative research to cultural adaptation 6 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ second, based on the two workshops, the content of the fgs was elaborated and the first version of the adaptations from the workshops was adapted in writing in the document. third, based on the results of the fgs, the existing adaptations were modified and written down if necessary. fourth, the four arabic-speaking experts were sent the form with all of the existing preliminary adaptations. the experts either agreed to the proposals in writing or noted changes in writing in the monitoring form. explicit linguistic comments were also made here. finally, another two-day workshop of the research group took place. this was again prepared by mb and re, who had written down the suggestions of the four experts so that the members of the research group could see the changes beforehand. during these two days, all changes in the document were discussed and voted on. cultural concepts of distress (ccd) three cultural adaptations of ceta were made with regard to the ccd. two adaptations were made regarding idioms of distress. first, based on the bemi-c (au & ap), five idioms of distress were integrated into the introduction of ceta/eceta (table 2; in bold). second, the ap interviews showed that the assessment of suicidal ideation in the component “safety” should be carried out gradually, i.e. with the topic being introduced indirectly (n = 6/11, e.g. “have you had thoughts that you would be better off dead or not waking up in the morning?”), followed by direct questions regarding suicidal thoughts and plans. the description of arabic-speaking refugees’ ccd (hassan et al., 2015), as well as the data from the he interviews, highlighted the importance of an exploratory model of psychological symptoms. therefore, the introduction of ceta/eceta was expanded with a section addressing fear of becoming crazy, the relationship between body and mind, and awareness of mental health problems (he: n = 3/6, supplement 2). treatment components (specific and unspecific elements, and therapeutic techniques) with regard to therapeutic treatment components, he stated that all specific ceta components were suitable for the treatment of arabic-speaking refugees. therefore, all components remained in the adapted manual (supplement 1). the he interviews did not result in a clear conclusion regarding the fit of the compo­ nent “problem solving”, since half of the respondents assessed the content as not feasible (e.g. too cognitive, difficult to work with). therefore, the focus groups and the research group discussed this component further during the process. ultimately, the component böttche, kampisiou, stammel et al. 7 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ remained in the manual, as it was considered useful to address post-migration living difficulties. regarding the unspecific treatment elements, two adaptations were carried out in the introductory part of ceta. first, the component “encouraging participation” was extended regarding the presentation of the rules of interpretation, because interpreters are of crucial importance in the face-to-face context. second, the literature and ap interviews (n = 11/11) emphasised the importance of understanding the treatment proc­ ess in order to increase compliance (e.g., patients' active role during sessions, possible destabilisation). therefore, the analogy of “walking on a mountain path” was explicitly added to this component in ceta/eceta (supplement 2). based on discussions and practical experiences of the research group, four therapeu­ tic techniques were excluded due to the difficulties in implementation and delivery in an adequate online format (supplement 1). results from the ap interviews showed that all other therapeutic techniques were suitable (supplement 1). due to the asynchronous communication of lay counsellor and patient in eceta, two role plays were adapted. this therapeutic technique, which requires simultaneous interaction, was transformed into a written "letter to a friend", in which the patient addresses an imaginary friend with the same problem. also due to the asynchronous communication, the decision was made to fix the order of the techniques in tdw-ii in ceta/eceta. table 2 typical somatic and mental symptoms of arabic-speaking refugees (selection from bemi-c) symptoms free list interview (au) key informant interview (ap) total men women total men women somatic n (%) sleep disturbances 15 (75) 11 (73.3) 4 (80) 9 (81.8) 4 (80) 5 (83.3) pain/aches 17 (85) 12 (80) 5 (100) 10 (90.9) 4 (80) 6 (100) fatigue/tiredness 20 (100) 15 (100) 5 (100) 11 (100) 5 (100) 6 (100) nerves/being agitated/restless 19 (95) 14 (93.3) 5 (100) 11 (100) 5 (100) 6 (100) bodily weakness 16 (80) 11 (73.3) 5 (100) 9 (81.8) 4 (80) 5 (83.3) nausea or feeling sick 12 (60) 7 (46.7) 5 (100) 8 (72.7) 5 (100) 3 (50) mental n (%) dysphoria (feeling down) 9 (45) 4 (26.7) 5 (100) 6 (54.5) 2 (40) 4 (66.7) feeling irritable or fed up/bored 20 (100) 15 (100) 5 (100) 7 (63.6) 3 (60) 4 (66.7) feeling nervous, anxious 17 (85) 13 (86.7) 4 (80) 9 (81.8) 5 (100) 4 (66.7) feeling frightened or fearful 17 (85) 12 (80) 5 (100) 9 (81.8) 4 (80) 5 (83.3) lack of concentration/forgetfulness 18 (90) 13 (86.7) 5 (100) 10 (90.9) 5 (100) 5 (83.3) loss of interest/ not being able to enjoy things 18 (90) 13 (86.7) 5 (100) 7 (72.7) 5 (100) 3 (50) note. bold, five most prominent symptoms included in the manual. from formative research to cultural adaptation 8 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ treatment delivery (format, surface) regarding the delivery format, two changes were implemented. first, ceta is also of­ fered in an internet-based context (eceta). second, the handling of self-endangering and third-party-endangering behaviour had to be adapted for eceta, which is conducted by lay counsellors. as soon as such behaviour is detected, the communication immediately changes from asynchronous to synchronous (i.e., telephone). the final category of adaptations refers to the surface, e.g. text, examples, and migration-, language-, and culture-related material. arabic-speaking individuals (au, ap) revealed that the expressions used in the manual are for the most part culturally appropriate. four specific adaptations were made (i.e. translation of the phrases “a day in the life” and “here and now”, expressions for “suicide” and “suicidal ideation and plans”). all other 17 adaptations are shown in supplement 5). d i s c u s s i o n in this study, the transdiagnostic ceta was adapted for arabic-speaking refugees in germany. the cultural adaptation process followed an approach that enables a replicable and systematic documentation (heim et al., 2021, this issue). the results showed that ceta in its original form seems to be largely culture-sensitive for this target group. mainly surface adaptations were made, especially for eceta due to its asynchronous communication. based on our formative research, the cultural adaptation of the manual comprised three main aspects: i) cultural concepts of distress in the target population (i.e. arabic speakers from the mena region), ii) treatment components to address post-migration living conditions, and iii) treatment delivery, i.e., the provision of an additional online version to address potential treatment barriers. concerning the cultural concepts of distress, all adaptations are in line with previous findings. the qualitative interviews showed that the introduction of ceta should be expanded to include an explanatory model to address cultural explanations. thus, the relationship between physical and mental well-being is now more clearly demonstrated and explained, since the literature underlines that arabic idioms of distress do not dis­ tinguish between somatic experiences and psychological problems (hassan et al., 2015). furthermore, the “fear of going crazy” (shannon, 2014) was addressed by explaining the concept of mental disorders and psychological treatment. to assess suicidal ideation, different opinions were expressed, which tended either to assess suicidal ideation directly or indirectly. this difference was affected both by culture (e.g. suicide is a crime in some arab countries, hassan et al., 2015) and by legal aspects of the german health care system (suicidality must be clearly clarified). accordingly, the adaptation comprises the böttche, kampisiou, stammel et al. 9 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ gradual assessment of suicidal tendencies (i.e. starting with an indirect question, followed by a direct question). with regard to treatment components, the results indicated that the specific ceta components as well as the unspecific elements are suitable for the current context of arabic-speaking refugees in germany. this is in line with a review examining the effec­ tiveness of psychological interventions in different lowand middle-income countries (singla et al., 2017). the specific component of "problem solving" was considered to be important in the discussions of the research team and in the literature (singla et al., 2017). the difficult living conditions, in which refugees have to deal with multiple social problems (e.g. asylum process, housing), have been shown to affect refugees’ mental health (schick et al., 2018). to address these difficulties, “problem solving” will be offered to every patient in order to provide problem-solving skills to manage some of these existential problems. with regard to treatment delivery, an online version of ceta was developed. since this type of asynchronous communication requires more active patient involvement, the therapeutic tasks have to be described in more detail and include more examples. thus, some adaptations will only be applied in eceta. adaptations with regard to materials mostly referred to analogies, as well as examples and translations of words or phrases. a distinction was made between linguistic adaptations (e.g. translation of the phrase "a day in the life") and adaptations based on culture and migration (e.g. typical receptacles used for alcohol, everyday situations). this is in line with other studies in the field (e.g., shala et al., 2020). in sum, a small number of mainly surface adaptations were required. this might be a consequence of the fact that ceta was developed particularly for culturally diverse groups, already used simple language, already had an easily understandable structure, and has been used in different countries (murray et al., 2014). this very well thought-out structure of the original ceta provided an excellent basis for the current adaptation process. even though the cultural adaptation was facilitated by the existing framework, some limitations remain. first, only people from two different cities in germany were inter­ viewed, and most of them were from syria. however, the interviewees were of different ages and gender, and the four arabic-speaking experts were from different countries of origin. second, although we did not consider the entire ceta manual for adaptation, we selected an exact choice of words to explain a technique, main parts, and all interven­ tional components that corresponded to the framework (heim & kohrt, 2019). third, the decision to use the online format with an asynchronous communication was made prior to the formative research. these decisions are based on known contextual conditions (e.g. fear of stigmatisation, difficulties in accessing the health care system). all further adjustments to the format were then again part of the formative research. from formative research to cultural adaptation 10 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://www.psychopen.eu/ the conceptual framework and the recapt guidelines simplify, standardise and clarify the cultural adaptation process. it can thus be summarised that adaptations do not always have to start from scratch; rather, practitioners and researchers are able to use existing material. future research needs to compare different levels of adaptation and their impact on treatment acceptance and effectiveness. such results might enable a balance between adaptation and the required time and financial effort. funding: this project has received funding from the german federal ministry of education and research (bmbf) under grant agreement no. 01ef1806a and no. 01ef1806h acknowledgments: we would like to thank dr. kristina metz for providing us with the opportunity to gain a deep insight into ceta and to adapt the existing manual. our sincerest thanks go to the interviewers a. alsaod and l. ighreiz, who did a tremendous job, as well as to the interviewees who participated and gave us constructive feedback. we would also like to thank a. hajjir, p. selmo, p. nour and j. abi ramia for giving us their expert opinions during the final steps in the decision-making process. competing interests: eva heim is one of the guest editors of this cpe special issue but played no editorial role in this particular article or intervened in any form in the peer review process. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials (for access see index of supplementary materials below) include detailed information about: 1. components of ceta and decision regarding remaining, adaptation or exclusion from the adapted manual (supplement 1) 2. process of cultural adaptation based on the reporting criteria (recapt, supplement 2) 3. extract from the adaptation monitoring form (supplement 3) 4. qualitative research checklist (coreq, supplement 4) 5. surface adaptations (supplement 5) index of supplementary materials böttche, m., kampisiou, c., stammel, n., el-haj-mohamad, r., heeke, c., burchert, s., heim, e., wagner, b., renneberg, b., böttcher, j., glaesmer, h., gouzoulis-mayfrank, e., zielasek, j., konnopka, a., murray, l., & knaevelsrud, c. (2021). supplementary materials to "from formative research to cultural adaptation of a face-to-face and internet-based cognitive-behavioural intervention for arabic-speaking refugees in germany" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.5137 böttche, kampisiou, stammel et al. 11 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://doi.org/10.23668/psycharchives.5137 https://www.psychopen.eu/ r e f e r e n c e s applied mental health research group. (2013). design, implementation, monitoring, and evaluation of mental health and psychosocial assistance programs for trauma survivors in low resource countries: a user's manual for researchers and program implementers (adult version). module 1: qualitative assessment. baltimore, md, usa: johns hopkins university, bloomberg school of public health. retrieved from http://hopkinshumanitarianhealth.org/assets/documents/vot_dime_module1_final.pdf colucci, e., minas, h., szwarc, j., guerra, c., & paxton, g. (2015). in or out? barriers and facilitators to refugee-background young people accessing mental health services. transcultural psychiatry, 52(6), 766-790. https://doi.org/10.1177/1363461515571624 federal office for migration and refugees. (2020). figures of asylum (08/2020). retrieved from https://www.bamf.de/shareddocs/anlagen/de/statistik/asylinzahlen/aktuelle-zahlenaugust-2020.pdf gillespie, m., ampofo, l., cheesman, m., faith, b., iliadou, e., issa, a., osseiran, s., & skleparis, d. 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(2015). community-based mental health treatments for survivors of torture and militant attacks in southern iraq: a randomized control trial. bmc psychiatry, 15, article 249. https://doi.org/10.1186/s12888-015-0622-7 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. from formative research to cultural adaptation 14 clinical psychology in europe 2021, vol. 3(special issue), article e4623 https://doi.org/10.32872/cpe.4623 https://doi.org/10.1016/j.invent.2020.100339 https://doi.org/10.1093/fampra/cmu017 https://doi.org/10.1017/s2045796017000713 https://doi.org/10.1146/annurev-clinpsy-032816-045217 https://doi.org/10.1186/s13033-017-0156-0 https://doi.org/10.1186/s12888-015-0622-7 https://www.psychopen.eu/ from formative research to cultural adaptation (introduction) method procedures and participants data collection data analysis results decision-making and expert reviews cultural concepts of distress (ccd) treatment components (specific and unspecific elements, and therapeutic techniques) treatment delivery (format, surface) discussion (additional information) funding acknowledgments competing interests supplementary materials references early adverse effects of behavioural preventive strategies during the covid-19 pandemic in germany: an online general population survey research articles early adverse effects of behavioural preventive strategies during the covid-19 pandemic in germany: an online general population survey michael witthöft 1 , stefanie m. jungmann 1 , sylvan germer 1 , anne-kathrin bräscher 1 [1] department of clinical psychology, psychotherapy, and experimental psychopathology, johannes gutenberg university of mainz, mainz, germany. clinical psychology in europe, 2022, vol. 4(3), article e7205, https://doi.org/10.32872/cpe.7205 received: 2021-07-23 • accepted: 2022-04-13 • published (vor): 2022-09-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: michael witthöft, department of clinical psychology, psychotherapy, and experimental psychopathology, johannes gutenberg university of mainz, wallstrasse 3, d-55099 mainz, germany. tel.: +496131-3939202. e-mail: witthoef@uni-mainz.de abstract background: quarantine and physical distancing represent the two most important nonpharmaceutical actions to contain the covid-19 pandemic. comparatively little is known about possible adverse consequences of these behavioural measures in germany. this study aimed at investigating potential early adverse effects associated with quarantine and physical distancing at the beginning of the countrywide lockdown in germany in march 2020. method: using a cross-sectional online survey (n = 4,268), adverse consequences attributed to physical distancing, symptoms of psychopathology, and sociodemographic variables were explored in the total sample as well as in high-risk groups (i.e., people with a physical or mental condition). results: the most frequently reported adverse effects were impairment of spare time activities, job-related impairment, and adverse emotional effects (e.g., worries, sadness). participants with a mental disorder reported the highest levels of adverse consequences (across all domains) compared to participants with a physical disease or participants without any mental or physical condition. no significant association between the duration of the behavioural protective measures and the severity of adverse mental health effects was observed. conclusion: results showed that non-pharmaceutical actions were associated with adverse effects, particularly in people with mental disorders. the findings are of relevance for tailoring support to special at-risk groups in times of behavioural preventive strategies. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7205&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0002-4928-4222 https://orcid.org/0000-0003-0201-9517 https://orcid.org/0000-0002-8134-976x https://orcid.org/0000-0002-2621-5689 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords quarantine, social, physical distancing, anxiety, depression, somatic symptoms highlights • physical distancing and quarantine were associated with negative psychological effects. • the most frequently affected areas were spare time activities, job, and emotional condition. • participants with a mental disorder reported the highest levels of adverse consequences. • no significant relation between duration of the protective measures and severity of adverse effects. b a c k g r o u n d behavioural non-pharmaceutical interventions and preventive strategies (i.e., isolation, quarantine, and physical distancing) represent the most important first-line interventions to counteract novel pandemics such as covid-19. despite its effectiveness, already findings from earlier pandemics suggest that behavioural preventive strategies have psychological costs (e.g., brooks et al., 2020; henssler et al., 2021). similar findings were observed in meta-analyses related to covid-19 which found small positive associ­ ations between the implementation, duration, and stringency of behavioural measures and symptoms of mental disorders (e.g. jin et al., 2021; o’hara et al., 2020; wang et al., 2021). however, another meta-analysis using longitudinal data suggests that the psychological impact of behavioural measures (e.g. lockdown) is weak and heterogenous at best (prati & mancini, 2021), and one meta-analysis comparing countrywide point prevalences of depression and stringency levels regarding early interventions (e.g. coun­ trywide lockdowns) found less severe adverse mental health consequences associated with more stringent early interventions (lee et al., 2021). due to the heterogeneity of existing findings, this study aimed at investigating possible adverse effects associated with different behavioural preventive strategies (quarantine and physical distancing), particularly during the early stage of the covid-19 pandemic in germany in march and april 2020. shortly after covid-19 was declared a pandemic by the who on march 11th 2020, preventive actions were taken by the german government and the federal states. since march 16th, federal states decided to close kindergartens and schools and the federal government restricted cross-border traffic from a number of neighboring countries. on 23rd of march, a nationwide assembly ban was established, prohibiting assemblies of more than two persons (except people and families living in the same household). additionally, restaurants and businesses concerned with body care were immediately psychological effects of physical distancing 2 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ closed (robert koch institut [rki], 2020a), resulting in a partial nationwide lockdown. despite their effectiveness, comparatively little is known about possible psychological side effects of these preventive actions. studies from germany (benke et al., 2020), italy (fornili et al., 2021), the uk (fancourt et al., 2021), u.s. (daly & robinson, 2021), and china (gan et al., 2022) suggest that government restrictions on daily life (e.g., lockdown and stay-at-home orders) result in significantly elevated levels of psychological distress (mainly increased symptoms of anxiety, depression, and higher levels of loneliness) at the beginning of the pandemic in march 2020. longitudinal population-based studies in the uk (fancourt et al., 2021) and u.s. (daly & robinson, 2021) suggest that after an initial increase in mental distress during the first wave of the pandemic in march 2020, distress levels significantly declined on the population level, despite continued behavioural restrictions and lockdown measures. it therefore remains unclear, to what extend the observed higher levels of mental distress are directly (i.e., causally) attributa­ ble to behavioural preventive strategies. interestingly and rather unexpectedly, no direct evidence of a dose-response relationship between the intensity (i.e., duration) of the behavioural preventive strategies and levels of psychological distress could be observed, neither in a study from china (gan et al., 2022) nor an early german study (benke et al., 2020). moreover, observed associations between behavioural restrictions and mental distress appear small in terms of effect sizes (benke et al., 2020; prati & mancini, 2021). gan et al. (2022) interpret this observation as a “psychological typhoon eye effect”, i.e., during an immediate threat, the negative emotional response to a disaster might appear atypically weak at first glance. alternatively, these findings might suggest that the threat by the disease itself, rather than behavioural precautions might be responsible for the observed adverse mental health effects. when considering adverse effects of behavioural precautions, three types of strat­ egies have to be conceptually distinguished: (a) isolation (i.e., separation of already infected and thus potentially contagious individuals); (b) quarantine (i.e., separation of individuals with contact to potentially contagious individuals); and (c) social distanc­ ing/physical distancing (i.e., restricting social physical contacts as a primary preventive strategy to reduce the number of new infections in the population). early reviews and meta-analyses suggest adverse mental health effects associated with isolation and quar­ antine in terms of increased levels of anxiety, depression, and stress (jin et al., 2021; wang et al., 2021) and those findings appear similar to results from earlier pandemics as e.g. sars-cov or mers-cov (e.g., brooks et al., 2020; henssler et al., 2021). still, empirical evidence directly related to different behavioural measures in the covid-19 pandemic is comparatively sparse. moreover, earlier reviews and meta-analyses mainly focus on the effects of isolation and quarantine, rather than more general social and physical restrictions that are characteristic of the global response to the covid-19 pandemic. witthöft, jungmann, germer, & bräscher 3 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ the primary aim of this study was to explore the early psychological effects of the most important behavioural non-pharmacological interventions (i.e., physical distancing and quarantine) initiated against the covid-19 pandemic in germany in march 2020. furthermore, this study aimed at examining whether potential high-risk groups within the general population (i.e., people with a current mental disorder or physical disease) were more negatively affected by these actions compared to healthy people without a current mental or physical condition. finally, it was hypothesized that significant positive dose-response relationships would exist between the duration of the respective behavioural actions (i.e., lockdown, physical distancing, and quarantine) and individual levels of psychological distress or adversities, suggesting first evidence of a causal rela­ tionship between the duration of preventive actions and psychological distress levels. m e t h o d sample and procedure the online survey took place between 25th of march and 13th of april 2020, at an early stage of the virus outbreak in germany, and was presented in german language. the first cases of sars-cov-2 infection in germany became known at the end of january 2020. on march 25th, about 31,554 cases of sars-cov-2 infection, including 149 deaths (worldwide: 413,467 infections), and on april 13th about 123,016 cases, including 2,799 deaths (worldwide: 1,773,084 infections) were registered (rki, 2020a, 2020b; who, 2020a, 2020b). participants were recruited via social media (e.g., twitter), e-mail distribution lists of student councils at universities, and our department's website. in addition to information on the study (type, content, duration, lottery of gift vouchers as compensation for partic­ ipation), the study announcements included a link to the online study. inclusion criteria were a minimum age of 16 and informed consent. the study protocol was approved by the local ethics committee. altogether, 4288 persons completed the survey. twenty persons were excluded due to the following reasons: implausible indication of age (n = 2), very fast completion of the questionnaire (n = 3), long quarantine (> 33 days) for reasons other than sars-cov-2 (n = 6), long period (> 50 days) of social distancing (n = 9) possibly for reasons other than sars-cov-2. the final sample consisted of n = 4268 persons (table 1). of the participants, 10.5% (n = 449) reported to be in quarantine themselves (for m = 9.86 days, sd = 3.83 [range: 2-30]), 27.1% (n = 1156) reported to know someone in their close social environment (family/friends) and 34.0% (n = 1451) in their wider social environment (e.g., acquaintances or at the same residence) who had been in quarantine. concerning physical distancing, participants reported to practice it for an average of 11.85 days (sd = 5.18, range [0, 50]). while 0.6% (n = 25) reported not reducing their physical contacts psychological effects of physical distancing 4 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ at all, 1.7% (n = 71) reported to reduce their physical contacts a little, 3.8% (n = 161) a medium amount, 23.5% (n = 1005) considerably, and 70.4% (n = 3,006) very strongly. table 1 sample characteristics (n = 4268) variable m sd age 32.89 12.07 n % sex female 3389 78.9 male 886 20.8 diverse 13 0.3 born in germany 4015 94.1 professional status employed 1698 39.8 students 1286 30.1 in school/vocational training 209 4.9 public servants 209 4.9 self-employed 204 4.8 unemployed 145 3.4 retired 134 3.1 on parental leave 132 3.1 housewife/househusband 96 2.2 other 158 3.7 education college/university degree 1866 43.7 general qualification for university entrance 1662 39.0 general certificate of secondary education 529 12.4 basic school education 117 2.7 still in school/dropped out of school 74 1.7 health status healthy 2877 67.4 physical disease 817 19.1 psychological disorder 331 7.8 physical disease and psychological disorder 243 5.7 witthöft, jungmann, germer, & bräscher 5 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ measures somatic symptom reporting the patient health questionnaire somatic symptom scale (phq-15; kroenke et al., 2002) is a self-administered instrument that assesses the severity of fifteen common somatic symptoms on a scale from 0 (not bothered at all) to 2 (bothered a lot) covering the preceding four weeks. the phq-15 has shown good reliability and validity in previous studies (gräfe et al., 2004; kroenke et al., 2002; van ravesteijn et al., 2009). in the current study, the internal consistency was cronbach’s α = 0.80. psychosocial stress the stress module of the patient health questionnaire (phq-stress; gräfe et al., 2004) assesses psychosocial stressors (including health, work/financial, social, and traumatic stress) that provide indications of potentially causing or maintaining factors of mental disorders. it is a self-report questionnaire and consists of ten questions referring to the last month, which can be answered on a scale ranging from 0 (not bothered at all) to 2 (bothered a lot). a limited number of studies suggest adequate reliability and validity of the questionnaire (beutel et al., 2018; klapow et al., 2002). internal consistency in the present study was cronbach’s α = 0.69. anxiety and depression the patient health questionnaire depression and anxiety screener (phq-4; kroenke et al., 2009) is an ultra-brief screener for anxiety and depression. it is a composite instrument that consists of two items assessing the core criteria for depression and two items assessing core aspects of general anxiety disorder. the scale ranges from 0 (not at all) to 3 (almost every day) and refers to the last two weeks. adequate reliability and validity have been demonstrated (kroenke et al., 2009; löwe et al., 2010). the internal consistency in this study was cronbach’s α = 0.84. loneliness the three-item loneliness scale (ucla-ls-3; hughes et al., 2004) is the short version of the ucla-loneliness scale (russell et al., 1980) and assesses subjective isolation. items can be answered on a scale from 1 (hardly ever) to 3 (often). some evidence confirms sufficient reliability and adequate validity of the questionnaire (hughes et al., 2004). for the current study, the authors translated the three items to german. internal consistency in the current study was cronbach’s α = 0.74. strains/changes due to social/physical isolation in order to assess changes and strains due to the pandemic in more detail, participants were asked whether they experienced the following due to social/physical isolation: psychological effects of physical distancing 6 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ more socially isolated/lonely, being separated from important people, lack of leisure activities (e.g., sport), occupational restrictions/job loss, increased computer/internet use, increased tv consumption, more conflicts at home, worsened mood/sadness, worries, anger, boredom, or other. participants were also asked to indicate how much they felt distressed by the applicable changes/strains on a scale from 1 (not distressing at all) to 101 (extremely distressing). quantifying the duration of quarantine and physical distancing first, the duration of current quarantine and the reduction of social (physical) contacts were assessed via two questions (i.e., with an open-ended response format: for how many days have you been in quarantine? for how many days have you been limiting your social contacts?). as an additional, objective criterion for the duration of physical distancing, we computed the number of days since the official lockdown in germany (23rd of march 2020). statistical analyses analyses were conducted using spss 23 (ibm corp., 2015) and jasp 0.13 (jasp team, 2022). for all tests, the alpha level was set to 5%. eta-squared (η2) was calculated as effect size for anovas (η2 ≥ 0.01 small effect; η2 ≥ 0.06 medium effect; η2 ≥ 0.14 large effect) and cohen’s d for (post-hoc) t-tests (d ≥ 0.30 small, d ≥ 0.50 medium, d ≥ 0.80 large). for correlation analyses, effect size conventions are r ≥ |.10| small; r ≥ |.30| medium, r ≥ |.50| large (cohen, 1992). for the corresponding bayes analyses, bayes factors (bf) were used to quantify the evidence for h1 and h0, respectively (e.g. jarosz & wiley, 2014; nuzzo, 2017). r e s u l t s psychological effects of behavioural actions (i.e., lockdown, social/physical distancing, quarantine) strains/changes due to social/physical distancing of the participants, 1.4% (n = 59) did not report any change or distress due to social/phys­ ical distancing, 67.4% (n = 2875) observed increased computer and/or internet use, 61.7% (n = 2632) reported a lack of leisure activities (e.g., sport), 61.5% (n = 2624) felt separated from important people, 48.1% (n = 2055) reported worries, 44.8% (n = 1914) observed increased tv consumption, 42.5% (n = 1814) reported occupational restrictions or job loss, 44.2% (n = 1886) perceived boredom, 40.7% (n = 1735) perceived decreased mood or sadness, 36.9% (n = 1574) felt socially isolated or lonely, 17% (n = 726) reported to have more conflicts at home, 13.5% (n = 578) felt anger, and 12.7% (n = 544) noticed other witthöft, jungmann, germer, & bräscher 7 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ changes or strains. on average, participants experienced 4.91 changes/strains (sd = 2.20, range [0, 12]) and they reported an average level of distress of m = 54.70 (sd = 25.29, range [1, 101]). high-risk groups with mental disorder and/or physical disease perception of changes/strains due to social distancing the four subgroups (i.e., persons with a physical disease, persons with a mental disorder, persons with both a physical disease and a mental disorder, and persons without any reported physical or mental condition) differed significantly in the number of perceived changes/strains and perceived distress due to the changes/strains (table 2). according to bonferroni-corrected post-hoc tests, healthy individuals reported as much changes/ strains as individuals with a physical disease (t = -0.35, p > .999, d = -0.01) and were similarly distressed (t = 1.01, p > .999, d = 0.04) but reported less changes/strains and were less distressed than individuals with a mental disorder (t = -7.31, p < .001, d = -0.42; t = -8.45, p < .001, d = -0.50) or both a physical disease and a mental disorder (t = -5.30, p < .001, d = -0.35; t = -5.34, p < .001, d = -0.36). individuals with a physical disorder reported less changes/strains and were less distressed than persons with a mental disorder (t = -6.30, p < .001, d = -0.41; t = -8.14, p < .001, d = -0.53) and persons with both (t = -4.66, p < .001, d = -0.34; t = -5.42 p < .001, d = -0.39). individuals with a mental disorder did not differ from individuals who had both a physical disease and a mental disorder (t = -0.83, p > .999, d = 0.07; t = 1.59, p = .675, d = -0.14). phq-15 the subgroups differed concerning their reporting of somatic symptoms, f(3, 680.65) = 161.49, p < .001, η2 = 0.12. post-hoc tests indicated that all subgroups differed from each other; healthy individuals had lower scores than persons with a physical disease (t = -11.83, p < .001, d = -0.48), individuals with a mental disorder (t = -15.44, p < .001, d = -0.92), and individuals with both (t = -17.50, p < .001, d = -1.22). further, individuals with a physical disease showed lower scores than individuals with a mental disorder (t = -6.55, p < .001, d = -0.39) and individuals with both (t = -9.58, p > .001, d = -0.65). individuals with a mental disorder reported less somatic symptoms than individuals with both a physical disease and a mental disorder (t = -3.23, p = .007, d = -0.24). psychological effects of physical distancing 8 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ ta b le 2 m ea ns s ta nd ar d d ev ia ti on s, a nd a n o va r es ul ts ( fr eq ue nt is t an d b ay es ) of t he n um be r of c ha ng es /s tr ai ns p er ce iv ed d ue t o so ci al /p hy si ca l d is ta nc in g an d p sy ch om et ri c in st ru m en ts a ss es se d fo r th e w ho le s am pl e an d d if fe re nt s ub gr ou ps m ea su re s of p sy ch ol og ic al d is tr es s to ta l s am pl e m (s d) su bg ro up s f t es t (p ); bf in clu sio n po st -h oc t es ts 1 2 3 4 n o m en ta l o r ph ys ic al d is ea se m (s d) p h ys ic al d is ea se m (s d) m en ta l d is or de r m (s d) p h ys ic al d is ea se a n d m en ta l d is or de r m (sd ) n um be r of c h an ge s/ st ra in s 4. 91 ( 2. 20 ) 4. 79 ( 2. 18 ) 4. 92 ( 2. 13 ) 5. 71 ( 2. 25 ) 5. 56 ( 2. 27 ) 25 .6 4, (< .0 01 ); 1. 41 *1 01 3 1, 2 < 3 , 4 d is tr es s du e to c h an ge s/ st ra in s 54 .7 0 (2 5. 29 ) 53 .4 3 (2 4. 98 ) 52 .4 3 (2 6. 02 ) 65 .7 0 (2 2. 92 ) 62 .3 4 (2 4. 49 ) 37 .6 6, ( < .0 01 ); ∞ 1, 2 < 3 , 4 p h q -1 5 6. 97 ( 4. 71 ) 5. 97 ( 4. 19 ) 8. 05 ( 4. 78 ) 9. 95 ( 5. 16 ) 11 .1 6 (4 .8 6) 16 1. 49 , ( < .0 01 ); ∞ 1 < 2 < 3 < 4 p h q -s tr es s 5. 75 ( 3. 60 ) 5. 17 ( 3. 37 ) 6. 18 ( 3. 54 ) 7. 93 ( 3. 92 ) 8. 20 ( 3. 70 ) 10 0. 73 , ( < .0 01 ); ∞ 1 < 2 < 3 , 4 p h q -4 3. 66 ( 2. 88 ) 3. 21 ( 2. 64 ) 3. 59 ( 2. 62 ) 6. 12 ( 3. 28 ) 5. 84 ( 3. 19 ) 12 5. 15 , ( < .0 01 ); ∞ 1 < 2 < 3 , 4 u c la -l s3 6. 08 ( 1. 75 ) 5. 93 ( 1. 71 ) 5. 98 ( 1. 74 ) 7. 09 ( 1. 66 ) 6. 81 ( 1. 82 ) 60 .6 1, ( < .0 01 ); ∞ 1, 2 < 3 , 4 n ot e. p h q -1 5, p at ie n t h ea lt h q ue st io n n ai re s om at ic s ym pt om s ca le ; p h q -s tr es s, p at ie n t h ea lt h q ue st io n n ai re s tr es s m od ul e; p h q -4 , p at ie n t h ea lt h q ue st io n n ai re d ep re ss io n a n d a n xi et y sc re en er ; u c la -l s3, 3 -i te m s h or t ve rs io n o f th e u c la lo n el in es s sc al e. witthöft, jungmann, germer, & bräscher 9 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ phq-stress the subgroups differed with regards to their level of psychosocial stress, f(3, 688.77) = 100.73, p < .001, η2 = 0.08. according to post-hoc tests, healthy individuals had lower stress levels compared to individuals with a physical disease (t = -7.34, p < .001, d = -0.30), a mental disorder (t = -13.69, p < .001, d = -0.80), and both (t = -13.06, p < .001, d = -0.89). individuals with a physical disease were less stressed than individuals with a mental disorder (t = -7.73, p < .001, d = -0.48) and both (t = -7.96, p < .001, d = -0.56). there was no difference between individuals with a mental disorder and both a physical disease and a mental disorder regarding psychosocial stress level (t = -0.92, p = .793, d = -0.07). phq-4 the subgroups significantly differed in the screening for depression and anxiety, f(3, 681.77) = 125.15, p < .001, η2 = 0.11. healthy individuals had lower scores compared to individuals with a physical disease (t = -3.52, p = .003, d = -0.14), a mental disorder (t = -18.40, p < .001, d = -1.07), and both (t = -14.46, p < .001, d = -0.98). individuals with a physical disorder scored lower than individuals with a mental disorder (t = -14.25, p < .001, d = -0.90) and both (t = -11.31, p < .001, d = -0.82). individuals with a mental disorder did not differ significantly from individuals with both a physical disease and a mental disorder (t = 1.21, p = .621, d = 0.09). ucla-ls-3 the subgroups significantly differed in their perception of loneliness, f(3, 4264) = 60.61, p < .001, η2 = 0.04. post-hoc tests indicated that healthy individuals did not differ significantly from individuals with a physical disease (t = -0.71, p = .895, d = -0.03), but had lower scores compared to individuals with a mental disorder (t = -11.59, p < .001, d = -0.68) and both a physical disease and a mental disorder (t = -7.65, p < .001, d = -0.51). individuals with a physical disease had lower scores than persons with a mental disorder (t = -9.89, p < .001, d = -0.64) and individuals with both (t = -6.61, p < .001, d = -0.47). no significant difference occurred between individuals with a mental disorder and both a physical disease and a mental disorder (t = 1.91, p = .224, d = 0.16). associations between sociodemographic factors and perceived changes/strains (number of strains and perceived distress) due to physical distancing the results of (frequentist and bayesian) multiple regression analyses (table 3) suggest that the number of strains attributed to physical distancing was significantly (and inde­ pendently) associated with lower age, being female, lower educated, living alone, having a current mental disorder, and having a current physical disease. similarly, perceived psychological effects of physical distancing 10 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ distress of physical distancing was significantly (and independently) associated with the same factors, except for the presence of a current physical disease (table 3). table 3 associations (multiple regression) between sociodemographic factors and perceived changes/strains (number of strains and perceived distress) due to physical distancing (n = 4171) predictor variables dependent variables number of physical distancing strains (0 – 12) perceived distress of physical distancing (0 – 100) b se(b) β p b se(b) β p age < -0.04 < 0.01 -0.21b < .01 -0.24 0.04 -0.11b < .01 sex (1 = female; 2 = male) 0.37 0.08 -0.07b < .01 -4.41 0.94 -0.07b < .01 education (1 = low; 2 = medium; 3 = high) -0.24 0.06 -0.06b < .01 -4.61 0.68 -0.10b < .01 currently unemployed (1 = yes; 0 = no) 0.12 0.19 0.01e .53 0.56 2.17 < 0.01e .80 living alone (1 = yes; 2 = no) -0.21 0.09 -0.04e .02 -3.57 1.01 -0.06b < .01 children (1 = yes; 0 = no) 0.09 0.08 0.02e .27 4.22 0.91 0.08b < .01 current mental disorder (1 = yes; 0 = no) 0.72 0.10 0.11b < .01 9.74 1.15 0.13b < .01 current physical disease (1 = yes; 0 = no) 0.22 0.08 0.04a .01 -0.26 0.92 < 0.01e .78 r2 .07 (p < .01)b .05 (p < .01)b note. results of independent bayesian regression analyses: abfinclusion / bf10 = 3 10 (moderate evidence for h1), bbfinclusion / bf10 > 10 (strong evidence for h1), cbfinclusion / bf10 = 1/10 1/3 (moderate evidence for h0); dbfinclusion 7 bf10 = 1/30 – 1/10 (strong evidence for h0); eweak/inconclusive evidence. associations between behavioural actions (quarantine and physical distancing) and levels of psychological distress correlation analyses (table 4) suggest that current behavioural actions (quarantine and physical distancing) are weakly positively associated with symptoms of stress, anxiety, and depression (phq) as well as somatic symptoms (phq-15) and loneliness (uclals-3). the corresponding bayes factors (bf) suggest moderate to strong evidence for a witthöft, jungmann, germer, & bräscher 11 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ positive relationship in all but one of the associations (in case of stress and physical distancing; bf10 = 0.55 indicating inconclusive evidence for a relationship). further correlational analyses focusing on possible associations between the duration of behavioural actions and levels of psychological distress (table 4) suggest that the duration (in days) since the start of the lockdown is largely unrelated to symptoms of stress, anxiety and depression, somatic symptoms, and loneliness (with correlation coefficients ranging from -.04 to .001). the evidence in favour of h0 (i.e., no association between the respective variables) is thereby moderate (somatic symptoms) to strong (anxiety and depression, loneliness), and inconclusive regarding symptoms of stress (phq). using the self-reported number of days regarding physical distancing resulted in almost equivalent findings: correlation coefficients were very small in size (range: -.03 .04) with moderate (anxiety and depression, somatic symptoms, loneliness) to strong (stress symptoms) evidence in favour of h0 (i.e., no association between the respective variables). table 4 associations between behavioral actions and measures of psychological distress measures of psychological distress quarantine, currently at the day of assessment (1 = no; 2 = yes) strength of physical distancing, currently (1 = no to 5 = extremely) days since official lockdown in germany (23.03.2020) self-reported duration physical distancing (days) self-reported duration quarantine (days)‡ stress (phq) .06*b (.06*) .04e (.03) -.04*c (-.04*) .01d (.02) -.09e (-.09) anxiety/ depression (phq-4) .06*b (.04*) .06*b (.06*) <.01d (.02) .04c (.06*) -.04d (-.02) somatic symptoms (phq-15) .09*b (.08*) .05*a (.04*) -.03c (-.02) .04c (.05*) -.08c (-.05) loneliness (ucla-ls3) .07*b (.05*) .09*b (.10*) <-.01d (.01) -.03c (-.02) -.02d (-.01) note. coefficients represent pearson’s rho; corresponding partial correlation coefficients conditioned on age, sex and education in parentheses (npartial corr = 4171); results of independent bayesian regression analyses: abf10 = 3 10 (moderate evidence for h1). bbf10 > 10 (strong evidence for h1). cbf10 = 1/10 1/3 (moderate evidence for h0). dbf10 = 1/30 – 1/10 (strong evidence for h0). einconclusive evidence. phq = patient health questionnaire; phq-4 = patient health questionnaire-4 (brief screening for anxiety and depression). phq-15 = 15-item somatic symptom subscale of the patient health questionnaire; ucla-ls3 = 3-item short version of the ucla loneliness scale; ‡subsample of participants reporting at least 1 day of quarantine (n = 449; npartial corr = 431). *p < .01. psychological effects of physical distancing 12 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ similarly, the self-reported number of days in quarantine (for the subsample of partici­ pants n = 449 reporting at least 1 day of quarantine) showed consistently small negative associations (range: -.09 .02) with symptoms of stress, loneliness, and psychopathology. bayes factors were indicative of mostly moderate to strong support for h0 (i.e., no association exists between the respective variables). in sum, support for a dose-response relationship as evidence of causality between symptom severity and behavioural meas­ ures was observed neither for the duration of physical distancing nor the duration of quarantine. since the day-wise subsamples differ in terms of sociodemographic variables, we additionally computed partial correlations (with statistically controlling for age, sex, and education) as a robustness check (table 4). the pattern of correlations remained largely unchanged. only two of the reported associations reached statistical significance (the association between self-reported days of physical distancing and symptoms of anxiety and depression in the phq-4: rpartial = .06, p < .01; the association between self-reported days of physical distancing and somatic symptoms in the phq-15: rpartial = .05, p < .01). the changes in the strength of associations are generally small and not indicative of qualitatively meaningful differences, though. associations between covid-19 anxiety, strength of physical distancing, symptoms of stress and psychopathology, and perceived changes/strains of physical distancing associations between covid-19 anxiety, strength of physical distancing, number of covid-19 cases and subjective measures of distress and psychopathology are detailed in table 5. covid-19 anxiety shows significant medium sized associations with symptoms of stress, anxiety, depression, and somatic symptom distress in the phq. self-reported strength of physical distancing showed only small associations with loneliness, the number of strains of physical distancing and associated distress but not with any of the phq measures. neither the number of days since lockdown nor the daily number of covid-19 cases were significantly associated with symptoms of stress, psychopathology, or loneliness. d i s c u s s i o n the primary aim of this study was to investigate potential early adverse effects associ­ ated with behavioural non-pharmacological preventive strategies (i.e., quarantine and so­ cial/physical distancing) initiated at the onset of the covid-19 pandemic in germany in march 2020. the majority of the studied sample (98.6%) reported significant changes and adverse effects of physical distancing, with restricted spare time activities, job-related difficulties, and negative emotional consequences as the most frequent topics. regarding witthöft, jungmann, germer, & bräscher 13 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ potential high-risk groups, people with a mental disorder (regardless of an additional physical health condition) reported significantly higher levels of adverse effects associ­ ated with the social restrictions resulting from physical distancing. early reviews on potential adverse effects of quarantine and social distancing (e.g., brooks et al., 2020) suggest a dose-response relationship between the duration of quar­ antine and social distancing and the burden of adverse psychological effects. in our study, no such evidence for a dose-response relationship emerged, i.e., no meaningful association was observed between the duration of physical distancing (both at the level of self-report and objective assessment) or duration of quarantine and symptoms of psychopathology. the findings suggest that the (causal) association between the duration of behavioural preventive strategies (i.e., quarantine and social/physical distancing) and symptoms of psychopathology might be smaller than expected, although caution must be taken that these observations might be specific to the situation (and particularly the restrictiveness of the measures) in germany between march, 25th and april, 14th. conse­ quently, increased levels of psychopathology observed in early stages of the pandemic (e.g., benke et al., 2020) might be stronger related and attributable to the perceived threat table 5 associations between covid-19 anxiety, strength of physical distancing, symptoms of stress and psychopathology, and perceived changes/strains due to physical distancing predictor variables dependent variables stress (phq) anxiety/ depression (phq-4) somatic symptoms (phq-15) loneliness (ucla-ls3) physical distancing strains (0 12) distress physical distancing (0 – 100) covid-19 anxiety .34*b (.31*b) .30*b (.28*b) .33*b (.30*b) .19*b (.17*b) .14*b (.14*b) .23*b (.22*b) strength of physical distancing (1 = no to 5 = extremely) -.01d (-.02c) .02d (.02e) < -.01d (<-.01c) .07*b (.07*b) .09*b (.09*b) .09*b (.08*b) days since official lockdown in germany (23.03.2020) .15c (.19c) .24d (.19e) .13d (.13c) .24c (.22e) .04e (< -.01e) .19e (.18e) daily covid-19 cases (per million) -.18c (-.21e) -.22d (-.16e) -.15d (.-.14c) -.23c (-.19e) -.07e (.01e) -.23e (-.19e) note. table contains beta coefficients of multiple regression analyses; corresponding values after adjusting for sex, age, and education in parentheses (n = 4171); results of independent bayesian regression analyses: abfinclusion / bf10 = 3 10 (moderate evidence for h1). bbf inclusion / bf10 > 10 (strong evidence for h1). cbf inclusion / bf10 = 1/10 1/3 (moderate evidence for h0). dbf inclusion / bf10 = 1/30 – 1/10 (strong evidence for h0). eweak/inconclusive evidence. *p < .01. psychological effects of physical distancing 14 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ by covid-19, rather than to the behavioural measures imposed to contain the pandem­ ic. in line with this hypothesis, covid-19 anxiety appears to be stronger related to measures of negative affect and psychopathology compared to the strength of behavioral measures (table 5). overall, our results are in line with a recent meta-analysis focusing on longitudinal and natural-experimental data across europe, north america, and asia suggesting that “the psychological impact of covid-19 lockdowns is small in magnitude and highly heterogeneous, suggesting that lockdowns do not have uniformly detrimental effects on mental health and that most people are psychologically resilient to their effects” (prati & mancini, 2021, p. 201). additionally, the implementation of stringent behavioral measures might not exclusively be associated with more adverse negative mental health consequences but might also serve as a protective factor, not only in terms of physical but also for mental health (lee et al., 2021). it appears noteworthy that our study focused primarily on physical distancing compared to quarantine. since the restrictions associated with quarantine appear more stringent and severe, it might be possible that quarantine could have more stable adverse mental health effects compared to physical distancing (e.g. jin et al., 2021; wang et al., 2021). strengths and limitations the generalization of findings is restricted by the nature of the sample: the current sample represents an online convenience sample and therefore consists of a higher percentage of women, younger people, and people with higher education and socio-eco­ nomic status compared to strictly population-representative samples. therefore, two opposing biases might be existent in the data: women and younger people have been found to report higher levels of mental distress (bräscher et al., 2021), i.e., these groups might increase the distress levels observed in our study. on the other hand, the underre­ presentation of people with lower education and socio-economic status might lower the observed distress levels in our study. it is difficult to determine, which of the two trends is stronger in size, but representative samples are needed to confirm the current results. because this study relied on self-reported questionnaire data only, the formation of subgroups regarding the presence of a mental disorders or a physical disorder should be interpreted cautiously, and further studies using clinical interviews are necessary to confirm our findings and to quantify the amount of additional distress associated with different kinds of mental and physical disorders. finally, the examination of possible dose-response associations between distress lev­ els and the duration of the respective behavioural intervention is limited by the crosssectional nature of our study, the comparatively short period of data assessment (over the period of 20 days), and early point in time in the pandemic situation. more extended, longitudinal studies are needed to rigorously test the question of possible dose-response witthöft, jungmann, germer, & bräscher 15 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://www.psychopen.eu/ relationships that would be indicative of a causal relation between duration of non-phar­ macological interventions and adverse mental health effects. conclusion this study aimed at evaluating possible adverse effects associated with non-pharmaco­ logical preventive measures imposed to contain the covid-19 pandemic in germany. the findings suggest that most of the participants were negatively affected by the be­ havioural interventions with restrictions in spare time activities, occupational problems, and negative emotional reactions (e.g., worries, sadness, and loneliness). the adverse effects were highest in people with a mental disorder, suggesting that this group should receive particular attention and support in order to prevent exacerbations of mental distress levels. significant positive association (as possible evidence of a dose-response relationship) with mental distress could neither be observed for the duration of physical distancing nor for the duration of quarantine, leaving open the question whether higher levels of mental distress observed during early stages of the first wave of covid-19 are causally related to the behavioural interventions. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @witthoef, @steffi_jungmann, @sylvangermer, @annekbraescher r e f e r e n c e s benke, c., autenrieth, l. k., asselmann, e., & pané-farré, c. a. 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(2020b, april 13). coronavirus disease 2019 (covid-19) situation report – 84. retrieved from https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200413-sitrep-84covid-19.pdf?sfvrsn=44f511ab_2 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. witthöft, jungmann, germer, & bräscher 19 clinical psychology in europe 2022, vol. 4(3), article e7205 https://doi.org/10.32872/cpe.7205 https://doi.org/10.1038/s41380-021-01019-y https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200325-sitrep-65-covid-19.pdf?sfvrsn=ce13061b_2 https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200325-sitrep-65-covid-19.pdf?sfvrsn=ce13061b_2 https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200413-sitrep-84-covid-19.pdf?sfvrsn=44f511ab_2 https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200413-sitrep-84-covid-19.pdf?sfvrsn=44f511ab_2 https://www.psychopen.eu/ psychological effects of physical distancing background method sample and procedure measures quantifying the duration of quarantine and physical distancing statistical analyses results psychological effects of behavioural actions (i.e., lockdown, social/physical distancing, quarantine) high-risk groups with mental disorder and/or physical disease associations between sociodemographic factors and perceived changes/strains (number of strains and perceived distress) due to physical distancing associations between behavioural actions (quarantine and physical distancing) and levels of psychological distress associations between covid-19 anxiety, strength of physical distancing, symptoms of stress and psychopathology, and perceived changes/strains of physical distancing discussion strengths and limitations conclusion (additional information) funding acknowledgments competing interests twitter accounts references psychotherapy under lockdown: the use and experience of teleconsultation by psychotherapists during the first wave of the covid-19 pandemic research articles psychotherapy under lockdown: the use and experience of teleconsultation by psychotherapists during the first wave of the covid-19 pandemic jessica notermans 1,2 , pierre philippot 1,2 [1] consultations psychologiques spécialisées, université catholique de louvain, louvain-la-neuve, belgium. [2] laboratory for experimental psychopathology, université catholique de louvain, louvain-la-neuve, belgium. clinical psychology in europe, 2022, vol. 4(3), article e6821, https://doi.org/10.32872/cpe.6821 received: 2021-05-27 • accepted: 2022-05-31 • published (vor): 2022-09-30 handling editor: anton-rupert laireiter, university of vienna, vienna, austria corresponding author: jessica notermans, institut de recherche en sciences psychologiques, université catholique de louvain, place du cardinal mercier, 10, b-1348 louvain-la-neuve, belgium. phone: +32489195018. email: jessicanotermans@gmail.com supplementary materials: materials [see index of supplementary materials] abstract background: facing the covid-19 pandemic, some psychotherapists had to propose remote consultations, i.e., teleconsultation. while some evidence suggests positive outcomes from teleconsultation, professionals still hold negative beliefs towards it. additionally, no rigorous and integrative practice framework for teleconsultation has yet been developed. this article aims to explore the use and experience of teleconsultation by 1) investigating differences between psychotherapists proposing and not proposing it; 2) evaluating the impact of negative attitudes towards teleconsultation on various variables; 3) determining the perceived detrimental effect of teleconsultation, as opposed to in-person, on the therapeutic relationship and personal experience; and 4) providing insights for the development of a teleconsultation practice framework. method: an online survey was distributed via different professional organisations across several countries to 246 (195 women) french-speaking psychotherapists. results: psychotherapists who did not propose teleconsultation believed it to be more technically challenging than psychotherapists who proposed it, but felt less constrained to propose it, and had less colleagues offering it. attitudes towards teleconsultation showed no significant associations with therapeutic relationship, personal experience, and percentage of teleconsultation. as compared to in-person, empathy, congruence, and therapeutic alliance were perceived to significantly deteriorate online, whereas work organisation was perceived to be significantly this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6821&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0002-0602-560x https://orcid.org/0000-0003-0207-2430 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ better. while most psychotherapists proposed remote consultations, they did not provide adaptations to such setting (e.g., ascertaining a neutral video background); nor used videoconferencing platforms meeting privacy and confidentiality criteria. conclusion: training and evidenced-based information should be urgently provided to practitioners to develop rigorous guidelines and an ethically and legally safe practice framework. keywords teleconsultation, covid-19, attitudes, online psychotherapy, ethics, therapeutic relationship highlights • psychotherapists differ in their perceptions of teleconsultation as whether they propose it or not. • attitudes towards teleconsultation are not related to its use nor to the therapeutic relationship. • teleconsultation worsens perceived therapeutic relationship, but improves work organisation. • training is needed to improve an ethically and legally safe practice of teleconsultation. following the first wave of the covid-19 pandemic, many countries imposed a lock­ down, which resulted in the suspension of various healthcare practices, including faceto-face psychotherapy. consequently, many psychotherapists had to rapidly adapt their services and propose consultations at a distance, i.e., teleconsultation. teleconsultation refers to “interactions that happen between a clinician and a client for the purpose of providing diagnostic or therapeutic advice through electronic means” (pan american health organization, 2021). this drastic change in the provision of mental health serv­ ices was largely improvised as most psychotherapists and professional organisations were unprepared for this challenge. some evidence suggests positive outcomes from teleconsultation for the treatment of specific conditions (acierno et al., 2016; poletti et al., 2021; wright & caudill, 2020). moreover, recent evidence from the covid-19 pandemic also shows that most psycho­ therapists experience remote psychotherapy rather positively (feijt et al., 2020; humer et al., 2020; mcbeath et al., 2020). these attitudes towards teleconsultation are influenced by a set of factors (connolly et al., 2020), such as previous online experience, clinical experi­ ence (békés & aafjes-van doorn, 2020), perceived ability to develop a strong therapeutic relationship (aafjes-van doorn et al., 2021; roesler, 2017), and perceived therapeutic efficacy (aafjes-van doorn et al., 2021). in contrast, other evidence reports that mental health practitioners hold negative attitudes towards teleconsultation (mendes-santos et al., 2020; perle et al., 2013; varker et al., 2019). beliefs regarding poor efficacy (schulze et al., 2019) and ethical limitations (stoll et al., 2020) of such practices may hamper its psychotherapy under lockdown 2 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ use and implementation, as well as reduce clients’ adhesion. questions regarding the strengths and limitations of online therapy are known topics of discussion among mental health professionals (rochlen et al., 2004). therefore, it is important to further investigate current attitudes towards teleconsultation and evaluate their potential impact. last but not least, with the drastic transition from in-person to remote consultation, several authors underlined the importance to develop an integrative and balanced prac­ tice framework with specific guidelines to inform psychotherapists about the use of teleconsultation (smith et al., 2020). boldrini and colleagues (2020) provided a set of recommendations to help professionals support the implementation and use of telecon­ sultation. moreover, another team of researchers listed useful evidence-based guidelines for clinicians using telepsychiatry (smith et al., 2020). however, these recommendations are gathered from country-specific sources (italy and england respectively), and thus do not allow for a global perspective on the matter. finally, while a set of valuable recom­ mendations regarding the policy and practice of telepsychotherapy was also developed in field studies (shore et al., 2018; van daele et al., 2020), and suggested by professional organisations (british association for behavioral & cognitive psychotherapies, 2021), they are largely based on clinical consensus. further empirical data are thus required to provide a rigorous, ethical, and safe framework to support the provision of remote mental healthcare in times of crisis (ohannessian et al., 2020). in this perspective, the present survey aims to explore the use and experience of teleconsultation among french-speaking psychotherapists in order to provide insights regarding its challenges and benefits. first, we hypothesise that there will be significant differences between psychotherapists proposing teleconsultation and those who do not, specifically in terms of attitudes towards it, previous online experience, feelings of con­ straint, perceived support, and colleagues’ usage. second, attitudes towards teleconsulta­ tion will have significant and negative associations with the therapeutic relationship, the personal experience of teleconsultation, and the percentage of teleconsultation proposed. third, the therapeutic relationship and personal experience of teleconsultation will be perceived as significantly worse than in-person. lastly, this study will explore how various elements of teleconsultations (e.g., legal and ethical questions, adaptations, etc.) may contribute to the elaboration of a practice framework. altogether, it investigates the information, skills, and knowledge that would help psychotherapists improve their prac­ tice of teleconsultation, in terms of effectiveness, ethics, and well-being at work. thus, it may serve as a basis for establishing psychotherapists’ potential needs for training in teleconsultation, as suggested by recent studies (van daele et al., 2020; wijesooriya et al., 2020). notermans & philippot 3 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ m e t h o d recruitment and procedure the survey was developed online (on the qualtrics platform), and distributed via dif­ ferent professional organisations (e.g. uppcf, aemtc) to 246 french-speaking psycho­ therapists between september 15th and october 31st of 2020 in belgium, france, morocco, switzerland, and tunisia. the study was approved by the ipsy ethics committee of uclouvain (project 2020-30; approved on june 10th, 2020). survey questionnaire the questionnaire (appendix 1, supplementary materials) comprises four sections. sec­ tion 1 presents the aim of the study and provides informed consent details. if consent was given, participants were asked whether they proposed teleconsultations from the first lockdown (march 16th, 2020) onwards. those who answered positively were directed to section 2; others were directed to section 3. section 2 includes questions pertaining to the use and experience of teleconsultation for psychotherapists proposing it. section 3 examines the attitudes towards teleconsulta­ tion of psychotherapists not proposing it, as well as other variables that may shed light on the motives behind their non-adhesion to teleconsultation. section 4, was given to all participants, and covers demographics, namely gender, level of education, level of psychotherapy training, psychotherapeutic orientation, work status, years of experience, percentage of teleconsultations proposed since june 2020, living situation, number of dependent children and their age, if any, the extent to which the charge of dependent children living at home impacted their psychotherapy activities during the lockdown, age, and country of residence. measures to the authors’ knowledge, no valid and reliable measures evaluating their questions of interest were found in the literature. therefore, the survey’s validity and reliability are limited. survey’s questions are detailed below (see appendix 1 in the supplementary materials for the full survey). section 2 contains 20 questions inquiring on: 1) whether the number of consulta­ tions in 2020 decreased or increased (ranging from -100 to +100%) between march and june, and 2) between july and september, as compared to the same period in 2019; 3) attitudes (i.e., negative beliefs) towards teleconsultation, evaluated on a 5-point likert scale ranging from 0 “strongly disagree” to 4 “strongly agree”, from an 11-item ad hoc questionnaire; 4) what remote mediums were utilised (telephone, chat messaging, e-mails, and/or videoconferencing); 5) the type of platforms used (e.g., zoom, whatsapp, whereby, etc.); 6) whether they had prior experience with teleconsultation (no experi­ psychotherapy under lockdown 4 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ ence; experience as a supervisee/or as a patient; experience as a supervisor; and/or experience as a psychotherapist); 7) whether they felt constrained to use it (not at all, slightly, moderately, or strongly); 8) whether their colleagues used it (none; a few, some, most, or all); 9) whether they had specific concerns regarding data protection and confidentiality (no; “yes, i found satisfactory answers”; or “yes, but i still have ques­ tions (specify)”); 10) whether they received support to set up teleconsultation (no, mild, moderate, or complete support); 11) whether (yes or no), and 12) how they encouraged clients to engage in teleconsultation (selecting from a 10-item ad hoc questionnaire items such as “providing information regarding the efficacy of teleconsultation”, “providing a short free trial on the media used”, etc.); 13) whether they provided adaptations to the teleconsultation setting (“generally, i did not have to adapt the teleconsultation setting” or “i had to do minor changes”), and 14) how they adapted their online interventions, based on the population (e.g., children, adolescents, adults, etc.), and 15) disorder (e.g., mood disorder(s), anxiety disorder(s), eating disorder(s), etc.). question 16 investigated the percentage of clients for whom their issue was directly linked to the pandemic, aggravated by it, or independent from it. question 17 evaluated, on a 5-point likert scale (from 0 “highly degraded” to 4 “highly improved”), psychotherapists’ experience of teleconsultation as compared to in-person for the therapeutic relationship (empathy, con­ gruence, positive regard, and therapeutic alliance). question 18 asked whether psycho­ therapists will continue to propose teleconsultation after the pandemic (“yes, based on the patient/client demand, teleconsultation will be an option”; “yes, teleconsultation will become major in my clinical practice”; or no). question 19, evaluated on a 5-point likert scale (from 0 “much worse” to 4 “much better”), psychotherapists’ personal experience of teleconsultation (therapeutic efficacy, professional satisfaction, fatigue/exhaustion, work organisation, and ease of payment) as opposed to in-person. a final open-ended question asked about additional comments/remarks regarding teleconsultation. section 3 includes seven questions. first, a 7-item ad hoc questionnaire evaluates on a 5-point likert scale (from 0 “not at all important” to 4 “very important) psychothera­ pists’ motives for not providing teleconsultation (e.g., “this mode of communication does not seem appropriate for a psychotherapy”, or “people did not wish to start/continue via teleconsultation”). then, participants were asked whether they could have received support if they proposed teleconsultation (no, mild, moderate, or complete support); whether they felt constrained to offer it (not at all, slightly, moderately, or strongly); whether they had previous experience with it (no experience; experience as a supervi­ see/or as a patient; experience as a supervisor; and/or experience as a psychotherapist); whether their colleagues were offering it (none, a few, some, most, or all); and whether they intended to propose it in the future (no; “yes, if the pandemic persists”; or “yes, no matter what”). finally, the same ad-hoc questionnaire from section 2 investigated their attitudes towards teleconsultation. notermans & philippot 5 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ data analysis for hypothesis 1, an exploratory factor analysis (efa) explored the internal structure of attitudes. the kaiser–meyer–olkin index and the bartlett sphericity test were computed to assess the robustness of the results. then, independent t-tests evaluated the significant differences in attitudes between psychotherapists who did and did not propose telecon­ sultation, as well as for previous experiences, feelings of constraint, perceived support, and colleagues’ usage. levene's corrections were used for cases in which variances differed between groups. for hypothesis 2, pearson’s correlations were calculated be­ tween attitudes towards teleconsultation, therapeutic relationship, personal experience, and percentage of teleconsultation. for hypothesis 3, single sample t-tests determined whether teleconsultations were perceived as worse than in-person, for the therapeutic relationship and personal experience. finally, for hypothesis 4, single sample t-tests and descriptive statistics explored variables related to the use and experience of teleconsulta­ tion, and participants’ demographics. qualitative data complemented quantitative results. ibm spss statistics for windows, version 21.0, was used for all analyses. r e s u l t s participants characteristics a total of 246 individuals (195 women; 35 men) participated in the study. 16 participants did not fill the entire survey, mainly on demographic questions. they were aged between 25 and 70 years (m = 42.4). out of 230 participants, all were psychotherapists and most of them (186) had at least 3 years of postgraduate training in psychotherapy. they were mostly from belgium (133), switzerland (45), and france (37). the majority were self-em­ ployed (114) or part-time self-employed (59), while 94 were employees. most participants identified themselves as cbt (156) or integrative (58) psychotherapists. the majority (158) lived as a couple and 115 had children living at home (average 1.90 children). dependent children living at home were aged between 0 and 29 years of age (m = 11.32). out of the total sample (n = 246), 222 psychotherapists proposed teleconsultation (173 females; 33 males; 16 did not answer), and 24 (22 females; 2 males) did not. hypothesis 1 the factorability of the 11 attitudes towards teleconsultation was examined for the total sample. a three-factor solution explained 58.2% of the variance for the entire set of variables, with eigenvalues greater than 1 and a minimum of 10% of variance explained by each factor. the kaiser–meyer–olkin index for sampling quality was good: 0.191, and the bartlett sphericity test was correct, χ2(55) = 75.84, p > .04. the scree plot also suggests a three-factor solution. the factor solution, after oblimin rotation, is displayed in table psychotherapy under lockdown 6 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ 1. the first factor, “attention”, pertains to the belief that teleconsultation entails attention difficulties in both the client/patient and therapist. the second factor, “technical issues”, covers beliefs that teleconsultation requires significant technical skills and infrastructure. the last factor, “interpersonal communication”, reflects the belief that teleconsultation is detrimental to the communication quality between client/patient and therapist. table 1 factor loadings, after oblimin rotation, for the 11 items of attitudes towards teleconsultation for psychotherapists proposing and not proposing it items of attitudes towards teleconsultation factors (1) attention (2) technical issues (3) interpersonal communication (reversed) i will be too distracted .883 i will not be engaged/present enough .851 the client/patient will not be engaged/present enough .647 there will be too many distractions in the individual .572 my personal infrastructure will not be adequate for teleconsultation (e.g., limited infrastructure, isolated room for the session, etc.) .387 .328 teleconsultation requires a good handling of informatics tools .838 technical issues will have too big of an impact on communication .729 the lack of non-verbal information will be too important -.854 teleconsultation will limit the development of a good therapeutic relationship -.778 it will be difficult to set up some interventions .433 -.505 teleconsultation will increase dropout number in certain individuals (e.g., addictions) -.357 t-tests were run to determine whether attitudes differed between psychotherapists as a function of whether they proposed teleconsultations. a significant difference was ob­ served only for factor 2, “technical issues”, indicating that psychotherapists who did not propose teleconsultations believed they entailed more technical issues, t(32.247) = -3.159, notermans & philippot 7 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ p = .003, than those who proposed them. mean differences for each attitude towards tel­ econsultation between psychotherapists proposing and not proposing teleconsultations are found in appendix 2, supplementary materials. most psychotherapists had no experience with teleconsultation before the pandemic, whether they proposed it (n = 188) or not (n = 19), with no difference between these two groups, χ2(1, n = 243) = 0.764, p = .382. most psychotherapists who proposed teleconsul­ tation felt significantly more constrained (i.e., strongly constrained; m = 2.78, sd = 1.17) to do so than those who did not (i.e., slightly constrained; m = 1.79, sd = .66), t(41.249) = 6.340, p < .001. in addition, psychotherapists reported having received little support to set up teleconsultation, whether they offered it (m = 1.69, sd = .88) or not (m = 1.75, sd = 1.07), t(240)= -.321, p = .749. qualitative data indicate that support mainly came from colleagues (n = 55), it services (n = 22), supervisors (n = 13), friends and family (n = 15), and professional associations (n = 11). finally, the majority of psychotherapists (n = 116) expressed that some colleagues used teleconsultation. yet, psychotherapists proposing teleconsultation reported that most of their colleagues used it (m = 3.24, sd = .87) as opposed to colleagues of psychotherapists not offering it (m = 2.38, sd = .77), t(241) = 4.677, p < .001. hypothesis 2 no significant correlations above the coefficient .30 were found. however, for explorato­ ry purposes, significant (p < .001) and positive associations were found between thera­ peutic relationship, personal experience, and percentage of teleconsultation (appendix 3, supplementary materials). regarding the therapeutic relationship, empathy is correlated with congruence (r = .389), unconditional positive regard (r = .411), therapeutic alliance (r = .417), therapeutic efficacy (r = .378), and professional satisfaction (r = .303). thus, the more psychothera­ pists perceived empathy as better online than in-person, the more the above variables were perceived similarly, and vice versa. comparably, congruence is correlated with therapeutic alliance (r = .394), and therapeutic efficacy (r = .413), while unconditional positive regard is only correlated with therapeutic alliance (r = .309). finally, therapeutic alliance is correlated with therapeutic efficacy (r = .472), and professional satisfaction (r = .382). regarding therapeutic experience, therapeutic efficacy is correlated with professional satisfaction (r = .592), such that the more psychotherapists perceived therapeutic efficacy as better online than in-person, the more they perceived professional satisfaction as better online than in-person, and vice versa. therapeutic efficacy is also correlated with percentage of consultation (r = .343), meaning that the more psychotherapists perceived therapeutic efficacy as better online than in-person, the more their percentage of teleconsultation increased from june 2020, and vice versa. similarly, professional satisfaction is correlated with strain (r = .438), efficiency in work organisation (r = .352), psychotherapy under lockdown 8 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ and percentage of consultation (r = .356). finally, strain is also correlated with efficiency in work organisation (r = .403). hypothesis 3 single sample t-tests against 3 (neutral “no change” point) showed significant changes in three aspects of the therapeutic relationship: empathy, congruence, and therapeutic alliance. specifically, participants perceived that these significantly degraded online as compared to in-person (table 2). table 2 perceived effect of teleconsultation on therapeutic relationship as compared to face-to-face (n = 207) (1: highly degraded, 3: no change, 5: highly improved) aspects of therapeutic relationship m sd p empathy 2.81 0.59 < .001 congruence 2.76 0.67 < .001 unconditional positive regard 2.96 0.51 .206 therapeutic alliance 2.86 0.70 .006 similarly, single sample t-tests against 3 showed that all variables of personal experience of teleconsultation were perceived as significantly worse online, as compared to in-per­ son, except ‘organisation, time and task management, etc.’ which was perceived as significantly better (table 3). table 3 experience of teleconsultation as compared to face-to-face (n = 206) (1: much worse; 3: no difference, 5: much better) variables of personal experience of teleconsultation m sd p organisation, time and task management, etc. 3.24 1.17 .004 ease/rapidity to receive payments 2.49 0.91 < .001 therapeutic efficacy 2.39 0.77 < .001 professional satisfaction 2.24 0.96 < .001 strain, fatigue 2.24 1.12 < .001 notermans & philippot 9 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ hypothesis 4 data from psychotherapists proposing teleconsultation during the first lockdown (from march to june 2020), consultations significantly dropped by almost 24% (sd = 46.03), t(221) = -7.759, p < .001 (single sample t-test against 0). this decrease was observed for all job status: self-employed (n = 110, m = -24.81, sd = 58.46); employees (n = 83, m = -20.34, sd = 42.31); and part-time self-employed (n = 47; m = -40.28, sd = 44.71). however, from june to september 2020, consultations appeared to have slightly but significantly increased by 6.3%, (sd = 31.68), t(220) = 2.945, p = .004, as compared to the same period in 2019. such increase is also observed in all status: self-employed (n = 109, m = 2.95, sd = 30.09); employees (n = 83, m = 10.72, sd = 30.39); and part-time self-employed (n = 47, m = 11.57, sd = 39.56). then, from june to september 2020, 19.1% of consultations, on average, occurred remotely. out of 115 participants with dependent children at home, 53.9% did not report a decrease in their professional activities. however, 20.0% slightly reduced (10.0% to 30.0%) their professional activities, 14.8% moderately reduced (31.0 to 60.0%), 6.1% strongly reduced (61.0 to 80.0%), and 5.2% extremely reduced them (81.0 to 100.0%). no significant gender difference was found; such that dependent children did not present more difficul­ ties in professional activities for men, and vice versa. participants reported that the majority of their clients (n = 207, m = 64.9%, sd = 24.40) consulted for reasons independent of the covid-19 crisis. 12.8% (n = 207, sd = 15.56) consulted for issues mainly related to covid-19, and 29.5% (n = 207, sd = 21.23) consulted for issues significantly aggravated by covid-19. out of 222 participants, 94.1% used videoconference for teleconsultations; 67.1% used the telephone; 12.6% used e-mails; and 4.5% used chat messaging. regarding videoconfer­ encing platforms, 63.6% of psychotherapists reported using skype, 42.6% used zoom, 29.2% used whatsapp, and 26.3% used whereby (appendix 4, supplementary materials). more than half of the participants (n = 116, 52.3%) found satisfactory answers regard­ ing data protection and deontology issues, whereas a third (n = 61, 27.5%) did not have questions regarding these issues. still, a fifth (n = 41, 18.9%) found answers but had remaining questions, mainly concerning the confidentiality of videoconferencing platforms (n = 32). the majority of practitioners (n = 119, 54.6%) set up actions to encourage clients’ adhesion (table 4). most participants (n = 128, 57.7%) did not adapt their practice to the teleconsultation setting, while 27% (n = 60) provided minor changes. some (n = 19, 8.6%) adapted their therapeutic procedures (e.g., screen sharing to show schemas or other visuals; printing materials to present before the camera; emailing questionnaires and other documents); others (n = 18, 8.1%) adapted their room, desk, and/or video back­ ground; and 12 participants (5.4%) adapted their schedules and/or consultation timing and frequency. a small portion of respondents, 12.6% (n = 28), adapted significantly their consultation based on the type of population (see appendix 5, supplementary materials), psychotherapy under lockdown 10 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ while 10.4% (n = 23) adapted significantly their consultation based on the type of disorder (see appendix 5, supplementary materials). changes pertained mainly to therapeutic procedures and interventions (e.g., shortened session, flexible schedule, adaptation of interventions, etc.). table 4 actions set up to encourage adherence to teleconsultation actions to encourage adherence to teleconsultation n = 222 % communicating with the patient/client to assess the situation (via email, telephone, or other) 97 43.7 giving general advice to ensure optimal conditions for teleconsultations (e.g., be in a quiet space to avoid distractions and increase privacy, ensure a good internet connection, have charged devices, etc.) 79 35.6 underlining the importance of psychotherapy continuity for the well-being of the patient/client 75 33.8 giving information on the use of virtual platform (or other used media) 69 31.1 being flexible regarding schedule 67 30.2 giving information on the privacy of personal data (confidentiality regarding the session and the used media) 51 23 doing a trial test on the used media 45 20.3 giving information on the efficacy of teleconsultations 41 18.5 being flexible regarding payments 29 13.1 finally, out of 207 respondents, 65.8% (n = 146) intend to keep teleconsultation as an option, after the lockdown, if requested by their client. only, 6.8% (n = 15) intend to rely mainly on teleconsultation in their clinical practice. in contrast, 20.7% (n = 46) intend to not use teleconsultation anymore after the lockdown. qualitative results from participants’ comments (n = 74) provided additional useful information. some participants (n = 12) underlined numerous advantages (e.g., facility to consult regardless of geographical distance, schedule flexibility), while others (n = 17) enumerated disadvantages and difficulties (e.g., increased fatigue, lack of warmth, difficulty to set up specific intervention and/or share therapeutic information). few (n = 5) underlined that there was no important difference between teleconsultation and in-person. some (n = 4) were agreeably surprised by teleconsultation and saw their attitudes improved after using it. finally, 12 participants explained that the majority of clients refused to pursue via teleconsultation. notermans & philippot 11 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ data from psychotherapists not proposing teleconsultation only 24 participants did not propose teleconsultation during the lockdown. the two main reasons behind this decision concerned personal issues, and the belief that this type of communication was not appropriate for psychotherapy (table 5). open answers showed that personal reasons (n = 8) pertained mainly to limited infrastructure (n = 6), such as having access to adequate it material or a private room. more than half (n = 14; 58.3%) do not have the intention to use teleconsultation in the near future; over a third (n = 9; 37.5%) will use it if the pandemic persists; and one participant definitely intends to use it in a near future. table 5 reasons for not proposing teleconsultation (from 1: not at all important to 5: very important) reasons for not proposing teleconsultation m sd personal reasons (e.g., limited infrastructure, childcare, etc.) 3.75 1.62 this type of communication does not seem appropriate for psychotherapy 3.54 1.10 individuals did not want to start or pursue via teleconsultation 3.54 1.38 lack of it support 3.46 1.44 i have doubts regarding the therapeutic efficacy in teleconsultation 3.13 1.23 the (mental) state of individuals did not require the continuity of therapy 2.42 1.21 financial reasons (e.g., to receive governmental or other financial aid) 1.75 1.11 d i s c u s s i o n this survey shows that most psychotherapists rapidly responded to the sanitary crisis by proposing teleconsultations. they did so with little support and no previous experience with teleconsultation. the important drop (24%) in consultations observed during the first lockdown might have fostered for some the rapid transition to teleconsultation. regarding the first hypothesis, while psychotherapists who did not propose telecon­ sultation believed it to be more technically challenging, received less support, and had less colleagues using it, than those proposing it, attitudes towards teleconsultation did not appear to significantly influence its use. similar findings from a recent systematic review (connolly et al., 2020) suggest that, overall, practitioners tend to have positive attitudes towards telemental health regardless of its disadvantages. moreover, they sug­ gest that previous experience as well as repetitive use of telemental health is related to positive attitudes and acceptance of such method. comparably, our qualitative data sug­ gest that most therapists felt reassured about these issues after gaining some experience with teleconsultation, and surprisingly pleased; a finding also expressed in elford et al.’s study (2000). additionally, qualitative data suggest that the main determinant for not proposing teleconsultation lied in contextual factors, rather than being a personal choice. psychotherapy under lockdown 12 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ for example, working in an institution (e.g., hospital, prison) or at home made it difficult to set up teleconsultations due to the lack of appropriate infrastructure (e.g., it material, stable internet connection, private room). connolly et al. (2020) describe similar negative attitudes regarding the disadvantages of telepsychiatry but underline that the benefits of such methods often outweigh its costs. nevertheless, it is important to note that the sample of psychotherapists not proposing teleconsultation in the present survey is rather small, which calls for caution in interpreting the findings. rejecting our second hypothesis, no significant correlations were evidenced between attitudes and teleconsultation’s use and experience. a similar finding was reported by monthuy-blanc and colleagues (2013), such that intention to use telepsychotherapy was not determined by providers’ attitudes towards it, neither by how difficult they expected it to be, but merely by how useful they thought it to be to first nations clients in australia. nevertheless, a recent study also reported that therapists’ concerns about online connectedness predicted negative attitudes towards teleconsultation and decreased perceived efficacy (békés et al., 2021). therefore, it would be of interest to pursue researching the impact of attitudes on the experience of teleconsultation. in accordance to our third hypothesis, most aspects of the therapeutic relationship (empathy, congruence, and therapeutic alliance) were perceived as significantly deterio­ rated online, as compared to in-person, with the exception of unconditional positive regard. moreover, participants also reported that their personal experience with tele­ consultation in terms of ease of payment, work exhaustion, therapeutic efficacy, and professional satisfaction was also perceived as significantly worse online. unexpectedly, however, work organisation was perceived as significantly better online. regarding our fourth hypothesis, a plethora of findings could be used to help in the development of a practice framework. first, privacy and confidentiality information and trainings should be urgently provided to professionals. in fact, in our survey, the major­ ity of platforms used (e.g., skype, whatsapp, messenger) does not reach the minimal legal criteria for privacy and confidentiality (e.g., some platforms record and sell commu­ nication data) as requested by psychotherapy. moreover, ethical concerns are raised by the fact that many respondents (27.5%) did not seem concerned about deontology and data protection issues with respect to teleconsultation. however, current guidelines and recommendations from different countries strongly underline the importance of ensuring the privacy and confidentiality of videoconferencing platforms (american psychological association, 2020; british association for behavioral & cognitive psychotherapies, 2021; commission des psychologues, 2020; shore et al., 2018; smith et al., 2020; van daele et al., 2020). as lustgarten et al. (2020) explain, even if some platforms (e.g., skype, facetime) may be familiar for most providers and clients, other platforms may be more secure and legally compliant. these authors also provide further recommendations regarding safe practice. evidently, guidelines and recommendations must be made more accessible to all psychotherapists, and professional organisations should work actively notermans & philippot 13 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ in providing recommendations and safe-to-use platforms and apps protecting clients’ personal information (ohannessian et al., 2020). second, psychotherapists should keep encouraging clients’ adhesion to teleconsulta­ tion. in the survey, half of the psychotherapists proposing teleconsultation actively sought to motivate their clients to accept teleconsultation. they mostly kept in touch with them and provided information regarding its use, safety, and efficacy. in fact, showing informational videos discussing the benefits of internet-based mental health services increases clients’ acceptance (ebert et al., 2015). surprisingly, however, only 20% proposed a trial on the chosen media, while theory and anecdotal evidence suggest this action to be very effective (sasangohar et al., 2020; smith et al., 2020). third, information and training should be provided regarding contextual and thera­ peutic adaptions to the teleconsultation setting. in the survey, most therapists did not significantly adapt their way of delivering psychotherapy beyond the switch towards teleconsultation. however, it is important to have a proper and professional setting for teleconsultation (british association for behavioral & cognitive psychotherapies, 2021; de witte et al., 2021; sasangohar et al., 2020; smith et al., 2020), such as ensuring that their video background conveys a feeling of safety and intimacy, and ensuring that clients are benefiting from a quiet, secure, and undisrupted space for the therapy session. more importantly, therapists should be aware of their clients’ location in order to contact them in case of communication failure (e.g., having a contact cell phone number) or emo­ tional breakdown (e.g., having a backup person in the client’s immediate surrounding who could be reached and intervene). regarding interventions, only slight adaptations were provided. our qualitative data and anecdotal evidence suggest that many therapists avoid interventions entailing the activation of intense or aversive emotions, such as exposure. however, recent evidence suggests that such interventions can be successfully and safely provided online (wells et al., 2020). furthermore, few adaptations were repor­ ted as a function of clients’ age or disorder, although some authors (smith et al., 2020; van daele et al., 2020) emphasise that teleconsultation be adapted to the population, its context, and the conditions they are facing. other authors and clinicians provide recommendations on how to adapt therapeutic interventions to the teleconsultation setting for groups (banbury et al., 2018), children (american academy of children and adolescent psychiatry, 2021; american psychiatric association, 2020; becqueriaux, 2020; landrum, 2020), as well as for people suffering from eating disorders (waller et al., 2020) and post-traumatic stress (kaltenbach et al., 2021; moring et al., 2020). nevertheless, such works are still in their infancy and more empirical evidence is needed to optimise the provision of teleconsultation. the present survey suffers from some limitations. first, it has been conducted online and among french-speaking psychotherapists, thus reducing its reach to participants from other countries, and with minimal internet literacy and/or accessibility. second, from a lack of valid measurements in the literature, no psychometrically sound measures psychotherapy under lockdown 14 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://www.psychopen.eu/ could be used to evaluate our hypotheses. third, a memory bias may have impacted our findings, as psychotherapists were asked retrospectively about their use and experience of teleconsultation. finally, it should also be noted that while this survey addressed the first lockdown, the situation kept evolving. further surveys, targeting the following phases of the pandemic should examine these evolutions in terms of increase in the provision of teleconsultation and professionals’ exhaustion. conclusion while some findings enlightened the use and experience of teleconsultation by psycho­ therapists during the first lockdown, many questions remain in all discussed domains: the impact of attitudes towards the use and experience of teleconsultation; the legal and ethical aspects of videoconferencing platforms; and ways to develop contextual and therapeutic adaptations to the teleconsultation setting. it is the authors’ opinion that basic psychotherapy training should address these questions, and that professional organisations should provide detailed information and instructions about the use of ethically and legally safe teleconsultation platforms. funding: the authors have no funding to report. acknowledgments: we would like to thank the team of the consultations psychologiques spécialisées for their support during the development of this survey, as well as the numerous professional associations (e.g., uppcf, aemtc, afforthec, aspco) of psychotherapists who helped us distributing the survey. competing interests: the authors have declared that no competing interests exist. twitter accounts: @philippotp_ucl s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include the entire survey questionnaire and additional tables related to some results (e.g., mean differences, correlations, etc.). for access see index of supplementary materials below. index of supplementary materials notermans, j., & philippot, p. (2022). supplementary materials to "psychotherapy under lockdown: the use and experience of teleconsultation by psychotherapists during the first wave of the covid-19 pandemic" [survey questionnaire, and additional tables]. psychopen gold. https://doi.org/10.23668/psycharchives.8181 notermans & philippot 15 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://twitter.com/philippotp_ucl https://doi.org/10.23668/psycharchives.8181 https://www.psychopen.eu/ r e f e r e n c e s aafjes-van doorn, k., békés, v., & prout, t. a. (2021). grappling with our therapeutic relationship and professional self-doubt during covid-19: will we use video therapy again? counselling psychology quarterly, 34(3-4), 473–484. https://doi.org/10.1080/09515070.2020.1773404 acierno, r., gros, d. f., ruggiero, k. j., hernandez‐tejada, m. a., knapp, r. g., lejuez, c. w., muzy, w., frueh, c. b., egede, l. e., & tuerk, p. w. 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(2020). remote treatment delivery in response to the covid-19 pandemic. psychotherapy and psychosomatics, 89(3), 130–132. https://doi.org/10.1159/000507376 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. notermans & philippot 19 clinical psychology in europe 2022, vol. 4(3), article e6821 https://doi.org/10.32872/cpe.6821 https://doi.org/10.3389/fpsyt.2019.00993 https://doi.org/10.1037/int0000218 https://doi.org/10.1037/ser0000239 https://doi.org/10.1002/eat.23289 https://doi.org/10.1002/jts.22573 https://doi.org/10.1016/j.prrv.2020.06.009 https://doi.org/10.1159/000507376 https://www.psychopen.eu/ psychotherapy under lockdown (introduction) method recruitment and procedure survey questionnaire measures data analysis results participants characteristics hypothesis 1 hypothesis 2 hypothesis 3 hypothesis 4 discussion conclusion (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references what is the common ground for modern psychotherapy? a discussion paper based on eaclipt’s 1st webinar editorial what is the common ground for modern psychotherapy? a discussion paper based on eaclipt’s 1st webinar stefan g. hofmann 1 , jacques p. barber 2 , paul salkovskis 3 , bruce e. wampold 4 , winfried rief 1 , anne-catherine i. ewen 1 , leonora nina schäfer 1 [1] department of clinical psychology and psychotherapy, philipps-university of marburg, marburg, germany. [2] gordon f. derner school of psychology, adelphi university in garden city, new york, ny, usa. [3] department of experimental psychology, university of oxford, oxford, united kingdom. [4] counseling psychology, university of wisconsin – madison, madison, wi, usa. clinical psychology in europe, 2022, vol. 4(1), article e8403, https://doi.org/10.32872/cpe.8403 published (vor): 2022-03-31 corresponding author: anne-catherine i. ewen, philipps-university of marburg, department of clinical psychology and psychotherapy, gutenbergstraße 18, 35032 marburg, germany. e-mail: ewen@uni-marburg.de abstract psychotherapy as it is implemented today, can be seen as the composition of unconnected groups of practitioners and scientists pursuing different theories. the idea of finding a common “umbrella” for all evidence-based treatments in the field of psychotherapy is gaining more interest. based on this background, experts in clinical psychology from various backgrounds led a fundamental discussion about modern psychotherapy and its basic mechanisms. process-based therapy (pbt) was presented by stefan hofmann as a possible novel approach to clinical research and practice. in this article we present the different perspectives of the four panelists on pbt and in how far the model builds a common ground for different treatment approaches. learning mechanisms and the therapeutic alliance were almost unanimously considered as indispensable factors in a global model of psychotherapy. in conclusion, the panelists emphasized a much-needed focus on characteristics and competencies of therapists themselves e.g., in communication, listening and empathy. these core competencies should be trained and promoted independently of the therapeutic approach. keywords psychotherapy, common ground, process-based therapy, panel discussion, eaclipt webinar this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8403&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0002-3548-9681 https://orcid.org/0000-0002-8762-2595 https://orcid.org/0000-0002-2951-2283 https://orcid.org/0000-0003-1507-980x https://orcid.org/0000-0002-7019-2250 https://orcid.org/0000-0002-9738-5300 https://orcid.org/0000-0002-4911-1073 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • the formulation of a common ground of modern psychotherapy is needed that integrates all evidence-based psychological therapies. • process-based therapy was proposed as a new overarching concept that complements former general psychotherapy approaches. • basic mechanisms of psychotherapy were discussed that considered different psychotherapeutic approaches. • implications for education and training in psychological therapies should focus on a competence-based approach. the european association of clinical psychology and psychological treatment eaclipt has the goal to promote and develop research in clinical psychology, its application and in psychological treatments and fostering the communication throughout the world. in this framework, a webinar has been organized by eaclipt leading a theoretical discussion about “what is the common ground for modern psychotherapy?” with stefan hofmann, jacques barber, bruce wampold, and paul salkovskis as panelists, and chaired by winfried rief. the webinar was streamed live on the 16th of november 2021, whereas already over 1.800 people watched the video (still online available on youtube under the following link: https://www.youtube.com/watch?v=wffzx2lolts). the background of organizing this expert panel was based on the idea of finding a common “umbrella” (eaclipt, 2019; rief, 2021), i.e. a common language, for all evidence-based treatments in the field of psychotherapy. the webinar was introduced with the following comments: psychotherapy was developed from different roots, and many clinicians and scientists still consider psychotherapy as a collection of unconnected groups of theories and associated interventions. however, as long as psychotherapy is not considered as one academic and clinical field, progress and reciprocal stimulation of developments is seriously hampered. goldfried labeled this stage as “prescientific”, and calls for search for a common ground, language and theory of psychotherapy, to develop one science and intervention model that could be used as overarching framework, before specifying into single approaches (goldfried, 2020). hofmann and hayes believe that the evaluation of complete treatment packages (e.g., exposure for phobias) has reached its limit and needs more flexible, process-based, and problem-focused treatment planning, grounded in scientifically proven mechanisms of change (hayes & hofmann, 2018). consequently, training of young clinical psychologists and psychotherapists may require a switch from a single traditional “school” of psychotherapy to a competence-based edu­ cation that can integrate different, scientifically proven methods, derived from different backgrounds (rief, 2021). this article summarizes the main discussion points. a short introduction about the presented theoretical background of process-based therapy (pbt) developed by hayes finding common ground for modern psychotherapy 2 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.youtube.com/watch?v=wffzx2lolts https://www.psychopen.eu/ and hofmann (2018) is given, followed by the main statements about common ground theories of psychotherapy between the panelists. a n i n t r o d u c t i o n t o p r o c e s s b a s e d p s y c h o t h e r a p y b y h o f m a n n nowadays, clinical psychology based on the nomothetic approach focuses strongly on disorder categories and general treatment approaches instead of on the individual as well as on treatment change processes. classification systems such as the icd or dsm laid grounds to study various mental problems and provided effective alternatives to drug treatments. however, they are based on the latent disease model which cannot measure, quantify, or test these syndromes properly. instead, syndrome clusters or disorders are an expression of symptoms based on a subjective report. hofmann argued that clinical scientist should be more interested in the interrelationships of complaints and psycho­ logical variables, regardless of a possibly underlying latent disease model. within this context hofmann referred to the complex network approach on clinical research of psychotherapy (hofmann et al., 2016). this network perspective considers therapy as a highly complex process that involves a multitude of variables that typically form dynamic processes. to target these processes hayes and hofmann propose a tran­ sition from the nomothetic approach to an idiographic approach of theory-based and process-based therapy. hofmann pointed out that pbt focuses on the biopsychosocial processes that should be targeted specifically for the given client and therapy goals to not only reduce symptoms but to enhance the client’s prosperity. next, he referred to one of his own reviews which examined the most frequently validated mediators of psychosocial interventions. as a result, features such as self-efficacy, acceptance, expect­ ations, psychological flexibility, coping skills etc. presented themselves as functionally important pathways of change, irrespective of being systemized into particular schools of psychotherapy. based on the idea to get away from a syndromic perspective, hayes and hofmann developed the so-called “extended evolutionary meta-model” (eemm). as a meta model of adaptive change, the facilitation of clients’ competencies for adaption is targeted as a primary goal in pbt. this model is based on evolutionary theories assuming (mal-)adap­ tive change based on context-dependent variation, selection, and retention. to achieve a specific situational outcome, it is important to firstly be aware of various options (variation), secondly to select the most fitting one (selection) and thirdly to retain it (retention) for the given context, respectively. these change processes are expressed in interrelated dimensions of affect, cognition, attention, self, motivation, overt behavior, physiology and social background/ culture. by developing a whole problem network with the client called ‘grid’, it is possible to identify maladaptation of the individual in the dimensions, respectively, and to help change it to an adaptive self-sustaining hofmann, barber, salkovskis et al. 3 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.psychopen.eu/ network. this concept opens the possibility to quantify and therefore predict (critical) psychological events (through e.g., critical slowing) such as psychotic breaks, suicide attempts or state of recovery. in summary, the strategy of pbt is to depart from the latent disease model and embrace an idiographic and functional analytic approach. according to hofmann, pbt emphasizes on flexibility and the widening of treatment goals from merely reducing negative affect towards positive affect to social connectedness, purpose, and quality of life. d i s c u s s i o n p o i n t s the main discussion points are summarized in the following: moving away from a syndrome-based approach: is there an additional benefit of process-based therapy as new concept? all panelists agreed on the current issues in clinical research and practice presented by hofmann in his talk: clinical psychology is too focused on the syndrome level, whereby the individual moves more and more in the background, especially in research. psycho­ therapy is a more complex mechanism than just “reducing symptoms” or following treatment protocols. salkovskis and wampold pointed out, that these tedious issues are still leading to a constant formation of “new” therapy approaches which basically are still based on old concepts. these therapy approaches are not supposed to be disorder-specif­ ic but should rather focus on formulation and the client’s adaptation of that formulation as a mechanism of change. this covers helping the client to be less rigid and to formulate alternative interpretations of situations. by working in that collaboration therapy can help the person to learn how to operate in the world. further, the novelty of the pbt approach was questioned as several process or contextual models of therapy were gener­ ated in clinical research over time. other well-established concepts and therapy models were referenced which address similar therapeutic aspects as pbt such as epistemic trust, common factors model, the idea of flexibility or behavioral activation. wampold and salkovskis agreed with hofmann that different approaches and interventions in ther­ apy should be evaluated to improve the understanding of underlying processes. hofmann added that the pbt approach is meant to provide broad guidelines from a wide length of therapeutic strategies to make therapy more individualized. from the pbt perspective therapy is a dynamic process of change. through the complex network concept, it can be visualized and explained to the client as well as systematically adapted as goals change over time within the therapeutic context. finding common ground for modern psychotherapy 4 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.psychopen.eu/ concept of learning vs. evolutionary theory the eemm model of pbt is based on an evolutionary perspective on adaptation. build­ ing psychotherapy concepts on evolutionary processes was highly discussed between the panelists. this perspective was compared with learning principles as basic mechanism of therapy, whereas learning itself can be seen as an adaption process. it was pointed out that evolutionary theories are rather associated with long-term development processes on a group level whereas learning principles are possibly more applicable and compre­ hensible for patients on the individual level in a short-term context and therapeutic setting, respectively. where to find the therapeutic relationship in pbt? the therapeutic relationship in the pbt-model can be found and considered in the social dimension. salkovskis, wampold, and barber expressed the idea, to include it in a more salient way into the pbt-model, especially if pbt should present a ground for different psychotherapy traditions. as the need of an evidence-based grounding is crucial in psy­ chotherapy, the therapeutic alliance should be included in experimental psychopathology research. it was proposed to go even further and to include the different aspects of a therapeutic relationship (e.g. communication; expectations about the therapeutic alliance; therapeutic alliance as corrective emotional experience). for psychodynamics this would be essential, as the therapist takes a much more active role in shaping and interpreting the therapist-patient relationship. further on, computerized psychotherapy with no real therapeutic relationship was consulted. even in this context, the therapeutic alliance could be seen as the expertise and authority presumed by the patient of the person they imagine behind the book or the program, whereas trust in the medium is discussed as crucial. in agreement, wampold pointed out that the therapeutic alliance in computer-assis­ ted therapies is just as predictive as in face-to-face therapy. inclusion of different therapy training approaches? pbt aspires to be a therapy schoolindependent approach that integrates different therapy training approaches. in accordance with all panelists, the idea of finding a com­ mon language for different schools of therapy was welcomed. however, it was argued that although the combination in pbt of neurobiological aspects with psychology is admirable, important aspects of psychotherapy in general e.g., the ability to listen to somebody well are not instantly recognizable in this model. it was questioned if pbt rather creates a common language for cognitive-behavioral therapy (cbt) and not for all therapies. in response hofmann pointed out that over the years ‘cbt’ has become a very broad term for a therapy school including constantly evolving therapy approaches hofmann, barber, salkovskis et al. 5 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.psychopen.eu/ and clinical strategies which do not necessarily represent the traditional image of cbt. it should therefore just be called “therapy”. implications in psychotherapy training according to hofmann, one core issue is that therapists are mainly trained based on guidelines that are based on disorders, although therapy is a much more complex process than just reducing symptoms. the therapy school approach is too rigid. related to this, the selection of therapist in training itself should be considered. characteristics of a decent human being with the ability to empathize and collaborate with people should be looked out for. the importance of empirical grounding in training and the need of a permanently self-correcting system on the level of own therapy outcomes as well as on the service level was discussed. in this context the example of the iapt improving access for psychological treatment by david clark was proposed (clark, 2018). using feedback systems and informing about deviances from expected improvements, different measures can be taken such as proposing additional supervision or shifting the training. furthermore, to evolve psychotherapy training, the question about what characterizes an effective therapist in delivering different treatments should be addressed. as a main criterion, therapists should be trained, regardless of what model they adopt, to do it effectively. finding common ground for modern psychotherapy 6 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.psychopen.eu/ c o n c l u s i o n the present paper summarizes the main discussion points between the panelists jacques barber, stefan hofmann, paul salkovskis, and bruce wampold on finding a common ground in psychotherapy within the context of the pbt model presented by s. hofmann. the common agreement about getting away of a school-dependent system towards a more global approach considering school-independent factors became clear. pbt as a proposed modern therapy approach brought up different points of criticism and addition. the focus on more general evidence-based change processes is welcomed, but a better consideration of common factors was proposed, and the therapeutic alliance was specifi­ cally highlighted to be integrated. moreover, the basic process of psychotherapy based on evolutionary theory in pbt was balanced against using the basic principles of learning. to conclude, the way to a common ground in psychotherapy is a highly important and well discussed topic, and when further perspectives are integrated, this can result in a dynamic and developing meta-model for psychotherapy. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: winfried rief is editor-in-chief of clinical psychology in europe but played no editorial role for this particular article. r e f e r e n c e s clark, d. m. (2018). realizing the mass public benefit of evidence-based psychological therapies: the iapt program. in t. widiger & t. d. cannon (eds.), annual review of clinical psychology (vol. 14, pp. 159-183). https://doi.org/10.1146/annurev-clinpsy-050817-084833 eaclipt task force on “competences of clinical psychologists”. (2019). competences of clinical psychologists. clinical psychology in europe, 1(2), article e35551. https://doi.org/10.32872/cpe.v1i2.35551 goldfried, m. r. (2020). the field of psychotherapy: over 100 years old and still an infant science. clinical psychology in europe, 2(1), article e2753. https://doi.org/10.32872/cpe.v2i1.2753 hayes, s. c., & hofmann, s. g. (2018). process-based cbt: the science and core clinical competencies of cognitive behavioral therapy. new harbinger publications. hofmann, s. g., curtiss, j., & mcnally, r. j. (2016). a complex network perspective on clinical science. perspectives on psychological science, 11(5), 597–605. https://doi.org/10.1177/1745691616639283 rief, w. (2021). moving from tradition-based to competence-based psychotherapy. evidence-based mental health, 24, 115–120. https://doi.org/10.1136/ebmental-2020-300219 hofmann, barber, salkovskis et al. 7 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://doi.org/10.1146/annurev-clinpsy-050817-084833 https://doi.org/10.32872/cpe.v1i2.35551 https://doi.org/10.32872/cpe.v2i1.2753 https://doi.org/10.1177/1745691616639283 https://doi.org/10.1136/ebmental-2020-300219 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. finding common ground for modern psychotherapy 8 clinical psychology in europe 2022, vol. 4(1), article e8403 https://doi.org/10.32872/cpe.8403 https://www.psychopen.eu/ finding common ground for modern psychotherapy (introduction) an introduction to process-based psychotherapy by hofmann discussion points moving away from a syndrome-based approach: is there an additional benefit of process-based therapy as new concept? concept of learning vs. evolutionary theory where to find the therapeutic relationship in pbt? inclusion of different therapy training approaches? implications in psychotherapy training conclusion (additional information) funding acknowledgments competing interests references shame mediates the relationship between negative trauma attributions and posttraumatic stress disorder (ptsd) symptoms in a trauma exposed sample research articles shame mediates the relationship between negative trauma attributions and posttraumatic stress disorder (ptsd) symptoms in a trauma exposed sample rebecca seah 1 , david berle 1,2 [1] graduate school of health, university of technology sydney, sydney, australia. [2] school of psychiatry, university of new south wales, sydney, australia. clinical psychology in europe, 2022, vol. 4(3), article e7801, https://doi.org/10.32872/cpe.7801 received: 2021-11-09 • accepted: 2022-07-29 • published (vor): 2022-09-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: david berle, discipline of clinical psychology, graduate school of health, university of technology sydney, po box 123, broadway, nsw 2007, australia. p: +61 2 9514 4278. e-mail: david.berle@uts.edu.au supplementary materials: materials [see index of supplementary materials] abstract background: theoretical models of self-conscious emotions indicate that shame is elicited through internal, stable, and global causal attributions of the precipitating event. the current study aimed to investigate whether these negative attributions are related to trauma-related shame and ptsd symptom severity. method: a total of 658 participants aged 18 to 89 (m = 33.42; sd = 12.17) with a history of trauma exposure completed a range of self-report measures assessing trauma exposure, negative traumarelated attributions, shame, and ptsd symptoms. results: higher levels of internal, stable, and global trauma-related attributions were significantly associated with shame and ptsd. shame mediated the association between trauma-related attributions and ptsd symptom severity, even after controlling for the effects of number of trauma exposures, worst index trauma and depression. conclusions: the present results suggest that negative attributions are a critical cognitive component related to shame and in turn, ptsd symptom severity. future research should aim to replicate these findings in a clinical sample and extend these findings using prospective designs. keywords shame, posttraumatic stress disorder, ptsd, negative attributions, trauma this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7801&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0003-4724-1568 https://orcid.org/0000-0002-4861-2220 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • cognitive antecedents of shame were investigated in a large trauma-exposed sample. • internal, stable, and global trauma attributions were associated with shame severity. • trauma-related shame mediated the association between trauma-related attributions and ptsd symptoms. • specific attributions may be an important predictor of trauma-related shame. the exposure to a potentially traumatic event (pte) often elicits a myriad of emotional responses that intensify traumatic stress reactions. moreover, these reactions are thought to contribute to the development and maintenance of current threat characteristic of posttraumatic stress disorder (ptsd). recently, there has been a growing interest in the role of shame as an important emotional trauma sequalae linked to poorer adjustment and maladaptive coping and predictive of the development of ptsd symptoms (e.g., intrusive recollections, hyperarousal and avoidance) (saraiya & lopez-castro, 2016). the cognitive model of ptsd offers a framework for understanding how shame may emerge following exposure to ptes (ehlers & clark, 2000; elwood et al., 2009). according to the model, the nature of the emotional responses in persistent ptsd varies according to appraisals of the trauma and its sequalae (ehlers & clark, 2000). for example, the mod­ el posits that appraisals concerning attributions of responsibility and perceived violation of internal and societal standards may evoke feelings of shame. in line with this, theoretical models of shame classify it as a self-conscious emotion, as it arises when the self is implicated by a negative and aversive event that violates internal and/or external standards and evokes judgement from others (gilbert, 1997; lewis, 1971; tangney & dearing, 2002). specifically, shame is said to arise through a cog­ nitive-evaluative process, where the eliciting event is attributed to internal, stable, and global attributions; causes that relate to aspects of the individual that are present across all situations and likely to affect situations across one’s life (e.g., one’s character) (lewis, 1971; tangney & dearing, 2002; tracy & robins, 2004). guilt, which also arises from internal attributions, is distinct from shame in that the attribution pertains to a specific action (unstable) which does not affect all situations (specific) (e.g., one’s behaviour). this subtle difference in cognitive attributions is important as guilt and shame prompt distinct responses. the phenomenological experience of shame is the desire to withdraw and hide due to perceived judgement from others and threat of being exposed (gilbert, 2000). in contrast, guilt tends to prompt behavioural responses that are motivated by reparative efforts. indeed, higher levels of internal, stable and global attributions has been associated with higher levels of ptsd. while, these studies have focused on negative attributional style, which is the tendency to attribute events to internal, stable and global causes to common negative and/or hypothetical life events (elwood et al., 2009), ptes can be attributions, shame and ptsd 2 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ considered phenomenologically distinct to general negative life events and exert greater influence on current ptsd symptoms (gray & lombardo, 2004; reiland et al., 2014). following exposure to a traumatic event, posttraumatic shame may arise through this appraisal process, where the individual erroneously blames themselves for having caused the event. consequently, the self is implicated in an unwanted event, and the trauma and its effects are appraised as having occurred due to the individual being inadequate or worthless in some way. even in the absence of an external threat, the individual may still feel a sense of impending threat due to fear of rejection and stigmatisation but also an internal threat due to ongoing negative self-evaluation. consequently, feelings of trauma related shame are likely to be painful, prompting avoidance that inhibits trauma processing, which impedes recovery (leonard et al., 2020). for example, in their conceptual model of shame and adjustment in child sexual abuse survivors, feiring et al. (1996) proposed that shame arises from sexual abuse through the mediation of cognitive attributions and that such shame in turn leads to poorer overall adjustment. a number of studies of child sexual abuse survivors have reported findings consistent with this model as well as the possibility that shame may mediate the relationship between negative attributions and ptsd symptom severity (alix et al., 2017; feiring et al., 2002; uji et al., 2007). although promising, these studies utilised abuse specific attributions and shame measures which limit their generalisability to other trauma exposed populations. further, the attribution measure did not explicitly assess the dimensions of internal, stable and global attributions which is considered a necessary component of the attribution-emo­ tion link to shame (lewis, 1971; tangney & dearing, 2002; tracy & robins, 2004). although negative attributions are purported to be a cognitive antecedent to shame, there are several trauma characteristics that may impact the severity of posttraumatic cognitions and emotions. firstly, although trauma exposure is insufficient to elicit trau­ ma related shame, the nature of the traumatic event may function as a diathesis toward making more negative appraisals and higher levels of shame. for example, individuals with interpersonal trauma exposure, defined as an event that involves deliberate perpe­ tration of harm to another individual (e.g., sexual assault, armed robbery, physical threats etc.) (forbes et al., 2014) have reported increased levels of shame and ptsd (la bash & papa, 2014). in a recent study, zerach and levi-belz (2018) found that experiencing a morally injurious event may contribute to an increased tendency to make internal, stable and global attributions, trauma related shame and more severe posttraumatic stress symptoms (ptss). their findings indicate that it is possible that certain trauma types may increase one’s tendency to make negative attributions, subsequently eliciting higher levels of shame. secondly, routine self-report ptsd screening measures require a single designated trauma event to be used in assessing the severity of symptoms. however, the exposure to multiple potentially traumatic events can be considered a rule not the exception. there is robust evidence indicating that, with an increased number of pte exposures, ptsd seah & berle 3 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ risk increases in a dose-dependent manner (tortella-feliu et al., 2019). also, the severity of ptsd symptoms increases when participants are asked to rate symptoms across their trauma history (simpson et al., 2011). furthermore, the potential effect of time elapsed since the indexed trauma event may also impact endorsement of self-conscious cognitions and emotions (bryant et al., 2017). thus, consideration of the cumulative impacts of ptes along with time since trauma exposure is pertinent. regardless of overall trauma exposure, it is expected that individuals will seek to assign meaning and provide causal attributions to explain their experiences. thus, the current study sought to extend previous findings in two ways. firstly, it aimed to inves­ tigate the relationships between trauma specific negative attributions (higher internal, stable, and global attributions) shame and ptsd symptom severity in a broad sample of trauma exposed survivors. based on previous findings, it was hypothesised there would be significant associations between negative attributions, shame, and ptsd symptoms. secondly, it explored whether trauma-related shame would mediate the relationship between higher levels of internal, stable, and global attributions on the one hand, and ptsd symptoms on the other. to examine the unique contributions of trauma related attributions and shame in relation to ptsd, the current study controlled for the effects of the various trauma characteristics mentioned. this included cumulative lifetime exposure to ptes, reference trauma type (interpersonal vs. non-interpersonal) and time elapsed since reference trau­ ma. symptoms of depression were also controlled for due to depression’s significant comorbidity with ptsd (flory & yehuda, 2015). it was hypothesised that even after controlling for these covariates, trauma-related shame would mediate the relationship between attributions and ptsd symptom severity. m e t h o d participants six hundred and sixty-seven participants consented to participate in the study, however nine participants failed the attention checks, and were excluded from the analyses. the final sample consisted of 658 participants between the ages of 18 to 89 (m = 33.42; sd = 12.17) who consented to participate in the study. a majority (n = 257; 39.1%) of the sample resided in the united states, with a similar proportion from the united kingdom (n = 249; 37.8%). the sample consisted of 346 women (52.6%), 300 men (45.6%) and 12 (1.9%) preferring to self-describe. just over half the participants (n = 371; 56.4%) reported being in a relationship or were married, 258 (39.2%) had never been married and 29 (4.4%) were either separated or divorced. slightly under half (n = 206; 31.3%) of participants disclosed at least one mental health disorder diagnosis from a professional. among those who chose to specify, 223 (n = 33.9%) reported a current diagnosis of depression and/or attributions, shame and ptsd 4 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ anxiety. 80 participants reported currently seeking mental health support from a health­ care professional. just over half of participants’ (58.7%) self-reported ptsd symptoms placed them within the clinical range for a provisional ptsd diagnosis (pcl-5 total scores ≥ 31) (bovin et al., 2016). participants endorsed exposure to an average of 6.3 (sd = 2.2) potentially traumatic events (pte) across their lifetime. in terms of type of trauma exposure, transportation accidents (n = 406; 61.7%), severe life-threatening illnesses (n = 227; 34.5%), and unwan­ ted/uncomfortable sexual experiences, including sexual assault (n = 209; 31.8%) were the most common trauma categories endorsed. the most common reference trauma endorsed was some form of direct exposure (personally experienced and/or witnessed it happening to a close family member/friend) to an interpersonal trauma (e.g., physical and/or sexual assault and psychological abuse) (n = 219; 33.3%), followed by some form of transport accident (n = 154; 23%), and various forms of illnesses and/or physical injury (n = 109; 16.7%). the mean elapsed time since the reference trauma was 11.6 years (sd = 10.7). measures the lifetime events checklist (lec) the lec (weathers, blake, et al., 2013b) is a 17-item self-report measure used to screen for exposure to potentially traumatic events (pte) in a respondent’s lifetime. it consists of 16 known events and an additional item assessing any stressful life events not listed. respondents indicate their level of exposure for each pte on a 6-point nominal scale. following this, participants are asked to identify and briefly describe the worst event they experienced, specifically the event that they classify as the most distressing. this event was used as the reference trauma for assessing current symptoms of ptsd. the lec does not yield a total composite score. the lec demonstrated adequate psychomet­ ric properties as a stand-alone measure for trauma exposure (gray et al., 2004). in the current study, a total lifetime trauma load was calculated by summing the number of traumatic experiences across each type of trauma endorsed by the individual. the ptsd checklist for dsm-5 (pcl-5) the pcl-5 (weathers, litz, et al., 2013) a 20-item self-report questionnaire which was administered to assess ptsd symptoms. participants endorse the extent to which they were bothered by ptsd symptoms in relation to their reference trauma in the past month (e.g., “repeated disturbing and unwanted memories of the stressful experience”) on a 5-point likert scale, 0 (not at all) to 4 (extremely). a total symptom severity score was obtained by summing each item, with a score higher than 31 indicating the presence of probable ptsd (bovin et al., 2016). the pcl-5 has demonstrated strong reliability and validity and is psychometrically sound instrument for quantifying ptsd symptom severity (bovin et al., 2016). seah & berle 5 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ the expanded attributional style questionnaire trauma (easq-t) the easq (peterson & villanova, 1988) is a measure used to assess a respondent’s tendency to generate specific attributions for hypothetical aversive events. participants are asked to rate the cause of each event. on this scale, respondents are asked to rate the cause of each event on 7-point likert scale for three dimensions; 1) internal or external (“is the cause something about you or about other people and/or circumstances”), 2) stable or unstable (“in the future, will this cause be present?”) and 3) specific or global (“is this cause something that affects just this type of situation or does it influence other aspects of your life?”). the easq has previously demonstrated adequate to good internal consistencies (peterson & villanova, 1988). the easq was adapted by reiland et al. (2014) to assess trauma related attributions. on the easq-trauma, participants rate the cause of each traumatic event they were exposed to according to the lec (weathers, blake, et al., 2013b) on the easq dimensions of internal-external, stable-unstable and specific-global. the score on each attribution dimension ranged between 1 and 7. an overall attribution score or negative trauma score was calculated by averaging the sum of each dimension. higher overall scores on the scale indicate higher levels of internal, stable and global attributions. the trauma related shame inventory (trsi) the trsi (øktedalen et al., 2014) is a 24-item measure of trauma related shame. respond­ ents rate the extent that they experience thoughts and feelings associated with shame in relation to their traumatic experiences over the past week on a 4-point likert scale, 0 (not true of me) to 4 (completely true of me). sample items include “because of what happened, i am disgusted with myself”, “if others knew what happened to me, they would be ashamed”. a total trauma-related shame score was computed by summing all items on the trsi. the trsi has demonstrated strong content and construct validity and discriminate validity from the trauma related guilt inventory (kubany et al., 1996). the depression anxiety and stress short form scale (dass-21) the dass-21 (lovibond & lovibond, 1995) is a widely used screening measure of distress in both clinical and non-clinical settings. it consists of 21 items comprised of three self-report scales of depression, anxiety, and stress symptoms. in the current study, only the 7-item depression subscale was used to yield a total depression score. respondents endorse the extent to which they experienced symptoms over the past week on a 4-point likert scale, 0 (did not apply to me at all) to 4 (applied to me very much, or most of the time). a total depression score was computed by summing all the items on the depression subscale. the dass-21 has demonstrated good discriminant validity relative to other depression measures and high internal consistency (henry & crawford, 2005). attributions, shame and ptsd 6 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ procedure participants were recruited from australia, canada, ireland, the united kingdom and united states via prolific academic (proa), an online crowdsourcing platform. only participants over the age of 18 and who endorsed being exposed to at least one potential­ ly traumatic event (pte) within their lifetime according to the lec (weathers, blake, et al., 2013b) were included in the study. participants were administered a battery of self-report questionnaires which assessed their lifetime exposure to ptes, along with their attributions for these events, trauma related shame, ptsd symptoms and symptoms of depression and anxiety. statistical analyses spearman’s rank order correlations were calculated given the non-normal positively skewed distributions of depression, ptsd, and trauma-related shame. bootstrapping (5,000) iterations were performed to test the indirect effects of shame and negative attributions in relation to ptsd symptom severity using conditional process analysis (hayes, 2017). trauma exposure, depression symptoms, worst reference trauma type, and time since worst reference trauma were entered as covariates. the use of bootstrapping, a non-parametric resampling method offers an advantage over the traditional sobel test as it does not require the assumption of normality to be met for the product of co-efficients. further, the resampling methods minimises bias that arises from non-normal sampling distributions (hayes, 2017). indirect effects are significant when the 95% confidence interval (ci) does not contain zero. r e s u l t s univariate and bivariate statistics mean, standard deviation and range of all self-reported measures are reported in table 1. the internal consistency for all scales was excellent. all measures were significantly and positively correlated with each other and small to moderate in magnitude (table 2). mediation analysis figure 1 reports the results of the bootstrapped mediation analysis. together, after con­ trolling for lifetime trauma exposure, depression symptoms, worst trauma type, and time since worst trauma, negative attributions and trauma-related shame accounted for significant variance in ptsd symptom severity, f(6,652) = 107.53, r 2 = .50, p < .001. trauma related negative attributions exhibited significant direct effects on shame, b = 1.47, p < .001, 95% ci [.56, 2.38], and shame also had a significant direct effect on ptsd seah & berle 7 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ symptoms, b = .57, p < .001, 95% ci [.48, .66]. trauma related attributions exhibited a significant indirect effect on ptsd symptoms via shame, 95% ci [.35, 1.34]. table 1 means, standard deviations, and reliability of measures variable m sd range cronbach’s α exposure (lec) 6.31 2.16 2-16 – depression (dass-21) 6.67 6.26 0-21 .94 internal attributions (easq-t internal) 2.45 1.43 1-7 – stable attributions (easq-t stable) 3.73 1.63 1-7 – global attributions (easq-t global) 3.34 1.56 1-7 – attributions (easq-t total) 3.17 1.07 1-6.58 – shame (trsi) 14.33 15.94 0-70 .97 ptsd (pcl-5) 27.78 19.59 0-80 .95 note. exposure = total lifetime trauma exposure to distinct trauma types; depression = depression symptoms; internal, stable and global = internal, stable and global trauma-related attributions; attributions = total trauma related attributions; shame = trauma related shame; ptsd = ptsd symptoms. table 2 spearman’s rank order correlations between trauma exposure, depression symptoms trauma-related attributions, trauma related shame, ptsd symptoms variable 1 2 3 4 5 6 7 8 1. exposure – .16** .10** .10** .08 .13** .30** .19** 2. depression – .27** .16** .14** .31** .59** .56** 3. attributions – .54** .73** .79** .27** .29** 4. internal – .04 .23** .25** .20** 5. stable – .42** .04 .08* 6. global – .35** .37** 7. shame – .66** 8. ptsd – note. n = 587. exposure = total lifetime trauma exposure to distinct trauma types (lec); depression = depression symptoms (dass-21); attributions = total trauma related attributions (easq-t total); internal, stable, and global = internal, stable and global trauma-related attributions (easq-t subscales); shame = trauma related shame (trsi); ptsd = ptsd symptoms (pcl-5). *p < .05. **p < .01. attributions, shame and ptsd 8 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ figure 1 the relationship between trauma-related attributions and ptsd symptom severity mediated by trauma-related shame trauma-related attributions ptsd symptom severity trauma related shame b: b =.57, β =.46, se = .05, 95% ci [.48, .66] c: b = 2.62, β = .140, se =.60, 95% ci [1.45, 3.79] c’: b = 1.78, β = .10, se = .54, 95% ci [.72, 2.84] a: b = 1.47, β = .10, se = .46, 95% ci [.56, 2.38] note. c = total effect; c’ = direct effect; b = non-standardised regression coefficient; β = standardised regression coefficient; se = standard error; ci = confidence interval. indirect effect = 95% ci = [.35 to 1.34]. figure 1 the relationship between trauma-related attributions and ptsd symptom severity mediated by trauma-related shame. note. c = total effect; c’ = direct effect; b = non-standardised regression coefficient; β = standardised regression coefficient; se = standard error; ci = confidence interval. indirect effect = 95% ci = [.35, 1.34]. however, when trauma related shame was included in the model, the direct effect of trauma-related attributions remained significant, b = 1.78, p < .001, 95% ci [.72, 2.84], indicating that trauma-related shame partially explains the relationship between traumarelated casual attributions. thus, it is likely that there are additional mediators that could contribute to the understanding the effect of negative trauma attributions and ptsd symptoms. as a secondary exploratory analysis, we repeated the mediation analyses for each separate attribution dimension. the results of these are presented in figures 1-3 in the supplementary materials. in brief, both internal, 95% ci [.53, 1.30] and global, 95% ci [.32, 1.10] attributions exhibited significant indirect effects on ptsd symptoms via shame. in contrast, there was no significant indirect effect for stable attributions, 95% ci [-.65, .03]. d i s c u s s i o n to our knowledge, this is the first study that examines the role of internal, stable and global trauma-related attributions in relation to shame and ptsd symptoms in a broad trauma exposed sample. the purpose of the study was two-fold. firstly, it aimed to inves­ tigate the relationship between negative attributions (higher levels of internal, stable, and global attributions), trauma-related shame and ptsd. secondly, it investigated whether seah & berle 9 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ trauma-related shame would mediate the relationship between negative trauma-related attributions and ptsd symptoms. as predicted, negative attributions, that is, higher levels of internal, stable, and glob­ al attributions and trauma-related shame both had significant direct effects on ptsd symptom severity. interestingly, although cumulative trauma exposure is an important risk factor for ptsd (tortella-feliu et al., 2019), correlation analysis of the present data indicated that the relationship between trauma load and ptsd is negligible. these find­ ings are consistent with both empirical and theoretical evidence implicating maladaptive cognitive appraisals and subsequent emotional reactions as important predictors of ptsd beyond trauma exposure (cromer & smyth, 2010; ehlers & clark, 2000). the finding that internal, stable and global attributions are significantly associated with higher levels of ptsd is consistent with previous research indicating strong associ­ ations between negative causal attributions and ptsd symptoms (gómez de la cuesta et al., 2019). the attribution that one’s experiences are due to internal causes that are unchanging, and pervasive in all domains of life is likely to increase expectancy that future events would reoccur and engender feelings of helplessness and loss of control over life events and one’s future (mikulincer & solomon, 1988). indeed, a sense of helplessness has been associated with a perception of ongoing threat and perceived lack of safety among domestic violence survivors (salcioglu et al., 2017). moreover, findings from neuroimaging studies have indicated that cognitive distortions are linked to ptsd through intense re-experiencing of the trauma memory elicited by trauma related cues (berman et al., 2018; daniels et al., 2011). as our findings indicate, negative attributions of the traumatic event were associated with higher levels of trauma-related shame which in turn, were associated with more severe ptsd symptoms. thus, the appraisal that negative events are due to internal, stable and global attributions may lead to the focus of evaluation being directed inward where the self and its entirety is judged negatively, prompting feelings of intense shame. the cross-sectional nature of our study precludes causal inferences; however, further prospective studies of these variables should seek to confirm this possibility. the phenomenological experience of shame is painful, motivating the desire to withdraw and hide due to the fear of rejection or stigmatisation. in this way, feelings of shame may increase the intensity of ptsd symptoms through responses such as avoidance (feiring et al., 2002; leonard et al., 2020), a core symptom of ptsd that maintains overgeneralised fear and inhibits new learning (craske et al., 2008). indeed, a recent study indicates that experiential avoidance may be one of the key mechanisms that explains the relationship between shame and ptsd symptoms (leonard et al., 2020). however, future research will be needed to bolster such findings. in addition, current theoretical models of shame indicate that feelings of shame are also avoided due to their association with the event and trauma related cues (lee et al., 2001; wilson et al., 2006). attributions, shame and ptsd 10 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ consequently, the inability to process shame is likely to intensify these feelings where, in the absence of physical danger, feelings of shame become a source of internal threat. although the current results support our second hypothesis, there may be other var­ iables that influence and explain the relationship between shame and ptsd. following trauma exposure, shame is typically accompanied by other emotional responses such as fear, guilt, alienation, and betrayal that also promote avoidance and intense reliving of trauma memories (dewey et al., 2014; held et al., 2015). moreover, there may be other attributional processes such as perceived controllability and importance of events (tracy & robins, 2006) that may be relevant to shame worth investigating. overall, the findings support the assertion that individual variability in trauma attri­ butions and reactions are linked to not only an increase in ptsd symptom severity, but this relationship can also be explained by emotional and behavioural reactions associated with shame related to one’s traumatic experiences. some limitations of the current study should be noted as avenues for future research. first, the use of a cross-sectional design precludes any causal inferences. it is likely that both negative appraisals and trauma related shame have a bi-directional relationship, however the extent to which they reinforce each other remains an empirical question. thus, longitudinal research is needed to assess the directionality of these constructs. second, although the use of self-report questionnaires is common in clinical psychology research, responses may be influenced by participants’ introspective ability and other response biases. third, additional demographic data was not obtained with respect to ethnicity, or employment status which may be important risk factors for ptsd (tortellafeliu et al., 2019). also, not all participants in our sample were in the clinical range for ptsd, limiting the generalizability of our results to clinical populations. fourth, the construct validity of the “global” dimension of the easq may be im­ perfect in that the global dimension items appeared to assess attributions about the perceived consequences of traumas, rather than attributions about the cause itself (“is this cause something that affects just this type of situation, or does it also influence other areas of your life”). this may have contributed to the relatively stronger associa­ tions observed between global attributions and ptsd symptoms when compared with the internal-external and stable-variable dimensions. future studies should ideally use interviewer-based approaches to allow careful distinctions between attributions about the causes versus the consequences of trauma events. further, although the pcl-5 is widely accepted and utilised within trauma research as a ptsd symptom screening tool, it does not examine trauma relatedness of symptoms and significant overlap between ptsd and other psychiatric symptoms may inadvertent­ ly inflate ptsd symptom severity scores (monson et al., 2008). it is worth noting that an individual can make multiple attributions for a single event, especially when the event consists of multiple, closely related events. in the attempt to account for multiple lifetime exposures, we assessed attributions for all pte exposures. however, an individual can seah & berle 11 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ have multiple exposures to the same type of traumatic event, complicating the identifica­ tion of the particular event that a given attribution corresponds to. thus, assessment of the index trauma event to assess event specific attributions using a clinician adminis­ tered diagnostic assessment tool is warranted. for example, the clinician-administered ptsd scale for dsm-5 (caps5; weathers, blake, et al., 2013a) could be used to identify the index trauma and assess specific attributions in accordance with the event. further, the use of a diagnostic interview can provide a more accurate diagnostic picture of ptsd symptoms and increase the generalizability of current findings to clinical samples. although specific attribution dimensions may exert greater influence on shame and ptsd symptoms than others, the results indicate that, together, internal, stable and global attributions for lifetime exposure to ptes functions as a potential cognitive vul­ nerability toward trauma related shame. thus, targeting these cognitions may constitute an important mechanism for trauma recovery. cognitive based interventions that utilise attribution retraining such as cognitive processing therapy (cpt; resick & schnicke, 1992) has been found to be useful in modifying self-blaming attributions and ptsd (resick et al., 2002). moreover, there is some indication that gradual exposure to and pro­ cessing of trauma memories can significantly reduce shame based cognitive distortions (cohen et al., 2004). more recently, there has been increasing interest and empirical support for the use of compassion-based therapies are a potential adjunct to existing cognitive interventions for ptsd in facilitating the effectiveness of cognitive reappraisal strategies (au et al., 2017). overall, the present study indicates that following exposure to a pte, negative attributions are associated with shame, which in turn is associated with higher levels of ptsd symptoms. the findings underscore the potential clinical utility of assessing negative attributions as a potential antecedent of shame. in doing so, clinicians can seek to target these processes and potentially change the trajectory of shame responses and reduce the emotional impact of the trauma and the severity of ptsd symptoms. funding: the authors have no relevant financial or non-financial interests, and no conflicts or competing interests to disclose. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the author(s) declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. data availability: participants in the present study did not consent for their data to be shared publicly, so supporting data for the present study is not available. attributions, shame and ptsd 12 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • figure 1 – the relationship between internal attributions and ptsd symptom severity mediated by trauma-related shame. • figure 2 – the relationship between stable attributions and ptsd symptom severity mediated by trauma-related shame. • figure 3 – the relationship between global attributions and ptsd symptom severity mediated by trauma-related shame. index of supplementary materials seah, r., & berle, d. 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(2018). moral injury process and its psychological consequences among israeli combat veterans. journal of clinical psychology, 74(9), 1526–1544. https://doi.org/10.1002/jclp.22598 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. seah & berle 17 clinical psychology in europe 2022, vol. 4(3), article e7801 https://doi.org/10.32872/cpe.7801 http://www.ptsd.va.gov http://www.ptsd.va.gov http://www.ptsd.va.gov https://doi.org/10.1177/1524838005285914 https://doi.org/10.1002/jclp.22598 https://www.psychopen.eu/ attributions, shame and ptsd (introduction) method participants measures procedure statistical analyses results univariate and bivariate statistics mediation analysis discussion (additional information) funding acknowledgments competing interests data availability supplementary materials references perceived criticism and family attitudes as predictors of recurrence in bipolar disorder research articles perceived criticism and family attitudes as predictors of recurrence in bipolar disorder claudia lex 1,2 , martin hautzinger 3 , thomas d. meyer 4 [1] department of psychiatry, villach general hospital, villach, austria. [2] department of psychology, university klagenfurt, klagenfurt, austria. [3] department clinical psychology and psychotherapy, eberhard karls university tuebingen, tuebingen, germany. [4] mcgovern medical school, louis a. faillace, md, department of psychiatry and behavioral sciences, university of texas hsc at houston, houston, tx, usa. clinical psychology in europe, 2022, vol. 4(1), article e4617, https://doi.org/10.32872/cpe.4617 received: 2020-10-29 • accepted: 2021-12-02 • published (vor): 2022-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: thomas d. meyer, mcgovern medical school, louis a. faillace, md, department of psychiatry and behavioral sciences, university of texas hsc at houston, 1941 east road (bbsb 3118), houston, texas 77054, usa. e-mail: thomas.d.meyer@uth.tmc.edu abstract background: bipolar disorder (bd) is a highly recurrent psychiatric condition. while combined pharmacological and psychosocial treatments improve outcomes, not much is known about potential moderators that could affect these treatments. one potential moderator might be the quality of interpersonal relations in families, for example, familial attitudes and perceived criticism. method: to explore this question we conducted a post-hoc analysis that used an existing data set from a previous study by our group that compared cognitive behavioral therapy (cbt) and supporting therapy (st) in remitted bd. in the present study, we used cox proportional hazard models. results: we found that the relatives’ ratings of criticism predicted the likelihood of depressive recurrences, especially in the st condition. the patients’ ratings of negative familial attitudes predicted the risk of recurrences in general, irrespective of the therapy condition. conclusion: these results suggest that it might be important to assess perceived criticism and familial attitudes as potential moderators of treatment outcome in bd. keywords bipolar disorder, cognitive behavioral therapy, expressed emotion, perceived criticism, illness course, family, psychotherapy this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4617&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0003-4523-3580 https://orcid.org/0000-0001-6082-2602 https://orcid.org/0000-0003-4236-7778 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • patients with bd had an increased risk for depressive recurrences when their relatives had rated themselves as highly critical towards the patients. this was only true for patients who attended an unspecific therapy instead of cbt. • patients with bd had an increased risk for depressive recurrences when they thought that their relatives had negative attitudes towards them. • there was no significantly increased risk for manic recurrences in relation or criticism or negative familial attitudes. bipolar disorder (bd) is a mental health condition characterized by depressive and hypo­ manic or manic episodes. while individuals experiencing bd can remit, it is considered a life-long condition and over 50% of patients with bd suffer at least one recurrence within two years (perlis et al., 2006; tohen et al., 2003). furthermore, functional impairments at work, home, or school, and in interpersonal relations often persist beyond sympto­ matic states of the disorder and despite medication (gitlin & miklowitz, 2017). these findings on long-term outcomes of bd have encouraged experts to develop and evaluate psychosocial and psychological therapies adjuvant to medication. the combination of psychological and pharmacological treatments overall improves the long-term outcome in bd (miklowitz & scott, 2009; swartz & swanson, 2014) but the evidence is mixed. a recent network analysis showed that the evidence is stronger for some therapies such as family focused therapy (fft) or cognitive behavior therapy (cbt) than others, but that these findings should be balanced against evidence that dropping out of cbt is more likely than for fft, and that efficacy varies depending on the outcome such as recurrence, depressive or manic symptoms (miklowitz et al., 2021). for example, fft seems to protect against recurrences, especially in families with greater levels of impairment (kim & miklowitz, 2004). cbt, however, was specifically associated with stabilizing depressive symptoms (miklowitz et al., 2021). in general, more studies are needed to determine under what circumstances which form of psychological therapy is most effective. one potential factor or moderator of outcome in bd could be the quality of interper­ sonal relations, because similar to other psychiatric disorders (e.g. grover & dutt, 2011; hooley & teasdale, 1989; weintraub et al., 2017) it has been suggested that characteristics of familial relations may also predict outcome in bipolar depression (johnson et al., 2016). in regard to bd, criticism expressed by families when interacting with their ill relative predicted hospital admissions (scott et al., 2012) and relapse (rosenfarb et al., 2001). also, high expressed emotion, which is a construct that is characterized by critical com­ ments, hostility, and emotional over-involvement that family members express towards an affected relative (kavanagh, 1992; vaughn & leff, 1976), predicted relapses as does a communication style called ‘negative affective style’ (miklowitz et al., 1988; o’connell et al., 1991). finally, two studies found that perceived criticism and expressed emotion predictors of expressed emotion 2 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ were specifically associated with depressive rather than with manic recurrences (kim & miklowitz, 2004; yan et al., 2004). most of the before mentioned studies looked at the natural course of bd. in order to examine if perceived criticism and hostile/critical attitudes influence the effect of cbt on recurrences in bd, we reanalyzed data previously collected in a randomized controlled trial (meyer & hautzinger, 2012). in this study individual cbt and supportive therapy (st) were administered to patients with remitted bd. cbt was manual-based including cognitive and behavioral strategies, techniques to prevent relapse, and coping strategies for symptoms (basco & rush, 1996). st was less structured and followed a client-centered approach. in the original study (meyer & hautzinger, 2012), it was found that the relapse rates did not significantly differ between the two therapy groups in the long run. however, a higher number of prior mood episodes and a lower number of attended therapy sessions were associated with less time to relapse in both groups, indicating that other potential factors shared by both groups influenced outcome. based on the evidence cited above, we hypothesized that higher levels of negative familial attitudes and perceived criticism expressed by the patients with bd and their relatives could be such a moderator of outcome. m e t h o d participants initially, 141 individuals who were interested to participate in a study of psychological treatment for bd contacted our study team. they were either referred by local hospitals, psychiatrists or were self-referrals due to public information in newspapers, brochures, or radio. sixty-five individuals were excluded (figure 1), therefore, the present paper reports data relating to clinical course and attitudes of 76 participants who were random­ ized for a study on psychotherapy for bd (meyer & hautzinger, 2012). inclusion criteria were a diagnosis of bd, age between 18 and 65, informed consent to the present study, and adherence to their usual psychiatric treatments. participants with severe manic or depressive symptoms, i.e. scores > 20 on the bech-rafaelsen melancholia scale (brms; bech, 2002) or > 20 on the bech-rafaelsen mania scale (brmas; bech et al., 1978), were excluded. also, participants with comorbid substance dependency requiring detoxification and/or the presence of current psychotic symptoms could not participate in the present study. we obtained informed consent that included the consent to send a questionnaire to their spouse, or if single or divorced to their partner or closest relative (e.g. mother). lex, hautzinger, & meyer 3 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ figure 1 flow chart of the recruitment process note. not bd = individuals who were not diagnosed with bd. predictors of expressed emotion 4 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ procedures and measurements first, the participants were in a baseline screening session. they gave informed consent, were administered clinical interviews (e.g., scid-i and scid-ii), and completed selfand observer-rated measures (see for further details: meyer & hautzinger, 2012). then they were randomized either to an individual cbt or supportive therapy (st), which both contained individual 20 sessions over 9 months. the cbt followed a structured manual similar to the manual by basco and rush (1996), which included relapse prevention plans, coping strategies, and interpersonal skills. in the st a client centered approach was adopted focusing on whatever topics the individuals brought into the sessions. all ses­ sions were video-taped. qualified therapists who were at least in a 1-year postgraduate training led the sessions. in addition, all therapists attended a 2-day workshop relating to cbt and st therapy. raters who were blind to group allocation assessed conducted assessments at month 0, 3, 6, 9, 12, and 24 during the trial. information on recurrences was obtained by using repeatedly the scid-i modules for mood episodes during the follow-up but also by monitoring hospitalizations, clinical notes, and mood diaries of the participants. family attitude scale (fas) the fas (kavanagh et al., 1997) contains 30 items covering 4 key aspects of critical attitudes among close family members: criticism, hostility, anger, and warmth. the items are rated on a 5 point scale ranging from always (4) to never (0), therefore scores may range between 0 to 120. higher scores reflect higher levels of critical familial attitudes. we used two versions of the fas, one for patients (fas-p; e.g., “he/she thinks, that i am a real burden”) and one for relatives (fas-r; e.g., “he/she is a real burden”). the fas-p, therefore, reflects how the patient perceives the attitudes of his/her relative, while the relative reports in the fas-r how he/she feels about the patient and what he/she thinks about the patient. in order to obtain a german version, the senior author translated the original english version, and then a native english speaker did the backtranslation. the inconsistencies were discussed and finally removed. to our knowledge, the german fas has not been formally validated, but we published high internal consistencies for the fas-p (cronbach's α = 0.94) and for the fas-r cronbach's α = 0.95; lex et al., 2019). perceived criticism measure (pcm) the rating on a 10 point scale of the question "how critical is your relative of you?" has been used as a valid indicator of overall criticism in families (hooley & miklowitz, 2017; renshaw, 2007). therefore, in the pcm-p (hooley & teasdale, 1989) we asked the patients to rate the question “how critical has he/her been of you?”. parallel, the relatives self-rated their level of criticism with the question “how critical have you been of him/ her?” (pcm-r). although there is no recommended cutoff, higher scores reflect higher levels of criticism and a score above 6 raises concern about an increased relapse risk lex, hautzinger, & meyer 5 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ (masland & hooley, 2015). information about correlates of the german pcm scale can be found in lex et al. (2019). beck depression inventory (bdi) the bdi (beck et al., 1961) is a self-report questionnaire measuring the severity of depression. participants rate 21 items that correspond to depressive symptoms on a four-point scale from 0 to 3. scores above 9 reflect mild, and scores above 18 reflect moderate depression. in the present study, we used the validated german version with comparable psychometric properties compared to the english version (brieger et al., 2007; hautzinger et al., 1994). self rating mania inventory (srmi) the srmi (shugar et al., 1992) is a 47-item self-rating instrument that assesses manic and hypomanic symptoms. it can be used to assess acute symptoms or residual symptoms in remitted states. in the present study, we asked the participants to focus on the previous month when rating their (hypo)manic symptoms. scores above 14 reflect a high probability of acute mania. the srmi shows a good internal consistency (cronbach's α = 0.94) and high retest reliabilities between 0.79 and 0.93 (shugar et al., 1992). bech rafaelsen melancholia scale (brms) the observer-based brms (bech, 2002; smolka & stieglitz, 1999) has 11 items that relate to depressive symptoms and is used to rate the severity of depression. the rating for each items ranges from 0 (no symptom) to 4 (severe). a sum score ≤ 14 indicates no or doubtful depression, scores between 15 and 20 indicate mild depression, 21–28 indicate moderate depression, and scores above 28 reflect severe depression (lam et al., 2005). bech rafaelsen mania scale (brmas) the brmas (bech et al., 1978) has 11 items and the observer rates the presence of manic symptoms on a scale from 0 (not present) to 4 (severe). parallel to the brms, scores range between 0 and 44, and scores < 14 suggest no or doubtful mania, scores between 15 and 20 indicate mild mania, and scores above 20 are interpreted as moderate to severe mania (lam et al., 2005). the brmas shows good interrater reliabilities between 0.80 and 0.95 (e.g., bech, 2002). the brmas is often combined with the brms to cover the full range of bipolar symptoms (rossi et al., 2001). statistical methods hierarchical cox proportional hazard models were used to assess the relapse risk for depression in relation to the patients’ and the relatives’ assessments of familial attitudes and perceived criticism. the potential covariates were therapy condition (cbt vs. st; predictors of expressed emotion 6 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ block 1), attitudes (fas or pcm scores; block 2), and the interaction between therapy and attitudes (block 3). when looking at the recurrence risk for (hypo)manic events, srmi scores were entered at block 1, the subsequent blocks were the same as before. srmi scores were included, because in a previous analysis we found that the only baseline clinical variable that predicted recurrence of manic episodes was the level of subthreshold self-reported manic symptoms (bauer et al., 2017). with less than 5% of the corresponding z-scores being greater than 1.96, there were no outliers for the fas and pcm measures. there were no substantial bivariate correlations between predictors (see table 1) indicating that there was no problem with multicollinearity (field, 2013). in addi­ tion, bivariate listwise correlations and independent t-tests were used. the significance level was set at 5% for all statistical procedures, exact p values and effect size values will be displayed. table 1 bivariate listwise pearson correlations between predictors, fas, and pcm measures n = 76 fas-p pcm-p fas-r pcm-r therapy condition .05 .19 .17 .04 fas-p .48** .47** .29* pcm-p .30* .49** fas-r .40** note. fas-p = family attitude scale rated by patients; fas-r = family attitude scale rated by relatives; pcm-p = perceived criticism scale rated by patients; pcm-r = perceived criticism scale rated by relatives. *p < .05. **p < .01. r e s u l t s demographics the participants’ mean age was 43.96 (sd = 11.81) and included 38 women. thirty-two individuals were single, 31 were married, and 13 were divorced. sixty individuals were diagnosed with bd-i, and 16 were diagnosed with bd-ii. based on the scid-i, all partici­ pants were in full remission; looking at rating scales, most patients had scores below 15 on the brms (93.4%) and the brmas (98.7%). table 2 displays demographical and clinical data of the participants. the participants of cbt and st did not differ significantly on age, gender, clinical course of bd, and time until first relapse (meyer & hautzinger, 2012). also, conducting independent t-tests revealed that scores on the fas-p, t(66) = -.66, p = .51 and the pcm-p, t(66) = -1.47, p = .15, for the patients did not differ significantly between the two treatment conditions. similarly, the scores in the fas-r, t(62) = -.90, p = .37 and the pcm-r, t(61) = -.18, p = .85, were not significantly different in relatives of the patients who had been randomly assigned to cbt and st. lex, hautzinger, & meyer 7 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ table 2 means (m) and standard deviations (sd) of patients with bd who received either cbt or st variable cbt st m sd m sd age 44.40 11.00 43.53 12.72 bdi 13.53 9.23 11.03 7.60 brms 6.08 4.70 5.55 5.24 srmi 17.65 10.98 19.00 11.19 brmas 2.34 3.69 1.03 2.56 n of prior episodes 11.18 15.17 10.13 10.61 age of onset 26.63 9.24 29.84 12.44 weeks until relapse 54.95 46.36 50.08 51.64 patient fas 39.63 19.58 40.10 15.58 patient pcm 4.69 2.49 5.47 1.81 relative fas 33.08 15.99 36.68 16.18 relative pcm 4.88 2.31 4.97 1.64 note. bdi = beck depression inventory; brms = bech rafaelsen melancholia rating scale; brmas = bech ra­ faelsen mania rating scale; fas = family attitude scale; pcm = perceived criticism scale; srmi = self-rating mania inventory (meyer & hautzinger, 2012). cox proportional hazards models the cox proportional hazards model included the two measures of interest (fas and pcm), the therapy condition (cbt and st), and their interaction. first, the outcome was defined as recurrence of a depressive episode. table 3 contains the relevant outcome values of these analyses. two separate models were calculated: one for patients’ and one for relatives’ scores. although, the overall model for the patients was not significant; χ2 = 7.65, p = .18, the fas-p predicted significantly more recurrences of depressive episodes. the overall model for relatives was also not significant, χ2 = 6.27, p = .28, but pcm-r significantly interacted with therapy group in predicting depressive recurrences. specifically, increased pcm-r predicted a higher number of depressive recurrences in the st group but not in the cbt group (figure 2). predictors of expressed emotion 8 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ table 3 cox proportional hazards models testing fas and pcm as predictors of depressive recurrence variable b wald p hr 95% ci for hr χ2 pll ul patients model 1 0.16 .69 therapy .14 0.16 .69 1.15 0.57 2.31 model 2 6.38 .09 therapy .07 0.04 .84 1.08 0.53 2.19 fas-p .03 5.89 .01 1.03 1.01 1.06 pcm-p -.14 1.53 .22 0.87 0.70 1.08 model 3 7.65 .18 therapy -.74 0.54 .46 0.47 0.06 3.49 fas-p .04 2.94 .09 1.04 1.00 1.08 pcm-p -.28 2.63 .10 0.76 0.54 1.06 fas-p x therapy -.01 0.16 .69 0.99 0.94 1.04 pcm-p x therapy .24 1.16 .28 1.27 0.82 1.97 relatives model 1 0.36 .55 therapy .22 0.36 .55 1.25 0.61 2.57 model 2 2.27 .52 therapy .27 0.51 .48 1.32 0.62 2.80 fas-r .01 1.19 .28 1.01 0.99 1.04 pcm-r .03 0.06 .81 1.03 0.83 1.27 model 3 6.27 .28 therapy 1.82 2.12 .15 6.19 0.53 71.92 fas-r -0.01 0.27 .61 0.99 0.96 1.03 pcm-r 0.40 3.52 .06 1.50 0.98 2.28 fas-r x therapy 0.03 1.68 .20 1.03 0.98 1.09 pcm-r x therapy -0.52 4.43 .03 0.59 0.37 0.97 note. b = regression coefficient; fas-p = family attitude scale rated by patients; fas-r = family attitude scale rated by relatives; pcm-p = perceived criticism scale rated by patients; pcm-r = perceived criticism scale rated by relatives; hr = hazard ratio; srmi = self rating mania scale; wald = wald test. lex, hautzinger, & meyer 9 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ figure 2 percentage of participants with a depressive recurrence whose pcm-r scores were below/on and above the median note. cbt = cognitive behavioral therapy; pcm-r = perceived criticism scale rated by relatives; st = supportive therapy. when the outcome was defined as recurrence of (hypo)manic episodes, the overall models for patients (χ2 = 11.89, p = .07) and for relatives (χ2 = 7.34, p = .29) were not significant. in both models, the score of the srmi was the only significant predictor of manic recurrences (table 4). table 4 cox proportional hazards models testing fas and pcm as predictors of (hypo)manic recurrence variable b wald p hr 95% ci for hr χ2 pll ul patients model 1 5.11 .02 srmi .04 4.92 .03 1.04 1.01 1.08 model 2 6.01 .05 srmi .04 5.00 .03 1.04 1.01 1.08 therapy .44 1.05 .31 1.55 .67 3.56 predictors of expressed emotion 10 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ variable b wald p hr 95% ci for hr χ2 pll ul model 3 10.01 .04 srmi .05 6.63 .01 1.05 1.01 1.09 therapy .37 .74 .39 1.45 .62 3.37 fas-p -.01 .66 .42 .99 .95 1.02 pcm-p -.12 1.10 .29 .88 .70 1.11 model 4 11.89 .07 srmi .06 8.12 .004 1.07 1.02 1.11 therapy -.30 .05 .82 .74 .06 9.18 fas-p -.05 3.23 .07 .95 .90 1.01 pcm-p .05 .07 .77 1.05 .73 1.51 fas-p x therapy .06 2.56 .11 1.06 .99 1.13 pcm-p x therapy -.29 1.26 .26 .75 .45 1.24 relatives model 1 4.24 .04 srmi .04 4.13 .04 1.04 1.00 1.08 model 2 4.86 .09 srmi .04 4.25 .04 1.04 1.00 1.08 therapy .37 .70 .40 1.44 .61 3.40 model 3 6.50 .17 srmi .05 4.93 .03 1.05 1.00 1.08 therapy .41 .85 .36 1.51 .63 3.64 fas-r .001 .01 .95 1.00 .97 1.03 pcm-r -.13 1.38 .24 .88 .70 1.09 model 4 7.34 .29 srmi .04 4.48 .03 1.05 1.00 1.09 therapy 1.27 .86 .35 3.58 .24 52.50 fas-r .004 .02 .89 1.00 .95 1.06 pcm-r -.03 .02 .90 .97 .58 1.62 fas-r x therapy -.01 .06 .80 .99 .93 1.06 pcm-r x therapy -.12 .18 .67 .89 .51 1.55 note. b = regression coefficient; fas-p = family attitude scale rated by patients; fas-r = family attitude scale rated by relatives; pcm-p = perceived criticism scale rated by patients; pcm-r = perceived criticism scale rated by relatives; hr = hazard ratio; srmi = self rating mania scale; wald = wald test. d i s c u s s i o n the present study explored whether negative familial attitudes and perceived criticism predicted recurrences in euthymic individuals with bd who attended individual cbt or lex, hautzinger, & meyer 11 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ st. in general, there was no significant difference in risk of recurrence between the two groups (meyer & hautzinger, 2012), but the present post-hoc exploration showed that the relatives’ rating of their own perceived criticism towards the patient influenced the likelihood of depressive recurrences to a greater extent in the st than in the cbt condi­ tion. in addition, the patients’ perception of the family climate was related to the risk of depressive recurrences. there was no significant link between indicators for the familial climate and the risk for manic recurrences. these results are in line with previous studies that report familial criticism was linked to depressive relapse and symptoms but not to mania (kim & miklowitz, 2004; yan et al., 2004). at first sight, the interaction between treatment condition and self-rated perceived criticism of the relatives towards the patient (pcm-r) remains puzzling. however, the wording of the item for relatives refers to how much they see themselves being critical of the patients. the data therefore suggests that admitting more critical comments on side of the relatives increased risk for depressive recurrences specifically in the st group, while it did not make a difference in the cbt group. one goal of the manual-based cbt was to help patients to differently communicate and solve problems which often includes how to react to perceived criticism. although this is speculative, this perhaps helped to protect against being criticized or differently to react to perceived criticism. for example, the patients might learn to attribute critical remarks to their relatives’ mood or the specific situation instead to their own person. in st, the patients did not specifically learn communication or coping skills, therefore pre-treatment differences in actual or perceived criticism by the relative might still have had the same effect on risk of recurrence as having had no treatment, while cbt helped to attenuate the effect of this factor. while the latter is a potential explanation of the differential effect, it remains unclear why the relatives’ but not the patients’ perception of criticism had an impact on recurrence rates. this is puzzling because a) pc measures were administered at baseline, i.e. before the therapy sessions started, b) the pc of patients and relatives were positively correlated at baseline, and c) both therapies were done in an individual and not in a couple or family setting. in addition, while it is an intriguing idea that individual cbt might be effective in families with a hostile and critical climate, it is important to keep mind that these conclusions are exploratory and based on post-hoc analyses. regardless of the condition, patients who perceived their familial climate as more hostile had an increased risk for depressive recurrences. this is in line with previous studies that found that expressed emotions were linked to more depressive symptoms (kim & miklowitz, 2004) and recurrences (yan et al., 2004). those studies, however, used observer-based assessments based on frequency counts of critical and hostile behavior while we assessed the familial climate with questionnaires. the mostly used version of the fas is self-rated by the patient and asks for specific thoughts, behaviors and feelings expressed by the relative towards the patient (e.g., “he/she loses his/her temper with me”; “he/she thinks i am real burden”; “he/she feels very close to me”). the pa­ predictors of expressed emotion 12 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ tient-rated fas was found to be related to relapse in patients with psychosis (pourmand et al., 2005), and its content rather taps into hostility and criticism than to emotional overinvolvement, which is considered as one of the key factors of expressed emotion (kavanagh et al., 1997). in the present study, we also used a relatives’ version of the fas, and we found that it did not significantly predict the risk of recurrences. although observer-rated measures, e.g., the camberwell family interview (leff & vaughn, 1985), are regarded as the gold standard to assess the familial climate (hooley & parker, 2006), our results suggest that the patient-rated fas could be a sensible instrument to tap intrafamilial hostility and criticism and to predict depressive recurrences in bd. it is essential to keep in mind that in the fas the patient reports his/her perception of the family member’s attitudes and feelings, while the relative reports how he/she actually feels and what he/she thinks. interestingly, the relatives’ one-item measure pcm interacted with therapy group to predict relapses, while the patients’ fas predicted relapses regardless of the treatment condition. first, this result emphasizes the importance to assess criticism and hostility in both interaction partners, because it is still not clear how the reciprocity of interactions relate to hostility, criticism and expressed emotion (hooley & gotlib, 2000). for example, hostility expressed by a relative’s remark could be escalated or descaled depending on the response by the patient. second, patients’ actual perceptions of the attitudes are important, because the patient might or might not identify the hostility and criticism expressed by the relative (yan et al., 2004). while the fas and pcm share variance, they do not assess identical constructs (lex et al., 2019). while perceived criticism, whether rated by the patient or relative, is fairly specific, the fas encompasses more general negative attitudes within the family beyond critical comments. possibly, in patients this perception of criticism can be better measured by ratings of a range of specific behaviors, feelings and thoughts, i.e., fas, while in relatives the one-item measure pcm might be sufficient. this is one of the few studies in which criticism and hostile familial attitudes, two key elements of expressed emotion, were rated by the affected individuals and their relatives themselves instead by observers. although the pcm and the fas have empirical evidence to predict relapse similar to the more time consuming interviews or observations of actual family interactions (chambless & blake, 2009; hooley & parker, 2006; kavanagh et al., 1997), relying solely on self-reports is a limitation of the study. also, emotional overinvolvement as a key factor of expressed emotion was not assessed. we also received information from only one relative who might not be the one who necessarily was the most critical or most relevant person for the patient. some studies suggest that the kind of relation between the relative and patient might play a crucial role (hooley, 2007). finally, as mentioned before, these were post hoc analyses, therefore the study was probably not powered to test for these interactions which is probably reflected in the non-significant overall models. lex, hautzinger, & meyer 13 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://www.psychopen.eu/ conclusions despite this limitations, we found preliminary evidence that perceived criticism and familial attitudes in individuals with bd and their relatives were associated with an increased risk for depressive recurrences. specifically, the relatives’ self-rated own criti­ cism towards the patient affected outcome in the st group more that in the cbt group, and an overall negative family climate as perceived by patients predicted outcome regardless of the therapy conditions, when it referred to depressive recurrences. the different results for the one-item measure pcm and the fas support the idea that these instruments share some variance but do not assess identical constructs. while this was a first step to explore the usefulness of self-ratings of family attitudes and expressed emotion in bd, our results encourage the idea to use such questionnaires that are easy to administer in clinical practice to assess the familial climate (chambless & blake, 2009; 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(2004). expressed emotion versus relationship quality variables in the prediction of recurrence in bipolar patients. journal of affective disorders, 83(2-3), 199–206. https://doi.org/10.1016/j.jad.2004.08.006 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. lex, hautzinger, & meyer 17 clinical psychology in europe 2022, vol. 4(1), article e4617 https://doi.org/10.32872/cpe.4617 https://doi.org/10.1111/j.1545-5300.2001.4010100005.x https://doi.org/10.1016/s0165-0327(00)00228-7 https://doi.org/10.1016/j.jad.2012.04.005 https://doi.org/10.1016/0010-440x(92)90040-w https://doi.org/10.1016/s0165-0327(98)00150-5 https://doi.org/10.1176/appi.focus.12.3.251 https://doi.org/10.1176/appi.ajp.160.12.2099 https://doi.org/10.1192/bjp.129.2.125 https://doi.org/10.1111/famp.12208 https://doi.org/10.1016/j.jad.2004.08.006 https://www.psychopen.eu/ predictors of expressed emotion (introduction) method participants procedures and measurements statistical methods results demographics cox proportional hazards models discussion conclusions (additional information) funding acknowledgments competing interests references competency-based training and assessment of listening skills: a waitlist-controlled study in european telephone emergency services research articles competency-based training and assessment of listening skills: a waitlist-controlled study in european telephone emergency services simone jennissen 1,2 , stefan schumacher 3, diana rucli 4, melinda hal 5,6 , andrás székely 7, derek de beurs 8 , ulrike dinger 1,2 [1] department of general internal medicine and psychosomatics, university hospital heidelberg, heidelberg, germany. [2] department of psychosomatic medicine and psychotherapy, medical faculty, heinrich heine university düsseldorf, düsseldorf, germany. [3] telefonseelsorge hagen-mark, hagen, germany. [4] studio rucli formazione e consulenza organizzativa, udine, italy. [5] department of applied psychology, faculty of health sciences, semmelweis university, budapest, hungary. [6] szent rókus hospital, psychiatry, baja, hungary. [7] végeken egészséglélektani alapítvány, budapest, hungary. [8] trimbos-instituut, utrecht, the netherlands. clinical psychology in europe, 2022, vol. 4(4), article e7933, https://doi.org/10.32872/cpe.7933 received: 2021-12-08 • accepted: 2022-03-13 • published (vor): 2022-12-22 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: simone jennissen, department of psychosomatic medicine and psychotherapy, medical faculty, heinrich heine university düsseldorf, moorenstraße 5, 40225 düsseldorf, germany. e-mail: simonejennissen@gmail.com supplementary materials: materials [see index of supplementary materials] abstract background: telephone emergency services (tes) provide an essential part of suicide prevention and emotional support services across different health care settings. tes are usually provided by paraprofessional counselors, who need specific training in listening skills to meet the demands of callers. method: this project developed a competency-based training for listening skills which was then evaluated in a randomized controlled waitlist study across four eu countries (germany, hungary, italy, and the netherlands). each country provided one training group and one waitlist group. across countries, a total of 71 (trained: n = 36, waiting: n = 35) counselor trainees were assessed in a standardized, simulated emergency call with an actor client either before or after training participation. calls were audiotaped and competencies in listening skills were evaluated by external raters using a standardized rating form. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7933&domain=pdf&date_stamp=2022-12-22 https://orcid.org/0000-0002-9219-3641 https://orcid.org/0000-0002-3864-4472 https://orcid.org/0000-0002-0166-6897 https://orcid.org/0000-0002-4126-5676 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ results: trained counselors showed significantly better listening skills than participants from the waitlist condition. conclusion: results provide support for the efficacy of a competency-based training for listening skills in the field of tes across europe. furthermore, results demonstrated that a standardized competency-based assessment with an actor client is suitable to assess listening skills. keywords listening skills, training, telephone emergency services, helpline, paraprofessional counselors highlights • a competency-based training can improve paraprofessionals’ listening skills in a relatively short training time. • listening skills can be assessed in a simulation with an actor client. • the use of competency-based training and assessment methods could be expanded to the field of paraprofessional counseling. telephone emergency services (tes) form an important part of psychosocial health care, emotional support services, and suicide prevention (dinger et al., 2019). tes are usually free of charge, available at all times, and do not require help-seeking individuals to disclose their identity. thus, there is a small barrier for those in need to reach out to tes. this is also represented in the number of calls tes receive. in 2019, the german tes telefonseelsorge responded to 1.2 million calls (telefonseelsorge, 2019). similarly, the australian lifeline reports over one million calls yearly (lifeline, 2020), the united kingdom’s samaritans reported over 3.6 million calls in 2018 (samaritans, 2019), and the united states’ national suicide prevention lifeline reported more than 22 million calls in 2018 (the national suicide prevention lifeline, 2019), which underlines the widespread acceptance and need for tes. during the covid-19 pandemic, tes have gained even more importance since there were both needs for social distancing as well as increased mental health burdens. tes responds well to both needs as a low-threshold mental health service that can be accessed even by high risk patients during times of rigorous infection control measures (arenliu et al., 2020; humer et al., 2021; kavoor et al., 2020). as opposed to psychotherapists, psychiatrists, and social workers who participate in year-long professional training curricula before providing mental health services, tes counselors are paraprofessionals with limited and regionally different training. a study conducted on the german telefonseelsorge showed that tes counselors receive training over the course of seven to 24 months (m = 13.3 months; dinger & rek, 2017). the samaritans’ conduct their training in five to ten sessions over the course of a few months (samaritans, 2020). despite having no formal medical or psychological education, tes counselors frequently deal with highly stressed callers. in 2019, 43.7% of callers in germany presented suicidal thoughts, 6.6% stated an intent to commit suicide, and competency-based training and assessment of listening skills 2 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ 7.1% had formerly attempted suicide (telefonseelsorge, 2019). most callers repeatedly contacted tes for emotional support, which could be an indicator of high mental strain. frequently discussed topics included experiencing depression or anxiety, interpersonal difficulties, or physical health issues (telefonseelsorge, 2019). studies from the united kingdom (coveney et al., 2012), the united states (ingram et al., 2008; mishara et al., 2007), and australia (burgess et al., 2008) report similar contents. as such, the topics discussed in tes calls are comparable with the contents of psychotherapy sessions, despite tes counselors receiving far less formal training for handling difficult clients. training is important not only to provide adequate service to callers, but also for the well-being of tes counselors themselves. in a meta-analytic review, hattie et al. (1984) showed that the amount of training that paraprofessionals received was associated with their effectiveness as counselors on a variety of outcome measures such as clients’ selfreported change, clinical ratings by independent raters, information provided by signifi­ cant others, work performance, or therapist improvement ratings. paraprofessionals with “some experience” (e.g. hospital workers, medical students, or speech pathologists) were more effective than inexperienced paraprofessionals (e.g. college students, volunteer adults). a more recent review on the effectiveness of professional and paraprofessional counselors to deliver cognitive-behavioral treatment for depression and anxiety also concluded that training is important for paraprofessional counselors to deliver effective service (montgomery et al., 2010). furthermore, a qualitative survey suggests that par­ aprofessional counselors wish for more training in order to feel confident in dealing with difficult clients (skoglund, 2006). studies on psychotherapists show that training increases therapists’ self-efficacy (hess et al., 2006; pascual-leone & andreescu, 2013). note that while skills are defined as the ability to carry out an activity and competencies additionally include the knowledge of when and how to apply one’s skills, self-efficacy encompasses one’s confidence in one’s own capabilities, but not actual skills or compe­ tencies (bandura, 1977; butler, 1978; le deist & winterton, 2005). however, evidence from a systematic review suggests that counselor self-efficacy is related to counselor performance as assessed by trained raters and supervisors (larson & daniels, 1998). thus, training is necessary to both directly increase counselors’ efficacy as well as to boost their confidence in their own capabilities. within tes, as there are large numbers of callers and limited resources, paraprofessionals’ training is distinctively shorter than professionals’ training. since tes are local organizations without uniform training standards, there is a need for more research on time-efficient, focused training opportunities that equip volunteer counselors with the key competencies they require. listening skills form an integral part of many counselor trainings and are the core of tes trainings (hill, 2009; ivey et al., 1987). they comprise a variety of techniques such as active listening, showing empa­ thy, supporting clients’ self-efficacy, establishing rapport with the client, and exploring feelings of the client (hill, 2009; rogers & farson, 1957). listening skills may rather be jennissen, schumacher, rucli et al. 3 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ categorized as competencies, since they also include the knowledge about when and how to apply a specific skill and refer to the broader concept of being able to listen to, soothe, and help another person (butler, 1978; le deist & winterton, 2005). however, since listening skills is an established term, this term will be used throughout the paper. this study aimed to develop and evaluate a competency-based training for listening skills. to account for the heterogeneity of tes and extend the generalizability of our results, the study was conducted as an international multisite project in germany, ita­ ly, hungary, and the netherlands. furthermore, while research in psychotherapy and counseling mostly relies on self-report measures, these are likely biased due to limited introspectiveness of respondents. counselors, for instance, might overor underestimate their skills depending on their level of self-criticism (anderson et al., 2016). in psycho­ therapy research, recent studies have therefore employed competency-based assessments of therapist skills, such as the facilitative interpersonal skills (fis) performance test (anderson et al., 2009). the fis is used to assess therapists’ interpersonal behavior in a standardized test situation. therapists are asked to respond to challenging therapy situa­ tions that are presented to them either as video clips or with actor clients. therapists’ responses are filmed and later evaluated by trained judges according to a rating manual (munder et al., 2019). in this study we intended to employ a competency test methodolo­ gy similarly to the fis. specifically, we aimed to assess listening skills in a simulated tes call with an actor representing a typical tes client. as in the fis, trained judges evaluate participants’ listening skills based on recordings of the simulated calls using a standardized rating sheet. this allows a more objective assessment of paraprofessional counselors’ listening skills in an ecologically valid setting, while also directly assessing the competencies needed in a tes call. we hypothesized that trained participants would demonstrate better listening skills in the standardized simulated emergency call than participants who had not received the listening skills training. m e t h o d the ethics committee (institutional review board) of the department of psychology at heidelberg university approved the study procedures (reference number: az jenn 2020 1/1). participants were informed about all study procedures by the local member of the research team and provided informed consent prior to participation. participants and procedure the study was designed as a randomized-controlled waitlist trial. participants were recruited at local tes posts in germany, hungary, italy, and the netherlands via partici­ pating institutions in the erasmus+ funded network empowering (educational path for emotional well-being). as a widely known organization, tes posts are regularly contac­ competency-based training and assessment of listening skills 4 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ ted by individuals who are interested in becoming a volunteer counselor for tes. during our study period from november 2016 to april 2017, those who contacted tes about becoming a volunteer counselor were informed about the study and the opportunity to participate in the listening skills training. those consenting to the study procedures were then cluster-randomized within site to start training either immediately (training group) or delayed (waitlist group). within each country, the research team randomized each individual to either an immediate training group or a waitlist group. participants in the training group immediately started the listening skills training. after the training groups had completed their training, listening skills of participants in both training and waitlist groups were assessed in a standardized, simulated emergency call with an actor client. after the assessment, the waitlist group received their listening skills training. due to the naturalistic recruitment, there is no information available on the number of individuals who decided against participating in our study. there were no dropouts after enrollment. participants had to be 18 years or older to be eligible. a total of n = 71 volunteer counselors (n = 12 from germany, n = 20 from hungary, n = 20 from italy, and n = 19 from the netherlands) participated in our study. each country provided on training group and one waitlist group. across countries, a total of n = 36 participants were randomized to the training group and n = 35 were randomized to the waitlist group. the majority of participants (82%) were female. participants’ mean age was 38.51 years (sd = 15.86). about half of the sample (48%) reported a school diploma and 52% a university degree as their highest level of education. participants were asked whether they had prior work experience as a “listener”, either volunteering for a counseling or emergency service or as a professional therapist or counselor before participating in this study. about half (45%) of participants reported prior professional or voluntary work experience as a listener for a mean duration of 6.96 years (sd = 8.76). descriptive characteristics by group (training vs. waitlist) are presented in table 1. there were no significant differences between study groups regarding descriptive characteristics. listening skills training a focus group of professionals in tes counseling and pastoral care developed a manual for the listening skills training. the 120 hr training is split into three parts: a 30 hr self-study online module to convey the theoretical basis of listening, a 40 hr practical group training in listening which is provided in 10 structured sessions, and a 50 hr module for in-depth practice and supervised training calls. table 2 provides a more detailed overview of the training modules. participants’ attendance was monitored for all in-class events and there were no missed sessions. attendance of the self-study online module was not assessed by the research team. jennissen, schumacher, rucli et al. 5 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ assessment listening skills were assessed in a standardized, simulated emergency call with a trained actor client. the actor role represented a typical tes caller. actors received a standar­ dized role script with a detailed description of their role as well as instructions for a 15-minute tes call. there was one native speaking actor in each country. before the assessment, actors prepared their role and practiced the simulated call with paraprofes­ sional counselors of different experience levels. this ensured that actors were trained to respond realistically to a variety of possible interventions by participants. furthermore, these practice calls were recorded and used as training material for the observer ratings of listening skills. during the assessment period, a local member of the research team listened to recordings of the standardized, simulated emergency call and gave feedback regarding role adherence to the trained actor client on a weekly basis. assessments were conducted by telephone to mimic a naturalistic tes setting. calls were recorded for assessment purposes. participants were called by blinded research assistants and instructed to be a good listener for an actor client for about 15 minutes. table 1 descriptive characteristics for the training and waitlist group characteristic training group n = 36 waitlist group n = 35 difference test m sd m sd t p age 40.1 15.7 36.9 16.1 -0.848 .400 former experience in listening (years) 2.4 6.0 3.8 7.5 0.832 .408 n % n % χ2 p gender 2.53 .112 male 4 11.1 9 25.7 female 32 88.9 26 74.3 highest educational level 1.283 .733 basic secondary school 5 13.9 7 20.0 high school 12 33.3 10 28.6 bachelor’s degree 10 27.8 12 34.3 master’s degree 9 25.0 6 17.1 former experience in listening 0.137 .712 yes 17 47.2 15 42.9 no 18 52.8 20 57.1 note. former experience in listening refers to prior work experience as a “listener”, either volunteering for a counseling or emergency service or as a professional therapist or counselor before participating in this study. competency-based training and assessment of listening skills 6 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ after assuring that the instructions were clear, the actor then took over the phone and presented herself as “laura”, a 27-year-old office clerk, who was struggling in her relationship and also stressed out by her current job workload. “laura” was calling tes when she was home alone in the evening and overwhelmed by her feelings. she was severely distressed, but not in an acute suicidal crisis. “laura” was struggling to identify her own emotions, but she was willing to respond to the paraprofessional counselor’s questions and able to benefit from the listening process. listening skills were assessed using an observer rating measure. the listening skills scale (lss) was developed by members of the research team (sj, ud) based on several validated psychotherapy process scales, i.e. the multitheoretical list of therapeutic inter­ ventions (multi; mccarthy & barber, 2009), the active empathetic listening scale (ael; drollinger et al., 2006), the working alliance inventory (wai-sr; hatcher & gillaspy, 2006), and the therapist empathy scale (tes; decker et al., 2014) and adopted the meth­ table 2 description of contents of the listening skills training modules module content 1. self-study (30 hrs) using an e-learning tool, participants are provided with 100 multiple choice questions regarding the theoretical basis of listening. after each question, participants receive feedback on their selected answer(s) and are presented with a brief theoretical explanation. topics include cognitive-behavioral, psychodynamic, systemic, and humanistic/client-centered theories. 2. practical group training (40 hrs) this part of the training is performed on site in groups of maximum 15 participants. session 1: introduction • focuses on a personal introduction of group members, self-reflection of training goals and motivations, and the assessment of existing knowledge and views on listening session 2: active listening • teaches the principles of active listening (how to ask for thoughts/feelings/ behaviors, give the other person space, and paraphrase meaningful contents) session 3: emotional stability • teaches ways to regulate one’s own and the other person’s feelings session 4: respect and boundaries • fosters acceptance of differences between people • teaches ways to set boundaries in the listening process session 5: empathy • fosters perspective taking and empathic responses to another person’s story session 6: mirroring • teaches ways to reflect the other person’s feelings or statements session 7: self-reflection • encourages reflection on own feelings, motivations, and resources session 8: structuring conversations • teaches the five-phase model of the listening process (welcome, exploration, goal setting, elaboration, conclusion) session 9: strengths and resources • teaches how to ask for resources and foster strengths of the other person session 10: feedback and conclusions • summarizes acquired listening skills and encourages reflection on personal progress 3. in-depth practice (50 hrs) having acquired the theoretical knowledge as well as practical experience in role plays and group exercises, the final part of the listening skills training is focused on supervised training cases. this module should be adapted to suit the needs of listeners in their specific work environment. jennissen, schumacher, rucli et al. 7 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ odology of the fis performance test (anderson et al., 2009). items were modified to suit the tes environment (i.e. “client” instead of “patient”; “listener” instead of “therapist”) and to reflect an observer perspective. the scale consisted of 33 items representing listening skills such as perspective taking, respect, active listening, resource activation, and structuring the conversation. higher values represent better listening skills. items include “the listener sometimes finds it difficult to see things from the other person’s point of view (inversed)” or “the listener appreciates their client as a person”. items are evaluated on a 5-point likert scale (1 – totally disagree; 5 – totally agree) with one additional n/a category in case an item cannot be assessed from the information in the audio recording of the standardized simulated emergency call. two items are reverse coded. higher values represent better listening skills. internal consistency of the scale was excellent in the present study (cronbach’s α = .94). the full scale is available in the online supplement. ratings were provided by at least on trained research assistant in each country. recordings of practice calls from the actor training were used to train raters in the appli­ cation of the lss. during the assessment period, at least once per week the local member of the research team listened to recordings of the standardized, simulated emergency calls, gave feedback to the actor (see above), and supervised the local research assistant in ratings on the lss. in the german subsample, all lss ratings were performed by two independent observers. interrater reliability of these two raters was excellent, icc(3,1) = .86. data analytic strategy as a first step, we explored missing data and investigated the factor structure of the listening skills scale as a basis for further analyses. we performed a principal component analysis (pca) using the scree criterion for factor retention to determine whether cal­ culating a mean score for listening skills was appropriate. next, we assessed whether our data was normally distributed. since each of the four countries provided one train­ ing group and one waitlist group, groups were nested within country. we therefore assessed whether this introduced dependency in our data by calculating the intraclass correlation (icc) within countries in a multilevel intercept only model. we intended to employ a multilevel model to assess group differences if there were an icc ≥ .05. an icc < .05 would indicate that country does not affect outcome and therefore single level multiple regression models would be appropriate (tabachnick & fidell, 2014). we employed a stepwise modeling procedure. the first model tested for group differences in listening skills without covariates. to assess the robustness of results, the second model introduced age and gender as common covariates and the third model adjusted for years of previous experience as a listener outside of the tes environment. effect sizes were calculated as standardized regression coefficients. a standardized regression coefficient competency-based training and assessment of listening skills 8 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ of b = .10 is considered small, b = .30 is considered moderate, and b = .50 is considered large (cohen, 1988). r e s u l t s preliminary analyses missing data analysis demonstrated more than 5% missing values in six items of the lss. we therefore excluded these items from the following analysis. next, we conducted a principal component analysis (pca) to explore the factor structure of the lss. the kaiser-meyer-olkin score of kmo = .86 and the significant bartlett’s test of sphericity, χ2(351) = 1562.15, p < .001, demonstrated the adequacy of the data for pca. the scree plot was slightly ambiguous and showed inflexions that would justify both retaining one or two components. inspections of the factor loadings indicated a higher-order general factor of “listening skills” which explained 48.58% of variance. we therefore decided to retain one component and calculate a mean value for listening skills as a basis for further analyses. factor loadings are available in the online supplement. based on a visual inspection of the histogram, negligible skew (-0.18) and kurtosis (-0.54), as well as a nonsignificant kolmogorov-smirnov test (p = .20), listening skills were normally distributed across participants. effect of the listening skills training since groups were nested within countries, we first assessed the dependency in our data by calculating the icc within countries in a multilevel intercept only model. with an estimated icc of .01, the model suggested negligible dependency in the data. hence, multiple regression was deemed an appropriate method to test for group differences. the first model predicted listening skills as measured by the lss from group (waitlist group vs. training group). group was a significant predictor of listening skills with a large standardized regression coefficient of b* = .52 (see table 3). participants in the training group (m = 3.99, sd = 0.69) demonstrated significantly better listening skills than participants in the waitlist group (m = 3.20, sd = 0.62, see figure 1). to assess the robustness of this effect, we next employed a hierarchical model introducing age and gender as covariates in the first step and group in the second step. while there was no significant effect of age or gender, group remained as a predictor of listening skills with a large standardized regression coefficient of b* = .54 (see table 3). lastly, we assessed whether previous experiences in listening affected the observed listening skills. the final hierarchical model introduced years of previous experiences in listening outside of tes in the first step and group in the second step. age and gender as nonsignificant predictors were dropped from this model. there was no significant effect of previous jennissen, schumacher, rucli et al. 9 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ experience, while group continued to significantly affect listening skills with a large standardized regression coefficient of b* = .52 (see table 3). table 3 linear regression models predicting listening skills parameter model 1 model 2 model 3 coefficient (se) 95% ci coefficient (se) 95% ci coefficient (se) 95% ci intercept 3.20 (0.11)* [2.97, 3.42] 3.46 (0.27)* [2.93, 4.00] 3.20 (0.12)* [2.96, 3.45] age -0.01 (0.01) [-0.02, 0.00] gender -0.06 (0.21) [-0.48, 0.35] experience -0.00 (0.01) [-0.03, 0.02] group 0.79 (0.16)* [0.48, 1.11] 0.82 (0.16)* [0.50, 1.14] 0.79 (0.16)* [0.47, 1.11] model fit r 2 0.27 0.28 0.27 adjusted r 2 0.26 0.26 0.25 note. n = 71; gender was dummy coded (0 – male, 1 – female). experience = years of previous experience in listening outside of telephone emergency services. group was dummy coded (0 – waitlist group, 1 – training group). listening skills were assessed in a standardized, simulated emergency call using the observer-rated listening skills scale (lss). *p < .05. figure 1 mean listening skills of participants in the training group and the waitlist group 1 1,5 2 2,5 3 3,5 4 4,5 5 waitlist group training group note. n = 71 (n = 36 participants were randomized to the training group and n = 35 were randomized to the waitlist group). error bars represent the standard error of the mean. listening skills were assessed in a standardized, simulated emergency call using the observer-rated listening skills scale (lss). scale values range from 1-5, where higher values indicate better listening skills. the difference between the groups is significant (p < .05), see result of the linear regression model in table 3. competency-based training and assessment of listening skills 10 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ d i s c u s s i o n this study aimed to develop and evaluate a competency-based training for listening skills in an international multisite project across europe. results provide support for the efficacy of the 120 hr training. trained individuals demonstrated significantly better listening skills than their untrained counterparts. the effect size for this group differ­ ence was large, which implies that this relatively short training makes a meaningful difference in paraprofessional counselors’ abilities to adequately respond to tes calls. furthermore, the effect of the training was independent from participants’ age, gender, and previous experience as a listener in other contexts. although approximately half of the participants reported previous experiences in the field of “listening”, e.g. in their profession as social workers, nurses, or pastoral care workers, or as a volunteer for other services, these experienced participants benefitted as much from the training as inexper­ ienced participants. this implies that the training is suitable for groups with different levels of expertise and equips paraprofessional counselors with specific competencies needed within tes. listening on the telephone may require a different set of skills than listening in a face-to-face setting, such as the ability to fully rely on verbal expressions in understanding the client, without the option to consider nonverbal cues (sötemann, 2019). the counselors themselves also have to convey their interest in the client, their caring and respectful attitude, and the comfort they provide solely through speech and voice modulation. silence, which could serve a holding function in a face-to-face setting, might feel uncomfortable or even threatening to a client on the phone who has no means to determine whether the counselor is still with them. lastly, the anonymity of tes could be unfamiliar to those who have never worked in listening of the phone and make it difficult to build a relationship at the beginning (sötemann, 2019). these differences between face-to-face and telephone settings might explain while experiences in listening outside of the tes environment were not an advantage in our study and experienced participants also needed the training to acquire the specific competences needed to adequately respond to a tes call. in this study, the assessment of listening skills was realized with an actor patient in a simulated emergency call. this method was chosen not only for a more objective assessment, independent of participants’ ability to accurately report on their own listen­ ing skills, but also to tap into the exact competencies needed for the later task as a paraprofessional counselor in tes. competency-based assessment methods have gained increased popularity in medical education and psychotherapy over the last decades (anderson et al., 2016; dannefer & henson, 2007; lurie, 2012). they are based on the insight that neither factual knowledge, nor self-evaluation are sufficient to guarantee the mastery of a practical task (miller, 1990). to assure that trainees can perform their tasks competently, assessments should be performed in the context of the actual work­ place or in a realistic simulation (holmboe et al., 2010; issenberg et al., 2005). thereby, the assessment can include context factors from the real life setting and confirm that jennissen, schumacher, rucli et al. 11 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ trainees are prepared for authentic encounters. the employed assessment method of a standardized, simulated emergency call with an actor client fulfilled these requirements. participants were presented with a typical tes caller and could therefore demonstrate their competency as a paraprofessional counselor in tes. the assessment showed that the training sufficiently teaches listening skills as they a required in everyday practice at tes. limitations this study is limited in generalizability by the recruited sample. although we performed the study as a multisite project across four different european countries, tes operate internationally, and future studies will determine whether the listening skills training is effective in other than the investigated countries. however, investigating the training across four countries with very different local structures (germany, italy, hungary, and the netherlands) is a major strength of this study and the focus on european countries seems sensible since a large number of tes sites operate in europe (ifotes, 2020). another limitation of this study is the small sample size within each country. although the achieved power to detect the overall group difference was ≈ 1 (faul et al., 2007), drawing statistical inferences at the country level would have proven difficult. however, by calculating the icc we assured that outcomes did not differ depending on the country in which participants were assessed. next, although actors received a detailed role script, prepared their role thoroughly, and were trained and supervised frequently, the actors had to react flexibly to partic­ ipants’ interventions and therefore the assessment was not completely standardized. future studies could investigate whether presenting pre-recorded audio sequences is a viable alternative, although this comes at the cost of a less ecologically valid assessment situation. furthermore, although participants received a standardized training of 120 hrs in to­ tal, their attendance in the 30 hr online module was not monitored by the research team and thus may have varied. further evaluations of the training should assess attendance in all modules and control for missed classes in statistical analyses. next, though reliability measures within this study demonstrated excellent interrater agreement and internal consistency of the lss, further validation of the scale, preferably with listening skills measures from different perspectives, would be useful. lastly, due to limited resources we designed the study as a randomized controlled waitlist trial with a single assessment in each group. assuming randomization was successful, this procedure should result in correct effect size estimates for the training. however, a baseline assessment in the training group could have been used to examine the successfulness of randomization and could also have served as a more direct measure of existing knowledge than asking for previous experiences in listening. furthermore, competency-based training and assessment of listening skills 12 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ future evaluations of the listening skills training may want to include a follow-up assess­ ment to examine long-term effects of the training. implications and conclusion our findings have several implications. first and foremost, demonstrating the efficacy of the training in participants from several european countries suggests that the listening skills training can be used to train paraprofessional counselors at tes from different countries. the modular structure allows for flexibility while also providing an evaluated and effective basis. international tes sites may use the listening skills training as a basic curriculum and adapt it to their regionally different needs. to monitor their trainees’ development of competencies, they could also make use of the assessment method with the standardized acting role. although role-plays are typically part of the tes group training, introducing a standardized assessment could help trainers and trainees identify their specific needs while also providing a consistent background against which parapro­ fessional counselors’ listening skills can be evaluated. furthermore, the increased demand for mental health services during the covid-19 pandemic together with the necessity to reduce in-person contact between individuals has highlighted two core competencies of tes: they are widespread available and offer emotional support in a socially distant manner (humer et al., 2021; kavoor et al., 2020). although trainings such as the helping skills training or postgraduate training programs for psychotherapists, psychiatrists, and social workers are well-established (hill, 2009; hill & lent, 2006), the current rapid increase in demand for mental health services underlines the usefulness of short, effective trainings for listening skills. lastly, this study aimed to evaluate the use of competency-based training and assess­ ment methods in the field of paraprofessional counseling. although commonly accepted as beneficial in medical education (lane et al., 2001; scalese et al., 2008), competencybased methods are still rare in the field of psychotherapy and counseling. similarly to simulation patients in medical education, this study introduced an assessment with a standardized actor client to a paraprofessional counseling environment. future studies should investigate the use of an actor client to assess counseling competencies in the field of professional counseling and psychotherapy. to conclude, this international multisite study demonstrated the efficacy of a compe­ tency-based training for listening skills across europe. trainees successfully acquired listening skills in the 120 hr course, as demonstrated in a standardized simulated emer­ gency call with an actor representing a typical tes caller. findings encourage the appli­ cation of the training in tes to prepare volunteers for their tasks as paraprofessional counselors. furthermore, results suggest that competency-based assessment in a simula­ ted tes call is a suitable method to measure listening skills. jennissen, schumacher, rucli et al. 13 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://www.psychopen.eu/ funding: this research was supported by a grant from the erasmus+ program of the european union (2015-1-de02ka204-002492), which is gratefully acknowledged. acknowledgments: we thank our project partners frank ertel from ifotes europe, bence buza and linda engwau from magyar lelki elsosegely telefonszolgalatok szovetsege hungary, monica petra and christina rigon from telefono amico italia, ulrike dahme and ulrike zeller from telefonseelsorge münchen, noor bossers and cootje roosenboom from sensoor zuid-holland, luca rusi from studio rucli, and valeria puletti and silvia cordellini from scuola nazionale servizi italy for their support. competing interests: the authors have declared that no competing interests exist. s u p p l e m e n t a r y m a t e r i a l s provides an observer-rating measure of listening skills (listening skills scale). the listening skills scale (lss) was used by independent observers to rate listening skills of participants in simulated emergency calls (for access see index of supplementary materials below). index of supplementary materials jennissen, s., 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(2019). the national suicide prevention lifeline—the nation’s mental health public safety net. https://988lifeline.org/wp-content/uploads/2019/04/nspl-overview-2019.pdf clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. jennissen, schumacher, rucli et al. 17 clinical psychology in europe 2022, vol. 4(4), article e7933 https://doi.org/10.32872/cpe.7933 https://doi.org/10.1521/bumc.2010.74.1.45 https://doi.org/10.1002/jclp.22846 https://doi.org/10.1080/14733145.2012.739633 https://media.samaritans.org/documents/samaritansimpactreport2018_19_web_low_res.pdf https://www.samaritans.org/support-us/volunteer/become-samaritans-listening-volunteer https://doi.org/10.1007/s11606-007-0283-4 https://doi.org/10.1093/hsw/31.3.217 https://www.telefonseelsorge.de/unsere-statistiken https://988lifeline.org/wp-content/uploads/2019/04/nspl-overview-2019.pdf https://www.psychopen.eu/ competency-based training and assessment of listening skills (introduction) method participants and procedure listening skills training assessment data analytic strategy results preliminary analyses effect of the listening skills training discussion limitations implications and conclusion (additional information) funding acknowledgments competing interests supplementary materials references ‘open source’ opportunities for enhanced collaboration in psychotherapy science letter to the editor, commentary ‘open source’ opportunities for enhanced collaboration in psychotherapy science conal twomey 1, richard cody 2, john a. johnson 3, gary o’reilly 4 [1] health service executive, dublin, ireland. [2] púca technologies limited, dublin, ireland. [3] department of psychology, pennsylvania state university, state college, pa, usa. [4] school of psychology, university college dublin, dublin, ireland. clinical psychology in europe, 2021, vol. 3(2), article e6569, https://doi.org/10.32872/cpe.6569 published (vor): 2021-06-18 corresponding author: conal twomey, ballyfermot & palmerstown primary care & mental health centre, upper ballyfermot road, dublin 10, d10 c973, ireland. e-mail: conal.twomey@hse.ie according to marvin goldfried, psychotherapy remains an infant science characterised by a lack of consensus surrounding core and basic principles, research-practice disparity, and excessive theory-reinvention by competing schools of therapy (goldfried, 2020). goldfried’s concerns together point to suboptimal collaboration within the psychothera­ py research community. in our view, collaboration could be improved through the wider application of ‘open source’ software development principles (e.g., open access, free distribution, and unconstrained modification) to psychotherapy science. the origins of open source illustrate its promotion of collaboration. initially, soft­ ware products were invariably perfected ‘behind-closed-doors’ before being released as copyrighted products. in the mid-1990s, however, the internet enabled a new way of working: members of online developer communities started to freely share modifiable software source code with each other, leading to the creation of open and free networks of online collaboration (raymond, 1999), and subsequently to the production of several high-quality software and internet products (e.g., linux and wikipedia) and mainstream adoption across industries. like open source, science is—at its best—an open, collaborative endeavor (johnson, 2014). it is therefore unsurprising that open source has increasingly infiltrated science in recent years, most notably in the ‘open science’ movement, which promotes meth­ odological transparency and open access to data and research outputs (vicente-saez & martinez-fuentes, 2018); but also in the production of laboratory equipment (pearce, 2014), off-patent medications (woelfle et al., 2011), and psychometric questionnaires (dworak et al., 2021; goldberg et al., 2006). regarding psychotherapy, journals routinely this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6569&domain=pdf&date_stamp=2021-06-18 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ promote open-science practices, data from psychotherapy studies are often shared (e.g., in patient level meta-analyses), many outcome measures are freely available online, and there are an increasing number of open research networks. regrettably given their potential to enhance the open collaboration inherent in good science, there exist few applications of open source principles to the development of psy­ chotherapy interventions. most intervention manuals are not freely available online, lim­ iting access and creating a financial barrier to the exploration of manuals from different schools of therapy. moreover, for the vast majority of psychotherapies, copyright control and vested interests discourage (a) the collaborative modification and distribution of new versions of intervention manuals, and (b) the collaborative combination of components from different schools of therapy into transtheoretical interventions, or ‘process-based therapies’ (hofmann & hayes, 2019). regarding (a), such collaboration could be enabled if freely modifiable versions of intervention manuals were periodically released on open source platforms such as the open science framework (https://osf.io). this would signpost progress and later facilitate the empirical comparison of different versions, in turn facilitating ‘component analyses’ that tap into basic principles. on a cautionary note, there is potential for the misuse of open source intervention manuals by unqualified persons and this should be closely monitored (goldberg et al., 2006). regarding (b), the vested interest of a school of therapy is to keep the learner within their school, so that the learner can eventually graduate as a proponent of the school’s teachings; however, the wider community interest is to build unifying theories that transcend the teachings of particular schools (goldfried, 2020). transtheoretical open source interventions provide a means for this theory unification. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s dworak, e. m., revelle, w., doebler, p., & condon, d. m. 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(2018). open science now: a systematic literature review for an integrated definition. journal of business research, 88, 428-436. https://doi.org/10.1016/j.jbusres.2017.12.043 woelfle, m., olliaro, p., & todd, m. h. (2011). open science is a research accelerator. nature chemistry, 3(10), 745-748. https://doi.org/10.1038/nchem.1149 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. twomey, cody, johnson, & o’reilly 3 clinical psychology in europe 2021, vol. 3(2), article e6569 https://doi.org/10.32872/cpe.6569 https://doi.org/10.32872/cpe.v2i1.2753 https://doi.org/10.1177/2167702618772296 https://doi.org/10.1016/j.jrp.2014.05.003 https://doi.org/10.1038/505618d https://doi.org/10.1016/j.jbusres.2017.12.043 https://doi.org/10.1038/nchem.1149 https://www.psychopen.eu/ developmental coordination disorder (dcd): relevance for clinical psychologists in europe scientific update and overview developmental coordination disorder (dcd): relevance for clinical psychologists in europe emily j. meachon 1 , martina zemp 1,2 , georg w. alpers 1 [1] department of psychology, school of social sciences, university of mannheim, mannheim, germany. [2] department of clinical and health psychology, university of vienna, vienna, austria. clinical psychology in europe, 2022, vol. 4(2), article e4165, https://doi.org/10.32872/cpe.4165 received: 2020-08-04 • accepted: 2022-02-04 • published (vor): 2022-06-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: georg w. alpers, l13, 17, mannheim germany 68131. phone: +49 621 181-2106. e-mail: alpers@uni-mannheim.de abstract background: developmental coordination disorder (dcd) is a common neurodevelopmental disorder primarily characterized by fine and gross motor coordination difficulties. yet, many aspects remain unclear regarding the clinical presentation of secondary symptoms and their implications for clinical psychology. therefore, the purpose of this review is to provide an update about the current understanding of dcd for clinical psychologists and psychotherapists across europe, particularly based on new insights stemming from the last decade of research. method: we provide a narrative review of articles published in the last decade on the topic of dcd, and relevant aspects to clinical psychologist, including lesser known aspects of dcd (e.g., executive functions, psychological consequences, and adult dcd). results: dcd is a highly prevalent, disruptive, and complex disorder, which should be investigated further in many areas (e.g., co-occurrence to adhd). existing evidence points toward a key role of executive functioning difficulties at all ages. most patients report secondary psychological problems, but little headway has been made in examining the effectiveness of psychotherapy for dcd. conclusions: insights and remaining research gaps are discussed. it is critical for psychologists and clinical researchers to raise awareness for dcd, take note of the growing literature, and foster continued interdisciplinary approaches to research and treatment of dcd. keywords dyspraxia, neurodevelopmental disorders, motor coordination, clinical practice, psychotherapy this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4165&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0002-1456-4515 https://orcid.org/0000-0003-0065-5966 https://orcid.org/0000-0001-9896-5158 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • awareness about developmental coordination disorder (dcd) is low among some european psychologists. • growing knowledge about dcd should be disseminated among psychotherapists. tanja1 is a 20-year-old female from germany who studies part time at university and has a part-time job as a store manager. she has noticed she takes much longer than her peers to type her papers, and she often struggles to pay attention to long lectures. when she was younger, she had trouble learning how to ride a bike, and struggled to grip her pencils correctly, however, she improved both skills during childhood. she has found that her struggles to pay attention and difficulties with typing are becoming problems at work, but her classmates and colleagues do not seem to notice she is struggling. as the demands of her job and studies increased, her difficulties have become extremely burdensome. therefore, tanja is seeking psychotherapy to manage her stress. at first glance, some clinicians may suspect the patient has attention-deficit/hyper­ activity disorder (adhd) based on the characteristic problems with sustained attention. however, she also exemplifies several hallmark symptoms of developmental coordi­ nation disorder (dcd). a correct diagnosis in tanja’s case could be critical because treatment for adhd may require different strategies (i.e., medication). considering the common misconceptions and lack of knowledge surrounding dcd, it is important clinicians treating complex cases like these are aware of the current clinical picture of dcd. key aspects of developmental coordination disorder dcd is a neurodevelopmental disorder with primary deficits in fine and gross motor coordination (american psychiatric association, 2013). the dsm-5 criteria for a dcd diagnosis include: (1) the acquisition and execution of motor skills and related coordi­ nation are below what is expected based on age, (2) the deficits of motor skill and coordination significantly interfere with daily life in the domains of self-care, scholastics, work, leisure, and play, (3) the symptoms began in childhood, and (4) the deficits cannot be better explained by any other condition (e.g., cerebral palsy or neurodegenerative disorder; american psychiatric association, 2013; see table 1). dcd has a profound impact on the lives of individuals suffering from the disorder. 1) this case is based on collective experiences of individuals with dcd, and is not based on any one real person. dcd: relevance to clinical psychologists 2 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ table 1 diagnostic criteria and examples of symptoms of dcd diagnostic manual / criteria practical example recommendations dsm 5: developmental coordination disorder (a) the acquisition and execution of motor skills and related coordination are below what is expected based on age the individual might have taken longer to learn to crawl, walk, ride a bike, write, kick a football, climb or descend stairs, etc. they might have also learned motor skills but struggle to execute them in a coordinated fashion. in children, the mabc-2 (henderson et al., 2007) can be used to objectively assess motor functions in comparison to same-aged peers (in a percentile score based on age-band). in adults, mabc-2 can be used loosely, a selfreport by the patient of novel motor experiences in adulthood might be considered, e.g., a new skill in the workplace or school: typing, driving. (b) the deficits of motor skill and coordination significantly interfere with daily life in the domains of self-care, scholastics, work, leisure, and play the individual might avoid socialization, or team sports, in fear of embarrassment for lack of coordination. screen for impact of motor skills on daily life, and other psychosocial factor (e.g., cooccurring anxiety, depression). (c) the symptoms began in childhood – if patient is an adult at the time of assessment, the adult dcd checklist (adc; kirby et al., 2010) section 1 can be used as a proxy for symptoms in childhood. (d) the deficits cannot be better explained by any other condition patient should not have cerebral palsy, huntington’s disease, acquired brain injury, difficulties related to surgery, etc. complete diagnostic history, including physical, mental, and genetic conditions, should be considered. icd-10: specific developmental disorder of motor function (f82) (1) a disorder with primary deficits of motor coordination as listed in dsm 5 criterion (a) above. as listed in dsm 5 criterion (a) above. (2) impairments in fine and gross motor coordination general difficulties might involve fine motor tasks such as trouble gripping objects, poor handwriting, challenges typing on a keyboard. difficulties might also involve gross motor functions, such as, trouble walking in a coordinated manner, frequently tripping over or bumping into objects, difficulties kicking or catching a ball. as listed in dsm 5 criterion (a) above. (3) not better explained by an intellectual disability or acquired neurological disorder patient should not have disorder of intellectual development, cerebral palsy, huntington’s disease, acquired brain injury, difficulties related to surgery, etc. as listed in dsm criterion (d) above. potential rationale for iq testing. note. the icd-11 “developmental motor coordination disorder” lists symptoms entirely in line with the dsm 5, adding that symptoms must begin in childhood. notably, the different name contradicts nomenclature stand­ ards set out by dcd experts (see blank et al., 2019) and the patient preferred name “dyspraxia.” diagnostic criteria are summarized from the latest guidelines of each diagnostic manual (dsm-5-tr; american psychiatric meachon, zemp, & alpers 3 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ association, 2022; icd-11; world health organization, 2020). in the new dsm-5-tr, dcd is listed under a further subcategory entitled “motor disorders. accumulating research highlights the psychological effects of dcd symptoms still re­ main unclear (e.g., kirby et al., 2013; tal saban & kirby, 2018; zwicker et al., 2018) and executive functioning differences may be present (e.g., bernardi et al., 2018; sartori et al., 2020). furthermore, there is a lack of established gold standard diagnostic procedure for adults with dcd despite increasing evidence that motor symptoms and psychosocial consequences continue into adulthood in most cases (purcell et al., 2015; tal saban & kirby, 2018). dcd is a common neurodevelopmental disorder, with a prevalence frequently cited as 5% (blank et al., 2019). despite this, dcd has received minimal attention in research, especially compared to other neurodevelopmental disorders (see figure 1; bishop, 2010). even child and adolescent psychiatrists have been reported to profess poor general knowledge of dcd (wilson et al., 2013). this alludes to a history of potentially overlook­ ing individuals with dcd. figure 1 publications with the term “developmental coordination disorder” in the title, abstract, or key words from 2000-2020 note. a) a total of k = 2,068 articles were retrieved from the search in web of science in june 2021. while many search topics have increased in research volume over the years, as a closer comparison, the search term “attention deficit hyperactivity disorder” returned k = 28,533 articles from the same time period with at least k = 1,000 per year from 2009 on, and k = 2,480 in 2020 alone; exceeding the number in one year for all dcd articles across 20 years. dcd: relevance to clinical psychologists 4 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ while the number of publications and citations for papers about dcd is still far behind comparable conditions (e.g., adhd), there has been a promising increase in publications over the last decade (see figure 1). in addition, international guidelines for most aspects of dcd were recently released for health care professionals of all fields (blank et al., 2019). the guidelines solidify that dcd is a unique condition to be recognized by psy­ chologists and offer important insights. therefore, in this narrative review, we (1) extend upon these guidelines to include an overview on the current state of lesser understood features of dcd (e.g., executive functions, co-occuring adhd, adult dcd), and (2) highlight available resources specifically for european psychologists (e.g., tools available in various european languages). we include recent insights with research primarily published in the last decade to provide an up-to-date overview of dcd. m e t h o d the present review is narrative in nature and included evidence from several systematic searches on the psycinfo and web of science databases in november 2020. search terms included “developmental coordination disorder,” “dyspraxia,” and “dcd” in all sections, and some subsections required separate extensive searches. for example, screening tools for dcd were searched by name (i.e., mabc-2; bot-2; dcd-q; adult developmental coordination disorders/dyspraxia checklist; aac-q). in order to find a comprehensive list of these tools in all european languages, additional searches were conducted on google scholar with the name of the language as an additional search term for each of the screening tools (see table 2). eligible records were those published between 2009-2020, which were reviews, expert consensus papers, empirical papers, and metaanalyses regarding dcd and relevant aspects to clinical psychology (e.g., psychosocial consequences; executive functions; dcd in adults). table 2 published and validated screening tools for developmental coordination disorder in european languages language motor screening tests questionnaires for children questionnaires for adults mabc-2 (ages 3 to 16) bot-2 (ages 4-21) dcd-q (ages 5-15) little dcd-q (ages 3-4) adc (ages 17 42) aac-q (ages 16-35) language relevant to europe czech psotta et al., 2012 n/a n/a n/a n/a n/a danish reported available by blank et al., 2019 n/a milidou et al., 2015 n/a n/a n/a meachon, zemp, & alpers 5 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ language motor screening tests questionnaires for children questionnaires for adults mabc-2 (ages 3 to 16) bot-2 (ages 4-21) dcd-q (ages 5-15) little dcd-q (ages 3-4) adc (ages 17 42) aac-q (ages 16-35) dutch schoemaker et al., 2012 n/a dcdq-nl; schoemaker et al., 2006 ldcdq-nl; cantell et al., 2019 n/a n/a english uk, henderson et al., 2007a usa, bruininks & bruininks, 2005a wilson et al., 2009a canadian, wilson et al., 2015 uk, kirby et al., 2010a tal saban et al., 2012a flemish n/a n/a n/a reported available by rihtman et al., 2015 l-dcd-q-vl moret et al., 2019 n/a n/a french marquet-doléac et al., 2016 n/a dcdq-fe: raykaeser et al., 2019 reported available by rihtman et al., 2015 n/a n/a german petermann, 2008 blank et al., 2014 dcdq-g; kennedy-behr et al., 2013 reported available by rihtman et al., 2015 meachon et al., 2022 n/a greek ellinoudis et al., 2011 n/a n/ab n/a n/a n/a italian zoia et al., 2019 n/a caravale et al., 2015 n/a n/a n/a maltese n/a n/a camilleri et al., 2020 n/a n/a n/a norwegian holm et al., 2013 n/a n/a n/a n/a n/a polish n/a n/a dcdq’07-pl; nowak, 2016 n/a n/a n/a slovenian reported available by blank et al., 2019 n/a tercon et al., 2015 reported available by rihtman et al., 2015 n/a n/a spanish age band 1: niñocruz et al., 2019 for 4-7 years old children: serrano-gómez & correabautista, 2015 salamanca et al., 2012 reported available by rihtman et al., 2015 n/a delgado-lobete et al., 2021 swedish reported available by blank et al., 2019 n/a iwar, 2015 n/a n/a n/a dcd: relevance to clinical psychologists 6 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ language motor screening tests questionnaires for children questionnaires for adults mabc-2 (ages 3 to 16) bot-2 (ages 4-21) dcd-q (ages 5-15) little dcd-q (ages 3-4) adc (ages 17 42) aac-q (ages 16-35) other relevant languages hebrew n/a n/a version 1: barilan traub et al., 2005 ldcd-q; rihtman et al., 2011a kirby et al., 2010a n/a portuguese (brazil) valentini et al., 2014; capistrano et al., 2015 okuda et al., 2019 prado et al., 2009 reported available by rihtman et al., 2015 n/a n/a turkish n/a n/a yildirim et al., 2019 n/a n/a n/a note. mabc-2: movement assessment battery for children 2nd edition; bot-2: bruininks-osteretsky test of motor proficiency; dcd-q: developmental coordination disorder questionnaire; adc: adult developmental coordination disorders/dyspraxia checklist; aac-q: adolescents and adults coordination questionnaire; n/a indicates tool is not yet available in the listed language. adenotes original version. blisted in dcdq administration manual, but not elsewhere. clinical presentation and secondary psychosocial consequences dcd has a lifetime prognosis with major symptoms including difficulties with planning and execution of fine motor (e.g., sketching) and gross motor coordination (e.g., riding a bicycle). as described in the dsm 5, individuals with dcd can appear to be generally clumsy, and often have delays in reaching motor milestones compared to their peers (american psychiatric association, 2013). examples of this can be very evident, such as having to spend longer than other children in learning how to hold a pencil, or subtler, such as having more trouble learning to play a musical instrument in school than other children. notably, research in the last decade has provided increasing evidence that symptoms of dcd extend beyond motor coordination. more specifically, impaired execu­ tive functions (i.e., inhibition, cognitive control, working memory, and related processes such as attention) can be recognized as a prominent feature of dcd (bernardi et al., 2018; leonard & hill, 2015; sartori et al., 2020). however, neither the dsm-5 nor the icd-11 consider these as potential symptoms of dcd (purcell et al., 2015; see table 1). furthermore, the specific symptom profiles and the extent to which executive function impairments in dcd can be attributed to co-occurring conditions (e.g., attention and inhibition difficulties typical to adhd) remains unclear (blank et al., 2019). a combination of executive functioning and motor coordination difficulties may re­ sult in a plethora of consequences and challenges for individuals with dcd in all stages of life. recent research has suggested core symptoms of dcd likely entail secondary psychological problems, such as decreased quality of life, lower self-esteem, impaired social relationships compared to typically developing peers (e.g., tal saban & kirby, meachon, zemp, & alpers 7 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ 2018; zwicker et al., 2018). internalizing symptoms in the form of secondary anxiety and depression may often occur as a consequence of dcd (draghi et al., 2020; kirby et al., 2013; mancini et al., 2019; omer et al., 2019; rigoli & piek, 2016), which should be of concern in psychotherapy. more research is needed to understand the specificity of these features as they are known in similar conditions (e.g., adhd). consequences of dcd also include a risk for obesity, cardiovascular problems, reduced fitness ability, and worse self-reported general health compared to typically developing peers (cairney et al., 2017; joshi et al., 2015; kirby et al., 2013). existing evidence of dcd prevalence and etiology despite the often stated dcd prevalence rate of 5% (blank et al., 2012; blank et al., 2019), prevalence in some in many countries is not clear. among existing estimates is that 1-19% of school-aged children in the uk suffer from dcd (zwicker et al., 2012), but more recent estimates are around 10% in samples from the us and 24% from brazil based on a study children in these regions (valentini et al., 2017). while the prevalence rate in adults is not known, dcd is estimated to persist into adulthood in 30-70% of cases (tal saban & kirby, 2018). in addition, a recent cross-sectional analysis of children in spain estimates the prevalence of high risk for dcd is about 12% (delgado-lobete et al., 2019). differences in prevalence estimates still vary greatly between existing studies, possibly due to a variance in identification of dcd. previous research has estimated that dcd occurs three to seven times more often in males than females (zwicker et al., 2012), with recent evidence of a more equal gender ratio in a brazilian sample (valentini et al., 2017). however, these gender differences are not necessarily universal, as some recent research has found a more equal ratio between gender in brazil (valentini et al., 2017). these gender differences may also be a consequence of bias in detection of symptoms or referral bias, as has occurred for similar neurodevelopmental disorders such as adhd (young et al., 2020). beyond gender differ­ ences, recent research found that left-handedness is nearly twice as prevalent among those with dcd as it is for typically developing controls (darvik et al., 2018). further research has yet to explore the underlying mechanisms in this phenomenon. relatively little is known about the causes of dcd. compelling evidence for a 70% heritability estimate for dcd was calculated with a population of swedish twin pairs (lichtenstein et al., 2010). low birth weight and premature birth are also predictors of dcd, particularly among males (spittle et al., 2021; zwicker et al., 2012). while little is known about risk factors for dcd aside from being male and preterm (van hoorn et al., 2021), some research on neurodevelopmental disorders in general suggests there may be additional links to family income in addition to low birthweight and premature birth (e.g., carlsson et al., 2021). dcd: relevance to clinical psychologists 8 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ dcd with co-occurring adhd or autism spectrum disorder among the various challenges in the diagnosis and detection of dcd are its co-occurring conditions (cleaton & kirby, 2018). for instance, dcd and attention-deficit/hyperactiv­ ity disorder (adhd) have a particularly high co-occurrence of about 50% (blank et al., 2019). given the symptomatic overlaps, including motor impairments in adhd (kaiser et al., 2015), and attention, inhibition, and hyperactivity sometimes observed in dcd (harrowell et al., 2018; wilson et al., 2020), some have speculated whether dcd might be a subtype of adhd. while concrete evidence for this assumption remains limited to date, more research speaks for a unique pathology in dcd (e.g., in the genetic pro­ file, pearsall-jones et al., 2009; physiological responding, goulardins et al., 2015; neural mechanisms, meachon et al., 2021). this has also been supported by findings for unique functional pathways in co-occurring dcd and adhd as opposed to just one disorder (mcleod et al., 2014). it is important that this co-occurrence receives more scientific attention in the future to identify not only the extent to which the clinical symptoms but also their endophenotypes overlap (e.g., conzelmann et al., 2009). this may help to prevent misdiagnosis, given the many similarities between dcd and adhd. one simple step researchers and clinicians can take to work toward this goal is to screen for dcd when working with patients who have adhd (lange, 2018), and vice versa. another common co-occurrence is autism spectrum disorder (asd; caçola et al., 2017). asd can be diagnosed as a co-occurring disorder of dcd since the dsm-5, and researchers are just beginning to explore the co-occurring diagnosis. unlike adhd, existing literature clearly supports that the difficulties sourcing from dcd or asd are unique (paquet et al., 2019). for example, a systematic review of dcd and asd behavio­ ral outcomes primarily found clear differences between dcd and asd (caçola et al., 2017). thus, it can be assumed that co-occurring cases of dcd and asd present a much more complex symptom profile than dcd or asd alone available screening tools for dcd in european languages in the screening and diagnostic process for dcd, the current best practice is to ensure all four major dsm-5 criteria for diagnosis are met. there are various tests and screening tools which european clinicians can use to identify if a diagnosis of dcd should be con­ sidered. the most common tools relevant to european psychologists will be highlighted in this section. motor skill assessment is crucial to establish meeting the first criterion for a dcd diagnosis in the dsm-5: that motor skills are below the expected development compared to same-age peers. while there are many tools which can be used to assess motor skills (see cancer et al., 2020 for an overview of other motor screening tools for children), two of the most common screening tools used to assess risk for dcd are the movement assessment battery for children (mabc-2; henderson et al., 2007) and the bruininks-oser­ meachon, zemp, & alpers 9 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ etsky test of motor proficiency (bot-2; bruininks & bruininks, 2005). the mabc-2 was developed in english to identify probable dcd in children aged 3 to 16, and is available in dutch (schoemaker et al., 2012), german (petermann, 2008), italian (zoia et al., 2019), greek (ellinoudis et al., 2011), norwegian (holm et al., 2013), and spanish (age band 1 validated by niño-cruz et al., 2019; see table 2). in addition, some researchers have reported using the mabc-2 but do not reference a validated translation or test of the psychometric properties of the reported language used (e.g., danish, slovenian, swedish; blank et al., 2019). the bot-2 was designed in english as a motor competency test for broader popula­ tions among children from 4 to young adults of 21 years old, and available in german (blank et al., 2014), and spanish (validated for 4-7 years old children by serrano-gómez and correa-bautista, 2015). the bot-2 can reportedly be used to diagnose individuals of any language group, because it uses motor-skill games independent of language (baharudin et al., 2020), however, its norms should be extended beyond what is now exclusively based on us norms. for example, recent research on the ecological validity of the german bot-2 showed it strongly relates to other relevant fine motor skills and some gross motor skills, however subtests for bilateral coordination and balance do not have clear ecological validity (e.g., to sports and bike riding) among german children (vinçon et al., 2017). notably, the concerns of translation (i.e., for the mabc-2 checklist) and norms is also prevalent with mabc-2, which was developed with uk samples. some slight differences were observed between british norms and those of other nationalities tested on the mabc-2, suggesting the consideration norms for motor tests be adapted to specific countries, even within europe (barnett, 2014; zoia et al., 2019). given the age cutoffs, caution should be taken in the interpretation of scores for adolescents and adults, and should not outweigh assessment of the other diagnostic criteria for dcd. there are several questionnaires which can be used to assess the second and third dsm-5 criterion regarding persistent interruptions of symptoms and presence of symp­ toms in childhood. for children, the developmental coordination disorder questionnaire is a popular parent-report measure of dcd symptoms developed in english (wilson et al., 2009). the dcd-q has been translated and validated into many languages spoken in europe (see table 2, including german, (dcdq-g; kennedy-behr et al., 2013), dutch (dcdq-nl; schoemaker et al., 2006), italian (caravale et al., 2015), spanish (salamanca et al., 2012), danish (milidou et al., 2015), and french-european (dcdq-fe: ray-kaeser et al., 2019). in addition, a version to indicate dcd in young children (ages 3-4) exists, known as the little developmental coordination disorder questionnaire developed in hebrew (ldcd-q; rihtman et al., 2011) and translated into english (ldcdq-ca; wilson et al., 2015) and dutch (ldcdq-nl; cantell et al., 2019). the ldcdq was also translated into many european languages (rihtman et al., 2015; see table 1), however validation studies to confirm these translations have not yet been published. notably, in adolescent populations, parents were less accurate in identifying motor competencies than their dcd: relevance to clinical psychologists 10 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ adolescent children’s self-reports (timler et al., 2018), but to our knowledge, there is no evidence if this is the same in children versus parent-reports. therefore, parent-reports should be used with caution in older children, and should be accompanied by in-depth assessment of the adolescents themselves. to gain better insight into the daily life interruptions in adulthood, the self-report adult developmental co-ordination disorders/dyspraxia checklist (adc) was developed and validated in english and hebrew to detect probable cases of dcd in individuals 16 years and older (kirby et al., 2010). the adc was also recently translated into german (meachon et al., 2022) and reevaluated for potential to screen for motor and executive functioning parameters of dcd (meachon et al., 2022). in addition to the adc, tal saban et al. (2012) developed the adolescents and adults coordination questionnaire (aac-q) as a shorter-form self-report tool to screen for dcd compared to the adc. the aac-q was developed in english (tal saban et al., 2012) and recently translated into spanish (delgado-lobete et al., 2021). while retrospective diagnosis of dcd in adulthood is certainly possible, it must be on the premise that symptom experiences began in childhood. there is currently no gold standard motor assessment tool for screening in adults. in accordance with the final criterion of the dsm-5 for dcd, causes of clumsiness or differences in gait from other medical conditions or brain injury must be ruled out. con­ trary to the exclusion criteria of intellectual disorders listed in the dsm-5 and icd-10 (dsm-5; american psychiatric association, 2013; icd-10; world health organization, 2016), children with dcd may score lower than average on some or all domains of iq tests due to interruptions in motor processing and perception (jaščenoka & petermann, 2018). recent consensus established that iq score cutoffs should not prevent the diagno­ sis of dcd (blank et al., 2019). more research is needed to conclude if this is consistent across the development and into adulthood. dcd in adolescents and adults most of the existing research on dcd examines populations of affected children rather than adolescents and adults, even though a majority of adults with dcd continue to experience symptom-related difficulties in their daily lives (tal saban & kirby, 2018). this mirrors a pattern observed in adhd research, which primarily focuses on child and adolescent populations (targum & adler, 2014). the history of overlooking adult populations could be for strictly following diagnostic criteria for dcd (i.e., it must begin in childhood; american psychiatric association, 2013). other possibilities might include (1) the lack of assessment tools for adults, (2) the complex phenotype in adulthood (e.g., co-occurring conditions, symptom progression), and (3) the heterogeneous compensatory strategies adults develop to deal with their motor constraints. concerning the latter, compensatory strategies may mask symptoms for simple motor tasks (e.g., hand rotation meachon, zemp, & alpers 11 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ task; wilmut, 2017). this should be carefully considered in the diagnostic process for dcd, especially for adults with dcd who were not diagnosed in childhood. adults with dcd often struggle with difficulties in psychosocial domains, executive functioning, physical fitness, time management, and organization (e.g., kirby et al., 2013; kirby et al., 2011; tal saban & kirby, 2018). in general, underlying mechanisms of dcd are not likely change across the lifespan, however the context, experience of the individual, and compensation may change. for example, motor challenges and difficulty with distance estimation may manifest in adulthood as problems in learning to drive or even crossing the road compared to typical adults (kirby et al., 2010; wilmut & purcell, 2020). while the most relevant dcd symptoms for adults may vary interindividually, symptoms that are less easily detected or treated could become more problematic in adulthood. for example, executive functioning challenges were among the most com­ monly reported daily concerns for adults with suspected dcd (purcell et al., 2015), a concern that might not be addressed in traditional physical training to treat symptoms of dcd. there are also relationships between dcd and increased cognitive difficulties, fati­ gue, and somatic symptoms compared to a control group, albeit findings are based on cross-sectional data (thomas & christopher, 2018). because of the considerable overlaps between dcd and adhd that can also be present in adulthood, future research should work toward identifying the specific symptom profiles of dcd and adhd. despite considerable research gaps on adult populations with dcd, some recent research has investigated dcd in emerging adults between the ages of 16 to 25 (e.g., kirby et al., 2011). this group may still be dependent on their parents but are working toward independence and identity exploration (tal saban & kirby, 2018). due to the major life changes this age group commonly faces, it may be at risk for experiencing heightened difficulty in coping with dcd symptoms, and should be examined more in future research. multidisciplinary interventions for dcd there are several training programs frequently utilized for treating specific motor features of dcd used by occupational and physical therapists such as cognitive ori­ entation to daily occupational performance (co-op) and neuromotor task training (smits-engelsman, 2013; smits-engelsman et al., 2018). co-op and ntt are activity or task-oriented approaches which specifically target physical fitness and motor task-per­ formance (montgomery et al., 2018) and are historically effective for treating children with dcd (polatajko & mandich, 2004). these trainings, along with any other existing treatment, are not intended to cure dcd, and can substantially help the patient improve specific motor skills. however, the increasing evidence that dcd is more than just a disorder of motor functions qualifies that more psychological interventions should be comprehensively investigated (tamplain & miller, 2021). it is possible that psychological dcd: relevance to clinical psychologists 12 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ support may be equally important as physical treatment for some patients with dcd. this is especially relevant to reduce any risk for potential secondary psychosocial conse­ quences such as depression or anxiety (kirby et al., 2013). presently, an interdisciplinary approach along with occupational therapists and phys­ iotherapists (e.g., typical treatment: co-op; ntt for training specific motor skills) is recommended for effective intervention with dcd (blank et al., 2019; montgomery et al., 2018). it is also important that specific difficulties to the individual and the goals of the patient are considered in treatment, as this has led to reduced anxiety compared to preset large-group interventions in children (caçola et al., 2016). for example, one individual might find it most pertinent to practice typing on a keyboard for work or school, while another might want to reduce their anxiety participating in group sports. the role of motor concerns may be direct or indirect in treatment, but regardless, the patient’s preferences should determine the approach and prioritization of goals in their treatment plan. a recent review and meta-analysis of motor-based interventions for dcd also suggests that effective interventions are personalized for the patient and their specific goals, contexts, active involvement, functionality and support from peers (smits-engelsman et al., 2018). in sum, tailor-made treatments have potential to improve both motor and psychological outcomes, and psychological interventions for secondary problems and psychological consequences of dcd should be examined in great detail future research. d i s c u s s i o n returning to the case of tanja, it is now clear the patient should be assessed for dcd, with consideration of potential co-occurring adhd. it is important in her case, to identify if her attentional difficulties are linked to motor activity, in which case she may just have dcd. in psychotherapy, screening for secondary anxiety and depression and working on stress-management would be important for immediate action. a psycho­ therapist should also consider referrals to a physical or occupational therapist to work on specific motor skills training relevant to her work and school activities (e.g., practicing typing). with a collaborative and patient-focused approach, there is hope for tanja to feel substantially less burdened by her motor and attentional difficulties. taken together, the recent research on dcd highlights several key areas of consid­ eration for clinical psychologists in europe. first, dcd is a complex disorder with motor-based symptoms, several probable secondary symptoms and psychological conse­ quences (e.g., executive functions; anxiety; depression). these secondary impairments of dcd should continue to be examined systematically in all age groups, and with the consideration of co-occurring disorders. more specifically, the prevalence of dcd should be examined more thoroughly across europe in adults and children to identify a more accurate prevalence rate that may exceed the presumed international rate of 5% (e.g., meachon, zemp, & alpers 13 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ delgado-lobete et al., 2019). this research may function in parallel with the necessary validation of dcd screening tools in additional languages. future research should also aim to identify if prevalence differs across genders, as well as the consistency of other links such as left-handedness (darvik et al., 2018) and links to motor integration. second, more attention should be devoted to the co-occurrences with dcd, especially between dcd and adhd. while some research has identified important differences between the two disorders (e.g., goulardins et al., 2015), there is still ambiguity in the extent to which symptoms overlap and how this might impact co-occurrence rates. it has been suggested that one way to increase detection of dcd could be to screen for it in all potential adhd cases, considering their high co-occurrence rate (lange, 2018). moreover, screening for dcd when at least one other neurodevelopmental condition is clearly present, especially adhd, should be consistently practiced. future research should also identify unique symptomatic profiles of dcd and adhd, and researchers examining dcd or adhd should consistently screen for the other disorder. third, additional attention should be given to the emerging adult and adult popula­ tions with dcd in research and practice. while it is possible to diagnose dcd in adults, there are few tools that can be used for the diagnostic process. furthermore, while there is evidence of psychosocial problems in adulthood (kirby et al., 2013) there is no research to explore the effects of psychotherapy among adults. while it is thought that the same core motor symptoms generally cross into adulthood (e.g., kirby et al., 2010; kirby et al., 2011), along with potential secondary psychological concerns (e.g., depression, anxiety; kirby et al., 2013), there is a paucity of evidence on the manifestation of these difficulties in new contexts (e.g., transitioning to news schools or jobs). future research should continue to build the evidence for symptom profiles and screening tools for adults, and more specifically, psychological interventions should be examined for effectiveness in all age groups. finally, evidence-based treatments for the primary symptoms and secondary prob­ lems are crucial to foster the improvement in quality of life for dcd patients. there is increasing evidence that the psychosocial sequelae of dcd can be addressed with elements of psychotherapy adjunct to motor therapies. thus, treatment should be collab­ oratively tailored toward the individual needs of each patient (e.g., smits-engelsman et al., 2018). it may also be worth considering if other therapies may be relevant to the treatment of dcd, such as a familial approach in treatment that is often used for adhd (weyers et al., 2019). future research should include a broader examination of the family and social system in the impact and treatment of dcd. conclusion overall, there are existing research gaps in the understanding of dcd, however, a recent increase in international attention to the condition is promising. we deem it relevant that more european psychological researchers and practitioners take note of this upsurge dcd: relevance to clinical psychologists 14 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ and integrate motor skill screenings into their work where possible. such inclusion is pertinent for more accurate symptom profiles, prevalence estimates, improved differen­ tial diagnosis, and effective treatment of the symptoms of dcd across all age groups. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @emeachon r e f e r e n c e s american psychiatric association. 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(2018). developmental coordination disorder is more than a motor problem: children describe the impact of daily struggles on their quality of life. british journal of occupational therapy, 81(2), 65–73. https://doi.org/10.1177/0308022617735046 meachon, zemp, & alpers 23 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://doi.org/10.1080/01942630902784761 https://doi.org/10.3109/01942638.2014.980928 https://doi.org/10.1111/j.1365-2214.2012.01403.x https://doi.org/10.1111/dmcn.14646 https://icd.who.int/browse10/2016/en https://icd.who.int/ https://doi.org/10.1177/0031512518809161 https://doi.org/10.1186/s12888-020-02707-9 https://doi.org/10.1016/j.ridd.2018.04.013 https://doi.org/10.1016/j.ejpn.2012.05.005 https://doi.org/10.1177/0308022617735046 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. dcd: relevance to clinical psychologists 24 clinical psychology in europe 2022, vol. 4(2), article e4165 https://doi.org/10.32872/cpe.4165 https://www.psychopen.eu/ dcd: relevance to clinical psychologists (introduction) key aspects of developmental coordination disorder method clinical presentation and secondary psychosocial consequences existing evidence of dcd prevalence and etiology dcd with co-occurring adhd or autism spectrum disorder available screening tools for dcd in european languages dcd in adolescents and adults multidisciplinary interventions for dcd discussion conclusion (additional information) funding acknowledgments competing interests twitter accounts references symptom perceptions in functional disorders, major health conditions, and healthy controls: a general population study research articles symptom perceptions in functional disorders, major health conditions, and healthy controls: a general population study angelika weigel 1,2 , thomas meinertz dantoft 3 , torben jørgensen 3,4,5 , tina carstensen 2,6 , bernd löwe 1 , john weinman 7 , lisbeth frostholm 2,6 [1] department of psychosomatic medicine and psychotherapy, university medical center hamburg-eppendorf, hamburg, germany. [2] the research clinic for functional disorders and psychosomatics, aarhus university hospital, aarhus, denmark. [3] center for clinical research and prevention, bispebjerg and frederiksberg hospital, capital region of denmark, denmark. [4] department of public health, faculty of medical sciences, university of copenhagen, copenhagen, denmark. [5] faculty of medicine, aalborg university, aalborg, denmark. [6] department of clinical medicine, aarhus university, aarhus, denmark. [7] school of cancer & pharmaceutical sciences, king's college london, london, united kingdom. clinical psychology in europe, 2022, vol. 4(4), article e7739, https://doi.org/10.32872/cpe.7739 received: 2021-10-28 • accepted: 2022-08-14 • published (vor): 2022-12-22 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: angelika weigel, university medical center hamburg-eppendorf, department of psychosomatic medicine and psychotherapy, martinistr. 52, 20246, hamburg, germany. phone: 0049 40 7410 52996. email: a.weigel@uke.de abstract background: the present study investigated differences in symptom perceptions between individuals with functional disorders (fd), major health conditions, and fds + major health conditions, respectively, and a group of healthy individuals. furthermore, it investigated the relevance of fds among other health-related and psychological correlates of symptom perceptions in the framework of the common sense model of self-regulation (cms). method: this cross-sectional study used epidemiological data from the danish study of functional disorders part two (n = 7,459 participants, 54% female, 51.99 ± 13.4 years). symptom perceptions were assessed using the brief illness perception questionnaire (b-ipq) and compared between the four health condition groups. multiple regression analyses were performed to examine associations between symptom perceptions, fds, and other health-related and psychological correlates from the cms framework. results: individuals with fds (n = 976) and those with fds + major health conditions (n = 162) reported less favorable symptom perceptions compared to the other two groups, particularly this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7739&domain=pdf&date_stamp=2022-12-22 https://orcid.org/0000-0001-6820-8316 https://orcid.org/0000-0001-7437-7052 https://orcid.org/0000-0001-9453-2830 https://orcid.org/0000-0001-5086-4331 https://orcid.org/0000-0003-4220-3378 https://orcid.org/0000-0002-6786-0166 https://orcid.org/0000-0002-9683-7416 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ regarding perceived consequences, timeline, and emotional representations (effect size range cohen’s d = 0.12-0.66). the presence of a fd was significantly associated with all b-ipq items, even in the context of 16 other relevant health-related and psychological correlates from the cms framework, whereas symptom presence last year or last week was not. conclusion: in the general population, symptom perceptions seem to play a more salient role in fd than in individuals with well-defined physical illness. symptom perceptions should therefore be targeted in both primary and secondary interventions for fds. keywords symptom perceptions, functional disorders, epidemiological study, quality of life, common-sense model of illness, personality traits highlights • symptom perceptions were poorest in individuals with functional disorders with and without co-occuring major health conditions. • functional disorders in oneself and in the family were associated with symptom perceptions. • symptom presence last year or last week was not associated with symptom perceptions. experiencing physical symptoms is a common everyday phenomenon in the general population (hinz et al., 2017). their perception and appraisal are results of multidimen­ sional processes that go beyond a recognition of peripheral bodily changes (petersen et al., 2011). in major health conditions (e.g., cancer, heart attack), the relationship between peripheral bodily dysfunctions and self-reported symptoms is weaker in chronic multisymptomatic than in acute monosymptomatic diseases (janssens et al., 2011). in functional disorders, i.e., bothersome physical conditions that are not better explained by physical diseases or mental disorders and are associated with reduced health-related quality of life, evidence suggests a weaker relation between physical parameters (e.g., respiratory changes after gradually increased ventilation) and symptom perceptions (e.g., perceived dyspnea) compared to healthy controls (bogaerts et al., 2010). these varying associations between peripheral bodily changes and symptom perceptions underline the relevance of cognitive and emotional processes in symptom perception and appraisal (van den bergh et al., 2017). symptom perceptions describe dynamic mental representations and personal ideas that individuals generate to make sense of and respond to their symptoms (broadbent et al., 2015). among numerous empirically tested theoretical models of symptom perception and appraisal (whitaker et al., 2015), the common-sense model of self regulation is particularly established (csm; leventhal et al., 2016). according to the csm, individuals’ mental models of experienced symptoms include cognitive representations of the symp­ symptom perceptions in functional disorders 2 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ tom identity (lay diagnosis), the coherence and the perceived timeline, the control over and consequences of the experienced symptoms as well as emotional representations of symptom concerns and emotional reactions. symptom perceptions thereby directly affect the coping efforts that may be more or less beneficial. individuals then appraise the effects of these coping efforts, which may result in changes to their cognitive representa­ tions and emotional responses in a feedback loop. however, while healthy individuals can form their symptom perceptions based on their experience that symptoms are usual­ ly non-threatening and short-lived everyday phenomena and individuals with chronic diseases usually receive a biomedical explanation of their symptoms and a diagnostic label with an associated treatment rational, individuals with functional disorders lack these aspects. instead, individuals with functional disorders are often confronted with inconclusive medical findings and receive no diagnostic label or external information about the possible course of the disease, which might negatively influence their symptom perceptions. symptom perceptions have an impact on health outcomes in both mental and somatic disorders (dempster et al., 2015; hagger et al., 2017). for example, one methodologically rigorous study that investigated illness perceptions in a primary healthcare sample with diverse new health complaints provided evidence for the impact of symptom perceptions on quality of life (frostholm et al., 2007). furthermore, there is a large body of litera­ ture on the influence of symptom perceptions in clearly defined medical conditions on various health outcomes (aalto et al., 2006; de gucht, 2015; o’donovan et al., 2016; tiemensma et al., 2016; timmers et al., 2008; tribbick et al., 2017; van erp et al., 2017; xiong et al., 2018). despite valuable insights into the relevance of symptom perceptions on health outcomes, previous studies have rarely investigated symptom perceptions in individuals with functional disorders with potential co-occuring medical conditions. research into this area is crucial as suggested by a dutch epidemiological study showing that the functional impairments associated with functional disorders are similar in se­ verity to those in major health conditions (joustra et al., 2015). in addition, more negative symptom perceptions have been observed in individuals with functional gastrointestinal disorders compared with patients with peptic ulcer or reflux esophagitis (xiong et al., 2018) and functional disorders might co-occur with medical conditions (halpin & ford, 2012). according to the csm, a number of contextual, health-related, and psychological fac­ tors may influence the formation of symptom perceptions. a recent systematic review on so-called modifiable correlates of symptom perceptions observed an association between higher symptom severity and less favorable symptom perceptions in different somatic conditions (arat et al., 2018). the same review highlighted a negative influence of de­ pression and anxiety on symptom perceptions, with the limitation that no differentiation was made between lifetime mental disorders and the current presence of symptoms. only few studies have considered other mental comorbidities than depression and anxi­ weigel, meinertz dantoft, jørgensen et al. 3 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ ety. two studies investigated the influence of post-traumatic stress disorder (ptsd) on symptom perceptions in patients with a myocardial infarction and observed significantly less favorable symptom perceptions in patients with ptsd symptomatology compared with those without (princip et al., 2018; sheldrick et al., 2006). in contrast, many studies have investigated coping and symptom perceptions. a meta-analysis by dempster and colleagues concluded that symptom perceptions and coping explain a valuable amount of variance in distress outcomes across a range of physical health conditions (dempster et al., 2015). one cross-sectional study investigated the association between type d personality and illness perceptions in colorectal cancer survivors and observed significantly less favorable symptom perceptions in those with high type d personality traits (mols et al., 2012). however, the concept of type d personality has been criticized in favor of the big five personality traits (neuroticism, extraversion, openness, agreeableness, conscientiousness; horwood & anglim, 2017). furthermore, there is evidence that per­ sonality traits are more relevant to symptom perceptions than current illness severity (goetzmann et al., 2005), and that symptom perceptions at least partially mediate the association between personality traits and coping (rassart et al., 2014). within this body of literature on correlates of symptom perceptions in the framework of the cms, the possible influence of functional disorders in a patient or his/her significant others has not yet been investigated. knowledge of symptom perceptions within the csm framework from a large repre­ sentative general population sample can help shed light on the possible differences in symptom perceptions in functional disorders and somatic diseases, respectively. such an investigation would increase the evidence base for the current theoretical understanding of the role of specific symptom perceptions in functional disorders. furthermore, it may pave the way for the identification of intervention components to improve symptom management and improve health outcomes as has been shown in patients with myocar­ dial infarction (petrie et al., 2002) and severe functional disorders (christensen et al., 2015). the first aim of the present epidemiological study was to compare symptom per­ ceptions in healthy individuals and individuals with either functional disorders, major health conditions or both. we hypothesized that there would be differences between the four health condition groups, with particularly less favorable symptom perceptions in individuals with functional disorders. the second aim was to examine whether the presence of a functional disorder in a participant or his/her significant others would explain meaningful variance in symptom perceptions besides a large number of other possible correlates of symptom perceptions from the cms framework by means of an exploratory approach. symptom perceptions in functional disorders 4 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ m e t h o d study population data collection took place in the context of the “danish study of functional disorders” (danfund; dantoft et al., 2017). the complete danfund sample comprises a random sample of 9,656 participants aged between 18-76 years from the danish general popula­ tion living in the western part of greater copenhagen (participation rate 33.7%). recruit­ ment occurred in two cross-sectional waves with the same eligibility criteria: danfund part one from 2011 to 2012 (2,308 participants) and danfund part two from 2012 to 2015 (7,493 participants). all danfund participants completed a general health examination and a self-report questionnaire battery at the research centre for prevention and health, glostrup, denmark. the danfund part two self-report questionnaire battery included a questionnaire on symptom perceptions, and this cohort was therefore eligible for the present study. all participants gave their written informed consent prior to study participation. the study was approved by the ethical committee of copenhagen country (ka-2006-0011, h-3-2011-081, h-3-2012). measures symptom perceptions the danish version of the b-ipq was applied to assess symptom perceptions with eight numerous rating scales (range 1–10, for item wording see table 2, broadbent et al., 2006). the b-ipq uses a single-item scaling to measure symptom perceptions based on the csm with five items related to cognitive perceptions, two items to emotional aspects and one item to the understanding of an illness. participants were instructed only to fill out the b-ipq items if they had experienced symptoms during the last year according to the bds checklist (see below) or the last week (scl-90 somatization subscale). as symptom perceptions were assessed with respect to physical symptoms and not to a certain illness, the b-ipq item assessing illness identity was removed. items assessing personal control, treatment control and coherence were reversed to facilitate interpretation, i.e., that higher scores indicate less control and less coherence. four health condition groups the questionnaire set comprised a predefined 22-item list that covered diagnosed major health conditions, functional disorders and mental health disorders that were categorical­ ly answered (yes/no) to the question “has a doctor ever told you that you have/had…”. participants were asked to answer this 22-item list with regard to themselves and each family member (i.e., fathers, mothers, siblings). within this list, cancer, heart attack and thrombosis or embolism in the brain were operationalized as major health conditions. fibromyalgia, chronic fatigue, irritable bowel syndrome, whiplash syndrome, and multi­ weigel, meinertz dantoft, jørgensen et al. 5 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ ple chemical sensitivity were operationalized as functional disorders. lifetime depression and anxiety were operationalized as mental disorders. of note, the list did not include questions on mental disorders in the family. in each case, a major health condition, functional disorder, or mental disorder was evaluated as being present either in the patient or in the family if one of the respective items was answered positively. the four health condition groups were: functional disorders, major health conditions, functional disorders and major health conditions, and healthy (i.e., no major health condition or functional disorder). perceived symptoms the bodily distress syndrome (bds) checklist (budtz-lilly et al., 2015) uses a likert-scale to assess 25 symptoms related to the cardiopulmonary, gastrointestinal, musculoskaletal and general symptom clusters of the diagnostic concept of the bodily distress syndrome. the danish version of the bds checklist was applied to assess the presence of physical symptoms during the last year. as we focussed on the number of symptoms during the last year rather than the burden of each symptom, answers were dichotomized (0 = not at all; 1 = little to a lot) and summed up with higher values indicating a higher number of symptoms (range 0-32). likewise, physical symptoms during the last week were operationalized through the 12-item sum score of the scl-90 somatization subscale (range 0-12, cronbach’s alpha in this sample = 0.80; olsen et al., 2004). psychological factors current symptoms of depression and anxiety were assessed using the 8-item sum score of the scl-90 mental distress subscale (range 0-24, cronbach’s alpha in this sample = 0.87; fink et al., 2004). personality traits were operationalized based on the neo-five factor inventory that assesses the personality traits neuroticism, extraversion, agreeableness, openness, and conscientiousness through 60 likert-scaled items (subscale range 0-48 points; körner et al., 2002). the number of adverse life events was operationalized through the cumulative life­ time adversity measure (range 0-37, additional item to mention specific life adversaries). the questionnaire asks respondents whether they ever experienced one or more of 37 different negative life events (carstensen et al., 2020). the 10-item perceived stress scale with a likert-scaled answering format was used to assess current stress (sum score range 0-40 points, cronbach’s alpha in this sample = 0.87; cohen et al., 1983). the 10-item general self-efficacy scale with a likert-scaled answering format was applied to assess coping abilities (sum score range 0-30 points, cronbach’s alpha in this sample = 0.91; luszczynska et al., 2005). symptom perceptions in functional disorders 6 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ self-perceived health one likert-scaled item of the 12-item short form health survey (ware et al., 1996) was applied to assess self-perceived health as an indicator of health related quality of life. objective health measures body mass index (bmi = kg/m2) and waist-to-hip ratio were obtained. sociodemographic aspects age, sex and years of school education (≤10 years = “elementary school education” >10 years = “beyond elementary school education”) were included. statistical analyses participants with a minimum of four answered b-ipq items (i.e., completers) and those with zero to three answered items were compared with regard to sex, age, marital status, and school education to identify potential selection biases. the four health condition groups were compared with regard to sociodemographic and clinical characteristics us­ ing χ2-tests for categorical (sex, marital status, school education) and anova for metric variables (age, bmi, waist-to-hip ratio, self-perceived health). first study aim: b-ipq items were compared between each of the four health con­ dition groups applying an ancova with age and sex as covariates and bonferroni corrected post hoc tests. adjusted means, standard errors (se) and in case of significant differences effect sizes (cohen’s d) are reported. second study aim: seven multiple regression analyses with each including a total of 18 independent variables were applied to examine associations between the b-ipq items and functional disorders (own; in the family) as well as other health-related (own major health condition or in the family, symptom presence in the last year and the last week) and psychological correlates of symptom perceptions (own mental disorder, mental dis­ tress, perceived stress, coping ability, number of adverse life events, personality traits) and sociodemographic variables (i.e., sex, age,) in the framework of the cms. b-ipq items were log10 transformed due to skewness and linearity. no imputation procedure was applied on the study variables and the maximum avail­ able information was used in each analysis. ibm spss version 25 (spss inc., chicago, il, usa) was used for all analyses. the significance level was set at p < .05 with adjustments in case of multiple testing. r e s u l t s among the 7,459 participants, 7% affirmed on the predefined list that a doctor told them they had cancer, 2% a heart attack and 2% thrombosis or embolism in the brain. further weigel, meinertz dantoft, jørgensen et al. 7 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ 1% affirmed to have been told to have fibromyalgia, 1% chronic fatigue, 12% irritable bowel syndrome, 3% whiplash syndrome, and 2% multiple chemical sensitivity. sociode­ mographic and clinical characteristics differed significantly between healthy individuals and the other three health condition groups with regard to age, sex, marital status, bmi, and waist-to-hip ratio (see table 1). within this total sample, 2,135 did not answer any b-ipq items (84% healthy individuals, 9% major health conditions, 6% functional disorders, 1% both). an additional 107 answered one to three (76%, 10%, 6%, 3%,) and 5,217 participants answered ≥4 b-ipq items (71% of the cohort). table 1 sample characteristics of participants from the danfund part two study sample variable healthy n = 5524 major health condition n = 601 functional disorder n = 976 major health condition + functional disorder n = 162 statistics sex % (n) female 51 (2821) 52 (311) 69 (672) 67 (108) χ2 = 117.377, p < .001 age m (sd) 50.49 (13.50) 59.94 (9.19) 53.29 (12.68) 60.21 (8.37) f = 125.064, p < .001 marital status % (n) married 64 (3544) 72 (429) 66 (639) 67 (109) χ2 = 95.259, p < .001 school education % (n) > 10 years 56 (2972) 52 (303) 53 (496) 50 (80) χ2 = 9.103, p = .028 body mass index m (sd) 25.84 (4.53) 27.15 (4.57) 26.30 (5.06) 27.08 (4.60) f = 18.726, p < .001 waist-to-hip ratio m (sd) 0.88 (0.09) 0.91 (0.10) 0.87 (0.09) 0.90 (0.09) f = 22.888, p < .001 self-perceived healtha m (sd) 2.39 (0.76) 2.76 (0.80) 2.86 (0.83) 3.17 (0.79) f = 166.024, p < .001 note. m = mean; se = standard deviation; cancer, heart attack and thrombosis or embolism in the brain were operationalized as major health conditions from a predefined list of 22 diseases; fibromyalgia, chronic fatigue, irritable bowel syndrome, whiplash syndrome, and multiple chemical sensitivity were operationalized as functional disorders from the same list of diseases. aincreasing scores equal a worse self-perceived health. symptom perceptions in functional disorders 8 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ aim 1: comparison of symptom perceptions in the four health condition groups all health condition groups differed significantly from each other with regard to the b-ipq subscale items when controlling for age and sex (see figure 1, table 2 and appen­ dix). participants with major health conditions reported significantly less favorable consequences (cohen’s d = 0.20) and emotional representations (cohen’s d = 0.17) than healthy participants. participants with major health conditions also reported significant­ ly more favorable consequences (cohen’s d = 0.32), timeline (cohen’s d = 0.27), symptom concern (cohen’s d = 0.31), and emotional representations (cohen’s d = 0.45) as well as significantly less favorable treatment control (cohen’s d = 0.27) than participants with functional disorders. with the exception of treatment control, a similar picture occurred between participants with major health conditions and those with functional disorders and major health conditions (cohen’s d range = 0.30–0.37). figure 1 mean comparisons of symptom perceptions as assessed with the b-ipq in the four health condition groups adjusted for age and sex * * * * * * * * * * * * * * * * healthy major health conditions functional disorders major health conditions + functional disorders * * * * * note. x-axis = items of the brief illness perception questionnaire (b-ipq), y-axis = visual analog scale, range of 0-10. * = significant group difference. error bars represent standard errors. cancer, heart attack, and thrombosis or embolism in the brain were operationalized as major health conditions from a predefined list of 22 diseases; fibromyalgia, chronic fatigue, irritable bowel syndrome, whiplash syndrome, and multiple chemical sensitivity were operationalized as functional disorders from the same list of diseases. weigel, meinertz dantoft, jørgensen et al. 9 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ table 2 symptom perceptions as assessed with the b-ipq in four health condition groups adjusted for age and sex b-ipq item healthy n = 5524 major health conditions n = 601 functional disorders n = 976 major health condition + functional disorders n = 162 statistics consequences m (se) how much do your symptoms affect your life? 2.79 (0.03) 3.24 (0.10) 3.90 (0.07) 3.99 (0.17) f = 77.670, df = 3, p < .001 timeline m (se) how long do you think your symptoms will last? 5.13 (0.06) 5.64 (0.17) 6.64 (0.12) 6.89 (0.29) f = 50.959, df = 3, p < .001 personal controla m (se) how much control do you feel you have over your symptoms? 4.62 (0.05) 4.84 (0.15) 5.34 (0.10) 5.08 (0.25) f = 13.872, df = 3, p < .001 treatment controla m (se) how much do you think your treatment can help your symptoms? 5.50 (0.05) 5.80 (0.16) 4.95 (0.11) 5.18 (0.27) f = 10.959, df = 3, p < .001 symptom concern m (se) how concerned are you about your symptoms? 3.20 (0.04) 3.40 (0.12) 4.13 (0.08) 4.18 (0.20) f = 40.059, df = 3, p < .001 coherencea m (se) how well do you feel you understand your symptoms? 3.66 (0.04) 3.71 (0.13) 4.13 (0.09) 4.06 (0.23) f = 7.687, df = 3, p < .001 emotional representations m (se) how much do your symptoms affect your emotionally? (e.g. make you angry, scared, upset or depressed) 2.81 (0.04) 3.31 (0.12) 3.95 (0.08) 4.34 (0.20) f = 69.459, df = 3, p < .001 note. b-ipq = brief illness perception questionnaire; item wordings are in italics. m = mean; se = standard error. cancer, heart attack and thrombosis or embolism in the brain were operationalized as major health conditions from a predefined list of 22 diseases; fibromyalgia, chronic fatigue, irritable bowel syndrome, whiplash syndrome, and multiple chemical sensitivity were operationalized as functional disorders from the same list of diseases. areversed item, age groups comprise missing values. participants with functional disorders reported significantly less favorable symptom perceptions than healthy individuals on all but one b-ipq subscales (cohen’s d range = symptom perceptions in functional disorders 10 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ 0.16–0.56), i.e., treatment control was significantly more favorable in participants with functional disorders. participants with functional disorders and major health con­ ditions reported significantly less favorable consequences (cohen’s d = 0.32), timeline (cohen’s d = 0.58), symptom concern (cohen’s d = 0.42) and emotional representations (co­ hen’s d = 0.66) compared to healthy participants. notably, participants with functional disorders and those with both major health conditions and functional disorders reported comparable b-ipq subscale item scores. aim 2: correlation between functional disorders in oneself and significant others and symptom perceptions in the context of other possible correlates from the cms framework there was no evidence of multi-collinearity as assessed by tolerance values greater than 0.1 and vif between 1.056 and 3.298. there was indepence of residuals as indicated by durbin-watson values between 1.958 and 2.041. the assumption of normality was met as assessed by q-q plots. higher, i.e., more negative, perceived consequences were significantly associated with own and family functional disorders, own major health conditions, mental disorders, higher mental distress and perceived stress, and more adverse life events (for regression coefficients, standard errors, 95% confidence intervals and model summary, see table 3). higher, i.e., more negative, perceived timeline was significantly associated with own and family functional disorders, own major health conditions, higher levels of mental distress, more adverse life events, and lower levels of extraversion. higher, i.e. less, perceived personal control was significantly associated with own functional disorders, higher levels of mental distress, and perceived stress as well as a lower coping ability, lower levels of conscientiousness, and female sex. higher, i.e. less, perceived treatment control was significantly associated with, own functional disorders, the absence of functional disorders in the family, lower levels of extraversion and agreeableness, and younger age. higher, i.e. more negative, perceived symptom concerns were significantly associated with own and family functional disorders, higher mental distress and perceived stress and female sex. higher, i.e. less, coherence was significantly associated with own functional disorders, the absence of a mental disorder, higher levels of mental distress and perceived stress as well as a lower coping ability, higher levels of neuroticisms and lower levels of openness and agreeableness, younger age and female sex. higher, i.e. more negative, emotional representations were significantly associated with own and family functional disorders and major health conditions, mental disorders and higher levels mental distress, perceived stress, and neuroticism. weigel, meinertz dantoft, jørgensen et al. 11 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ ta b le 3 su m m ar y of m ul ti pl e r eg re ss io n a na ly se s to p re di ct s ym pt om p er ce pt io ns i n a d an is h p op ul at io nb as ed s am pl e v ar ia bl e c on se qu en ce s t im el in e sy m pt om c on tr ol t re at m en t co n tr ol b se 95 % c i b se 95 % c i b se 95 % c i b se 95 % c i fu n ct io n al d is or de rs a n d m aj or h ea lt h c on di ti on s o w n f un ct io n al d is or de rs 1. 26 ** 1. 02 [1 .1 5, 1 ,3 2] 1. 34 ** 1. 03 [1 .2 5, 1 .4 3] 1. 14 ** 1. 03 [1 .0 8, 1 .2 1] 1. 06 ** 1. 19 [0. 83 , 0. 95 ] fu n ct io n al d is or de rs in f am il y 1. 05 ** 1. 02 [1 .2 0, 1 .1 0] 1. 06 * 1. 03 [1 .0 0, 1 .1 2] 1. 04 1. 03 [0. 99 , 1 .0 9] -0 .8 9* 1. 03 [0. 89 , 0. 99 ] o w n m aj or h ea lt h c on di ti on s 1. 07 * 1. 03 [1 .0 1, 1 .1 4] 1. 09 * 1. 04 [1 .0 0, 1 .1 9] 0. 99 1. 04 [0. 92 , 1 .0 6] -0 .9 4 1. 03 [0. 96 , 1 .1 2] m aj or h ea lt h c on di ti on s in f am il y 1. 02 1. 03 [1. 01 , 1 .0 7] 1. 05 1. 04 [0 .9 8, 1 .1 3] 1. 00 1. 03 [0. 94 , 1 .0 7] -1 .0 4 1. 04 [0. 92 , 1 .0 6] sy m pt om s la st y ea r 1. 00 1. 00 [0. 97 , 1 .0 0] 1. 00 1. 00 [0. 99 , 1 .0 0] -1 .0 0 1. 00 [1. 00 , 1 .0 0] -0 .9 9 1. 04 [1. 00 , 1 .0 1] sy m pt om s la st w ee k 1. 00 1. 00 [0. 99 , 1 .1 0] -1 .0 0 1. 01 [0. 99 , 1 .0 1] -1 .0 0 1. 01 [0. 99 , 1 .0 1] -1 .0 0 1. 00 [0. 99 , 1 .0 1] p sy ch ol og ic al c or re la te s of s ym pt om p er ce pt io n s m en ta l d is or de rs 1. 06 * 1. 03 [0 .9 9, 1 .1 2] -1 .0 4 1. 04 [0. 96 , 1 .1 2] -0 .9 4 1. 03 [0. 88 , 1 .0 0] -1 .0 0 1. 01 [0. 88 , 1 .0 2] m en ta l d is tr es s 1. 03 ** 1. 00 [1 .0 0, 1 .0 3] 1. 02 ** 1. 00 [1. 01 , 1 .0 3] 1. 02 ** 1. 00 [1 .0 1, 1 .0 2] 0. 95 1. 04 [0. 99 , 0 .0 0] p er ce iv ed s tr es s 1. 01 ** 1. 00 [1 .0 2, 1 .0 2] 1. 00 1. 00 [1. 00 , 1 .0 1] 1. 02 ** 1. 00 [1 .0 1, 1 .0 2] 1. 00 1. 00 [0. 99 , 1 .0 1] c op in g ab il it y 1. 00 1. 00 [1. 01 , 1 .0 1] 1. 00 1. 00 [1. 00 , 1 .0 1] -0 .9 9* * 1. 00 [0. 99 , 1. 00 ] -1 .0 0 1. 00 [0. 99 , 1 .0 0] a dv er se li fe e ve n ts 1. 01 ** 1. 00 [1 .0 0, 1 .0 2] 1. 02 ** 1. 00 [1 .0 1, 1 .0 3] 1. 01 1. 00 [1. 00 , 1 .0 2] -0 .9 9 1. 00 [0. 99 , 1 .0 0] n eu ro ti ci sm 1. 00 1. 00 [1. 01 , 1 .0 1] 1. 00 1. 00 [1. 00 , 1 .0 1] 1. 00 1. 00 [1 .0 0, 1 .0 1] -0 .9 9 1. 00 [0. 99 , 1 .0 0] e xt ra ve rs io n 1. 00 1. 00 [1. 00 , 1 .0 0] -0 .9 9* * 1. 00 [0. 99 , 1. 00 ] -1 .0 0 1. 00 [0. 99 , 1 .0 0] -0 .9 9* * 1. 00 [0. 98 , 0. 99 ] o pe n n es s 1. 00 1. 00 [1. 00 , 1 .0 0] -1 .0 0 1. 00 [0. 99 , 1 .0 0] -1 .0 0 1. 00 [0. 99 , 1 .0 0] -0 .9 9 1. 00 [1. 00 , 1 .0 1] a gr ee ab le n es s 1. 00 1. 00 [0. 99 , 1 .0 1] 1. 00 1. 00 [1. 00 , 1 .0 1] -1 .0 0 1. 00 [0. 99 , 1 .0 0] -1 .0 0* * 1. 00 [0. 99 , 1. 00 ] c on sc ie n ti ou sn es s 1. 00 1. 00 [1. 00 , 1 .0 0] -1 .0 0 1. 00 [0. 99 , 1 .0 1] -0 .9 9* * 1. 00 [0. 99 , 1. 00 ] -0 .9 9 1. 00 [0. 99 , 1 .0 1] so ci od em og ra ph ic f ac to rs se x 1. 02 1. 02 [0. 99 , 1 .0 7] -0 .9 8 1. 03 [0. 92 , 1 .0 3] -0 .9 5* 1. 03 [0. 91 , 1. 00 ] -1 .0 0 1. 00 [0. 98 , 1 .0 9] a ge 1. 00 1. 00 [0. 98 , 1 .0 0] 1. 00 1. 00 [1. 00 , 1 .0 0] -1 .0 0 1. 00 [1. 00 , 1 .0 0] -1 .0 3* * 1. 03 [0. 99 , 1. 00 ] m od el s um m ar y f 1 8, 40 38 = 4 2. 22 8, p = < .0 01 ad j. r 2 = 0 .1 55 d ur bi n -w at so n = 1 .9 88 v if m ax = 3 .2 90 ( n eu ro ti ci sm ) f 1 8, 39 65 = 1 7. 37 7, p = < .0 01 ad j. r 2 = .0 69 d ur bi n -w at so n = 1 .9 67 v if m ax = 3 .2 98 ( n eu ro ti ci sm ) f 1 8, 3 98 6= 2 6. 89 4, p = < .0 01 ad j. r 2 = .1 04 d ur bi n -w at so n = 2 .0 41 v if m ax = 3 .2 95 ( n eu ro ti ci sm ) f 1 8, 3 97 1= 5 .3 75 , p = < .0 01 ad j. r 2 = .0 19 d ur bi n -w at so n = 1 .9 58 v if m ax = 3 .2 77 ( n eu ro ti ci sm ) symptom perceptions in functional disorders 12 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ ta b le 3 [ co n ti n u ed ] su m m ar y of m ul ti pl e r eg re ss io n a na ly se s to p re di ct s ym pt om p er ce pt io ns i n a d an is h p op ul at io nb as ed s am pl e v ar ia bl e sy m pt om c on ce rn s c oh er en ce e m ot io n al r ep re se n ta ti on s b se 95 % c i b se 95 % c i b se 95 % c i fu n ct io n al d is or de rs a n d m aj or h ea lt h c on di ti on s o w n f un ct io n al d is or de rs 0. 08 ** 1. 03 [1 .1 4, 1 .2 7] 1. 13 ** 1. 03 [1 .0 7, 1 .2 0] 1. 04 ** 1. 15 [1 .1 7, 1 .2 9] fu n ct io n al d is or de rs in f am il y 1. 06 * 1. 02 [1 .0 1, 1 .1 1] 1. 02 1. 03 [0. 98 , 1 .0 8] 1. 23 ** 1. 03 [1 .0 2, 1 .1 2] o w n m aj or h ea lt h c on di ti on s 1. 02 1. 04 [0 .9 5, 1 .1 0] -0 .9 7 1. 04 [0. 90 , 1 .0 5] 1. 07 ** 1. 02 [1 .0 4, 1 .1 8] m aj or h ea lt h c on di ti on s in f am il y 1. 03 1. 03 [0. 98 , 1 .1 0] 1. 03 1. 03 [0. 96 , 1 .0 9] 1. 11 1. 03 [0. 95 , 1 .0 6] sy m pt om s la st y ea r 1. 00 1. 00 [1. 00 , 1 .0 1] -1 .0 0 1. 00 [0. 99 , 1 .0 0] 1. 01 1. 03 [1. 00 , 1 .0 0] sy m pt om s la st w ee k 1. 00 1. 00 [0. 99 , 1 .0 1] 1. 00 1. 01 [0. 99 , 1 .0 2] 1. 00 1. 00 [0. 99 , 1 .0 1] p sy ch ol og ic al c or re la te s of s ym pt om p er ce pt io n s m en ta l d is or de rs -0 .9 8 1. 03 [0. 92 , 1 .0 4] -0 .9 1* 1. 03 [0. 86 , 0. 98 ] 1. 00 ** 1. 00 [1 .0 3, 1 .1 5] m en ta l d is tr es s 1. 04 ** 1. 00 [1 .0 3, 1 .0 5] 1. 01 ** 1. 00 [1 .0 1, 1 .0 2] 1. 09 ** 1. 03 [1 .0 4, 1 .0 6] p er ce iv ed s tr es s 1. 01 ** 1. 00 [1 .0 1, 1 .0 2] 1. 01 ** 1. 00 [1 .0 0, 1 .0 2] 1. 05 ** 1. 00 [1 .0 1, 1 .0 2] c op in g ab il it y 1. 00 1. 00 [0. 99 , 1 .0 0] -0 .9 9* * 1. 00 [0. 98 , 0. 99 ] -1 .0 2 1. 00 [0. 99 , 1 .0 0] a dv er se li fe e ve n ts 1. 01 1. 00 [1. 00 , 1 .0 1] -0 .9 9 1. 00 [0. 99 , 1 .0 0] 1. 00 1. 00 [1. 00 , 1 .0 1] n eu ro ti ci sm 1. 00 1. 00 [1 .0 0, 1 .0 1] 1. 01 * 1. 00 [1 .0 0, 1 .0 1] 1. 00 ** 1. 00 [1 .0 1, 1 .0 2] e xt ra ve rs io n 1. 00 1. 00 [1 .0 0, 1 .0 1] -1 .0 0 1. 00 [0. 99 , 1 .0 0] 1. 01 1. 00 [1. 00 , 1 .0 1] o pe n n es s 1. 00 1. 00 [0. 99 , 1 .0 0] -0 .9 9* * 1. 00 [0. 99 , 1. 00 ] -1 .0 0 1. 00 [0. 99 , 1 .0 0] a gr ee ab le n es s 1. 00 1. 00 [1. 00 , 1 .0 0] -0 .9 9* * 1. 00 [0. 99 , 0. 99 ] -1 .0 0 1. 00 [1. 00 , 1 .0 0] c on sc ie n ti ou sn es s 1. 00 1. 00 [0. 99 , 1 .0 0] -0 .9 9* 1. 00 [0. 99 , 1. 00 ] 1. 00 1. 00 [1. 00 , 1 .0 1] so ci od em og ra ph ic f ac to rs se x -0 .9 5* 1. 02 [0. 91 , 0. 99 ] -0 .9 5* 1. 03 [0. 90 , 1. 00 ] -1 .0 0 1. 00 [0. 96 , 1 .0 4] a ge 1. 00 1. 00 [1 .0 0, 1 .0 0] -1 .0 0* 1. 00 [1. 00 , 1. 00 ] 1. 00 1. 02 [1. 00 , 1 .0 0] m od el s um m ar y f 1 8, 4 00 6 = 3 9. 01 4, p = < .0 01 ad j. r 2 = .1 45 d ur bi n -w at so n = 1 .9 86 v if m ax = 3 .2 71 ( n eu ro ti ci sm ) f1 8, 3 99 3 = 2 5. 12 5, p = < .0 01 ad j. r 2 = .0 98 d ur bi n -w at so n = 1 .9 92 v if m ax = 3 .2 69 ( n eu ro ti ci sm ) f1 8, 3 99 8 = 8 5. 39 6, p = < .0 01 ad j. r 2 = .2 74 d ur bi n -w at so n = 1 .9 96 v if m ax = 3 .3 02 ( n eu ro ti ci sm ) weigel, meinertz dantoft, jørgensen et al. 13 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ d i s c u s s i o n this large population-based study observed more negative symptom perceptions in indi­ viduals with functional disorders with and without co-occuring major health conditions than in those with major health conditions only or healthy individuals. more specifically, individuals with functional disorders judged their symptoms to affect their life and their emotional well-being more and to last longer than the other health condition groups. they expressed less symptom understanding, less treatment control, but higher personal control than those with major health conditions. these results have three important implications. firstly, the higher levels of neg­ ative cognitive representations and emotional reactions observed in individuals with functional disorders confirm previous research that perceptual, cognitive, and emotion regulation processes may play a more salient role in functional disorders as compared to well-defined physical illness (henningsen et al., 2018; okur güney et al., 2019). secondly, our results support previous findings from clinical samples that functional disorders in some cases are comorbid with major health conditions (duffield et al., 2018; halpin & ford, 2012). our results extend the existing evidence by showing that this comorbidity results in more negative symptom perceptions and more negative self-perceived health. thirdly, more research is needed to investigate the consequences of these more negative symptom perceptions in individuals with functional disorders on relevant outcomes such as symptom burden, symptom course, and individual symptom management. in terms of correlates of symptom perceptions from the cms framework, our results indicate that not only the presence of a functional disorder in oneself was associated with symptom perceptions but also functional disorders in family members, albeit to a lesser extent. interestingly, the presence of a major health condition in the family was not associated with more negative symptom perceptions. these results might indicate that the experience of an illness or symptoms in significant others does not in itself lead to a more negative evaluation of present symptoms but that particularly in functional disorders, learning of illness behavior, and beliefs within families seem to be crucial (brace et al., 2000; palermo et al., 2014). it is of note that the presence of a major health condition, but neither the number of symptoms in the last year, nor the number of symptoms during the last week, was associated with current symptom perceptions in the multivariate regression models. on the one hand, this result might be interpreted in light of former evidence on a weaker association between health states and symptom reports in chronic health conditions (janssens et al., 2011). on the other hand, the inclusion of functional disorders in the analyses might have erased the impact of symptom reports. with regard to personality traits, extraversion, openness, and agreeableness were all significantly associated with more favorable symptom perceptions, whereas neuroticism was (to a lesser extent) associated with more negative associations. notably, conscien­ tiousness was associated with lower personal control. one may speculate that persons symptom perceptions in functional disorders 14 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ with high conscientiousness may need a more controlled environment to feel in control and therefore be prone to appraise less control when experiencing symptoms. overall, interpretating these results from the perspective of a recent meta-analysis, extraversion, openness, and agreeableness might be regarded as resilience factors in the context of symptom perceptions (oshio et al., 2018). in line with the accumulating evidence from other research fields (anda et al., 2006), multiple experiences of adverse life events were associated with more negative symptom perceptions. additionally, our results indicate that current symptoms of depression and anxiety as well as perceived stress and coping abilities were psychological correlates of most symptom perceptions. this result was in line with evidence derived from a systematic review on so-called modifiable correlates of symptom perceptions in samples with somatic diseases (arat et al., 2018) and indicates that these variables might be considered as potential moderators or mediators in future studies. taken together, our results support the notion from the perspective of the csm that a range of biopsychosocial factors are involved in the formation of symptom perceptions (leventhal et al., 2016), i.e., broadly speaking, that a person's life experience is involved in how the person reacts to and copes with symptoms and illness. extending on previous evidence, the present study found significant associations between functional disorders in significant others and oneself for the formation of symptom perceptions. still, the emerging picture is somewhat complex, as it remains challenging to judge which factors might be of particular relevance, given that each b-ipq subscale displayed an individual pattern of significant biopsychosocial correlates. from a clinical perspective, screening for functional disorders in individuals with major health conditions may be a valuable approach to identify vulnerable patients that might be at risk for more complex illness trajectories and to personalize the given treatment rationale with psychosocial interventions to challenge symptom perceptions if needed. derived from the observed associations of symptom perceptions in the present cross-sectional study, these interventions should address present symptoms of depres­ sion, anxiety, and current stress and should aim at improving coping skills. the present study was to the best of our knowledge the first to investigate symptom perceptions and their correlates in a population-based sample. this approach enabled a sufficient sample size and high representativeness. however, the results of the present study should to be interpreted in light of the following limitations. firstly, the crosssectional design of the present study prevented us from making any causal/temporal interpretations of our results. secondly, the participation rate in the danfund study was rather low (30%), which is a challenge for all epidemiological studies (galea & tracy, 2007). further, there seemed to be a selection bias, which has also been observed in other epidemiological studies (keeble et al., 2015), with females and more educated indi­ viduals being more likely to participate. thirdly, the four health condition groups were operationalized through self-report with a predefined list of health conditions. in doing weigel, meinertz dantoft, jørgensen et al. 15 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ so, some participants may not have indicated a diagnosis of a functional disorder because they disagree with it. also, other major health conditions not included in this list might have explained some of the perceived symptoms. fourthly, the present study applied a crude measure of school education. therefore, the effect of educational level (i.e., vocational training) on the outcome measures has to be investigated in future studies. fifthly, the b-ipq uses a single scale approach, which does not allow the determination of internal validity and might be more prone to random measurement error than mul­ ti-item scales. additionally, a scale deviating from the original scale was used and the b-ipq was answered in terms of symptoms in general, so the item assessing symptom identity was removed. these aspects and large amounts of missing responses on the b-ipq items decrease the comparability with other studies. last, further major health conditions or functional disorders and treatment related variables, such as prior illnesses and treatment, symptom duration or severity might be further relevant correlates of symptom perceptions but were not included in the present study. conclusions researchers can benefit from the results of the present study with respect to expectable differences in symptom perceptions in healthy individuals and those with functional disorders and major health conditions. further, the present study identified potential moderators and mediators of symptom perceptions that might be worth further investi­ gation in experimental and treatment studies. clinicians and health policy makers can benefit from the results in that the present results could inform the future development of preventive interventions in the context of symptom perceptions. symptom perceptions in functional disorders 16 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ funding: this study was a part of the danfund study funded by trygfonden (grant number 7-11-0213), the lundbeck foundation (grant number r155-2013-14070) and the center for clinical research and prevention. the danfund scientific management group consists of professor, dmsci torben jørgensen (pi); professor, dmsci per fink; senior consultant, phd lene falgaard eplov; msc, phd susanne brix pedersen; md, phd michael benros; msc, phd betina heignsbæk thuesen, and danfund scientific officer msc, phd thomas m dantoft. the university medical center hamburg-eppendorf supported this study by funding a three-month research visit in 2018 for angelika weigel. acknowledgments: the authors would like to thank the participants in the health survey and the team behind the survey at the center for clinical research and prevention, the capital region of denmark, for their great work with collecting and assuring data of high quality. competing interests: the authors declare that they have no conflicts of interest. ethics statement: all study procedures were approved by the ethical committee of copenhagen country (ka-2006-0011, h-3-2011-081, h-3-2012). all participants provided written informed consent. data availability: the datasets generated during and/or analyzed during the current study are available on reasonable request from the danfund project leader thomas dantoft by email: thomas.meinertz.dantoft@regionh.dk r e f e r e n c e s aalto, a.-m., aro, a. r., weinman, j., heijmans, m., manderbacka, k., & elovainio, m. 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(2018). illness perception of patients with functional gastrointestinal disorders. frontiers in psychiatry, 9, article 122. https://doi.org/10.3389/fpsyt.2018.00122 weigel, meinertz dantoft, jørgensen et al. 21 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://doi.org/10.1348/135910705x71434 https://doi.org/10.2147/copd.s109227 https://doi.org/10.1080/14768320701246535 https://doi.org/10.1097/sga.0000000000000225 https://doi.org/10.1016/j.neubiorev.2017.01.015 https://doi.org/10.1007/s12529-016-9599-y https://doi.org/10.1097/00005650-199603000-00003 https://doi.org/10.1038/bjc.2015.39 https://doi.org/10.3389/fpsyt.2018.00122 https://www.psychopen.eu/ a p p e n d i x ta b le a .1 a dj us te d m ea n c om pa ri so ns o f b -i p q s ub sc al es b et w ee n th e fo ur h ea lt h c on di ti on g ro up s b -i p q s ub sc al e h ea lt h y vs . m h c h ea lt h y vs . f d h ea lt h y vs . m h c + f d m h c v s. f d m h c v s. m h c + f c fd v s. m c h + f d m di ff 95 % c i d m di ff 95 % c i d m di ff [9 5% c i] d m di ff [9 5% c i] d m di ff [9 5% c i] d m di ff [9 5% c i] d c on se qu en ce s -0 .4 3* [0. 72 , 0. 16 ] 0. 20 -1 .1 1* [1. 31 , 0. 90 ] 0. 56 -1 .2 0* [ -1 .6 6, 0. 73 ] 0. 61 -0 .6 6* [0. 98 , 0. 34 ] 0. 32 -0 .7 5* [1. 27 , 0. 23 ] 0. 35 -0 .0 9 [0. 58 , 0 .4 0] t im el in e -0 .5 1 [0. 98 , 0. 03 ] -1 .5 1* [1. 86 , 1. 15 ] 0. 47 -1 .7 6* [2. 54 , 0. 97 ] 0. 58 -1 .0 0* [1. 55 , 0. 46 ] 0. 27 -1 .2 5* [2. 13 , 0. 37 ] 0. 37 -0 .2 5 [1. 08 , 0 .5 8] p er so n al c on tr ol -0 .2 2 [0. 63 , 0 .1 9] -0 .7 3* [1. 03 , 0. 42 ] 0. 24 -0 .4 6 [1. 14 , 0 .2 1] 0. 51 [0. 98 , 0. 04 ] -0 .2 4 [1. 01 , 0 .5 2] 0. 26 [0. 45 , 0 .9 8] t re at m en t co n tr ol -0 .2 0 [0 .6 4, 0 .2 4] 0. 64 * [0 .3 2, 0 .9 7] 0. 21 0. 41 [0. 32 , 1 .1 4] 0. 85 * [0 .3 4, 1 .3 5] 0. 27 0. 62 [0. 20 , 1 .4 4] -0 .2 3 [1. 00 , 0 .5 4] sy m pt om c on ce rn -0 .2 0 [0. 52 , 0 .1 3] -0 .9 3* [1. 17 , 0. 69 ] 0. 40 -0 .9 8* [1. 52 , 0. 44 ] 0. 42 -0 .7 3* [1. 11 , 0. 36 ] 0. 31 -0 .7 8* [1. 40 , 0. 18 ] 0. 33 -0 .0 5 [0 .6 2, 0 .5 2] c oh er en ce -0 .0 5 [0. 42 , 0 .3 2] -0 .4 7* [0. 73 , 0. 20 ] 0. 16 -0 .4 0 [1. 01 , 0 .2 1] -0 .4 2 [0. 84 , 0 .0 0] -0 .3 5 [1. 03 , 0 .3 3] 0. 07 [0. 57 , 0 .7 1] e m ot io n al re pr es en ta ti on s -0 .5 0* [0. 83 , 0. 18 ] 0. 17 -1 .1 5* [1. 38 , 0. 91 ] 0. 50 -0 .5 3* [2. 07 , 1. 00 ] 0. 66 -0 .6 5* [1. 01 , 0. 28 ] 0. 45 -1 .0 3* [1. 63 , 0. 43 ] 0. 30 -0 .3 9 [0. 95 , 0 .1 8] n ot e. m h c = m aj or e h ea lt h c on di ti on , i .e . c an ce r, h ea rt a tt ac k an d th ro m bo si s or e m bo li sm in t h e br ai n ; f d = f un ct io n al d is or de rs , i .e . f ib ro m ya lg ia , c h ro n ic fa ti gu e, ir ri ta bl e bo w el s yn dr om e, w h ip la sh s yn dr om e, a n d m ul ti pl e ch em ic al s en si ti vi ty ; d = c oh en ’s d e ff ec t si ze o f si gn if ic an t di ff er en ce ; m di ff = m ea n di ff er en ce ; 9 5% c i = 9 5% c on fi de n ce in te rv al , r an ge o f b -i p q s ub sc al es = 1 -1 0. *s ig n if ic an t at b on fe ro n i c or re ct ed p -v al ue f or m ul ti pl e co m pa ri ss on s. symptom perceptions in functional disorders 22 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. weigel, meinertz dantoft, jørgensen et al. 23 clinical psychology in europe 2022, vol. 4(4), article e7739 https://doi.org/10.32872/cpe.7739 https://www.psychopen.eu/ symptom perceptions in functional disorders method study population measures statistical analyses results aim 1: comparison of symptom perceptions in the four health condition groups aim 2: correlation between functional disorders in oneself and significant others and symptom perceptions in the context of other possible correlates from the cms framework discussion conclusions (additional information) funding acknowledgments competing interests ethics statement data availability references appendix premature dropout from psychotherapy: prevalence, perceived reasons and consequences as rated by clinicians research articles premature dropout from psychotherapy: prevalence, perceived reasons and consequences as rated by clinicians niclas kullgard 1 , rolf holmqvist 1 , gerhard andersson 1,2,3 [1] department of behavioural sciences and learning, linköping university, linköping, sweden. [2] department of biomedical and clinical sciences, linköping university, linköping, sweden. [3] department of clinical neuroscience, karolinska institute, stockholm, sweden. clinical psychology in europe, 2022, vol. 4(2), article e6695, https://doi.org/10.32872/cpe.6695 received: 2021-05-07 • accepted: 2022-01-16 • published (vor): 2022-06-30 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: niclas kullgard, department of behavioural sciences and learning, linköping university, se-581 83 linköping, sweden. tel.: +46-705-789848. e-mail: niclas.kullgard@liu.se abstract background: why clients discontinue their psychotherapies has attracted more attention recently as it is a major problem for many healthcare services. studies suggest that dropout rates may be affected by the mode of therapy, low-quality therapeutic alliance, low ses, and by conditions such personality disorders or substance abuse. the aims of the study were to investigate what happens in therapies which end in a dropout, and to estimate how common dropout is as reported by practicing clinicians. method: an online questionnaire was developed and completed by 116 therapists working in clinical settings. they were recruited via social media (facebook and different online psychotherapy groups) in sweden and worked with cognitive behavioural therapy (cbt), psychodynamic therapy (pdt), interpersonal psychotherapy (ipt) and integrative psychotherapy (ip). results: psychotherapists rated the frequency of premature dropout in psychotherapy to be on average 8.89% (md = 5, sd = 8.34, range = 0-50%). the most common reasons for a dropout, as stated by the therapists, were that clients were not satisfied with the type of intervention offered, or that clients did not benefit from the treatment as they had expected. the most common feeling following a dropout was self-doubt. conclusion: in conclusion, premature dropout is common in clinical practice and has negative emotional consequences for therapists. premature dropout may lead to feelings of self-doubt and powerlessness among therapists. the therapeutic alliance was mostly rated as good in dropout this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6695&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0002-2445-0079 https://orcid.org/0000-0003-2093-2510 https://orcid.org/0000-0003-4753-6745 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ therapies. further research is needed to validate the findings with data on the prevalence and subjective reasons behind a dropout from point of view of clients. keywords premature dropout, psychotherapy dropout, psychotherapy, therapeutic alliance highlights • the dropout rate was estimated to 8.89% by the therapists in this study. • the psychotherapists believe that reasons as to dropout was that clients were not satisfied with interventions in therapy. • the most common feeling following a dropout was self-doubt. • the therapeutic alliance was generally rated as good in therapies resulting in dropout. dropout from psychotherapy has been defined as “termination of the treatment without fulfilment of the therapeutic goals, without attainment of the full therapeutic benefit that would have been possible with normal termination of the therapy or without completion of the full scope of the therapy” (swift & greenberg, 2012). there is a significant amount of variation on how to operationalize dropout, for example when it is meaningful to use dropout as a description of what happened in a therapy (garfield, 1994; hatchett & park, 2003; swift et al., 2009; swift & greenberg, 2012). one way to operationalize dropout is to consider anyone who do not attend a special number of sessions as a dropout. the idea is that clients need to attend a minimal number of sessions in order to improve (lambert, 2007). another operationalization is failure to complete a specific treatment protocol. in this definition anyone who fails to complete a full treatment protocol is considered a dropout. a third operationalization is based on missed sessions. this approach suggests that anyone who misses or fails to reschedule sessions is considered a dropout. another fourth approach is to let the therapist decide if the client has prematurely dropped out or not. a final approach is to define a dropout when a client terminates prior to a reliable improvement has occurred and prior to obtaining an outcome score within the normal range (hatchett & park, 2003). there are both positive and negative aspects of all these operationalizations. while number of sessions, missed sessions and failure to follow a treatment protocol are relatively easy to assess they do not say anything about actual change or improvement. it is problematic to classify a client as a dropout when attending few sessions and showing major improvement when a client who attends all scheduled sessions but do not engage in the therapy and show no improvement will not be defined as a dropout. when using therapists’ judgement there is a considerable risk that the judgment is biased or even flawed (garb, 2005; grove et al., 2000). despite numerous studies there is no consensus regarding the definition of dropout. for example, as mentioned it is possible to drop out from a therapy while still reaching the treatment goals. the term premature dropout from psychotherapy 2 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ premature suggests that the therapy is terminated before the goals of the treatment are obtained. while there are premature terminations of therapy that are agreed upon, not turning up and ending therapy without explanation or any notice can be a major problem. for example, clients may not get the treatment they need, and therapists and services are disrupted (for example when trying to locate the client). in a meta-analysis of 125 psychotherapy studies, wierzbicki and pekarik (1993) estimated that about 47% of the therapies resulted in a unilateral dropout. however, swift and greenberg (2012) reported dropout rates across methods and disorders at approximately 19.7%, and unilateral drop­ outs ranged between 0 to 74% (m = 19.7%) (swift & greenberg, 2012, 2014). most studies included in these reviews were clinical trials on adult clients who were participants in studies in which both clients and methods had been carefully selected. thus, there may be differences in reasons behind dropout in therapies conducted in clinical practice and in clinical trials depending on the definition of dropout or the context (for example interviews, questionnaires, videorecording, compliance to a specific method or manual) often present in clinical trials. psychotherapy in clinical practice more often includes patients that would not be included in clinical trials depending on multiple psychiatric diagnosis, psychosocial problems or other problems that excludes them from clinical trials. effects of premature dropouts premature dropout has been associated with a range of negative effects for both clients and therapists. in clinical trials, dropouts tend to report more dissatisfaction (björk et al., 2009; knox et al., 2011; kokotovic & tracey, 1987) and poorer treatment outcomes (cahill et al., 2003; klein et al., 2003; lampropoulos, 2010; pekarik, 1983, 1992; swift et al., 2009), compared with therapy completers. therapists are likely to experience loss of revenue (i.e., in private practice), and a sense of failure or demoralization when clients prematurely drop out (barrett et al., 2008; ogrodniczuk et al., 2005; piselli et al., 2011). factors related to premature dropout the therapeutic alliance has consistently been associated with outcome in psychotherapy (horvath et al., 2011; lambert & barley, 2002; safran et al., 2014). research commonly shows that a strong alliance is related to better outcomes (bickman et al., 2012; flückiger et al., 2018; spinhoven et al., 2007; zuroff & blatt, 2006), and that a weak alliance is related to dropout (barrett et al., 2008; sharf et al., 2010). some meta-analyses show sig­ nificant correlations between repairing ruptures in the therapeutic alliance and therapy outcome measured either as therapy completion, premature dropout or as change on symptoms measures (eubanks et al., 2018; safran et al., 2011; safran et al., 2014). more­ over, the ability to manage behavioural, cognitive, somatic, and affective reactions during psychotherapy (related to the therapist’s own unresolved emotional stressful events or kullgard, holmqvist, & andersson 3 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ themes during therapy) may also influence psychotherapy process and outcome. the ability to manage and potentially use own reactions to “what happens during psycho­ therapy” – for example if the therapist has dealt with his/her own negative experiences and are aware of them may increase the ability to effectively help the client (hayes et al., 2011; hayes et al., 2018). overall, the proportion of dropout reported in different studies is related to the definition of dropout, and since there is no consensus on the definition comparisons on rates is difficult. however, the literature suggests that dropout is common, has negative effects on clients and their therapists, and that a poor therapeutic alliance may increase the risk of a premature dropout. the aim of this study was to investigate how common premature dropout is in clinical practice, to analyse perceived reasons behind a dropout, the role of therapeutic alliance and feelings associated with dropouts. psychotherapists working with different orientations, target groups, and in different settings completed an online survey with the aim to reach a broad sample. m e t h o d procedure the study was conducted online using an anonymous questionnaire during 2 months in the spring of 2020. the study was announced via social media (facebook), email to employees at two outpatient psychiatric clinics and networks for psychotherapists. in sweden, where the study was conducted, almost all practicing clinicians have regular internet access. in total 594 persons accessed the website, and, of those, 116 persons (19.5%) completed the whole questionnaire. data analysis the data from the survey were prepared with spss statistics version 26. means (m), medians (mdn), standard deviations (sd) and ranges were calculated. anovas were calculated to investigate differences between means. nominal data were compiled and descriptive measures such as percentages were calculated. participants participants were psychotherapists from different professional backgrounds. they had at least basic psychotherapy training (which in sweden is 3 years) and used psychothera­ peutic methods in their work. participation was anonymous and no data was collected that could be used to identify the participant. of the 116 psychotherapists who partici­ pated, 83 were female (70.9%). they had worked as psychotherapists for an average of 10.51 years (sd = 7.91). the professional background of the participants was: clinical premature dropout from psychotherapy 4 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ psychologists (n = 67; 57.8%), social workers (n = 28; 24.1%), nurses (n = 4; 3.4%), medical doctors (n = 1; 0.9%) and other (n = 16; 13.8%). regarding the therapists’ main methodological orientation, the following distribution was obtained (multiple answers were possible): cognitive behavioural therapy (cbt) (n = 99; 84.6%), psychodynamic psychotherapy (pdt) (n = 47; 40.2%), interpersonal psychotherapy (ipt) (n = 19; 16.2%), family therapy (ft) (n = 11; 9.4%), humanistic/existential psychotherapy (n = 7; 6%) and 20 (n = 20; 17.1%). see table 1 for further description of the participants. table 1 background data of the participating psychotherapists (n = 117) variables n (%) gender (female) 83 (70.9%) age in profession m = 10.51 years profession psychologists 67 (57.8) social workers 28 (24.1) nurses 4 (3.4) medical doctors 1 (0.9) others 16 (13.8) workplace public sector (primary care) 46 (39.6) public sector (psychiatry) 43 (37.1) private sector (psychiatry) 11 (9.4) private sector (primary care) 13 (11.2) private practice 31 (26.7) other 6 (5.2) age group children (0-13 years) 14 (12.1) youths (14-18 years) 21 (18.1) young adults (18-25 years) 35 (30.2) adults (18-65 years) 97 (83.6) older adults (65 years-) 14 (12.1) psychotherapeutic orientation cognitive behaviour therapy (cbt) 99 (84.6) psychodynamic therapy (pdt) 47 (40.2) interpersonal psychotherapy (ipt) 19 (16.2) other 21 (17.9) kullgard, holmqvist, & andersson 5 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ measures a brief questionnaire was developed for use in the present study. the questionnaire was developed in discussion with clinicians, by consulting the literature on dropout and the therapeutic relationship in psychotherapy. to increase the content validity, the questionnaire was piloted with 6 colleagues, all licensed clinical psychologists, and researchers in clinical psychology. they filled out the questionnaire individually which was followed by a discussion which resulted in some adjustments and clarifications. the final questionnaire started with this definition: the aim of this study is to explore psychotherapists’ clinically based opinion of the frequency of dropouts in psychotherapy and, also their feelings prior to and after a dropout. our definition of dropout is “when a client stops coming to an agreed and started psychother­ apy without notice.” the initial part of the questionnaire consisted of 6 items on generic information regard­ ing gender, years of working with psychotherapy, primary age group in the work, type of organization, professional background and use of psychotherapeutic methods. the scales were made as nominal variables where the most common professional back­ grounds, organizations and most used psychotherapeutic methods were specified as single response options. there was also an open-ended alternative to capture alternatives that were not specified. the participants were asked to estimate the dropout rate in their therapies, based on our definition of a premature dropout, as a percentage of their total number of psychotherapies. in the next section participants were asked why they believed a typical dropout had occurred, their own feelings during the therapy and after the dropout. further, feelings before and after the dropout were derived from a feeling checklist used in psychotherapy process research (lindqvist et al., 2017). there were 20 different feelings which were rated on a five-point likert-scale ranging from 1 (‘not very important for me’) to 5 (‘very important to me’). in the next part, the therapeutic alliance was rated with three items (task, goal, and emotional bond). these items were rated on a three-point likert-scale from 1 (‘bad’) to 3 (‘very good’). further the participants rated if they had suspected that the clients would drop out. the rating was made on a five-point likert-scale ranging from 1 (‘not very important for me’) to 5 (‘very important to me’). finally, questions regarding discussing the suspicion of a potential dropout with someone (yes/no/don’t know) and in that case with whom (e.g. supervisor, colleague, friend, partner), and lastly if they had received the support they needed in psychotherapy supervision. the time for filling out the form was approximately 15 minutes. premature dropout from psychotherapy 6 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ r e s u l t s the average estimated dropout-rate, defined as the percentage of the total number of psychotherapies during the last two years was 8.89% (mdn = 5, sd = 8.34, range = 0–50%). we conducted an anova-analysis to test if there were any differences regard­ ing the estimated dropout rate between cbt, pdt, ipt and eclectic therapy and no differences were found, all p-values were above p > .11. ratings in the survey done with questions on likert-scales generally generated responses in the middle of the scales, as measured by median. few therapists rated in the top end of the scales (4 or 5). the views among the therapists were primarily that dropout depended on the clients, by for example not wanting to do specific interventions or not responding to certain interventions. reasons for dropout table 2 shows the therapist’s ratings of reasons for dropout (in the order of highest rating first). table 2 therapists’ ratings of reasons for dropout variables m mdn sd the client did not want to do specific interventions related to the method. 3.08 3 1.10 the client did not “respond” to the intervention. 2.99 3 1.25 it seemed like the client did not believe that the method would help. 2.92 3 0.10 the client was in a difficult psychosocial situation. 2.79 3 1.21 the client had difficulties in the attachment with me (the therapist). 2.61 3 1.04 we had a weak emotional bond. 2.55 2 1.05 the client was discontent with me (the therapist). 2.47 2 0.90 the client had too complex psychological problems. 2.43 2 1.15 the therapy had low effect. 2.41 2 0.92 it was the wrong method for the problem. 2.38 2 0.92 we disagreed about the goals with the therapy. 2.31 2 0.97 i think we had too few sessions for our disposal. 2.28 2 1.32 i thought that the client was too difficult. 2.20 2 0.11 i (the therapist) had difficult to attach to the client. 2.08 2 0.92 it was the client’s age. 1.69 1 0.94 the client used drugs. 1.65 1 1.06 the client started another psychotherapy. 1.39 1 0.87 note. n = 107. instruction: think of a typical dropout, what do you think it was related to? (mark one or several alternatives (1 not important and 5 very important). kullgard, holmqvist, & andersson 7 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ when using mean as measure the most common reason for a dropout was that the client did not want to perform the intervention, respond to it, or did not believe in it. the lowest ratings were reasons for dropout related to clients age, clients using drugs or had started another therapy. emotions related to dropout the therapists were asked to rate their feelings during the therapy and after the dropout. table 3 shows the rating of feelings during therapy as indicated by the therapists. table 3 rating of feelings during therapy as indicated by the therapists variables m mdn sd interested 2.94 3 0.67 calm 2.52 3 0.72 energetic 2.31 2 0.76 insecure 2.28 2 0.81 sceptical 2.13 2 0.84 powerless 2.07 2 0.82 content 2.01 2 0.68 irritated 2.01 2 0.78 worried 1.97 2 0.77 tired 1.96 2 0.85 neutral 1.94 1 0.86 disappointed 1.93 2 0.73 tense 1.90 2 0.84 surprised 1.84 2 0.79 shame 1.70 2 0.78 overwhelmed 1.62 1 0.81 relieved 1.58 1 0.67 bored 1.54 1 0.72 angry 1.54 2 0.69 note. n = 107. instruction: if you think of the same therapy, which of the following emotions did you experience during therapy, as you remember it? for example “i felt…..” (1 not important and 4 very important). mark one or several feelings. feelings with the highest mean reported by the therapists during therapy were interes­ ted, calm, and energetic. feelings with the lowest mean were relieved, bored, and angry. in table 4, the therapists’ feelings following a dropout are presented. the feelings with highest mean after dropout was self-doubt, being touched and powerless. feelings with lowest mean were satisfied, overwhelmed, and bored. premature dropout from psychotherapy 8 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ table 4 therapists’ feelings following a dropout variables m mdn sd self-doubt 2.79 3 1.04 touched 2.66 3 1.01 powerless 2.61 2 1.13 disappointed 2.52 2 0.96 calm 2.38 2 1.12 surprised 2.22 2 1.08 annoyance at the client 2.13 2 0.87 doubt regarding my method 2.12 2 1.06 annoyance at myself 2.10 2 1.03 guilt 2.10 2 1.06 relieved 1.96 2 0.94 worried 1.93 2 1.00 shame 1.92 2 0.96 neutral 1.73 1 0.98 indifference 1.39 1 0.72 satisfied 1.39 1 0.66 overwhelmed 1.37 1 0.78 bored 1.28 1 0.69 note. n = 107. instruction: what did you feel after the dropout? i felt…. mark one or several options. (1 not important and 5 very important). therapeutic alliance and dropout the therapeutic alliance with the client who dropped out in mind was rated by the therapists using an ordinal scale with three response options (bad, good, very good). ratings of alliance in association with a dropout therapy are presented in table 5. table 5 ratings of alliance in association with a dropout therapy items low good very good m mdn sd the task of the therapy 32% 55% 13% 1.81 2 0.65 the goal in the therapy 26% 64% 10% 1.84 2 0.58 emotional bond in the therapy 33% 55% 12% 1.79 2 0.64 note. n = 107. instruction: afterwards, how would you rate the therapeutic alliance between you and the client who dropped out? (rate between 1-3 were 1 is low and 3 is very good). kullgard, holmqvist, & andersson 9 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ all three dimensions (task, goal, and bond) of the alliance were generally rated as good, with few (10-13%) stating that it was very good. one third rated the alliance in all three dimensions as low. there was no significant difference between the different aspects of the therapeutic alliance, f(2, 105) = .24, n.s.). support from others regarding suspicions about dropout regarding the question if the therapists had suspected the dropout during therapy, 24% did not suspect dropout while 76% had suspected dropout. about one fourth (23%) of the therapists had talked with their clients about their suspicions, 37% of the therapists did not talk to the client and 40% did not remember. about 59% of the therapists had talked to a supervisor or a colleague when they suspected that their client would drop out. only one third (30%) felt that they had received support. d i s c u s s i o n one aim of this study was to explore the extent of premature dropout in clinical practice as rated by therapists. the estimated dropout for the last two years was 8.89%. the results indicate that in clinical practice the dropout-rate, as defined in this study, is lower than in earlier studies in which the estimated dropout-rate has been 20% or higher (swift & greenberg, 2014). as mentioned in the introduction, wierzbicki and pekarik (1993) estimated the dropout-rate to be 47% based on 125 studies, whereas swift and greenberg (2012) reported a dropout rate of 19.7% in their meta-analytic study of 669 research studies. it is important to note that these discrepancies most likely depend on the difference in definition of dropout used in studies and reviews. regarding studies on differences between psychotherapy orientations a significant difference has been reported in depression studies in which cbt was found to result in more dropouts than other therapies (cuijpers et al., 2008). swift and greenberg (2014) reported that that there may be differences between psychotherapies related to diagnosis and that depression, eating disorders and ptsd may be associated with differential dropout rates. these differences were not investigated in our study, but we cannot exclude that the sample we obtained and the groups of clients and/or psychotherapy method the therapists worked with influenced the estimated dropout rate. information about the proportion of dropout in regular clinical practice seems to be scarce. cinkaya (2016), in a study on outpatients in germany, reported that patients with personality disorder were most likely to drop out whereas patients with depression, somatoform, and anxiety disorder were less likely to drop out. although the estimation done by the therapists in this study could be biased and uncertain, our findings is relevant for the understanding of how common dropout is in clinical practice. premature dropout from psychotherapy 10 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ overall, some prior studies have reported substantially higher dropout rates than we found in this study. there are some possible explanations. first, we used a definition that leaves out agreed upon terminations that would have been regarded as dropouts in research studies. another possibility, again referring to the difference between research studies and clinical settings, it that the length of a therapy and the demands on the client may be more flexible in clinical settings than in research studies in which for example the number of therapy sessions tend to be tied to treatment manuals. however, this does not mean that the figure we found is low. if almost one out of ten client dropout without any discussion or agreement it is still a problem in clinical settings both for the client and the service provider. our study explored reasons and feelings related to a typical premature dropout and the perception of the therapeutic alliance in such therapies. based on means, the three most common emotions during therapy were interested, calm, and insecure. after the dropout the three most common emotion were self-doubt, touched and powerlessness. our results indicate that premature dropouts affect the therapists negatively. after premature dropout therapists tend to feel self-doubt and experience emotions like powerlessness. on the other hand, the most common reasons for dropout stated by the therapists were that the client did not want to perform the intervention, respond to it, or did not believe in it. it appears as if the therapists blame themselves emotionally but rationally blame the client. another explanation might be that therapists do not manage to convince their client of about the ways in which they are supposed to work in therapy and therefore feel powerless in relation to what they are supposed to do in therapy, agreement about goals in therapy, or own conviction about what is best for the client. overall, the therapists rated the therapeutic alliance as good. approximately 30% rated the alliance as low regarding agreement on tasks and the emotional bond, and 26% rated the alliance as regarding goal. the result is a bit puzzling because it would be expected that maybe a higher percentage would rate the alliance as low or weak. as mentioned in the introduction, research has consistently showed that a strong alliance is related to good outcomes (bickman et al., 2012; spinhoven et al., 2007; zuroff & blatt, 2006), and that a weak alliance is related to dropout (barrett et al., 2008; sharf et al., 2010). some meta-analysis showed a significant correlation between repairing the alliance and therapy outcome (safran et al., 2011; safran et al., 2014), which we did not study but could be important to investigate in relation to dropout in future research. another possibility would be to investigate ruptures in the alliance, which also have been associated with treatment outcome (larsson et al., 2018). in a micro-analysis of sessions before a dropout more withdrawal alliance ruptures were observed (gülüm et al., 2018). findings also suggested that both therapists and clients decreased the pace of work and engaged in less exploration during the sessions before the dropout (gülüm et al., 2018). our findings correspond with these findings as approximately 30% rated the alliance as low and suspected a dropout. the fact that they mostly did not talk to kullgard, holmqvist, & andersson 11 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ the client suggests a withdrawal pattern in the therapeutic alliance. nissen-lie et al. (2017) found that when therapists actively help clients deal with clinical problems by exercising reflexive control and problem solving, it was associated with positive change while avoiding problems was associated with less change. it seems reasonable to assume that when clients dropout, they do so because they experience that they are not getting the help they hoped for or do not have enough trust in the therapist being able to be helping them sufficiently. the therapists provided the highest ratings for the following reasons: a) the client did not want to engage in or respond to specific interventions, b) the clients did not seem to believe that the method would help them. the discrepancy between what therapists reported as reasons for the dropout and their own feelings during therapy suggests that the client and the therapist have different experiences related to therapy. one example of this would be that the therapist is interested and eager to help but the client do not want to engage in or even resists interventions. it is likely that relational strains, which may be interpreted as a rupture in the therapeutic alliance, affects therapy negatively. if the rupture is not articulated there may be a silent withdrawal rupture in the therapeutic alliance, it may also be that psychological mecha­ nisms (for example countertransference or avoidant coping) may be involved without the therapist necessarily being aware of it and still communicating these sentiments in the therapy. another possibility in terms of psychological mechanisms is when we suspect that a client will leave therapy and this suspicion triggers anxiety about being inferior, being left in other relationships, not being “good-enough”, a failure or other signs of downgrading our competence or even ourselves as persons. thoughts and emotions like this are hard to verbalize and therapists may hesitate to reveal to the client that that he/she suspect that the client will leave the therapy. our findings showed that a majority suspected premature drop out but only 23% of the therapists had communicated about their suspicions with the client. it seems like many therapists suspect a dropout, but do not communicate their suspicions. limitations and strengths the study has several limitations. first, the recruitment of therapists was done on the internet via facebook, email to psychiatric outpatient clinics and different psychotherapy networks. this narrowed down the sample to persons frequently using the internet (e.g. social media and online networks) and could be reached. even if the sample was limited by the number of persons who could answer the questionnaire, we still believe we reached a fairly broad sample and that many currently active psychotherapists use the internet and social media. using a postal survey or telephone interview could possibly lead to different estimates and findings even if we doubt there would be major discrepan­ cies. further, although we asked the therapists to think of a particular premature dropout it is difficult to know if the answers reflect a single dropout or if they rather mirror general opinions related to non-agreed premature dropouts. it can be hard to remember premature dropout from psychotherapy 12 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://www.psychopen.eu/ specific emotions or what was going on in hindsight, and we cannot exclude memory bias and selective reporting. cuijpers et al. (2015) also showed that there were differences in how dropout had been defined which makes it difficult to interpret the findings. some strengths with our study are that we measured what therapists clinically en­ counter in association with dropouts. further, the observation that clients drop out fairly often most likely reflects what occurs in a typical clinical setting and adds information to what is already known regarding research and educational settings for psychotherapy where most studies regarding estimated dropout rates have been conducted. finally, the respondents were from different organizations, used therapeutic methods and had varied work experience as therapists. future research this study indicates that there are discrepancies in the number of premature dropouts observed in clinical settings, research studies, and studies made in psychotherapy educa­ tion settings. however, the number of people in the general population who have an experience of premature dropout from psychotherapy is to our knowledge not known and could be investigated as was done long ago with regards to therapy experiences in the consumers report study (seligman, 1995). it is reasonable to assume that there are different reasons behind premature dropouts. to investigate reasons for premature dropout it will be vital to ask clients about their reasons for terminating therapy. to further investigate therapists’ views on the impact of dropout, interviews or focus groups are possible methods to obtain a deeper understanding of processes related to dropout. by analysing video clips of therapy session in which clients subsequently dropout, one could gain a deeper understanding the reasons for and the process of dropout. funding: this study was sponsored in part by linköping university. acknowledgments: we thank webmaster george vlaescu for his help with the survey. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s barrett, m. s., chua, w.-j., crits-christoph, p., gibbons, m. b., casiano, d., & thompson, d. 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(2006). the therapeutic relationship in the brief treatment of depression: contributions to clinical improvement and enhanced adaptive capacities. journal of consulting and clinical psychology, 74(1), 130–140. https://doi.org/10.1037/0022-006x.74.1.130 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. premature dropout from psychotherapy 16 clinical psychology in europe 2022, vol. 4(2), article e6695 https://doi.org/10.32872/cpe.6695 https://doi.org/10.1080/00107530.2014.880318 https://doi.org/10.1037/0003-066x.50.12.965 https://doi.org/10.1037/a0021175 https://doi.org/10.1037/0022-006x.75.1.104 https://doi.org/10.1037/a0017003 https://doi.org/10.1037/a0028226 https://doi.org/10.1037/a0037512 https://doi.org/10.1037/0735-7028.24.2.190 https://doi.org/10.1037/0022-006x.74.1.130 https://www.psychopen.eu/ premature dropout from psychotherapy (introduction) effects of premature dropouts factors related to premature dropout method procedure data analysis participants measures results reasons for dropout emotions related to dropout therapeutic alliance and dropout support from others regarding suspicions about dropout discussion limitations and strengths future research (additional information) funding acknowledgments competing interests references from broken models to treatment selection: active inference as a tool to guide clinical research and practice editorial from broken models to treatment selection: active inference as a tool to guide clinical research and practice lukas kirchner 1, anna-lena eckert 2, max berg 1 [1] department of psychology, clinical psychology and psychotherapy, philipps-university of marburg, marburg, germany. [2] department of psychology, theoretical cognitive science, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2022, vol. 4(2), article e9697, https://doi.org/10.32872/cpe.9697 published (vor): 2022-06-30 corresponding author: lukas kirchner, department of psychology, clinical psychology and psychotherapy, philipps-university of marburg, gutenbergstraße 18, 35037 marburg, germany. e-mail: lukas.kirchner@unimarburg.de computational theories have fundamentally changed the scientific understanding of how the mind works for both healthy and pathological experiences and behaviours. in this context, the active inference framework has gained considerable attention within the scientific community (heins et al., 2022; smith et al., 2022). as a process theory, it integrates complex phenomena, such as perception, learning, and action under a unified theory of bayesian inference (da costa et al., 2020; friston et al., 2017). active inference has proven useful in modelling data from heterogeneous fields ranging from cognitive neuroscience to biology and general psychology (e.g., friston et al., 2016, 2017). its com­ putational tractability and biological plausibility have also made it increasingly relevant to clinical psychology in recent years (e.g., smith, badcock, et al., 2021). in active inference and related, bayesian neurocomputational theories, it is assumed that individuals do not have direct access to the circumstances in their surroundings. instead, they have to infer the (probabilistic) properties of their environment through action and perception by integrating prior information about their environment with ambiguous sensory input in a rational (i.e., bayes-optimal) manner (friston et al., 2016; hohwy et al., 2008). the resulting “internal model of the world” (i.e., the agent’s beliefs about how certain sensory information relates to environmental conditions) shapes future perception (friston, 2010) and enables agents to leverage the past to predict the future in an ever-changing environment (badcock et al., 2017). in accordance with this perspective, perception, action, and learning are all subject to inferential process­ this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9697&domain=pdf&date_stamp=2022-06-30 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ es on different timescales (smith et al., 2022). individuals thus take an active role in constructing their experiences, which they can further alter by actively changing their environment. whereas accurate internal models provide good predictions about which action se­ quences lead to preferred sensory observations, distorted internal models can lead to aberrant experiences and behaviours that may hinder the organism from achieving its goals (badcock et al., 2017; schwartenbeck et al., 2015). there is evidence that the internal models of individuals with mental disorders show substantial deviations from each other and from the models of healthy individuals. for example, recent accounts of depression have conceptualised patients' tendency to reappraise or disregard posi­ tive information in terms of highly precise and hence tenacious negative prior beliefs (kube et al., 2020). this computational perspective has inspired novel ideas for the treat­ ment of depression (e.g., chekroud, 2015). similar reconceptualisations with relevance for psychological treatments have been suggested for numerous mental disorders and health conditions, including psychosis (sterzer et al., 2018), persistent somatic symptoms (paulus et al., 2019), and eating disorders (barca & pezzulo, 2020). in this context, the active inference framework offers the opportunity to formalise deviations in a person’s internal models, thus enabling a detailed description and op­ erationalisation of relevant experiential and behavioural distortions (e.g., montague et al., 2012). from our point of view, this could improve clinical research, diagnostics, and the treatment of mental disorders in several ways. clinical research may benefit from a finely grained formalisation of deviant experiences and behaviours within the active inference framework because it opens up a possibility for studying aetiological mechanisms from a computational perspective (stephan, binder, et al., 2016). because of their generative structure, computational theories enable the derivation of well-opera­ tionalised hypotheses about pathological processes in mental disorders and the computer simulation of aberrant experience and behaviour. in comparison with empirical data, researchers could thus rigorously formalise, simulate, and compare different mechanis­ tic models of patients’ experiential and behavioural symptoms. moreover, the active inference perspective could inform the diagnostics of mental disorders (or rather the diagnostics of patients’ implicit belief systems) by providing practitioners with individual estimates of their patients’ internal model parameters in disorder-relevant situations (stephan, bach, et al., 2016). for example, using probabilistic gambling tasks that dis­ tinguish between goal-directed information seeking and random exploration behaviour could provide clinicians with individual parameter diagnostics regarding the relationship between information seeking, reward sensitivity, and psychopathology in substance abusers (smith, schwartenbeck, et al., 2021). such applications could not only strengthen a more transdiagnostic perspective on mental disorders, but also have tangible implica­ tions for treatment development and treatment selection. if we assume that therapeutic interventions may have different effects on patients' model parameters, finely grained active inference – a tool to guide clinical research and practice 2 clinical psychology in europe 2022, vol. 4(2), article e9697 https://doi.org/10.32872/cpe.9697 https://www.psychopen.eu/ operationalisation in the context of active inference could contribute to tailored interven­ tions that target specifically these parameters. from the practitioner's perspective, it would be particularly important to investigate which tasks are likely to diagnose internal models that inform treatment selection and guide psychotherapy. the active inference approach affords an improved mechanistic understanding of pathological processes in mental disorders. as a unifying process theory of brain and mind function, it brings together perception, learning, action, and decision making un­ der the umbrella of a bayesian principle, which predestines it for clinical application. because of its high degree of formalisation and its flexibility, we believe that the active inference approach is well suited to functionally link heterogeneous clinical phenomena to patients’ internal belief systems. this will enable researchers to better differentiate and operationalise underlying mechanisms and tailor the diagnosis, aetiology, and treat­ ment of mental disorders. funding: this work was funded by the hessian ministry of higher education, research, science, and the arts. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: this work was realised within the cluster initiative “the adaptive mind” (tam) which brings together scientists from experimental psychology, clinical psychology, and artificial intelligence to improve the understanding of how the human mind successfully adapts to changing conditions. tam is funded by the hessian ministry of higher education, research, science, and the arts. r e f e r e n c e s badcock, p. b., davey, c. g., whittle, s., allen, n. b., & friston, k. j. 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(2018). the predictive coding account of psychosis. biological psychiatry, 84(9), 634–643. https://doi.org/10.1016/j.biopsych.2018.05.015 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. kirchner, eckert, & berg 5 clinical psychology in europe 2022, vol. 4(2), article e9697 https://doi.org/10.32872/cpe.9697 https://doi.org/10.1016/s2215-0366(15)00360-0 https://doi.org/10.1016/j.biopsych.2018.05.015 https://www.psychopen.eu/ engaging turkish immigrants in psychotherapy: development and proof-of-concept study of a culture-tailored, web-based intervention research articles engaging turkish immigrants in psychotherapy: development and proof-of-concept study of a culturetailored, web-based intervention hanna reich 1,2 , daniela zürn 1, ricarda mewes 1,3 [1] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. [2] depression research centre of the german depression foundation, department for psychiatry, psychosomatics and psychotherapy, goethe university, frankfurt, germany. [3] outpatient unit for research, teaching and practice, faculty of psychology, university of vienna, vienna, austria. clinical psychology in europe, 2021, vol. 3(4), article e5583, https://doi.org/10.32872/cpe.5583 received: 2021-01-26 • accepted: 2021-08-25 • published (vor): 2021-12-23 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: hanna reich, forschungszentrum depression der stiftung deutsche depressionshilfe c/o universitätsklinikum frankfurt am main, klinik für psychiatrie, psychosomatik und psychotherapie, heinrichhoffmann-str. 10, 60528 frankfurt am main, germany. tel.: +49-69-6301-86341. e-mail: hanna.reich_de_paredes@deutsche-depressionshilfe.de supplementary materials: data, materials [see index of supplementary materials] abstract background: culturally tailored interventions can increase the engagement and the success rate of psychotherapy in immigrant and ethnic minority patients. in this regard, the integration of the patients’ illness beliefs is a key element. applying principles of motivational and ethnographic interviewing, we developed a culture-tailored, web-based intervention to facilitate engagement of turkish immigrant inpatients in psychotherapy. method: the different aspects of the engagement intervention development are described and its acceptance and usefulness were tested in a proof-of-concept trial with an experimental control group design (active control condition: progressive muscle relaxation) in a sample of turkish immigrant inpatients in germany (n = 26). illness perception, illness-related locus of control, and self-efficacy were assessed pre and post intervention. results: the engagement intervention was rated better than the control condition (p = .002) and in particular, participants felt better prepared for therapy after working with it (p = .013). by working with the engagement intervention, self-efficacy increased (p = .034) and external-fatalistic control beliefs diminished (p = .021). however, half of the participants needed assistance in using the computer and web-based interventions. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.5583&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0002-9577-1144 https://orcid.org/0000-0002-4724-9597 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: the developed intervention provides a first step towards feasible culture-tailored psychotherapeutic elements that can be integrated into routine clinical care. the first results regarding acceptance and usefulness are promising. keywords engagement, motivational interviewing, psycho-education, web intervention, cultural tailoring highlights • culturally tailored psychotherapeutic interventions are more effective than generic ones. • we explored the use of native language, web-based interventions for ethnic minority patients. • an engagement intervention facilitated feeling ready for psychotherapy in turkish immigrants. • web-based interventions can address complex themes such as motivational factors and illness beliefs. prevalence rates of psychological distress and disorders are higher in many ethnic minor­ ity populations than in the general population (aichberger et al., 2010; de wit et al., 2008; sariaslan et al., 2014). psychotherapy is a well-established and effective treatment for many mental disorders, but its interventions are based in european tradition and may be difficult to embrace for ethnic minorities (priebe et al., 2011). reasons for less favorable outcomes might be that socioeconomic stressors that have been reported to negatively impact mental health treatment (e.g. lower education, unemployment) are common among immigrant populations in europe (mösko et al., 2008; priebe et al., 2011). meta-analytical evidence on premature discontinuation of psychotherapy showed that low education, but not ‘race’ (i.e., the proportion of white patients) was a predictor of dropout (swift & greenberg, 2012). moreover, conventional psychotherapy may not be sufficiently specific and can be incongruent with the cultural values and worldviews of ethnic minorities (mösko et al., 2008; priebe et al., 2011). unfavorable treatment expecta­ tions, different expectations about the roles of doctors/ psychotherapists and patients, and a different understanding of illness and treatment have been shown to reduce patient motivation to seek for or engage in psychotherapy (drieschner et al., 2004; priebe et al., 2011; reich et al., 2015). last but not least, even if language, per se, is not crucial for the successful delivery of culturally appropriate psychotherapy (benish et al., 2011), the patient must at least have some understanding of what is being said within an intervention. limited access to interpreting services has been shown to curtail immigrant health care throughout europe (priebe et al., 2011). fortunately, some of these factors can be addressed: preparatory interventions in advance of inpatient treatment have been shown to improve knowledge and reduce engaging turkish immigrants in psychotherapy 2 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ tension among patients (best et al., 2009). meta-analytic evidence showed that culturally adapted psychotherapy is more effective than unadapted therapy (hall et al., 2016) and that the extent of cultural adaptation of minimally guided mental health interventions had an effect on intervention efficacy (harper shehadeh et al., 2016). the adaptation of the ‘illness myth’ (i.e., the subjective concepts of illness) in particular was the key moderator for a superior outcome (benish et al., 2011). patients’ ‘illness myths’ include, among others, treatment expectations and self-efficacy beliefs that influence the moti­ vation for psychotherapy and treatment outcome (drieschner et al., 2004; hagger & orbell, 2003). both, subjective illness concepts and self-efficacy, can be influenced by psychological interventions such as motivational interviewing (miller & rollnick, 1991; petrie & weinman, 2012). an integration of techniques from motivational interviewing (mi) and ethnographic interviewing (ei) has been proposed to engage patients from ethnic minorities in psychotherapy (swartz et al., 2007). mi is a ‘directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence’ (miller & rollnick, 1991). it is effective in a broad range of behavioral prob­ lems and diseases (rubak et al., 2005), and is particularly helpful in clients from ethnic minority groups (lundahl et al., 2010). complementing mi, ei focuses on the patient’s cultural background, including perceptions of the world and its nature, values, and faith (westby, 1990). in this regard, it encourages patients to share their own ‘narrative’, the adaptation of which benish and colleagues (2011) found to be the key to a superior outcome in culturally adapted psychotherapy. however, there is a lack of culturally adapted, standardized interventions for immi­ grant patients (mösko et al., 2008; priebe et al., 2011). osilla and colleagues (2012) dem­ onstrated how to develop and deliver a culturally relevant mi intervention successfully on the web. the use of technological platforms is considered as a strategy with great potential to address major barriers to mental healthcare (rebello et al., 2014). given the background outlined above, we aimed to design a web-based intervention providing in­ patients with information and ideas on how they could benefit from the therapies offered in inpatient treatment. the primary goal was to encourage patients to accept psychother­ apy as a culturally appropriate healing practice and thereby increase motivation for psy­ chotherapy. the present study focused on turkish immigrant inpatients who are among the largest immigrant populations in european countries (european commission, 2011). turkish immigrants reported about language problems and difficulties obtaining medical information when hospitalized (giese et al., 2013) and inpatient treatment for common mental disorders was less successful in turkish immigrants than in non-migrants (mösko et al., 2008). the aims of our study were twofold: a) to develop a culture-tailored, web-based intervention to facilitate treatment engagement that can be integrated into routine clinical care without major expense, and b) to conduct a proof-of-concept study, testing the acceptance and feasibility of the intervention and its effect on motivation, control beliefs, and illness representations in a randomized controlled pilot trial. reich, zürn, & mewes 3 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ m a t e r i a l s a n d m e t h o d a) development of the engagement intervention the engagement intervention was based on mi and ei techniques and developed as a web-based tool in german and turkish language versions for the use as one session (approx. 50 minutes) within the first two weeks of inpatient treatment for common mental disorders. we chose a bi-lingual, web-based approach to bridge the gap between patients of turkish origin with poor knowledge of german and the german healthcare system with very scant resources of turkish-speaking therapists. the engagement and the active control intervention were drafted in german and then fully developed in both languages simultaneously through expert discussion, pilot testing and feedback with the help of five turkish native speakers (psychotherapists, medical doctors, professional interpreters, and university students of psychology). summary of the contents the intervention was named sağlığa doğru (turkish for ‘path to health’) and was organized into five sections following the structure of the engagement session developed by swartz and colleagues (2007). at the beginning, a short introduction to the structure and elements of the intervention was given. the first section of sağlığa doğru addressed individual symptoms, illness beliefs, and social consequences of the illness. the aim for the patients was to feel accepted, understood, taken seriously regarding their individual history, and to achieve a positive general orientation about the inpatient treatment. the second section dealt with the patients’ previous treatment experiences, allowing them to specify wishes for the current treatment. the professional help offered in the hospital was introduced as support in addition to the patients’ own resources, such as the family. the patients’ own resources were thereby validated while the integration of professional mental health care into the patients’ support system was facilitated. educational material about the concept, process, and efficacy of psychotherapy was provided in the next section. positive outcome expectancies regarding treatment success were encouraged by providing automated feedback using previous information entered by the patients. section four gave the patients scope to express concerns about their treatment. in addition to practical obstacles (e.g. worries about being away from family during inpatient treatment), psychological and cultural barriers that may hamper partici­ pation in the therapy were addressed (e.g. being ashamed of symptoms, being seen as ‘crazy’). feedback was given that such concerns are quite common, and the patients were encouraged to talk about their concerns with their therapist. the aim of the final section was to strengthen the patients’ commitment to engage in treatment. after a brief summary of the previous contents, the patients were asked to write down their individual goals for the inpatient treatment as concretely as possible, and what they engaging turkish immigrants in psychotherapy 4 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ could do to achieve them. a structured overview of sağlığa doğru is given in table 1; the script of the engagement intervention is available as supplementary materials. table 1 overview of the engagement intervention sağlığa doğru topic of the section aims central message culture-tailored web-mi elements 1. my story reflect upon symptoms and their social consequences; learn that therapist is validating and interested in individual story your personal view of your illness counts, each disease history is different. • turkish sample patient and therapist talk about symptoms and social consequences in a video. therapist behaves in a validating and encouraging manner. • patient is asked about his/her most impairing symptom and to check areas of life in which he/she is impaired. written feedback corresponding to the chosen areas is provided. • patient is asked to write down his/her ‘good reason’ for therapy (‘what do you want to do again after treatment?’). examples and hints are given. 2. treatment – what do i already know? reflect upon previous treatment experiences and draw conclusions for your current treatment you can shape your therapy – say what you like and what you don’t like! • previous treatment experiences are queried in adapted stages. • questions about personal do’s and don’ts for the current treatment based on prior experiences (personal, hearsay, positive or negative nature of experience, personal opinion about psychotherapy). • invitation to express a wish for the treatment. examples are given; patients are encouraged to tell their practitioners about their wish. 3. psychotherapy can help learn about the efficiency and effectiveness of psychotherapy; see how a psychological model can integrate mixed causal illness attributions psychotherapy is an efficient and effective treatment for your disease. • written and graphic material about process and effectiveness of psychotherapy. • video sequence in which the sample patient and the therapist develop a rationale for psychotherapeutic treatment and integrate mixed causal illness attributions (genetic predisposition, family stress, punishment from god, problems dealing with emotions) into a working model for psychotherapeutic interventions. • rating of the personal relevance of causal illness attributions addressed in the video sequence. reich, zürn, & mewes 5 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ topic of the section aims central message culture-tailored web-mi elements 4. possible obstacles clarify and handle (expected) treatment difficulties it is normal to have concerns about treatment – talk about them! • rating of the importance of different practical problems associated with inpatient treatment (e.g. unfamiliar food, difficulties to comply with religious requirements in the inpatient setting). • video in which the sample therapist asks about the sample patient’s concerns regarding treatment. • rating of the importance of psychological and cultural problems associated with psychotherapy. • feedback acknowledging the concerns and stimulating courage to talk about them openly with the therapist. 5. next steps commit to engage in treatment and work for individual goals you can influence the achievement of your goals and improve your health and life. • open-ended questions about individual goals and actions planned. • examples from the sample patient. motivational interviewing (mi) and ethnographic interviewing (ei) elements sağlığa doğru was informed by principles of mi and ei. using open-ended questions and empathic feedback, the patients were asked about their motivation for treatment, their motivation for change, and about their own health history (cf. table 1, sections 1, ‘my story’, and 5, ‘next steps’). natural resistance to change was integrated into the intervention by actively addressing possible barriers and concerns of the patient without judgment (see section 4, ‘possible obstacles’). instead, the patients’ concerns were validated by written feedback and they were encouraged to actively talk about these concerns with their therapist. this should facilitate redirection of resistance into an active client behavior in actual therapy sessions. a further goal informed by principles of mi was patient empowerment that constituted a particular aim of sections 2 and 3 of the intervention. knowledge about the treatment offered and an evaluation of previous treatment experiences were stimulated, as those formed the basis for informed decision making. principles of ei helped us to focus on the cultural background of turkish immigrants living in germany, especially their values and faith. we addressed typical values with video sequences of a male turkish sample patient who talked openly about some issues prevalent in turkish immigrants (e.g. high relevance of religious beliefs and ‘punishment from god’ as a causal illness attribution). after watching the video, the participants were asked to rate how relevant the respective attributions or concerns were to them (see sections 3 and 4, table 1). encouragement to tell one’s own individual story and to actively talk about one’s own illness beliefs was given at various points throughout the intervention. engaging turkish immigrants in psychotherapy 6 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ culturally adapted elements in order to plan and evaluate the cultural adaptations, we used the parameters suggested by hinton and jalal (2014) to create culturally sensitive cbt interventions, i.e., identify­ ing the cultural group, culturally appropriate framing of cbt techniques, identifying and addressing key stressors, and incorporating key local sources of recovery and resilience. sağlığa doğru was culturally adapted in terms of its surface structure, e.g., the use of the native language and an ethnically matched therapist, as well as its deep structure, involving the incorporation of cultural ideas, beliefs, and values (heim & kohrt, 2019). surface structure adaptations included the turkish name sağlığa doğru that was used in all presentations and materials (also the german ones). moreover, we provided a complete turkish language version, for which idiomatic expressions and german stand­ ard terms were carefully translated. in addition, names and identities of sample patient and therapist were informed by turkish immigrants living in germany. for instance, a high relevance of the family and religion were taken into account. comprehensibility for persons with low literacy was also an important goal, as many turkish immigrants in germany had a poor educational background. therefore, as much information as possible was delivered using video, audio, or graphics, and sentences were kept short and grammatically simple. deep structure adaptations were made regarding the ingredients of psychotherapy that make it a culturally accepted ‘healing practice’: a trusting relationship between patient and therapist was modeled in video sequences by a female therapist and a male sample patient both originating from turkey, aimed to help the patient to identify with the intervention and its contents. the therapist embedded in the program gave meaningful feedback and comprehensive information in order to foster the image of a capable ‘healer’. a common rationale for illness was developed by way of example in a video session, in which we integrated a broad variety of causal illness attributions that have been shown to be culturally relevant (minas et al., 2007; reich et al., 2015). to strengthen confidence in the effectiveness of psychotherapy, general information was provided in conjunction with a case vignette as an example of a patient with a turkish migration background who got better following psychotherapy. active control condition the active control intervention consisted of an applied progressive muscle relaxation (pmr) with a duration of approx. half an hour (see table 3). the structure of the pmr was harmonized with sağlığa doğru and offered through a web-based platform with the same content management system. the design was interactive and patients were addressed directly. in videos, the same sample patient as in sağlığa doğru gave illustrative information and examples and reported on his experience with the relaxation process. after introducing the content and structure of the intervention, the purpose and principles of the muscle and breathing relaxation were explained in the first section. in reich, zürn, & mewes 7 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ addition, the participant could select answers to related questions regarding the relaxa­ tion technique. in section two, ‘my muscle and breathing relaxation’, the participant was given the opportunity to participate in a 15-minute pmr audio relaxation session with specific instructions. then, the participants were asked about their positive and negative experiences with the relaxation, with the sample patient providing example answers. the program concluded with further information and suggestions on how to transfer the relaxation exercise to everyday life. b) proof-of-concept study participants and setting the institutional review board of the department of psychology, marburg university, germany, gave ethics approval to the study protocol. all participants provided written informed consent. the study was based on an experimental control group design (see figure 1) to test the feasibility and usefulness of the culture-tailored, web-based engagement intervention described above. participants were recruited between august 2013 and march 2014 in two psychiatric hospitals in the federal state of hessen, germany. we included adult inpatients with a turkish migration background and an icd-10 f3 or f4 principal diag­ nosis (depressive, somatoform, anxiety, or adjustment disorder) in their first or second week of treatment. migration background was categorized as present when one or both parents were not born in germany (schenk et al., 2006). patients with bipolar disorders, acute psychosis, substance abuse disorders, neurodegenerative diseases, and a primary diagnosis of eating disorders were excluded. during the study period, nearly all eligible patients were contacted (about 95%; see figure 1). about 60% of the contacted patients participated in the study. self-reported reasons for non-participation included shame, the current mental state, the duration of the study, lack of reading ability or lack of schooling, little experience in using comput­ ers, and the planned storage of study data. during the first half of the study period, participants were randomly assigned to the experimental conditions (engagement inter­ vention or active control intervention). in the second half, groups were gender-matched to prevent a bias in the results due to an unequal gender distribution and increase internal validity of the study. three patients dropped out shortly after the initiation of the trial. reasons for discontinuation were exhaustion, as well as language difficulties and problems with the contents of the questions. the final total study sample comprised n = 26 inpatients. we hypothesized that patients working with sağlığa doğru were going to feel better prepared for therapy and be more strongly motivated to engage in therapy than those working with the pmr, and that personal and treatment control beliefs as well as self-ef­ ficacy would be stronger after using the engagement intervention than before, while engaging turkish immigrants in psychotherapy 8 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ external-fatalistic control beliefs and threatening illness perceptions would diminish after using sağlığa doğru. figure 1 study design and flow chart process of the study trial participants could choose their preferred language, as all instruments and both interven­ tions were provided in german and turkish. they completed all questionnaires and the intervention on a computer in the presence of a bilingual research assistant (d.z.). the research assistant was ready to provide help at any time, while paying attention to ensure standardized test conditions. written instructions were given for the individual parts of the study. the participants could take a break or discontinue assessments at any time without any consequences. to make participation less taxing, all questionnaires (see below) were completed in a morning session. in the afternoon, participants worked with the intervention, provided feasibility feedback, and completed the questionnaires for the post-assessment. measures clinical diagnoses were reported by the treating physician or psychologist after receiv­ ing written consent. socio-demographics, migration-related characteristics, and dimen­ reich, zürn, & mewes 9 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ sional psychopathology (see supplementary materials) were assessed at the beginning. questionnaires about illness concept and self-efficacy (brief ipq, ipq-r personal and treatment control scales, kkg external-fatalistic control scale, and swe) were applied before and after the interventions. questions regarding acceptance and feasibility were completed at the end of the interventions. all self-rating questionnaires were provided on a computer in german or turkish according to the participants’ choice. the brief illness perception questionnaire (brief ipq) — the brief ipq (nine items) assesses the cognitive and emotional representations of illness (broadbent et al., 2006). response options range from 0 to 10 with labeled endpoints. item 9 (illness causes) has an open response format and was not used in this study. sum scores range from 0 to 80, with higher scores indicating a more pessimistic and threatening illness representation. broadbent and colleagues (2006) demonstrated its validity and reliability. turkish and german versions of the brief ipq were available (weinman et al., 2012). the revised illness perception questionnaire (ipq-r) — the ipq-r scales ‘personal control’ (six items) and ‘treatment control’ (five items) (moss-morris et al., 2002) were used to assess the individual’s assumed self-efficacy and efficacy of treatments, respec­ tively, for controlling the disorder. response options range from 1 (‘strongly disagree’) to 5 (‘fully agree’). high values indicate high controllability of the disorder by the respective domain. reliability and validity of the ipq-r have been confirmed repeatedly (e.g. moss-morris et al., 2002). german and turkish versions of the ipq-r were available online (weinman et al., 2012). locus of control inventory for illness and health (kkg) — the kkg scale ‘exter­ nal-fatalistic control’ (lohaus & schmitt, 1989) captured the extent to which a patient is convinced that his/her complaints depend on chance, fate, or luck. its seven items are answered from 1 (‘not at all’) to 6 (‘fully agree’); sum scores range from 7 to 42. higher values indicate a higher conviction of external-fatalistic control of the illness. acceptable reliability and validity has been shown (lohaus & schmitt, 1989). as no turkish version was available, it was translated following the forward-backward-translation method (brislin, 1970). generalized self-efficacy scale (swe) — based on ten items, the swe (schwarzer & jerusalem, 1995) measures an optimistic anticipation of one’s competence to cope with a situation successfully. it shows convincing evidence of validity and good psychometric properties (luszczynska et al., 2005). response options range from 1 (‘not at all true’) to 4 (‘exactly true’) and sum scores range from 10 to 40. the reliability of the german (jerusalem & schwarzer, 1999) and turkish version (yeşilay et al., n.d.) was satisfactory (luszczynska et al., 2005). engaging turkish immigrants in psychotherapy 10 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ acceptance and feasibility — at the end of the interventions, patients provided their global evaluation of the interventions by rating them on a scale from 0 to 10, with higher values indicating a better rating. subsequently, they answered to four items (‘are you motivated to engage in therapy?’, ‘after using the tool, do you feel better prepared for therapy?’, ‘would you recommend this tool to other patients?’, and ‘was the tool easy to handle?’) on a rating scale ranging from 0 ‘no, not at all’ to 10 ‘yes, absolutely’. the research assistant noted whether participants used the computer and the interventions without assistance and how much time participants spent using the interventions. statistical analyses the distribution of continuous variables was assessed for normality using q-q plots. one univariate outlier was detected: one participant reported 17 years of education because of his university degree. since all other participants had reported 2-12 years of schooling, his value was replaced with the maximum schooling duration (i.e. 12 years). univariate normality was assessed with shapiro-wilk tests and confirmed for all variables except for ‘german language proficiency’, most feasibility variables (see table 3), and self-effica­ cy (swe pre and post). homoscedasticity was inspected visually via box-plots and tested statistically with bartlett’s test for normally distributed variables or fligner-killeen test for non-parametric variables. for all variables, homoscedasticity was confirmed (all p > .05), with the exception of treatment control pre (p = .049). first, the experimental groups were compared regarding socio-demographic, clinical, and feasibility variables. discrete variables were coded dichotomously and their distribu­ tion was checked with 2x2 cross tables. group differences were assessed using a χ2 test or fischer’s exact test in the case of cells with a count less than 5. for sample compari­ sons in continuous variables (see table 2 and table 3), t-tests for normally distributed variables and mann-whitney-wilcoxon u tests for nonparametric variables were applied. then, the effectivity of the engagement intervention in comparison to the active control intervention with regard to treatment-related variables was analyzed using analyses of variance (anovas) for repeated measures with time (pre vs. post) as within-subjects-fac­ tor and experimental group (engagement intervention vs. active control intervention) as between-subjects-factor for each variable. since self-efficacy (swe) was not normally distributed, an equivalent nonparametric analysis was conducted additionally using the package nparld in r (noguchi et al., 2012). for the group that had worked with the engagement intervention, contrast analyses (one-sided t-tests for dependent samples: pre vs. post / wilcoxon signed rank test with continuity correction) were carried out to differentiate whether the observed effects originated from an improvement through the use of the engagement intervention, and were not merely due to variations in the active control condition. reich, zürn, & mewes 11 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ table 2 study sample characteristics variable active control intervention (n = 12) engagement intervention (n = 14) test statistic socio-demographic characteristics age in years 36-59, 48.6 (7.3) 38-58, 47.8 (5.5) t(20) = -0.31, p = .76 female sex 6 (50) 7 (50) χ2(1) = 0, p = 1 education in years 2-11, 6.8 (2.7) 4-12, 7.4 (2.7) t(23) = 0.71, p = .48 being employeda 6 (50) 10 (71.4) or = 2.4 [0.4;17.2], p = .42 migration-related characteristics years since immigrationb 9-40, 30.8 (9.6) 17-43, 28.1 (7.4) t(16) = -0.75, p = .46 german language proficiencyc 1-4, 3.1 (0.9) 2-5, 3.4 (0.8) u = 98.5, p = .43 clinical characteristics (categorical) depressive disorder 9 (75.0) 11 (78.6) or = 1.2 [0.1;11.4], p = 1 somatoform disorder 2 (16.7) 2 (14.3) or = 0.8 [0.1;13.4], p = 1 stress or adjustment disorder 1 (8.3) 1 (7.1) or = 0.9 [0.1;72.3], p = 1 comorbid disorders 10 (83.3) 8 (57.1) or = 0.3 [0.02;2.2], p = .22 note. for continuous variables, minimum to maximum, mean and standard deviation are given. for discrete variables, the frequency and percentage rates are given. aworking part-time or full-time. bn = 2 participants in the active control group were born in germany and are not included here. cself-reported german language proficiency (1 = very good, 5 = none). effect sizes and 95% confidence intervals (as far as available) are reported for all feasibili­ ty variables and treatment-related measures. for normally distributed variables, cohen’s d was calculated; a value of .2 was considered a small effect, .5 a medium effect, and .8 a large effect. cliff’s d was used for non-parametric continuous variables. cliff’s d ranges between -1 and 1, with 0 indicating no effect; |d| < 0.147 was considered a negligible effect, |d| < 0.33 small, |d| < 0.474 medium, and otherwise a large effect. generalized eta squared (ηg2 ) was given as a measure of effect size for the anovas described above; an ηg2 of .02 was considered a small effect, .13 a medium effect, and one of .26 as large. phi was calculated as a measure of effect size for discrete feasibility variables. a value of phi = .1 was considered a small effect, .3 a medium effect, and .5 a large effect. the significance level was set at α = .05; a p-value < .10 was considered a statistical trend and also reported in the results section. with respect to anovas with repeated measures, only statistically significant effects were reported in the results section; all fand p-values can be obtained as supplementary materials. statistical analyses were conducted using r version 3.5.0 (r development core team, 2008). engaging turkish immigrants in psychotherapy 12 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ r e s u l t s participants the sample consisted of n = 26 turkish immigrant inpatients (see table 2). the mean age was 48 ± 6 years, and 50% of the participants were female. on average, participants had received 7 ± 3 years of schooling and approximately 60% were employed in a part-time or full-time job. self-reported german language proficiency was moderate, even though 29 ± 8 years had passed since immigration and two participants were born in germany. the most frequent main diagnosis was depression (77%), followed by somatoform disorder (15%), and stress or adjustment disorder (8%). about 70% of participants had one or more comorbid diagnoses. there were no statistically significant differences between the experimental groups in terms of socio-demographic and clinical characteristics. acceptance and feasibility the overall rating for sağlığa doğru was better than that for the pmr and participants working with sağlığa doğru felt better prepared for therapy (see table 3). participants in both groups showed statistically similar levels of motivation to engage in therapy and willingness to recommend their tool to other patients. table 3 acceptance and feasibility of the interventions variable active control interventionb engagement interventionc test statistic effect size [95% ci] overall rating 5.3 (2.5) 8.4 (1.6) t(18) = 3.63, p = .002 cohen’s d = 1.48 [0.55; 2.41] ‘are you motivated to engage in therapy?’ 8.1 (2.5) 8.7 (1.7) u = 86.5, p = .65 cliff’s d = .11 [-.34; .51] ‘after using the tool, do you feel better prepared for therapy?’ 3.6 (3.1) 7.0 (2.6) u = 115, p = .013 cliff’s d = .60 [.10; .86] ‘would you recommend this tool to other patients?’ 7.2 (2.8) 7.9 (2.1) u = 94, p = .62 cliff’s d = .12 [-.33; .53] ‘was the tool easy to handle?a 8.0 (2.7) 9.4 (1.1) u = 21.5, p = .50 cliff’s d = .23 [-.45; .74] use of the intervention without assistance [n (%)] 5 (45.5) 7 (50) χ2(1) = 0.0009, p = .98 phi = 0.08 time working with the intervention (minutes) 31.7 (6.8) 49.6 (6.9) t(23) = 6.34, p < .001 cohen’s d = 2.61 [1.51; 3.71] note. unless otherwise indicated, m (sd) are presented. rating scales ranged from 0 ‘no, not at all’ to 10 ‘yes, absolutely’. aonly participants that used the intervention without assistance. bn = 12. cn = 14. reich, zürn, & mewes 13 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ only half of the participants were able to use the interventions without assistance, regardless of the experimental condition. however, those who used the interventions by themselves indicated that they were very easy to handle. participants worked approxi­ mately 28 minutes longer with sağlığa doğru than with the pmr. illness perception and self-efficacy brief ipq threatening illness perceptions decreased on a descriptive level after using sağlığa doğru as expected, while there was no change in the pmr-condition. the contrast analysis confirmed a statistical trend in the expected direction (cohen’s d = -0.43, see table 4). after using sağlığa doğru, beliefs in personal (cohen’s d = 0.34) and treatment control (cohen’s d = 0.20) increased, and beliefs in external-fatalistic control decreased significantly (cohen’s d = -0.60). self-efficacy increased after working with sağlığa doğru, while it decreased after working with the pmr with a small and statisti­ cally significant effect for the group*time interaction (ηg2 = 0.024) that was confirmed by the nonparametric approach (wald-type and anova-type test statistic = 7.432, df = 1, p = .006). the contrast analyses confirmed a small effect and a statistically significant increase in self-efficacy after using sağlığa doğru (cliff’s d = 0.22). table 4 usefulness of the engagement intervention regarding treatment-related variables variable active control interventiona engagement interventionb anova (group*time interaction) c contrast analysesd pre post pre post test statistic ηg2 test statistic d [95% ci]e illness concept (brief-ipq) 58.7 (8.5) 58.6 (7.6) 60.3 (6.0) 57.0 (7.5) f(1, 24) = 1.18, p = .288 0.012 t(13) = 1.62, p = .065 -0.43 [-1.22; 0.35] personal control (ipq-r) 17.3 (2.1) 16.7 (3.9) 17.4 (3.9) 18.8 (4.1) f(1, 24) = 2.27, p = .145 0.020 t(13) = -1.36, p = .111 0.34 [-0.44; 1.13] treatment control (ipq-r) 14.7 (2.8) 14.9 (3.6) 15.8 (5.1) 16.7 (4.9) f(1, 24) = 0.17, p = .683 0.001 t(13) = -0.74, p = .236 0.20 [-0.58; 0.98] external-fatalistic control (kkg) 17.0 (6.3) 18.8 (7.1) 16.8 (6.4) 15.0 (6.9) f(1, 24) = 3.94, p = .059 0.019 t(13) = 2.26, p = .021 -0.60 [-1.40; 0.19] self-efficacy (swe) 15.7 (4.1) 14.6 (3.8) 17.4 (6.4) 19.9 (8.2) f(1, 24) = 6.81, p = .015 0.024 v = 15.5, p = .034 0.22 [-0.24; 0.60] note. m (sd) are presented. an = 12. bn = 14. call main effects for group and time were statistically not significant in anova and are not shown. dpre-post comparison for the engagement intervention group only (see statistics section). ecohen’s d for normally distributed data, cliff’s d for swe (not normally distributed). engaging turkish immigrants in psychotherapy 14 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ d i s c u s s i o n our work aimed at developing and piloting a culture-tailored intervention assisting turkish immigrant inpatients to engage in psychotherapeutic treatment. in a proof-of­ concept study, this intervention was rated better than an active control intervention, in particular concerning a better preparedness for psychotherapy. self-efficacy and personal and treatment control beliefs improved through working with sağlığa doğru, while threatening illness perceptions and external-fatalistic control beliefs diminished. multicultural, web-based mi interventions have received positive feedback before, particularly regarding less shame, embarrassment, and discomfort compared to face-to­ face group interventions (osilla et al., 2012). our study demonstrated that a web-based intervention is applicable even in a group of relatively low-educated immigrants, but the pilot trial showed that half of the sample was unable to use the computer and the web-based interventions on their own. we assume that the recruitment strategy of the current study (i.e., approaching potential participants in-person during specialized inpatient treatment for turkish migrants) resulted in a sample that was potentially older and less digitally literate than participants who are typically included into randomized controlled trials, particularly into trials on web-based and app-based interventions with inclusion criteria such as having access to the internet (e.g., heim et al., 2020). under­ standing this barrier to implementation could be addressed by an even more rigorous emphasis on user-centered design for the target population (burchert et al., 2019) or through task-sharing with turkish-speaking non-therapists (e.g. nursing staff) assisting patients with low technical or digital literacy (rebello et al., 2014). the improvements in self-efficacy and personal control beliefs indicate the engage­ ment intervention’s capability to strengthen the belief in one’s own coping abilities. the beliefs that health depends on chance, fate, or luck diminished after working with sağlığa doğru. however, even though the illness perception was less threatening, it remained in the range of a rather pessimistic and threatening concept of disease. it has been shown previously that a threatening illness perception was associated with poor psychological health and low motivation for psychotherapy (petrie & weinman, 2012). while this highlights the relevance of sağlığa doğru, it also suggests that continuous work is needed to achieve longer lasting changes in illness perception (petrie et al., 2012). limitations this proof-of-concept study comprised a small sample, limiting the generalizability of the present findings. only 60% of patients were willing to participate in the study, imply­ ing that participant burden due to study duration and concerns about data storage were relevant barriers towards participation. german and turkish language versions of ques­ tionnaires and interventions were provided to the participants ad libitum, including the options to switch between language versions and use both versions. this approach was reich, zürn, & mewes 15 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ well received and facilitated participation but tracking of the use of language versions was not possible within the system and hence, no further analysis could be undertaken regarding language use. for most turkish-language versions of the questionnaires, psy­ chometric properties, cultural validity, and measurement equivalence with the german versions have not been established to a satisfactory degree, which might compromise reliability and validity of the findings regarding treatment-related variables. contrast analyses were carried out to give a first impression of the effect of the engagement intervention on treatment-related variables, but effects need to be replicated in larger trials since statistical power was, at best, acceptable due to the small sample size. wide confidence intervals containing zero point out that the estimates are imprecise and cannot be readily transferred to a population level. the intervention material included no female sample patient. therefore, the identification with the (male) sample patient might have differed between male and female participants. conclusions the present proof-of-concept study gave an example of how to adapt psychoeducational information and foster treatment engagement in turkish immigrant inpatients in a one­ session, web-based intervention. while we found promising first results, the effect of the engagement intervention on actual treatment engagement and treatment outcome is still to be evaluated. further evaluation is also needed regarding whether a one-session inter­ vention is sufficient, or whether more sessions are necessary to create a reliable effect regarding treatment engagement. the evident limitations notwithstanding, this study provided a novel approach to fostering the engagement of an immigrant population in psychotherapy. it might encourage the further development and application of culturally tailored, web-based treatment elements which facilitate the delivery of psychotherapy or single techniques (e.g., pmr as a relaxation technique). treatment enhancement by web-based interventions can add language and cultural resources in a scalable way and bridge gaps in the field of immigrant and minority psychotherapy. clinical applications may be realized for immigrant and minority patients undergoing professional treatment to increase readiness for and thereby effectiveness of psychotherapy. further applications can be envisioned to facilitate the uptake of professional treatment by using culturally tailored, web-based interventions to bridge gaps in mental health literacy and foster openness for psychotherapy in the most vulnerable populations (e.g. asylum seekers and refugees (böttche et al., 2021), as well as other socio-economic disadvantaged groups, or adolescents and young adults). engaging turkish immigrants in psychotherapy 16 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://www.psychopen.eu/ funding: the authors have no funding to report. acknowledgments: we would like to thank the cooperating clinic sites, namely: vitos clinic for psychiatry and psychotherapy marburg (medical director: prof. dr. dr. matthias j. müller), and parkland clinic bad wildungen (medical director: dr. hartmut imgart). we also express our thanks to dr. david daniel ebert and dipl. psych. christian rosenau for technical support and feedback during the development of the web-based interventions. competing interests: the authors have declared that no competing interests exist. data availability: all data, analytic methods, and study materials are available to other researchers and can be obtained from psycharchives as supplementary materials to this article (reich, zürn, & mewes, 2021a, 2021b). s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include the turkish and german versions of the sağlığa doğru intervention script, additional analyses of the sample characteristics using self-report measures for dimensional psychopathology, test statistics for main effects (table 4), and the full dataset including a codebook (for access see index of supplementary materials below). index of supplementary materials reich, h., zürn, d., & mewes, r. (2021a). supplementary materials to "engaging turkish immigrants in psychotherapy: development and proof-of-concept study of a culture-tailored, web-based intervention" [research data]. psychopen gold. https://doi.org/10.23668/psycharchives.5156 reich, h., zürn, d., & mewes, r. (2021b). supplementary materials to "engaging turkish immigrants in psychotherapy: development and proof-of-concept study of a culture-tailored, web-based intervention" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.5155 r e f e r e n c e s aichberger, m. c., schouler-ocak, m., mundt, a., busch, m. a., nickels, e., heimann, h. m., ströhle, a., reischies, f. m., heinz, a., & rapp, m. a. (2010). depression in middle-aged and older first generation migrants in europe: results from the survey of health, ageing and retirement in europe (share). european psychiatry, 25(8), 468-475. https://doi.org/10.1016/j.eurpsy.2009.11.009 benish, s. g., quintana, s., & wampold, b. e. (2011). culturally adapted psychotherapy and the legitimacy of myth: a direct-comparison meta-analysis. journal of counseling psychology, 58(3), 279-289. https://doi.org/10.1037/a0023626 reich, zürn, & mewes 17 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://doi.org/10.23668/psycharchives.5156 https://doi.org/10.23668/psycharchives.5155 https://doi.org/10.1016/j.eurpsy.2009.11.009 https://doi.org/10.1037/a0023626 https://www.psychopen.eu/ best, m., lange, m., karpinski, n., hessel, a., söpper-terborg, b., sieling, w., & petermann, f. 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(2007). engaging depressed patients in psychotherapy: integrating techniques from engaging turkish immigrants in psychotherapy 20 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://doi.org/10.18637/jss.v050.i12 https://doi.org/10.1037/a0027751 https://doi.org/10.1111/j.2044-8287.2011.02033.x https://doi.org/10.1177/0963721411429456 https://doi.org/10.1186/1471-2458-11-187 http://www.r-project.org https://doi.org/10.1097/yco.0000000000000068 https://doi.org/10.1007/s40615-014-0054-y https://doi.org/10.1007/s00115-013-3767-y https://doi.org/10.1007/s00103-006-0018-4 https://www.psychopen.eu/ motivational interviewing and ethnographic interviewing to improve treatment participation. professional psychology, research and practice, 38(4), 430-439. https://doi.org/10.1037/0735-7028.38.4.430 swift, j. k., & greenberg, r. p. (2012). premature discontinuation in adult psychotherapy: a metaanalysis. journal of consulting and clinical psychology, 80(4), 547-559. https://doi.org/10.1037/a0028226 weinman, j., petrie, k. j., moss-morris, r., broadbent, e., & sivertsen, b. (2012). the illness perception questionnaire. http://www.uib.no/ipq/ westby, c. e. (1990). ethnographic interviewing: asking the right questions to the right people in the right ways. journal of childhood communication disorders, 13(1), 101-111. https://doi.org/10.1177/152574019001300111 yeşilay, a., schwarzer, r., & jerusalem, m. (n.d.). turkish adaptation of the general perceived selfefficacy scale. genelleştirilmiş özyetki beklentisi. http://userpage.fu-berlin.de/~health/turk.htm clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. reich, zürn, & mewes 21 clinical psychology in europe 2021, vol. 3(4), article e5583 https://doi.org/10.32872/cpe.5583 https://doi.org/10.1037/0735-7028.38.4.430 https://doi.org/10.1037/a0028226 http://www.uib.no/ipq/ https://doi.org/10.1177/152574019001300111 http://userpage.fu-berlin.de/~health/turk.htm https://www.psychopen.eu/ engaging turkish immigrants in psychotherapy (introduction) materials and method a) development of the engagement intervention b) proof-of-concept study process of the study trial results participants acceptance and feasibility illness perception and self-efficacy discussion limitations conclusions (additional information) funding acknowledgments competing interests data availability supplementary materials references interoception and premonitory urges in children and adolescents with tic disorders research articles interoception and premonitory urges in children and adolescents with tic disorders christina schütteler 1 , katrin woitecki 2, manfred döpfner 2,3 , alexander l. gerlach 1 [1] department of psychology, clinical psychology and psychotherapy, university of cologne, cologne, germany. [2] school of child and adolescent cognitive behavior therapy (akip), faculty of medicine and university hospital cologne, university of cologne, cologne, germany. [3] department of child and adolescent psychiatry, psychosomatics and psychotherapy, faculty of medicine and university hospital cologne, university of cologne, cologne, germany. clinical psychology in europe, 2023, vol. 5(1), article e8185, https://doi.org/10.32872/cpe.8185 received: 2022-01-20 • accepted: 2022-10-25 • published (vor): 2023-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: christina schütteler, department of psychology, clinical psychology and psychotherapy, university of cologne, pohligstr. 1, 50969 cologne, germany. tel.: 0221 470 5381. e-mail: c.schuetteler@uni-koeln.de supplementary materials: data, preregistration [see index of supplementary materials] abstract background: compared to healthy controls (hcs), adult tic disorder (td) patients exhibit a lower interoceptive accuracy (iacc) in heartbeat perception. since the lower iacc is not evident in children, the age at which tics develop, but in adults only (pile et al., 2018, https://doi.org/10.1007/ s10803-018-3608-8), lower iacc may reflect a pathological mechanism relevant with regard to tics, premonitory urges (pus) or the resulting impairment. although tics are a motor phenomenon, up to date, iacc has been assessed only with a heartbeat-counting task. this study aims at comparing cardiac and muscular iacc using two different paradigms and investigates how iacc is related to premonitory urges in youth. method: interoceptive measures (heartbeat-counting task, muscle tension paradigm) of 28 youth with td were compared to 23 control participants and related to self-rated premonitory urges and tic symptoms. results: td patients did not differ from hcs in any iacc measures. however, within td patients, iacc explained additional variance in pus when controlling for tic severity. muscular iacc in td patients is related to urges and tics, but the direction of this association is unclear. iacc is lower in td patients than in hcs, indicating imprecise sensory input which is more easily overcome by priors within the predictive coding framework. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8185&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0003-4196-4503 https://orcid.org/0000-0002-7929-0463 https://orcid.org/0000-0001-6794-5349 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusions: muscle tension feedback tasks could extend interoceptive trainings aimed at improving iacc to improve accuracy of urge perception (more precise sensory input) to foster the ability to control tics via hrt. longitudinal studies could provide further insights in causal relationships between iacc, premonitory urges and tics. keywords heartbeat, muscle, emg, interoceptive accuracy, predictive coding highlights • a muscle tension paradigm assessed interoceptive accuracy. • patients with tics did not differ from healthy controls in interoceptive accuracy. • muscular interoceptive accuracy in patients relates to premonitory urges and tics. • muscular tension feedback tasks could improve treatment via habit reversal training. tics are sudden repetitive movements or vocalizations that occur in up to 21% of children (cubo et al., 2011; kurlan et al., 2001). in most cases tics disappear with increasing age and remain stable in only about 1% of people worldwide (robertson & cavanna, 2008). tics regularly are preceded by an unpleasant premonitory urge or sensation (pu). pus are often perceived as an urge to move, an impulse to move, inner tension or restlessness and mostly occur in the face, neck, shoulders, arms or hands (kwak et al., 2003). in psychotherapy, the perception of pus is both necessary and problematic. on the one hand, in line with habit reversal training, a precise perception of pus improves the ability to successfully suppress tics (mcguire et al., 2015). on the other hand, pus illicit tics, negatively reinforce tics and correlate with tic severity (li et al., 2019). the capability to perceive bodily signals (‘interoception’) entails several different facets: iacc is defined as the process of accurately detecting and tracking internal bodily sensations (garfinkel et al., 2015). interoceptive sensibility refers to the self-reported at­ tention given to and detection of interoceptive information. finally, interoceptive aware­ ness refer to the metacognitive correspondence between objective iacc and self-report of interoceptive information (garfinkel et al., 2015). in the following, we will only focus on iacc based on the notion that iacc may be an underlying dimension in pus, necessary to perceive interoceptive sensations. adult individuals suffering from a td exhibit a lower iacc in a heartbeat perception tasks whilst reporting a heightened perception of sensory stimuli (interoceptive sensibili­ ty) as compared to individuals without tics. however, this lower iacc is not evident in children but in adults only (pile et al., 2018). so far, iacc in individuals with tds has exclusively been assessed with a heartbeat-counting task (schandry, 1981). arguably, tic symptoms are muscle movements. thus, assessing iacc by looking at the ability of an individual to perceive heart activity may not be the best test of the possible involvement of iacc in td. consequently, this study plans to investigate whether iacc in a muscle interoception and urges in tics 2 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ tension perception paradigm is associated with pus in addition to or over the ability to perceive heart activity. according to a predictive coding account of bodily symptom perception, bodily changes such as heart activity or muscle tension often are weak and imprecise signals. against this background, a heightened interoceptive sensibility for tic related symptoms may be the result of overly precise interoceptive priors. specifically, in tds, an overac­ tive putamen and insula may lead to overly precise predictions at hierarchically higher levels, overriding the actual weak and imprecise sensory inputs. the resulting prediction error may be reduced by performing an ‚involuntary’ tic and/or be the basis for the perception of an unpleasant pu (rae et al., 2019). on the behavioral level, pus may represent a conditioned response to aversive exter­ nal stimuli such as criticism, offenses or social marginalization as result of tic execution. in the course of a td, tics may become associated with those negative emotional va­ lences that subsequently constitute the pu. after a tic is executed, the unpleasant pu dissolves and ticking is negatively reinforced, promoting maintenance of tics (o’connor, 2002). following the o’connor model, an attentional focus on pus and tics may, over time, enhance the overly precise prior even further. as a result, unpleasant pus are perceived even more, impairing patients’ quality of life. indeed, adult td patients with a long history of the experience of tics exhibit lower iacc (ganos et al., 2015; rae et al., 2019). simultaneously, in adults, physical sensations are self-reported more often (interoceptive sensibility) compared to individuals without tics (rae et al., 2019). since a lower iacc is not evident in children but in adults only (pile et al., 2018), lower iacc in adults may reflect a failure to develop, over time, a better iacc if individuals suffering from td, which is commonly found in healthy individuals (murphy et al., 2019). in consequence, given this overly precise prior, the experience of pus continues and may even be strengthened into adulthood. however, given that iacc, so far, has been assessed only with a heartbeat-counting task, it is important to additionally assess whether iacc in children with tds may be increased with regard to the perception of muscular activity, since muscles are involved in the execution of tics. we opted to assess facial muscle tension given that most td patients experience at least one tic in the face (mcguire et al., 2016). thus, in this study we wanted to test the hypotheses, that children and adolescents with pathological tics exhibit lower iacc with regard to both heart activity as well as facial muscle tone as compared to children and adolescents without tics. we also test the hypotheses, that variance in pus is explained by iacc scores. furthermore, we compare muscular to cardiac iacc, using two different paradigms. schütteler, woitecki, döpfner, & gerlach 3 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ m e t h o d participants a total of 51 children and youth between 10 and 19 years old were recruited at the university hospital cologne (28 patients and 23 control participants) and surrounding schools. one patient fulfilled the criteria of a chronic td, 27 patients fulfilled the crite­ ria of tourette’s syndrome according to icd-10. inclusion criteria were a previously diagnosed tic disorder, age 10-21 years and fluency in german. exclusion criteria were insufficient german language skills and the absence of any tic during the last week. twenty of these 28 td patients (71%) were male (13 of 23 hcs, 57%). 7 td patients were diagnosed with a comorbid disorder via diagnostic checklists (5 adhd, 1 ocd, 1 conduct disorder, 1 trichotillomania). two td patients received anti-tic medication (aripiprazole, tiapride), three received medication targeting adhd (methylphenidate). td patients and hcs did not differ with respect to gender (χ2 = 1.229, p = .268) or age. cbcl total scores differed significantly between groups, but not ysr scores (table 1). procedure a two-group design compared td patients with control participants not suffering from a td (hc). td patients and their parents additionally completed questionnaires regarding tic symptomatology and other psychopathology measures. participation took between 70 to 90 minutes. the experimental paradigms measuring iacc were presented via computer screen. participants received an allowance of 8€ per hour. the current study was carried out according to the declaration of helsinki. the ethics commission of the university of cologne’s faculty of medicine approved the study (cshf0044) and the study was pre-registered (see supplementary materials). all participants and their legal guardians gave informed consent. the data that support the findings of this study are openly available in figshare (see supplementary materials). questionnaires the german version of the child behavior checklist (cbcl; döpfner et al., 2014) is a caregiver report and assesses a variety of psychopathological symptoms. in the current study, the internal consistency of the total score was excellent (α = 0.93). the german version of the youth self report (ysr; döpfner et al., 2014) aims at children and youth, is constructed equivalently to the cbcl, and assesses self-reports of a variety of psychopathological symptoms. the total score exhibited good internal consistency in the current study (α = 0.84). both cbcl and ysr consists of the subscales aggressive behavior, anxious/depressive symptoms, attention problems, rule-breaking behavior, somatic complaints, social problems, thought problems, and withdrawal/depression. interoception and urges in tics 4 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ the self-rated symptom checklist for tic disorders scl-tic-s (scl-tic-s) and scl-tic-p (parent-rated) are part of the disyps-iii diagnostic system (döpfner & görtzdorten, 2017). they each assess the number of tics. on a 5-point likert-type scale for each tic the respective intensity (very mild to severe, irritates others), frequency (a few times a week to constantly, every few minutes), and overall impairment (very low, hardly disturbs to extreme) is assessed. additionally, the scl-tic-s assesses overall controlla­ bility (very low to very high). a tic symptom score (range: 0 – 16) is calculated by multiplying intensity with frequency for each tic, summing up the results and dividing the sum by the number of tics (döpfner & görtz-dorten, 2017). internal consistency of the scl-tic total score in the current study was excellent (α = 0.91 for scl-tic-s, α = 0.92 for scl-tic-p). the premonitory urge to tic scale (puts) consists of 10 items and assesses pus (woods et al., 2005). we used the german translation (rössner et al., 2010). the 10th item asks about tic controllability and is usually excluded or interpreted separately to sustain internal consistency (woods et al., 2005). puts’ internal consistency in the current study was acceptable (α = .75 for puts-9, α = .71 for puts-10). experimental measures the mental tracking paradigm (schandry, 1981) was employed to assess iacc based on cardiac sensibility. participants were instructed to concentrate on their heartbeats for three randomly presented time intervals (à 25s, 35s and 45s) and silently count the perceived heartbeats. they were instructed to only count heartbeats that they felt (koch & pollatos, 2014). after a trial run, ecg-electrodes assessed the participant’s ecg (sample rate: 512 hz) and heart beats were assessed online using the software uvariotest (gerhard mutz, cologne, compare meyerholz et al., 2019). a sound signal indicated begin and end of each time interval. participants were not allowed to measure their pulse or time and were not informed about their average heart rate nor the length of each time interval. the mental tracking paradigm is applicable for children and youth at least 10 years old (koch & pollatos, 2014). in the current study, internal consistency of the iacc score for heart activity (hiacc) based on the scores of the three time intervals was good (α = 0.94). facial emg was assessed by skin electrodes placed on the masseter and corrugator supercilii on the left side of each participant’s face. emg placement followed the emg guidelines by (fridlund & cacioppo, 1986). muscle tension iacc was assessed with a paradigm originally developed by flor et al. (1992). reported muscle tension and emg measures were correlated to form an iacc score for the masseter (miacc) and corrugator supercilii (ciacc), respectively. we opted for two facial muscles that have previously been used in muscle discrimination tasks, because most td patients display facial tics (flor et al., 1992). during the task, participants looked at a screen that represented their muscle tension as measured by emg. muscle tension was visualized by a soccer ball schütteler, woitecki, döpfner, & gerlach 5 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ that moves along a line colored in red, green and yellow. participants were instructed to keep the soccer ball in the green target zone for 2.5 seconds by tensing their facial muscles accordingly. a sound signal indicated the successful completion of the task. af­ ter regulating the respective muscle, participants reported the degree of muscle tension they believed the task required on a likert-type scale ranging from 1 to 5. since the axis of the colored line changed with the task (i.e., the green zone represented different intensities of muscle tension), participants needed to rely on interoceptive information only. overall, participants went through 16 tasks as described above for each muscle. the required muscle tension levels varied in equal parts between 15%, 30%, 45% and 60% of the maximal achievable tension level for each participant. this maximal achievable tension level for each participant had been measured directly before the perception task by asking participants to tense the respective muscle as much as possible. data analysis the correlation between perceived and via emg measured muscle tension represent masseter and corrugator iacc scores, respectively. the heartbeat perception accuracy score (hiacc) indicated the ability to perceive one’s own heartbeat accurately and was calculated by employing the following formula with i = time intervals (25s, 35s, 45s) and no = measured heartbeats ns = counted heartbeats: hiacc = 13 ∑i = 1 3 1 − noi − nsinoi the resulting scores ranged between 0 to 1 with higher scores indicating higher cardiac accuracy. independent samples two-tailed t-tests or chi2-tests were used to compare clinical between group measures and group differences in iacc scores. effect sizes are indicated by cohen’s d. all statistical tests are two-sided with p < .05. pearson-productmoment-correlations and multiple regressions determined the relation between iacc scores and tics or pus, respectively. we used spss for these calculations. r e s u l t s interoception in youth with tic disorders does not differ from healthy controls when investigating iacc scores, n = 2 masseter datasets, n = 5 corrugator datasets and n = 1 hiacc dataset needed to be excluded due to technical failure. on average m = 13.18 corrugator trials (range from 2 to 16 trials) and m = 14.92 masseter trials (range from 10 to 16 trials) were valid and could be included. interoception and urges in tics 6 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ table 1 displays descriptive statistics for each group and group comparisons between td patients and hcs. td patients’ and hc’s masseter and corrugator iacc scores are shown in table 1. masseter and corrugator iacc scores did not significantly differ be­ tween td patients and hcs. td patients and hcs did not significantly differ in any of the three iacc measures, even when td patients with comorbidities were excluded and the analysis was repeated (hiacc: t = -0.414, df = 49, p = .68; miacc: t = -1.795, df = 38, p = .08; ciacc: t = -1.309, df = 40, p = .20). table 1 group differences variable td patients healthy controls t (df) p cohen's dn m (sd) n m (sd) age 28 12.65 (2.21) 23 12.86 (2.47) t = -0.324 (df = 49) .75 -0.09 cbcl total score 27 32.19 (17.13) 21 11.24 (7.84) t = 5.188 (df = 46) < .001*** 1.51 ysr total score 26 49.96 (18.50) 23 45.26 (10.62) t = 1.072 (df = 47) .29 0.31 interoceptive accuracy scores hiacc 27 0.59 (0.28) 23 0.61 (0.29) t = -0.244 (df = 48) .81 -0.07 miacc 26 0.42 (0.32) 23 0.53 (0.33) t = -1.115 (df = 47) .27 -0.32 ciacc 26 0.26 (0.36) 20 0.43 (0.34) t = -1.614 (df = 44) .11 -0.48 note. cbcl = child behavior checklist; ysr = youth self report; hiacc = heartbeat perception accuracy score; miacc = masseter interoceptive accuracy score; ciacc = corrugator interoceptive accuracy score. ***p < .001. iacc in a proprioceptive perception task explains variance in premonitory urges in youth scl-tic-s score was m = 5.54 (sd = 2.98, n = 26), mean scl-tic-p score was m = 6.22 (sd = 3.33, n = 27). the mean puts total score for 9 items was m = 18.14 (sd = 5.02, n = 28). ciacc and miacc correlated substantially with each other indicating internal validity, while not correlating significantly with hiacc. table 2 gives an overview over correlations between interoception scores and tic symptoms including pus. table 2 pearson correlations variable 1 2 3 4 5 6 1. puts-9 r – .14 .47 -.06 .39 .24 p .50 .01 .77 .05 .22 n (27) (26) (26) (26) (27) schütteler, woitecki, döpfner, & gerlach 7 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ variable 1 2 3 4 5 6 2. scl-tic-p r – .34 .06 .11 .00 p .08 .77 .59 .99 n (27) (26) (25) (27) 3. scl-tic-s r – .12 .36 .07 p .57 .08 .73 n (26) (25) (27) 4. ciacc r – .58** -.30 p .00 .14 n (25) (26) 5. miacc r – -.23 p .27 n (25) 6. hiacc – note. puts-9 = premonitory urge to tic scale (9 items); scl-tic-s = self-rated symptom-checklist for tic disorders; scl-tic-p = parent-rated symptom-checklist for tic disorders; ciacc = corrugator interoceptive accuracy score; miacc = masseter interoceptive accuracy score; hiacc = heartbeat perception accuracy score. *p < .05. **p < .01. table 3 linear model of predictors of puts-9 total scores with confidence intervals reported in parentheses predictors b 95% ci se b β p zero-order correlation partial correlationll ul step 1 constant 13.45 9.39 17.50 1.96 < .001** scl-tic-s 0.78 0.13 1.42 0.31 .46 .02* .462 .462 step 2 constant 9.70 4.00 15.40 2.73 .002* scl-tic-s 0.50 -0.15 1.14 0.31 .30 .12 .462 .340 hiacc 5.14 -1.51 11.79 3.19 .29 .12 .279 .339 ciacc -4.40 -10.62 1.82 2.98 -.31 .16 -.059 -.313 miacc 8.09 0.88 15.31 3.46 .52 .03* .378 .464 note. r 2 = .21 (p = .020) for step 1, δr2 = .22 (p = .08) and r = .43 (p = .02) for step 2. puts-9 = premonitory urge to tic scale (9 items); scl-tic-s = self-rated symptom-checklist for tic disorders; scl-tic-p = parentrated symptom-checklist for tic disorders; ciacc = corrugator interoceptive accuracy score; miacc = masseter interoceptive accuracy score; hiacc = heartbeat perception accuracy score. *p < .05. **p < .01. interoception and urges in tics 8 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ in youth, tic symptoms vary substantially with age parallel to pus, so tic severity should be accounted for when investigating pus. multiple regression analysis was used to investigate how iacc relates to pus. with puts total score as the dependent variable, self-reported tic total score was entered in step 1 to control for tic severity. hiacc and ciacc and miacc scores were entered in step 2. adding the iacc scores in step 2 led only to a marginally significant change in r 2. note, however, that the miacc score explained significant variance in pus in addition to tic severity in model 2 (compare table 3). d i s c u s s i o n in the present sample of children and adolescents with and without tics, we found that neither hiacc nor proprioceptive iacc scores differed between these groups. these results are in line with recent studies that also did not find any difference in interocep­ tive accuracy (iacc) in children with td (pile et al., 2018). our study extends those findings to the perception of muscle tension. although iacc scores were numerically lower in participants with td, these differences did not reach significance (d = -.07 – .43). whereas lower hiacc compared to hcs has been established in adult td patients, we were not able to demonstrate such differences in our sample of children and adolescents. however, such differences in ia may evolve with increasing age of the td, equal to increasing duration of a childhood-onset td and may be compared to a model of altered interoception in children with chronic pain: top-down processes, such as expectations of uncontrollably ticcing, and bottom-up processes, such as a stressed bodily state, may lead to altered interoception over time (hechler, 2021). it would consequently be highly interesting to assess a sample of adult individuals with td using our muscle tension paradigm. within td patients, recent studies found iacc to be positively correlated with pus in adults (ganos et al., 2015; rae et al., 2019). our findings corroborate this assumption. adding iacc scores (miacc, ciacc and hiacc) to tic severity scores when predicting pus, a substantial (δr 2 = .22) additional amount of variance in pus was explained. note, that neither masseter nor corrugator ia scores were significantly correlated with hiacc. consequently, these different measures of interoceptive ability may cover different facets indicating that different body domains may matter when assessing ia. when taking a closer look at the results, the miacc (r = .39) correlated more strongly with the puts than the ciacc (r = -.06), which even correlated negatively with the puts. in contrast to the corrugator supercilii, the masseter is more frequently contracted deliberately and thus might it be easier to control and it might be easier to estimate its tension. arguably, this may result in a more reliable measure. however, the corrugator supercilii is linked with emotional expression (tan et al., 2012) and, arguably, the location of the corrugator supercilii overlaps with locations most frequently affected by tics (mcguire et al., 2016). schütteler, woitecki, döpfner, & gerlach 9 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ we therefore recommend that future studies nonetheless continue to assess both facial muscles when looking at ia with regard to muscular tension. herbert et al. (2012) compared interoceptive accuracy in eating disorders across two bodily domains – cardiac and gastric –and showed them to be inversely correlated. similarly, we found cardiac and muscular iacc to be inversely correlated in td (rciacc = -.30, rmiacc = -.23), although not reaching significance. following the interpretation by herbert et al., trying to control muscles that feel uncontrollably at times, might increase activation in the sympathetic nervous system which in turn might increase cardiac iacc. in line with flack et al. (2017), activation in the sympathetic nervous system might as well be the result of heightened levels of fear when focusing on muscles associated with unpleasant tic execution. hiacc score did marginally significantly correlate with the puts in our sample of children and adolescents. children have smaller hearts and a lower stroke volume, associated with a higher heart rate which influences heartbeat detection positively (knapp-kline & kline, 2005). in light of this it may be concluded that increased hiacc promotes the perception of pus in children. in summary, these results on the association between ia and pu provide an ambigu­ ous picture. on the one hand, ia clearly is associated with pu, but the direction of this association remains unclear. following our hypotheses, we would have assumed that ia should be negatively associated with pu, as was the case for corrugator perception. in contrast, we find a clear positive association between the perception of cardiac activity as well as tension of the masseter and pu. obviously, more research is needed here. note that the findings linking interoception and pus rely on the puts to represent pus. however, the puts is a self-report measure that more likely represents interocep­ tive sensibility. interoceptive sensibility is known to be altered in children and adults with td (owens et al., 2011; rae et al., 2019) and the measure is challenged by the usual problems associated with self-reports. the relative relationship of interoceptive accuracy, interoceptive sensibility und interoceptive awareness constitute pus’ presence and cognitive, emotional and clinical consequences (garfinkel et al., 2015). we find it especially intriguing to interpret our findings within the predictive coding framework (ainley et al., 2016; friston, 2010; khalsa et al., 2018; rae et al., 2019). in this framework, a difference between sensory input and prior expectation results in a prediction error. following bayesian inference, the prediction error may be resolved by updating the prior expectation or executing a movement to change sensory input. in td patients, in hierarchical higher brain structures, an over-precise interoceptive prior might predict movements. if the weak bottom-up sensory input does not correspond with this prediction, the insula has to resolve the resulting interoceptive prediction error. the anterior insula is hypothesised to update predictions to reduce prediction errors (seth, 2013; seth et al., 2012) and is known to show functional abnormalities in td patients. due to the prior’s over-precision and weight, imprecise sensory input may be interoception and urges in tics 10 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ overcome by the prediction and the prediction error is being ‘explained away’ by the anterior insula as a premonitory sensation (urge to move). in adults, lower iacc is found which, arguably, indeed indicates weaker priors. however, in line with previous research in adults (ganos et al., 2015), we found that lower ia (heart activity and tension of the masseter) is correlated with lower pus. assuming that good ia, over time, leads to weaker priors, a smaller prediction error may result in less pu. in contrast, ia for the tension of the corrugator, was negatively correlated with pu. following this finding, one could argue that the worse the perception of actual physical sensations in areas in which tics occur the more top-down predictions will overshadow interoceptive sensations and result in the perception of pus (perceptual inference). there are a number of limitations to the current study that offer opportunities for fu­ ture research. studies investigating the perception of muscle tension in adult td patients are yet to be conducted to gain further insights on the development of pus over the life span. since the current cross-sectional study allows correlative interpretations only, the longitudinal comparison of chronological changes in hiacc, miacc and ciacc scores, puts and urge thermometers over the lifespan would provide further information on their etiological meanings. in addition, the exploratory findings on ia in child and adolescent td patients need to be replicated, preferably in larger samples. our study exclusively focused on iacc in youth with td. future studies may extend our findings to interoceptive sensibility to disentangle the influence of interoceptive sensibility and iacc on the self-reported perception on premonitory urges. altogether, our sample size was relatively small, compromising statistical power to some degree. td patients usually differ from hcs not only with regard to tics but also with regard to comorbidities such as adhd or ocd, depression or anxiety. when comparing td patients to typically developing children, our study cannot account for the impact of comorbidities such as adhd or ocd due to the relatively small sample size. therefore, the relationship between interoception and tics and pus in td patients with multiple comorbid diagnoses is hard to disentangle. panic and somatic ratings, for example, were found to correlate with higher hiacc in adults in children (eley et al., 2007). comparing td patients with a control group exhibiting matching comorbidities could help to disentangle the complex influences of comorbidities on iacc and pus. in line with pile et al. (2018), additional instructions could be added to muscle tension perception tasks to reduce effects of inattention, a frequent comorbid symptom in td patients, and task-misunderstanding. the puts measures pus as a whole but does not differentiate between contextand time-dependent urges as a state and the pu as a general trait. it is yet to be examined how contextand time-dependent urges, measured by urge thermometers, vary in rela­ tion with changes in pus as a trait and changes in iacc. similar to the puts that measures pus as a general trait, the scl-tic-s and scltic-p measure selfand parent-reported mean tic severity over the course of a week. it schütteler, woitecki, döpfner, & gerlach 11 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ is not clear how accurate self-assessed tic frequency reflects actual tic expression. on the one hand, both child and adult patients underestimate their tic expression (müller-vahl et al., 2014; pappert et al., 2003). on the other hand, parent-reports cannot be accurate either. at least adolescent patients are not observed by their parents most of the day and tic frequency highly depends on context. another study compared children’s self-re­ ported account of tic frequency to objective video ratings of tic frequency in various experimental situations. self-reported tic frequency related to objective measures depen­ ded on the situation. interestingly, the higher children scored on the puts, the better their self-report predicted objective tic-frequency (barnea et al., 2016). this implies that self-reported tic frequency depends on pus and probably iacc. still, as our multiple re­ gression analysis showed, ia explains variance in addition to self-reported tic frequency. the moderate correlation with parent-reported tic-frequency (r = .34) further validates self-reported tic-frequency. the current study holds clinical implications. interoceptive trainings specifically targeting interoceptive domains that are impaired in td may be more beneficial than multisystem interventions (khalsa et al., 2018), so research on the impact of interoceptive trainings aimed at improving heartbeat perception (schaefer et al., 2014) could be expan­ ded by adding muscle tension biofeedback tasks to improve accuracy of urge perception to foster the ability to control tics via hrt. observations from intervention studies examining muscle tension biofeedback in td would provide further insights in causal relationships between iacc, pus and tics. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: christina schütteler reports no conflict of interest. katrin woitecki received royalties from treatment manuals published by hogrefe. manfred döpfner received consulting income and research support from lilly, medice, takeda, and eyelevel gmbh and research support from the german research foundation, german ministry of education and research, german ministry of health, and innovation fund. he received income as head, supervisor, and lecturer of the school of child and adolescent cognitive behaviour therapy at the university hospital cologne and as consultant for child behaviour therapy at the national association of statutory health insurance physicians (kassenärztliche bundesvereinigung). he also received royalties from treatment manuals, books and psychological tests published by beltz, elsevier, enke, guilford, hogrefe, huber, kohlhammer, schattauer, springer, wiley. alexander l. gerlach reports no conflict of interest. data availability: for this article, a data set is freely available (schütteler, woitecki, döpfner, & gerlach, 2020). interoception and urges in tics 12 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • pre-registration protocol • research data index of supplementary materials schütteler, c., woitecki, k., döpfner, m., & gerlach, a. l. (2020). supplementary materials to "interoception and premonitory urges in children and adolescents with tic disorders" [preregistration protocol]. osf registries. https://doi.org/10.17605/osf.io/v3zky schütteler, c., woitecki, k., döpfner, m., & gerlach, a. l. (2021). supplementary materials to "interoception and premonitory urges in children and adolescents with tic disorders" [research data]. figshare. https://doi.org/10.6084/m9.figshare.17121632 r e f e r e n c e s ainley, v., apps, m. a. j., fotopoulou, a., & tsakiris, m. (2016). ‘bodily precision’: a predictive coding account of individual differences in interoceptive accuracy. , philosophical transactions of the royal society: b. biological sciences, 371(1708), article 20160003. https://doi.org/10.1098/rstb.2016.0003 barnea, m., benaroya-milshtein, n., gilboa-sechtman, e., woods, d. w., piacentini, j., fennig, s., apter, a., & steinberg, t. (2016). subjective versus objective measures of tic severity in tourette syndrome – the influence of environment. psychiatry research, 242, 204–209. https://doi.org/10.1016/j.psychres.2016.05.047 cubo, e., galan, j. m. t. g. y., villaverde, v. a., velasco, s. s., benito, v. d., macarron, j. v., guevara, j. c., louis, e. d., & benito-leon, j. (2011). prevalence of tics in schoolchildren in central spain: a population-based study. pediatric neurology, 45(2), 100–108. https://doi.org/10.1016/j.pediatrneurol.2011.03.003 döpfner, m., & görtz-dorten, a. (2017). disyps-iii: diagnostik-system für psychische störungen nach icd-10 und dsm-5 für kinder und jugendliche-iii [diagnostic system for psychiatric disorders according to icd-10 and dsm-5 for children and adolescents]. hogrefe. döpfner, m., plück, j., & kinnen, c. 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(2008). tourette syndrome. oxford university press. rössner, v., müller-vahl, k., & neuner, i. (2010). puts – premonitory urge tics scale: fragebogen für kinder. tourette-syndrom und andere tic-erkrankungen im kindes-und erwachsenenalter [puts – premonitory urge for tics scale: questionnaire for children. tourette-syndrom and other tic disorders in children and adults]. mwv medizinische wissenschaftliche verlagsgesellschaft. schaefer, m., egloff, b., gerlach, a. l., & witthöft, m. (2014). improving heartbeat perception in patients with medically unexplained symptoms reduces symptom distress. biological psychology, 101, 69–76. https://doi.org/10.1016/j.biopsycho.2014.05.012 schandry, r. (1981). heart beat perception and emotional experience. psychophysiology, 18(4), 483– 488. https://doi.org/10.1111/j.1469-8986.1981.tb02486.x seth, a. k. (2013). interoceptive inference, emotion, and the embodied self. trends in cognitive sciences, 17(11), 565–573. https://doi.org/10.1016/j.tics.2013.09.007 seth, a. k., suzuki, k., & critchley, h. d. (2012). an interoceptive predictive coding model of conscious presence. frontiers in psychology, 2, article 395. https://doi.org/10.3389/fpsyg.2011.00395 tan, j.-w., walter, s., scheck, a., hrabal, d., hoffmann, h., kessler, h., & traue, h. c. (2012). repeatability of facial electromyography (emg) activity over corrugator supercilii and zygomaticus major on differentiating various emotions. journal of ambient intelligence and humanized computing, 3(1), 3–10. https://doi.org/10.1007/s12652-011-0084-9 woods, d. w., piacentini, j., himle, m. b., & chang, s. (2005). premonitory urge for tics scale (puts): initial psychometric results and examination of the premonitory urge phenomenon in youths with tic disorders. journal of developmental and behavioral pediatrics, 26(6), 397–403. https://doi.org/10.1097/00004703-200512000-00001 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. interoception and urges in tics 16 clinical psychology in europe 2023, vol. 5(1), article e8185 https://doi.org/10.32872/cpe.8185 https://doi.org/10.1016/j.biopsycho.2014.05.012 https://doi.org/10.1111/j.1469-8986.1981.tb02486.x https://doi.org/10.1016/j.tics.2013.09.007 https://doi.org/10.3389/fpsyg.2011.00395 https://doi.org/10.1007/s12652-011-0084-9 https://doi.org/10.1097/00004703-200512000-00001 https://www.psychopen.eu/ interoception and urges in tics (introduction) method participants procedure questionnaires experimental measures data analysis results interoception in youth with tic disorders does not differ from healthy controls iacc in a proprioceptive perception task explains variance in premonitory urges in youth discussion (additional information) funding acknowledgments competing interests data availability supplementary materials references the cooperative revolution reaches clinical psychology and psychotherapy: an example from germany scientific update and overview the cooperative revolution reaches clinical psychology and psychotherapy: an example from germany jürgen margraf a , jürgen hoyer b, thomas fydrich c, tina in-albon d, tania lincoln e, wolfgang lutz f, angelika schlarb g, henning schöttke h, ulrike willutzki i, julia velten a [a] mental health research and treatment center, ruhr university bochum, bochum, germany. [b] clinical psychology and psychotherapy, technical university of dresden, dresden, germany. [c] department of psychology, humboldtuniversität zu berlin, berlin, germany. [d] clinical child and adolescent psychology and psychotherapy, university of koblenz-landau, landau, germany. [e] clinical psychology and psychotherapy, universität hamburg, hamburg, germany. [f] clinical psychology and psychotherapy, trier university, trier, germany. [g] clinic psychology and psychotherapy of children and adolescents, bielefeld university, bielefeld, germany. [h] clinical psychology and psychotherapy, osnabrück university, osnabrück, germany. [i] clinical psychology and psychotherapy, university witten/herdecke, witten, germany. clinical psychology in europe, 2021, vol. 3(1), article e4459, https://doi.org/10.32872/cpe.4459 received: 2020-09-25 • accepted: 2020-12-30 • published (vor): 2021-03-10 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: jürgen margraf, mental health research and treatment center, ruhr university bochum, massenbergstrasse 9-13, bochum, d-44787, germany. tel: +492343223169. fax: +492343203169. e-mail: juergen.margraf@rub.de supplementary materials: materials [see index of supplementary materials] abstract background: psychology is at the beginning of a cooperative revolution. traditionally, psychological research has been conducted by individual labs, limiting its scope in clinical samples and promoting replication problems. large-scale collaborations create new opportunities for highly powered studies in this resource-intensive research area. to present the current state of a germany-wide platform for coordinating research across university outpatient clinics for psychotherapy. method: since 1999, over 50 such clinics were created in germany. they represent a unique infrastructure for research, training, and clinical care. in 2013, a steering committee initiated a nationwide research platform for systematic coordination of research in these clinics (german abbreviation “kodap”). its main goal is to aggregate and analyze longitudinal treatment data – including patient, therapist, and treatment characteristics – across all participating clinics. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.4459&domain=pdf&date_stamp=2021-03-10 https://orcid.org/0000-0001-5207-7016 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ results: an initial survey (100% response rate) yielded recommendations for improved integration of data collection. pilot data from 4,504 adult (16 clinics) and 568 child and adolescent patients (7 clinics) proved feasibility of data transfer and aggregation despite different data formats. affective, neurotic, stress, and somatoform (adults) and anxiety and behavioral (children and adolescents) disorders were most frequent; comorbidity was high. overcoming legal, methodological, and technical challenges, a common core assessment battery was developed, and data collection started in 2018. to date, 42 clinics have joined. conclusions: kodap shows that research collaboration across university outpatient clinics is feasible. fulfilling the need for stronger cumulative and cooperative research in clinical psychology will contribute to better knowledge about mental health, a core challenge to modern societies. keywords psychotherapy research, outpatient clinics, collaborative research, replication crisis highlights • data from 4,504 adult and 568 child and adolescent patients were successfully aggregated across 23 outpatient clinics. • affective, neurotic, stress, and somatoform (adults) and anxiety and behavioral (children and adolescents) disorders were most frequent; comorbidity was high. • legal, methodological, and technical challenges were overcome, and a common core assessment battery was developed. • 42 clinics have joined a germany-wide research platform for systematic coordination of research in these clinics. longitudinal data collection started in 2018. psychology and psychotherapy are at the beginning of a cooperative revolution (chartier et al., 2018; spellman, 2015). traditionally, research in these fields has been conducted by individual labs, limiting its scope in clinical samples and promoting replication problems. in response to the so-called “replication crisis” in medicine, psychology and related fields (camerer et al., 2018; dumas-mallet et al., 2017; ioannidis, 2005; open science collaboration, 2015; pashler & wagenmakers, 2012), the search for causes revealed meth­ odological issues including insufficient sample sizes (button et al., 2013; flint et al., 2015; rossi, 1990; simmons et al., 2011) and the “file drawer problem” (aka publication bias; kirsch et al., 2002; rosenthal, 1979; turner et al., 2008). these proximal causes are wors­ ened by misaligned incentives in a context of dwindling research funding and increasing pressure to publish or perish (margraf, 2015; spellman, 2015). in addition, basic aspects of our academic cultures may serve as major contributors to the crisis by accelerating a race that, under the motto "winner takes all", favors fundamentally undesirable developments (fang & casadevall, 2012b). these “cultural” aspects include an exaggerated cult of originality (fang & casadevall, 2012a) and the “toothbrush problem” (mischel, 2008): we collaborative psychotherapy research in germany 2 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ tend to treat other peoples’ theories like toothbrushes — every decent person uses one but no self-respecting person wants to use anyone else’s. if getting and keeping your job and status requires achieving “originality” by not building on anyone else’s work, it may directly undermine the goal of building a cumulative science (mischel, 2008). the conflict applies not only to theories but also to therapies: the field is full of overstated claims of originality and uniqueness, leading to ill-founded distinctions and misguided competition that impede fruitful cooperation. as a result of this “disconnect between what is good for scientists and what is good for science” (nosek et al., 2012, p. 616) we have a situation, where “most published research findings are false” (ioannidis, 2005) and “most clinical research is not useful” (ioannidis, 2016). we cannot, however, simply deplore external pressures and individual misconduct, we must also devote our critical attention to the cult of originality and priority and the overemphasis on individual contributions that underlie them. we need to pursue an academic community that works collectively, albeit competitively, to advance theory and therapy. this requires developing common shared tools and a more serious quest for ro­ bust, replicable and consequential findings (mischel, 2009). the importance of teamwork in science has never been greater (fang & casadevall, 2012a). teams increasingly domi­ nate science and are contributing the highest-impact and most reliable research. collabo­ rations, consortia and networks are essential for tackling many of the most important challenges in psychotherapy and psychosomatics. luckily, scientists in psychology and medicine recently have opened up much more to new forms of increased collaboration, allowing them to initiate projects at a scale previously unattained. perhaps the most visible hallmark of the cooperative revolution has been the rapid increase in large-scale collaborations such as manylabs, manybabies, open science collaboration, psychologi­ cal science accelerator, registered replication reports, and studyswap (chartier et al., 2018). our research questions as well as our often still inadequate measurement accuracy typically require very large samples (margraf, 2015). large joint projects and individual projects coordinated with them must complement each other, and the necessary infra­ structure must be developed. this should create new opportunities for highly powered studies even in resource-intensive areas such as psychotherapy research. the present article describes the example of an innovative approach to collaborative psychotherapy research from germany (hoyer et al., 2015; in-albon et al., 2019; velten et al., 2017, 2018). since germany established the legal basis for psychotherapy outpatient clinics at university departments of clinical psychology in 1999, over 50 such clinics devoted to research (i.e., research clinics) and to clinical training of psychotherapists (i.e., training clinics) were created. each year, many thousand patients across all age and clinical groups are treated under routine clinical conditions as well as in circumscribed research projects (in-albon et al., 2019; velten et al., 2018). together, they represent a unique infrastructure for research, training and clinical care that rapidly has proven to be an important facilitator of research in psychotherapy and mental health. the clinics margraf, hoyer, fydrich et al. 3 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ routinely gather a large amount of data on therapy outcomes as well as on patient and therapist characteristics (velten et al., 2017). high standards of quality assurance are achieved in these outpatient clinics through regular, standardized diagnostic assessments. these data can also be used for research, in particular psychotherapy research (e.g., ziem & hoyer, 2020). in spite of this remarkable track record, the full potential of synergetic gain from a systematic coordination of research at the clinics had until recently not yet been sufficiently exploited. the scientific evaluation of treatment data is particularly difficult for clinics with a smaller number of cases: patients and therapists often invest time and effort to answer questions about symptoms, the course of therapy or therapeu­ tic relationships without sufficiently large samples for quantitative analysis. up to now, the combination of the collected data with other clinics has been an exception that was limited to individual multicenter research projects (e.g., gloster et al., 2011; hoyer et al., 2016; lutz et al., 2009). nonetheless, the chances of an aggregation of research data across clinics are manifold. research coordination would involve a standardization in diagnostic documentation, a standardized reporting system and consequently the possibility of aggregating data from several or all outpatient clinics. proposals for practice research networks have already been discussed on various occasions (e.g., borkovec et al., 2001; castonguay, 2011). a collaborative approach offers a number of important advantages: with the aggregated basic data, research with a large number of cases can be carried out in a short time. if necessary, comparatively rare disorders or their variants (e.g., skin picking disorder, depersonalization/derealization disorder, sexual dysfunctions; balon, 2017; sierra & david, 2011; velten et al., 2021) even those not yet explicitly defined in classification systems (e.g. facebook addiction disorder; brailovskaia et al., 2018, 2019) can be investigated. in the case of more frequent disorders, the high number of cases allows subgroup comparisons and valid benchmark analyses to be carried out. current topics such as the investigation of therapist data, discontinuation rates, the hotly debated topic of failures and side effects (jacobi et al., 2011), transgenerational psychotherapy effects (schneider et al., 2013) or groundbreaking developments in basic research (such as in the area of therapygenetics; coleman et al., 2017; rayner et al., 2019; roberts et al., 2017, 2019; wannemüller et al., 2018a; wannemüller et al., 2018b) could be addressed more quickly with highly visible studies based on large clinical data sets. ultimately, the collaborative database provides a valuable starting point for applying for major projects. in 2013, an initiative group began to lay the groundwork for the systematic coordi­ nation of research in the german university outpatient clinics for psychotherapy in order to create a nationwide research platform for clinical psychology and psychothera­ py (german abbreviation “kodap” for “coordination of data acquisition at research clinics for psychotherapy”). this platform will allow the aggregation and analysis of longitudinal treatment data – including patient, therapist, and treatment characteristics – across all participating clinics for adults, children and adolescents. the short-term goal collaborative psychotherapy research in germany 4 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ of kodap was to establish the feasibility of large-scale coordinated research. medium to long-term goals of the project are the advancement of theory, practice, and dissemination of psychotherapy and clinical psychology. the present article describes the steps taken, the challenges that had to be overcome and four feasibility studies that were carried out. o v e r v i e w o f f e a s i b i l i t y s t u d i e s immediate goals of study 1 (hoyer et al., 2015) were (a) to gather information on the core characteristics of the clinics and on this basis (b) to develop proposals for better integration of research efforts. in order to estimate the size and clinical composition of potential populations for future studies the number of patients initiating treatment in the participating kodap outpatient clinics in 2016 as well as their diagnoses and psychopathological complaints together with the database, research and administrative software used in the clinics were recorded. immediate goals of study 2 (velten et al., 2017) were (a) to develop a comprehensive catalogue of the considerable logistical, technical and legal data protection challenges facing the planned research collaboration, (b) to use this to examine the workability of cross-clinic collection of patient, therapist and therapy data and (c) to plan the third and fourth pilot studies. study 3 (velten et al., 2018) and study 4 (in-albon et al., 2019) aimed (a) to actually aggregate patient data across a pilot sample of clinics (study 3: adults, study 4: children and adolescents) treated in 2016 and use this (b) to test all the processes necessary for data preparation, transmission and aggregation at the cooperation partners and the central coordination center. the focus was on the frequency distribution of treatment diagnoses to answer the following research questions: which disorders are frequently treated, which are rarely? how high is the proportion of severely distressed patient groups with more than one disorder diagnosis, at least one personality disorder or severe symptoms? study 1 (hoyer et al., 2015) method a complete list of outpatient clinics at german university departments of clinical psy­ chology and psychotherapy for the psychotherapeutic treatment of adults, children and adolescents (referred to as “clinics” in the following) was compiled in 2014 (hoyer et al., 2015). this yielded 53 institutions whose scientific and managing directors were contacted by e-mail in may 2014 with the request to complete a short survey form. a questionnaire was developed by the initiative group to record the characteristics of the clinics. it asked for the diagnostic instruments, disorder-specific and general clinical questionnaires, as well as the patient and therapist variables of interest. in addition, the type, strengths and weaknesses of the clinical, research and administrative software used was assessed by open questions. finally, the clinics reported the annual number of pre margraf, hoyer, fydrich et al. 5 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ and post therapy datasets of all patients (i.e., defined as any person for whom a patient file was created) treated in 2013. case numbers for adults and children and adolescents were asked separately. results all 53 clinics contacted provided data on their institution by november 2014 (100% response rate). whereas some of the clinics were still in the planning or construction stage or could not provide reliable data on current patient numbers for technical reasons, 49 clinics were able to provide information on their annual number of patients. estimates (some of the clinics were able to provide only approximate data) for patients treated in 2013 yielded 8200 preand 5400 post-therapy data records for adults, and 2400 preand 1100 post-therapy data records for children and adolescents. there were clear overlaps in the methods used for the diagnosis of mental disorders as shown in table 1. given the large number of different mental disorders treated in the clinics, it is not surprising that more than 150 different disorder-specific instruments were identified by the survey. table 1 diagnostic assessments utilized routinely in outpatient clinics (instruments used by at least 15% of clinics). instrument % of clinics using instrument instruments used for icd/dsm diagnoses adults structured clinical interview for dsm-iva, scid 89.2 international diagnostic checklistb, idcl 21.6 diagnostic interview for mental disordersc, dips 16.2 children and adolescents diagnostic interview for mental disorders in childhood and adolescenced, kinder-dips 85.7 general clinical instruments adults brief symptom inventorye, bsi 62.2 symptom checklist 90-revisedf, scl 90-r 45.9 inventory of interpersonal problemsg, iip 27.0 clinical global impressions scaleh, cgi 24.3 children and adolescents child behavior checklisti, cbcl/6-18r 64.3 youth self-report of the child behavior checklisti, ysr/11-18r 57.1 teacher report formi, trf/6-18r 50.0 inventory for the assessment of life quality in children and adolescentsj, ilk 42.9 collaborative psychotherapy research in germany 6 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ instrument % of clinics using instrument disorder-specific instruments adults beck depression inventoryk, bdi i or bdi ii 89.2 body sensations questionnaire, agoraphobic cognitions questionnaire, mobility inventoryl 64.9 screening for somatoform symptoms 2m, soms 2 56.8 eating disorder inventory 2n, edi 2 48.6 social interaction anxiety scaleo, sias 48.6 hamburg obsessive/compulsive inventoryp, hzi 45.9 social phobia-scaleo, sps 43.2 posttraumatic stress diagnostic scaleq, psd 40.5 impact of event scaler, ies 35.1 eating inventorys, fev 29.7 borderline-symptom-list-23t, bsl-23 29.7 yale brown obsessive compulsive scaleu, y-bocs 27.0 children and adolescents children's depression inventoryv, dikj 64.3 fear survey schedule for children – revisedw, phoki 57.1 social phobia and anxiety inventory for childrenx, spaik 35.7 anxiety questionnaire for school studentsy, afs 35.7 awittchen et al., 1997. bhiller et al., 1997. cmargraf et al., 2017; schneider & margraf, 2011. dmargraf et al., 2017; schneider et al., 2009. ederogatis & spencer, 1993; franke, 1997. fderogatis, 1992; franke & derogatis, 1995. ghorowitz et al., 2000. hguy, 1976; kadouri et al., 2007. idöpfner et al., 2014. jmattejat & remschmidt, 2006. khautzinger et al., 2000, 2009. lehlers et al., 2001. mrief et al., 1997. npaul & thiel, 2004. ostangier et al., 1999. pzaworka et al., 2003. qgriesel et al., 2006. rmaercker & schützwohl, 1998. spudel & westenhöfer, 1989. twolf et al., 2009. uhand & büttner-westphal, 1991. vstiensmeier-pelster et al., 2014. wdöpfner et al., 2006. xmelfsen et al., 2001. ywieczerkowski et al., 1981. the systematic collection of essential patient characteristics such as age, gender and diagnosis (see table 2) is a standard in all participating clinics. in addition, most clin­ ics also record level of education, marital status and the number of therapy sessions. the documentation of therapist characteristics is limited to therapist gender, age and training status in most clinics. a large number of different software programs for patient data maintenance, room planning and billing as well as other administrative purposes are used by the clinics. these include programs from commercial providers as well as individual database solutions created in-house. the three most frequently cited software tools were psychoeq (psychoware software), ambos (therapy organization software) and self-developed spss or microsoft excel databases. the most frequently named strengths of the respective software solutions are their individual adaptability to the needs of the clinic, easy exportability of the data, simple operation and good support from the manufacturer. frequently mentioned weaknesses of the programs are the susceptibility to errors, the limitation of data export only via employees of the manu­ margraf, hoyer, fydrich et al. 7 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ facturer as well as the missing possibility to record specific variables such as therapist characteristics. table 2 patient and therapist characteristics reported in feasibility study 1 variable % of clinics giving information patient characteristics age 100 gender 100 diagnosis (icd-10) 100 level of education 95.9 marital status 93.9 number of treatment sessions 93.9 index diagnosis 89.8 therapist characteristics gender 77.6 age 69.4 training status (fully licensed vs. in training) 65.3 study 2 (velten et al., 2017) method the results of the first pilot study were evaluated by the initiative group1 in several face­ to-face meetings as well as in telephone and skype conferences in 2015 and 2016. two subgroups dealt with the variables for adults and for children/adolescents, respectively. this led to the following structure of the catalogue of logistical, technical and legal data protection challenges facing the planned research collaboration: (1) organizational framework conditions, (2) cooperation agreement, (3) steering group, (4) coordination center, (5) initial set of variables to be collected for adults and for children and adoles­ cents, (6) process to expand the dataset in the future, (7) data protection of transmitted information and ethical approval, (8) planning of the final feasibility study (velten et al., 2017). for each of these sections specific recommendations were formulated on the basis of unanimous decisions. in addition, the procedures for patient informed consent and ethical approval of the project had to be developed. 1) c. bennecke, m. berking, j. hoyer, t. in-albon, t. lincoln, w. lutz, j. margraf, a. schlarb, h. schöttke, u. willutzki. collaborative psychotherapy research in germany 8 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ results based on the results of study 1, the initiative group for the development of research cooperation derived recommendations regarding the catalogue of challenges for the cooperation project listed below. all recommendations were formulated on the basis of unanimous decisions by the initiative group. (1) organizational framework conditions — the planned research cooperation re­ quires a solid organizational basis that must be supported by a legal entity. on 20 march 2017, unith.ev began to serve as the organizing institution of the kodap project. unith.ev (the network of german university outpatient clinics for psychotherapy) is a registered non-profit association (the german “ev” stands for registered association, “unith” combines “university” and “therapy”). the sponsorship by a registered associa­ tion clarifies the continued legal responsibility, and the non-profit character underlines the non-commercial character of its research, which serves the common good. (2) cooperation agreement — in order to legally secure the ambitious project, a cooperation agreement was drafted which regulates the rights and obligations of all par­ ticipating clinics. it specifies the subject matter of the contract and provides the relevant information on the duration, confidentiality, liability and termination of membership in the project. in order to ensure the effective execution of the scientific and operational work of the research network, a steering group and a coordination center had to be established. their respective tasks are also defined in the cooperation agreement (in german language, available from the first author on request). (3) steering group — the tasks of the steering group include the development, sup­ port and conception of kodap's research activities. at present (mid-2020), the steering group consists of most members of the initiative group, which was formed in october 2013 at the annual meeting of german university professors of clinical psychology and psychotherapy. so far, the group met about three times a year, addressing the essential steps of the project, taking decisions by consensus. it currently consists of 8 members, representing 8 different universities. rules of procedure were adopted in january 2017 to govern the rights and duties of the steering group (in german language, available from the first author on request) and contain guidelines for publications based on kodap data. (4) coordination center — the main tasks of the coordination center are the collection, storage, quality control, aggregation and statistical analysis of the data obtained. the data sets which the participating clinics provide annually for the kodap project are aggregated and stored in the coordination center. this task was taken over by the mental health research and treatment center of ruhr university bochum. regular reports, margraf, hoyer, fydrich et al. 9 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ which serve to keep the partners continuously informed about the progress of work, are prepared by the coordination center. the rights and duties of the coordination center are set out in the cooperation agreement (in german language, available from the first author on request). (5) initial set of variables — the initial core data set defined is presented in table 3. table 3 initial core set of variables to be collected for adults and for children and adolescents patient characteristics all age (years) gender previous psychological or psychosocial treatments index and additional diagnoses (icd-10, before and after therapy) based on structured or standardized clinical interviews level of education clinicians global impression scalea, cgi adults marital status brief symptom inventoryb, bsi or symptom checklist 90-revisedc, scl 90-r beck depression inventoryd, bdi i or bdi ii children and adolescents child behavior checkliste, cbcl youth self-report of the child behavior checkliste, ysr 11-18r psychosocial stressors (max. 5) living situation parent variables: bsib or scl-90-rc, level of education, partnership status therapist characteristics gender age training status (fully licensed vs. still in training) treatment variables number of therapy sessions type of treatment performed current treatment status (ongoing, discontinued, regular termination) aguy, 1976; kadouri et al., 2007. bderogatis & spencer, 1993; franke, 1997. cderogatis, 1992; franke & derogatis, 1995. dhautzinger et al., 2000, 2009. edöpfner et al., 2014. collaborative psychotherapy research in germany 10 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ the aim of assessing only a limited number of variables was to minimize the additional burden of data collection for kodap and to allow clinics to continue using established assessments. since the psychometric instruments are given before and after treatment, it is possible to evaluate therapy outcome. all patient and therapist data are collected in pseudonymized form. special consider­ ation needs to be given to the problem of personal data, as is emphasized in article 26 of the basic eu data protection regulation (see regulation [eu] 2016/679; european parliament and council, 2016), which became effective in may 2018. kodap follows the recommendations of a task force of the german society of psychology. as a consequence, the kodap project does not collect data that are used in combination by a "person at his or her own discretion [...] to identify the natural person directly or indirectly" (article 26). in order to ensure that individual patients even those with rare disorders cannot be identified on the basis of personal characteristics such as occupation or date of birth, only basic characteristics (level of education, age in years, gender, preand post-therapy diagnoses) are to be collected in the kodap project. this procedure enables the storage of different data for a given patient over several years necessary for the longitudinal data collection, one of the central goals of kodap. the same considerations also apply to the selection of therapist variables; therefore only information on age, gender and training status are recorded. with respect to treatment variables, the current treatment status (ongoing, completed or discontinued therapy), number of sessions and type of psychotherapeutic procedure are stored. (6) process to expand the dataset in the future — since the success of kodap essentially depends on smooth and reliable data collection and combination, only a manageable number of patient, therapist and therapy variables should be transmitted at the start of the project. however, a particular strength of a large-scale collaborative project is that it allows the investigation of rare disorders or therapy phenomena as well as new survey instruments. an extension of the initial data set is therefore planned for the future. it is relatively easy to extend the data set with instruments or variables, of which we know from study 1 (hoyer et al., 2015) that the majority of clinics already use them (e.g., sps, sias, soms 2, edi 2). in the long term, the survey can be expanded by follow-up data through multiple measurements across the course of therapy as well as freely available psychometric instruments. similar to the british improving access to psychological therapies (iapt) (clark, 2018) program, kodap will also serve to develop and establish public domain instruments. in addition, all participating project partners are free to propose additional time-limited research questions. if an additional variable that is relevant for many patients is specifically collected over a clearly defined period (e.g., 3 or 6 months) in all clinics, large, clinically well-documented samples can be obtained in a very short time. margraf, hoyer, fydrich et al. 11 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ (7) data protection and ethical approval — as the variables to be collected in the clinic include sensitive treatment and health data special attention had to be given to data protection aspects in the run-up to the project as discussed in section (5) above. with regard to data transmission, various technical implementations were examined by the steering group. the solution needed to ensure longitudinal data collection, secure data transmission and storage, easy application by the clinic and low maintenance in the coordination center. in order not to delay the start of the project due to costly and time-consuming technology, we decided to merge the data records into one spss data record. a corresponding spss template (for adults or children and adolescents) is provided to all participating clinics at the start of the project, which will be sent back to the coordination center on encrypted data carriers at the end of the first project year. the data are stored in secured form on the server of the coordination center. in order to ensure that the transfer of patient data in kodap is ethically acceptable, an informed consent form was developed, which has to be signed by the patients before the start of treatment (in german language, available from the first author on request). before the start of the project, the ethics committee of the faculty of psychology at ruhr university bochum approved the project. the clinics are, however, free to additionally secure their participation in the project by submitting their own applications to their local ethics committees. (8) planning of the final feasibility studies — the first transmission of data, which form the basis for longitudinal analyses over several years, was planned to take place between the clinics and the coordination center in january 2019. at this point, the core data of those patients whose treatment started in 2018 were to be transmitted. before this, however, it was planned to pilot the processes necessary for data preparation, trans­ mission and aggregation at the cooperation partners and the coordination center. for this purpose, the clinics that joined the project by september 2017 provided the patients' core data sets from 2016 for two final (the third and fourth) feasibility studies. the benefits of these feasibility studies go far beyond the mere optimization of the project processes as descriptive statistics of patient data (e.g., distribution of diagnoses, age structure, type and number of co-morbidities and severity of treated disorders) are not yet available for german psychotherapy clinics. study 3 (velten et al., 2018) method as of june 2018, 32 clinics from 15 locations had joined the kodap project (26 for adults and 6 for children and adolescents). these were invited to contribute the initial core set for adult patients (see table 3). all patients treated in the participating clinics in 2016 as well as their therapists were to be included, no other inclusion or exclusion criteria applied. a total of 16 clinics for adults were able to provide data sets (velten et al., 2018). collaborative psychotherapy research in germany 12 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ reasons for non-participation were the lack of data due to the recent establishment of clinics and the missing approval by ethics committees for the transmission of data from 2016 because of a lack of coordinated consent forms. the participating clinics checked their internal data for completeness and compatibility and assessed the time and personnel required to process and transmit the data. in the coordination center data quality and ease of data transmission were tested. faulty data points were reported back to the clinics. in addition, study protocols with precise information on all variables were sent to the clinics, which were to be returned to the coordination center together with the quantitative data set. a qualitative evaluation of the study protocols was used to check the variables for conclusiveness and to identify difficulties in data collection. in order to prevent possible personal identification, some variables (e.g., occupa­ tion, exact time of treatment, transgenderness) were not collected. icd-10 f diagno­ ses (dilling, mombour, schmidt, & weltgesundheitsorganisation, 2005; world health organization, 1993) at the beginning of treatment were recorded separately for the initial or index diagnosis (defined as the main reason for presentation) and for additional diagnoses. reported diagnoses had to be derived from a standardized diagnostic tool or a structured interview according to icd-10, dsm-iv or dsm-5. in addition to the patient, therapist, and therapy variables listed in table 3, the average number of patients treated during the study period was computed. results of the 26 kodap adult clinics, 16 clinics (61.5%) from ten locations (humboldt-universi­ tät zu berlin, freie universität berlin, bochum, dresden, greifswald, hamburg, landau, mainz, trier, osnabrück) provided data on 4504 individuals treated in 2016 (start of treatment could have been in 2016 or earlier). the number of records transmitted per clinic ranged from 24 to 756. the completeness and quality of the data (e.g. with regard to the coding of the response options) were checked in the clinics. with the support of the coordination center, all clinics were able to adapt their internal data collection in such a way that all defined variables for the future longitudinal study could be transmitted in an adequate form. all participating clinics were able to provide the time and personnel resources needed for the preparation and transfer of the data records. all clinics transmitted the data sets to the coordination center in compliance with data protection regulations (velten et al., 2017). patient sociodemographic — the majority of the persons treated (mean age = 37.87; sd = 13.47; range = 15-86 years) were female (n = 2937, 65.3%) and currently in a partnership (n = 2383, 67.5%). marital status was reported as 49.4% (n = 1777) single, 29.4% (n = 1058) married and 9.2% (n = 332) divorced. the highest school degree attained was the german “abitur” (equivalent to a-level or international baccalaureate diploma) for 48.2% (n = 1518), intermediate school certificate (german “mittlere reife”) for 29.4% margraf, hoyer, fydrich et al. 13 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ (n = 926) and basic school certificate (german “hauptschulabschluss”) for 18.1% (n = 570). at the start of treatment, 68.7% (n = 803) of the patients were able to work. in addition to the 18.6% (n = 217) disabled patients, 5.5% (n = 64) received a retirement pension and 3.1% (n = 36) an invalidity pension. patient diagnoses — nearly all clinics stated that the diagnosis at the beginning of treatment was confirmed by structured or standardized interview procedures. only one outpatient clinic reported that an interview was not always used. a total of 7947 diagnoses were assigned to 4266 patients. neurotic, stress and somatoform disorders (f4) were the most common category, followed by affective disorders (f3). a recurrent depressive disorder, currently a moderate episode (f33.1), was diagnosed 844 times, making it the most common disorder. with 651 and 539 assigned diagnoses, social phobia and the moderate depressive episode were the second and third most common disorders. personality and behavioral disorders were diagnosed a total of 563 times. at least one personality disorder (f60 or f61) was present in 10.8% of all patients. the distribution of index diagnoses, which were defined as treatment causes in this study, differed from that of the overall distribution of all diagnoses assigned. although f4 diagnoses were the most frequently assigned, affective disorders (f3) were by far the most frequent index diagnoses with 39.4% (n = 1682). phobias (f40.-) and other anxiety disorders (f41.-) accounted for 14.2% (n = 607) of the initial diagnoses. also frequently given were index diagnoses in the area of somatoform disorders (f45.-) with 5.5% (n = 233), post-traumatic stress disorder (f43.1) with 4.5% (n = 190), adaptation disorders (f43.2) with 4.5% (n = 190), eating disorders (f50.-) with 4.4% (n = 186) and emotionally unstable personality disorder: borderline type (f60.31) with 2.6% (n = 113). however, patients with bipolar affective disorders (n = 42; 0.9%), schizophrenia (n = 44; 1.0%) and sexual dysfunction (n = 8; 0.2%) as index diagnoses were rarely treated. the average number of diagnoses given was 1.84 (sd = 0.99, range = 0-7). thus, multimorbidity was found in the majority of cases. 43.1% (n = 1865) had only one diagnosis, 33.4% (n = 1448) had two and 21.6% (n = 942) had three or more. only 1.7% (n = 74) had no diagnosis at the start of treatment or no diagnosis was recorded in the system. the most frequent comorbidity pattern was the co-occurrence of affective disorders (f3) and neurotic, stress and somatoform disor­ ders (f4). for example, 581 patients (13.7%) with f4 index diagnosis had an additional f3 diagnosis. the reverse pattern, f3 as first diagnosis and f4 as second and/or third diagnosis, applied to 546 patients (12.8%). figure 1 shows the proportion of patients treated in research and training clinics by index diagnosis (icd-10). collaborative psychotherapy research in germany 14 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ figure 1 proportion of patients treated in research and training clinics by index diagnosis (icd-10) f0: mental and behavioural disorders due to psychoactive substance use f1: schizophrenia, schizotypal and delusional disorders f3: mood (affective) disorders f4: neurotic, stress-related and somatoform disorders f5: behavioural syndroms associated with physiological disturbances and physical factors f6: disorders of adult personality and behaviour other f0 2% f1 1% f3 39% f4 44% f5 6% f6 7% other 1% f0 2% f1 8% f3 47% f4 30% f5 8% f6 5% other 0% training clinicsresearch clinics table s1 in the supplementary materials shows the 50 most frequently assigned diagno­ ses, broken down by main disorder categories. table s2 in the supplementary materials shows the 50 most frequently assigned index diagnoses, which were defined as treatment causes in this study. table s3 in the supplementary materials shows the most frequent diagnostic combinations or comorbidity patterns after icd-10-f disorder sections. patient psychopathological symptoms — four clinics (n = 844 patients) provided data on the severity of the impairment at the start of therapy as assessed by the cgi. according to their therapists, 0.1% of the patients were not ill at all, 1.1% were borderline cases of mental disorder, 5.9% were only mildly ill, 28.9% were moderately ill, 49.8% were markedly ill, 12.1% were severely ill and 0.7% were among the most extremely ill patients. table 4 shows the bsi and bdi values at the start of therapy. at the start of treatment, clinically relevant elevated bsi values (gsi > 0.61) were present in 76% (n = margraf, hoyer, fydrich et al. 15 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ 2823), clinically significant bdi values (total values in bdi-i or bdi-ii > 14) in 70% (n = 2298) of the treated persons. severe depression symptoms (total values in bdi-i or bdi-ii > 29) were reported by 24.3% (n = 797) of patients at the start of treatment. table 4 level of patients´ psychopathological symptoms at the beginning of treatment instrument n m sd brief symptom inventorya, bsi 3753 0.89 0.77 somatization 3757 1.47 0.87 obsession-compulsion 3758 1.44 1.00 interpersonal sensitivity 3760 1.36 0.93 depression 3754 1.14 0.83 anxiety 3760 0.96 0.76 hostility 3756 0.85 0.88 phobic anxiety 3760 1.10 0.88 paranoid ideation 3756 0.92 0.77 psychoticism 3763 1.12 0.67 beck depression inventoryb, bdi bdi-i 642 18.47 10.10 bdi-ii 640 22.08 11.73 aderogatis & spencer, 1993; franke, 1997. bhautzinger et al., 2000, 2009. psychotherapeutic treatments — in accordance with german psychotherapy regula­ tions, a limited number of sessions are reserved for diagnostic procedures including case history and indicative decisions (so called probatory sessions). an average of 4.77 probatory sessions (sd = 0.85; range = 0-13) were performed. an outlier analysis showed only 1.5% of the treatments involved more than five probatory sessions. the number of regular therapy sessions after the probatory sessions was 35.01 (sd = 22.28, range = 0-117). while 42.7% (n = 1371) of the therapies were terminated consensually by patient and therapist (mean duration 43.09 therapy sessions, sd = 17.09), 23.3% (n = 748) were still ongoing at the time of data retrieval and 32.9% (n = 1057) of patients had dropped out of treatment (mean duration 23.8 sessions, sd = 22.04). in all cases, cognitive behav­ ior therapy was used as therapeutic procedure. in the vast majority, only individual therapy sessions took place (90.9%, n = 2683), combined individual and group therapy were applied in 9.0% (n = 284) of the treatments. therapists — a total of 675 persons (mean age = 30.91 years, sd = 5.82, range = 22-58) were involved as therapists. most therapists were female (n = 502, 83.3%) and the majority (n = 427, 70.6%) in advanced psychotherapy training (not licensed yet). on average, therapists treated 6.67 patients (sd = 5.75, range = 1-54) during the study period. collaborative psychotherapy research in germany 16 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ an average of 5.19 (sd = 6.94, range = 1-43) patients per therapist were treated in the research clinics and 6.80 (sd = 5.29, range = 1-54) patients per therapist in the training clinics. an outlier analysis showed that 95% of therapists were responsible for less than 17 patients. study 4 (in-albon et al., 2019) method this study characterized the patient population treated in 2016 in seven university outpatient psychotherapy clinics for children and adolescents (in-albon et al., 2019). these submitted the initial core data set for children and adolescent patients (see table 3). completeness and quality of the data were checked in the clinics as well as in the coordination center as described in study 3. descriptive data on the diagnoses and comorbidity patterns of the patient population as well as sociodemographic information of their parents and therapists were analyzed. for the cbcl/6-18r and ysr/11-18r, t-values adapted for age and gender for a total, an externalizing and an internalizing score are reported. results study 4 characterized the patient population treated in 2016 in seven university outpa­ tient psychotherapy clinics for children and adolescents. for the year 2016, data from 568 children and adolescents between 3 and 20 years of age (m = 11.89, sd = 3.68; 46.6% female) were available. the most frequent diagnoses were anxiety disorders (f40, f41, f93; n = 317, 35.30%) followed by attention-deficit hyperactivity disorders and conduct disorders (f90, f91, f92; n = 195, 21.71%). in 45.6% of the patients, there was at least one additional comorbid diagnosis. the mean t-value of the cbcl/6-18r (mother reports) was 67.60 (sd = 9.94) for the total score, 67.03 (sd = 10.70) for internalizing problems, and 61.84 (sd = 12.01) for externalizing problems. the mean t-value of the ysr/11-18r was 61.35 (sd = 10.23) for the total score, 63.43 (sd = 12.75) for internalizing problems, and 54.88 (sd = 9.53) for externalizing problems. all of these are above the clinical cut-off (t > 60; based on german norms; döpfner et al., 2014). therapist cgi severity scores classified the vast majority of patients as mentally ill (15.1% mildly, 46.6% moderately, 28.8% markedly, and 5.5% severely) and only few patients as not at all (1.4%) or borderline mentally ill (2.7%). of the 126 therapists (83.1% female, mean 29.76 years, sd = 5.04), the majority (78.9%) were still in psychotherapy training (not licensed yet). each therapist was responsible for a mean of 4.51 patients (range 1-13). cognitive behavior therapy was used for all patients, and almost all treatments (99.3%) were conducted in an individual setting (combination of individual and group setting in 0.8%). an average of 6.93 probato­ ry sessions (sd = 1.59, range 1-13) were performed. most of the treatments (52.3%) had not yet been terminated. overall, this study indicated the feasibility of consolidating and margraf, hoyer, fydrich et al. 17 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ evaluating research data across university outpatient psychotherapy clinics for children and adolescents. d i s c u s s i o n while other fields of research, such as physics, astronomy and genetics, have been practicing collaborative research on a large scale for some time, their value in the field of psychotherapy and mental health has only been increasingly recognized in recent years (margraf, 2015). with the establishment of university outpatient clinics at departments of clinical psychology and psychotherapy in germany in 1999, a unique infrastructure for research, training and clinical care became available, offering opportunities for a collaborative approach. since 2013, a steering committee works towards a systematic co­ ordination across clinics in order to create a nationwide research platform. this platform will allow to aggregate and analyze longitudinal treatment data for adults, children and adolescents across all participating clinics and thereby contribute to the advancement of theory, practice and dissemination of psychotherapy and mental health research. the feasibility of large-scale coordinated research was investigated in a series of four descriptive studies. an initial survey with 100% response rate (study 1) in 2014 identi­ fied the most relevant features of the then 53 clinics and led to recommendations for improved integration of data collection. already in 2014, the annual number of patients reported by the clinics surpassed 10,000 children, adolescents, and adults, with a strongly growing trend. based on these results, we defined a catalogue of challenges facing the planned research collaboration and gave unanimously derived recommendations (study 2). study 3 collected data on 4,504 patients from 16 clinics treated in 2016 allowing for the first time to systematically describe patients, therapists and treatments available for collaborative research in the german psychotherapy outpatient clinic network. finally, study 4 analyzed data of 568 child and adolescent patients from seven clinics starting treatment 2016 providing the first description of this patient population within kodap. adult patients diagnoses are based on evaluated, structured or standardized interviews whose validi­ ty and reliability exceed clinical judgment and other non-standardized diagnostic pro­ cedures (margraf et al., 2017). the most frequently treated diagnostic groups in the kodap clinics in 2016 were neurotic, stress and somatoform disorders (f4) and affective disorders (f3), the latter also yielding the most frequent index diagnoses and cause of treatment. this is in line with previous studies of psychotherapy outpatient clinics in germany and england (clark, 2018; jacobi et al., 2011; richter et al., 2013; victor et al., 2018). the majority of kodap patients (55%) had several mental disorders at the start of treatment. this is more than previously reported in non-university clinics (victor et al., collaborative psychotherapy research in germany 18 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ 2018), individual university clinics (peikert et al., 2014; richter et al., 2013) or routine care by practicing psychotherapists (köck, 2012). while patients with almost all diagnoses and degrees of severity are treated, severe disorders (e.g., severe depressive episode, bor­ derline disorder, chronic pain disorders, post-traumatic stress disorder) are very frequent. in addition, a sub-sample of four clinics showed that almost two thirds of the patients were rated by their therapists as markedly, severely or extremely ill. the fact, however, that psychotic disorders accounted only for one percent of treatment reasons (34th rank) calls for an increased proportion of this patient group in outpatient training settings (schlier et al., 2017). further investigation of the 7% of patients labeled by their therapists as borderline or only mildly ill may help to determine whether these patients may not have been in need of psychotherapy or whether some patient characteristics (e.g., certain diagnoses or symptoms, age, gender) may result in therapists’ underestimation of patient distress. while patients on average had a high level of education, a lack of comparative values prevented a direct comparison with earlier studies. the results for age and gender as well as the bsi and bdi scores show that the patient population in kodap clinics is largely comparable to other german outpatient clinics and routine care by fully licensed behavior therapists (jacobi et al., 2011; köck, 2012; lutz et al., 2013; richter et al., 2013; victor et al., 2018). child and adolescent patients the most frequently assigned diagnoses were anxiety disorders and behavioral disorders. this is in line with epidemiological studies, e.g. a meta-analysis (polanczyk et al., 2015) indicating a prevalence rate of 6.5% for anxiety disorders, 5.7% for disruptive disorders, and 3.4% for adhd. as in the adult clinics, the diagnoses are based on validated struc­ tured clinical interviews. the results of the questionnaires cbcl/6-18r and ysr/11-18r are comparable with a clinical control group of an outpatient sample in a child and ado­ lescent psychiatric clinic (walter et al., 2018). the categorical and dimensional diagnostic assessments as well as the comorbidity rate of almost 50% underline the clinical severity and the breadth of the problems treated in the participating child and adolescent clinics. the age range of 3 to 20 years reflects the legal restrictions for child and adolescent psychotherapists in germany who may treat patients up to the age of 21. in contrast to the adult patient samples where roughly two thirds of the patients were female, girls and boys were equally distributed in the child and adolescent clinics. therapists the high proportion of female therapists (83%) is comparable with that of non-university training institutes (victor et al., 2018) and somewhat higher than for practicing fully licensed psychotherapists in germany (74.4%), or psychologist in the usa (73%) (apa center for workspace studies, 2015). this reflects an ongoing international trend toward margraf, hoyer, fydrich et al. 19 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ more women entering psychotherapy training and practice (apa center for workspace studies, 2015). because most of the reported treatments took place in training clinics, the majority of the therapists were not yet fully licensed. the fact that therapists treated an average of seven patients in training clinics during the study period underlines the intensity and structure of psychotherapy training in the participating clinics. variability in number of patients treated per therapist in our data reflects the different training models (part-time vs. full-time training). treatments with an average of 43 treatment sessions for adults and 36 sessions for children and adolescents (regularly terminated therapies), the length of treatment is identical to that reported in other german outpatient clinics (victor et al., 2018). this duration, howev­ er, is higher than internationally reported as the optimal dose for routinely delivered psychological therapies (robinson et al., 2020). patients dropped out in about one third of the treatments. although this figure appears high, these values are comparable with termination rates reported in similar treatment settings (hiller et al., 2009). in order to record the proportion of quality-relevant (e.g. low therapeutic success) in comparison to non-quality-relevant drop-outs (e.g., change of residence, low level of suffering), the reasons for early termination or non-execution of approved sessions should be systemati­ cally and uniformly documented in the future. limitations although a large number of the clinics in question have already joined the kodap project and more than half of the current member clinics contributed data to the last two feasibility studies, it is unclear to what extent the clinics included in this study are representative of all german university outpatient clinics for psychotherapy. causes for non-participation of kodap clinics in this study or reasons for missing variables in the transmitted data sets were not systematically documented. a more detailed, quantitative analysis of feasibility aspects related to data processing in clinics was therefore not possible. in addition, this study did not examine the extent to which clinics differ in terms of process and structural quality. due to ethical and data protection considerations, only a limited number of personal variables of patients and therapists can be evaluated across clinics. a detailed analysis of the influence of specific personal variables, such as occupation or place of residence, is therefore not possible. instead, this study deliber­ ately focuses on a description of the patient population and treatment diagnoses at the beginning of treatment. the majority of clinics use the bdi-ii, while two clinics still use the bdi-i. the comparability of the pre-treatment depression values across clinics with different bdi versions is therefore limited. since the primary focus of this study was the estimation of feasibility aspects, the clinics were free to decide whether this first data collaborative psychotherapy research in germany 20 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ transmission included variables already collected at the end of therapy. the analysis of treatment outcomes is planned for the longitudinal data collection that has been ongoing since the beginning of 2018. opportunities and challenges the network provides a distinctive, unprecedented infrastructure for research, training and clinical care in psychotherapy and mental health. clinical research designs, field experiments, and multicentric randomized controlled trials can be implemented rapidly and with large samples (e.g., 20 clinics per condition, inclusion of 1,000-5,000 patients), hence systematically solving typical problems such as recruitment issues, the lack of standardized assessments, and replicability. challenges for the collaborative project include expanding the core data set (e.g., be­ havioral data, social and biological variables), agreeing on new questions (e.g., long-term follow-up, systematic causality testing of predictors with experimental designs), and last but not least, full-cost funding of the joint research. a transfer of the network into a national structure would be desirable; a first application for consideration in the planned future national research center for mental health has already been submitted. the proof of a successfully established patient flow and the smooth realization of the coop­ eration will also improve the chances of success for acquisition of further third-party funding. conclusions despite different data formats, data transfer and aggregation proved feasible. affective, neurotic, stress, and somatoform disorders accounted for most of the diagnoses within the adult patients and anxiety and behavioral disorders within the child and adolescent patients. in both groups, comorbidity was the rule rather than the exception. overcoming legal, methodological, and technical challenges, a common core assessment battery was developed and data collection for kodap started in 2018. as of today, 42 clinics have joined and 30 already have provided data. the compilation of selected core data from the participating clinics makes it possible to answer important scientific and technical questions. these include but are not limited to the provision of normative data on patient, therapist, parents (for the child sample) and treatment characteristics, the inter­ actions of such variables (e.g., success in specific subgroups, interaction of patient and therapist characteristics), treatment outcomes under routine conditions, dropout rates as well as failures and side effects in therapy, rare disorders, subgroup analyses of frequent disorders, special comorbidity patterns, specific age groups (e.g., preschool age, primary school or adolescent age; older patients) and high-powered studies for the development of new instruments and treatments. the first steps of kodap reported here show that research collaboration across university outpatient clinics is feasible, provided that clin­ margraf, hoyer, fydrich et al. 21 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://www.psychopen.eu/ ics invest time and effort for data collection, data checking and data transfer. fulfilling the need for stronger cumulative and cooperative research in psychotherapy and related fields will contribute to better knowledge about mental health, a core challenge to modern societies. funding: financial support was provided by unith.ev, kinderund jugendlichenpsychotherapie verhaltenstherapie e.v., the mental health research and treatment center at ruhr university bochum, the alexander von humboldtprofessorship awarded to the first author, the departments of clinical child and adolescent psychology and psychotherapy and clinical psychology and psychotherapy at the university of koblenz-landau. competing interests: all authors are employed by the universities listed in the affiliations. they have no conflicts of interest to declare. acknowledgments: the authors gratefully acknowledge the support by the participating clinic directors, therapists and patients. christian leson and amelie scupin of the mental health research and treatment center at ruhr university bochum helped with data transfer and aggregation and preparation of tables and supplementary materials. author contributions: jürgen margraf, thomas fydrich, jürgen hoyer, tina in-albon, tania lincoln, wolfgang lutz, angelika schlarb, henning schöttke, ulrike willutzki and julia velten jointly conceived the work described here. julia velten coordinated data collection and data transfer. jürgen margraf wrote the first draft of the manuscript. tina in-albon contributed the first draft of the sections on study 4. all authors read the manuscript, gave feedback and agreed to the final version of the manuscript. all authors except for the first, second, and last are listed in alphabetical order. statement of ethics: this research complies with the guidelines for human studies and was conducted ethically in accordance with the world medical association declaration of helsinki. all patients gave their written informed consent and that the study was approved by the ethics committee of the faculty of psychology at ruhr university bochum. twitter accounts: @psychojule, @fbzrub s u p p l e m e n t a r y m a t e r i a l s the supplementary materials include three tables listing the diagnoses of patients in study 3 (for access see index of supplementary materials below). index of supplementary materials margraf, j., hoyer, j., fydrich, t., in-albon, t., lincoln, t., lutz, w., & velten, j. 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(1997). skid i. strukturiertes klinisches interview für dsm-iv. achse i: psychische störungen. interviewheft und beurteilungsheft. eine deutschsprachige, erweiterte bearb. d. amerikanischen originalversion des skid i. göttingen, germany: hogrefe. wolf, m., limberger, m. f., kleindienst, n., stieglitz, r.-d., domsalla, m., philipsen, a., . . . bohus, m. (2009). kurzversion der borderline-symptom-liste (bsl-23): entwicklung und überprüfung der psychometrischen eigenschaften. psychotherapie, psychosomatik, medizinische psychologie, 59(8), 321-324. https://doi.org/10.1055/s-0028-1104598 zaworka, w., hand, i., jauernig, g., & lünenschloß, k. (2003). hamburger zwangsinventar. weinheim, germany: beltz. ziem, m., & hoyer, j. (2020). modest, yet progressive: effective therapists tend to rate therapeutic change less positively than their patients. psychotherapy research, 30(4), 433-446. https://doi.org/10.1080/10503307.2019.1631502 world health organization. (1993). the icd-10 classification of mental and behavioural disorders: diagnostic criteria for research. retrieved from https://apps.who.int/iris/handle/10665/37108 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. margraf, hoyer, fydrich et al. 29 clinical psychology in europe 2021, vol.3(1), article e4459 https://doi.org/10.32872/cpe.4459 https://doi.org/10.1007/s00787-017-1021-z https://doi.org/10.1016/j.brat.2018.06.003 https://doi.org/10.1159/000486100 https://doi.org/10.1055/s-0028-1104598 https://doi.org/10.1080/10503307.2019.1631502 https://apps.who.int/iris/handle/10665/37108 https://www.psychopen.eu/ collaborative psychotherapy research in germany (introduction) overview of feasibility studies study 1 (hoyer et al., 2015) study 2 (velten et al., 2017) study 3 (velten et al., 2018) study 4 (in-albon et al., 2019) discussion adult patients child and adolescent patients therapists treatments limitations opportunities and challenges conclusions (additional information) competing interests funding acknowledgments author contributions statement of ethics twitter accounts supplementary materials references multidimensional assessment of strengths and their association with mental health in psychotherapy patients at the beginning of treatment research articles multidimensional assessment of strengths and their association with mental health in psychotherapy patients at the beginning of treatment jan schürmann-vengels 1 , stefan troche 2 , philipp pascal victor 1, tobias teismann 3 , ulrike willutzki 1 [1] department of psychology and psychotherapy, witten/herdecke university, witten, germany. [2] department of psychology, university of bern, bern, switzerland. [3] mental health research and treatment center, ruhr-universität bochum, bochum, germany. clinical psychology in europe, 2023, vol. 5(2), article e8041, https://doi.org/10.32872/cpe.8041 received: 2021-12-28 • accepted: 2023-05-07 • published (vor): 2023-06-29 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: jan schürmann-vengels, department of psychology and psychotherapy, universität witten/herdecke, alfred-herrhausen-straße 50, 58448 witten, germany. e-mail: jan.schuermann-vengels@uniwh.de abstract background: modern concepts assume that mental health is not just the absence of mental illness but is also characterized by positive well-being. recent findings indicated a less pronounced distinction of positive and negative mental health dimensions in clinical samples. self-perceived strengths were associated with markers of mental health in healthy individuals. however, analyses of strengths and their association with different mental health variables in clinical populations are scarce. method: a cross-sectional design was conducted at a german outpatient training and research center. 274 patients before treatment (female: 66.4%, mean age = 42.53, sd = 13.34, range = 18-79) filled out the witten strengths and resource form (wirf), a multidimensional self-report of strengths, as well as other instruments assessing positive and negative mental health variables. data was analyzed with structural equation modeling and latent regression analyses. results: confirmatory factor analysis of the wirf showed good model fit for the assumed threesubscale solution. regarding mental health, a one-factor model with positive and negative variables as opposite poles showed acceptable fit. a correlated dual-factor model was not appropriate for the data. all wirf subscales significantly predicted unique parts of variance of the latent mental illness factor (p = .035 – p < .001). this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8041&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0002-8963-1129 https://orcid.org/0000-0002-0961-1081 https://orcid.org/0000-0002-6498-7356 https://orcid.org/0000-0002-0149-4554 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: the context-specific assessment of patients’ strengths was confirmed and led to an information gain in the prediction of mental health. results suggest that positive and negative facets of mental health are highly entwined in people with pronounced symptoms. the scientific and practical implications of these findings are discussed. keywords strengths, resources, resilience, mental health, dual-factor model, structural equation model highlights • the witten strengths and resource form (wirf) captures strengths in three situational contexts. • a confirmatory factor analysis supported the context-structure of the wirf in a clinical sample. • positive and negative mental health variables were highly correlated in patients before treatment. • wirf subscales provided incremental information in the prediction of patients’ mental health. traditionally mental health has been understood as the absence of psychopathology. this view suggests that people are either mentally ill or mentally healthy at a given point in time. in contrast, modern dual-factor models emphasize a two-dimensional structure of mental health (keyes, 2002; who, 2005). according to such models, a dimension of negative mental health (nmh) is defined by the absence or presence of mental illness and burden, whereas a positive mental health (pmh) dimension is characterized by high or low emotional, psychological, and social well-being. in contrast to the unidimensional view of mental health, two-factor models assume that these two dimensions are nega­ tively related but still distinct from each other (iasiello et al., 2020; keyes, 2005). on the one hand, this means that individuals with mental disorders can still have moderate to high levels of well-being. on the other hand, a person with low well-being may not necessarily develop psychopathology. these assumptions were examined using various statistical approaches in healthy samples (iasiello et al., 2020). in most studies, both di­ mensions were assessed with specific instruments and then examined with confirmatory factor analysis or structural equation models (sem). these procedures are used when created theoretical models are to be tested with empirical data (schreiber et al., 2006). latent factors, such as mental health, that cannot be measured directly are extracted from the observed data. this allows a way to determine whether the study participants' data are more consistent with a one-dimensional or a two-factor understanding of mental health. findings with healthy samples consistently showed that a model with two corre­ lated factors (nmh and pmh) best reflects mental health (kim et al., 2014; magalhães & calheiros, 2017). this result means that psychopathology is only on average and not strengths and mental health 2 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ necessarily associated with lower well-being. if nmh and pmh are at least partially distinct factors, it may be useful to examine specific correlates and predictors of these two dimensions (schotanus-dijkstra et al., 2017). findings from clinical samples showed mixed results for the dual-factor hypothesis. most studies also found evidence for a correlated two-dimensional model of mental health (alterman et al., 2010; de vos et al., 2018; díaz et al., 2018; franken et al., 2018; teismann et al., 2018; tomba et al., 2014). on the other hand, van erp taalman kip and hutschemaekers (2018) showed that only a one-factor model of mental health fitted the data in an outpatient sample (n = 1069). the authors stated that psychopathology and well-being were more entwined in people with pronounced symptoms than in healthy subjects. this would imply that high psychopathology is almost always connected with low well-being (van erp taalman kip & hutschemaekers, 2018). one possible reason for this may be that people with mental disorders experience high levels of negative affect, meaning they often feel bad in everyday life (stanton & watson, 2014). this, in turn, could make it more difficult to feel good about potentially pleasant experiences or situations (carl et al., 2013). such limited positive reactivity might prevent individuals with marked psychopathology from also feeling well (at least temporarily). statistically, such a global perception by patients of either feeling bad or good is expressed in a high negative correlation between psychopathology and well-being. various studies, including the ones that found evidence for a dual-factor structure of mental health, found large correlations of nmh and pmh measures in clinical samples, r = -.67 – -.72 (bos et al., 2016; franken et al., 2018; lukat et al., 2016; van erp taalman kip & hutschemaekers 2018). these correlations are significantly higher than in healthy individuals, suggesting that patients may have less access to or less acknowledge positive experiences and situations at the beginning of psychotherapy because these are overshadowed by high symptom burden (iasiello et al., 2020). in turn, this makes it difficult for clinicians to utilize the positive experience of patients in psychotherapy. psychological strengths (also named resources; munder et al., 2019) are discussed as promotive factors of mental health for both healthy and clinical samples (grawe & grawe-gerber, 1999; taylor & broffman, 2011). strengths are defined as already existing intraand interpersonal potentials and abilities of a person (grawe, 1997; willutzki, 2008). several authors argued that an aspect is defined as a strength by the following criteria: (1) subjective positive evaluation, and/or (2) functionality to reach personal goals (grawe 1997; willutzki, 2008). the literature often distinguishes personal and social strengths (taylor & broffman, 2011). examples of personal strengths are the optimistic handling of difficulties and the implementation of individually positive activities, while social strengths are characteristics that help to form good relationships or perceive contacts. current concepts of strengths point to the importance of situational context in judging whether an aspect is positive and/or helpful (flückiger, 2009; taylor & broffman, 2011; willutzki, 2008). for example, a supporting family member or friend can be a high­ schürmann-vengels, troche, victor et al. 3 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ ly important resource to cope with everyday problems. however, a supporting person may also be part of the avoidance system of an anxiety disorder, making approach coping more difficult in this specific situation. research findings further indicated that aspects, rated as strengths by the person him-/herself (self-perceived strengths), are stronger related to good mental health outcomes compared to observer rated factors (melrose et al., 2015; prati & pietrantoni, 2010). various studies showed that self-perceived strengths were strongly associated with higher pmh and predicted participants’ long-term wellbeing in healthy samples (gloria & steinhardt, 2016; mc elroy & hevey, 2014; niemeyer et al., 2019; siedlecki et al., 2014). strengths and their relationship to mental health are less researched in clinical populations, although the activation of strengths is a widely supported mechanism in psychotherapy (munder et al., 2019). it is assumed that people with mental disorders often do not perceive possible strengths in themselves as strengths, although these are recognized as such by outsiders (for example, the therapist values the patient's creativity as helpful, while the patient perceives it as trivial for coping with the problem). high levels of psychopathology appear to be associated with negativity biases, which may be one reason why patients have less access to their own strengths that are present despite their distress (stanton & watson, 2014; trompetter et al., 2017). with respect to this, two studies showed that both psychiatric inpatients and psychotherapy outpatients report significantly lower levels of self-perceived strengths compared to healthy individuals with large effect sizes for this difference (goldbach et al., 2020; victor et al., 2019). most available instruments assess strengths over all situations a person experiences (trans-situational). such global measures can be problematic in clinical samples because they only reflect that patients have a strong focus on their problems and, in turn, a low perception of their strengths (iasiello et al., 2022; joseph & wood, 2010). thus, such instruments do not provide additional information compared to problem measurements in the clinical context. therefore, victor et al. (2019) developed the witten strengths and resource form (wirf), an assessment tool designed to capture strengths in three situational contexts: (1) strengths in everyday life (evdays), (2) strengths used to successfully cope with previous crises (crisess), and (3) strengths in connection with current problems (probs). the multidimensional structure was transferred from an existing diagnostic interview and obtained for the questionnaire by means of an exploratory factor analysis using data from a sample of 144 psychotherapy patients (victor et al., 2019; willutzki et al., 2005). to determine construct validity, the subscales were correlated with relevant instruments: all subscales showed significant positive correlations with an established strengths instrument (tagay et al., 2014; victor et al., 2019). the instrument is designed to capture how patients rate their strengths in dealing with different situations. a person may indeed have different thoughts about how pronounced and helpful one's strengths are in different circumstances, so that diverse aspects of patients' perceptions could be strengths and mental health 4 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ represented by the subscales of the wirf. for example, people who are currently under a lot of stress, but at the same time know what strengths have helped them in the past, may feel more able to manage the difficulty. the inclusion of different subscales of the wirf would amount to incremental prediction of, for example, mental health, because the subscales contain different information of patients’ experience. however, whether the subscales of the wirf capture different aspects of strengths perception is still unclear and needs to be confirmed confirmatory in a larger sample. objectives to the best of our knowledge, no study has yet analyzed the association of strengths with different mental health variables in the clinical context. the first aim of this study was to confirm the three-subscale structure of the wirf in a sample of psychotherapy outpatients. furthermore, to extend research on the dual-factor model, the second aim was to analyze the latent factor structure of mental health in psychotherapy outpatients with different positive and negative measures. the third aim of this study was to explore whether the strengths subscales of the wirf may predict unique parts of patients’ mental health/mental illness. h1: it is expected that the structure of the wirf with (1) strengths in everyday life (evdays), (2) strengths used to successfully cope with previous crises (crisess), and (3) strengths in connection with current problems (probs) as separate subscales will show a good model fit in a clinical sample. h2: it is expected that a dual-factor model of mental health – with pmh and nmh as correlated, but distinct factors – will be a more appropriate description of mental health related data in a clinical sample compared to a one-factor model with pmh and nmh as op­ posite poles of the same dimension. to address this hypothesis, two latent factor models will be created based on actual measurements and tested against each other in terms of model fit. h3: it is further hypothesized that all wirf subscales will signifi­ cantly predict unique variance in the latent factors of mental health/ mental illness. for the evdays scale, small to moderate positive cor­ relations are expected only with measures of pmh. for the crisess scale, small to moderate correlations are expected with measures of pmh (positively directed) and nmh (negatively directed). probs is expected to correlate strongly positive with pmh measures and strongly negative with nmh measures. schürmann-vengels, troche, victor et al. 5 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ m e t h o d design and sample description participants were recruited between 2016 and 2019 at the center of mental health and psychotherapy (cmhp), an outpatient training and research center for cognitive behav­ ioral therapy (cbt) at witten/herdecke university, germany. a cross-sectional design was applied where patients filled out all instruments at one point in time before the first psychotherapy session. general inclusion criteria were as follows: (1) at least one mental disorder according to dsm-iv criteria, (2) at least 16 years of age, (3) sufficient german language skills. patients that fulfilled inclusion criteria were informed about the study procedures and signed the informed consent. after study inclusion, patients’ diagnoses were determined with the structured clinical interview for dsm-iv (scid; wittchen et al., 1997) within the first treatment sessions. diagnostic interviews were performed by licensed cbt therapists or trainee therapists in advanced cbt training. all therapists were trained in the use of diagnostic interviews in prior workshops as a part of their training schedules. the total sample consisted of 274 adult psychotherapy outpatients (female: 66.4%, mage = 42.53, sd = 13.34, range = 18-79). most common primary diagnoses were affective disorders (33.58%), anxiety disorders (17.88%), and adjustment disorders (12.04%). 33 pa­ tients (12.04%) had at least two disorders. on average, patients had 1.14 diagnoses (sd = 0.40, range: 1-3). more than half the patients (52.55%) had prior psychological treatment. table 1 shows demographic data of the clinical sample. instruments self-perceived strengths patients’ strengths were assessed with the wirf (victor et al., 2019). the instrument conceptualized strengths as individually usable abilities that help to cope with specific situations (munder et al., 2019; taylor & broffman, 2011). the wirf is a multidimension­ al self-report with 36 items (likert scale from 0 “completely disagree” to 5 “completely agree”), assessing a person’s strengths with three subscales: strengths in everyday life (evdays), strengths in previous successful crises management (crisess), and strengths in connection with current problems (probs). participants are presented with various strengths and asked to what extent they were able to use them in the specific context. in each subscale, the same 12 items are presented in a different order to compare a person's perception of strengths across contexts. each subscale starts with a short introduction referring to the context (e.g., for crisess: in the next step we would like to ask you to think back to rather difficult times of your life. everybody goes through such times. please now think of a situation that was difficult for you to handle, but which you never­ theless tackled successfully, i.e., a situation about which you would say today: “i handled strengths and mental health 6 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ that pretty well”, or “i’m quite happy with myself about how i did that”. the following statements suggest some possible actions people can take in difficult situations). a mean score was calculated for each subscale, which represents a patient’s global perception of whether he/she experiences his or her existing strengths as sufficient and helpful in the respective context. items can be further grouped into three themes: action regulation (planning and performing activities), relaxation (taking time to relax and enjoy life), and social strengths (helpful interaction patterns). the wirf was developed based on a multidimensional concept from an existing diagnostic interview (willutzki et al., 2005). a survey of psychotherapy experts, identify­ ing relevant strengths, was conducted to create an item pool. after this, a preliminary strengths questionnaire was developed and tested in a sample of psychotherapy outpa­ table 1 description of the clinical sample characteristic m sd age 42.53 13.34 n % gender female 182 66.42 male 86 31.39 missing 6 2.19 relationship statusᵃ single 80 29.20 in a relationship 146 53.28 level of educationᵃ no graduation 4 1.46 secondary education 56 20.44 a levels 46 16.79 academic degree 36 13.14 completed apprenticeship 122 44.53 employmentᵃ employed 164 60.00 self-employed 7 2.55 unemployed 49 17.88 training/studies 3 1.09 retired 29 10.58 aoptional answer. schürmann-vengels, troche, victor et al. 7 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ tients different from the one in this study (n = 144), yielding to the wirf. item indices as well as psychometric properties were analyzed in both a clinical sample and healthy con­ trols (victor et al., 2019). all subscales showed good internal consistency (α = .84 – .88). moreover, the subscales showed hypothesis-consistent correlations with other strengths and social support assessments, indicating convergent validity (victor et al., 2019). pmh constructs the who-5 well-being index — the who-5 (bech et al., 2003; who, 1998) is an internationally used five item self-report to assess the general subjective well-being of a person in the last two weeks (likert scale from 0 “at no time” to 5 “all the time”). subjective well-being is characterized by the frequency of positive feelings and one’s satisfaction with life (topp et al., 2015). a mean score of the five items was used to represent a person’s general well-being in this study. the german version showed excel­ lent internal consistency, α = .92 (brähler et al., 2007). moreover, a systematic review indicated good construct and predictive validity of the instrument in healthy and clinical samples (topp et al., 2015). internal consistency in our sample was α = .88. the sense of coherence scale – short form — the soc-l9 (schumacher et al., 2000) assesses a person’s sense of coherence as conceptualized in the salutogenic model of health (antonovsky, 1987). sense of coherence is operationalized by three components (comprehensibility, manageability, meaningfulness) and describes the global orientation of an individual that he/she has the resources to cope with stress and life in general (antonovsky, 1987). the instrument contains nine items (likert scale from 1 “very often” to 7 “rarely/never”), from which a mean score is formed that reflects the global sense of coherence. the german version showed good internal consistency, α = .87 (singer & brähler, 2007). another study showed evidence for construct validity of the soc-l9 with significant correlations with established pmh scales, r = .60 – .64 (lin et al., 2020). internal consistency in our sample was α = .85. nmh constructs the brief symptom inventory – short version — the bsi-18 (spitzer et al., 2011) is a self-report measure to assess psychopathology in the last week. it contains 18 items (likert scale from 0 “not at all” to 4 “nearly every day”), measuring symptoms of somatization, anxiety, and depression. the global severity index (gsi) of the instrument was used to represent a person’s level of general psychopathology in this study. internal consistency of the gsi was good to excellent in several clinical samples, α = .88 – .93 (franke et al., 2017; spitzer et al., 2011). internal consistency in our sample was α = .89. the perceived stress questionnaire — the psq-20 (fliege et al., 2001) is an inter­ nationally used self-report measure to assess stress experience in the last four weeks. strengths and mental health 8 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ stress is operationalized by four components (tension, worries, overload, lack of joy) and represents the global level of current burden. the instrument contains 20 items (likert scale from 1 “almost never” to 5 “usually”), that were averaged to a mean score in this study. the german version showed good internal consistency, α = .80 – .86 (fliege et al., 2001). moreover, evidence of construct validity was indicated with negative associations with quality of life and social support measures (fliege et al., 2001). internal consistency in our sample was α = .92. the incongruence questionnaire – short version — the k-ink (grosse holtforth & grawe, 2003) is a self-report assessing psychological incongruence resulting from an insufficient realization of motivational goals. a high level of incongruence occurs when a person’s real-world experiences do not match with their desired goal states. the au­ thors stated that incongruence is closely related to the experience of psychopathological symptoms (grosse holtforth & grawe, 2003). it consists of 23 items (likert scale from 1 “far too little” to 5 “perfectly good”) measuring incongruence in the context of both approximation and avoidance. a mean score was formed from the 23 items representing global incongruence. the german version showed good to excellent internal consistency in clinical samples, α = .87 – .91 (grosse holtforth & grawe, 2003). internal consistency in our sample was α = .89. statistical analyses all analyses were conducted using r, version 3.6.3, packages: lavaan (rosseel, 2012). descriptive statistics of sample characteristics and analyzed variables were determined. normality of analyzed variables was tested with separate shapiro-wilk’s tests. bivariate correlations between analyzed variables were determined and tested with a significance level of α = .05. in order to examine the main hypotheses, sem using maximum likelihood estimation with robust standard errors (huber-white) and scaled test-statistics were conducted (mlr; rosseel, 2012). this procedure allows constructs that are not directly observable to be derived from the data (latent factors) and placed in relation to one another (schreiber et al., 2006). goodness of fit for all models was evaluated with a combination of well-es­ tablished fit indices: comparative fit index (cfi), root mean square of approximation (rmsea), standardized root mean square residual (srmr). hu and bentler (1999) recom­ mended the following criteria: cfi ≥ .95, rmsea ≤ .06, srmr ≤ .08 (good fit); cfi ≥ .90, rmsea ≤ .08 (acceptable fit). moreover, chi-square statistics for each sem were determined. several studies found that results of chi-square tests in sem were highly related to sample size, therefore, it was not used for an interpretation of model fit in this study (hu & bentler, 1999; peugh & feldon, 2020). to examine the first hypothesis, whether the subscales of the strengths instrument capture different facets, a sem with the latent variables wirf-evdays, wirf-crisess, schürmann-vengels, troche, victor et al. 9 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ and wirf-probs was arranged. latent variables are usually defined with the single items of the respective measure. however, based on assumptions from prior studies, it was as­ sumed that such a model would have included too many parameters and would have led to estimation problems with respect to the sample size (little et al., 2002). therefore, item parceling was used to reduce the number of parameters in this sem. parceling describes that a subset of items is bundled to packages. in this case, the single items were averaged to scores of the three strengths themes found by victor et al. (2019): action regulation (5 items) relaxation (4 items) social strengths (3 items). latent variables were defined with the item bundles in each context (see figure 1). all latent variables were allowed to covary. furthermore, residual covariances were allowed between corresponding manifest variables in the three subscales (e.g., relaxation in wirf-evdays and wirf-crisess). figure 1 structural equation model of the three-subscale solution of the wirf crisess action1 relax1 social1 action2 relax3 social3 action3 social2 relax2 evdays probs .46 .62 .24 .68 .74 .48 .61 .80 .48 .76 .75 .52 note. evdays = witten strengths and resource form, strengths in everyday life; crisess = witten strengths and resource form, strengths used in prior crises; probs = witten strengths and resource form, in connection with current problems; action/relax/social = items of wirf parceled to action regulation, relaxation, and social support. to examine the second hypothesis, two measurement models for mental health were compared. the first model assumed a dual-factor structure with who-5 and soc-l9 being indicators of a latent variable representing pmh and bsi-18, psq-20 and k-ink being indicators of a latent variable representing nmh. latent variables were allowed strengths and mental health 10 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ to covary. the second model assumed a one-factor structure with all manifest variables loading on one latent variable. models were compared with akaike information criterion (aic) to determine which model better fit the data. the aic is used to compare nested models, with lower values indicating a better model fit (boedeker, 2017). to examine the third hypothesis, a sem combining the better fitting model of men­ tal health from hypothesis 2 with the wirf model from hypothesis 1 was arranged. stepwise regression analyses with the latent variables wirf-evdays, wirf-crisess, and wirf-probs as predictors of the latent mental health/illness factor were conducted and tested with a significance level of α = .05. r e s u l t s preliminary analyses total missing data was 4.93%. all analyzed variables but wirf-probs showed deviations from the normal distribution, p = .028 – p < .001. therefore, non-parametric correlations (spearman) were determined for these relationships: wirf subscales as manifest varia­ bles were significantly correlated with moderate to large coefficients, r = .35 .60, ps < .001. all pmh and nmh variables were strongly correlated to each other. wirf-evdays and wirf-crisess showed modest correlation coefficients in their association with pmh and nmh variables. wirf-probs was moderately to strongly correlated to pmh and nmh measures. table 2 shows descriptive statistics and correlations of analyzed varia­ bles. measurement models the first step was to review the context structure of the wirf. although the chi-square test statistic was statistically significant, the other fit indices suggested that the threesubscale solution for the wirf could be confirmed by means of confirmatory factor analysis, χ2mlr(15) = 28.43, p = .019, cfi = .98, rmsea = .06, srmr = .06. although all wirf subscales consist of the same items, three delineable factors could be filtered from the data. thus, it seems warranted to assess strengths in the different contexts separately, since the subscales overlap only partially. in a next step, the dualand the one-factor model of mental health were computed and compared against each other. the model fit for the dual-factor model was good regarding cfi (.99) and srmr (.02). however, χ2 mlr-test statistic was significant, χ 2(4) = 12.29, p = .015, and the rmsea of .09 was too large. the aic was 2275.38. moreover, the covariance matrix of the latent variables in the dual-factor model was not positive definite due to a high estimated correlation between nmh and pmh suggesting virtual identity of the two latent variables. schürmann-vengels, troche, victor et al. 11 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ table 2 descriptive statistics and correlations of analyzed variables measure 1 2 3 4 5 6 7 8 1. wirf-evdays – 2. wirf-crisess .60*** – 3. wirf-probs .43*** .35*** – 4. who-5 .19** .18** .55*** – 5. soc-l9 .16** .24*** .42*** .50*** – 6. bsi-18 -.12 -.14* -.44*** -.56*** -.67*** – 7. psq-20 -.11 -.13* -.44*** -.58*** .67*** .61*** – 8. k-ink -.19** -.17** -.50*** -.53*** .75*** .59*** .68*** – m 3.39a 3.00a 2.87a 1.62b 3.80c 1.13d 2.89e 3.05f sd 0.82 0.91 0.94 1.00 1.13 0.72 0.56 0.66 note. spearman ρ coefficients are displayed; wirf-evdays = witten strengths and resource form, strengths in everyday life; wirf-crisess = witten strengths and resource form, strengths used in prior crises; wirfprobs = witten strengths and resource form, strengths in connection with current problems; who-5 = who-5 well-being index; soc-l9 = sense of coherence scale – short form; bsi-18 = brief symptom inventory – short version; psq-20 = perceived stress questionnaire; k-ink = incongruence questionnaire – short version. an = 274. bn = 257. cn = 258. dn = 245. en = 243. fn = 259. *p < .05. **p < .01. ***p < .001. the fit of the one-factor model, however, was worse compared to the dual-factor model, χ2mlr(5) = 25.54, p < .001, cfi = .97, rmsea = .13, srmr = .03, aic = 2287.22. in sum, the dual-factor model led to estimation problems, but the one-factor model did not describe the data adequately. therefore, we sought to improve the data description of the one-factor model, which could be achieved by allowing a residual correlation between the two indicators of pmh (i.e., who-5 and soc). this led to a trending acceptable data fit of the one-factor model, χ2mlr(4) = 12.29, p = .015, cfi = .99, rmsea = .09, srmr = .02, aic = 2275.38. thus, confirmatory factor analysis revealed that a dual-factor structure for mental health with a differentiation between positive and negative aspects was not appropriate in our sample. the closest fit was a bipolar model (one factor) in which high mental illness was almost always associated with low mental health. the further analyses were conducted based on the adjusted one-factor model. the latent factor of this model will be named mental illness in the following, because nmh constructs loaded positively, while pmh constructs loaded negatively on that factor (see figure 2). strengths and mental health 12 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ figure 2 structural equation model of the one-factor model of mental illness .37 bsi-18 psq-20 k-ink who-5 soc-l9 mi .83 .74 .82 .74 .89 note. mi = latent mental illness factor; bsi-18 = brief symptom inventory – short version; psq-20 = perceived stress questionnaire; k-ink = incongruence questionnaire – short version; who-5 = who-5 well-being index; soc-l9 = sense of coherence scale – short form. latent regression analyses after having established measurement models of strengths and mental health, we inves­ tigated the relationship between the wirf subscales and general mental illness by means of a latent regression analysis (see figure 3). figure 3 core of the structural equation model for the regression of the wirf subscales on mental illness probs .41 bsi-18 psq-20 k-ink who-5 soc-l9 mi .83 .74 .82 .76 .88 crisess evdays .47 .62 .24* -.27** -.73*** .24 note. evdays = witten strengths and resource form, strengths in everyday life; crisess = witten strengths and resource form, strengths used in prior crises; probs = witten strengths and resource form, in connection with current problems; mi = latent mental illness factor; bsi-18 = brief symptom inventory – short version; psq-20 = perceived stress questionnaire; k-ink = incongruence questionnaire – short version; who-5 = who-5 well-being index; soc-l9 = sense of coherence scale – short form. schürmann-vengels, troche, victor et al. 13 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ when mental illness was regressed on the three subscales of the wirf separately, all three regression coefficients were statistically significant with β = -0.36, p = .007, for wirf-evdays, β = -0.29, p = .007, for wirf-crisess, and β = -0.67, p < .001, for wirf-probs. the model resulting from the multiple regression of mental illness on all three wirf subscales fitted the data well, χ2mlr(61) = 126.12, p < .001, cfi = .96, rmsea = .06, srmr = .05. wirf-crisess and wirf-probs were almost unchanged when compared to the single regression analyses. more self-perceived strengths in these contexts were asso­ ciated with less mental illness. the two scales are incrementally significant and predict independent proportions of mental illness. however, the link between mental health and wirf-evdays changed its sign from negative to positive. this may be interpreted as a negative suppression effect resulting from the inclusion of other predictors (beckstead, 2012). in a post-hoc analysis, it was found that the inclusion of wirf-probs affected this suppression effect on wirf-evdays, suggesting that these two subscales share a high common intersection with the criterion (mental illness). wirf-evdays can, therefore, not be considered an independent predictor. table 3 shows results of the latent regression analysis. table 3 results of the latent regression analysis with all wirf subscales included as predictors variables b se z p std.lv criterion: mental illnessa wirf-evdays 0.20 0.10 2.11 .035 0.24 wirf-crisess -0.21 0.08 -2.62 .009 -0.27 wirf-probs -0.44 0.05 -8.69 < .001 -0.73 note. wirf-evdays = witten strengths and resource form, strengths in everyday life; wirf-crisess = witten strengths and resource form, strengths used in prior crises; wirf-probs = witten strengths and resource form, in connection with current problems; b = estimate of predictor in the sem; se = standard error; std.lv = standardized estimate of the continuous latent variable. alatent factor of the one-factor model (positive and negative mental health as two opposite poles). d i s c u s s i o n one aim of this study was to analyze a multidimensional assessment of strengths devel­ oped for the application in clinical samples. many patients experience a lot of negative feelings and low self-efficacy in dealing with current problems at the beginning of psy­ chotherapy (tecuta et al., 2015). as studies suggest, the perception of one's own strengths also seems to be limited by this negative perspective. strengths that are present despite the problems and symptoms (e.g., taking up a hobby) are not necessarily experienced by patients as helpful, although outsiders would name these aspects as strengths. only strengths and mental health 14 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ measuring strengths to deal with current problems seems to provide little information gain in the clinical context, as such measures tend to inversely express problem burden. the assessment tool used in this study (i.e., the wirf) measured strengths with three subscales: (1) strengths in everyday life (evdays), (2) strengths used to successfully cope with previous crises (crisess), and (3) strengths in connection with current problems (probs). it was intended to examine whether the subscales are indeed distinguishable and whether they provide a better prediction of mental health. another aim of this study was to test the assumptions of the dual-factor model of mental health on another clinical sample. for this purpose, we investigated whether patients' data at therapy start point to an independence of well-being and distress, or whether only one of these states was experienced at a time. results showed that the wirf subscales were significantly interrelated with moder­ ate to large coefficients. probs showed moderate correlation coefficients in relation to pmh and nmh measures, while evdays and crisess were only slightly associated with these variables. although each subscale was comprised of the identical 12 items, the three-subscale solution of the wirf was confirmed. the subscales were filtered out as partially independent factors, suggesting that strengths can be captured in separate contexts by using explicit instructions. only a one-factor model of mental health/illness was appropriate for data of the clinical sample. nmh measures were positively related, and pmh measures negatively related to the latent factor. this result means that patients with high symptom burden hardly experienced well-being at the same time. all wirf subscales were significant predictors of the mental illness factor in the latent regression analysis. the coefficients of wirf-crisess and wirf-probs remained stable in the multi­ ple regression analysis. these two subscales were significant and incremental predictors of lower mental illness. interpretation of results our first hypothesis was confirmed as findings support the multidimensional structure of the wirf. although all subscales query the same 12 items and the same strengths in terms of content, they could be statistically distinguished. the questionnaire uses in­ structions to focus patients' perceptions on the particular context. in contrast, established instruments only capture positive trait characteristics or strengths that are currently ex­ perienced (peterson & park, 2009; tagay et al., 2014). a unique feature of the instrument in this study is that the wirf also captures strengths that have been used successfully in the past and in good times. this differential assessment of strengths seems to be relevant in clinical samples, as studies indicate a high problem focus and negative affect in patients (stanton & watson, 2014). willutzki (2008) states that the high level of suffering of individuals at the beginning of therapy leads to the fact that they hardly perceive existing strengths in themselves or evaluate them as helpful. in other words, patients’ perception of their strengths is strongly related to current distress and can hardly be schürmann-vengels, troche, victor et al. 15 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ assessed independently of problems (cf. iasiello et al., 2022). the statistically independent subscales of the wirf may make existing strengths more visible to patients themselves and their therapists. this might have scientific implications: as shown in the testing of the third hypothesis, the wirf subscales were independent predictors of mental illness. wirf-probs accounted for the largest proportion of variance, which means that a person with many self-perceived strengths for coping with current problems had fewer symptoms and more well-being. this result was to be expected since successful problem management usually leads to less stress. beyond this effect, wirf-crisess incrementally predicted mental illness. this indicates that patients who are currently under a lot of stress, but at the same time know what strengths have helped them in the past, have better mental health in comparison to persons with less good strengths awareness. the awareness of strengths in coping with previous crises may be associated to a stable sense of mastery, which was positively related to resilience and mental health in prior studies (burns et al., 2011). wirf-crisess may be relevant to research that focuses on the description and etiology of mental health in clinical populations, as it seems to be less entwined with psychopathology and, therefore, may contribute to an increase in information (bos et al., 2016). moreover, in the context of psychotherapy research, wirf-crisess was found to be a significant predictor of treatment outcome beyond problem-associated measures (schürmann-vengels et al., 2022). the independence of wirf subscales also provide practical implications: although recent studies indicated that patients perceive fewer current strengths than healthy individuals, this does not mean that strengths to cope with their problems do not exist (goldbach et al., 2020; victor et al., 2019). the results of this study highlight that it makes sense for therapists to actively address existing strengths to further foster mental health. it may be helpful to draw the patient’s attention to helpful abilities, pleasant activities, or positive relationships. for example, interventions from the solution-focused brief therapy are recommended because these target situations in which patients have already been able to use their strengths successfully (similar to wirf-crisess; franklin et al., 2017). the diagnostic of strengths during treatment with the wirf can have the advantage that patients on the one hand recognize which strengths have helped them in the past (via crisess) and on the other hand experience how strengths develop during psychotherapy (via probs). patients answered the subscales differently in this study, which suggests that a comparison between the contexts may provide therapists with additional information. this could facilitate working with patients’ strengths in sessions. the dual-factor model of mental health was not supported in this clinical sample. a high association of positive and negative variables was found, similar to prior studies in this framework (franken et al., 2018; lukat et al., 2016; van erp taalman kip & hutschemaekers, 2018). this finding suggests that positive and negative facets of mental health are more entwined in people with pronounced symptoms than in healthy subjects. one possible explanation for this finding could be that patients focus strongly on bur­ strengths and mental health 16 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ densome factors at the beginning of psychotherapy. from a clinical perspective, such negativity bias may contribute to patients' poorer ability to perceive positive aspects in their lives or to judge them as relevant (carl et al., 2013; gollan et al., 2016). this, in turn, might lead to patients frequently talking about problems and little about positive experi­ ence in the therapy session. a recent study also showed that instruments assessing pmh are answered differently by individuals with severe distress than by healthy subjects (iasiello et al., 2022). patients may tend to condition their well-being on the presence of psychopathological symptoms and automatically fill out positive questionnaires low. these explanatory attempts should be considered as hypotheses and tested in future research. almost all studies on the dual-factor model find degree of independence of positive and negative facets of mental health even in clinical samples (de vos et al., 2018; díaz et al., 2018; franken et al., 2018; teismann et al., 2018). in addition, a study using ecological momentary assessment in individuals with generalized anxiety disorder showed that these people self-reported several positive phases in their daily lives, despite severe worry (vîslă et al., 2021). these results suggest that patients can, in principle, also report well-being and positive moments. however, a problem focus often dominates in patients themselves and in therapy. therefore, it is recommended to provide space for positive reports from patients (even if they are rare or seem small). therapists should also ask specifically about patients’ strengths, exceptions, and positive changes. limitations and future directions this study has several limitations. the size of the clinical sample was small for sem, according to established thumb rules of 5-10 observations per parameter, so that repli­ cation studies are needed. on the other hand, simulation studies indicated that even smaller sample sizes could be sufficient for particular sem analyses (e.g. wolf et al., 2013). no comparisons to other clinical samples or healthy controls were included, which limits generalizability of the results. moreover, the cross-sectional design restricted the predictive value assumed in the regression analysis. longitudinal designs should analyze the predictive relevance of the strengths subscales for pmh and nmh. furthermore, moderation analyses should differentiate how resources act on mental health in clinical samples. our results suggest the assessment of strengths in psychotherapy studies. re­ peated assessment of strengths during treatment should trace potential increases of pmh and related process factors. conclusion the wirf is a promising complementary instrument of strengths in clinical psychology and psychotherapy. its multidimensional structure reaching beyond current problems is a unique feature of the instrument and may be relevant for etiology and intervention schürmann-vengels, troche, victor et al. 17 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://www.psychopen.eu/ studies. the results of this study suggest that pmh is not easily detected in the presence of simultaneous marked psychopathology. this underlines the relevance of differential assessments of patients’ positive facets. funding: this research did not receive any special grant from funding agencies in the public, commercial or nonprofit sectors. primary sponsor of this study is witten/herdecke university. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors declare that they have no competing interests. author contributions: jsv, st, ppv, tt, and uw contributed to the study design. ppv and uw implemented the study at the treatment center. jsv and ppv contributed to the data collection. jsv and st conducted all statistical analyses. jsv wrote the initial draft of the manuscript. all authors read and approved the final version of the manuscript. ethics statement: ethics approval for the study was provided by the ethics committee of witten/herdecke university (germany) in april 2015, approval no. 40/2015. all participants provided written informed consent. twitter accounts: @clinicalsherman r e f e r e n c e s alterman, a. i., cacciola, j. s., ivey, m. a., coviello, d. m., lynch, k. g., dugosh, k. l., & habing, b. 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(2005). promoting mental health: concepts, emerging evidence, practice. world health organization. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. schürmann-vengels, troche, victor et al. 23 clinical psychology in europe 2023, vol. 5(2), article e8041 https://doi.org/10.32872/cpe.8041 https://doi.org/10.1002/jclp.22621 https://doi.org/10.1024/1661-4747/a000388 https://doi.org/10.3389/fpsyg.2021.722881 https://doi.org/10.1177/0013164413495237 https://www.psychopen.eu/ strengths and mental health (introduction) objectives method design and sample description instruments statistical analyses results preliminary analyses measurement models latent regression analyses discussion interpretation of results limitations and future directions conclusion (additional information) funding acknowledgments competing interests author contributions ethics statement twitter accounts references alcohol and substance use disorders diagnostic criteria changes and innovations in icd-11: an overview scientific update and overview alcohol and substance use disorders diagnostic criteria changes and innovations in icd-11: an overview alice matone 1 , claudia gandin 1 , silvia ghirini 1 , emanuele scafato 1 [1] osservatorio nazionale alcol, centro nazionale dipendenze e doping, istituto superiore di sanità, rome, italy. clinical psychology in europe, 2022, vol. 4(special issue), article e9539, https://doi.org/10.32872/cpe.9539 received: 2022-05-24 • accepted: 2022-10-04 • published (vor): 2022-12-15 handling editor: andreas maercker, university of zurich, zurich, switzerland corresponding author: emanuele scafato, istituto superiore di sanità, viale regina elena, 299 – 00161, roma, italy. tel.: 06 49904028. e-mail: emanuele.scafato@iss.it related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si abstract background: the new revision of the icd came into effect on january 1st, 2022, and significant changes have been introduced in the section related to substance use disorders. method: in the present work we describe the new icd-11 section “disorders due to substance use and addictive behaviors” and outline the innovations in classification and diagnosis introduced, with a view to addressing the most important issues in terms of new opportunities for identifying and caring for people in need of treatment. results: the main innovations introduced in the icd-11 chapter of interest are the expanded classes of psychoactive substances, the introduction of single episodes of substance use, the introduction of harmful patterns of substance use and severity qualifiers for substance intoxication. furthermore, the new category “disorders due to addictive behaviors” has been added, including “gambling disorder” and the new diagnostic category “gaming disorder”. conclusions: icd-11 calls for renewed public health response and policies fostering the multiprofessional and multidisciplinary management of alcohol and substance abuse treatment, giving to these forms of addiction new chances also towards the reaching of the un 2030 agenda sustainable development goals. keywords disease international classification, icd-11, substance use disorders, addictive behaviors, public health, psychoactive substances this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9539&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0003-4530-908x https://orcid.org/0000-0002-2039-1171 https://orcid.org/0000-0001-8552-7474 https://orcid.org/0000-0001-5663-6751 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • icd-11 represents a new opportunity for those who are in need for treatment to be timely identified. • icd-11 allows to fill the existing therapeutic gap and increase the coverage of substance use disorders. • icd-11 pushes for necessary changes in the post-covid era: an integrated approach aimed at using standard tools and training for adequate intervention. • the new definitions adopted by icd-11 are in line with the un 2030 agenda, aimed at ensuring healthy lives and promote well-being for all ages. on january 1st, 2022, the 11th revision of the international classification of disease (icd) system, icd-11, came into effect. the icd is a collection of human disorders and related health conditions which is used from approximately 180 countries around the globe and is periodically revised from the world health organization (who). disease classification and coding is crucial not only for accurate clinical diagnosis and effective communica­ tion between medical professionals, but also for epidemiological data gathering in order to monitor trends in disease prevalence and incidence, and for providing a basis for precision in research (sanusi et al., 2022; saunders, 2017). within the wide spectrum of recognized disorders that have an impact on human health and society, of non-trivial importance are disorders related to psychoactive sub­ stance use. psychoactive substances, when taken in or administered into a person’s system, affect mental processes such as consciousness, cognition, perception, mood and emotions. especially if untreated, substance use disorders increase morbidity and mortal­ ity risks, and can lead to major suffering and impairment in important areas of function­ ing, such as family, occupational and social life. substance use disorders are associated with significant costs to society due to lost productivity, premature mortality, increased health care expenditure, and costs related to criminal justice, social welfare, and other social consequences (world health orgnization, 2022). therefore, careful consideration of these spectrum of diseases within the international coding systems is necessary and unavoidable. the section of the icd-11 dedicated to mental health is called “mental, behavioral or neurodevelopmental disorders” (mbnd), and is the result of a wide international, multidisciplinary and participative process that involved many experts and stakeholders around the world, such as mental health professionals and users of mental health serv­ ices (gaebel et al., 2020; reed et al., 2019). the who department of mental health and substance abuse (dmhsa) assigned a dedicated advisory group for the revision of icd-10 chapter on mental health, and working groups were established worldwide in order to collaborate to the development of the new mbnd chapter in icd-11. based on the available evidence, the working groups proposed improvements to the classification system related to mental health, resulting in a beta draft that was made available online innovations in icd-11 and substance use disorders 2 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ from 2015, in order to receive additional comments and inputs (gaebel et al., 2020). the 11th version of the icd was approved in may 2019 by the world health assembly, after which the who dmhsa published the clinical description and diagnostic guidelines (cddg) for the icd-11 mbnd, as the result of a multidisciplinary and international collaboration process that lasted for over a decade (reed et al., 2019). the main criteria adopted for the development of the icd-11 mbnd process have been the consideration of clinical utility, adherence to scientific soundness, and global applicability. further­ more, since the development of the diagnostic and statistical manual of mental disor­ ders (dsm)-5 was partially contemporary to the one of the icd-11 clinical descriptions and diagnostic guidelines, the coherence between the two tool was considered of crucial importance, particularly in terms of minimizing arbitrary differences between the two (reed et al., 2019). the dsm is one of the most widely used diagnostic tools for mental disorders, it is published from the american psychiatric association (apa), and the 5th revision was completed in 2013. the dsm covers all categories of mental health disorders and has a widespread importance and influence on how disorders are diagnosed, treated, and investigated. although great efforts have been made to harmonize the icd-11 with the dsm-5, the two systems do have some differences, also considering that they have, to some extent, different aims. while the dsm-5 aims at providing a common research and clinical language for mental health problems, the icd-11 pays particular attention to issues of clinical utility in a broad range of settings, aiming at global applicability, and especially the area of ‘addictions’ has been handled by the latest revisions of the two systems with somewhat divergent approaches, that will be discussed later in this article (grant & chamberlain, 2016). the icd-11 mbnd chapter includes disorders related to substance use in the section “disorders due to substance use and addictive behaviors” (saunders et al., 2019; world health organization, 2019). several important changes have been made in this section with this last revision, that reflect adjustment to modern times, in terms of new sub­ stances, behaviors and psychological dynamics (poznyak et al., 2018). in this work we describe the changes in substance use disorders and addictive behaviors classification between icd-10 and icd-11 and their implications, specifically: 1. expanded classes of psychoactive substances; 2. introduction of single episodes of substance use; 3. introduction of harmful patterns of substance use; 4. severity qualifiers for substance intoxication; 5. introduction of the category “disorders due to addictive behaviors” that includes “gambling disorder” (previously under “habit and impulse disorders”) and the new diagnostic category “gaming disorder”. matone, gandin, ghirini, & scafato 3 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ globally, the need for treatment for substance use disorders did not yet reach a satisfying level and the changes introduced in the icd-11 have important implications for public health in terms of opportunities for improved monitoring, prevention and treatment and for restructuring of health services in such a way that patient-centered care is prioritized. interventions must be supported from informed strategies and one of the main priorities in this respect is to provide health professionals with an effective tool for identifying people in need (poznyak et al., 2018). therefore, with the present manuscript we aim at providing professionals with valuable insights by outlining the main changes in the 11th revision of the icd that will have important implications in terms of public health approaches. i c d 1 1 “ d i s o r d e r s d u e t o s u b s t a n c e u s e a n d a d d i c t i v e b e h a v i o r s ” chapter 6 of the icd-11, “mental, behavioral and neurodevelopmental disorders”, in­ cludes a new grouping of conditions in the 12th section called “disorders due to sub­ stance use and addictive behaviors” (see figure 1) which is described as follows: “disorders due to substance use and addictive behaviors are mental and behavioral disorders that develop as a result of the use of pre­ dominantly psychoactive substances, including medications, or spe­ cific repetitive rewarding and reinforcing behaviors” (world health organization, 2019). the who strategic approach to minimize harm from substance use is reflected in this new version of the icd-11, where the public health approach to substance use and addic­ tive behaviors is emphasized from diagnoses (reed et al., 2019). the section is divided itself in two parts, “disorders due to substance use” and “disorders due to addictive behaviors”. disorders due to substance use expanded classes of psychoactive substances in icd-11 disorders due to substance use include disorders that result from a single occasion or repeated use of substances that have psychoactive properties, including certain medica­ tions, and are classified according to the substance. the list of substances has been broadened from 9 (icd-10) to 14, to comprehend contemporary patterns of use: alcohol, cannabis, synthetic cannabinoids, opioids, sedative hypnotics and anxiolytics, cocaine, stimulants including amphetamine methamphetamine or methcathinone, synthetic cath­ inones, caffeine, hallucinogens, nicotine, volatile inhalants, mdma and related drugs, dissociative drugs including ketamine and phencyclidine (poznyak et al., 2018). other innovations in icd-11 and substance use disorders 4 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ classes have been added to include for those substances that are not mentioned and are known of not known: “disorders due to use of…” other specified psychoactive substan­ ces, including medications; multiple specified psychoactive substances, including medica­ tions; unknown or unspecified psychoactive substances; non-psychoactive substances. figure 2 illustrates the differences between the list of substances in icd-10 and icd-11. the structure of the classification implies that diagnosis should start from the substance rather than the clinical syndrome. the grouping revision is meant to allow capturing health information to be used in different contexts, support accurate monitoring and inform prevention and treatment. following the list of substance classes is the list of specific diagnostic categories that apply to the classes of psychoactive substances (reed et al., 2019; world health organization, 2019). figure 1 schematic representation of chapter 6 of the icd-11, “disorders due to substance use and addictive behaviors” matone, gandin, ghirini, & scafato 5 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ figure 2 list of substances in icd-10 and icd-11 icd-10 icd-11 chapter v: “mental and behavioural disorders” chapter 6: “mental, behavioural or neurodevelopmental disorders" f10-f19 mental and behavioural disorders due to psychoactive substance use disorders due to substance use or addictive behaviours mental and behavioural disorders due to use of… f10 alcohol f11 opioids f12 cannabinoids f13 sedatives or hypnotics f14 cocaine f15 other stimulants, including caffeine f16 hallucinogens f17 tobacco f18 volatile solvents f19 multiple drug use and use of other psychoactive substances disorders due to use of… 6c40 alcohol 6c41 cannabis 6c42 cannabinoids 6c43 opioids 6c44 sedatives, hypnotics or anxiolytics 6c45 cocaine 6c46 stimulants including amphetamines, methamphetamine or methcathinone 6c47 synthetic cathinones 6c48 caffeine 6c49 hallucinogens 6c4a nicotine 6c4b volatile inhalants 6c4c mdma or related drugs, including mda 6c4d dissociative drugs including ketamine and phencyclidine [pcp] 6c4e other specified psychoactive substances, including medications 6c4f multiple specified psychoactive substances, including medications 6c4g unknown or unspecified psychoactive substances 6c4h non-psychoactive substances 6a41 catatonia induced by substances or medications 6c4y other specified disorders due to substance use 6c4z disorders due to substance use, unspecified note. entries in bold show the new or differently classified/named substances in icd-11 compared to icd-10. substance use related diagnoses: innovations in icd-11 introduction of single episodes of substance use and of harmful patterns of substance use are among the main features introduced in this version of the icd for classification of primary diagnoses of substance use disorders (sud): while with the icd-10 these were only “substance dependence” and “harmful substance use” classifications, with the icd-11 the primary diagnoses classes are “substance dependence”, “harmful pattern of psychoactive substance use” and “episode of harmful psychoactive substance use”. one of these three diagnoses, or “disorder due to substance use, unspecified” – when the use pattern in unknown at the time of evaluation – must be given when making a diagnosis of a disorder due to substance use (world health organization, 2019). these categories are hierarchical and mutually exclusive, in such a way that only one of these can diagnosed for one substance group, therefore removing overlapping and ambiguity. early identification and response of sud can be eased from having different catego­ ries for harmful substance use and substance dependence as these can be addressed with different intervention schemes, for instance there are substance use patterns that may innovations in icd-11 and substance use disorders 6 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ benefit from brief psychological interventions (for instance motivational interviewing), while other require more extensive treatment (such as detoxification or agonist mainte­ nance). in addition, the who considers harmful consumption categories to be very important for understanding the impact of substance use on public health in morbidity and mortality statistics (first et al., 2021). furthermore, there are a number of diagnoses that can be added to the primary ones, which include “substance intoxication”, “substance withdrawal” and different “substance induced mental disorders”. the manual includes also categories related to “hazardous substance use”, which are classified in chapter 24, ‘factors influencing health status or contact with health services’, and not considered to be mental disorders and can be referred to in cases where no evident harm has occurred but the pattern of use increases the risk of harmful health consequences to the user, or to others, in a way that advice from health professionals is needed (reed et al., 2019; world health organization, 2019). episode of harmful psychoactive substance use inclusion of the single episode of harmful substance use in the icd-11 is noteworthy, as it allows for early intervention and prevention of increased use and worsening of the condition and harm. the diagnosis should follow an episode where damage has been caused to someone’s physical or mental health, not only referred to the user but also to others: this is an important added value of the icd-11, where harm to the health of others is explicitly included (reed et al., 2019). the episode of harmful use usually refers to acute effects and may include substance-induced psychological disorders and should not include harm due to a known harmful pattern of use (world health organization, 2019). harmful pattern of psychoactive substance use the harmful pattern of use definition, instead, indicates a case where interventions must be intensified, and refers to a situation where clinically significant harm to a person’s physical or mental health is evident, and can be due not only to the direct intoxicating effects of the substance, but also to secondary effects or harmful route of administration. the pattern can be further specified as episodic or continuous and should be detected for a period of at least one year for episodic use and at least one month for continuous use. furthermore, harm to health should not be better accounted for by another medical condition or another mental disorder, including another disorder due to substance use, such as substance withdrawal or substance dependence. harm caused by substance dependence can be similar to that observed in harmful pattern of psychoactive substance use, however, alcohol dependence also includes additional features of the diagnosis and requires at least two of three central features to be present at the same time: impaired control after substance use, substance use becomes an increasing priority in life, phys­ matone, gandin, ghirini, & scafato 7 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ iological features that indicate neuroadaptation to the substance, such a tolerance and withdrawal symptoms (world health organization, 2019). severity qualifiers for substance intoxication diagnosis of substance intoxication requires some essential characteristics, that include transient and clinically significant alteration – such as in behavior, consciousness or coordination – that appear during or shortly after substance use, the pharmacological effects of which must be compatible with the symptoms. intoxication can last from only a few minutes or even several days after the episode of use. the effects of intoxication are limited in time and fade away as the substance is cleared from the body and symp­ toms are not better attributable to other medical conditions or mental disorders. the icd-11 allows for specification of severity of intoxication, that can be classified as mild, moderate or severe, and depends on a variety of factors, such as the amount of substance used, its half-life and the route of administration, and of course individual susceptibility which can be influenced from body weight, tolerance or concurrent conditions such as kidney of liver impairment. substance intoxication is considered mild if disturbances in psychophysiological functions and responses (for instance attention, judgement or motor coordination) are clinically recognizable but there is no – or little – disturbance in the level of consciousness. in moderate intoxication, instead, the above-mentioned disturban­ ces are evident and the tasks that require psychophysiological functioning and response are substantially impaired. there is also some disturbance in the level of consciousness. severe substance intoxication is a state in which motor coordination, attention and judgement are obviously impaired, as well as the level of consciousness. the person may not be capable of self-care or self-protection and may not be capable to communicate or cooperate with assessment and intervention. the intensity of intoxication decreases after reaching a peak of absorption of the substance, and the effects eventually disappear in there is no further use of the substance (world health organization, 2019). disorders due to addictive behaviors the new section introduced in the 6th icd-11 chapter, called “disorders due to addictive behaviors”, includes “gambling disorder”, which was previously listed in the category “habit and impulse control disorders (icd-10)”, and the new diagnostic category “gam­ ing disorder” (saunders, 2017). diagnosis of gambling and gaming disorders need the manifestation of clinical signs and functional impairment that are observed for a period of at least 12 months, unless severe symptoms arise. both gambling and gaming disorders are classified as “predominantly online” or “predominantly offline” and are characterized by a pattern of persistent or recurrent behavior. the disorders are defined by impaired control over gambling or gaming, increasing priority given to it, and continuation or escalation despite the occurrence of negative consequences. the pattern of the behavior may be continuous or episodic and recurrent, and results in marked distress or signifi­ innovations in icd-11 and substance use disorders 8 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ cant impairment in important areas of functioning, such as occupational, family and social life. gambling disorder in icd-10 gambling was classified under the “disorders of adult personality and behav­ ior” section “habit and impulse disorders” and was named “pathological gambling”. since recent evidence shows important phenomenological analogies between substance use disorders and disorders due to addictive behaviors, gambling has been associated, togeth­ er with gaming, in the “disorders due to substance use and addictive behaviors” section. this change is important also because a high co-occurrence has been detected within the phenomena, as well as the fact that they are both initially pleasurable and then followed by progression to loss of hedonic value and need for increased use. there is also some scientific evidence that disorders due to substance use and disorders due to addictive behaviors share similar neurobiology, especially activation and neuroadaptation within the reward and motivation neural circuits (fauth-bühler et al., 2017; reed et al., 2019). gaming disorder gaming disorder, either ‘digital gaming’ or ‘video-gaming’, is described as pattern of persistent or recurrent gaming behavior, which may be online or offline, characterized by impaired control over gaming in terms onset, frequency, intensity, duration, termina­ tion, and context. furthermore, increasing priority is given to gaming in such a way that it takes precedence over other life interests and daily activities and, despite the occurrence of negative consequences, the disorder shows continuation or escalation of gaming (world health organization, 2019). solid evidence and intensive discussions among experts over the past years recognized excessive gaming patterns as a clinically significant syndrome, leading to the inclusion of gaming disorder in the 11th revision of the icd, making a diagnosis for this disfunction a real possibility for patients and clinicians, where the issue is of such a nature and intensity that it results in marked distress or significant impairment in personal, family, social, educational or occupational functioning (borges et al., 2021; world health organization, 2018). in fact, implications of gaming disfunction are not limited to gaming itself, but come along with other health issues, such as aggressive behaviors, depression, insufficient physical activity, unhealthy diet, eyesight and hearing issues and sleep deprivation (higuchi et al., 2021; world health organization, 2018). unlike gambling disorder, gaming disorder does not involve the betting of money or other valuables with the hope of obtaining something of greater value. if gaming behavior is focused on wagers (for instance internet poker), gambling disorder is generally the more appropriate diagnosis (world health organization, 2019). matone, gandin, ghirini, & scafato 9 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ i c d 1 1 a n d d s m 5 the icd and the dsm both have a substantial impact of psychiatric practice and research worldwide, and much effort has been made over the years to harmonize the two clas­ sifications and both the who and the american psychiatric association believe that the differences between the two systems should be minimized and maintained only if conceptually justified (first et al., 2021; reed et al., 2019). nevertheless, there are some significant differences in the classification of sud between the icd-11 and the dsm-5. the icd-11 paragraph “disorders due to substance use and addictive behaviors” has a corresponding one in the dsm-5: “substance-related and addictive disorders”. in order to facilitate data collection on their public health impact, some psychoactive substances have been added in the icd-11 due to their increasing global importance (european monitoring centre for drugs and drug addiction and eurojust, 2016): synthetic canna­ binoids (in the dsm‐5 are included in the cannabis class), cocaine (in the dsm‐5 are included in the stimulant class), synthetic cathinones (in the dsm‐5 included in the “other or unknown” class), and methylenedioxyphenethylamine (mdma) (in the dsm‐5 are included in the hallucinogen class) (first et al., 2021). distinct categories for pattern of use included in the icd-11 are discussed above, the dsm-5, instead, considers only one “substance use disorder” category, and identifies three levels of severity depending on the number of recognized symptoms among a list of 11: two or three symptoms identify mild sud, four or five symptoms identify moderate sud, and six or more symptoms identify severe sud. furthermore, dsm-5 does not consider classification of sud based on harm caused to the person’s physical or mental health or health of others. although there is a noticeable similarity between the dsm-5 11 classifications for sud and the three icd-11 categories, a number of cases detected with dsm-5 would not find correspondence in the icd-11: diagnosis of sud in icd-11 requires two out of three items, while in dsm-5 two out of 11. “craving” and “recurrent use in situations which are physically hazardous” are two items of dsm-5 that are not included nor have a correspondence in icd-11. furthermore, all the items related to a substance taking over in daily life activities described in the dsm-5: time spent using or obtaining substances, failure to fulfill role obligations, continued use despite social or interpersonal problems, important activities given up, and continued use despite physical or psychological prob­ lems, in icd-11 are represented in only one category: “increasing precedence of sub­ stance use over other aspects of life” (first et al., 2021). all the above might imply that, since there is not a complete homogeneity between the two tools in identifying all the sud categories, different diagnoses can be made for some groups of sud (degenhardt et al., 2019). as for gaming disorder, some studies suggest that there might be noticeable differen­ ces between the two classification systems in gaming disorder cases detection, where prevalence of cases detected with the dsm-5 are much higher compared to icd-11 innovations in icd-11 and substance use disorders 10 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://www.psychopen.eu/ (borges et al., 2021). however, clinical validity studies are needed in order to assess these differences. c o n c l u s i o n s overall, icd-11 can represent a new opportunity for several harmful behaviors and for those who are in need for treatment to be timely identified, filling the existing therapeu­ tic gap and increasing the coverage of alcohol and substance use disorders. icd-11 also pushes for some needed changes, particularly in the post-covid era (lópez-pelayo et al., 2020), to support a much more integrated approach aimed at using standard tools to identify the level of risk as well as training on how to ensure an adequate form of intervention valuing renewed treatment systems for substance use disorders. finally, the new definitions adopted by icd-11 call for renewed public health response and policies fostering the multi-professional and multidisciplinary management of alcohol and substance abuse treatment, giving to these forms of addiction new chances also towards the reaching of the un 2030 agenda sustainable development goals (sdgs) (united nations, 2015), aimed at ensuring healthy lives and promote well-being for all ages by mean "strengthen the prevention and treatment of substance abuse including narcotic drug abuse and harmful use of alcohol". funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. 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(2017). substance use and addictive disorders in dsm-5 and icd 10 and the draft icd 11. current opinion in psychiatry, 30(4), 227–237. https://doi.org/10.1097/yco.0000000000000332 saunders, j. b., degenhardt, l., reed, g. m., & poznyak, v. (2019). alcohol use disorders in icd-11: past, present, and future. alcoholism, clinical and experimental research, 43(8), 1617–1631. https://doi.org/10.1111/acer.14128 united nations. (2015). transforming our world: the 2030 agenda for sustainable development. https://sustainabledevelopment.un.org/post2015/transformingourworld/publication world health organization. (2019). international statistical classification of diseases and related health problems (11th ed.). world health organization. (2018). inclusion of “gaming disorder” in icd-11. https://www.who.int/news/item/14-09-2018-inclusion-of-gaming-disorder-in-icd-11 world health orgnization. (2022). mental health and substance use. https://www.who.int/teams/mental-health-and-substance-use/overview clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. matone, gandin, ghirini, & scafato 13 clinical psychology in europe 2022, vol. 4(special issue), article e9539 https://doi.org/10.32872/cpe.9539 https://doi.org/10.1186/s12889-022-13118-8 https://doi.org/10.1097/yco.0000000000000332 https://doi.org/10.1111/acer.14128 https://sustainabledevelopment.un.org/post2015/transformingourworld/publication https://www.who.int/news/item/14-09-2018-inclusion-of-gaming-disorder-in-icd-11 https://www.who.int/teams/mental-health-and-substance-use/overview https://www.psychopen.eu/ innovations in icd-11 and substance use disorders (introduction) icd-11 “disorders due to substance use and addictive behaviors” disorders due to substance use disorders due to addictive behaviors icd-11 and dsm-5 conclusions (additional information) funding acknowledgments competing interests twitter accounts references make a wish – what are the wishes for clinical psychology and psychological treatment? editorial make a wish – what are the wishes for clinical psychology and psychological treatment? winfried rief 1 , cornelia weise 1 [1] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2021, vol. 3(4), article e7957, https://doi.org/10.32872/cpe.7957 published (vor): 2021-12-23 corresponding author: cornelia weise, division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, gutenbergstrasse 18, 35032 marburg, germany. e-mail: weise@unimarburg.de it's the end of the year – and we look back to an enormously challenging year. we went through several restrictions in our professional and private lives, we adapted study programs to legal regulations on behaviour during the pandemic, we missed the direct personal contacts which in the past used to be so essential to find solutions during debates, and we saw things during zoom conferences that we didn’t want to see. our society is experiencing a deep and bitter division that is challenging psychology more than it has in a long time. it is quite understandable that people are annoyed, and have lost the motivation to reflect on the current situation. but still, it's also the time of the year that stands for dreams and wishes. a world without dreams and hopes and wishes is something we would not want to imagine. to exile such a nightmare, we needed an optimistic outlook which can bring us safely through the year 2022. therefore, we from cpe encouraged the members of our editorial board to take the time to express some of their wishes. and this is what came back: a new vaccination shot, filled with positive ideas, with perspectives and demands to our professional competences, with visions we would like to follow, and lots of optimism. the wishes show the strength of our collaboration to bring clinical psychology and psychological treatments forward for the benefit of the people. but, read yourself: in every european country psychological therapies are less available than they should be. a lesson from the english iapt programme is that politicians will invest more in therapy if we collect and report outcome data in our routine services. such data shows our value, our focus on patient benefit, and our openness to learning. my new this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7957&domain=pdf&date_stamp=2021-12-23 https://orcid.org/0000-0002-7019-2250 https://orcid.org/0000-0001-5216-1031 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ year wish is that clinical psychologists will once again lead the field in mental health by showing that we as a group embrace outcome monitoring. other professionals and funding will follow our leadership. (david clark, uk) that psychological treatments and all the strategies for care already available in clinical psychology reach everyone in need. (christina botella, spain) christmas time makes people focus more than usual on other people's needs, joys and concerns. as clinical psychologists, we are sensitive to the needs of our patients and clients, regardless of the season. may this attitude of listening and openness accompany our work, so that we can accompany those who ask for our professional help. (roman cieślak, poland) a significant portion of research in clinical psychology is unusable because of incomplete or poor reporting. descriptions of interven­ tions, particularly complex, psychosocial ones, are often sketchy and just reference a manual. my wish is that clinical research is reported more completely, by actually following (not just declaring to have followed) available reporting guidelines. (ioana a. cristea, italy/ usa) actually, i have a dozen wishes for clinical psychology, some for our patients or clients, others for ourselves. here's one: that in the bitter dispute between covid vaccine supporters and opponents, we can pro­ vide empathic communication strategies that both increase willingness to vaccinate and diminish the rifts between supporters and opponents. who, if not us, should provide such helpful interventions to the rest of society? (andreas maercker, switzerland) i wish that the awareness, at all levels of our society, of the core value of mental health during the covid crisis does not disappear once it is over. i also want european countries to invest heavily in research (which will then undoubtedly be published in the excellent cpe ;-) and in the implementation of prevention and intervention programmes to improve mental health that are accessible to all people living on european soil. (céline douilliez, belgium) a more widespread use of clinimetric strategies in psychological assess­ ment. (giovanni a. fava, usa/italy) editorial 2 clinical psychology in europe 2021, vol. 3(4), article e7957 https://doi.org/10.32872/cpe.7957 https://www.psychopen.eu/ particularly in current times that challenge mental health, i wish all european clinical psychologists loads of resilience, strength, wisdom and self-care. in my own country (belgium), clinical psychology is facing several important legislative and organisational transitions. i wish that once this phase of uncertainty and burden has passed, clinical psychology will find itself in a renewed and stronger posi­ tion to the benefit of our clients. (dirk hermans, belgium) my wish for 2022 is to be dancing with you all at conference parties again! (tania lincoln, germany) romanian wish for clinical psychology: day by day, in many ways, be more and more personalized, high-tech, and evidence-based, for the sake of people's wellbeing! (daniel david, romania) the role of clinical psychology is not evenly distributed in europe and not even within countries. given modern information technology it is technically easy to deliver treatments across borders. however, legal and administrative issues make it hard and sometimes even impossible to share treatments and do research. my wish is that we increase collaboration between countries and reduce administrative burden to facilitate spread of evidence-based treatments within europe. (gerhard andersson, sweden) may clinical psychology continue to flourish in the year 2022, contribute to an understanding of the basic processes of the devel­ opment of psychopathology and the principles of change in the treatment of psychological disorders (and help to overcome the pan­ demic!). (bernhard strauss, germany) i wish that we develop clear and agreed upon competencies of clinical psychologists that would help our profession and training of the next generation of clinical psychologists. (maria karekla, cyprus) i would like santa to become a spiritual member of the cpe team to help us make inter-european networking in the field of clinical psychology even more vibrant, to keep our fire of curiosity burning, and to remind us of the importance of bringing hope and light to those who need us. (robert masten, slowenia) wishing happy, healthy and peaceful lives for all. may we feel connec­ ted with our hearts and one another, during the holidays and through­ out the new year 2022! (jolanda meeuwissen, the netherlands) rief & weise 3 clinical psychology in europe 2021, vol. 3(4), article e7957 https://doi.org/10.32872/cpe.7957 https://www.psychopen.eu/ i wish more kindness in this world because we are all part of the same beautiful miracle. love, peace, and compassion. (stefan hof­ mann, germany/usa) 2022, please give us healthy clinical psychologists for research and practice in europe and around the world. (anonymous) personally, i have only the wish for "more time" (we need two more hours per day and an extra free day per week). professional­ ly, i wish: more collaboration [national, international (european)] in large scale studies; more research on moderators of treatment outcome in different groups of disorders; more research on media­ tors (mechanism) of change using psychological and biological basic science results; more support and funding for young (female) scien­ tists; more replication studies; less egoism and competition; and again, more personal meetings. (martin hautzinger, germany) what a time we have all had! i’d like to wish all of you and your families and friends in europe as well as further afield a restful time over the coming weeks, so that we can embrace 2022 with renewed energy. carpe diem. (trudie chalder, uk) i wish us all much inspiration in 2022 in generating new ideas to improve the impact of treatments for mental disorders, because that is what people suffering from these conditions very much need. (pim cuijpers, the netherlands) i wish for clinical psychology research to rapidly develop and empiri­ cally validate even better treatments for those with co-morbid chronic physical conditions – and for these to be recognized and implemented by national health care systems. (claus vögele, luxembourg) i send out a wholehearted thanks to all the psychological therapists who have managed to support and help people in mental health need by delivering treatments online or in person, whilst they them­ selves have often had challenges in their own lives and at home. my wish for 2022 is that clinical psychology can be at the forefront of preventing mental health problems across europe and beyond. (colette hirsch, uk) i wish clinical psychology in europe (and beyond) a contagious opti­ mism and resilience in 2022. (omer van den bergh, belgium) editorial 4 clinical psychology in europe 2021, vol. 3(4), article e7957 https://doi.org/10.32872/cpe.7957 https://www.psychopen.eu/ i wish you all merry christmas with, hopefully, some face-to-face gatherings with your loved ones. (claudi bockting, president of the eaclipt) now it’s your turn: take a minute and express your wish for your professional engage­ ment during the year 2022. finally to us: for 2022, we wish that our journal will again receive as much support as this year, be it from authors, reviewers, editors, readers, and the excellent team of our publisher psychopen, so that we can continue to strengthen the visibility of the many facets of clinical psychology in europe. as editors-in-chief of clinical psychology in europe, we promise to address all your and our wishes to the corresponding institution (see photo). we wish you a happy holiday season and a peaceful and prosperous new year. winfried rief & cornelia weise acknowledgments: the authors wish to thank all members of the editorial board of clinical psychology in europe for expressing their wishes for 2022. rief & weise 5 clinical psychology in europe 2021, vol. 3(4), article e7957 https://doi.org/10.32872/cpe.7957 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. editorial 6 clinical psychology in europe 2021, vol. 3(4), article e7957 https://doi.org/10.32872/cpe.7957 https://www.psychopen.eu/ title of “ambassador of clinical psychology and psychological treatment” awarded to danutė gailienė letter to the editor, commentary title of “ambassador of clinical psychology and psychological treatment” awarded to danutė gailienė evaldas kazlauskas 1, andreas maercker 2 [1] center for psychotraumatology, institute of psychology, vilnius university, vilnius, lithuania. [2] department of psychology, division psychopathology and clinical intervention, university of zurich, zurich, switzerland. clinical psychology in europe, 2022, vol. 4(3), article e7747, https://doi.org/10.32872/cpe.7747 published (vor): 2022-09-30 corresponding author: andreas maercker, department of psychology, university of zurich, binzmuehlestrasse 14/17, ch-8050 zurich, switzerland. e-mail: maercker@psychologie.uzh.ch abstract the paper presents professional activities and the major works of an ambassador of the european association of clinical psychology and psychological treatment (eaclipt), prof. danutė gailienė. prof. gailienė is among the most influential european clinical psychologists who contributed to clinical psychology training, research, and practice in former post-communist east european countries. her entire career was dedicated to the development of clinical psychology, and through her work, prof. gailienė demonstrated how even in an oppressive and politically difficult environment, it is possible to keep the integrity and work up to higher standards. keywords danutė gailienė, psychotraumatology, suicidology, societal impact ambassador of the european association of clinical psychology and psychological treatment (eaclipt) prof. danutė gailienė was born in 1951 in lithuania which was oc­ cupied by the soviet union at a time. in 1969 the first psychology training program was launched at vilnius university in lithuania, and she enrolled at the university to study psychology that year. due to ideological reasons of refusal of any individuality, clinical psychology and psychotherapy were not approved by the communist regime (gailienė, 2000), and the psychology study program was focused on industrial and engineering psychology (bagdonas et al., 2008) at the time. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7747&domain=pdf&date_stamp=2022-09-30 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ however, danutė gailienė was very interested in clinical psychology, and since the beginning of her psychology studies, she has aimed to pursue a ca­ reer as a clinical psychologist. danutė gailienė, against the odds, managed to get the position of the first clinical psy­ chologist in a clinical setting in the country during soviet regime. thus, she began to make an outstanding con­ tribution to clinical psychology in the region. she has been the first professor of clinical psychology in the country and was the founder and chair of the clinical psychology program. e a r l y c a r e e r d u r i n g s o v i e t o c c u p a t i o n danutė gailienė graduated from vilnius university in lithuania in 1974. the head of the psychology department was prof. alfonsas gučas, who was very supportive of young professionals. prof. gučas managed to include a small number of special courses related to clinical or health psychology, even in a very restrictive political situation where political officials in moscow fully controlled the curriculum. danutė gailienė was very interested in clinical psychology during her studies and insistently searched for possibilities to work as a clinical psychologist after obtaining her diploma. however, such positions were not available due to the critical attitude of the soviet regime towards clin­ ical psychology. due to her persistence, danutė gailienė managed to get a position as a psychologist in one of the psychiatric hospitals in vilnius and was the first psychologist to work in a psychiatric hospital in the country and the baltic republics. danutė gailienė was searching for advanced training; however, the possibility of receiving a ph.d. degree in her preferred area in psychology was not possible due to the mentioned ideological reasons. it required a lot of dedication and hard work, especially to somebody not loyal to the communist party, to receive a ph.d. danutė gailienė worked on her ph.d. thesis (called 'candidate of sciences' at the time) on cognitive processes in schizophrenia supervised by the internationally famous experimental psy­ chologist, prof. bluma zeigarnik (herself born in lithuania; discoverer of a psychological cliffhanger effect named after her) from moscow. at the same time, she was working in vilnius in a clinical setting, was invited to teach at the university, and raised her three children. dr. gailienė received her ph.d. in psychology from moscow state university in 1985. prof. danutė gailienė – lithuanian psychologist and pioneer of clinical psychology behind 'iron curtain.' ambassador of clinical psychology and psychological treatment: danutė gailienė 2 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://www.psychopen.eu/ during that time, psychology was highly affected by communist ideology (e.g., the primacy of the ruling party, the material sphere was to be given precedence over the subjective sphere) in the soviet union, and the regime was highly oppressive. the psychologist had very restricted or no access to international journals or books. so active and eager to get knowledge, professionals had to find ways for their professional development. a very significant impact on the development of danutė gailienė was a visit of prof. vytautas bieliauskas from usa in 1977 (bieliauskas, 1977), and following his visits. prof. bieliauskas was a lithuanian professor of clinical psychology in the us who managed to come to lithuania during soviet occupation and provided training and supervision for a selected group of professionals. the other ways of getting knowledge were poland and east germany, which had slightly less restrictive regimes and more access to international professional literature (leuenberger, 2001). it was also possible to visit poland and the east german democratic republic for training and conferences, and danutė gailienė used this opportunity to travel and meet professionals and achieve more specialized knowledge on clinical psychology and psychological treatments. not a communist party member and critical of communist party ideology danutė gailienė in the 1980s had limited possibilities for an academic or professional career as such professionals were under constant surveillance by the kgb. having to start her career during soviet times, which was marked by betrayal, opportunistic loyalty to the communist regime by some of her colleagues who wanted to have a faster and safe career, she has always understood the importance of integrity, a robust value system, and ethical behavior which guided all her professional career. t h e c o l l a p s e o f t h e s o v i e t u n i o n a n d c a r e e r b r e a k t h r o u g h in the late 1980s, "perestroika" emerged, which was the first signal for the eventual collapse of the soviet union. the years of 1988–1990 was a turning point in society in lithuania and globally. brave intellectuals, and danutė gailienė, among them, participa­ ted in peaceful demonstrations against the soviet regime and soviet occupation. on march 11, 1990, the lithuanian parliament declared independence from the soviet union. almost immediately after the collapse of the soviet union, danutė gailienė with colleagues interested in clinical psychology (r. bieliauskaitė, g. gudaitė, r. kočiūnas) established the first department of clinical and social psychology, and the first clinical psychology program was launched in lithuania (kazlauskas & grigutyte, 2020). in the again independent country, danutė gailienė could be promoted to a full professor in clinical psychology (2001), was chair of the department of clinical (and social) psychol­ ogy (2000-2017). over the years, she supervised many ph.d. students who conducted research in clinical psychology and could write their dissertations in lithuanian. kazlauskas & maercker 3 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://www.psychopen.eu/ prof. gailienė has been teaching a clinical psychology course for undergraduate students, trauma and crisis psychology course in a clinical psychology program (since 2000), and delivering post-diploma training in clinical psychology. without restrictions to travel abroad, she was a visiting researcher at munster university in germany (2003), antwerp and gent universities (2004). prof. gailienė was frequently participating in international conferences. since the start of her career, prof. gailienė maintained her clinical practice with at least one day per week meeting clients over decades of her professional activities, and expected her staff at the department of clinical psychology to have an active clinical practice, as an integral part of their professional life. one of her pioneering works in lithuania and the region was the first systematic study on suicide prevalence in her country (e.g., gailienė, 2004a; gailienė et al., 1995; gailienė & ružyte, 1997). furthermore, she was among the first to study the effects of the communist regime's political oppression in former post-communist countries. t h e m a j o r w o r k s b y d a n u t ė g a i l i e n ė taken together, danutė gailienė has been particularly interested in the impact of soci­ etal and cultural factors on mental health processes. her groundbreaking research in suicide prevention was published in her monograph "they should not have died. suicide in lithuania [jie neturėjo mirti. savižudybės lietuvoje]" (gailienė, 1998). this book is fundamental for its first comprehensive analysis of epidemiological data on suicide rates in lithuania. it analyzes social and cultural factors of a steep increase in around 10 times of suicide rates from the beginning of the 20th century to the last decade of the 20th century in lithuania, resulting in among the highest in europe and the world. prof. gailienė draws parallels in an increase in suicide rates as an indicator of the public mental health status in response to the social transitions and transformations, primarily associated with devastating effects of long-term political violence and oppression of the soviet regime. following an analysis of the suicidal behavior in the country, prof. gailienė edited a volume "ideas of suicide prevention [savižudybių prevencijos idėjos]" published in 2001. this influential volume included other leading suicidology experts working from lithuania, norway, canada, slovenia, and germany on effective suicide prevention programs. she became a widely known suicide researcher in europe as a result of this research, representing clinical psychology at many expert meetings and congresses across disciplines. after demonstrating the importance of societal and cultural factors on self-destruc­ tive behaviors, prof. gailienė made a profound impact in the area of research of political oppression by initiating the first large scale study of survivors of political violence in the country during the nazi and communist regimes in particular, former political prisoners and displaced population to the remote areas of siberia and other areas. the project was initiated in 2000 and was conducted in collaboration with the lithuanian genocide ambassador of clinical psychology and psychological treatment: danutė gailienė 4 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://www.psychopen.eu/ and resistance research center. in the course of the research project, a much-acclaimed conference was organized in vilnius, which focused on the effects of political oppres­ sion (kazlauskas & zelviene, 2016). as a result of the conference, an important book, "the psychology of extreme traumatisation: the aftermath of political repression" was published in lithuanian in 2004 and english in 2005 (gailienė, 2004b, 2005). this volume was among the first fundamental works exploring the effects of political violence and oppression in the region of the former soviet hemisphere by showing how lithuanian historical trauma and psychotraumatology research should be included in the global agenda of traumatic stress studies. the next important monograph by prof. gailienė was published in lithuanian "what they did to us. lithuanian life in the view of trauma psychology [ką jie mums padarė: lietuvos gyvenimas trauma psichologijos žvilgsniu]" (gailienė, 2008). this book provided a deeper view of the impact of the soviet regime occupation on lithuanian mental health and is an important contribution to how the general population and professionals could use the theoretical conceptualization and empirical data from a psychotraumatology per­ spective to discuss complex social issues. the book was published in the context of some nostalgia of the soviet period in the population and attempts from former communist party leaders and their associates to clean their reputation in stating that they were doing their best in people's interest during the soviet regime. prof. gailienė's book had a significant impact of showing how the communist regime had negative long-term consequences on society (gailienė, 2008). this work resonated in other countries such as the baltic countries and poland, where her name thus became recognized. a further larger project by a major grant from the european social fund resulted in another book both in lithuanian and in english "lithuanian faces after translation" psychological consequences of cultural trauma" (gailienė, 2015a, 2015b). it reveals the diversity of the effects of political trauma and the multigenerational impact of prolonged traumatization. a chapter on cultural trauma is the highlight of this book which explores differences and similarities of psychological and cultural trauma based on the lithuanian historical context (gailienė, 2015c). f i n a l t h o u g h t s prof. danutė gailienė dedicated her life to the advancement of clinical psychology. her efforts in pursuing training in clinical psychology and psychological treatments, dissemi­ nation of clinical psychology knowledge, assisting patients, teaching clinical psychology at university, training other professionals, establishing a department and clinical psychol­ ogy program is a clear manifestation of how even under the conditions of an oppressive political regime it was possible to overcome barriers. as an excellent educator, over the years, prof. gailienė developed a much praised style of teaching. she received numerous kazlauskas & maercker 5 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://www.psychopen.eu/ awards for her outstanding work in lithuania and frequently appeared in national media, commenting on various social and public health issues. moreover, prof. gailienė has always stressed the importance of the social responsi­ bility of clinical psychologists as professionals. from the perspective of prof. gailienė, clinical psychologists must use their knowledge not only to help and treat individual clients but also should be active in social and political life in the country, join professio­ nal networks, participate in legislation relevant to psychology and mental health, and be active in the dissemination of knowledge for general population via media. we can conclude that prof. gailienė is an outstanding european psychologist. her personal and professional integrity and dedication to establish the discipline of clinical psychology out of a hostile societal environment can as an ambassador of eaclipt inspire the future generation of psychologists worldwide. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. r e f e r e n c e s bagdonas, a., pociute, b., rimkute, e., & valickas, g. (2008). the history of lithuanian psychology. european psychologist, 13(3), 227–237. https://doi.org/10.1027/1016-9040.13.3.227 bieliauskas, v. j. (1977). mental health care in the ussr. the american psychologist, 32(5), 376–379. https://doi.org/10.1037/0003-066x.32.5.376 gailienė, d. (1998). jie neturėjo mirti. savižudybės lietuvoje [they should not have died: suicide in lithuania]. tyto alba. gailienė, d. (2000). perspectives from lithuania. in a. s. bellack & m. hersen (eds.), comprehensive clinical psychology (vol. 10, pp. 325–334). elsevier science. gailienė, d. (2004a). suicide in lithuania during the years of 1990 to 2002. archives of suicide research, 8(4), 389–395. https://doi.org/10.1080/13811110490476806 gailienė, d. (ed.). (2004b). sunkių traumų psichologija: politinių represijų padariniai [psychology of heavy traumatization: aftermath of political repression]. lggrtc. gailienė, d. (ed.). (2005). the psychology of extreme traumatisation: the aftermath of political repression. akreta. gailienė, d. (2008). ką jie mums padarė. lietuvos gyvenimas traumų psichologijos žvilgsniu [what they did to us: lithuanian life in the view of trauma psychology]. tyto alba. gailienė, d. (ed.). (2015a). gyvenimas po lūžio: kultūrinių traumų psichologiniai padariniai [life after the turning point: psychological consequences of cultural trauma]. eugrimas. ambassador of clinical psychology and psychological treatment: danutė gailienė 6 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://doi.org/10.1027/1016-9040.13.3.227 https://doi.org/10.1037/0003-066x.32.5.376 https://doi.org/10.1080/13811110490476806 https://www.psychopen.eu/ gailienė, d. (ed.). (2015b). lithuanian faces after transition: psychological consequences of cultural trauma. eugrimas. gailienė, d. (2015c). trauma and culture. in d. gailienė (ed.), lithuanian faces after transition: psychological consequences of cultural trauma (pp. 9–23). eugrimas. gailienė, d., domanskiené, v., & keturakis, v. (1995). suicide in lithuania. archives of suicide research, 1(3), 149–158. https://doi.org/10.1080/13811119508251954 gailienė, d., & ružyte, i. (1997). ancient attitudes towards suicide in lithuania. nordic journal of psychiatry, 51(1), 29–35. https://doi.org/10.3109/08039489709109081 kazlauskas, e., & grigutyte, n. (2020). clinical psychology in lithuania: current developments in training and legislation. clinical psychology in europe, 2(1), article e2835. https://doi.org/10.32872/cpe.v2i1.2835 kazlauskas, e., & zelviene, p. (2016). trauma research in the baltic countries: from political oppression to recovery. european journal of psychotraumatology, 7(1), article 29259. https://doi.org/10.3402/ejpt.v7.29295 leuenberger, c. (2001). socialist psychotherapy and its dissidents. journal of the history of the behavioral sciences, 37(3), 261–273. https://doi.org/10.1002/jhbs.1034 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. kazlauskas & maercker 7 clinical psychology in europe 2022, vol. 4(3), article e7747 https://doi.org/10.32872/cpe.7747 https://doi.org/10.1080/13811119508251954 https://doi.org/10.3109/08039489709109081 https://doi.org/10.32872/cpe.v2i1.2835 https://doi.org/10.3402/ejpt.v7.29295 https://doi.org/10.1002/jhbs.1034 https://www.psychopen.eu/ ambassador of clinical psychology and psychological treatment: danutė gailienė (introduction) early career during soviet occupation the collapse of the soviet union and career breakthrough the major works by danutė gailienė final thoughts (additional information) funding acknowledgments competing interests references paul emmelkamp becomes “ambassador of clinical psychology and psychological treatment” letter to the editor, commentary paul emmelkamp becomes “ambassador of clinical psychology and psychological treatment” maaike h. nauta 1 , thomas ehring 2 [1] department of clinical psychology and experimental psychopathology, university of groningen, groningen, the netherlands. [2] department of psychology, clinical psychology and psychological treatment, lmu munich, munich, germany. clinical psychology in europe, 2022, vol. 4(1), article e8303, https://doi.org/10.32872/cpe.8303 published (vor): 2022-03-31 corresponding author: maaike h. nauta, department of clinical psychology and experimental psychopathology, university of groningen, groningen, the netherlands. grote kruisstraat 2/1, 9712 ts groningen, the netherlands. e-mail: m.h.nauta@rug.nl paul emmelkamp is a scientist-practitioner pur sang. from the start of his career on, he has put an emphasis on the importance of integrating science and clinical practice, providing many important contributions to clinical psychology and psychological treat­ ment in europe and beyond. in 1975, paul obtained his phd on ‘the behaviou­ ral treatment of agoraphobia’ from the university of utrecht, where he had previously studied and com­ pleted his postdoctoral training in psychotherapy. he then moved to the university of groningen, starting as an assistant professor and being appointed as a full professor in clinical psychology and psychother­ apy in 1986. since 1996, he has been based as a university of professor of clinical psychology at the university of amsterdam. in 2006, paul received the very prestigious appointment as academy professor of the royal academy of arts and sciences (knaw). from 2013 to 2016, he then served as the rector of the netherlands institute for advanced studies (nias). he is currently a fellow at the institute for advanced studies in paris. paul emmelkamp (2018) (source: paul emmelkamp's own private collection) this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8303&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0001-7694-1382 https://orcid.org/0000-0001-9502-6868 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ the main focus of paul’s research is to investigate the efficacy and effectiveness of psychological interventions, especially using randomized controlled trial methodology. since the earlier 70s, he has published more 70 randomized controlled trials together with a large number of national and international collaborators. since his early studies on agoraphobia, he has extended his work to cover other anxiety disorders, obsessive compulsive disorder, post-traumatic stress disorder, depression, burn-out, addiction, per­ sonality disorders, perpetrators of sexual violence, and childhood adhd and behavioral problems. his work is not limited to studies on adult populations, but also includes studies on children, adolescents and the elderly. having collaborated closely with him at different time points in his career (mn from 1996-2005; te from 2007 – 2012), we would like to share some impressions of paul emmelkamp as a scientist-practitioner that we think make him an excellent ambassador for eaclipt. readers may wonder what motivates a researcher to focus especially on one of the most challenging and time-consuming type of research in clinical psychology, i.e. mainly conducting clinical trials. in our impression, paul’s motivation has always been to conduct research that matters, that has a real impact on clinical practice. in particular, he is driven to develop and test treatments that can work for many different patients, not just for the highly motivated “yavis” (young, attractive, verbal, intelligent, and successful) patients or students with elevated levels of psychopathology, but in particular for those who typically get referred to mental health institutions, often with a variety of comorbidity and a long duration of mental health problems. when embarking on his career, he perceived psychotherapy as too elitist, and it has always been his mission to have psychotherapy available for all in need, including “the man in the street”. therefore, paul has conducted many rcts with “real-life” patients recruited within routine mental health settings, while at the same time ensuring rigorous methodology and the use of well-described treatment manuals. to study the effectiveness of treatments, paul made important contributions to manu­ alizing treatments. he was the first in the netherlands to break down treatments to manuals that were transparent and transferrable. the first aim was scientific: to define and consolidate the content of the treatments, so that therapists would adhere to the same set of interventions, and that patient would receive a similar treatment in one treatment condition in a trial. the side-effect of this has had a large impact on the field: once treatments were proven effective, they were transparently described, suitable for transfer to new therapists, and available for implementation. paul has contributed to the dissemination of many of such manuals. for paul, the most important quest is to establish scientific evidence of the effective­ ness of treatments, so that individuals with mental health problems can receive those treatments that have been proven effective. even though he has mainly conducted stud­ ies on cognitive behavioral therapy, he is not necessarily identified with this specific treatment orientation. “i am fine with anything, as long as it works” (interview at the ambassador of clinical psychology and psychological treatment: paul emmelkamp 2 clinical psychology in europe 2022, vol. 4(1), article e8303 https://doi.org/10.32872/cpe.8303 https://www.psychopen.eu/ dutch radio series noorderlicht in 2003). he keeps looking for the evidence (and also for the non-evidence, as illustrated by the book “failures in behavior therapy” co-edited with edna foa in 1983). as such, he likes to remain critical of the advances that have been made, to keep questioning things that seem “self-evident” without the data behind them, and to remain looking for further evidence. he is also not shy of – and even enjoys – raising controversial issues, playing the devil’s advocate, or pointing out that the emperor may actually not be clothed. if you are looking for a stimulating and contro­ versial discussion about the state of clinical psychology, invite paul to talk e.g. about the role of experimental psychopathology in clinical innovation, the use of non-clinical or analogue samples in clinical research, the ubiquitous claim of “novelty” in psychological interventions, or the rise of trademarked interventions. you may not necessarily agree with him on all these issues, but will certainly have a good and stimulating time! on the other hand, when a new promising treatment or treatment format is devel­ oped, paul may be among the first to start a trial investigating its efficacy. for example, he was one of the first to investigate e-health interventions and virtual reality therapy. he conducted trials investigating act or emdr when many cbt-oriented researchers in europe were still quite skeptical about these approaches. in addition, he has investigated interventions for mental health conditions that seem hard to implement, like interven­ tions for sexual offenders in the context of a forensic clinic. as a supervisor, paul is and has been an inspiration to many, and has motivated many to continue in his tradition of studying treatment effectiveness. he has supervised 45 phd students as well as numerous master students, bachelor students, and clinicians. he is a co-founder of the research school "experimental psychopathology" (epp), a graduate school and research network uniting epp researchers from various universities in the netherlands and flanders, and was the chair from its foundation in 1995 until 2014. the research school has contributed to the development of a strong and active research network. from the very beginning of his career, he has been building a strong network with colleagues across europe and beyond, starting with a seminal collaboration with edna foa and isaac marks in the 70s. similarly, he has also always been open to collaboration coming from outside of academia. when we were working with paul in groningen (mn) and amsterdam (te), most projects we collaborated on had actually been initiated by practitioners who wanted to answer a research question of relevance for their respective settings. topics ranged from evaluating treatments for ptsd in adults or for oppositional behavior in children in routine clinical settings to studying psychological consequences of a severe earthquake on emergency personnel in pakistan. his current fellowship in paris focuses on mental health interventions for refugees, a very timely and societal relevant topic. the networking and intensive collaboration that is characteristic of his research has certainly been facilitated by the fact that paul is a very approachable, open, and warm person, with a brilliant sense of humor, and an open door. in addition, paul has always nauta & ehring 3 clinical psychology in europe 2022, vol. 4(1), article e8303 https://doi.org/10.32872/cpe.8303 https://www.psychopen.eu/ been the opposite of a remote researcher in the ivory tower. instead, he has continued seeing patients as a therapist throughout his career, has trained and supervised gener­ ations of students and therapists in conducting psychological treatment. he has also provided service to many different institutions, nationally as well as internationally, as a committee member, advisor, or board member, e.g., hosting the eabct conference as president in the netherlands (1987 and 2014), and serving as president of the president of the international federation for psychotherapy from 2014-2018. last but not least, he is the founder of clinical psychology & psychotherapy and has been its editor since 1993. we are confident paul emmelkamp will prove being a wonderful ambassador for eaclipt. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. ambassador of clinical psychology and psychological treatment: paul emmelkamp 4 clinical psychology in europe 2022, vol. 4(1), article e8303 https://doi.org/10.32872/cpe.8303 https://www.psychopen.eu/ coping in the emergency medical services: associations with the personnel’s stress, self-efficacy, job satisfaction, and health research articles coping in the emergency medical services: associations with the personnel’s stress, self-efficacy, job satisfaction, and health roberto rojas 1 , maxi hickmann 1 , svenja wolf 1, iris-tatjana kolassa 2 , alexander behnke 2 [1] university psychotherapeutic outpatient clinic, institute of psychology and education, ulm university, ulm, germany. [2] clinical and biological psychology, institute of psychology and education, ulm university, ulm, germany. clinical psychology in europe, 2022, vol. 4(1), article e6133, https://doi.org/10.32872/cpe.6133 received: 2021-02-12 • accepted: 2022-01-16 • published (vor): 2022-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: roberto rojas, university psychotherapeutic outpatient clinic, institute of psychology and education, ulm university, schaffnerstraße 3, 89073 ulm, germany. phone: +49/731-50 31601, fax: +49/731-50 1231601. e-mail: roberto.rojas@uni-ulm.de supplementary materials: materials [see index of supplementary materials] abstract background: emergency medical services personnel (emsp) are recurrently exposed to chronic and traumatic stressors in their occupation. effective coping with occupational stressors plays a key role in enabling their health and overall well-being. in this study, we examined the habitual use of coping strategies in emsp and analyzed associations of coping with the personnel’s health and well-being. method: a total of n = 106 german red cross emsp participated in a cross-sectional survey involving standardized questionnaires to report habitual use of different coping strategies (using the brief-cope), their work-related stress, work-related self-efficacy, job satisfaction, as well as mental and physical stress symptoms. results: a confirmatory factor analysis corroborated seven coping factors which have been identified in a previous study among italian emergency workers. correlation analyses indicated the coping factor “self-criticism” is associated with more work-related stress, lower job satisfaction, and higher depressive, posttraumatic, and physical stress symptoms. although commonly viewed as adaptive coping, the coping factors “support/venting”, “active coping/planning”, “humor”, “religion”, and “positive reappraisal” were not related to health and well-being in emsp. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.6133&domain=pdf&date_stamp=2022-03-31 https://orcid.org/0000-0003-2144-7832 https://orcid.org/0000-0002-8414-3812 https://orcid.org/0000-0001-7847-1847 https://orcid.org/0000-0002-4128-9627 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ exploratory correlation analyses suggested that only “acceptance” was linked to better well-being and self-efficacy in emsp. conclusion: our results emphasize the need for in-depth investigation of adaptive coping in emsp to advance occupation-specific prevention measures. keywords emergency medical services, coping strategies, stress, job satisfaction, work-related self-efficacy highlights • previously reported seven factor structure of briefcope was confirmed in german ems personnel. • adaptive coping factors (e.g., support/venting) are not linked to better health and well-being. • self-criticism correlates with lower job satisfaction, higher stress, and more stress symptoms. • acceptance is associated with less stress symptoms and higher self-efficacy. emergency medical services personnel (emsp) are recurrently confronted with traumat­ ic events during medical rescue missions and undergo adverse working conditions such as shiftwork, time pressure, insufficient sleep, and social conflicts (donnelly & siebert, 2009; karutz et al., 2013; sterud et al., 2006). these factors pose a high emotional stress on emsp (johnson et al., 2005; karrasch et al., 2020; schmid et al., 2008), which can compromise their job satisfaction (boudreaux et al., 1997; portero de la cruz et al., 2020; sterud et al., 2011) and may trigger mental health problems, including depression, posttraumatic stress disorder (ptsd), and alcohol abuse (berger et al., 2012; kleim & westphal, 2011; petrie et al., 2018; sterud et al., 2006; s. l. wagner et al., 2020) as well as physical health problems (aasa et al., 2005; bentley & levine, 2016; friedenberg et al., 2022; hegg-deloye et al., 2014). to maintain their health and work capacity, emsp are required to employ effective strategies to cope with chronic stress and recurrent exposure to traumatic events on duty (arble & arnetz, 2017; karrasch et al., 2020). coping is defined as a person’s effort to deal with external or internal demands that are perceived as stressful or possibly exceed the individual’s resources (lazarus & folkman, 1984). research has described various strategies to cope with stress. some of them such as social support seeking, acceptance, and positive reappraisal are viewed as adaptive in reducing stress and benefiting health and well-being (holton et al., 2016; moritz et al., 2016). conversely, strategies involving self-criticism, denial, dissociation, and avoidance are viewed as maladaptive for stress management and can lead to impaired health and well-being (holton et al., 2016; prati & pietrantoni, 2009). coping strategies in emergency medical services 2 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ in the context of their work, emsp and other frontline workers are confronted with high emotional demands and physical stressors due to shift work, time pressure, high responsibility, and recurrent traumatic event exposure. as a result, emsp may find certain coping strategies not helpful in handling their work-related demands, although in other contexts, the same strategies may be highly adaptive, and vice versa. in this line, growing evidence shows that coping strategies may differ in their actual adaptiveness depending on the context of their application (cheng et al., 2014; folkman & moskowitz, 2004; levy-gigi et al., 2016). “maladaptive” coping in emsp there is consistent evidence that “maladaptive” coping strategies are linked to poorer well-being and health in emsp. self-criticism is linked to more burnout, compassion fatigue, depression, and ptsd symptoms, and lower compassion satisfaction (boland et al., 2019; boudreaux et al., 1997; cicognani et al., 2009; kirby et al., 2011; prati et al., 2011). furthermore, avoidant coping such as substance (ab)use and denial was linked to poorer mental health outcomes in the long-term such as elevated ptsd symptoms (arble & arnetz, 2017; cicognani et al., 2009; kerai et al., 2017; kirby et al., 2011; leblanc et al., 2011; portero de la cruz et al., 2020; regehr et al., 2002). despite negative consequences, emsp engage in avoidant coping because these strategies allow to instantly alleviate emotional strain (levy-gigi et al., 2016; regehr et al., 2002). for example, it was shown that emsp use emotional avoidance after critical mission incidents (figley, 2008). “adaptive” coping in emsp previous studies reported that coping strategies, which are assumed adaptive in the gen­ eral population, show inconsistent or even negative associations with the well-being and health of emsp (cicognani et al., 2009; prati et al., 2011; raynor & hicks, 2019). upon exposure to stressful events, emsp may profit from social support to receive emotional support and relief (alexander & klein, 2001; almutairi & el mahalli, 2020; boland et al., 2019; donnelly & siebert, 2009). in emsp, social support has been associated with lower risk of depressive, burnout, and trauma-related symptoms (boland et al., 2019; essex & scott, 2008; feldman et al., 2021; fjeldheim et al., 2014; guilaran et al., 2018; prati & pietrantoni, 2010; wild et al., 2016). however, other studies found that social support did not moderate the negative influence of stressful mission experiences on ptsd symptoms (c.-m. chang et al., 2008). higher social support was also linked to burnout and compassion fatigue among emsp (cicognani et al., 2009; prati et al., 2011). moreover, emsp may cope actively with stress through focusing on the next step in planning and actively solving problems (boland et al., 2019; regehr et al., 2002). active coping/planning was associated with lower stress levels (brown et al., 2002; jamal et al., 2017) and stronger posttraumatic growth (kirby et al., 2011) in emsp. however, folkman rojas, hickmann, wolf et al. 3 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ and moskowitz (2004) theorized that the effectivity of active coping depends on the controllability of stressors. emsp are regularly confronted with critical mission events and adverse working conditions they cannot fully control. therefore, active coping may be ineffective or possibly counterproductive in certain situations. indeed, previous studies linked active coping to higher levels of stress and burnout in emergency workers (cicognani et al., 2009; prati et al., 2011). it is proposed that humor enables emsp to experience critical situations as less serious and threatening (moran, 2002). healthcare workers who used humor perceived work-related situations less stressful (canestrari et al., 2021), and the use of humor was linked to less ptsd symptoms among firefighters (sliter et al., 2014). however, humor is a very complex construct with various subtypes which may have opposite effects in handling stress (leist & müller, 2013; martin et al., 2003). indeed, humor was also associated with higher burnout levels in emsp (cicognani et al., 2009; prati et al., 2011). as an emotion-focused coping strategy, religion has been linked to less burnout symptoms (boland et al., 2019) and higher levels of posttraumatic growth (ogińska-bulik & zadworna-cieślak, 2018), but also with more burnout symptoms and compassion fatigue in emsp (cicognani et al., 2009; prati et al., 2011). in their concept of posttrau­ matic growth, tedeschi and calhoun (1996) assume increasing spirituality as an adaptive consequence of traumatic experiences. accordingly, positive associations between stress symptoms and religious coping in emsp could indicate emerging posttraumatic growth. moreover, emsp reported to manage their work-related stress through acceptance of negative emotions as well as positive reappraisal (boland et al., 2019; kirby et al., 2011). acceptance was consistently linked to increased posttraumatic growth (kirby et al., 2011; prati & pietrantoni, 2009) and milder posttraumatic stress symptoms in emsp (zhao et al., 2020). positive reappraisal was associated with more burnout and compassion fatigue symptoms (almutairi & el mahalli, 2020; cicognani et al., 2009) but was also related with stronger posttraumatic growth (kirby et al., 2011). adaptive coping and self-efficacy self-efficacy refers to the deep conviction that one has sufficient resources and abilities to cope successfully with adversity (bandura, 1997). self-efficacy determines the individ­ ual’s approach and self-perception when coping with stressors. thereby, it influences ex­ ecution of coping strategies as well as the persistency of coping efforts (bandura, 1997). as a result, self-efficacious individuals experience job stress less threatening, working conditions more positively, and focus more on available resources (e.g., social support) (consiglio, borgogni, alessandri, & schaufeli, 2013). studies in the ems found that personnel with longer work experience report higher self-efficacy, which contributed to less burnout and compassion fatigue as well as more compassion satisfaction (cicognani et al., 2009; groß et al., 2004; prati et al., 2010). in nurses, the beneficial effect of coping strategies in emergency medical services 4 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ self-efficacy on health and well-being was partially mediated through problem-focused coping (chang & edwards, 2015). present study coping behavior of emsp may change with increasing professional experience and/or as a function of the recurrent exposure to stress and traumatic events (essex & scott, 2008). through habituating with their work, emsp will increasingly engage in coping strategies they experience as helpful in alleviating stress in the short-term (figley, 2008). resulting coping habits will conceivably differ from those of the general population as well as of occupations with other demands. therefore, cicognani et al. (2009) explored specific factors of coping strategies in 764 italian emergency workers, including emsp, firefight­ ers, and civil-protection personnel. from the 14 coping strategies assessed with the brief­ cope, an exploratory factor analysis extracted seven coping factors, i.e., support/venting, active coping, positive reappraisal, humor, religion, self-distraction, and self-criticism, which showed complex associations with the personnel’s quality of life and mental health. the coping factor model identified by cicognani et al. (2009) is yet to be confirmed. with this study, we tested whether cicognani et al.’s factor model fits the coping behav­ ior of german emsp. moreover, we hypothesized “maladaptive” coping (e.g., self-distrac­ tion, self-criticism) is linked to higher perceived stress, lower job satisfaction, and more mental and physical stress symptoms. conversely, we expected “adaptive” coping (e.g., support/venting, active coping, positive reappraisal, humor, religion) to be linked to better health and well-being. additionally, we hypothesized that emsp with longer work experience show higher work-related self-efficacy. higher self-efficacy was expected to correlate with higher job satisfaction, lower work-related stress, and fewer mental and physical symptoms. m e t h o d procedure the authors conducted an in-house training module offered seven times within three months at two ambulance stations of the local german red cross (grc) division. of the division’s 318 employees, 241 attended the training and were invited to participate in this study. interested emsp left their email address, and via email they received the link to the study survey. at the beginning of the survey, participants were informed about the study aims and procedures. a total of 115 employees declared their written informed consent and participated in the survey (46.6% response rate) that assessed sociodemographic characteristics (e.g., age, gender) and exposure to traumatic events, personality traits, mental and physical health conditions as well as coping strategies using standardized questionnaires. the survey also assessed other health-relevant factors rojas, hickmann, wolf et al. 5 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ such as emotion regulation and sense of coherence that were reported in previous studies (behnke, conrad, et al., 2019; gärtner et al., 2019). the survey took approximately one hour for completion. participants received no remuneration. the study protocol was approved by the ulm university ethics committee. participants regarding the variables investigated in this study, complete data were available from n = 106 emsp (63.2% men), presenting 33.3% of the local grc divisions’ total workforce. participating emsp were 18 to 61 years of age, mdn (iqr) = 26 (15.8), and their work experience ranged from one month to 35 years, mdn (iqr) = 3.3 (10.3) years. additional sociodemographic characteristics are detailed in table 1. study participants corresponded well to the entirety of local ems employees in terms of sex, stationing, and ems work experience. small differences occurred regarding employment type and age. measures coping strategies were measured with the 28-item german brief-cope (knoll et al., 2005). the brief-cope subscales’ internal consistency ranged from cronbach’s α = .43–.89. as an exception, the subscale behavioral disengagement showed an inaccepta­ ble internal consistency of α = -.04 (see supplementary materials, table x1, for details). perceived work-related stress was recorded with an ems-specific questionnaire (gärtner et al., 2019). on eight items, participants reported their perceived stress due to alarms, shift work, etc. on a 5-point likert scale anchored at 0 (never experienced) and 4 (very bothering). reponses were aggregated to a sum score (range: 0–32; cronbach’s α = .77). depressive symptoms were measured with the 9-item german patient health ques­ tionnaire scale for depression (phq-9; löwe et al., 2002). responses are recorded on a four-point likert scale ranging from 0 (not at all) to 3 (almost every day) and were aggregated to a sum score (range: 0–27; cronbach’s α = .83). posttraumatic symptoms were assessed with the german ptsd checklist for dsm-5 (pcl-5; krüger-gottschalk et al., 2017). participants were requested to recall their most stressful life event. as previously reported, 53% of the emsp participating in this study encountered their most stressful life events in the line of their duty (behnke, rojas, et al., 2019). with eight qualitative items, the pcl-5 evaluates whether the most stressful life event fulfils the dsm-5 criteria of a traumatic event. on 20 items, participants rated the severity of their posttraumatic stress symptoms on a 5-point likert scale ranging from 0 (not at all) to 4 (very strong). severity ratings were aggregated to a sum score (range: 0–80, cronbach’s α = .91). physical ailments were assessed using the 15-item german patient health question­ naire scale for physical symptoms (phq-15; löwe et al., 2002). the item asking for coping strategies in emergency medical services 6 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ menstrual pain was excluded for reasons of gender comparability. responses are recor­ ded on a 3-point likert scale ranging from 0 (not at all) to 2 (very strong). the sum score of all items represents the severity of physical ailments (range: 0–30, cronbach’s α = .84). table 1 demographic sample characteristics compared to the local ems personnel demographic variable study cohort local ems employees statistical test n % n % test statistic p effect size total 106 33.3# 318 sex – .229 -.061 male 67 63.2 222 69.8 female 39 36.8 96 30.2 ambulance station – 1 -.003 ulm 74 69.8 223 70.1 heidenheim 32 30.2 95 29.9 employment form χ2(2) = 11.51 .003 .165 salaried 80 75.5 198 62.3 voluntary 16 15.1 101 31.8 in apprentice 10 9.4 19 6.0 professional qualification emt–paramedic (“notfallsanitäter”) 64 60.4 – – emt–basic (“rettungssanitäter”) 32 30.2 – – emt–paramedic trainee 10 9.4 – – family status single 50 47.2 – – divorced 8 7.5 – – partnership/married 48 45.3 – – m (sd) mdn m (sd) mdn age [years] 29.8 (10.9) 26.0 32.1 (11.1) 27.5 u = 13906 .007 -.131 ems working experience [years] 7.5 (8.7) 3.3 5.7 (5.5) 3.8 u = 16172.5 .629 -.023 note. #proportion of total staff. population and sample frequency distributions were compared using fisher’s exact tests and χ2 tests, where applicable, and φ as effect-size measure. continuous variables were compared using mann-whitney u-tests using cohen’s r as effect-size measure. rojas, hickmann, wolf et al. 7 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ job satisfaction was evaluated using a subscale of the german michigan organiza­ tional assessment questionnaire (cammann et al., 1979). on three items, participants rated their job satisfaction on a 4-point likert-scale ranging from 1 (strongly disagree) to 4 (strongly agree). responses were combined as sum score (range: 3–12, cronbach’s α = .69). work-related self-efficacy was assessed using the two items of the professional self-ef­ ficacy expectation scale with the highest item-total correlation (schyns & collani, 2014). responses were recorded on a 4-point likert scale ranging from 0 (not at all) to 4 (very strong) and combined to a sum score (range: 0–8, cronbach’s α = .67). statistical analyses statistical analyses were performed in r 3.6.2 (r core team, 2019). to examine whether the factor structure reported in cicognani et al. (2009) fits the present data, a confirmato­ ry factor analysis (cfa) was performed using the lavaan package (rosseel, 2012). as a majority of the brief-cope items did not follow unior multivariate normal distribution (energy test: e = 2.44, p < .001), we used pairwise maximum likelihood (pml) estimators as a computationally less intense alternative to full information maximum likelihood (fiml) (katsikatsou et al., 2012). the absolute χ2 statistic and its p-value (p > .05), the root mean square error of approximation (rmsea ≤ .06) and its 90% confidence interval (ci), and robust versions of the standardized root mean square residual (srmr ≤ .08), the comparative fit index (cfi ≥ .95), and the tucker-lewis index (tli ≥ .95) were used as model fit criteria (hu & bentler, 1999). convergent and discriminant factor validity was examined applying the criteria by fornell and larcker (1981), and bollen’s ω (raykov, 2001) quantified the internal factor consistency. bivariate correlations were analyzed using nonparametric spearman correlations because several variables were not normally distributed. p-values were corrected for multiple testing using the false discovery rate (fdr) (benjamini & yekutieli, 2001). r e s u l t s confirmatory factor analyses all brief-cope subscales were non-normal distributed, and some subscales were strong­ ly right-skewed, that is, these strategies were almost never used by our study cohort (table x1, supplementary materials). this was also observed by cicognani et al. (2009), and in accordance with their procedure, we disregarded the items 3/8 (denial: skew = 2.32), 6/16 (behavioral disengagement: skew = 1.45), and 4/11 (substance use: skew = 2.10) in the cfa. additionally, the scales self-blame (skew = 1.27) and religion (skew = 1.87) displayed a strong right skew in our sample. we nevertheless retained these items to allow testing the adequacy of cicognani et al.’s factor model in our data. coping strategies in emergency medical services 8 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ the cfa revealed the model by cicognani et al. (2009) fits our data relatively well: robust-χ2(5.54) = 9.47, p = .120; cfirob = .926; tlirob = .911; srmrrob = .069; rmsea < .001, 90% ci [.001, .041], prmsea = .988. the first factor (figure 1) comprised the six items of the subscales emotional support, instrumental support, and venting (standardized factor loadings: β = .58–.89, p’s < .001) with an internal factor consistency of ω = .89. figure 1 results of the confirmatory factor analysis examining the fit of cicognani et al.’s (2009) seven-factor model of coping to the data of this study .60 .37 f2 “active coping/planning” item 7 item 2 item 25 item 14 .59 .62 .55 .70 .35 .38 .31 .49 ε ε ε ε f3 “humor” item 18 item 28 .73 .97.93 ε ε .54 f4 “religion” item 22 item 27 .87 .72.52 ε ε .75 f5 “self -distraction” item 1 item 19 .56 .70.50 ε ε .32 f6 “self -criticism” item 13 item 26 .86 .81.66 ε ε .74 f7 “positive reappraisal” item 12 item 17 .36 .76.58 ε ε .13 f1 “support/venting” item 15 item 5 item 23 item 10 .75 .89 .80 .84 .56 .79 .65 .71 ε ε ε ε item 21 item 9 .33 .35 ε ε .59 .58 .40 .28 .54 .85 .48 .65 .51 .42 note. n = 106. values on paths indicate standardized regression coefficients (β) and values on covariance paths indicate significant factor correlations (r). italic values above the items display the explained variance per item (r 2). rojas, hickmann, wolf et al. 9 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ the second factor comprised the items of active coping and planning (β = .55–.70, p’s < .001; ω = .71). the third factor presented the humor subscale (β = .73–.97, p’s < .001; ω = .83), the fourth religion (β = .72–.87, p’s < .001; ω = .78), the fifth self-distraction (β = .56–.70, p’s < .001; ω = .58), the sixth self-criticism (β = .81–.86, p’s < .001; ω = .83), and the seventh positive reappraisal (β = .36–.76, p’s < .005; ω = .49). examining the factors’ convergent and discriminant validity (table 2) revealed that support/venting, humor, religion, and self-criticism are clearly distinguishable albeit correlated factors. conversely, the items of active coping/planning share considerable variance with the items of self-distraction and positive reappraisal, indicating that their factors are not clearly separable. as a result, these factors had a low internal factor consistency (see table 2). table 2 indicators of internal factor consistency ω (at diagonal), convergent and discriminant validity along with factor correlations coping factor f1 f2† f3 f4 f5† f6 f7† f1 support/venting .89 .60*** -.17 .37*** .40* .28* .54*** f2 active coping/planning .71 -.04 .19 .85*** .48*** .65*** f3 humor .83 -.16 .22 -.11 .19 f4 religion .78 .02 .06 .28 f5 self-distraction .58 .42** .51** f6 self-criticism .83 .16 f7 positive reappraisal .49 average variance extracted (ave) .576 .380 .709 .650 .420 .705 .354 maximum shared variance (msv) .356 .724 .047 .139 .724 .226 .422 note. an average variance extracted of ave > .50 indicates sufficient convergent factor validity (i.e., more than 50% of the items’ variances converged on their common factor). satisfactory discriminant factor validity is assumed when the maximum shared variance msv < ave. factors indicated with † violate aforementioned criteria. *p < .05. **p < .01. ***p < .001, two-tailed, corrected for multiple testing with fdr. correlation of coping factors with well-being and health correlation analyses (table 3) indicated that support/venting was less used by older emsp, whereas no associations emerged with other studies variables. active coping/plan­ ning, religion, self-distraction, and positive reappraisal were not related to any study variable. in trend, emsp with more work experience also reported more self-criticism (pfdr = .102), and frequent use of self-criticism was positively associated with higher perceived stress, more mental and physical symptoms, and lower job satisfaction. coping strategies in emergency medical services 10 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ ta b le 3 sp ea rm an r an k c or re la ti on s (n = 1 06 ) c op in g fa ct or a ge se xa e m s w or k ex pe ri en ce p c l5 p h q -1 5 p h q -9 p er ce iv ed st re ss jo b sa ti sf ac ti on b w or k -r el at ed se lf -e ff ic ac y f1 s up po rt /v en ti n g -.2 8* -. 07 -. 08 .0 9 -. 07 -. 15 .0 7 .1 7 .1 4 f2 a ct iv e co pi n g/ p la n n in g .0 5 .0 5 .0 5 .2 3 .0 5 .0 2 .1 6 -. 07 .1 1 f3 h um or .1 5 .2 4 .1 1 -. 01 .0 8 .0 9 -. 03 .0 0 .3 4* f4 r el ig io n -. 10 -. 10 .0 0 .2 6 .0 4 .0 0 .1 3 .1 0 -. 08 f5 s el fdi st ra ct io n .1 1 .1 3 .1 0 .1 6 .0 1 .0 1 .1 0 -. 05 .2 6 f6 s el fcr it ic is m .0 9 -. 02 .2 2 .4 9* ** .3 2* .3 4* .2 7* -.2 7* -. 22 f7 p os it iv e re ap pr ai sa l -. 10 -. 02 -. 10 .1 7 -. 02 -. 05 .0 9 .1 2 .1 3 w or kre la te d se lf -e ff ic ac y .2 1 .2 9* .1 8 -. 22 -. 23 -. 26 -. 04 .2 4 a p os it iv e co ef fi ci en t in di ca te h ig h er v al ue s in m en t h an w om en . b tw o m is si n g va lu es . *p < .0 50 . * ** p < .0 01 , t w ota il ed , c or re ct ed f or m ul ti pl e te st in g w it h f d r . rojas, hickmann, wolf et al. 11 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ these associations were also supported by the zero-order correlations between the brief­ cope subscales and the study variables (table x2, supplementary materials). additional­ ly, we observed relevant correlations of the brief-cope’s acceptance subscale, which has been neglected in the cfa in order to test the factor solution reported by cicognani et al. (2009). in detail, emsp in our sample who reported higher acceptance showed less stress-related symptoms (pcl-5: rs = -.21, pfdr = .138; phq-15: rs = -.31, pfdr = .020; phq-9: rs = -.32, pfdr = .018). work-related self-efficacy and coping male (pfdr = .037) and older emsp (pfdr = .102) reported higher work-related self-ef­ ficacy, which was associated in trend with higher job satisfaction (pfdr = .081) and less posttraumatic (pfdr = .101), depressive (pfdr = .053), and physical stress symptoms (pfdr = .090, cf. table 3). moreover, self-efficacy correlated with a conceivably more adaptive coping behavior, in a way that emsp with higher self-efficacy were prone to use less self-criticism in trend (pfdr = .102) as well as more humor (see table 3) and acceptance (rs = .38, pfdr = .002; table x2, supplementary materials). d i s c u s s i o n we investigated habitual coping behavior in a cohort of german emsp and its relevance for the personnel’s health and well-being. thereby, we replicated the seven-factor struc­ ture of brief-cope items which has been previously identified by cicognani et al. (2009) in italian emergency workers. among these coping factors, self-criticism showed significant associations with stress, job satisfaction, and stress symptoms of emsp. similar to the italian emergency workers (cicognani et al., 2009), our cohort of german emsp rarely engaged in denial, behavioral disengagement, and substance (ab)use when coping with stress. unlike the italian sample, however, our cohort of emsp almost never coped through religion. cross-cultural studies indicate that reliance on religion in coping with adversity and stress varies across countries (chai et al., 2012; shirazi et al., 2011). therefore, differences in the use of coping strategies between our study cohort and that of cicognani et al. (2009) may result from cultural differences between italian and german rescue personnel. future cross-cultural research should compare coping in frontline workers with different cultural and social background. consistent with cicognani et al. (2009), our cfa corroborated a factor unifying items of support seeking and venting, indicating that emsp seek the support of others to share their unpleasant emotions and find comfort. unexpectedly, this factor was not associated with better health or well-being, adding to previous inconsistent findings on the adap­ tiveness of social support for the well-being of emsp (boland et al., 2019; essex & scott, 2008; feldman et al., 2021; fjeldheim et al., 2014; kleim & westphal, 2011; kshtriya et al., coping strategies in emergency medical services 12 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ 2020; wild et al., 2016). one reason for these heterogeneous findings could be the timing of social support: in their review, wagner at al. (2016) conclude that pre-trauma social support can enhance resilience against ptsd, while post-trauma social support appears to promote posttraumatic growth. conceivably, emsp actively seek social support when feeling particularly stressed, and this adaptive behavior could enable personal growth. moreover, previous research has differently defined and operationalized social support: while we included support and venting into one factor (cf. cicognani et al., 2009), other studies focused on received and/or perceived social support by different groups, e.g., family, colleagues (fjeldheim et al., 2014; wild et al., 2016). as previously reported (essex & scott, 2008), we found that older emsp reported less support seeking and a lower tendency to communicate their feelings. senior emsp with many years of work experience are likely to have encountered more traumatic mission events, and studies showed that after highly aversive missions, a relevant proportion of emsp refrains from talking to their colleagues to avoid showing personal weakness, pos­ sible consequences of perceived mistakes, and “unnecessarily” raising their colleagues’ emotional burden (häller et al., 2009; richter, 2014). this behavior could lead to social distancing and isolation in the long-term. however, in western societies, there is a general trend toward decreasing social support networks across the lifespan (nicolaisen & thorsen, 2017), and social isolation particularly affects men (e.g., gurung, taylor, & seeman, 2003; walen & lachman, 2000). in our cohort, the correlation of higher age and work experience with decreased social support/venting could be specifically pronounced, as the ems has been primarily a “male profession”, and our study participants with longer work experience were almost exclusively men. preventive measures to maintain emsps’ health could aim to impart social and emotional competencies among colleagues and supervisors, establish an institutional support culture, and develop structured profes­ sional counselling interventions for personnel (wild et al., 2020). in this sample, using humor as a coping strategy was not associated with well-being and health. previous evidence on humor in helping profession is mixed. some studies showed, humor allowed perceiving work less stressful (canestrari et al., 2021) and was linked to fewer ptsd symptoms (sliter et al., 2014). other studies linked humor to higher burnout symptoms (cicognani et al., 2009; prati et al., 2011). this inconsistency may originate from different styles of humor which may exert opposite effects in stress coping (leist & müller, 2013). black or “gallows” humor presents a form of emotional avoidance that can help emsp to quickly distance from adverse experiences (moran, 2002). however, in the long-term, black humor may establish cynicism towards their patients in emsp, and this attitude might compromise the emotional support they receive from their family and friends (rowe & regehr, 2010). in this study and previous studies (cicognani et al., 2009; prati et al., 2011), humor was assessed with two items, thus not allowing to differentiate humor styles. future studies are required to investigate the rojas, hickmann, wolf et al. 13 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ role of humor styles more comprehensively to understand its effect on the health and well-being of emsp. in our study, the factors active coping/planning and positive reappraisal were unrela­ ted to emsps’ well-being and health, whereas previous studies linked active coping to reduced stress (brown et al., 2002; jamal et al., 2017; prati et al., 2011) and fewer stress symptoms (kirby et al., 2011). moreover, the inclination to find positive reinterpretations of adverse experiences has been linked to stronger posttraumatic growth (kirby et al., 2011). in our study, however, the factors overlapped with the emsps’ engagement in self­ distraction. this suggests that emsp tend to actively engage in compensatory activities and denying stress through positive reinterpretations in order to distract themselves from work-related stress. unlike the classical view of active coping and positive reappraisal as adaptive stress coping, in emsp, such attempts rather reflect a distraction tendency to achieve short­ term stress relief. in par with this, levy-gigi et al. (2016) reported firefighters engage in distractive strategies to achieve immediate stress relief, although such distractive coping attempts exert counterproductive effects on the regulation of stress in the long-run (cicognani et al., 2009; kirby et al., 2011; leblanc et al., 2011). however, in our study, using these strategies seemed to have no implications for the emsps’ health status and well-being. additional research is required to better distinguish the shortor long-term motives of frontline workers to engage in distractive coping strategies. in addition, active coping aims to overcome a stressful situation through planning and problem solving. thus, the actual effectiveness of this strategy depends on whether stressors are actually controllable and changeable (folkman & moskowitz, 2004). as emsp regularly face adverse situations which they may not be able to control or change, it could be that attempting to actively change uncontrollable problems has no (gärtner et al., 2019) or even opposite implications for the well-being of emsp (cicognani et al., 2009; prati et al., 2011). persistent attempts to find solutions for uncontrollable adversity might even initiate rumination (ayduk & kross, 2010), which is a major risk factor for developing ptsd, depression, and burnout in emsp and firefighters (e.g., bryant & guthrie, 2007; gärtner et al., 2019; wild et al., 2016). correspondingly, our results indicate that engaging in self-critical reflections about one’s actions and feelings is associated with poorer health and well-being in emsp. this result corroborates previous studies implicating self-criticism as a maladaptive coping strategy (boland et al., 2019; boudreaux et al., 1997; cicognani et al., 2009; kirby et al., 2011; prati et al., 2011). self-criticism involves repetitive negative evaluations of one’s own abilities and decisions. in this sense, it is closely related to rumination as the tendency to repeatedly focus mentally on negative emotional experiences as well as their causes and consequences (james et al., 2015). longitudinal studies are warranted to assess self-criticism and rumination in the prospect of health and well-being in emsp. coping strategies in emergency medical services 14 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ beyond the coping factors reported by cicognani et al. (2009), the briefcope subscale acceptance was linked to higher self-efficacy and better well-being in emsp. this result suits previous findings and meta-analyses which established acceptance as highly adap­ tive in retaining health upon adverse experiences (aldao et al., 2010; kirby et al., 2011; schäfer et al., 2017; zhao et al., 2020). acceptance-related elements are featured in several evidence-based therapeutic approaches (e.g., mentalization-based therapy, bateman & fonagy, 2012; acceptance and commitment therapy, hayes, 2016), and initial research on stress-preventive trainings in emsp indicates that imparting strategies to differentiate, name, and accept unpleasant feelings can decrease symptoms of burnout and emotional exhaustion (buruck & dörfel, 2018). bandura (1997) theorized self-efficacy enhances stress resilience through influencing which and how persistently coping strategies are executed upon stress. accordingly, self-efficacy was positively linked to problem-focused and active coping and negatively linked to emotion-focused coping in nurses (chang & edwards, 2015). our findings partially corroborate this perspective, as we found emsp with higher self-efficacy to use less self-criticism when coping with stress. however, self-efficacy was not linked to strategies such as coping/planning or support/venting. instead, it was linked to acceptance and humor presenting rather emotion-focused coping strategies. moreover, in line with previous studies in the ems (behnke, conrad, et al., 2019; cicognani et al., 2009; groß et al., 2004; prati et al., 2010, 2011), personnel with longer work experience reported higher self-efficacy, and higher self-efficacy was associated with higher job satisfaction and fewer physical and depressive symptoms in trend. future research could aim to comprehensively examine the nature and relationship of self-efficacy, acceptance, humor, and self-criticism/rumination with health and well-being in frontline workers. limitations and future directions studies did not conclude on a unique hierarchical structure of the coping strategies assessed with the brief-cope (hanfstingl et al., 2021; solberg et al., 2021). therefore, we decided to test the adequacy of the factor solution explored by cicognani et al. (2009) and were able to replicate the factor structure. however, additional reliability analyses showed that some of the extracted factors overlap, which compromises their factor reliability. our sample size is rather small for conducting cfa, and future studies should aim to recruit larger samples. moreover, simulation studies demonstrated that drawing reliable conclusions about model-to-data fit in cfa is not trivial, as hu and bentler’s (1999) criteria may lead to unreliable results (beierl et al., 2018; heene et al., 2011). compared to previous studies in the ems, the response rate in our study (46.6%) is in the upper range (brown et al., 2002; fritz & sonnentag, 2005). nevertheless, general­ izability of our findings is limited by convenience sampling. results may be biased by differences between study participants and non-participants; i.e., emsp with more stress symptoms and/or socially inappropriate coping behaviors (e.g., substance abuse) were rojas, hickmann, wolf et al. 15 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ perhaps unmotivated or avoided participation (non-response bias; bortz & döring, 2004). emsp who were unable to work or had changed their profession due to severe stress-re­ lated health problems could not be included in the study. this may lead to biased results, as highly stressed personnel might use less effective coping strategies (healthy-worker effect; costa, 2003). future studies should compare coping habits of emsp capable to work and those with work-related health problems. limitations in validity could result from retrospective recall errors (jonkisz et al., 2012). that is, emsp remembered stressful events but did not associate them with specific cop­ ing strategies, or they are completely unaware of using certain strategies. moreover, the study’s cross-sectional correlative design does not allow causal or predictive conclusions. longitudinal research is required to better characterize the interplay of coping, stress exposure, and well-being through high-frequency measurements, for example, on a daily basis using mobile phone applications. such “ecological momentary assessments” enable identifying coping behaviors with prospective relevance in handling daily occupational stressors and traumatic mission events in the ems. conclusions effective coping with occupational stressors is pivotal for retaining health and well-being in emergency workers. with this cross-sectional study in german emsp, we confirmed seven coping factors that were previously identified by cicognani et al. (2009) in italian emergency workers. among these coping factors, only self-criticism was significantly as­ sociated with the emsps’ work-related stress, job satisfaction, and well-being. addition­ ally, exploratory correlations indicated that using acceptance was potentially beneficial for the self-efficacy and well-being of emsp. our findings implicate investigating the use and relevance of self-criticism and acceptance in prospective longitudinal designs. determining the relevance of certain coping strategies regarding health and well-being is key to developing occupation-tailored preventive interventions. coping strategies in emergency medical services 16 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://www.psychopen.eu/ funding: this study was supported by the german red cross (deutsches rotes kreuz), rescue service heidenheimulm ggmbh. acknowledgments: we thank suchithra varadarajan for proof reading. competing interests: the authors have declared that no competing interests exist. author contributions: rr, ab, and itk developed the study concept. rr and ab conducted the study setup and data collection. ab and mh performed the statistical analysis. rr, mh, sw, and ab drafted the paper under supervision of itk. all authors contributed to the interpretation of data, critically revised the manuscript, and approved the final version of the paper for submission. data availability: the datasets for this manuscript are not publicly available because we do not have the consent of the ethics committee or our participants to grant any form of access to or insight in all or parts of the collected data. s u p p l e m e n t a r y m a t e r i a l s supplementary tables presenting: descriptive statistics, internal consistencies, and univariate nor­ mality assessment of brief-cope subscales (table x1), and spearman correlations between brief­ cope subscales and the other study variables (table x2) (for access see index of supplementary materials below). index of supplementary materials rojas, r., hickmann, m., wolf, s., kolassa, i.-t., & behnke, a. 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(2020). self-acceptance, post-traumatic stress disorder, posttraumatic growth, and the role of social support in chinese rescue workers. journal of loss and trauma, 25(3), 264–277. https://doi.org/10.1080/15325024.2019.1672935 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. rojas, hickmann, wolf et al. 25 clinical psychology in europe 2022, vol. 4(1), article e6133 https://doi.org/10.32872/cpe.6133 https://doi.org/10.1002/jts.2490090305 https://doi.org/10.1080/10926771.2016.1152341 https://doi.org/10.1037/trm0000251 https://doi.org/10.1177/0265407500171001 https://doi.org/10.1080/00332747.2020.1750215 https://doi.org/10.1017/s0033291716000532 https://doi.org/10.1080/15325024.2019.1672935 https://www.psychopen.eu/ coping strategies in emergency medical services (introduction) “maladaptive” coping in emsp “adaptive” coping in emsp adaptive coping and self-efficacy present study method procedure participants measures statistical analyses results confirmatory factor analyses correlation of coping factors with well-being and health work-related self-efficacy and coping discussion limitations and future directions conclusions (additional information) funding acknowledgments competing interests author contributions data availability supplementary materials references selected trends in psychotherapy research: an index analysis of rcts systematic reviews and meta-analyses selected trends in psychotherapy research: an index analysis of rcts winfried rief 1 , melina kopp 1, roya awarzamani 1, cornelia weise 1 [1] division of clinical psychology and psychotherapy, department of psychology, philipps-university of marburg, marburg, germany. clinical psychology in europe, 2022, vol. 4(2), article e7921, https://doi.org/10.32872/cpe.7921 received: 2021-12-06 • accepted: 2022-04-05 • published (vor): 2022-06-30 handling editor: ulrich stangier, goethe university, frankfurt, frankfurt, germany corresponding author: winfried rief, philipps-university of marburg, department of psychology, division of clinical psychology and psychotherapy, gutenbergstrasse 18, 35032 marburg, germany. e-mail: rief@staff.unimarburg.de supplementary materials: materials [see index of supplementary materials] abstract background: we wanted to analyze trends in psychotherapy research during the last decade. we used published randomized clinical trials (rcts) that are cited in web of science (wos) as an index for these activities. method: we searched for rcts published between the years 2010 and 2019. search criteria included cognitive-behavioral treatments (cbt), e-mental health, acceptance and commitment therapy (act), psychodynamic treatments, interpersonal therapy (ipt), schema therapy, systemic therapy, mindfulness treatments, and emotion-focused therapy (eft). the numbers of publications for each treatment approach were accumulated for 5-year blocks (2010 to 2014; 2015 to 2019). results: the search revealed 4,523 hits for the selected treatment options, of which 1,605 were finally included in the analysis. there was a continuous increase in published rcts, with 68% more trials during the second five-year block. cbt (68%) and ehealth interventions (18%) show an increase in the number of studies, but there were no significant changes in its percentage in relation to all published rcts. the next frequent treatments were act (4%), psychodynamic treatments (2%), ipt (2%), and mindfulness interventions (2%). we found a significant increase of the percentage of mindfulness (p = .008) and a significant decrease of the percentage of psychodynamic treatments (p = .02). systemic (1.1%), emotion-focused (0.7%) and schema therapy (0.6%) represented smaller parts of published rcts. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7921&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0002-7019-2250 https://orcid.org/0000-0001-5216-1031 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: a continuous increase of published rcts underlines an active field of research on psychological interventions. third wave treatments such as mindfulness increased their representation in research, while the part of psychodynamic treatments decreased. keywords psychotherapy research, randomized clinical trials rct, cbt, psychodynamic treatments, act, ehealth, mindfulness, schema therapy, systemic therapy, mental health care highlights • over the period from 2010 to 2019, the number of randomized clinical trials (rcts) of psychological treatments continuously increased, with cbt representing the majority of published rcts. • the number of trials on ehealth-interventions increased over time, but their percentage in relation to all clinical trials did not increase significantly. • third wave interventions either already represented a significant proportion of rcts (e.g., act), or showed significantly increasing numbers (mindfulness interventions). • more traditional approaches represented very small percentages of rcts (e.g., systemic treatments), or even showed a significant decreased percentage of all rctbased research (i.e., psychodynamic therapy). evidence based psychotherapy is a dynamic field of research. in particular, the last 30 years were characterized by innovations in the field of psychological treatments. advances have been made both in terms of newly developed interventions (e.g. “third wave”-therapies like act or mindfulness-based interventions (haller, breilmann, schroter, dobos, & cramer, 2021; hayes, luoma, bond, masuda, & lillis, 2006; hofmann & asmundson, 2008; teasdale et al., 2000); mentalization based therapy (bateman & fonagy, 2010; taubner & volkert, 2019), and new formats to provide psychological treat­ ment (e.g. using electronic media such as the internet and mobile phones; andersson et al., 2019; miloff, lindner, & carlbring, 2020). however, clear data proving these trends in terms of research activities (i.e. clinical trials) are lacking. how do the flagships of psychotherapy such as psychodynamic treatments, cbt, and others progress in this continuously changing field? do they lose terrain to new concepts, or are they able to maintain their positions? more knowledge about current research trends in psychotherapy is helpful to esti­ mate and predict future developments. it can be postulated that those approaches that are currently under investigation will likely influence the future delivery of psychother­ apy in health care systems that are based on empirical evidence (awmf, 2021; berry & haddock, 2008; clark, 2011, 2018; nhs, 2019). to date, several countries aim to link the provision of psychotherapy to its evidence base; however, there is still a wide range. while some countries provide mental healthcare that is more linked to traditional orientations (e.g. china; ng et al., 2017), other countries offer (and permit) nearly all selected trends in psychotherapy research: an index analysis of rcts 2 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ orientations of psychotherapy without making a link to their differing evidence base (e.g. austria; laireiter & weise, 2019). a pioneer in this context is england, which tries to implement a fully evidence-based system for psychological therapies, the "improving access to psychological therapies"-program (iapt; nhs, 2019). if countries want to move forward with their health care systems in the direction of evidence-based psycho­ logical treatments, they need to know current trends and developments in psychotherapy research. in the german healthcare system we find an example for the interaction between evi­ dence-base and health care regulations. the federal government established a scientific advisory board on psychotherapy ("wissenschaftlicher beirat psychotherapie" [wbp]), that evaluates whether psychotherapeutic approaches are considered as evidence-based for a broad variety of mental disorders. a final positive vote opens the door for the respective treatment to enter a publicly financed health care system. such a positive statement was given for psychodynamic treatments, systemic treatments and cbt. a re­ cent application for approval of humanistic treatments (including rogerian psychothera­ py) was rejected on the grounds that the quantity of submitted studies were considered insufficient, and the quality criteria of studies did not meet current standards (wbp, 2018). a clear decline of research activities in this field in the 90ies was evident. human­ istic and rogerian psychotherapy is therefore not a stand-alone treatment of the german public health care system. the current manuscript reports on a databased analysis of research trends in psycho­ logical treatments. while we did not aim to detect all published trials, we focus on the use of a plausible index of publication activities (index approach). we limit our analysis to one of the major global citation databases (i.e. web of science, wos), in which indexed journals have to go through a thorough editorial selection process ensuring sufficient quality of the included journal (e.g. journal must contain primarily original scholarly material). furthermore, we limit our research to randomized clinical trials (rct). these results are used as an index of current trends in psychotherapy research. we are aware that these results only indicate trends, and are not a comprehensive summary of all potentially relevant research activities. our approach is limited to the used search terms, and treatments of interest. we decided to focus on the three traditional and approved treatment for which evidence has been sufficiently proven and which were commonly used in mental health care (psychodynamic, systemic, cbt), to compare them to newer developments such as act, mindfulness, ipt, schema therapy, emotion-focused treat­ ments, or ehealth applications. mentalization-based interventions were grouped with psychodynamic treatments. a specific problem is evident for cbt treatments, although it partly applies to other treatments as well: labels and approaches for one treatment approach can be very diverse, thus preventing them to be covered by search terms (e.g., some textbooks on cbt report up to 100 different techniques). therefore again, our rief, kopp, awarzamani, & weise 3 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ analysis is only able to reveal indices, but not a complete picture for general trends in psychotherapy research. m e t h o d search procedure we chose the citation database “web of science” to search for research activities during the last decade for the following reasons: (1) we wanted to ensure a certain quality of trials. wos requires indexed journals to provide a minimum of quality criteria (e.g. peer review, content relevance, appropriate citations). (2) wos is less focused on medical research, and includes more psychological and social science studies than pubmed. it includes all publications of the science citation index and the social science citation index (falagas, pitsouni, malietzis, & pappas, 2008). (3) wos has a strong focus on peer-reviewed journal publications of research studies, while other databases also include conference abstracts or monographies (e.g. scopus). in a recent analysis exploring the op­ timal combination of databases needed for a systematic review, wos had an overall recall rate of 68% (bramer, rethlefsen, kleijnen, & franco, 2017). yet, it must be considered that recall rates are topic-sensitive and that we did not aim to conduct a systematic review. since exploratory searches revealed publications of the non-clinical field (e.g. system­ ic approaches to strengthen the impact of a business, or to improve performance in a school-based setting), we selected specific wos-categories for our search (e.g., “psycholo­ gy, clinical” or “neurosciences”). the complete list of selected categories as well as the specific search terms are available in the supplementary materials). language restrictions were not applied to the searches. the search was conducted in november 2020 and was updated in august 2021. eligibility criteria studies were included if they met the following criteria: a. the study reported results of a randomized clinical trial. b. the rct investigated one or more of the following psychological treatment approaches: cognitive behavior therapy (cbt), psychodynamic treatments, internetbased psychological treatments and other digital approaches using new technologies (ehealth, mhealth, uhealth), mindfulness-based intervention (mindfulness-based stress reduction (mbsr), mindfulness-based cognitive therapy (mbct)), acceptance and commitment therapy (act), interpersonal therapy (ipt), systemic psychological therapy, schema therapy and emotion-focused therapy (eft). c. the study was published between 2010 and 2019. this criterion was chosen as we were interested in the most recent trends in psychotherapy research. selected trends in psychotherapy research: an index analysis of rcts 4 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ we included studies on all age groups (e.g. adults, children, adolescents), all clinical indications for psychotherapy and all countries of origin. study selection only articles reporting the major results of the trials were included (i.e. corrections, conference abstracts, comments etc. were excluded to avoid double-counting). in the case of multiple publications of one trial (e.g., post-treatment findings, follow-up data, other secondary analyses), we selected the publication reporting the primary outcomes at post-treatment. ehealth interventions were only counted under this category, but not further according to the conceptual background. the search was conducted stepwise for all treatment approaches, reviewed by two co-authors (mk, ra); weekly consensus meetings took place. in case of uncertainty, the main supervisor (wr) gave advice. if a study investigated two or more of the above-mentioned treatment approaches in the investigated treatment arms (e.g. cbt versus act), the study was counted for both treatments. due to their own theoretical background, we did not consider “third wave interven­ tions” as variants of cbt, but counted act, mindfulness, schema therapy, ipt etc. as separate groups, without considering them as cbt variants. analyses publications were first grouped according to treatment approach, publication year, and national origin of the principal investigators, to enable an examination of potential regional differences. for the first analysis of publication trends and to avoid too small cell numbers, publications were additionally grouped into five-year periods (2010 to 2014, and 2015 to 2019). for each treatment group, we compared the number of publications between these two time blocks using the chi2 test. in case of more than an average of ten annual publications per treatment approach, we report both, analyses of five-year blocks and annual number of rcts. additionally, the percentage of publications per treatment approach of all publication hits is computed for the five-year blocks. we also computed the determination coefficient r 2 according to holt (holt, 2004) and investigated linear trends in the relationship between publication year and number of publications. this analysis did not only focus on observed data, but also provides an estimation of future developments according to times series modeling. all analyses were conducted using ibm spss (version 26.0) (ibm corp., 2019). r e s u l t s table 1 shows the number of hits of the original searches, and the number of finally included trials after checking the inclusion criteria. from the first to the second five-year rief, kopp, awarzamani, & weise 5 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ block of the last decade (i.e. from 2010-2014 to 2015-2019), we found an overall increase in published rcts in psychotherapy from 598 to 1,007 (increase of 68%). from 2010 to 2019, the annual number of published rcts (subsumed over all treatments) increased from 67 to 230 (343%). table 1 comparison of search hits and finally included trials treatment hits finally included cbt 3081 1094 ehealth 931 294 psychodynamic treatments 96 53 act 140 61 systemic therapy 86 21 ipt 87 42 mindfulness-based interventions 72 21 schema therapy 18 10 eft 12 9 total 4523 1605 most frequently investigated psychological treatments cbt continues to represent a major part of psychotherapy research with a slight, but non-significant increase from 66% to 68% of all publications comparing the first and the second time block (table 2). this proportional increase is founded in a more substantial increase in the number of annually published treatment arms using cbt from year to year (see figure 1a). considering absolute annual numbers, cbt arms in randomized clinical trials have more than doubled from 2010 to 2019. holt’s r 2 of .95 indicates that this trend of increasing publications on cbt is highly robust. the second most frequently investigated psychological treatment approach is ehealth interventions. however, considering the overall increase of published clinical trials, the proportion of ehealth interventions remained constant from the first to the second five-year period. the increase was based on a continuous increase in published trials on ehealth interventions per year (see figure 1b) and parallels the growing numbers for psychotherapy trials in general. selected trends in psychotherapy research: an index analysis of rcts 6 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ table 2 treatment arms in rcts from 2010 to 2019 (five-year blocks) treatment approach 2010–2014 2015–2019 p (χ2) r 2 (holt; prediction per year) cbt 396 (66.2%) 698 (68.2%) 0.20 (1.52) .94 ehealth 113 (18.9%) 181 (17.7%) 0.64 (0.21) .85 act 22 (3.7%) 39 (3.8%) 0.84 (0.04) .62 psychodynamic treatments 28 (4.7%) 25 (2.4%) 0.02 (5.69)* -.15 ipt 21 (3.5%) 21 (2.1%) 0.08 (3.00) -.12 schema therapy 4 (0.7%) 6 (0.6%) 0.86 (0.03) -.06 systemic therapy 10 (1.7%) 11 (1.1%) 0.32 (0.08) -.17 mindfulness-based interventions 2 (0.3%) 19 (1.9%) 0.008 (7.02)** .83 eft 2 (0.3%) 7 (0.7%) 0.35 (0.88) .53 total 598 1007 note. cbt: cognitive behavior therapy; ehealth: internet-based psychological treatments and other digital approaches using new technologies; act: acceptance and commitment therapy; ipt: interpersonal therapy; eft: emotion-focused treatments. please note: because of its linear model, holt’s r 2 can be negative even if five-year block comparisons indicate a significant increase in published treatment arms (e.g., for schema therapy). figure 1 frequency of published studies including treatment arms testing cbt interventions (figure 1a) and ehealth/ mhealth interventions (figure 1b) per year from 2010 to 2019 0 20 40 60 80 100 120 140 160 180 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 n um be r of p ub li sh ed s tu di es cbt publications 0 5 10 15 20 25 30 35 40 45 50 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 n um be r of p ub li sh ed s tu di es ehealth publications a b rief, kopp, awarzamani, & weise 7 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ for all other types of psychological treatments, the numbers of published trials were not large enough (each less than 5% of all trials) to allow for robust predictions of developments based on annual changes. the specific numbers are listed in table 1 in the supplementary materials. changes from the first to the second five-year block after cbt and ehealth interventions, the next most commonly studied treatments are act (2015-2019: 4%), psychodynamic treatments (2%), ipt (2%), and mindfulness interventions (2%). we found a significant increase in the percentage of mindfulness interventions (p = .008) and a significant decrease in the percentage of psychodynamic treatments (p = .02). systemic therapy (1.1%), emotion-focused treatments (0.7%) and schema therapy (0.6%) represent smaller parts of published rcts. together with systemic therapies, psychodynamic treatments have the highest nega­ tive r 2. however, the scores are still very close to zero, indicating that future develop­ ment is hard to predict. although only on a trend level, the situation for ipt seems similar. the number of published treatment arms using this intervention remains stable, but in light of the increasing overall numbers, the proportion of ipt trials is decreasing. finally, the low number of eft treatment arms does not allow for any predictions about developments. countries of origin interestingly, the countries of origin of the principal investigator differed depending on the treatment approach. studies on cbt are dominant in the anglo-american field (us: 295 treatment arms, uk: 126 treatment arms, australia: 112 treatment arms). ehealth studies mainly originate from sweden (67 trials), but also from australia (48) and ger­ many (45). studies on act show a strong dominance in the us (20) and sweden (15). mindfulness trials originate from many different countries (e.g., us: 4, the netherlands: 3, and 2 trials each from china, germany and iran). studies with treatment arms using psychodynamic interventions mainly originate from germany (21), while rarely coming from other countries (uk: 6; sweden and den­ mark: 5). finally, ipt trials have a strong dominance in the us (19), with some further activities in china (5) and germany (4). d i s c u s s i o n with our study, we wanted to investigate indices for research trends. to ensure some basic methodological quality, we limited our search to studies quoted in “web of science”, and included only rcts. using these specifications, we found a substantial and continu­ ous increase in published research trials on psychotherapy from 2010 to 2019, which selected trends in psychotherapy research: an index analysis of rcts 8 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ more than doubled in this period. considering the five-year blocks, the increase was 71% in 2015-2019 as compared to 2010-2014. cbt continues to be the most frequently investigated treatment condition, currently representing 68% of treatment arms in rcts. the increase in cbt studies is quite robust, and statistical predictions indicate that it will continue this way in coming years. ehealth interventions are considered an emerging field in psychotherapy research. indeed, the total number of published trials continuously increased from 2010 to 2019. the proportion of ehealth interventions in psychotherapy research remained stable. research activities on third-wave interventions are also very dynamic and characterized by a continuous increase in published trials. on­ ly for mindfulness interventions and schema therapy did we find a significant increase in the proportion of trials in relation to other published rcts. the role of the more traditional treatment approaches such as psychodynamic inter­ ventions and systemic therapies seems to have continuously decreased. we found signif­ icantly smaller proportions of studies that characterized by psychodynamic treatment arms, and a slight (but not significant) decrease in the proportion of systemic treatment arms. in the 2015-2019 period, psychodynamic approaches accounted for only 2.4% of all psychotherapy treatment trials. interestingly, the various treatment approaches are differently represented across countries. for example, a large proportion of studies on ehealth interventions originate from sweden and australia, whereas cbt treatment arms are dominant in studies from the us. the reasons for these differences can be manifold: regulations of the national health care systems, financial issues imposed by health care providers and pressure for the provision of short-term interventions, the need for cultural adaptation, or regional conditions such as the distance to available health care providers are just a few of the variety of reasons that can contribute to these national differences (andersson et al., 2019). obviously, the reasons for the trends shown can be manifold. while some people might argue that cbt is over-investigated, others might favor a position that cbt reveals robust results, and is thus the best anchor for comparisons with other/new interventions. not surprisingly, cbt has been frequently used as comparison group in non-inferiority trials (rief & hofmann, 2018). the decreasing influence of the more traditional approaches, which have also been surpassed by third-wave interventions (e.g. act) also poses several questions. is this just the regular up and down in dynamic research fields that should be accepted and called “progress”? especially psychotherapy is a vivid field that can reflect the cultural and attitude changes in societies. moreover, the success of psychotherapy as a first line treatment for most mental disorders also changed psychotherapy itself. it should no longer be a luxurious and costly treatment option for a few rich people of societies – given the strong evidence base of several psychological treatments, a responsible health care system has the highly important task to develop strategies on how affordable psychological treatment can rief, kopp, awarzamani, & weise 9 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ be made available to all patients who need it (corscadden, callander, & topp, 2018). this need for better availability of evidence-based treatments increases the pressure to develop economic, fast-acting and easily accessible treatments. accordingly, attempts on how to provide psychological treatments sufficiently on a community and society level are highly laudable, like the iapt program in england (clark, 2018). is more research needed in psychotherapy? first, there are still clinical fields where too few studies on psychological treatments are available, e.g. anorexia and dissociative disorders (zhu et al., 2020). moreover, it is the continuous competition of approaches that helps to better specify and increase the efficacy of interventions. trends in psycho­ therapy research cannot only indicate what is more effective, but also what is more suitable for the current needs in society. for example, the rising availability and use of modern technologies (i.e. the internet and smartphones) has laid the groundwork for the development of ehealth interventions. bringing these treatments to regular health care increases the number of people who can access and benefit from psychological interventions, and enables the treatment for people who would otherwise not have been able to participate in face-to-face treatments (e.g. because of long distances to the closest therapist, andersson & titov, 2014). continuous psychotherapy research is also the basis for continuing the journey of psychotherapy to become an evidence-based part of most national health care systems. first, there are several clinical conditions for which only very few psychological treat­ ments can be considered as evidence-based (such as in schizophrenia, obsessive-compul­ sive disorder, insomnia). it was a huge success for the field of psychotherapy to show that specific psychological treatments are effective in psychosis (lincoln et al., 2012; lincoln & pedersen, 2019), even if no concurrent medication is used (morrison et al., 2018). others found better effects for depression-specific interventions compared to plausible, but disorder-unspecific treatments (schramm et al., 2017). these are just a few examples confirming the potential of current psychotherapy research. further, the more treatment studies we have for one condition, the better we can predict expected treatment outcome. this allows us to compare new study results with these anchors of expected effects. and even if many comparison studies have not revealed significant differences between distinct interventions, some studies did (poulsen & lunn, 2014; schramm et al., 2017; simon et al., 2021). all these studies on psychological treatments provide important information for scientists, clinicians and stakeholders of health care systems alike. some people argue that psychotherapy research is just a reflection of the feasibility of some interventions being used in clinical trials, which does not mirror the necessity of these interventions in clinical practice (bohart, 2000). this can be considered right and wrong. however, before implementing insufficiently evaluated interventions in a national health care system, studies using controlled designs and valid outcome measures are necessary to prove their efficacy and thus justify their implementation. selected trends in psychotherapy research: an index analysis of rcts 10 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ our analysis has some specific limitations, such as the focus on one database (wos) and on randomized clinical trials. we did not aim for a complete representation of all trials investigating all specific treatments, but rather aimed to find indices of current treatment trends. whatever approach is selected to find these indices, it always has its specific characteristic and limitations, therefore, we consider our limitations also as a characteristic of this analysis. others might follow with similar analyses, but using other data sets and other inclusion criteria. for instance, a more hierarchical approach could al­ so be suitable to reveal insights in research developments, starting with a major category (e.g., cbt), and continuing with more detailed analyses (e.g., ehealth interventions using cbt). of special note is our limitation to rcts. we are aware that much more clinically relevant studies exist, such as process-oriented trials, qualitative research, effectiveness trials with mere pre-post-comparisons etc. it was our specific aim to focus on rcts, as this is the study design with the most influence on treatment guidelines (e.g., guide­ lines of national institute for health and care excellence nice; arbeitsgemeinschaft wissenschaftlich-medizinischer fachgesellschaften awmf). however, we agree that the development of psychotherapy research from more traditional approaches investigating one treatment package for one clinical condition, to more process-based treatments and competence-based training of psychotherapists will have consequences for adequate trial designs and thus future trends in psychotherapy research (hofmann & hayes, 2019; rief, 2021). a further unique part that defines the limitations of our approach is the selection of psychological treatments, and the selection of search terms. we focused on comparing three major treatment approaches with a long history (psychodynamic, systemic and cbt) with more recently developed and outlined approaches, such as act, schema ther­ apy, mindfulness, emotion-focused therapy and ipt. furthermore, we wanted to know what role ehealth developments play in relation to these interventions that are typically provided face-to-face. of course, this method left many developments unconsidered, such as unified protocol approaches, emdr, or cbasp, to name a few. however, using a comprehensive list of search terms and specific techniques would have been nearly impossible, particularly for cbt techniques. therefore, we decided to limit this search to major techniques, hereby neglecting further trials that focus on cbt techniques such as stimulus control, habit reversal, or dbt. further, especially considering this large field of cbt trials, we do not expect substantial differences in percentages if a more inclusive approach would be selected. finally, such a database invites to do more detailed analyses on further variables, such as sample sizes, diagnostic unities, study quality, comorbidity, to name just a few. for this first article, this was beyond the scope of the paper. to conclude, our study confirms the dynamic character of the field of psychotherapy research, with continuously increasing numbers of published trials. it further strengthens the note that the field is not constant, but in continuous change. while new interven­ rief, kopp, awarzamani, & weise 11 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://www.psychopen.eu/ tions conquer more and more parts of the field, others are losing their representation. unless we have evidence for negative effects due to these developments, they are primar­ ily to be interpreted as dynamic changes in a developing field. with these changes, challenges for health care systems become evident: how can new developments be considered and eventually included in notoriously conservative health care systems? our active field of psychotherapy research has shown that it provides specific, evidencebased treatments for most mental disorders, and accordingly, the most powerful and evidence-based treatments should be made available to all patients who need it. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: winfried rief is head of a psychotherapy outpatient clinic, with a focus on cbt and new developments (e.g., expectation-focused psychological interventions), and that will be extended with family therapy in 2022. he receives royalties for book publications on psychotherapy, and as an editor of a book series on progress in psychotherapy. he is also member of several boards of scientific journals, and editor in chief of “clinical psychology in europe”. however, he did not play an editorial role for this manuscript, and he did not intervene in any form in the peer review process. cornelia weise is one of the editors-in-chief of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. s u p p l e m e n t a r y m a t e r i a l s further details about the search process and origin of studies are presented in the supplementary materials (for access see index of supplementary materials below). index of supplementary materials rief, w., kopp, m., awarzamani, r., & weise, c. (2022). supplementary materials to "selected trends in psychotherapy research: an index analysis of rcts" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.6892 r e f e r e n c e s andersson, g., & titov, n. (2014). advantages and limitations of internet-based interventions for common mental disorders. world psychiatry, 13(1), 4–11. https://doi.org/10.1002/wps.20083 andersson, g., titov, n., dear, b. f., rozental, a., & carlbring, p. (2019). internet-delivered psychological treatments: from innovation to implementation. world psychiatry, 18(1), 20–28. https://doi.org/10.1002/wps.20610 awmf. 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(2020). psychological treatments for people with severe and enduring anorexia nervosa: a mini review. frontiers in psychiatry, 11, article 206. https://doi.org/10.3389/fpsyt.2020.00206 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. rief, kopp, awarzamani, & weise 15 clinical psychology in europe 2022, vol. 4(2), article e7921 https://doi.org/10.32872/cpe.7921 https://doi.org/10.1001/jamapsychiatry.2020.2496 https://doi.org/10.32872/cpe.v1i2.30639 https://doi.org/10.1037/0022-006x.68.4.615 https://doi.org/10.3238/arztebl.2018.gut_hpt01 https://doi.org/10.3389/fpsyt.2020.00206 https://www.psychopen.eu/ selected trends in psychotherapy research: an index analysis of rcts (introduction) method search procedure eligibility criteria study selection analyses results most frequently investigated psychological treatments changes from the first to the second five-year block countries of origin discussion (additional information) funding acknowledgments competing interests supplementary materials references chronic pain in the icd-11: new diagnoses that clinical psychologists should know about scientific update and overview chronic pain in the icd-11: new diagnoses that clinical psychologists should know about antonia barke 1 , beatrice korwisi 2 , winfried rief 2 [1] clinical psychology and psychological intervention, institute for psychology, university duisburg-essen, essen, germany. [2] department of psychology, clinical psychology and psychotherapy, philipps university of marburg, marburg, germany. clinical psychology in europe, 2022, vol. 4(special issue), article e9933, https://doi.org/10.32872/cpe.9933 received: 2022-07-18 • accepted: 2022-10-26 • published (vor): 2022-12-15 handling editor: andreas maercker, university of zurich, zurich, switzerland corresponding author: antonia barke, universität duisburg-essen, institut für psychologie, klinischpsychologische intervention, universitätsstr. 2, d-45141, essen, germany. e-mail: antonia.barke@uni-due.de related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si abstract background: in the 10th revision of the international classification of diseases and related health problems (icd-10), chronic pain was not represented adequately. pain was left undefined and not recognized as a biopsychosocial phenomenon. instead, a flawed dualism between psychological and somatic factors was implied. individual diagnoses were ill-defined and scattered randomly through different chapters. many patients received diagnoses in remainder categories devoid of meaningful clinical information. method: the international association for the study of pain launched a task force to improve the diagnoses for the 11th revision of the icd and this international expert team worked from 2013-2019 in cooperation with the who to develop a consensus based on available evidence and to improve the diagnoses. results: a new chapter on chronic pain was created with a biopsychosocial definition of pain. chronic pain was operationalized as pain that persists or recurs longer than three months and subdivided into seven categories: chronic primary pain and six types of chronic secondary pain. all diagnoses were based on explicit operationalized criteria. optional extension codes allow coding pain-related parameters and the presence of psychosocial aspects together with each pain diagnosis. conclusion: first empirical studies demonstrated the integrity of the categories, the reliability, clinical utility, international applicability and superiority over the icd-10. to improve reliability this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9933&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0002-6863-3213 https://orcid.org/0000-0003-1477-6742 https://orcid.org/0000-0002-7019-2250 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ and ease of diagnosis, a classification algorithm is available. clinical psychologists and other clinicians working with people with chronic pain should watch the national implementation strategies and advocate for multimodal and interdisciplinary treatments and adequate reimbursement for all providers involved. keywords icd-11, classification, biopsychosocial model of chronic pain, chronic primary pain, chronic secondary pain, implementation highlights • a systematic chapter on chronic pain in the icd-11 improves the representation of chronic pain. • chronic pain is pain that persists or recurs for more than three months. • chronic pain in the icd-11 is regarded as biopsychosocial. • icd-11 introduces chronic primary pain and distinguishes six types of chronic secondary pain. background what was wrong with the representation of chronic pain in the icd-10? in the previous version of the international classification of diseases and related health problems (icd), the icd-10, chronic pain was represented neither systematically nor adequately. the main shortcomings were: firstly, the icd-10 did not reflect the widely accepted biopsychosocial model of pain (rief et al., 2010; rief et al., 2008; treede et al., 2010), which is also a central aspect of the internationally widely accepted definition of pain by the international association for the study of pain (iasp) (raja et al., 2020). secondly, for many important types of chronic pain, no diagnoses were available at all: chronic neuropathic pain, chronic pain associated with cancer and its treatment, or chronic pain after surgery or accidents were missing in the icd-10 (rief et al., 2012). thirdly, even if a diagnosis was available in the icd-10, it often lacked clear definitions and criteria, e.g., “r52.2 other chronic pain”. in most cases, not even the information whether the pain was chronic or acute could be recorded (e.g., “m54.4 low back pain”) – despite agreement that highly relevant differences exist between acute and chronic pain (kröner-herwig, 2017; treede, 2019). as a result, one of the most frequently used diagnoses for chronic pain was the ill-defined residual category “r52.2 other chronic pain”, which held next to no information value for clinicians, patients or health statistics. fourthly, the diagnoses that were available in icd-10 were scattered rather arbitrarily among different chapters (rief et al., 2010; rief et al., 2012), depending upon the medical specialty that tended to treat them. for example, the diagnosis “m54.5 low back pain” was found in the chapter for diseases of the musculoskeletal system and connective chronic pain in the icd-11: new diagnoses 2 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ tissue while different types of headache (“g43 migraine”) were listed among the diseases of the nervous system (world health organization, 2019). clinical psychologists are probably most familiar with the chronic pain diagnosis “f45.4 persistent somatoform pain disorder” available in the so-called “icd-10 f-chapter” for mental and behavioral disorders. this diagnosis recognizes the role of psychological factors in the development and maintenance of the chronic pain and gives a definition that specifies the chronic course of the pain (world health organization, 2019). however, the contribution of biological or physiological factors is excluded. by definition, the diagnosis f45.4 cannot be assigned if a patient has chronic pain associated with an underlying disease such as, for example, rheumatoid arthritis. this contributes to the artificial and problematic dichotomy of “psychological” vs. “somatic” chronic pain in the icd-10 (arnold et al., 2017; rief et al., 2008; treede et al., 2010). the german modifica­ tion of the icd-10 includes an additional chronic pain diagnosis, “f45.41 chronic pain with somatic and psychological factors” which, for the first time, recognized the contri­ bution of both biological and psychological factors to chronic pain (nilges & rief, 2010) thereby overcoming the dichotomy (arnold et al., 2017; treede et al., 2010). this was a great step forward and the frequency with which this diagnosis has since been used (häuser et al., 2013) shows it is well-accepted – probably because it offers a much-needed way of classifying chronic pain according to the biopsychosocial model. despite these advances, the diagnosis f45.41 had to compromise. its location in the chapter on mental and behavioral disorders was a theoretical compromise since chronic pain is neither. the fact that the diagnosis is only available in the german modification (icd-10-gm), is a practical compromise since it means that the diagnostic advance is geographically limited to countries that use this national version (world health organization, 2022b). what were the consequences of the deficient representation of chronic pain in icd-10? negative consequences arose from the inadequate representation of chronic pain in the icd-10 for patient treatment, research into chronic pain as well as health statistics and health policies. most importantly, the distinction of “psychological” chronic pain on the one hand and “somatic” chronic pain on the other, is not useful because chronic pain is always an interplay of psychological, biological, and social factors (raja et al., 2020; rief et al., 2008; treede et al., 2010). since in many healthcare systems, icd codes are relevant for treatment choice and treatment access (boerma et al., 2016; jakob, 2018a, 2018b), patients with chronic pain may be excluded from specific multimodal interdisciplinary pain treatment programs as well as from psychological treatment (nilges & rief, 2010; rief et al., 2009; rief et al., 2008), unless they also receive a diagnosis of a mental disorder, such as f45.4. on an individual level, this meant that many patients tended to receive multimodal therapies including psychological treatments at a very late stage, often only when treatment providers and patients felt they had exhausted the somatic barke, korwisi, & rief 3 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ treatments without much progress. this made it unnecessarily hard for patients to accept the biopsychosocial model and engage with psychological treatments. individually, this may mean more distress and suffering. at a public health level, this translates into a larger societal burden of chronic pain and direct and indirect costs (blyth et al., 2019; blyth & huckel schneider, 2018). missing diagnoses meant that for treatment purposes, precise and appropriate codes for the chronic pain were lacking and clinicians chose various ways of expressing chron­ ic pain diagnoses, often with recourse to entities such as “chronic intractable pain” (r52.1). this led to numerous problems in communication with patients and health providers. considering the role of outcome expectations that have been shown for many areas (auer et al., 2016; di blasi et al., 2001; laferton et al., 2017) labeling a person’s pain as “intractable” may convey a nihilistic therapeutic attitude to clinician and patient alike. apart from problems of treatment and management of individual cases, the lack of diagnostic codes also rendered the different types of chronic pain and the associated burden invisible from the perspective of public health policy. the vague definitions and ambiguous diagnoses also presented difficulties for the communication between patients and healthcare providers as well as for the information exchange among healthcare professionals. on a larger scale, it impeded the formulation of fruitful research agendas. referring to a large variety of chronic pain syndromes as “non-cancer pain” or “non-specific pain” underestimated the differences between the syndromes – while researching only into very specific syndromes glossed over the commonalities. finally, in epidemiological and register studies based on inadequate representation, the true prevalence of chronic pain and its associated disease burden remained underestimated. such underestimation, in turn, was likely to influence health policy decisions and funding allocation (blyth et al., 2019; rice et al., 2016; treede et al., 2010). m e t h o d developing a new set of chronic pain diagnoses for icd-11 to remedy the situation of chronic pain in the icd-10, the community of pain specialists had long worked together and argued for a classification better reflecting the empirical and theoretical advances. in 2012 the iasp formed an international and interdisciplinary task force and collaborated with the world health organization (who) to reform the classification of chronic pain for the next revision of the icd. the who demanded consensus and evidence in order to enter diagnoses into the icd-11 (world health organization, n.d.). the task force provided both by striving for a consensus among the professionals working with patients with chronic pain and publishing the results in a series of papers (aziz et al., 2019; bennett et al., 2019; benoliel et al., 2019; nicholas et al., chronic pain in the icd-11: new diagnoses 4 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ 2019; nugraha et al., 2019; perrot et al., 2019; scholz et al., 2019; schug et al., 2019; smith et al., 2019; treede et al., 2019; treede et al., 2015). the development was accompanied by formative evaluations (barke et al., 2018; barke et al., 2022) and evaluative studies (hay et al., 2022; korwisi, garrido suarez, et al., 2022; korwisi et al., 2020; zinboonyahgoon et al., 2021). in 2019, the world health assembly endorsed the icd-11 with the new clas­ sification of chronic pain (world health assembly, 2019). the icd-11 came into effect on january 1st, 2022 for international mortality reporting (world health organization, 2022a). many countries are currently preparing the implementation of the icd-11 within their national healthcare systems. r e s u l t s : t h e n e w c h r o n i c p a i n d i a g n o s e s i n i c d 1 1 a n d h o w t h e y a d d r e s s t h e p r o b l e m s i n i c d 1 0 an improved definition of chronic pain the chronic pain classification implemented in the icd-11 forms one structured chapter, which contains all chronic pain diagnoses in one logical order (for details see below), which are subdivisions of the clearly operationalized entity “chronic pain” (mg30, id: http://id.who.int/icd/entity/1581976053) the definition of chronic pain was aligned with the updated iasp diagnosis of pain (raja et al., 2020): “pain is an unpleasant sensory and emotional experience asso­ ciated with, or resembling that associated with, actual or potential tissue damage.” it continues to specify chronic pain as “pain that persists or recurs for longer than 3 months”, providing a clear operationalization of chronic pain. the defining sentence is immediately followed by the clause regarding the typical nature of chronic pain: “chronic pain is multifactorial: biological, psychological and social factors contribute to the pain syndrome.” this sentence expresses the biopsychosocial model for all types of chronic pain. it is open for variable weights of the respective factors in different chronic pain syndromes, but unequivocally affirms the general model for all subdiagnoses that characterize specific syndromes. here it is important to note that in the icd-11 the subordinate diagnoses (called “children”) inherit the characteristics of the higher-order diagnoses (called “parents”), without repeating all the features in each child diagnosis. throughout the whole chapter of chronic pain, chronic pain is defined as explained here. with this definition, the icd-11 addressed and remedied a major criticism leveled at the earlier editions, and now accurately reflects the widely accepted biopsychosocial model of pain. barke, korwisi, & rief 5 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 http://id.who.int/icd/entity/1581976053 https://www.psychopen.eu/ adding missing diagnoses the second major criticism was that for many important types of chronic pain, no diagnoses were available at all in the icd-10. diagnoses were missing for chronic neuropathic pain, chronic pain associated with cancer or its treatments, chronic pain after surgery and accidents, as well as many types of chronic orofacial pain. the icd-11 classification contains systematically ordered diagnoses in these fields. chronic pain has seven subdivisions: mg30.0 chronic primary pain (nicholas et al., 2019) mg30.1 chronic cancer related pain (bennett et al., 2019) mg30.2 chronic postsurgical or post traumatic pain (schug et al., 2019) mg30.3 chronic secondary musculoskeletal pain (perrot et al., 2019) mg30.4 chronic secondary visceral pain (aziz et al., 2019) mg30.5 chronic neuropathic pain (scholz et al., 2019) mg30.6 chronic secondary headache or orofacial pain (benoliel et al., 2019) the reasoning behind these subtypes and the diagnoses classified there have been ex­ plained and discussed in the dedicated papers for each subtype. here we can only give a brief resumé – for fuller details we recommend the specific articles. chronic primary pain chronic primary pain is defined as chronic pain in one or more anatomical regions that is associated with significant emotional distress and/or significant functional disability (nicholas et al., 2019). the diagnosis should be assigned unless the symptoms are better accounted for by another diagnosis in the section of chronic secondary pain. the definition of the new diagnosis of chronic primary pain is formulated to be ag­ nostic regarding the etiology of the pain syndrome and is purely descriptive. subsuming a diagnostic term here does not commit us to the claim that no somatic factors contribute to the diagnosis. neither does it commit us to the claim that psychosocial factors are the main contributors. this is true on the level of diagnostic entities: classifying fibro­ myalgia as a type of chronic primary pain does not imply the empirical judgement that central sensitization or other somatic processes do not play a part in the fibromyalgia syndrome. at the patient level, assigning a diagnosis of chronic primary back pain does not mean to deny that biological factors contribute to the chronic pain or to claim that psychological factors dominate. this descriptive nature is viewed as a distinct advantage. if another diagnosis accounts better for the chronic pain, one of the secondary diagnoses should be assigned, usually in combination with the respective underlying condition. note, however that – again – this does not imply that no psychosocial factors may be present or relevant regarding the pain. the biopsychosocial model of chronic pain applies to chronic primary and chronic secondary pain in exactly the same way and thus psychosocial factors may be relevant in both instances. the difference is that: chronic pain in the icd-11: new diagnoses 6 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ a. for chronic primary pain significant distress or functional interference (or both) are required as part of the definition. b. for chronic secondary pain a clearly defined somatic factor as expressed in another icd-11 diagnosis is required and should be co-diagnosed. in the section on chronic primary pain several frequent pain syndromes are classified, including chronic pain often referred to as 'functional gastrointestinal disorders', as char­ acterized by the rome criteria (drossman & hasler, 2016). see table 1 for an overview. table 1 overview of chronic primary pain and its subdiagnoses in the icd-11 chronic primary pain in the mms linearization (mg 30.0) / subdiagnoses classified here foundation id a chronic primary visceral pain (mg30.00) 679352876 chronic primary chest pain syndrome 128474405 chronic primary epigastric pain syndrome 1983908934 chronic primary bladder pain syndrome 2093682836 chronic primary pelvic pain syndrome 1663013388 chronic primary abdominal pain syndrome 709631177 chronic widespread pain (mg30.01) 849253504 fibromyalgia syndrome 236601102 chronic primary musculoskeletal pain (mg30.02) 1236923870 chronic primary cervical pain 2014134682 chronic primary thoracic pain 642165115 chronic primary low back pain 1291385632 chronic primary limb pain 413174579 chronic primary headache or orofacial pain (mg30.03) 2104869000 chronic migraine 1336990680 burning mouth syndrome 618998878 chronic primary orofacial pain 1545281608 chronic primary temporomandibular disorder pains 975254799 chronic tension-type headache 107534985 complex regional pain syndrome (mg30.04) 1834504950 crps type i 2067142665 crps type ii 1415867395 ato locate the entities using their foundation id please use the icd-11 foundation browser (https://icd.who.int/dev11/f/en) and paste the id number in the search field. this is only required in case you would like to access the subdiagnoses that for technical reasons do not have an mg30 code. further details and explanations regarding these technical aspects can be found in (korwisi, barke, et al., 2022). barke, korwisi, & rief 7 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://icd.who.int/dev11/f/en https://www.psychopen.eu/ the terms chronic “primary” and chronic “secondary” were adapted from the headache classification (headache classification committee of the international headache society [ihs], 2018). they were chosen to express the fact that the chronic pain constitutes a health problem in its own right with high clinical priority for the patient and is not directly associated with another disease accounting for the pain. the term was preferred by the who and seen to have a number of advantages over other terms that might have been considered, such as “non-specific”, “functional” or “idiopathic”. chronic secondary pain chronic secondary pain is chronic pain that accompanies underlying diseases or health conditions that are coded elsewhere in the icd. in this section, chronic pain in connec­ tion with cancer or its treatment (bennett et al., 2019), chronic pain after surgery or accidents (schug et al., 2019), chronic musculoskeletal pain due to underlying conditions such as rheumatoid arthritis (perrot et al., 2019), chronic visceral pain due to persisting inflammation or mechanical causes (aziz et al., 2019), chronic neuropathic pain (scholz et al., 2019) and chronic secondary headache (benoliel et al., 2019) (including medication overuse headache) can be classified. it should again be noted that these diagnoses are also children of chronic pain, and thus inherit the fundamental biopsychosocial model. the diagnoses listed under chronic secondary pain address the criticism that many chronic pain conditions could not be diagnosed within icd-10. a typical case is chronic cancer-related pain. due to medical advances, many more people survive cancer (glare et al., 2022). in a significant number of cases, the cancer survivors suffer from chronic pain, either due to the cancer itself or due to the often aggressive treatments needed. for both types of chronic pain codes were created: the former can be coded as “chronic cancer pain” (mg30.10), the latter as “mg30.11 chronic post cancer treatment pain” (mg30.11). for the affected person and their families, the diagnosis can mean better understanding and acknowledgement of the chronic pain and improvements in the access to multimodal and interdisciplinary care. statistically, the chronic pain people suffer as a result of cancer and its therapies and the associated burden become visible and can be taken into account in health planning. the same is true for chronic neuropathic pain, chronic postsurgical pain and chronic pain after accidents. addressing unclear criteria and ambiguous diagnoses other diagnoses were part of the icd-10, but lacked clear criteria. this issue was ad­ dressed in the icd-11 by introducing operationalized diagnostic criteria, which at all levels state criteria that are individually necessary and jointly sufficient for the respec­ tive diagnosis. on average, each diagnosis relies on 4-7 explicit criteria. each diagnosis inherits the criteria of the diagnosis above and adds more specific criteria. in total, the diagnoses in the section on chronic pain are based on c. 200 explicit criteria. chronic pain in the icd-11: new diagnoses 8 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ better representation of relevant factors and pain parameters given the centrality of the biopsychosocial model of chronic pain, it is justified to expect that biopsychosocial factors can be expressed better in the icd-11. indeed, there are several ways in which they can be coded alongside all chronic pain diagnoses, primary and secondary. the tools provided for this purpose are “extension codes”. with extension codes, information can be added to the categorical diagnoses. in the section of chronic pain, extension codes for “pain severity” and the “presence of psychosocial factors” allow the expression of psychosocially relevant information. a further extension code can be assigned to communicate “temporal features” of the pain (continuous, episodic or continuous with additional flare-ups). the pain severity specifier captures three important aspects of chronic pain: its inten­ sity (how much does it hurt? how intense is the pain?), the pain-related emotional distress experienced by the person (how much does the pain distress you?) and the pain-related interference with everyday life and functioning (how much does the pain interfere with your daily life?). all three aspects should be rated on a numerical rating scale from 0 – 10, or – if preferred – on a visual analogue scale by the patient (see box 1 for the exact wording as well as a case vignette showing their application). the numeric scores can be used for individual documentation. however, they can also be converted into severity codes of “none – mild – moderate – severe”, which can be included with any chronic pain diagnosis in icd-11, thereby providing a fuller picture of the chronic pain and how it affects the individual person. more specifically, the presence of psychosocial factors can be coded with the exten­ sion code “presence of psychosocial factors”. this code is designed to allow coding problematic cognitive (e.g., catastrophizing, excessive worry, eccleston & crombez, 2007; sullivan et al., 2001), emotional (e.g., fear, anger; thibodeau et al., 2013; trost et al., 2012), behavioral (e.g. avoidance, endurance; hasenbring & verbunt, 2010; vlaeyen & linton, 2012) and social factors (e.g. work-related and economic factors (haukka et al., 2011; rios & zautra, 2011)) that accompany the chronic pain. it is important to note that the extension code should be used only in cases in which there is positive evidence that psychosocial factors contribute to the cause, the maintenance or the exacerbation of the pain or the associated disability, or when the chronic pain results in negative psy­ chobehavioral consequences (e.g. demoralisation, hopelessness, avoidance, withdrawal). assigning the code requires ascertaining the psychosocial factors, e.g. by use of explo­ ration of the patient and / or psychometric questionnaires. the inference “no somatic cause of the pain can be found, therefore the pain must have a psychological cause” is flawed and cannot form the basis of a use of the extension code “with psychosocial factors”. assigning the code does not entail any specific causal path: the psychosocial factors can be the consequence of the burden of living with chronic pain just as much as a mechanism contributing to the experienced functional interference. the intended use of the code is communicative – the possible presence of psychosocial factors should be barke, korwisi, & rief 9 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ box 1 case vignette: paul (55 years) history: paul works as a mechanic in the automotive industry. about 22 months ago, paul had been diagnosed with cancer of the prostate. he underwent surgery to remove the prostate. the surgery went well. after the initial shock of the diagnosis, he was glad that the surgery was over and he had very few side effects. on his doctor’s advice, he began a course of chemotherapy with docetaxel. during the chemotherapy, he developed neuropathic pain in the hands and feet. he was told that in many cases the pain resolves a while after the last dose, but in some cases, it does not. for paul, the pain did not remit. paul was on sick leave during the surgery and the subsequent recovery. afterwards, he went back to work, only pausing for a few days for each course of chemotherapy. when the neuropathic pain developed, he found his work harder and harder. hoping the pain would go away after the last treatment, he gritted his teeth and carried on working full hours despite the pain and the interference with his work. he is determined to continue in his present work schedule as a matter of pride. the family had bought a house a few years ago and there were a few years of mortgage payment left. paul worries a lot about his pain and how it affects his and his family’s life. he finds it difficult to fall asleep due to the pain and the worry. he feels exhausted and overstretched and often withdraws from activities he used to like. his family-life suffers from his dejected mood and irritability. on a scale from 0-10 he rates his pain in the last week as “7” (“how strong was your chronic pain in the last week [on average]?”) and the pain-related interference as “5” (“how much did the pain interfere with your activities in the last week [on average]?”), his pain-related distress he rates as a “7” (“how much pain-related distress did you experience in the last week because of your pain [on average]?”). diagnoses according to the icd-11 mg30.11 chronic post cancer treatment pain associated with: xs7g psychosocial factors present has severity: xs2e severe pain [pain intensity] has alternate severity 1: xs7n severe distress [pain-related distress] has alternate severity 2: xs2l moderate pain-related interference [pain-related interference] has causing condition: 2c82.y other specified malignant neoplasms of prostate final code: mg30.11&xs7g&xs5d&xs7c&xs5r/2c82 note. this code is optimized for machine readability and does not have to be memorized by humans – it is chosen via computer interface. however, it contains all of the above information. it could be augmented even further with information regarding the neoplasm itself (e.g. staging). chronic pain in the icd-11: new diagnoses 10 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ discussed between patient and clinician, their presence recorded and communicated to other health providers with the diagnosis. ideally, they are used to point to a treatment relevance of the psychosocial factors. in the future, such a code should entitle the person to multimodal care including psychological treatments. d i s c u s s i o n empirical support for the new chronic pain classification the classification of chronic pain in the icd-11 was developed with a view to the empir­ ical evidence accrued over many years. the classification and its implementation itself have also undergone first empirical evaluations. important targets of the revision process of the icd were clinical utility and international applicability of the new classification (jakob, 2018a; reed, 2010; üstün & jakob, 2005; üstün et al., 2007). clinical utility can be regarded as an approximation of validity and reflects how much a classification system offers a useful conceptualization of the diagnostic entities, enables selecting of adequate treatments, and is easy and feasible to use. high clinical utility allows application in rou­ tine practice, facilitates communication and documentation and – ideally – is predictive of treatment outcomes. (first et al., 2004; keeley et al., 2016) the integrity of the diagnostic categories is an important prerequisite for the utility of a classification. diagnostic categories should not overlap, but have clear boundaries (distinctness); together, the categories should cover the whole phenomenological space (exhaustiveness). these aspects were investigated in formative field tests (barke et al., 2018). in a sample of unselected patients, the categories demonstrated good distinctness and exhaustiveness: less than 3% could not be assigned one of the seven main categories of chronic pain, thus dramatically reducing the number of patients who received a diagnosis reflecting a non-descript remainder category. this favorable result has since been confirmed by a documentation-based retrospective coding study (zinboonyahgoon et al., 2021). as a further condition, clinical utility requires reliability of the code assignments. the who led extensive field tests of coding aspects of the icd-11. the results obtained for chronic pain showed that the icd-11 diagnoses outperformed icd-10 on all counts, including correct code assignments, ease of application, level of detail and fewer per­ ceived ambiguities (barke et al., 2022). a next step in reliability testing was testing the interrater-reliability of clinicians assigning diagnoses to real consecutive patients. in an international field testing study, consecutive patients were independently diagnosed by two clinicians and substantive kappa coefficients for interrater reliabilities reported (0.596 < κ < 0.783) (korwisi, garrido suarez, et al., 2022). the clinicians were asked to rate the clinical utility of the diagnoses and it was rated as high throughout all studies (barke et al., 2018; barke et al., 2022; korwisi, garrido barke, korwisi, & rief 11 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ suarez, et al., 2022). in addition, preliminary results of a survey among people with the lived experience of chronic pain also showed that they judged the new diagnoses to be helpful for communicating with health professionals, their families and others (korwisi et al., 2019). the detailed categories increased the visibility of the chronic pain diagnoses when compared with icd-10 diagnoses (zinboonyahgoon et al., 2021). international applicability was addressed in a multi-country field testing study in india, cuba and new zealand. details of the testing are described in the study protocol (korwisi et al., 2020). clinicians in specialist pain centers in each country were intro­ duced to the icd-11 classification in training workshops and subsequently coded n = 353 consecutive patients with the icd-11 classification as well as their usual diagnostic system. they provided data for the interrater-reliability and rated the clinical utility of the icd-11 and the standardly used system, showing a clear preference for the icd-11 classification (korwisi, garrido suarez, et al., 2022). this study provides evidence that the classification is clinically useful in a range of international settings, including countries with limited resources. the relationship with the diagnoses in the chapter on mental and behavioural disorders the icd-10 chapter on mental and behavioural disorders includes the group of somato­ form disorders, with a subdiagnosis on somatoform pain disorder. this led to several critical comments. the mind-body-dualism seemed to be amplified with this somatoform pain diagnosis, because a psychological etiology of pain conditions was emphasized in its definition. however, the whole category of somatoform disorders was associated with various problems (creed, 2006). despite substantial prevalence rates of 9% and above in the general population (creed et al., 2012), in countries like the us, these diagnoses were rarely used (dimsdale et al., 2011). based on this critique, dsm-5 decided to revise this chapter substantially, and introduced the somatic symptom and associated disorders cat­ egory. the relevance of whether somatic symptoms are medically explained or not was completely abolished, while psychological factors that are associated with the suffering from these physical complaints play a major role for the diagnosis of a somatic symptom disorder (rief & martin, 2014). the icd-11 decided to introduce a new category on “disorders of bodily distress and bodily experience”, and its prototypic diagnosis is called “bodily distress disorder (bdd)”. bdd has a similar concept to somatic symptom disorder in dsm-5: it requires bodily symptoms that are persistent, and present on most days for at least several months. as a psychological criterion, excessive attention is directed toward the symp­ toms. while the description acknowledges that pain symptoms are among the most common symptoms of bdd, no pain subtype is defined yet. it remains unclear whether the german modification will stick to the current f45.41 diagnosis of chronic pain with psychological and somatic factors. therefore, at this stage, we recommend the chronic chronic pain in the icd-11: new diagnoses 12 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://www.psychopen.eu/ primary pain diagnoses if chronic pain is the leading somatic complaint, and the other criteria for chronic pain are fulfilled. future directions over the next 5-10 years, the icd-11 will be implemented in many european countries’ health systems (world health organization, 2022a). even in countries in which it is not the basis for health planning and reimbursement, governments will provide data based on icd-11 diagnostic categories to the who in fulfillment of treaty obligations for the reporting of health data. it is recommended that for pain research the new diagnoses are used to inform research programs and utilize the improved diagnostic criteria as well as the specifiers (barke et al., 2020; treede et al., 2019). implementing changes in classification entails changes in other areas, including adaptations in administration and information technology, reimbursement practices and student education. in addition, it requires thorough training for clinicians, administrative and coding staff. a helpful resource when beginning to familiarize oneself with the icd-11 and the new chronic pain diagnoses, may be a paper in which questions regarding the classification were collected systematically and answers provided (korwisi, barke, et al., 2022). to improve the diagnostic reliability further and facilitate the training, a classification algorithm (cal-cp) was developed (korwisi, hay, et al., 2021) that guides the users through the criteria and diagnoses with a binary decision tree. the user decides for each diagnostic criterion whether it is present in a given patient and then follows the respective “yes” or “no” arrow. the decision tree guides the user through all levels that are available for the new diagnoses. in some settings, a less specific diagnosis might be sufficient (e.g., mg30.0 chronic primary pain in primary care) while the most specific diagnoses will probably be required in pain research and specific pain treatment (e.g., mg30.02 chronic primary musculoskeletal pain: chronic primary low back pain). hence, the algorithm is a central tool to apply the new diagnoses in practice as well as in research. the clinicians participating in the international field test had used a pilot version of the algorithm and rated it favourably (korwisi, hay, et al., 2021). currently an authorized version (a pdf with active hyperlinks) is available as digital supplement to the original publication (http://links.lww.com/pain/b277). a large test using online virtual patients is underway and its results will provide the basis for a digitized version. a further aspect, which will have to be discussed and decided on a national level, will be the implications of the new diagnoses in terms of treatment authorization and reimbursement policies. since the new diagnoses are based on the biopsychosocial model and it is recommended that chronic pain is no longer classified as a somatoform disor­ der, in some health systems, political and professional negotiations may be required to allow multimodal and interdisciplinary treatments including psychological interventions to be offered and reimbursed by multidisciplinary teams. for instance, in germany, barke, korwisi, & rief 13 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 http://links.lww.com/pain/b277 https://www.psychopen.eu/ psychotherapists and psychosomatic hospitals are currently limited to treating disorders that are classified in the icd-10 chapter v (mental and behavioural disorders). clinical psychologists and other health professionals working with people with chronic pain need to be aware of these developments in their respective countries and should seek to advocate for state of the art multimodal treatments for patients with chronic pain delivered by those who are qualified practitioners. funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: winfried rief is one of the editors-in-chief of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. r e f e r e n c e s arnold, b., lutz, j., nilges, p., pfingsten, m., rief, w., boger, a., brinkschmidt, t., casser, h. r., irnich, d., kaiser, u., klimczyk, k., sabatowski, r., schiltenwolf, m., & sollner, w. 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(2019). the 72nd world health assembly resolution for icd-11 adoption. https://www.who.int/standards/classifications/classification-of-diseases world health organization. (2019). international statistical classification of diseases and related health conditions (10th revision). https://icd.who.int/browse10/2019/en world health organization. (2022a). classifications and terminologies: who family of international classifications. https://www.who.int/standards/classifications world health organization. (2022b). internationale statistische klassifikation der krankheiten und verwandter gesundheitsprobleme 10. revision german modification. https://www.dimdi.de/static/de/klassifikationen/icd/icd-10-gm/kode-suche/htmlgm2022/ barke, korwisi, & rief 19 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://doi.org/10.1016/j.jpain.2012.10.014 https://doi.org/10.1007/978-3-662-574874_1 https://doi.org/10.1007/s00482-010-0907-1 https://doi.org/10.1097/j.pain.0000000000001384 https://doi.org/10.1097/j.pain.0000000000000160 https://doi.org/10.1016/j.pain.2011.10.023 https://doi.org/10.1016/j.pain.2011.12.009 https://www.who.int/standards/classifications/classification-of-diseases https://icd.who.int/browse10/2019/en https://www.who.int/standards/classifications https://www.dimdi.de/static/de/klassifikationen/icd/icd-10-gm/kode-suche/htmlgm2022/ https://www.psychopen.eu/ world health organization. (n.d.). icd-11 reference guide. retrieved 30 june 2022 from https://icdcdn.who.int/icd11referenceguide/en/html/index.html zinboonyahgoon, n., luansritisakul, c., eiamtanasate, s., duangburong, s., sanansilp, v., korwisi, b., barke, a., rief, w., & treede, r. d. (2021). comparing the icd-11 chronic pain classification with icd-10: how can the new coding system make chronic pain visible? a study in a tertiary care pain clinic setting. pain, 162(7), 1995–2001. https://doi.org/10.1097/j.pain.0000000000002196 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. chronic pain in the icd-11: new diagnoses 20 clinical psychology in europe 2022, vol. 4(special issue), article e9933 https://doi.org/10.32872/cpe.9933 https://icdcdn.who.int/icd11referenceguide/en/html/index.html https://doi.org/10.1097/j.pain.0000000000002196 https://www.psychopen.eu/ chronic pain in the icd-11: new diagnoses (introduction) background method developing a new set of chronic pain diagnoses for icd-11 results: the new chronic pain diagnoses in icd-11 and how they address the problems in icd-10 an improved definition of chronic pain adding missing diagnoses addressing unclear criteria and ambiguous diagnoses better representation of relevant factors and pain parameters discussion empirical support for the new chronic pain classification the relationship with the diagnoses in the chapter on mental and behavioural disorders future directions (additional information) funding acknowledgments competing interests references acute effect of physical exercise on negative affect in borderline personality disorder: a pilot study research articles acute effect of physical exercise on negative affect in borderline personality disorder: a pilot study samuel st-amour 1,2 , lionel cailhol 2,3 , anthony c. ruocco 4 , paquito bernard 1,2 [1] department of physical activity sciences, université du québec à montréal, montreal, quebec, canada. [2] mental health university institute of montreal research center, montreal, quebec, canada. [3] department of psychiatry and addictology, medicine faculty, university of montreal, montreal, quebec, canada. [4] department of psychology (scarborough), university of toronto, toronto, ontario, canada. clinical psychology in europe, 2022, vol. 4(2), article e7495, https://doi.org/10.32872/cpe.7495 received: 2021-09-13 • accepted: 2022-02-08 • published (vor): 2022-06-30 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: samuel st-amour, 141 avenue du président-kennedy (sb-4290), montréal, qc, canada, h2x 1y4. phone: (+1)514-987-3000(3606). fax: (+1)514.987.6616. e-mail: st-amour.samuel.2@courrier.uqam.ca supplementary materials: data, materials [see index of supplementary materials] abstract background: physical exercise is an evidence-based treatment to reduce symptoms and negative affect in several psychiatric disorders, including depressive, anxiety, and psychotic disorders. however, the effect of physical exercise on negative affect in patients with borderline personality disorder (bpd) has not yet been investigated. in this pilot study, we tested the safety, acceptability, and potential acute effects on negative affect of a single session of aerobic physical exercise in adults with bpd. method: after completing a negative mood induction procedure, 28 adults with bpd were randomly assigned to a 20-minute single session of stationary bicycle or a control condition (emotionally neutral video). results: no adverse effects attributed to the physical exercise were reported and it was considered acceptable to patients. following the negative mood induction, both conditions decreased the level of negative affect with a medium effect size but there was no significant difference between them. conclusion: the results suggest that a single 20-minute session of physical exercise does not produce a reduction of negative affect in bpd. future research should consider the duration and intensities of physical exercise with the greatest potential to reduce negative affect both acutely and in a more prolonged manner in this patient group. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.7495&domain=pdf&date_stamp=2022-06-30 https://orcid.org/0000-0002-6282-7885 https://orcid.org/0000-0002-5931-8182 https://orcid.org/0000-0002-1942-7181 https://orcid.org/0000-0003-2180-9135 https://cpe.psychopen.eu/ https://www.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords physical activity, emotion regulation, affect, emotion dysregulation, emotion induction highlights • adults with bpd have potential to benefit physical exercise. • in this pilot study, no adverse effects were attributed to physical exercise. • physical exercise was as effective as a neutral video in decreasing negative affect. borderline personality disorder (bpd) is characterized by an instability of self-image, goals, interpersonal relationships, and affect (gunderson et al., 2018). the one-year and lifetime prevalence rates of the diagnosis in the general population are estimated at 1.6% and 5.9%, respectively (american psychiatric association, 2013). among pathogenesis models of bpd (d’agostino et al., 2018), the biosocial developmental model proposes that emotion dysregulation is the core of bpd and underlies many characteristic behaviors (crowell et al., 2009). this model is based on three main components: heightened sensi­ tivity to emotional stimuli, intense reactions to emotional stimuli, and a delayed return to an emotional baseline (crowell et al., 2009; linehan, 1993). difficulties regulating emotions in bpd are linked to maladaptive behaviors, which presumably function to reduce negative affect (daros, guevara, et al., 2018). a higher level of emotion dysregu­ lation has also been associated with lower quality of life and daily functioning (gratz et al., 2016) and a poorer therapeutic relationship (gunderson et al., 2018). emotion dysregulation has also been identified as a mechanism in other psychopathologies such as major depression and bipolar disorder, but seems to be present at a higher level in bpd than in these disorders (gratz et al., 2016). moreover, little is known regarding the specific dimensions of emotion dysregulation to bpd and its development compared to those of other disorders and psychopathology in general (gratz et al., 2016). therefore, finding diagnosis specific interventions to improve emotion regulation and help regulate negative emotions should be among the priorities for research on bpd. from this perspective, a single session of physical exercise (pe) could be useful to help individuals with bpd regulate their emotions in the short term. the effect of a single bout of pe on affect has been the subject of two meta-analyses synthesizing the results of more than 150 studies totaling 13,000 adults in the general population (ekkekakis et al., 2011; reed & ones, 2006). these meta-analyses show that a single bout of pe significantly increases positive affect with a moderate effect size (d = 0.47) and that this effect is higher for individuals with a lower initial level of positive affect (d = 0.63). additionally, self-selected exercise intensity is more effective in increasing positive affect than an imposed intensity. the effects were moderated by cardiovascular capacity, obesity, and exhaustion tolerance (ekkekakis et al., 2011). similar results but with higher effect sizes have been demonstrated in adults with generalized anxiety disorder (d = 1.01; physical exercise and affects in bpd 2 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ herring et al., 2019), major depressive disorder (d = 1.25; meyer, koltyn, et al., 2016) and obsessive-compulsive disorder (d = 0.76; abrantes et al., 2009). another study (stanton et al., 2016) also measured the effect of a 20-minute pe session on core affect (valence and arousal) in individuals with anxiety, bipolar, and depressive disorders and reported an increase in arousal for individuals with depressive and bipolar disorders, and an increase in valence (more positive affect) across all participants. when studying the impact of pe on affect (bernstein & mcnally, 2017a, 2017b, 2018), researchers often experimentally induce an emotion to produce similar levels of affect across participants before exercising, or to modify affect after exercising (barrett et al., 2007; barrett & bliss‐moreau, 2009; kuppens et al., 2013; posner et al., 2005). different strategies are used to induce negative emotions, including frustrating tasks (gratz et al., 2006; sauer & baer, 2012), electric shocks (seibert-hatalsky & wilson, 2011), videos of sexual abuse or domestic violence (chapman et al., 2010; daros, williams, et al., 2018; elices et al., 2012; jacob et al., 2011), remembering negative memories (sauer & baer, 2012), music (diedrich et al., 2016) or emotionally charged images (sloan et al., 2010). of these approaches, presenting videos that induce negative emotions has been shown to be the easiest, most acceptable, and most frequently used strategy (for a review, see gilet, 2008). to our knowledge and according to two recent reviews (hall et al., 2019; mehren et al., 2020; st-amour et al., 2021), no study has yet examined the acute effects of pe on negative affect in bpd. in the present pilot study, our goal was to assess the acceptability and safety of a single session of 20 minutes of pe and quantify the effect size of the impact of such an intervention on core affect (valence and arousal) in patients with bpd following a negative emotion induction, compared to a control condition. we hypothesized that the pe session would be well accepted by the participants and that no adverse effects would be attributed by the participants to the pe condition. based on the research conducted on participants drawn from the general population and those with psychiatric disorders, we additionally hypothesized that the pe condition would increase the valence and decrease the arousal of their core affect with a moderate effect size after the negative emotion induction procedure. m e t h o d participants patients from the relational and personality disorders service from the mental health university institute of montreal gave their consent to their healthcare professionals to be contacted for research. thereafter, healthcare professionals referred patients to research­ ers based on their established bpd diagnosis. researchers then contacted patients by st-amour, cailhol, ruocco, & bernard 3 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ phone and/or email and planned an appointment after a short screening of inclusion and exclusion criteria. to be included in the study, participants were required to meet the following criteria: 18 years or older; previously diagnosed with bpd by two convergent psychological measures—borderline personality questionnaire (larivière et al., 2021) and structured clinical interview for dsm-iv axis ii disorders (bpd interview; lobbestael et al., 2011)— by a psychiatrist from the relational and personality disorders service from the mental health university institute of montreal; outpatient status at the mental health university institute of montreal; physically inactive (i.e., engaging in less than 150 minutes of physical activity weekly as measured with the simple physical activity questionnaire [simpaq]; rosenbaum et al., 2020); and have a sufficient written and oral comprehen­ sion of french for the completion of the study. participants were excluded if they had an active psychotic episode, a functional limitation preventing them from using a stationary bicycle, or a severe substance use disorder other than tobacco and cannabis. since active individuals in general population seem to better regulate their negative affects (bernstein et al., 2019), by recruiting inactive individuals only, we isolated the acute effect of pe from its chronic effect. all participants gave their informed consent by reading and signing a consent form. the research protocol was approved by the ethics board committee from the university integrated center of health and social services of montreal. participants were given $50 cad compensation at the end of the protocol. safety and acceptability at the end of the pe session, the participants reported how they felt and were asked to call or write to the research assistant to report any adverse effects that may have occurred in the following days. at the end of the session, the researcher asked each participant: “how did you feel about the physical exercise you just did?” the answer to this question was written on the participant’s results sheet. the psychiatrist from the mental health university institute of montreal (co-investigator in this study) who referred the participants was asked to report any adverse effects he noticed with his patients to the rest of the research team. baseline measures upon completion of the consent form, participants filled out questionnaires about socio­ demographic, physical activity, and mental health information. the sociodemographic questionnaire included questions on sex, age, education level, marital status, height, weight, household income, psychiatric history, and current medications. additional measures were used to assess physical activity, depression, bpd, and substance use symptoms. the simpaq is a validated five-item physical activity questionnaire for use physical exercise and affects in bpd 4 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ with adults with severe mental health disorders with good reliability, although it has not been validated in adults with bpd (rosenbaum et al., 2020). the beck depression invento­ ry-short form (bdi-sf) is a 13-item questionnaire that provides a rating of depression symptom severity (steer et al., 1997) and has been used in adults with bpd (hasler et al., 2014). for each item, answers are rated using a score from 0 to 3, producing a total score ranging from 0 to 39, with a score over 9 indicating a risk of moderate-to-severe depressive episode (furlanetto et al., 2005). this questionnaire has been thoroughly validated in adults with psychiatric illness with cronbach’s α ranging from 0.83 to 0.96; however, the measure has not been validated specifically in adults with bpd (wang & gorenstein, 2013). the short form of the borderline symptom list (bsl-23) is a self-rating scale that assesses the severity of bpd symptoms and has been validated in adults with bpd, with a cronbach’s α of 0.94 (nicastro et al., 2016). each item is answered on a 5-point likert scale ranging from 0 to 4, generating a total score ranging from 0 to 92. the questionnaire instructions were adapted in our protocol: participants self-reported their symptom severity for the day preceding the study and not the previous month (note that the validity of this form has not been tested). since there is a high prevalence of substance use disorder in adults with bpd (kienast et al., 2014) and substance use is linked to less pe (abrantes & blevins, 2019; lisano et al., 2018; martens et al., 2006; werneck et al., 2019), three questionnaires were administered to assess substance use in our sample. the cigarette dependence scale (cds) evaluates cigarette addiction with 5 items answered on a 5-point likert scale from 1 to 5. a global score of at least 16 indicates addiction. this questionnaire has been validated with individuals with bpd with a cronbach’s α of 0.89 (etter et al., 2009). the cannabis abuse screening test (cast) is a 6-item questionnaire assessing cannabis use (legleye et al., 2007). a score of at least 3 is associated with a problematic use risk. the questionnaire has good validity (cronbach’s α = 0.81) but has not been specifically validated in adults with bpd. the alcohol use disorder identification test (audit) short form (3-item) was used to assess risk for alcohol use disorder. a score of at least 3 for women and 4 for men indicates a high risk of alcohol use disorder. this questionnaire has been validated in adults with personality disorders with an estimated sensitivity of 87.1% (dawson et al., 2005). the difficulties in emotion regulation scale (ders) is a 36-item questionnaire that was used to measure different aspects of emotion regulation difficulties. each item is answered on a 5-point likert scale ranging from 1 to 5, with the total score of the questionnaire ranging from 36 to 180. the ders has been validated in individuals with bpd with a cronbach’s α of 0.94 (côté et al., 2013). we used four items from the dimensions of openness to emotions (doe-it) questionnaire, with each item representing an emotion regulation strategy regrouped into two categories: relaxation and physical activation. for these four items, participants were asked to report how frequently they engaged in the strategy, and to what extent the strategy was effective (or how effective st-amour, cailhol, ruocco, & bernard 5 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ they think it would be) on two 5-point likert scales from 0 to 4. the four items were: “1-listen to music corresponding to my affective state (e.g., that soothes me when i’m anxious or wakes me when i’m asleep); 2-let the different feelings, impressions or noises act on me without directing them; 3-let all the impressions and sensations go as they are; 4-get physically active, move, walk a few steps.” the original full questionnaire has been validated with adults with bpd with cronbach’s α ranging from 0.67 to 0.83, depending on the subscales (haymoz & reicherts, 2015). experimental procedure figure 1 describes the experimental procedure, including the administration of the ques­ tionnaires, negative emotion induction, and randomization to experimental conditions. participants attended the session individually between 4p.m. and 6p.m. participants were not instructed to refrain from using psychotropic substances (coffee, tobacco, cannabis, etc.) before the experiment. in the negative mood induction procedure, participants watched a scene lasting 3 minutes and 30 seconds from the movie silence of the lambs showing a pursuit in a dark and dirty basement. this movie clip has been shown to induce negative emotions in adults with bpd (chapman et al., 2010; kuo & linehan, 2009). after the scene, participants were randomized with a heads or tails phone app to a condition, either 20 minutes of pe or an emotionally neutral video of 20 minutes (control). fourteen participants were randomized to each condition. the pe session consisted of 20 minutes of stationary bicycle (life fitness life cycle 9500hr recumbent bicycle). participants were instructed to cycle at an intensity they can maintain with pleasure for 20 minutes (meyer, ellingson, et al., 2016). they were also suggested the target of 11-13 on the borg scale (borg, 1998), which was used to measure pe intensity, to help them find a low-moderate intensity in which they could be comfortable. the borg scale ranges from 6 to 20 and includes visual cues to help participants rate their pe intensity. participants were allowed to change the load and cycling speed at will to maintain the desired intensity. there was no practice run and the participants did not receive any encouragement through the session, but they were supervised by a member of the research team in case they needed something or had a problem. the control condition consisted of the first 20 minutes of the movie baraka, which has been validated to be emotionally neutral (liu & mcnally, 2017). this is a video documentary showing images of landscapes, people, and cultural rituals from around the world, with a soothing musical background and without dialogue or commentaries. physical exercise and affects in bpd 6 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ figure 1 research protocol schema note. negative emotion induction was presented after baseline questionnaires but before randomization to unify participants’ affects before the protocol. time of the measurements is indicated in minutes from the beginning of the protocol between the boxes representing both groups. affect measurement an experimental procedure was implemented to induce a state of negative affect, which is a common approach in affective science research (barrett et al., 2007; barrett & bliss‐moreau, 2009; kuppens et al., 2013; posner et al., 2005). consequently, core affect was selected as the main outcome of our study. core affect refers to any mental state of pleasure or displeasure with a degree of arousal (russell, 2003). the properties of core affect (i.e., pleasure/displeasure and arousal) are brain representations of changes in autonomic and hormonal systems of the body and regulation efforts (barrett, 2009; ekkekakis, 2013; kuppens et al., 2013), and are continuously changing over time. core affect was measured before and after the induction procedure, at the beginning of the experiment, at 5, 10 and 15 minutes into the experiment, and again at the end of each experimental condition, using two 11-point analog scales for a total of 7 measurements. the feeling scale (fs; hardy & rejeski, 1989) was used to measure affective valence (positive or negative). the instructions were to “estimate how good or bad you feel right st-amour, cailhol, ruocco, & bernard 7 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ now.” anchors are provided at 0 (neutral) and odd integers, ranging from -5 (very bad) to +5 (very good). the felt arousal scale (fas; svebak & murgatroyd, 1985) was used to measure arousal. it ranges from 1 to 6 with half points. the instructions were to “estimate how aroused you feel right now” (low arousal meaning calm or fatigued and high arousal meaning anxious or energized). anchors are provided at 1 (low arousal) and 6 (high arousal). the fs and fas items have been used in numerous studies, including with adults who have severe psychiatric illness (bernstein & mcnally, 2017b; edwards et al., 2018; herring et al., 2019; lebouthillier & asmundson, 2015; meyer, ellingson, et al., 2016; schuch et al., 2014), and are strongly correlated with the self-assessment manikin (unick et al., 2015). statistical analysis participants’ characteristics were compared between experimental conditions. quantita­ tive variables were compared between conditions using t-tests for gaussian variables (according to the shapiro-wilk test) and mann-whitney tests otherwise. fs scores were transformed by adding 5 to produce only positive scores for the analysis. fas scores were also transformed by multiplying them by 2 and subtracting 1 to create whole numbers only. a paired-samples t-test was used to examine the effects of the emotion induction. linear mixed effect models were fitted to examine the effects of acute pe on affective valence and arousal measures. participants were included as a random effect. all the prerequisites were met for conducting t-tests and linear mixed models. all statis­ tical analyses were carried out with r 4.0, and the nlme and ggplot2 packages (pinheiro & bates, 2006). data and analysis coding are available in open access in the open science framework account of the first author (https://osf.io/ncd6r/). post hoc achieved power analysis were carried out with g*power 3.1.9.7 (faul et al., 2007). r e s u l t s sample characteristics twenty-eight adults (21 women) with bpd participated in the study. they were aged 19 to 56 with a mean of 36.8 (sd = 11.5). sixteen participants were considered smokers (8 in each group) and 19 cannabis users (9 in the pe group and 10 in the control group). after randomization, our control group had a significantly lower household income, χ2(4) = 15.6, p = .004, and higher ders, t(25) = 2.42, d = 0.93, p = .023, score than the pe group. participant characteristics are reported in table 1. physical exercise and affects in bpd 8 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://osf.io/ncd6r/ https://www.psychopen.eu/ table 1 sample characteristics at baseline variables pe (n = 14) control (n = 14) age (sd) 37.29 (10.79) 36.35 (12.51) female (male) 8 (5) 13 (1) marital status single/divorced/widow 11 12 married 3 2 body mass index (sd) 32.75 (10.26) 26.37 (6.83) antidepressant user 9 6 antipsychotic user 6 9 other psychotropic user 4 4 education elementary school 3 4 high school 2 1 professional school 5 6 college 3 3 university 1 0 household income* < 20,000$ 0 7 20,000$-39,999$ 11 4 40,000$-59,999 0 3 60,000$ and over 1 0 do not know 2 0 bdi score (sd) 14.15 (6.91) 16.46 (5.11) min 1 9 max 26 26 bsl-23 score (sd) 20.69 (16.26) 25.46 (17.55) min 5 0 max 54 58 ders score (sd)* 103.08 (29.49) 122.92 (15.54) min 50 97 max 137 164 doe-it 1listen to music frequency (sd) 3.00 (1.18) 2.71 (1.44) efficiency (sd) 3.00 (1.04) 2.46 (1.13) 2let the feeling act on me frequency (sd) 1.36 (1.45) 1.86 (1.29) efficiency (sd) 1.57 (1.40) 2.23 (0.73) st-amour, cailhol, ruocco, & bernard 9 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ variables pe (n = 14) control (n = 14) 3let the feeling go frequency (sd) 1.07 (1.27) 1.50 (1.35) efficiency (sd) 1.36 (1.45) 1.62 (1.26) 4get physically active frequency (sd) 2.14 (1.23) 2.57 (1.34) efficiency (sd) 2.50 (1.29) 3.08 (0.76) cds score/smokers (sd) 16.13 (1.25) 15.63 (1.51) cast score/cannabis users (sd) 15.00 (6.61) 14.00 (6.88) audit score (sd) 6.15 (3.11) 6.00 (2.48) note. bdi = beck depression inventory; bsl-23 = borderline symptoms list short version; ders = difficulties in emotional regulation scale; doe-it = dimension of openness to emotions; cds = cigarette dependence score; cast = cannabis abuse screening test; audit = alcohol use disorder identification test. *p < .05 when comparing both groups. safety and acceptability an adverse effect was reported in two participants. both participants attributed this adverse effect to the negative emotion induction procedure, which reportedly triggered psychotic symptoms (hallucinations and distress) in one participant, leading to a need for psychiatric care immediately after completion of the protocol. however, the data col­ lected for this participant was similar to those collected for other participants. therefore, we kept these data for analyses. it also reminded another participant of an aggression that person had reportedly experienced, which produced a drastic increase in the partici­ pant’s anxiety. it forced the participant to take a break at the 10-minute mark of the pe session and led the person to increase their alcohol consumption in the following week to a point where they sought emergency psychiatric care. given that the participant interrupted the experiment, that individual was excluded from our analyses of the effect of the pe session. on the other hand, there were no reported adverse effects related to either the pe or control condition in the days following the protocol. all participants responded to the question, “how did you feel about the physical exercise you just did?” with positive answers (felt great, made them feel good, enjoyed exercising, etc.). however, three participants also expressed a slight discomfort related to pe (exhaustion, muscular fatigue, breathlessness). mood induction the valence of affect was significantly more negative (fs) after (m = -0.36, sd = 2.59) the mood induction than before (m = 1.29, sd = 2.49), t(26) = 2.41, p = .023, d = 0.46, but the clip did not impact arousal (fas), t(26) = -1.79, p = .086. however, there were individual differences in these effects: the emotion induction succeeded in increasing negative physical exercise and affects in bpd 10 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ affect in 18 participants, whereas 10 participants reported no change or a decrease in negative affect. the fs and fas data for each participant from the emotion induction are presented in figures 2 and 3, respectively. figure 2 negative emotion induction’s effect on the feeling scale by participants note. spaghetti plot with each line representing a participant. the bold blue line indicates the mean value of affect surrounded by a darker gray area representing the confidence interval. figure 3 negative emotion induction’s effect on the felt arousal scale by participants note. spaghetti plot with each line representing a participant. the bold blue line indicates the mean value of arousal surrounded by a darker gray area representing the confidence interval. st-amour, cailhol, ruocco, & bernard 11 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ effects of pe on negative affect the level of negative affect (fs) decreased in our sample during the 20 minutes of our protocol, t(106) = 2.79, b = .45, d = .54, se = .16, p = .006. the post hoc power analysis revealed a power of 0.85. however, the pe session did not decrease negative affect more than the control condition over time, t(106) = -0.40, b = -.09, se = .22, d = -.07, p = .70, as shown in figure 4. the post hoc power analysis revealed a power of 0.07. the arousal (fas) did not change over time, t(106) = -0.31, b = 0.04, se = 0.15, d = 0.05, p = .80, and the pe and control groups were not significantly different, t(106) = 0.09, b = .02, se = .21, d = .01, p = .92, as shown in figure 5. the post hoc power analysis revealed a power of .08 and .05 respectively. however, some participants were observed almost sleeping while watching the control video. each participant presented different patterns of fs and fas and reacted differently in both groups (pe and control). figure 4 protocol's effect on the feeling scale by participants note. spaghetti plots with each curve representing a participant with a smooth representation of the group effect with confidence intervals of the curve. the bold blue line indicates the mean value of affect valence surrounded by a darker gray area representing the confidence interval. preand post video marks indicate evaluation before and after emotion induction. 0min through 20min marks indicate the time from the beginning of the condition (exercise or control). physical exercise and affects in bpd 12 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ figure 5 protocol's effect on the felt arousal scale by participants note. spaghetti plots with each curve representing a participant with a smooth representation of the group effect with confidence intervals of the curve. the bold blue line indicates the mean value of arousal surrounded by a darker gray area representing the confidence interval. preand post video marks indicate evaluation before and after emotion induction. 0min through 20min marks indicate the time from the beginning of the condition (exercise or control). d i s c u s s i o n this pilot study is the first to our knowledge to examine the acute effects of pe on nega­ tive affect in adults with bpd. we hypothesized that pe would be safe, well accepted, and more effective than an emotionally neutral film in decreasing negative affect and arousal. our findings show that pe is safe and well accepted, and participants in both conditions had a decrease in negative affect with a medium effect size, although the effect did not differ between the groups and arousal did not decrease during the protocol. however, the effects of pe on affect have been extensively studied and a meta-analysis shows its efficacy in increasing positive affect (ekkekakis et al., 2011). the absence of a difference between the groups in our study is therefore unexpected. moreover, we met many obstacles during this study that might explain the absence of group difference and therefore make it difficult to draw conclusion on our hypothesis. one of the main reasons why our results were not significant was because this pilot study was underpowered to detect group effect. indeed, the between-group analysis of affect valence difference had a power of .07 which is weak. according to the a priori analysis we made with the effect size we found, a sample size of 70 would have been st-amour, cailhol, ruocco, & bernard 13 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ sufficient to detect a significant group difference. however, because of the reasons detailed below, this effect size might be biased. despite the unanticipated findings, this experiment is useful and informative for future research investigating the acute effects of physical exercise on emotion regulation in bpd. first, no adverse effect was reported from the exercise sessions in this study, which indicates the safety of such an intervention. second, every participant declared having appreciated the pe session with few negative feelings or discomfort toward it. however, this acceptability measure might not be the most valid and might be subject to biases. third, the validated emotion induction procedure had unexpected effects. as reported by chapman et al. (2010) and kuo and linehan (2009), it increased the mean level of negative affect in our sample. however, for nearly half of our sample, it had no effect or decreased the participants’ negative affect, as they either liked the thriller kind of movie or recognized the scene as being part of a movie they liked, suggesting that other mood induction content should be considered for future research of this nature. according to rottenberg et al. (2018), non-response to mood induction is frequent and may affect the validity of a study. to avoid nonresponse, researchers might use multiple induction strategies at once, an instruction to strengthen the induction, or a longer induction. on the other hand, two participants reacted enough to the emotion induction such that they needed psychiatric care after the protocol. those incidents indicate that this strategy might not be the safest available to induce negative affect in patients with bpd or that comorbid disorders (such as psychotic disorder) or previous traumas should be considered when selecting an induction strategy. therefore, further research might attempt other induction strategies that better suit this population. for example, viewing negative emotional photos from the international affective picture set paired with negative emotionally charged music (lynn et al., 2012), reading emotionally charged sentences from the velten validated battery (velten, 1968), and/or vividly imag­ ine personal negative situations (especially those relevant to bpd, such as abandonment experiences) triggered by a verbal script (barnow et al., 2012). finally, the neutral video that served as a control had a meditative effect on participants. some participants were observed as almost sleeping while watching the video regardless of being probed every 5 minutes to rate their affect. some participants also reported they meditated or used mindfulness strategies while looking at the video. therefore, this control video might have had a meditating effect and effectively decreased the self-reported arousal level and increased the self-reported valence of affect. indeed, meditation and mindfulness have been found to reduce negative affect (goyal et al., 2014; sathyanarayanan et al., 2019) and is currently used in dialectic behavioral therapy (linehan, 2014) to help reduce negative affect. therefore, the control condition should not give participants the opportunity to use these techniques. for example, participants could be directed to do light stretching or articular warm-up for the same period as the pe session (oberste et physical exercise and affects in bpd 14 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ al., 2017). these results may be informative for researchers who are considering mood induction in experimental studies of pe in bpd. apart from the induction strategy and the control video, other factors might explain the absence of a difference between pe and the video in this study. the low physical activity level coupled with the high bmi of our sample might also be contributory. in a meta-analysis from ekkekakis and colleagues (2011), inactive obese individuals were more likely to feel negative affect at low pe intensity than active individuals during a single bout of pe. therefore, future research should investigate this effect in physically active individuals with bpd or with a bmi under 30. our findings resemble a previous investigation examining the effects of acute pe on core affect in adults with psychiatric illness (depressive disorder, bipolar disorder and anxiety disorder) using the fs and the fas (stanton et al., 2016). this study found a significant increase of valence only among participants with bipolar disorder or depres­ sive disorder but not anxiety disorder. furthermore, the pe session did not decrease the self-reported arousal level. therefore, we can conclude that pe’s impact on affect likely differs depending on the specific psychiatric disorder. emotion dysregulation is a component of all three of the disorders included in the stanton et al. study, as well as bpd, with the latter associated with more severe emotion dysregulation than the other disorders (gratz et al., 2016). therefore, we can believe that pe might influence affect in bpd as well. table 2 presents a set of potential solutions to overtake the main limitations encountered in our study to improve future studies. table 2 study limitations and potential improvements limitations suggestion heterogenous emotion induction (i.e., positive emotion following negative induction) three steps negative emotion induction (kuo et al., 2014): 1. listening to emotionally charged music while watching emotionally charged photographs; 2. reading emotionally charged sentences; 3. vividly imagine personal negative emotion triggered by verbal script previously prepared. meditative effect of control condition use of placebo exercise (ex., light stretching, articular warm-up, oberste et al., 2017) group discrepancy regarding household income and difficulties in emotion regulation recruit a larger sample to decrease group difference risk or combined with a stratified randomization technique possible missed affect change after the ending of the measurement continue affect measurement for a period after the intervention (i.e., +5, +10, + 15 minutes) st-amour, cailhol, ruocco, & bernard 15 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ limitations suggestion participants’ comorbid disorders were not reported accessing participants’ medical file to report comorbid disorders possible missed adverse effects adverse effects and safety should have been systematically assessed in the days following the investigation by calling participants directly possible invalid acceptability measure acceptability should have been measured using a validated questionnaire or a numerical scale to answer a single question to provide more information (rabin et al., 2009). sample size based on a simulation analysis, a future well-powered study should include a total of 70 participants to reach a power of > 80% (kumle et al., 2021) on the other hand, this research has many strengths. the main strength is that it is the first study to include individuals with bpd to study the effect of pe. also, the low to moderate pe intensity as self-selected by the participants optimizes pe benefits on affect (ekkekakis et al., 2011). moreover, we used core affect to assess physical activity effect on emotional feeling since it is known to be an effective way to characterize subjective feeling (ekkekakis, 2013). future studies should use better suited negative emotion induction for adults with bpd (e.g., velten validated battery). other control strategies should also be used, such as light stretching or articular warm-up (lebouthillier & asmundson, 2015) considered as placebo pe. watching a pleasant video at the end of the protocol could be used to improve participants’ affective valence before they complete the study, improving the safety of the protocol (bernstein & mcnally, 2017a, 2017b, 2018). further work may study the impact of pe on affect in adults with bpd with ecological momentary assessments, which has been shown to be an efficient way to evaluate rapidly evolving phenomena in bpd (santangelo et al., 2014). for example, the study of affect over a day after a pe session could elucidate the emotion regulation dynamics following pe. other types, durations, and intensities of pe should also be tested, as these are all possible factors that might influence the affective response to pe (ekkekakis et al., 2011). finally, future exercise studies might evaluate the blood level of brain-derived neurotropic factor to measure the potential mediating role of this biomarker on affect in this population. physical exercise and affects in bpd 16 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ funding: the funding to carry this study has been given by the fond de recherche du québec – santé, and the fondation de l'institut universitaire en santé mentale de montréal. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @sstamour23, @paquitobernard data availability: for this article, a data set is freely available (st-amour et al., 2021). s u p p l e m e n t a r y m a t e r i a l s data and analysis coding are available in open access in the open science framework account of the first author (for access see index of supplementary materials below). index of supplementary materials st-amour, s., cailhol, l., ruocco, a. c., & bernard, p. 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and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. physical exercise and affects in bpd 24 clinical psychology in europe 2022, vol. 4(2), article e7495 https://doi.org/10.32872/cpe.7495 https://www.psychopen.eu/ physical exercise and affects in bpd (introduction) method participants safety and acceptability baseline measures experimental procedure affect measurement statistical analysis results sample characteristics safety and acceptability mood induction effects of pe on negative affect discussion (additional information) funding acknowledgments competing interests twitter accounts data availability supplementary materials references the role of expectancy violation in extinction learning: a two-day online fear conditioning study research articles the role of expectancy violation in extinction learning: a two-day online fear conditioning study daniel gromer 1 , lea k. hildebrandt 1 , yannik stegmann 1 [1] department of psychology, university of würzburg, würzburg, germany. clinical psychology in europe, 2023, vol. 5(2), article e9627, https://doi.org/10.32872/cpe.9627 received: 2022-06-03 • accepted: 2023-04-03 • published (vor): 2023-06-29 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: daniel gromer, department of psychology, marcusstraße 9-11, 97070 würzburg, germany. phone: +49 931 31-80030. fax: +49 931 31-80030-0. e-mail: daniel.gromer@uni-wuerzburg.de supplementary materials: data, materials, preregistration [see index of supplementary materials] abstract background: exposure therapy is at the core of the treatment of pathological anxiety. while the inhibitory learning model proposes a framework for the mechanisms underlying exposure therapy, in particular expectancy violation, causal evidence for its assumptions remains elusive. therefore, the aim of the current study was to provide evidence for the influence of expectancy violation on extinction retention by manipulating the magnitude of expectancy violation during extinction learning. method: in total, 101 individuals completed a web-based fear conditioning protocol, consisting of a fear acquisition and extinction phase, as well as a spontaneous recovery and fear reinstatement test 24h later. to experimentally manipulate expectancy violation, participants were presented only with states of the conditioned stimulus that either weakly or strongly predicted the aversive outcome. consequently, the absence of any aversive outcomes in the extinction phase resulted in low or high expectancy violation, respectively. results: we found successful fear acquisition and manipulation of expectancy violation, which was associated with reduced threat ratings for the high compared to the low expectancy violation group directly after extinction learning. on day 2, inhibitory cs-nous associations could be retrieved for expectancy ratings, whereas there were no substantial group differences for threat ratings. conclusion: these findings indicate that the magnitude of expectancy violation is related to the retrieval of conscious threat expectancies, but it is unclear how these changes translate to affective components (i.e., threat ratings) of the fear response and to symptoms of pathological anxiety. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9627&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0002-8619-7478 https://orcid.org/0000-0002-5513-3893 https://orcid.org/0000-0002-0933-8492 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords fear, anxiety, exposure therapy, inhibitory learning, expectancy violation, fear conditioning highlights • causal evidence for expectancy violation as a key mechanism of exposure therapy is sparse. • the current study experimentally manipulates the magnitude of expectancy violation. • high expectancy violation promotes extinction retention for threat expectancy ratings. • affective components of the fear response were not affected by expectancy violation. exposure therapy is considered the gold standard for the treatment of a variety of mental disorders, particularly anxiety disorders (hofmann & smits, 2008; norton & price, 2007). exposure-based interventions focus on repeated confrontations with the fearful object or situation, which typically results in fear extinction characterized as the reduction in fear responses (e.g., behavioral avoidance, physiological arousal, subjective feelings of fear) over time. there is unanimous evidence for the effectiveness of exposure therapy for the treatment of anxiety disorders (butler et al., 2006; carpenter et al., 2018; hofmann & smits, 2008; norton & price, 2007). yet, there is a considerable amount of patients, who do not profit from treatment, which is reflected in high rates of nonresponding and relapse (ali et al., 2017; arch & craske, 2009, 2011; taylor et al., 2012). the main obstacle to increasing the effectiveness of exposure-based interventions is that the underlying mechanisms are not yet fully understood (cooper et al., 2017; craske et al., 2008; craske et al., 2014). the inhibitory learning model suggests extinction learning as a key mechanism underlying exposure-based interventions resulting from a discrepancy between the con­ scious expectancy of an aversive event and its omission (craske et al., 2014; craske et al., 2022; rescorla & wagner, 1972). instead of erasing the original stimulus-harm associ­ ation, the omission of the expected aversive outcome (expectancy violation) is assumed to generate a new associative memory trace between the stimulus and the absence of harm, which is thought to exert an inhibitory influence on the original stimulus-harm association (bouton, 1993; bouton & king, 1983; quirk & mueller, 2008). see figure 1 for a graphical summary of the processes underlying the inhibitory learning model. to take advantage of inhibitory learning and expectancy violation during therapy, patients should become aware of their expectations for the upcoming exposure session and focus on the discrepancy between the expected and the actual outcome during exposure. in summary, the inhibitory learning model predicts that the strength of expectancy violation is positively related to symptom reduction and thus to the outcome of exposure therapy (craske et al., 2014; craske et al., 2022). the role of expectancy violation in extinction 2 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ figure 1 overview of the inhibitory learning model note. the exposure to a conditioned stimulus (cs, e.g., a dog), associated with an unconditioned stimulus (csus association, e.g., getting bitten), triggers the expectation of an aversive outcome (us-expectancy, e.g., getting bitten again). during therapy, patients are exposed to the cs, while the expected aversive outcome is omitted (expectancy violation, e.g., the patient was not attacked by the dog), giving rise to a new cs-nous memory trace, which is able to inhibit the original cs-us association. until now, although the inhibitory learning model provides a plausible mechanistic explanation for extinction, studies demonstrating unanimous evidence in support of the role of expectancy violation for positive treatment outcomes are sparse (craske et al., 2022). while recent models provide a comprehensive framework for studying the mech­ anisms underlying expectancy violation (panitz et al., 2021), more research is needed that specifically tests the key mechanisms of the inhibitory learning model. to address this issue, pavlovian fear conditioning protocols are well suited to examine changes in threat expectancy and thus allow to experimentally test the prediction of the inhibitory learning model that expectancy violation leads to enhanced fear extinction. in fear condi­ tioning paradigms, one conditioned stimulus (cs+) is repeatedly paired with an aversive event (us), resulting in a cs-us association (pavlov, 1927). during the following extinc­ tion phase, us delivery is usually omitted to generate a second cs-nous association. at a later timepoint, the spontaneous recovery of the cs-us and cs-nous associations can be tested by re-presenting the cs, while reinstatement of conditioned fear is usually tested by repeating the cs after an us presentation. using fear conditioning paradigms, extinc­ tion learning has been associated with the activation of inhibitory circuits including the ventromedial prefrontal cortex (vmpfc), potentially reflecting the neural correlate of the inhibitory influence of the cs-nous association on the original cs-us association (milad & quirk, 2012). however, how the extent of expectancy violation relates to the inhibitory influence of the cs-nous association is less well understood. for example, brown et al. (2017) investigated the relationship between expectancy violation and extinction retention, i.e., the persistent extinction at a follow-up reinstatement test. the authors demonstrated that the variation in us-expectancy during extinction learning, rather than gromer, hildebrandt, & stegmann 3 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ the decline in subjective or psychophysiological fear responding, predicted extinction retention at a follow-up test. these results provide correlational evidence for the role of expectancy violation in extinction learning. importantly, variation in us-expectancy during extinction as an index for expectancy violation only predicted us-expectancy ratings but not subjective fear or facial emg at the reinstatement test. in another fear conditioning study by scheveneels, boddez, vervliet, et al. (2019) a hierarchical extinction (i.e., presenting stimuli that increasingly signal the us with an incrementally increasing probability) was compared to a random extinction. although random extinction led to more expectancy violation during extinction, this did not result in improved cs-discrimi­ nation at a follow-up test. however, across groups, the amount of expectancy violation and the variability in us-expectancy during extinction were both positively associated with cs-discrimination at the follow-up test. in addition, findings of clinical (analogue) studies testing the relevance of expectancy violation are also mixed. while some studies support the role of expectancy violation during exposure therapy (guzick et al., 2020; salkovskis et al., 2007) others report no association between expectancy violation and therapy outcome (blakey et al., 2019; de kleine et al., 2017; raes et al., 2011; scheveneels, boddez, van daele, et al., 2019). most of these studies, however, used correlational designs: expectancy violation was measured by asking participants for their subjective ratings. while these correlational designs can be useful for detecting relationships, correlation does not imply causation – which is a prerequisite to interpret these relationships mechanistically. to demonstrate its impact on extinction learning, it is thus necessary to manipulate expectancy violation systematically. therefore, the goal of the current study is to experimentally test the influence of expectancy violation on extinction retention. specifically, we expected that increased expectancy violation during fear extinction leads to a) lower threat ratings towards the conditioned stimulus directly after extinction, and lower threat ratings and lower us-expectancy b) at a spontaneous recovery test as well as c) at a reinstatement test on the day following fear extinction. we used a web-based fear conditioning protocol in which participants are divided into two groups. during extinction, the high expectancy violation (he) group sees only the states of the cs that are strongly associated with an us. thus, a strong expectancy violation is possible. in contrast, the low expectancy violation (le) group is presented only with the cs states that are weakly related to the us. therefore, the magnitude of expectancy violation is minimized. furthermore, in the current study, we exploit the benefits of conducting a fear conditioning paradigm remotely. recent evidence suggests that fear conditioning data can be economically collected outside of the laboratory context (mcgregor et al., 2021; purves et al., 2019; stegmann et al., 2021; wise & dolan, 2020), providing a unique opportunity to draw on a larger and more diverse participant pool. the role of expectancy violation in extinction 4 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ m e t h o d all hypotheses and methods of this study were preregistered at https://osf.io/7bgtv subjects in total, 127 individuals completed the web-based paradigm. participants had to be at least 18 years and were excluded if they were classified as non-learners (i.e., if they reported higher us-expectancy ratings for the least reinforced conditioned size compared to the most reinforced conditioned size; n = 22) or if they admitted to having muted their computer audio during the main task (n = 1) or rated the volume of the us with zero (i.e., total silence, n = 3). after exclusion, complete datasets of 101 participants (77 females) with a mean age of 21.8  ±  4.3 years remained for analyses. all experimental procedures were approved by the ethics committee of the department of psychology at the university of würzburg. procedures were in agreement with the declaration of helsinki. all participants provided informed consent online. they received either course credits or could join a lottery for one of five 50€ coupons as compensation. stimuli and materials the cs consisted of a light grey sphere, which was centrally presented on a dark grey background. to manipulate threat imminence, the size of the cs varied between the baseline size of either 1.25% or 26.25% and eight potential final sizes (5%, 7.5%, 10%, 12.5%, 15%, 17.5%, 20%, and 22.5%) relative to the participant’s screen size. the stimulus size inor decreased from the baseline to the final size, resulting in a visual 3d effect of an approaching/receding sphere. to enhance this effect, two circular lines with a radius of 15% and 22.5% were displayed. the us was a female scream with a duration of 2.5 s (maderadeleste films, 2011). at the beginning of the experiment, participants had to adjust the volume of their computer using a pleasant example melody (frei, 2020) so that it was perceived as 5 on a scale from 0 (absolute silence) to 10 (unbearable volume). the setting was to be maintained during the experiment. after the main experiment, participants were asked to rate the loudness of the scream using the same scale. there was no difference in perceived loudness among groups, f(3, 97) = 1.26, p = .292 (see figure 2). design and procedure day 1: after giving informed consent, participants completed german versions of a demographic questionnaire and the anxiety sensitivity index-3 (asi-3; kemper et al., 2009; taylor et al., 2007), using an online survey platform (www.formr.org, arslan et al., 2020). they were then redirected to www.pavlovia.org, where the main experiment took place (peirce, 2007). the conditioning protocol on day 1 consisted of a habituation, gromer, hildebrandt, & stegmann 5 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://osf.io/7bgtv http://www.formr.org http://www.pavlovia.org https://www.psychopen.eu/ acquisition, and extinction phase (see figure 3). during habituation, each cs level was presented once. each trial started with the presentation of the baseline-sized cs (either 1.25% or 26.25% relative to the participant’s screen). after 0.8 – 1.3 s, the cs started to become larger/smaller (with a median rate of 6.8% per s) until it reached one of the 8 final sizes (5%, 7.5%, 10%, 12.5%, 15%, 17.5%, 20%, and 22.5%). once reaching its final size, the cs returned to its baseline size with the same velocity. since we expected that larger, approaching stimuli are perceived as inherently more threatening (coker-appiah et al., 2013), the cs for one half of the participants started at its smallest size and became larger (baseline size: 1.25%; cs level 1: 5% – cs level 8: 22.5%; approaching cs group), whereas the cs for the other half started at its largest size and became smaller (baseline size: 26.25%; cs level 1: 22.5% – cs level 8: 5%; receding cs group). during acquisition, each cs level was presented five times (40 total trials) in a randomized order with the following conditions: no cs level should be presented three times in a row and the us should not be presented three times in a row. in each trial, when the stimulus had reached its final size, participants were asked to rate how much they expected the us on a visual analog scale from 0 ("very unlikely") to 100 ("very likely"). subsequently, the us were presented according to the following pattern: no us were presented at cs level 1 (0% reinforcement rate; rr), one us was presented at cs levels 2 and 3 (20% rr), two us were presented at cs levels 4 and 5 (40% rr), three us figure 2 rain cloud plot of the perceived volume of the us asked at the end of day 2 note. code based on allen et al. (2021). it should be noted that one participant in the he group gave a loudness rating of 2. in order to avoid arbitrary post-hoc cut-offs, we decided not to exclude this outlier from the analyses. however, in exploratory re-analyses, excluding this participant did not change our results. the role of expectancy violation in extinction 6 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ were presented at cs levels 6 and 7 (60% rr), and four us were presented at cs level 8 (80% rr). the trial ended with the cs returning to its baseline size. figure 3 (a) summary of the experimental procedure and (b) description of the trial structure note. (a) on day 1, participants were divided into the receding (rec) and approaching (app) cs groups, before undergoing a habituation (hab) and fear acquisition phase (acq). in the subsequent extinction phase (ext), participants were again divided into two groups. to experimentally manipulate the extent of expectancy violation, one group (low expectancy violation; le group) was presented only with the cs levels associated with low us likelihoods (cs levels 1 – 4), whereas the other group (high expectancy violation; he group) saw only the cs levels associated with high us likelihoods (cs levels 5 – 8). on day 2, all participants completed a spontaneous recovery (spont rec) and reinstatement (reinst) test. threat ratings were collected for each cs level after each phase on day 1. on day 2, threat ratings for each cs level in each phase were collected directly after the expectancy rating for the respective cs level. (b) each trial started with the presentation of the baseline-sized cs (smallest size for the approaching groups or largest size for the receding groups). after 0.8 – 1.3 s, the cs started to become larger/smaller until it reached one of the 8 final sizes. once reaching its final size, participants were asked to rate the likelihood of being presented with an us (us expectancy rating). during acquisition, us were then presented according to the specific reinforcement rate related to the cs level before the cs returned to its baseline size. note, that no us expectancy ratings were collected during habituation. in the habituation, spontaneous recovery, and reinstatement phases, the cs reached each final size once, while in acquisition it reached each final size five times. in extinction, each of the group's four final sizes were reached ten times. gromer, hildebrandt, & stegmann 7 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ in the subsequent extinction phase, participants were again divided into two groups. to experimentally manipulate the extent of expectancy violation, one group (low expect­ ancy violation; le group) was presented only with the cs levels associated with low us likelihoods (cs levels 1 – 4), whereas the other group (high expectancy violation; he group) saw only the cs levels associated with high us likelihoods (cs levels 5 – 8). each respective cs level was presented 10 times (40 trials in total). importantly, no us was administered during the extinction phase and participants received no instruction about the cs-us contingencies. day 2: in the morning of the following day, participants received an email containing the hyperlink for the second part of the main experiment, consisting of spontaneous recovery and reinstatement test. at the beginning, participants were asked to re-adjust the volume of their computer. to test for spontaneous recovery, each cs level was presented once while online us-expectancy ratings were collected as described above. for the subsequent reinstatement test, a single us was delivered before each cs level was presented again. in addition to the online us-expectancy ratings, participants were asked to rate the perceived threat (“how threatening do you perceive this stimulus?”) for each cs level on a visual analogue scale from 0 (“very harmless”) to 100 (“very threatening”) after each phase (i.e., habituation, acquisition, extinction) and for spontaneous recovery and reinstatement. statistical analysis all statistical analyses were conducted with r 4.1.2 (r development core team, 2021). the afex package (singmann et al., 2020) was used for anova with type 3 sum of squares, the effectsize package (ben-shachar et al., 2020) was used to calculate omega squared (ω2), and the emmeans package (lenth, 2023) was used for simple contrasts. for acquisition, spontaneous recovery, and reinstatement, mean differences in threat and us-expectancy ratings were analyzed separately using 2 (expectancy violation: he vs le; between-subject factor) x 2 (cs direction: approaching vs receding; between-subject factor) x 8 (cs level: cs levels 1 – 8; within-subject factor) mixed anovas. threat ratings after habituation were analyzed using the identical procedure. significant main and interaction effects were followed-up with simple contrasts. to quantify the extent of expectancy violation, us-expectancy ratings obtained during the extinction phase were summarized analogous to scheveneels, boddez, vervliet, et al. (2019) and compared be­ tween groups using a 2 (expectancy violation: he vs le) x 2 (cs direction: approaching vs receding) anova. since the true probability of an us-occurrence during extinction was always zero, expectancy violation can be calculated as the trial-wise us-expectan­ cy ratings minus zero. thus, the sum of the us-expectancy ratings across individual trials yields the total value of expectancy violation. a significance level of .05 was used for all analyses and greenhouse–geisser correction was applied where appropriate the role of expectancy violation in extinction 8 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ (greenhouse & geisser, 1959). throughout this manuscript, we report corrected degrees of freedom, corrected p values and the omega squared (ω2). data and code for the reported analyses are available at https://osf.io/tg2fb/. r e s u l t s online expectancy ratings all results for us-expectancy ratings are illustrated in figure 4. the analysis of the last presentation of each stimulus in the acquisition phase demonstrated successful fear con­ ditioning as indexed by a significant main effect of cs level, f(5.73, 555.56) = 112.90, p < .001, ω2 = .44, indicating that participants expected the us more strongly with increasing threat imminence (larger physical sizes in the approaching cs groups, smaller physical sizes in the receding cs groups). in addition, there was a main effect of cs direction, f(1, 97) = 8.10, p = .005, ω2 = .07, which was further qualified by a significant interaction between cs level and cs direction, f(5.73, 555.56) = 2.57, p = .020, ω2 = .01. together, these results indicate higher us-expectancy ratings in the approaching compared to the receding cs groups, particularly, for the 6th, t(97) = 2.72, p = .008, and 7th level, t(97) = 3.84, p < .001, of cs level (all other levels, p’s > .050), suggesting that physical size interfered with acquisition learning, i.e., that larger physical sizes of an approaching cs are more readily associated with the occurrence of the us than smaller physical cs levels in the receding group. importantly, there were no differences between he and le groups, p’s > .259. during extinction training, the he group showed higher summarized us-expectancy ratings and thus stronger expectancy violation than the le group, f(1, 97) = 25.08, p < .001, ω2 = .19, implying a successful experimental manipulation of expectancy violation. on day 2 at the spontaneous recovery test, there was a main effect of cs level, f(2.97, 287.72) = 96.82, p < .001, ω2 = .35, demonstrating higher expectancy ratings with increasing threat imminence in all groups, while a significant cs level x expectancy vio­ lation interaction, f(2.97, 287.72) = 6.73, p < .001, ω2 = .03, indicates higher us-expectancy ratings and thus a stronger recovery of conditioned fear for le compared to he groups at the 7th: t(97) = 3.03, p = .003, and 8th: t(97) = 2.66, p = .009, cs levels (all other levels, p’s > .078). no effect of direction reached significance, p’s > .366. the us presentation at reinstatement did not substantially change these results. the main effect of cs level, f(3.08, 298.44) = 76.64, p < .001, ω2 = .29, and the cs level x expectancy violation interaction, f(3.08, 298.44) = 4.05, p = .007, ω2 = .02, remained significant. again, le compared to he groups reported higher expectancy ratings at the 6th: t(97) = 2.17, p = .032, 7th: t(97) = 2.47, p = .015, and 8th: t(97) = 2.05, p = .044, cs levels (all other levels, p’s > .167). no effect of direction reached significance, p’s > .161. gromer, hildebrandt, & stegmann 9 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://osf.io/tg2fb/ https://www.psychopen.eu/ threat ratings after habituation, the 2x2x8 anova for subjective threat ratings revealed a significant main effect of cs level, f(2.08, 201.70) = 10.10, p < .001, ω2 = .03. crucially, there was figure 4 us-expectancy ratings note. (a) summary of the us-expectancy ratings on single trial level for low (le) and high (he) expectancy violation groups, and each experimental phase (error bars indicate the standard error of the mean). (b) shows the same results separately for the approaching (app) and receding (rec) cs groups. conditioned stimulus level (cs level) corresponds to threat imminence, i.e., larger physical sizes for approaching cs groups and smaller physical sizes for receding cs groups. the role of expectancy violation in extinction 10 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ also a significant interaction between cs level and cs direction, f(2.08, 201.70) = 46.15, p < .001, ω2 = .12, indicating higher threat ratings for increasing cs levels (i.e., increasing sizes) in the approaching cs groups and higher threat ratings for decreasing cs levels (i.e., increasing sizes) in the receding cs groups (see figure 5). figure 5 threat ratings note. (a) summary of the threat ratings for low (le) and high (he) expectancy violation groups, and each experimental phase (error bars indicate the standard error of the mean). (b) shows the same results separately for the approaching (app) and receding (rec) cs groups. conditioned stimulus level (cs level) corresponds to threat imminence, i.e., larger physical sizes for approaching cs groups and smaller physical sizes for receding cs groups. gromer, hildebrandt, & stegmann 11 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ this result is in line with the notion that visual stimuli appear inherently more threaten­ ing with increasing physical size, i.e., lower cs levels in receding cs groups and higher cs levels in approaching cs groups. at the end of the acquisition phase, successful conditioning was indexed by a signif­ icant main effect of cs level, f(2.91, 282.23) = 92.07, p < .001, ω2 = .27. in addition, there was a cs direction x cs level interaction, f(2.91, 282.23) = 5.58, p = .001, ω2 = .02. taken together, these results demonstrate that participants perceived more threat with increasing threat imminence. yet, physical size of the cs still influenced threat ratings as indexed by slightly higher threat ratings in the approaching cs compared to the receding cs groups at the 4th: t(97) = 1.95, p = .055, 5th: t(97) = 1.98, p = .050, 6th: t(97) = 2.56, p = .012, 7th: t(97) = 2.45, p = .016, and 8th: t(97) = 1.81, p = .074, cs level. please note, that the 8th cs level was the largest physical size in the approaching cs group but the smallest physical size in the receding cs group. importantly, no differences between le and he groups were found, p’s > .610. directly after extinction, the effect of the expectancy violation manipulation was evi­ dent in a significant cs level x expectancy violation interaction, f(2.53, 245.24) = 12.42, p < .001, ω2 = .04, which could be retrieved in addition to main effects of expectancy violation, f(1, 97) = 6.18, p = .015,, ω2 = .05, and cs level, f(2.53, 245.24) = 58.70, p < .001, ω2 = .19. as illustrated in figure 5, the he groups reported lower threat ratings compared to the le groups at the 5th: t(97) = 2.45, p = .016, 6th: t(97) = 2.98, p = .004, 7th: t(97) = 3.78, p < .001, and 8th: t(97) = 3.95, p < .001, cs level, while there were no differences for smaller cs levels, p’s > .579. furthermore, we found no effect of cs direction, p’s > .521. to further analyze the effect of expectancy violation on threat ratings, we tested the differences between groups from acquisition to extinction. indeed, for the he group, we found a decrease in threat ratings for all cs levels, p’s < .003, except for the lowest level, t(48) = 1.62, p = .112, while threat ratings in the le groups decreased only for the four lowest (cs levels 1 – 4), p’s < .015, but not for the four highest levels (cs levels 5 – 8), p’s > .184, suggesting that participants in the le groups still perceived higher cs levels as threatening. for threat ratings at spontaneous recovery on day 2, the main effect of cs level, f(2.36, 229.23) = 54.61, p < .001, ω2 = .18, and the interaction between cs level and expectancy violation, f(2.36, 229.23) = 4.38, p = .009, ω2 = .01, remained significant. yet, simple contrasts revealed no significant differences between le and he groups at the individual cs levels, all p’s > .063. in addition, there was a cs level x cs direction interaction, f(2.36, 229.23) = 8.10, p < .001, ω2 = .03, indicating spontaneous recovery of the effect of physical size on threat ratings similar to the results of the habituation phase. together, these results suggest that the differential effect of expectancy violation on threat ratings did not persist until the second day of the study. to substantiate this finding, we also analyzed change scores between the end of acquisition and spontaneous recovery at the individual cs levels separately for the he and le groups. student’s the role of expectancy violation in extinction 12 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ t-tests revealed decreased threat ratings for cs levels 3 to 8 in the he groups, p’s < .029, and decreased threat ratings for cs levels 2 to 5 in the le groups, p’s < .018. a similar pattern of results could be obtained for threat ratings at the reinstatement test. main effects of cs direction, f(1, 97) = 5.31, p = .023, ω2 = .04, and cs level, f(2.08, 201.73) = 54.39, p < .001, ω2 = .18, were qualified by significant interactions between cs direction and cs level, f(2.08, 201.73) = 9.54, p < .001, ω2 = .03, as well as between cs level and expectancy violation, f(2.08, 201.73) = 3.68, p = .025, ω2 = .01. higher cs levels were generally associated with higher threat ratings, while physical size interfered with actual threat imminence similarly to the description above. again, simple contrasts revealed no significant differences between le and he groups at the individual cs levels, p’s > .079. d i s c u s s i o n the main goal of our study was to provide causal evidence for the influence of expect­ ancy violation on extinction retention. to this end, we employed a web-based fear conditioning protocol, in which we manipulated the magnitude of expectancy violation during the extinction learning phase. subjective threat and us-expectancy ratings were obtained throughout the acquisition and extinction phase on day 1, as well as during a spontaneous recovery and reinstatement test on day 2. in line with previous fear conditioning studies, our results showed successful fear acquisition and extinction for us-expectancy and threat ratings, indicating that partici­ pants learned the cs-us and cs-nous associations. consistent with our manipulation of expectancy violation, however, the he groups reported higher expectancy ratings than the le groups. because no us was presented during extinction, higher us-expectancy ratings also imply stronger expectancy violation, and according to the inhibitory learn­ ing model, stronger expectancy violation should have led to a stronger formation of the cs-nous association (craske et al., 2014; craske et al., 2022; scheveneels, boddez, vervliet, et al., 2019). as predicted by the inhibitory learning model, the he groups indeed reported lower subjective threat compared to the le groups at the end of the extinction phase on day 1, providing causal evidence for the notion that the strength of expectancy violation is related to the decline of subjective threat during fear extinction. on the second day, results for us-expectancy and threat ratings during the spontane­ ous recovery and reinstatement test were less conclusive. whereas reduced expectancy ratings, and thus, a stronger retrieval of the cs-nous association could be retrieved for the he compared to le groups, we found no substantial group differences for threat ratings. these findings indicate that the strength of expectancy violation did influence the extent of extinction retention, however, the effect was not as large as would have been expected according to the inhibitory learning model. this small effect might be due to extinction learning took place directly after fear acquisition and, therefore, might be gromer, hildebrandt, & stegmann 13 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ influenced by the immediate extinction deficit. the immediate extinction deficit refers to the phenomenon that extinction retrieval is impaired for shorter intervals compared to longer intervals (e.g., 24 hours) between initial fear acquisition and subsequent extinction training and has been previously demonstrated in rodent and human studies (chang et al., 2010; huff et al., 2009; maren, 2014; merz et al., 2016). however, it is important to mention that on day 2 we could retrieve the expected results for us-expectancy ratings, i.e., reduced us-expectancy ratings and thus a stronger retrieval of the cs-nous association for the high compared to low expectancy violation groups, as predicted by the inhibitory learning model. yet, the cs-nous association did not appear to inhibit the perceived threat. recently, it has been suggested that us-expectancy ratings are more likely to represent the conscious, cognitive component (boddez et al., 2013), whereas threat ratings are more likely to capture the affective component of the fear response (constantinou et al., 2021; lonsdorf et al., 2017). taken together, our results suggest that expectancy violation plays an important role in fear extinction, but it is unclear how it translates to changes in the affective component of the fear response. crucially, this finding is consistent with experience from clinical psychology and previous empirical findings. patients with anxiety disorders usually know that their fears are irrational and are aware that the probability of their feared event occurring is low (zimmerman et al., 2010). yet, they report intense affective reactions. in a similar line of thought, buchholz et al. (2022) compared treatment outcomes after exposure therapy following cognitive restructuring and vice versa. according to the inhibitory learning theory cognitive restructuring prior to exposure exercises should reduce threat expectancies and thus hinder expectancy violation. indeed, patients who received cogni­ tive restructuring before exposure showed a trend toward reduced expectancy ratings. however, contrary to the predictions of the inhibitory learning theory, the cognitive intervention did not attenuate the magnitude of change of expectancies due to exposure. in addition, the treatment outcomes of both groups were similar after treatment and at follow-up. in an analogous fear conditioning paradigm, scheveneels, boddez, de ceulaer, et al. (2019) instructed half of the participants before extinction that the probability of the us will be small, whereas the control group did not receive this information. according to the inhibitory learning theory, this safety information should attenuate inhibitory learning and thus lead to an increased return of fear. although participants in the informed group had a less pronounced decrease in us expectancies during extinction (which is consistent with the assumptions of the inhibitory learning model), it did not promote return of fear. on the contrary, the safety information reduced the return of fear compared to the control group. combined with the results of our current study, these findings underscore that the violation of conscious expectancies does not directly translate to the outcome of exposure therapy. in line with this, a recent therapy study (pittig et al., 2023) showed that not expectancy violation per se but rather how patients changed their threat expectancies after exposure exercises, calculated as pre-minus-postthe role of expectancy violation in extinction 14 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ exposure expectancy, i.e., “imagine repeating the same exposure practice. how likely is it that the aversive outcome will occur this time?” (craske et al., 2022), predicted treatment outcome. there are also some limitations that need to be discussed in the context of the current study. first, we found strong effects of cs direction. as expected, threat ratings after habituation revealed that cs physical size was associated with higher threat ratings, such that closer cs appeared generally more threatening. in line with preparedness theories of fear learning (coker-appiah et al., 2013; mineka & öhman, 2002; öhman & mineka, 2001), we also found that the cs direction interfered with fear conditioning, i.e., larger physical cs sizes were more readily associated with the occurrence of the us than smaller sizes during fear acquisition. importantly, the effect of cs direction on us-expectancy and threat ratings diminished during extinction learning. however, we found a strong return of this inherent fear in threat ratings during the spontaneous re­ covery and reinstatement test, suggesting that despite participants in the receding groups had learned that larger physical sizes indicated relative safety, they almost reverted to pre-acquisition threat levels, paralleling the difficulties in treating pathological forms of fear, as most anxiety disorders are rooted in evolutionarily prepared fears (e.g., fear of heights, spiders, snakes). it is also important to mention that this study was conducted remotely only, and therefore, we were not able to record physiological measures of the fear response. even though ratings are a valid and important measure of subjective threat perception (boddez et al., 2013), future studies should seek complementary evidence from physiological indices of defense system activation, such as cardiovascular or electrodermal activity (ojala & bach, 2020). in contrast to laboratory studies, we were not able to standardize us-intensities and had to rely on participants’ self-reported perceived loudness, which was collected at the end of day 2. based on these ratings and in combination with the us-expectancy ratings, we excluded participants who turned off their volume. neverthe­ less, the average us-intensity could be lower than in laboratory studies, and replications with offline samples are needed to ensure that effects remain consistent across different methods of stimulus delivery. importantly, when using a human scream as us, successful fear conditioning was already reported at us-intensities below 80 db (beaurenaut et al., 2020). in summary, the present web-based fear conditioning study demonstrated that exper­ imentally increasing the magnitude of expectancy violation increased extinction reten­ tion for us-expectancy ratings, but this did not affect subjective threat ratings on day 2. future studies need to further test the predictions of the inhibitory learning model, particularly how violation of conscious expectancies may translate to subjective feelings and symptoms of anxiety. this study provided a paradigm to experimentally target these processes. gromer, hildebrandt, & stegmann 15 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://www.psychopen.eu/ funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. ethics statement: all experimental procedures were approved by the ethics committee of the department of psychology at the university of würzburg. procedures were in agreement with the declaration of helsinki. twitter accounts: @leahilde, @yannikstegmann data availability: data and code for the analyses reported in this article are freely available (gromer, hildebrandt, & stegmann, 2023) s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • pre-registration protocol for all hypotheses and methods of the study • data and code for the analyses reported in this article index of supplementary materials gromer, d., hildebrandt, l. k., & stegmann, y. 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(2010). recognition of irrationality of fear and the diagnosis of social anxiety disorder and specific phobia in adults: implications for criteria revision in dsm-5. depression and anxiety, 27(11), 1044–1049. https://doi.org/10.1002/da.20716 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. gromer, hildebrandt, & stegmann 21 clinical psychology in europe 2023, vol. 5(2), article e9627 https://doi.org/10.32872/cpe.9627 https://cran.r-project.org/package=afex https://doi.org/10.1038/s41598-021-95200-6 https://doi.org/10.1016/j.janxdis.2012.02.010 https://doi.org/10.1037/1040-3590.19.2.176 https://doi.org/10.1038/s41467-020-17977-w https://doi.org/10.1002/da.20716 https://www.psychopen.eu/ the role of expectancy violation in extinction (introduction) method subjects stimuli and materials design and procedure statistical analysis results online expectancy ratings threat ratings discussion (additional information) funding acknowledgments competing interests ethics statement twitter accounts data availability supplementary materials references cognitive symptoms link anxiety and depression within a validation of the german state-trait inventory for cognitive and somatic anxiety (sticsa) research articles cognitive symptoms link anxiety and depression within a validation of the german state-trait inventory for cognitive and somatic anxiety (sticsa) rebecca overmeyer 1 , tanja endrass 1 [1] faculty of psychology, institute of clinical psychology and psychotherapy, chair for addiction research, technische universität dresden, dresden, germany. clinical psychology in europe, 2023, vol. 5(2), article e9753, https://doi.org/10.32872/cpe.9753 received: 2022-06-21 • accepted: 2023-05-07 • published (vor): 2023-06-29 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: rebecca overmeyer, technische universität dresden, institute of clinical psychology and psychotherapy, chair for addiction research, chemnitzer straße 46a, 01187 dresden, germany. tel.: +49 351 463 39720. e-mail: rebecca.overmeyer@tu-dresden.de supplementary materials: data, materials [see index of supplementary materials] abstract background: in the present study we aimed to develop a german version of the state-trait inventory for cognitive and somatic anxiety (sticsa) and evaluate the psychometric properties. associations of cognitive and somatic anxiety with other measures of anxiety, depression, and stress, elucidating possible underlying functional connections, were also examined, as symptoms of anxiety, depression and stress often overlap. method: two samples (n1 = 301; n2 = 303) were collected online and in the lab, respectively. dynamic connections between somatic and cognitive anxiety, other measures of anxiety, depression, and stress, were analyzed using a network approach. psychometric analyses were conducted using exploratory and confirmatory factor analyses. results: we replicated and validated the two-factorial structure of the sticsa with the german translation. network analyses revealed cognitive trait anxiety as the most central node, bridging anxiety and depression. somatic trait anxiety exhibited the highest discriminant validity for distinguishing anxiety from depression. conclusion: the central role of cognitive symptoms in these dynamic interactions suggests an overlap of these symptoms between anxiety and depression and that differential diagnostics should focus more on anxious somatic symptoms than on cognitive symptoms. the sticsa could therefore be useful in delineating differences between anxiety and depression and for differential this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9753&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0002-7336-7984 https://orcid.org/0000-0002-8845-8803 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ assessment of mood and anxiety symptoms. additional understanding of both cognitive and somatic aspects of anxiety might prove useful for therapeutic interventions. keywords questionnaire, anxiety, depression, somatic symptoms, cognitive symptoms highlights • cognitive symptoms link depression and anxiety within a network approach. • somatic symptoms exhibit high discriminant validity towards depression. • differentiating subcomponents of anxious symptoms may help differentiate anxiety and depression. • the german version of the sticsa is a reliable and valid measure of trait anxiety. anxiety disorders and depression are among the most prevalent mental disorders, are highly comorbid and cause a high burden of disease (bandelow & michaelis, 2015; leray et al., 2011; martin, 2003; michael et al., 2007). symptoms of anxiety, depression and stress often overlap (mineka et al., 1998) and identifying overlapping and distinctive fea­ tures of anxiety and depression is highly important (eysenck & fajkowska, 2018). anxi­ ety and depression are clearly not identical emotional states, but the high comorbidity rate and the diagnostic overlap point to common nonspecific features and mechanisms, that are also important for treatment (eysenck & fajkowska, 2018; marchetti et al., 2016). there is also evidence that anxiety and depression dynamically interact and may trigger each other (starr & davila, 2012a, 2012c). anxiety can be divided into state and trait anxiety (e.g. endler & kocovski, 2001). trait anxiety is a stable predisposition to experience anxiousness or to experience state anxiety frequently (spielberger, 1966). state anxiety is an anxiety experienced within a specific moment and varies significantly between individuals and is associated with the development of pathological anxiety when experienced more often and with high intensity (spielberger, 1966). many models describing anxiety emphasize the multidimen­ sionality of anxiety. this is particularly important when aiming for comprehensive assessment of anxiety and distinguishing anxiety from depression. dimensions include cognitive, physiological and behavioral aspects of anxiety (elwood et al., 2012). so far, established measures of anxiety rarely distinguish between cognitive and somatic dimen­ sions of anxiety. the cognitive somatic anxiety questionnaire (delmonte & ryan, 1983; schwartz et al., 1978) and the endler multidimensional anxiety scales (endler et al., 1991) both include scales on cognitive and somatic symptoms but exclusively focus on trait assessment. distinguishing between anxiety and depression requires examining the complex and multilayered facets of both syndromes (eysenck & fajkowska, 2018). several approaches examine anxiety and depression in a common theoretical framework. one approach cognitive symptoms link anxiety and depression 2 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ suggests that anxiety focuses on the future and depression on the past resulting in respective cognitive biases (eysenck et al., 2006; pomerantz & rose, 2014). however, there is evidence that worry and rumination differ in their effects on behavioral and physiological responses to every day events and stressors, and that there is not a specific link between anxiety and worry, or depression and rumination (kircanski et al., 2017; lewis et al., 2018). beck’s content-specificity hypothesis suggests that anxiety is marked by a focus on danger, and in depression by self-deprecation (beck, 1976; beck et al., 1987). lastly, the tripartite model of anxiety and depression posits that anxiety and depression share a component of underlying negative affectivity or distress but anxiety is additionally marked by physiological hyperarousal, whereas depression is additionally marked by low positive affectivity (clark, 2009; clark & watson, 1991). however, none of these approaches can fully capture the complexity of how anxiety and depression overlap, how they differ, and how they interact (eysenck & fajkowska, 2018). in addition, some of the established instruments for the assessment of anxiety exhibit low discriminant validity regarding depressive symptoms. for instance, the state-trait anxiety inventory (stai; spielberger et al., 1983) is almost exclusively used to assess state and trait anxiety, but recent findings suggest that the stai also assesses depressive symptoms alongside anxiety. anxiety and depressive symptom severity are similarly correlated with the stai trait and state score, and individuals with depressive disorders score significantly higher on average than individuals with anxiety disorders (kennedy et al., 2001; knowles & olatunji, 2020). both anxiety and depression appear to share a component of negative affect (e.g. anderson & hope, 2008; balon, 2005; bieling et al., 1998; caci et al., 2003). in clinical research and practice, it is important to assess distinct aspects of anxiety, rather than just negative affectivity. therefore, an instrument is needed that validly as­ sesses anxiety, separately from depressive symptoms. in contrast to other questionnaires, the state-trait inventory for cognitive and somatic anxiety (sticsa; ree et al., 2008) aims to measure anxiety without including negative affectivity. the sticsa has 21 items for the state and trait scales, respectively, and has been shown to be a reliable instrument for the assessment of anxiety. the sticsa considers the multidimensionality of anxiety, as well as the need to differentiate it from depressive symptoms (elwood et al., 2012; grös et al., 2007; ree et al., 2008). while the two-factorial structure of cognitive and somatic anxiety has been validated for the state and trait scale of the sticsa, other factorial solutions have also been proposed. factor solutions for all items of the sticsa state and trait version revealed a four-factor model, as well as a higher-order model with a global anxiety factor and four first-order factors (sticsa trait cognitive subscale, stic­ sa trait somatic subscale, sticsa state cognitive subscale, and sticsa state somatic subscale). aside from the two-factor solutions for the trait and state scale, respectively, utilized by ree et al. (2008), these four-factor solutions have also been validated (carlucci et al., 2018; roberts et al., 2016). superior concurrent and divergent validity has been overmeyer & endrass 3 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ shown compared to the stai (tindall et al., 2021). so far, the sticsa was not available in a german version. the aim of the present study was to develop and validate a german version of the sticsa. to this end, the sticsa was translated into german and assessed in two independent samples (online and in the lab). we expected to replicate the two-factorial structure of the questionnaire. we examined associations with other scales assessing anxiety, as well as depressive symptoms and stress, to establish discriminant validity and parse different components of anxiety and depression. we expected that the sticsa would be positively associated with depressive symptoms, anxiety and stress. we also expected the sticsa to better distinguish between anxiety and depressive symptoms, possibly with the somatic subscale being less influential in the dynamic interactions between anxious and depressive symptoms. m a t e r i a l s a n d m e t h o d samples sample size estimation minimum sample size for factor analysis was estimated based on simulation studies by gagne and hancock (2006), who proposed a method that bases sample size estimation on measurement model quality or reliability, which can both be derived from the number of indicators per factor and the factor loadings of each indicator. therefore, taking into account the number of indicators per factor (n = 10 and n = 11, respectively) and the factor loadings of the original questionnaire, we estimated a minimum sample size of n = 250. sample 1 complete data from 510 individuals were collected online using the internet platform limesurvey (limesurvey project team, 2015) and participants’ identity remained anony­ mous to the research team. all participants were above 18 years of age and were native speakers of german. 209 participants were excluded due to either false responding to the control items (n = 17), no fluency in german (n = 7), the presence of current or past self-reported mental disorders other than anxiety disorders or depression (n = 95), or neurological disorders (n = 90). other mental and neurological disorders were excluded to distinctly examine anxious and depressive symptoms, and avoid confounding effects (e.g. bulloch et al., 2015). the final sample included 301 participants (mean age 26.6 years ± 8.8 standard deviation (sd), range 18-62 years; 67.1% female and 0.1% diverse; 96.7% had completed advanced education degrees; 19.9% self-reported diagnoses of anxiety and/or depressive disorders). participants could take part in a lottery to win 10 euro. cognitive symptoms link anxiety and depression 4 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ sample 2 complete data from 311 individuals were collected using the internet platform limesur­ vey (limesurvey project team, 2015) during a session in the lab as part of another research project. all participants were above 18 years of age, native speakers of german and had no neurological disorders. 8 participants were excluded due to the presence of current or past self-reported mental disorders other than anxiety disorders or depression. the final sample included 303 participants (mean age 24.9 years ± 5.2 standard deviation (sd), range 18-45 years; 48.8% female; 93.4% had completed advanced education degrees; 7.6% self-reported diagnoses of anxiety and/or depressive disorders). participants were compensated for their participation with 10 euro per hour. the ethics committee at the technische universität dresden approved all study procedures (ek 330082018) and study procedures for sample 2 (ek 372092017, and ek 585122019). measures the assessment for sample 1 included both the sticsa state and trait (ree et al., 2008), the stai (laux et al., 1981; spielberger et al., 1983), the depression anxiety stress scales (dass-21; henry & crawford, 2005; nilges & essau, 2015), and the beck depression inventory ii (bdi; beck et al., 1996; kühner et al., 2007). for more information on these measures see the supplementary materials. we also obtained information about gender, age, education level, presence of mental and neurological disorders, and native language. two control items to check for attention were included (meade & craig, 2012). the order of the questionnaires was randomized across participants. the assessment for sample 2 included the sticsa trait (ree et al., 2008) as well as information about gender, age, education level, and native language. bilingual psychologists translated the sticsa into german and back into english. the retranslated questionnaire was compared to the original version. differing items were discussed and adapted. data analysis to validate the german version of the sticsa trait, we first performed exploratory factor analysis (efa) with oblique rotation (oblimin) and maximum likelihood estimation on sample 1. due to non-normality of the data, as assessed by mardia’s test (mardia, 1970), the analysis was conducted on a polychoric correlation matrix (holgado–tello et al., 2010). to extract the number of factors or components, we used techniques with comparably high accuracy rates (ruscio & roche, 2012): parallel analysis for component extraction (pa), minimum average partial procedure (map), optimal coordinates (oc), acceleration factor (af) and comparison data (cd). to validate the factorial structure of the sticsa trait, we performed a confirmatory factor analysis (cfa), also based on a polychoric correlation matrix, on sample 2. we used the diagonally weighted least overmeyer & endrass 5 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ squares (wlsmv) estimator, which is specifically designed for ordinal data (li, 2016). reliability was assessed using mcdonald’s omega and cronbach’s alpha (cronbach, 1951; mcdonald, 2013; revelle & zinbarg, 2009). convergent and discriminant validity were examined using kendall’s tau correlations (kendall, 1938) with measures of individual traits that have been linked to anxiety, within sample 1. kendall’s tau has been shown to be a better estimate of the correlation in the population if the data is distributed non-normally (howell, 2012). a validation of the sticsa state can be found within the supplementary materials. to analyze the dynamic connections between the assessed traits, we used a network approach and estimated a standardized gaussian graphical model (ggm) using the graphical lasso as a regularization method; the tuning parameter was selected according to the extended bayesian information criterion (chen & chen, 2008; foygel & drton, 2010; friedman et al., 2008; lauritzen, 1996). the analysis was performed based on polychoric correlations within sample 1 (epskamp & fried, 2018). edge weight, or corre­ lation accuracy and stability of node centrality indices as measures of node importance were assessed using bootstrapping (see epskamp et al., 2018). an alternative model for comparison of network estimation was also estimated, see supplementary materials. data and code are available at osf (overmeyer & endrass, 2023a). all analyses were carried out with r (r core team, 2018), for used packages see supplementary materials. r e s u l t s exploratory factor analysis (sample 1) assumptions for efa were met (see supplementary materials). an initial analysis was conducted to extract the number of factors to retain. pa extracted two components, map, cd and af extracted 2 factors and oc extracted five factors. we analyzed the data using five and two factors. compared to the two-factor solution, the five-factor solution yielded more cross loadings and did not seem to adhere to meaningful constructs (see supplementary materials). due to the more convincing results from the two-factor solu­ tion, two factors were retained in the analysis (for analysis choice recommendations see costello & osborne, 2005; fabrigar et al., 1999). table 1 displays the factor loadings after rotation. item clustering replicated the factors from the original sticsa cognitive and somatic factors. factors were correlated, ϕ = 0.61, 95% ci [0.50, 0.66]. cognitive symptoms link anxiety and depression 6 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ table 1 oblimin rotated standardized loadings (pattern matrix) based upon polychoric correlation matrix item no. sticsa cognitive sticsa somatic item 3 0.72 0.17 item 4 0.59 0.02 item 5 0.41 0.19 item 9 0.80 -0.01 item 10 0.87 -0.07 item 13 0.76 0.04 item 16 0.64 0.01 item 17 0.61 0.08 item 19 0.78 -0.02 item 11 0.22 0.13 item 1 -0.01 0.57 item 2 -0.15 0.77 item 6 0.31 0.49 item 7 0.24 0.56 item 8 0.09 0.67 item 12 -0.07 0.62 item 14 0.08 0.63 item 15 -0.01 0.55 item 18 0.17 0.69 item 20 0.21 0.51 item 21 -0.19 0.64 note. sticsa cognitive and sticsa somatic = state-trait inventory for cognitive and somatic anxiety, cognitive and somatic symptoms subscales (sticsa trait). confirmatory factor analysis (sample 2) as a second analysis, we performed a cfa, also on a polychoric correlation matrix. goodness of fit for the proposed model was tested via root mean square error of ap­ proximation, rmsearobust = 0.04, 95% ci [0.03, 0.05], and tucker lewis index of factoring reliability (tlirobust = 0.95), values of rmsea close to 0.06 and tli close to 0.95 indicate acceptable fit (hu & bentler, 1999). additionally, the rmsea test of close fit (χ2 = 247, df = 188, p = .998) indicates close fit, and the rmsea test of not-close fit (χ2 = 247, df = 188, p < .001) indicates the model does not fit poorly (maccallum et al., 1996; steiger, 2007). the χ2 test of model fit (χ2robust = 291, df = 188), however, was significant (probust < .001), providing evidence against perfect model fit. the standardized factor loadings (λ), their corresponding confidence intervals (ci) and standard errors (se) are presented in table 2. all factor loading estimates were significant and were of satisfactory magnitude. as expected, the two factors sticsa overmeyer & endrass 7 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ cognitive and somatic highly covaried in cfa (cov = 0.70; p < .001; 95% ci [0.61, 0.78]; se = 0.04). for a visualization of the sticsa structure see figure 1. table 2 standardized factor loadings (λ) based on polychoric correlations and estimated using diagonally weighted least squares item λ ci sell ul sticsa cognitive 3 0.75 0.68 0.83 0.04 4 0.57 0.46 0.68 0.06 5 0.54 0.44 0.64 0.05 9 0.71 0.63 0.78 0.04 10 0.75 0.67 0.82 0.04 11 0.27 0.15 0.40 0.06 13 0.72 0.63 0.80 0.05 16 0.69 0.60 0.77 0.05 17 0.63 0.53 0.73 0.05 19 0.72 0.63 0.81 0.05 sticsa somatic 1 0.55 0.44 0.66 0.05 2 0.55 0.45 0.65 0.05 6 0.73 0.62 0.85 0.04 7 0.62 0.49 0.76 0.04 8 0.62 0.50 0.75 0.04 12 0.55 0.43 0.67 0.06 14 0.76 0.61 0.91 0.06 15 0.47 0.32 0.61 0.06 18 0.64 0.51 0.61 0.04 20 0.67 0.57 0.77 0.04 21 0.28 0.15 0.42 0.07 note. ci = confidence interval; se = standard error; all loadings were significant. sticsa cognitive and sticsa somatic = state-trait inventory for cognitive and somatic anxiety, cognitive and somatic symptoms subscales (sticsa trait). cognitive symptoms link anxiety and depression 8 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ figure 1 path diagram of the sticsa trait (ree et al., 2008) results, including all items with their respective standardized factor loadings on the subscales as well as the correlation between the two subscales reliability mcdonald’s omega and cronbach’s alpha suggested satisfactory reliability for the stic­ sa in general (sample 1: ω = 0.89, 95% ci [0.86, 0.92], α = 0.89, 95% ci [0.86, 0.91]; sample 2: ω = 0.85, 95% ci [0.81, 0.88], α = 0.84, 95% ci [0.81, 0.87]), as well as for the subscales (sample 1: ωcog = 0.86, 95% ci [0.84, 0.89], ωsom = 0.81, 95% ci [0.76, 0.85], αcog = 0.86, 95% ci [0.83, 0.88], αsom = 0.81, 95% ci [0.76, 0.85]; sample 2: ωcog = 0.81, 95% ci [0.77, 0.84], ωsom = 0.73, 95% ci [0.67, 0.78], αcog = 0.81, 95% ci [0.77, 0.84], αsom = 0.73, 95% ci [0.67, 0.78]). overmeyer & endrass 9 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ validity and network dynamics we examined the validity of the sticsa and its subscales in sample 1, see table 3 for results. correlations were moderate to large in magnitude. it is important to note that the tau statistic has a different metric from other correlation coefficients (see gilpin, 1993). table 3 kendall’s tau correlations and their respective p-value between the two subscales of the sticsa and measures of anxiety, depression and stress within sample 1 measure 1 2 3 4 5 6 7 τ p τ p τ p τ p τ p τ p 1. sticsa cognitive – – 2. sticsa somatic 0.38 .001 – – 3. stai 0.38 .001 0.24 .001 – – 4. dass anx 0.44 .001 0.40 .001 0.33 .001 – – 5. dass stress 0.51 .001 0.34 .001 0.32 .001 0.41 .001 – – 6. dass depr 0.51 .001 0.19 .001 0.30 .001 0.31 .001 0.50 .001 – – 7. bdi 0.47 .001 0.21 .001 0.54 .001 0.37 .001 0.49 .001 0.54 .001 – note. sticsa cognitive and sticsa somatic = state-trait inventory for cognitive and somatic anxiety, cogni­ tive and somatic symptoms subscale scores (sticsa trait); stai = state-trait anxiety inventory-trait sum score; dass anx = depression anxiety stress scales sum score of anxiety subscale; dass stress = depression anxiety stress scales sum score of stress subscale; dass depr = depression anxiety stress scales sum score of depression subscale; bdi = beck depression inventory ii sum score. the connections between the nodes, or edge weights, within the network model calcu­ lated for sample 1 (for a visualization see figure 2) can be interpreted as partial correla­ tions. they therefore represent the connection between the different measures, control­ led for the presence of all other variables in the network (borsboom & cramer, 2013). the strongest connections were the connections between dass anxiety and sticsa somatic (pr = 0.33), between sticsa somatic and sticsa cognitive (pr = 0.28), between bdi and dass depression (pr = 0.39), between dass depression and dass stress (pr = 0.28) – and interestingly between sticsa cognitive and dass depression (pr = 0.30). the connection between sticsa somatic and dass depression was negative but small (pr = -0.14). sticsa cognitive appeared to be the most central node. it showed the highest values for node strength, closeness and expected influence, which indicate how strongly the node is connected to other nodes – directly as well as indirectly (epskamp et al., 2018). the z-standardized raw values of centrality indices of the ggm are visualized in the supplementary materials. in contrast, sticsa somatic has stronger links to dass anxiety and fewer or even negative connections with depression. results are supported within the alternative model (see supplementary materials). cognitive symptoms link anxiety and depression 10 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ figure 2 between-subject graphical lasso network with tuning parameter selected using the extended bayesian information criterion note. nodes represent the examined self-report measures or their respective subscales for depression, stress and anxiety. edges (connections) can be interpreted as partial correlation coefficients. red (dashed) lines represent negative edges, green (solid) lines positive edges. sticsatcog = sticsa trait (ree et al., 2008) cognitive subscale sum score, sticsatsom = sticsa trait (ree et al., 2008) somatic subscale sum score, stai = statetrait anxiety inventory (stai, spielberger et al., 1983) sum score, dassanx = depression anxiety stress scales (dass-21, henry & crawford, 2005) anxiety subscale sum score, dassstress = depression anxiety stress scales (dass-21, henry & crawford, 2005) stress subscale sum score, dassdepr = depression anxiety stress scales (dass-21, henry & crawford, 2005) depression subscale sum score, bdi = beck depression inventory ii (bdi, beck et al., 1996) sum score. overmeyer & endrass 11 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ d i s c u s s i o n this study investigated the psychometric properties of a german version of the sticsa and dynamic associations with depressive symptoms, stress and negative affectivity. the two-factorial structure of the original version was replicated and validated for both the trait and state version of the questionnaire (see supplementary materials for results for the state version). all items consistently loaded on the expected factors. the somatic and cognitive anxiety factors were moderately correlated, as expected. the subscales were differentially associated with measures of anxiety and negative affectivity, depression, and stress. the cognitive subscale of the sticsa was shown to be the most central node within the network, and therefore may influence the connections between all other measures. results show that not only is the german version of the sticsa a reliable and valid instrument, but that it also helps to distinguish the common and distinct facets of depression and anxiety. dynamic interactions between psychological constructs can be conceptualized within network analyses (costantini et al., 2019). our results suggest that cognitive symptoms, as assessed by the sticsa are at the centre of a network intertwining depressive, anxious and stress-related symptoms, with evidence that cognitive symptoms are the most influential node. interestingly, the stai exhibited a large correlation with the bdi, but not in the presence of other anxiety measures and stress measures. within the net­ work, the stai and measures of depression only exhibited an indirect connection, with the connecting node being the cognitive symptoms of the sticsa. this fits well with research suggesting that anxiety and depressive symptoms can be differentiated using the bdi and the beck anxiety inventory (beck et al., 1988), particularly using items of the cognitive domain in depression and those from the physical domain in anxiety (lee et al., 2018). a study using questionnaires as well as ecological momentary assessment found that overlapping symptoms between depression and generalized anxiety disorder bridged other symptoms across the diagnostic boundary, while cognitive and somatic symptoms still more strongly clustered within disorders (shin, 2020). another study identified “worrying about past” and “worrying about future” as the most prominent symptoms connecting individual depression and anxiety symptoms and “feeling unhap­ py” and “feeling lonely” as the most prominent disorder bridging symptoms among depression symptoms, with associations possibly explaining comorbidities (konac et al., 2021). when integrating the approach of worry symptoms bridging disorders with the tripartite model, the finding that the cognitive symptom of worrying links depression and anxiety seems fitting: as rumination increases, the association between anxious and depressed mood is strengthened (starr & davila, 2012b). the insufficient focus on differences in content between anxiety and depression within the tripartite model has been criticized before (eysenck & fajkowska, 2018), as has the failure of the different versions of the classification systems to delineate the blurred (diagnostic) line between anxiety and depression: demyttenaere and heirman (2020) proposed a more phenomeno­ cognitive symptoms link anxiety and depression 12 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ logical or psychopathological approach to better understand the differences between expressions of anxiety and depression. it has been suggested that the negative affectivity component can be subdivided into “worry or apprehension anxiety” and “dysthymia or valence depression” (eysenck & fajkowska, 2018; fajkowska et al., 2018; renner et al., 2018). interestingly, there is evidence the arousal or somatic symptoms component most strongly relates to fear as measured by the positive and negative affective schedule and that the reactive and regulative functions of affect are related to the structure and function of anxiety and depression components (domaradzka & fajkowska, 2018). this may also explain the central role of the cognitive subscale of the sticsa within our analysis – most of the items are focused on general cognitive aspects and the subscale does not differentiate between aspects of worry vs. dysthymia. within the network model, the somatic subscale was only indirectly associated with the bdi, and was even negatively associated with the dass depression subscale. these findings align with previous research indicating that the somatic anxiety subscale was less correlated with measures of depression (tindall et al., 2021). another study found that the somatic subscale was related to differences in both subjective and psychophysio­ logical responses to emotional stimuli between groups of high vs. low anxiety (barros et al., 2022). thus, the somatic subscale of the sticsa may be useful in differentiating between anxiety and depression. however, it is essential to continuously evaluate the sticsa for future conceptualizations of anxiety. especially research on dynamic interac­ tions between anxiety and depression, indicating that symptoms reinforce each other, potentially explaining the high levels of comorbidity (mcelroy et al., 2018), and that anxiety can worsen the severity of depression in late-life (an et al., 2019). future research into the delineation of depression and anxiety may benefit from examining these interac­ tions. limitations of the current study include the relatively small sample sizes and the high homogeneity of the samples pertaining education. not all items may be optimal for the subscales. for items 1, 7, 8 and 14 the highest step of the likert scale was not used. additionally, items 11 and 21 showed low factor loadings (λ ≈ 0.30) on their respective subscales, and it may be discussed if it is statistically meaningful to include these items (tabachnick et al., 2007). while the sticsa appears to clearly distinguish between cognitive and somatic aspects of anxiety, and acknowledges the multidimensionality of anxiety, it does not assess the behavioral dimension of anxiety as described by elwood et al. (2012). this might prove an oversight, as anxiety is often marked by fearful avoidance, which may be useful as a discriminant symptom – however, it has been shown that the presence of depressive symptoms exacerbates fearful avoidance behavior (seekatz et al., 2016). also, cultural context might change the importance of somatic symptoms in the interaction between anxiety and depression (escovar et al., 2018; kim et al., 2019; park & kim, 2020). despite the compelling findings on discriminant validity, there has been a study that reported evidence that the cognitive and somatic scales of the sticsa are not overmeyer & endrass 13 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://www.psychopen.eu/ equally robust, with the authors concluding that the items appear to measure a mixture of both latent cognitive and somatic anxiety (styck et al., 2022). however, styck et al. (2022) did assess the presence of mental or neurological disorders which could influence responses for somatic symptoms (bulloch et al., 2015) – future studies should evaluate the sticsa scales in other disorders. conclusion the german version of the sticsa appears to be a reliable and valid measure of trait and state anxiety, providing the ability to discriminate between the subscales of somatic and cognitive anxiety. as the subscales assess different facets of anxiety, it is not surprising they appear to differ in their discriminant validity and their associations to depressive symptoms and stress. somatic symptoms of anxiety appear to most reliably assess symptoms primarily associated with anxiety, whereas cognitive symptoms seem to link anxious and depressive symptoms. the central role of cognitive symptoms in these dynamic interactions suggests that differential diagnostics should focus more on anxious somatic symptoms than on cognitive symptoms. information gathered using the sticsa could be useful in differential diagnosis of mood and anxiety disorders, and additional understanding of both cognitive and somatic aspects of anxiety might prove useful for therapeutic interventions. funding: this work was funded by the deutsche forschungsgemeinschaft (dfg, german research foundation), grant number sfb 940, project c6. acknowledgments: the authors would like to thank tyler bassett and julia hartl for the translation of the questionnaire; and michael höfler and john venz for helpful discussion on data analysis. the authors express their gratitude to all participants for their time and cooperation. competing interests: the authors have declared that no competing interests exist. ethics statement: the authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the helsinki declaration of 1975, as revised in 2008. the ethics committee at the technische universität dresden approved all study procedures (ek 330082018) and study procedures for sample 2 (ek 372092017, and ek 585122019). twitter accounts: @r__overmeyer, @tendrass data availability: the data that support the findings of this study are openly available at the open science framework (osf) (overmeyer & endrass, 2023a). cognitive symptoms link anxiety and depression 14 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://twitter.com/r__overmeyer https://twitter.com/tendrass https://www.psychopen.eu/ s u p p l e m e n t a r y m a t e r i a l s the supplementary materials for this article contain the following items (for access see index of supplementary materials below): 1. the data that support the findings of this study 2. additional information on the analysis of the sticsa trait: • on methods • on the exploratory factor analysis, with alternative factor solutions • on the network analysis 3. additional information on the analysis of the sticsa state: • on methods • on the exploratory factor analysis, with alternative factor solutions • on the confirmatory factor analysis 4. the german version of the sticsa trait and sticsa state index of supplementary materials overmeyer, r., & endrass, t. 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(2021). dimensionality and measurement invariance of the state-trait inventory for cognitive and somatic anxiety (sticsa) and validity comparison with measures of negative emotionality. frontiers in psychology, 12, article 644889. https://doi.org/10.3389/fpsyg.2021.644889 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. overmeyer & endrass 21 clinical psychology in europe 2023, vol. 5(2), article e9753 https://doi.org/10.32872/cpe.9753 https://doi.org/10.1080/13548506.2015.1111392 https://doi.org/10.1007/s10608-011-9434-3 https://doi.org/10.1007/s10608-011-9363-1 https://doi.org/10.1016/j.brat.2011.11.005 https://doi.org/10.1016/j.paid.2006.09.017 https://doi.org/10.1177/1073191120953628 https://doi.org/10.3389/fpsyg.2021.644889 https://www.psychopen.eu/ cognitive symptoms link anxiety and depression (introduction) materials and method samples measures data analysis results exploratory factor analysis (sample 1) confirmatory factor analysis (sample 2) reliability validity and network dynamics discussion conclusion (additional information) funding acknowledgments competing interests ethics statement twitter accounts data availability supplementary materials references disorders specifically associated with stress in icd-11 scientific update and overview disorders specifically associated with stress in icd-11 andreas maercker 1 , david j. eberle 1 [1] department of psychology, division of psychopathology and clinical intervention, university of zurich, zurich, switzerland. clinical psychology in europe, 2022, vol. 4(special issue), article e9711, https://doi.org/10.32872/cpe.9711 received: 2022-06-15 • accepted: 2022-10-12 • published (vor): 2022-12-15 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: andreas maercker, university of zurich, division of psychopathology and clinical intervention, department of psychology; binzmühlestrasse 14/17, 8050 zürich, switzerland. e-mail: maercker@psychologie.uzh.ch related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si abstract background: after almost three decades of icd-10 use for diagnostic purposes, the world health organization has conducted a systematic and elaborate evaluation to revise the classification of mental disorders in this system. this revision resulted in the 11th version (icd-11), introduced in 2022. as one new feature, the icd-11 forms a new grouping of mental disorders specifically associated with stress. method: the current review presents an overview of the diagnostic features and cultural specifications of disorders specifically associated with stress. this grouping includes posttraumatic stress disorder and complex posttraumatic stress disorder, prolonged grief disorder, adjustment disorder, as well as two diagnoses for children, reactive attachment disorder and disinhibited social engagement disorder. results: overall, there is evidence for the improved clinical utility and applicability of these disorders. the disorders have been defined in a parsimonious way by few features, but they suffice for scientific purposes as well. conclusion: however, more research is needed to evaluate assessments for the diagnoses and diagnostic features in the icd-11. keywords disorders specifically associated with stress, icd-11, posttraumatic stress disorder, complex posttraumatic stress disorder, prolonged grief disorder, adjustment disorder this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9711&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0001-6925-3266 https://orcid.org/0000-0002-9578-667x https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ highlights • in the area of trauma and stress, there are two newly specified diagnoses and further redefinitions of the content of the existing diagnoses. • the icd-11 features a new grouping of disorders specifically associated with stress. for almost 30 years, the 10th version of the international classification of diseases (icd-10) was the standard in diagnosing physical diseases as well as mental disorders around the globe. on 1 january 2022, the world health organization (who) introduced the 11th revision of this diagnostic system and set a new milestone in the classification of mental disorders. back in 2011, the who had appointed several international working groups for revising the section on mental disorders in the icd-10. one of these working groups was commissioned to create the grouping of diagnoses specifically associated with stress (dsas). for the development of the 11th revision of the icd, the icd-11, the who placed particular emphasis on improving the clinical utility and applicability of the diagnoses. for dsas, several methodological preparations for the general revision of the icd-11 were particularly important. for instance, several global mental health surveys were conducted to assess the needs of psychologists and psychiatrists regarding mental health diagnoses (evans et al., 2013; reed et al., 2011, 2013). these preliminary mental health surveys concluded that there is a considerable need among health care professionals to create scientifically based diagnoses for stress-related phenomena like complex trauma and pathological grief reactions (robles et al., 2014). the advisory board of the who therefore expected the international working group on dsas to further evaluate these stress-related phenomena. researchers and clinicians with a broad global distribution took part in the working group for dsas, from africa (lynne m. jones, ashraf kagee), america (marylene cloitre, cecile rousseau), asia and australia (asma humayan, daya somasundaram, yuriko suzuki, richard bryant), and europe (chris brewin, andreas maercker, simon wessely), as well as members from global organizations such as the who (michael b. first, mark van ommeren, geoffrey reed) and the international committee of the red cross (renato souza). this composition of experts was chosen to ensure a global applicability of the diagnostic criteria for the new disorders in consideration. for the proposed mental disorders of the icd-11 and specifically for dsas, a compre­ hensive clinical evaluation was conducted. between the start of the working group and the final implementation of the icd-11, several evaluation steps were implemented: • diagnostic propositions of the working group for disorders specifically associated with stress were published and discussed in scientific journals (e.g., maercker et al., 2013) and in the global clinical practice network1. disorders specifically associated with stress 2 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ • for the entire icd-11 section of mental disorders, approximately 20 working groups worked on different disorder groupings as well as cross-sectional features. each working group developed clinical best practices, organized regional meetings with health care professionals, and consulted local patient representatives for a comprehensive validation of the working groups’ proposals. • 13 different research centres across the globe implemented clinical case studies to finalize the new disorder and symptom characterizations (reed et al., 2018). • more detailed clinical descriptions and diagnostic recommendations (cddr) for individual disorders were developed. for the cddr, the who pursued an open access approach. complementary to the frozen release of diagnostic features, the who published open access descriptions to implement future diagnostic changes2. as a major aspect of all revisions, the complexity of mental disorder’s characteristics was reduced. for this purpose, previous disorder subtypes were erased or limited (see reed, 2010). furthermore, only symptoms with a particular sensitivity and specificity were implemented as diagnostic features. as a consequence, the clinical utility and ap­ plicability of icd-11 diagnoses was significantly improved. regarding dsas, the expert group also discussed the inclusion of diagnoses such as embitterment disorder, burnout, continuous trauma disorder, and a more pronounced relation to – or even inclusion of – dissociative disorders. however, these proposals were not realized in the icd-11. furthermore, the diagnosis of an acute stress reaction was moved to the icd-11 section ‘factors influencing health status’, as such reactions are considered to be normal and are expected to be resolved within a short period after experiencing an aversive life event. d i s o r d e r s s p e c i f i c a l l y a s s o c i a t e d w i t h s t r e s s i n   a d u l t s table 1 presents an overview of disorders specifically associated with stress in the icd-11 and the corresponding stress-related disorders in the icd-10 and the dsm-5 (apa, 2013). the diagnostic features of the icd-11 diagnoses will be outlined in the following sections. 1) https://gcp.network 2) https://icd.who.int/dev11/l-m/en#/ maercker & eberle 3 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://gcp.network https://icd.who.int/dev11/l-m/en#/ https://www.psychopen.eu/ table 1 disorders related to stress and trauma according to the icd-11, the icd-10, and the dsm-5 icd-11 icd-10 dsm-5 6b40: posttraumatic stress disorder f43.1: posttraumatic stress disorder 309.81: posttraumatic stress disorder 6b41: complex posttraumatic stress disorder f62.0: enduring personality change after catastrophic experience – 6b42: prolonged grief disorder – – 6b43: adjustment disorder f43.2x: adjustment disorders 309.x: adjustment disorders 6b4y & 6b4z: other specified or unspecified disorders specifically associated with stress f43.8 & f43.9: other specified or unspecified reactions to severe stress 309.89 & 309.9: other specified or unspecified trauma and stressor-related disorders qe84: acute stress reaction (in subchapter 24 – no longer a diagnostic entity but a ‘factor influencing health status’) f43.0: acute stress reaction 308.3: acute stress disorder posttraumatic stress disorder for this category, there was essentially a revision and tightening up of the previous definition. posttraumatic stress disorder (ptsd) may develop after experiencing an ex­ tremely distressing or life-threatening event or series of events, such as sexual abuse or a serious accident (who, 2022). a core symptom of ptsd is the re-experiencing of the aversive life event in vivid memories. in most cases, such intrusive re-experiencing manifests as flashbacks or nightmares. however, intrusive symptoms can also involve other modalities or body-related re-experiencing, so that odours, sentiments, or other sensations from the traumatic event may be experienced again. intrusive re-experiencing typically occurs in combination with strong and overwhelming emotions such as fear or horror (see bar-haim et al., 2021). in the icd-11, repetitive or burdensome thinking of the experienced traumatic event is no longer considered to be a manifestation of intrusive re-experiencing as part of a ptsd. repetitive thoughts have also been found to be characteristic of resilient trauma survivors. even though remembering the traumatic event might be distressing for these individuals, such thoughts are not specifically associ­ ated with ptsd. the second symptom feature of ptsd is avoidance of memories, activities, situations, or people related to the traumatic event. importantly, this avoidance behaviour is de­ liberately produced by the affected individuals. in past conceptualizations, ptsd has sometimes been associated with amnesia as an unconscious avoidance strategy. such phenomena are no longer part of the avoidance symptoms in the icd-11, as they rarely disorders specifically associated with stress 4 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ occur and are not consciously reflected by affected individuals. in addition, symptoms such as numbing, diminished interest, and emotional alienation have been removed from avoidance definitions, as they are understood as manifestations of comorbid depressive symptoms. the third symptom group of ptsd consists of persistent perceptions of current heightened threat. such perceptions may manifest as hypervigilance or enhanced startled reactions to stimuli such as unexpected noises. due to their unspecific relation to ptsd, hyperarousal phenomena such as disturbed sleep, concentration problems, and increased irritability are no longer listed as ptsd symptoms in the icd-11. as for all disorders specifically associated with stress, ptsd is characterized by a significant impairment in personal, social, educational, occupational, or other important areas of functioning. however, some affected individuals are able to maintain a normal level of functioning, which is only possible through considerable psychological and phys­ ical effort. importantly, clinicians need to account for such compensatory behaviours in the diagnostic process to adequately assess the impairment level of an individual (see also rodriguez et al., 2012). ptsd typically emerges within several weeks after experiencing the traumatic life event, but it is possible for ptsd symptoms to emerge many months or years after the traumatic life experience. the icd-11 includes the possibility of delayed onset of ptsd symptoms, without specifying this phenomenon as a subtype. however, no time limit is introduced for this feature because specific time limits do not accurately reflect psychological processes (see reed et al., 2018). furthermore, the icd-11 no longer defines specific stressor characteristics of the traumatic life event, as it has been shown that the type of trauma is not particularly decisive for the subsequent psychopathology. there is empirical evidence showing that the described pattern of ptsd symptoms only occurs in traumatized individuals, thus allowing a reliable differentiation of individuals with and without ptsd (berntsen et al., 2003; brewin et al., 2009). it can therefore be strongly assumed that the symptom pattern in the icd-11 sufficiently describes the phenomenology of ptsd without the inclusion of stressor types. the icd-11 features a particular focus on the cultural characteristics of mental disor­ ders. in the case of ptsd, the icd-11 states that symptoms such as increased anger, headaches, intensified nightmares, or somatic symptoms might occur with different prevalence in certain cultural groups. the icd-11 also specifies that intrusive re-experi­ encing is not considered as something unusual in all cultures; rather, it might be seen as an intense but normal way of remembering a critical life event. furthermore, certain symptoms can also trigger dysfunctional health beliefs. for instance, anxiety-related symptoms such as persistent perceptions of heightened current threat might be interpre­ ted as a lifelong condition of weak nerves or a weak heart, as is sometimes observed in latin american countries or in cambodia. all these aspects need to be considered when working with individuals from different cultural groups. maercker & eberle 5 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ complex posttraumatic stress disorder complex posttraumatic stress disorder (cptsd) may develop after experiencing a trau­ matic life event that is particularly horrific or threatening (who, 2022). in most cases, the stressor consists of a series of traumatic situations or an ongoing event, such as slavery or repeated abuse. many psychosocial stressors with an extremely threatening nature have the potential to cause cptsd. however, as is the case for ptsd, the diagno­ sis mainly depends on symptomatic presentation instead of specific event characteristics (maercker et al., 2022). regarding the psychopathological features of cptsd, all symptom requirements of ptsd need to be met, including intrusive re-experiencing, avoidance, and persistent perceptions of heightened current threat. in addition, cptsd is characterized by distur­ bances in self-organization (dso), which is indicated by several symptom patterns. first, dso features problems in affect regulation, which might manifest as frequent excitability, anger, rage, or an increased self-harming behaviour. second, individuals with cptsd exhibit beliefs about the self as worthless, defeated, or diminished, which is often accompanied by feelings of guilt, shame, or failure related to the stressful life event. the third feature of dso constitutes interpersonal problems. the inability to trust, a suscept­ ibility to hyperbolic views, and difficulties in partnership interactions are particularly characteristic for this symptom group. individuals with cptsd also show an increased tendency for dissociation (see also hyland et al., 2020), which includes depersonalization experiences, clouding of consciousness, and amnesia. contrary to the dso symptoms, however, dissociation is not a diagnostic requirement for cptsd. the introduction of cptsd as a new disorder in the icd-11 generated significant criticism. for instance, one criticism is that cptsd only represents a comorbidity between ptsd and borderline personality disorder, which makes an introduction of a new disorder redundant (resick et al., 2012, see maercker, 2021). however, empirical findings demonstrated that cptsd possesses a distinct, reliable, and useful symptom profile (brewin et al., 2017; kazlauskas et al., 2018), which finally led to the inclusion of cptsd in the icd-11. in the icd-10, cptsd was classified as an enduring personality change after catastrophic experiences. however, continuous research showed that the related symptomatic features were part of a posttraumatic syndrome, which is why this psychopathological type has been reallocated to disorders specifically associated with stress. according to the icd-11, cptsd also exhibits an important cultural variation. in particular, dissociative and somatic symptoms are believed to increasingly emerge in certain cultural groups. furthermore, migrants across the globe are of particular concern in trauma sequelae. as they are frequently and often repeatedly confronted with severely stressful life events, migrants have a highly increased prevalence of suffering from cptsd. when migrating to countries with a different cultural background, cptsd might be triggered and intensified by the ongoing stressors experienced related to migration. disorders specifically associated with stress 6 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ as refugees are sometimes faced with continuous violence or discrimination in host countries, they represent a group that is particularly vulnerable to severe disorders specifically associated with stress. even though research has not yet identified a distinct set of cultural properties of cptsd, recent publications have started to shed light on these characteristics (see heim et al., 2022). prolonged grief disorder compared to other disorders specifically associated with stress, stressors leading to a prolonged grief disorder (pgd) are defined more precisely. pgd might develop after the death of a loved person, such as a partner, parent, child, other family member, or another person close to the bereaved (who, 2022). importantly, animals are not included in this definition. the event of loss causes an intense and long-lasting grief reaction, which can take on many individually different manifestations. however, in terms of common symptoms, pgd is defined by intensive yearning and longing for the deceased, as well as by intrusive preoccupation with the death of the loved person or the implications of this event. in addition to these core symptoms, the icd-11 defines several accessory symptoms, including guilt, sadness, denial, anger, blame, difficulty accepting the loss, an inability to be in a positive mood, numbness, and a diminished interest in activities. however, the icd-11 does not define the number of accessory symptoms needed for a pgd diagnosis. more cultural characteristics are specified for pgd than for other mental disorders. cultural practices and attitudes towards bereavement strongly differ across the globe. ideas and concepts of the afterlife manifest a broad range of clinical presentations and behaviours related to bereavement, which may also increase the chance for a prolonga­ tion of grief. for instance, the icd-11 states that in some religions, death is regarded as an important step in the transition to the afterlife. cultural beliefs focusing on rebirth, but also on karma, heaven, or hell, can have an enormous impact on a bereaved person. pgd might therefore be additionally triggered by concerns about the afterlife of the deceased. according to some religious beliefs, such as those common in southern europe, an encounter with the spirit of a deceased person – which may be regarded as a symptom of re-experience – is not considered as an abnormal event and may even be perceived as a positive experience. another culturally diverse feature in relation to pgd is the duration of grief, as there are different norms across the globe concerning mourn­ ing periods. in some countries, a one-year mourning period is considered as normal, whereas in other cultures, mourning periods are considered to trigger negative emotions and are therefore kept relatively short. due to these various cultural manifestations, the icd-11 states that for the diagnosis of pgd, the cultural background of patients needs to be evaluated thoroughly. the diagnosis of pgd should only be made if the grief reaction clearly exceeds the respec­ tive cultural norms of the individual. in general, the icd-11 states that pgd may be maercker & eberle 7 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ diagnosed no earlier than six months after the death of the loved person. however, due to the cultural variations outlined before, the duration of grief should correspond to the cultural background when considering a pgd diagnosis. long-lasting grief reactions that are still within a cultural norm are classified as a normal grief reaction and not as pgd. the extent to which different cultures affect the expression of symptoms remains the subject of further research. there were also some objections to the introduction of pgd as a new idc-11 diagno­ sis. for instance, one criticism was that the introduction of pgd as a new diagnosis represents disease mongering and that grief should always be classified as a natural process of life. however, it should be noted that in the past, prolonged grief has mostly been falsely diagnosed as depression, ptsd, or adjustment disorder, even for the small number of those it affects. such diagnoses are not only clinically inaccurate but can also cause inadequate treatment. for individuals affected by mental disorders, a diagnosis can be helpful to understand and address psychological problems, presupposing that the underlying problems are correctly identified in the first place. adjustment disorder another disorder specifically associated with stress is adjustment disorder (ajd). this disorder may develop after one or several critical life event(s), such as involuntary job loss, severe illness, or a relationship breakup (who, 2022). on a symptomatic level, ajd is characterized by an intrusive preoccupation with the aversive life event or its implications, which mainly manifests as repetitive and distressing thoughts of the event. failure to adapt constitutes a further ajd symptom, which may take the form of sleep and concentration problems or an inability to recuperate. due to the high levels of distress that individuals with ajd experience, suicidal tendencies are not uncommon as part of the disorder. importantly, the diagnosis of ajd specifies that disorder-related symptoms persist no longer than six months after the aversive life event. however, in the case of a prolonged exposure to a stressor, such as an ongoing illness, ajd may also be diagnosed for longer than six months. in general, all aversive life events have the potential to trigger ajd, which makes it particularly difficult to differentiate such experiences from traumatic events and seque­ lae. however, a great majority of individuals diagnosed with ptsd and cptsd have been confronted with life-threatening experiences, whereas events leading to ajd are not particularly overwhelming in most cases. even though stressors like a divorce might be extremely stressful for those affected, such events are usually not associated with a threat to one’s core identity and basic tenets of life during exposure to the stressor and therefore do not cause typical posttraumatic symptoms (brewin, 2014; eberle & maercker, 2022). the manifestation of ajd varies across the lifespan. according to the icd-11, chil­ dren with ajd may typically exhibit increased disruptive or oppositional behaviour, disorders specifically associated with stress 8 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ hyperactivity, irritability, concentration problems, increased clinginess, tantrums, regres­ sion, sleep disturbances, or bedwetting. in contrast to children, adolescents may manifest an intensification of substance use as well as increased behaviours of acting out or risk taking. children and adolescents with ajd often fail to verbalize their emotions related to the stressful experience. therefore, it is important to account for this interactive inhibition in the diagnostic process and relate reports of critical life events to changed behaviour patterns. meanwhile, older adults diagnosed with ajd increasingly manifest psychosomatic symptoms as a reaction to critical life events. consequently, in this age group, the core ajd symptom of preoccupation is especially focused on their own health (for more age-specific information, see also mulligan, 2018; who, 2022). the icd-11 states that in some cultural groups, ajd might intensify significantly in the case of lacking family or community support. furthermore, local idioms of distress and concepts of suffering can play a significant role in the manifestation of ajd. for example, exposure to aversive life events may result in particularly strong anxiety reac­ tions, as it has been observed in individuals from central america. a d d i t i o n a l d i s o r d e r s f o r c h i l d r e n in the icd-11, diagnoses for children and adolescents are no longer separately coded but are rather implemented in the disorder group of the appropriate life-span diagnoses. this means that the grouping of disorders specifically associated with stress also features two diagnoses for children and adolescents: disinhibited social engagement disorder and reac­ tive attachment disorder (who, 2022). one childhood-specific stress-related diagnosis listed in the icd-10 has not been transferred to the icd-11. due to the phenomenological overlap, autism spectrum disorder is an important exclusion criterion for both childhood disorders specifically associated with stress in the icd-11. disinhibited social engagement disorder develops as a consequence of grossly inade­ quate childcare, such as institutional deprivation, severe neglect of the child’s physical or emotional needs, a constant change of primary caregivers, parenting in inadequate settings, and child abuse (see also zeanah et al., 2016). according to the icd-11, children with disinhibited social engagement disorder are characterized by an indiscriminate approaching of adults, a lack of restraint to approaching, an overly familiar behaviour towards strangers, and a willingness to go away with unfamiliar adults. disinhibited social engagement disorder is relatively rare and has been found to develop only in a small proportion of children who have experienced inadequate care. reactive attachment disorder, as the second child-specific stress-related disorder in the icd-11, is also characterized by highly inadequate childcare. the disorder features an inhibited attachment behaviour of the child. according to the icd-11, this may manifest as an unwillingness to return to the primary caregiver for nurture, comfort, or support, even though an adequate caregiver is available. furthermore, the child does not respond maercker & eberle 9 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ when comfort is offered and rarely displays security-seeking behaviours towards any adult (zeanah et al., 2016). q u e s t i o n n a i r e s a n d c l i n i c a l i n t e r v i e w s with its revised diagnostic features for mental disorders, the icd-11 also requires an adaptation in the assessment of these disorders. in recent years, new measurement instruments for dsas have been developed. for the development of these diagnostic assessment tools, a european-american consortium has been founded: the international trauma consortium3, which offers freely available diagnostic instruments in numerous languages. while english versions of the developed scales are already fully validated, the validation processes for other languages, such as german or arabic, are not yet completed. t h e i c d 1 1 i n c l i n i c a l p r a c t i c e the new icd-11 diagnoses have been repeatedly evaluated. for instance, various disor­ ders have been cross-compared with mental health conceptualizations from the icd-10 and the dsm-5, as will be shown in the following paragraphs. however, with regard to prevalence studies, data sets based on epidemiological and high-risk samples often cover individuals who are not in treatment. therefore, studies with patients undergoing actual treatment are most relevant for an evaluation of the icd-11 in clinical practice. in addition, many previous studies have not assessed the diagnostic features of impair­ ment in personal, family, social, educational, occupational, or other important areas of functioning, even though this feature is a critical diagnostic element. these limitations need to be kept in mind when diagnostic findings are compared. regarding childhood disorders, studies have not yet managed to replicate the prevalence numbers of the disor­ ders, which is why the following section will not evaluate disinhibited social engagement disorder and reactive attachment disorder. ptsd and cptsd regarding ptsd, the first study to evaluate different diagnostic systems involving the icd-11 was conducted as part of the world mental health surveys (stein et al., 2014). the assessment applying the icd-11 indicated that 3.2% of screened individuals met the diagnostic criteria for ptsd. in comparison, a prevalence of 4.4% was found with the icd-10 and a prevalence of 3.0% was found with the dsm-5. among all individuals 3) www.traumameasuresglobal.com disorders specifically associated with stress 10 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 http://www.traumameasuresglobal.com https://www.psychopen.eu/ who received a ptsd diagnosis with the icd-11, the icd-10, or the dsm-5, 75% were diagnosed accordingly in all three classification systems. another study including a high-risk sample of older adults found a ptsd prevalence of 10.3% when diagnosed with the icd-11. in comparison, according to the icd-10, 15% of individuals met all diagnostic features of ptsd (glück et al., 2016). prevalence numbers differ for more specific populations, such as members of the military. wisco et al. (2016) found that, in a high-risk sample of us military personnel, 34% were diagnosed with ptsd according to the icd-11, while 45% were diagnosed with the icd-10 and 34% with the dsm-5. the diagnostic overlap between the icd-11 and the dsm-5 was 89%. a similar study has been conducted in the german military: kuester et al. (2017) found ptsd rates of 48% for the icd-11, 30% for the icd-10, and 56% for the dsm-5. the diagnostic overlap between the icd-11 and the dsm-5 was 84%. however, both of these studies only used validated dsm instruments for their assessment, which were adapted to also capture icd diagnoses. furthermore, møller et al. (2020) investiga­ ted ptsd and cptsd in a patient sample. of the patients who received a ptsd diagnosis according to the icd-10, 46% were also diagnosed with ptsd according to the icd-11, 28% were diagnosed with cptsd, and 26% were diagnosed with another mental disorder. in summary, empirical studies show that the diagnostic overlap between different classification systems must be estimated at roughly 60–90%. in clinical practice, this means that even though a patient might receive a ptsd diagnosis according to the icd-10 or the dsm-5, a ptsd diagnosis may no longer be assigned when using the icd-11. such empirical findings might seem upsetting, as all diagnostic systems are supposed to ensure valid diagnostic results. however, it must be considered that diag­ nostic tools are always subject to a minimal level of uncertainty, which may lead to different results. furthermore, the theoretical background for diagnostic characteristics have changed between different classification systems. for instance, symptoms of re-ex­ perience have been laid out more strictly in the icd-11. if an individual exhibits distress­ ing repetitive thoughts of a trauma but no vivid flashbacks or severe nightmares, the diagnosis of ptsd is no longer indicated by the icd-11. ajd and pgd prevalence numbers for both ajd and pgd are not yet conclusively determined due to sparse research activity and changing disorder definitions over the last years. a diagnostic evaluation based on the icd-10 found that across different countries, ajd exhibits a prevalence of approximately 1% (ayuso-mateos et al., 2001). this finding was replicated in a german study by maercker et al. (2012), which found an ajd prevalence of 0.9% by implementing icd-11 features. therefore, in contrast to other disorders spe­ cifically associated with stress, ajd appears to show little variability in the prevalence figures of the different diagnostic systems. since pgd was newly introduced in the icd-11, no comparison with broadly established conceptualizations of grief is possible. maercker & eberle 11 clinical psychology in europe 2022, vol. 4(special issue), article e9711 https://doi.org/10.32872/cpe.9711 https://www.psychopen.eu/ however, the dsm-5 defines persistent complex grief disorder as a research diagnosis. maciejewski et al. (2016) compared this diagnosis with the icd-11 definition and found a kappa coefficient of 0.82, which indicates a big overlap between the two disorders. importantly, in the upcoming dsm-5-tr, pgd will be included as a regular disorder in the classification system (moran, 2021). hence, it is hoped that future research will be able to conduct thorough comparisons between classification systems and adequate prevalence estimations. c o n c l u s i o n disorders specifically associated with stress encompass a set of psychopathological sequelae emerging after exposure to a stressful life event. research shows that these revised disorders entail an increased clinical utility and applicability. however, more studies are needed to investigate the long-term benefits of the new dsas grouping of disorders. it is hoped that the icd-11, which will guide clinicians and their therapeutic actions over the next decades, proves to be beneficial for individuals suffering mental disorders from the kinds of external sources outlined here. we may see further steps towards convergence with the dsm-5 as well, such as with pgd, which was included in the dsm-5-tr (text revision) in 2022. funding: this contribution did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. acknowledgments: thanks go to the work group members at who icd-11 development, whose names are listed in the text. competing interests: am had been the chair of the icd-11 work group on disorders specifically associated with stress. he is the guest editor of this special issue of clinical psychology in europe but played no editorial role in this particular article or intervened in any form in the peer review process. both authors have no financial conflicts of interest to declare. r e f e r e n c e s american psychiatric association. 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hofmann et al., 2012). absent such data, it would nevertheless be logical that, by and large, clients must benefit in some way, lest they would not this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9859&domain=pdf&date_stamp=2022-09-30 https://orcid.org/0000-0002-3751-0878 https://orcid.org/0000-0002-4484-9992 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ come back and healthcare systems would not spend capital on and regulate access to psychotherapy without a return on investment. similarly, all psychotherapies aim to exact lasting change. that is, clients and psycho­ therapists are working to establish meaningful changes that last beyond the psychother­ apy itself. here, large differences exist across psychotherapies: some explicitly address maintenance and generalization, whereas others are silent as how to help achieved gains “stick”. nevertheless, research shows that change for many can be maintained for years following treatment. as such, we believe it is uncontroversial that the basic tenants of evolution can be brought to bear on all psychotherapies: variation (change), selection (utility), and retention (lasting change). developments in evolutionary science demonstrate that evo­ lutionary processes are not limited to genetics, that they include processes that shape behavior and symbolic language (the bread and butter of psychotherapy), and can play out in much faster time spans than previously believed (wilson et al., 2014). one such attempt to conceptualize and organize empirically verified change process­ es in psychotherapy around evolutionary concepts is the process-based approach to psychotherapy (hayes et al., 2019; hofmann et al., 2022). although its implications are not yet established, the theoretical groundwork is now ready to guide the next steps of empirical examination of candidate processes of change (hayes et al., 2022). we believe this type of thinking is more promising than our fields’ history of fighting about which psychotherapy is better. it is also closer to clinical reality of the multi-method and multi-dimensional approach of most clinicians. the upshot here is that with concerted effort, clinical wisdom could be organized around evolutionary concepts (e.g., “meaning­ ful variation was achieved for this client using the empirically established procedure of x”, etc.). furthermore, this perspective is egalitarian and open to all psychotherapies, theories, and even our field’s favorite animal, the dodo bird. it may take time before the field concludes that nothing in psychotherapy makes sense except in the light of evolution – to borrow a famous phrase – but such a step could be meaningful change in itself. funding: this work was funded in part by the swiss national science foundation (grants: pp00p1_190082 & pp00p1_163716/1) awarded to the first author. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: the authors have declared that no competing interests exist. twitter accounts: @cpis_lab meaningful and lasting change 2 clinical psychology in europe 2022, vol. 4(3), article e9859 https://doi.org/10.32872/cpe.9859 https://twitter.com/cpis_lab https://www.psychopen.eu/ r e f e r e n c e s gloster, a. t., walder, n., levin, m. e., twohig, m. p., & karekla, m. 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(2014). evolving the future: toward a science of intentional change. behavioral and brain sciences, 37(4), 395–416. https://doi.org/10.1017/s0140525x13001593 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. gloster & haller 3 clinical psychology in europe 2022, vol. 4(3), article e9859 https://doi.org/10.32872/cpe.9859 https://doi.org/10.1016/j.jcbs.2020.09.009 https://doi.org/10.1016/j.brat.2022.104155 https://doi.org/10.1016/j.brat.2018.10.005 https://doi.org/10.1007/s10608-012-9476-1 https://doi.org/10.32872/cpe.8403 https://doi.org/10.1017/s0140525x13001593 https://www.psychopen.eu/ clinical psychology and the covid-19 pandemic: a mixed methods survey among members of the european association of clinical psychology and psychological treatment (eaclipt) research articles clinical psychology and the covid-19 pandemic: a mixed methods survey among members of the european association of clinical psychology and psychological treatment (eaclipt) julia asbrand 1 § , samantha gerdes 2 § , josefien breedvelt 3,4 , jenny guidi 5 , colette hirsch 6,7,8 , andreas maercker 9,10 , céline douilliez 11 , gerhard andersson 12,13 , martin debbané 14,15 , roman cieslak 16 , winfried rief 17 , claudi bockting 4,18 [1] department of psychology, humboldt-universität zu berlin, berlin, germany. [2] nhs veterans’ mental health and wellbeing service, camden and islington nhs trust, london, united kingdom. [3] natcen social research, london, united kingdom. [4] centre for urban mental health, university of amsterdam, amsterdam, the netherlands. [5] department of psychology "renzo canestrari", university of bologna, bologna, italy. [6] institute of psychiatry, psychology and neuroscience, king's college london, denmark hill, camberwell, london, united kingdom. [7] national institute for health research (nihr) biomedical research centre, south london and maudsley hospital, london, united kingdom. [8] south london and maudsley nhs foundation trust, denmark hill, camberwell, london, united kingdom. [9] department of psychology, division of psychopathology and clinical intervention, university of zurich, zurich, switzerland. [10] wissenschaftskolleg berlin–institute of advanced study, berlin, germany. [11] université catholique de louvain, psychological sciences research institute, louvain-la-neuve, belgium. [12] department of behavioral sciences and learning, department of biomedical and clinical sciences, linköping university, linköping, sweden. [13] department of clinical neuroscience, division of psychiatry, karolinska institute, stockholm, sweden. [14] psychoanalysis unit, research department of clinical, educational and health psychology, university college london, london, united kingdom. [15] developmental clinical psychology unit, faculty of psychology and educational sciences, university of geneva, geneva, switzerland. [16] department of psychology, swps university of social sciences and humanities, warsaw, poland. [17] department of clinical psychology and psychotherapy, university of marburg, marburg, germany. [18] department of psychiatry, amsterdam university medical centers (location amc), amsterdam, the netherlands. §these authors contributed equally to this work. clinical psychology in europe, 2023, vol. 5(1), article e8109, https://doi.org/10.32872/cpe.8109 received: 2022-01-10 • accepted: 2022-11-21 • published (vor): 2023-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8109&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0003-2740-6070 https://orcid.org/0009-0005-5352-2878 https://orcid.org/0000-0003-1864-1861 https://orcid.org/0000-0001-6815-2738 https://orcid.org/0000-0003-3579-2418 https://orcid.org/0000-0001-6925-3266 https://orcid.org/0000-0001-8912-885x https://orcid.org/0000-0003-4753-6745 https://orcid.org/0000-0002-4677-8753 https://orcid.org/0000-0002-2413-5343 https://orcid.org/0000-0002-7019-2250 https://orcid.org/0000-0002-9220-9244 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ corresponding author: josefien breedvelt, josefien breedvelt, natcen social research, london, uk, 35 northampton square, london ec1v 0ax, united kingdom. e-mail: josefienbreedvelt@gmail.com supplementary materials: materials [see index of supplementary materials] abstract background: the covid-19 pandemic has affected people globally both physically and psychologically. the increased demands for mental health interventions provided by clinical psychologists, psychotherapists and mental health care professionals, as well as the rapid change in work setting (e.g., from face-to-face to video therapy) has proven challenging. the current study investigates european clinical psychologists and psychotherapists’ views on the changes and impact on mental health care that occurred due to the covid-19 pandemic. it further aims to explore individual and organizational processes that assist clinical psychologists’ and psychotherapists’ in their new working conditions, and understand their needs and priorities. method: members of the european association of clinical psychology and psychological treatment (eaclipt) were invited (n = 698) to participate in a survey with closed and open questions covering their experiences during the first wave of the pandemic from june to september 2020. participants (n = 92) from 19 european countries, mostly employed in universities or hospitals, completed the online survey. results: results of qualitative and quantitative analyses showed that clinical psychologists and psychotherapists throughout the first wave of the covid-19 pandemic managed to continue to provide treatments for patients who were experiencing emotional distress. the challenges (e.g., maintaining a working relationship through video treatment) and opportunities (e.g., more flexible working hours) of working through this time were identified. conclusions: recommendations for mental health policies and professional organizations are identified, such as clear guidelines regarding data security and workshops on conducting video therapy. keywords psychotherapy, video therapy, online therapy, blended therapy, clinical psychology, covid-19 highlights • rapid change in psychotherapy delivery occurred due to the covid-19 pandemic. • clinical psychologists and psychotherapists report challenges (e.g., reluctance among patients) and opportunities, resulting from changes to the work environment. • data security is crucial as well as access to treatment via video therapy. • national policy and organizational guidance is crucial to support clinical psychologists and psychotherapists in their work. effects of covid-19 on eaclipt members 2 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ health care services globally have faced unprecedented challenges due to the covid-19 pandemic. alongside the physical health consequences of the covid-19 virus, mental health problems are also increasing, with reported increases for anxiety, depression, psychological distress and sleeping problems (bohlken et al., 2020; liu, heinzel, haucke, & heinz, 2021; rajkumar, 2020; salari et al., 2020; vindegaard & benros, 2020; xiong et al., 2020). furthermore, there has been an estimated additional 53.2 million cases of major depressive disorder and an estimated additional 76.2 million cases of anxiety disorders globally (santomauro et al., 2021). as a consequence, mental healthcare needs to be prioritized and clinical psychologists and psychotherapists1 play an important role in the prevention and treatment of these adverse consequences of the covid-19 pandemic. however, as yet little is known about how well clinicians and services have adapted to the increased demand and additional challenges presented by the covid-19 pandemic, and what might be done to improve mental health care for those who have suffered psychologically as a consequence of the covid-19 pandemic. clinical psychologists and psychotherapists had to find rapid alternatives to face-toface treatment such as telephone-based or video therapy (békés & aafjes-van doorn, 2020; humer, stippl, et al., 2020), or in-person sessions whilst adhering to their cov­ id-19 national containment measures from the start of the pandemic. prior studies have shown that the implementation of changes to service delivery can take an average of sixteen years to implement in a health care system (rogers et al., 2017). in contrast, during the pandemic, change in service delivery was rapid and unexpected, and there was little supervision or guidance available for clinicians (e.g., boldrini et al., 2020; probst, stippl, & pieh, 2020). moreover, the pandemic itself led to significantly higher stress levels in clinical psychologists and psychotherapists, especially in younger and less experienced professionals (aafjes-van doorn et al., 2020; probst, humer, stippl, & pieh, 2020). additionally, fear of infection and other issues related to the pandemic itself were also reported by clinical psychologists and psychotherapists (humer, pieh, et al., 2020). in the midst of such rapid and unforeseen changes to practice, several reassuring and thought-provoking phenomena have been observed. for instance, preliminary evidence showed video therapy to be more effective than previously expected (humer, stippl, et al., 2020). interestingly, the ability to adapt to conducting therapy via video is related to the individual clinical psychologists’ and psychotherapists’ attitudes and is influenced by their past experiences with video therapy (békés & aafjes-van doorn, 2020). further, challenges have been reported by mental health professionals regarding the lack of inter­ personal interactions, feelings of isolation and other technical issues whilst conducting therapy online (mcbeath et al., 2020). the aforementioned studies provide an interest­ 1) we use the term “clinical psychologists and psychotherapists” throughout, however in order to accommodate for different definitions between countries, the term includes clinical psychologists as well as psychotherapists, scientist practitioners, and all other mental health professionals who provide psychological therapy. asbrand, gerdes, breedvelt et al. 3 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ ing, yet heterogeneous, picture of the impact of the covid-19 pandemic on mental health professionals. however, most of the studies used closed questions and quantitative methods (e.g., békés & aafjes-van doorn, 2020; boldrini et al., 2020), thus limiting the possibility for participants to provide their own insight into offering psychotherapy during a global pandemic. professional organizations and other commissions have taken the initiative to provide the public and mental health care professionals with information regarding covid-19 (e.g., uk2, germany3, austria4, belgium5). however, it is also important for mental health care professionals who work ‘on the ground’ to share their experiences, in order for organizations to find ways to best support their clinicians. the current survey aimed to gather information ‘from the field’ to gain an understanding of the experiences of clinical psychologists and psychotherapists working during the covid-19 pandemic, across different european countries. members of the european association of clinical psychology and psychological treatment (eaclipt) were consulted; eaclipt is an association that aims to foster research, education and dissemination of scientifically evaluated findings on clinical psychology and psychotherapy. the current study seeks to provide a first european wide insight into the perceived changes to clinical practice and research of clinical psychologists and psychotherapists, as well as the barriers and opportunities, in order to improve support to people as part of the response to the covid-19 pandemic. the study also aims to gather information to highlight helpful ways for clinical psychologists and psychotherapists to approach, prioritize and manage their work in the context of the pandemic. finally, it aims to provide information on how organizations and organizational bodies (such as eaclipt) can best adapt to pandemic related changes. m e t h o d participants the survey (see appendix a, supplementary materials) was targeted at clinical psychol­ ogists and psychotherapists across europe who are members of eaclipt. potential participants were recruited via the eaclipt members database (n = 698) from 25th may 2020 to 1st september 2020, when covid-19 restrictions were still in place in most countries. however, it should be noted that restrictions at this time were often not as strict as they were during the first wave of the pandemic, and there were also 2) https://www.bps.org.uk/coronavirus-resources/professional 3) https://psychologische-coronahilfe.de/ 4) https://www.boep.or.at/psychologische-behandlung/informationen-zum-coronavirus-covid-19 5) https://www.compsy.be/fr/coronavirus effects of covid-19 on eaclipt members 4 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.bps.org.uk/coronavirus-resources/professional https://psychologische-coronahilfe.de/ https://www.boep.or.at/psychologische-behandlung/informationen-zum-coronavirus-covid-19 https://www.compsy.be/fr/coronavirus https://www.psychopen.eu/ substantial differences between countries. overall, n = 92 participants (13% of eaclipt members) voluntarily agreed to participate in the survey. most of the participants were from the united kingdom (17.6%), germany (16.5%), and austria (13.2%; see figure 1). further, most participants worked in a university or other academic institute (34.4%), hospital (14%), public community clinic (15%) or private clinic (18%). the other 30.7% responses included: academic hospital (6.5%), university clinic (7.5%), retired (1%), courts (1%), prison (1%), and not for profit (1%). finally, most participants self-identified as working in an urban area (79.1%) compared to rural areas (15.4%), suburban areas (3.4%) and national coverage (1.1%). figure 1 country of origin of participants 0 2 4 6 8 10 12 14 16 18 bulgaria czech republic slovenia portugal poland norway malta spain lithuania france ireland switzerland italy belgium the netherlands croatia austria germany united kingdom question: 'in which european country do you live?' note. please note that n = 6 participants chose to not comment on their country of origin. procedure and measures socio-demographic information was collected using nine closed questions (e.g., country of origin, place of work and most commonly presenting patient need during the pandem­ ic). five open questions were used to gain information on perceived changes in the work place, challenges and opportunities during the crisis, the effect of covid-19 safety measures on their practice, and other implications. the survey was open for completion between 25th may 2020 and 1st september 2020. the last response that was included was submitted on 19th august 2020. asbrand, gerdes, breedvelt et al. 5 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ quantitative and qualitative analysis the six phases of thematic analysis (nowell, norris, white, & moules, 2017) were fol­ lowed by the first two authors (j.a. and s.g), including familiarization with the data (phase 1), generating initial codes (phase 2), searching for themes (phase 3), reviewing themes (phase 4), defining and naming themes (phase 5) and producing the report (phase 6). the third author (j.b.) supervised their work and checked the data during phase 4, in order to review the themes that had been generated. this enabled research bias to be evaluated and the interpretation of the data to be confirmed. the first two authors screened the answers independently in phases 1, 2, and 3 and formed their own categories, which were then compared and agreed on and a list of themes per question was finalized. themes were then listed in terms of frequency for each question. the authors were each based in different countries, therefore all meetings took place over remote platforms. regarding the overall process, reflexivity is considered as a key aspect of the thematic analysis process (nowell et al., 2017). therefore, the first two authors kept their own reflexive journal to document the logistics and methodological considerations as well as their own personal reflections. the precise analysis was then conducted in line of the six step technique by braun and clarke (2006). r e s u l t s the results have been analyzed according to the six-phase method by braun and clarke (2006) i.e., familiarization with the data, generation of initial codes, searching for themes, reviewing themes, defining and naming themes, and producing the report. data are organized and summarized in the results section and the interpretation regarding signifi­ cance and implications follows in the discussion. quantitative results changes in patients seeking help based on the question that asked if participants were seeing more or less patients, the number of patient contacts (i.e., number of patients seen by a clinician) seemed to remain relatively stable during the first wave of the covid-19 pandemic, as reported by 42% of the participants who indicated no change in the number of patient contacts. nonetheless, almost 40% reported to see less patients, while 17% reported to see more patients. further, 78.8% reported that patients displayed similar psychological problems as they did prior to the covid-19 pandemic. however, 48.3% also reported that their patients seemed to be more distressed compared to one year before, whereas 28.7% reported no change in their patients’ distress. the most frequently reported patients’ clinical issues effects of covid-19 on eaclipt members 6 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ encompassed anxiety (86%), depression (82%), loss of social contacts and isolation (each 39%) (see figure 2). in terms of clinicians’ working practices, most responders reported that covid-19 had changed their work routines (73.6%), mostly in ways that they perceived to be undesirable. figure 2 main mental health issues reported by patients 0 10 20 30 40 50 60 70 80 anxiety depression loss of social contact isolation lonliness covid-19 economic hardship loss/bereavement substance abuse seperation/divorce psychosis medical interpersonal difficulties adhd other behaviour that challenges others ocd behaviours eating disorders suicidality anger/aggression neuropsychological testing trauma sleep problems life transitions gender transition process personality disorder question: 'please select the main issues patients currently present with ' note. please note that not all patients were seen in standard psychotherapeutic environments which is why alternative topics are listed as the presenting problem. this refers to other medical conditions, neuropsychological testing and other non-identified topics. qualitative results the overarching themes that were identified in the data were: changes to clinical prac­ tice; changes to other work activities and contexts; the challenges and opportunities; the effect of covid-19 measures on clinical practice and further reflections. within these themes, the following categories were found including: changes to working practices such as online working; psychotherapists reflections on the changes and an exploration of what could be improved and, implications for clinical practice and organizations. perceived changes in clinical practice perceived changes in clinical practice were mostly in regards to working online, e.g., conducting video therapy, and working from home. further, several participants reported changes in treatment frequencies (more/less patients, more sessions per patient), hygiene measures (such as wearing face masks, social distancing in assessments), challenges in asbrand, gerdes, breedvelt et al. 7 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ providing treatment while wearing personal protective equipment (such as face masks), redeployment and logistical difficulties if patients were not able to use online platforms. citation regarding hygiene measures: “every patient has to wash first his hands, more disinfection, mouth-nose-protection, plexiglass for breath protection, safety distance, and more time and space are needed between the appointments for disinfection” citation regarding personal protective equipment: “wearing masks, me and patient, which is very disturbing while there is no emotional expression.” some participants also reflected on patients’ concerns regarding treatment, such as more anxiety and individual differences in motivation to access online treatment. further, therapists’ concerns were also mentioned (e.g., if their hygiene procedure is correct). citation regarding therapists’ concerns: “the first thought in every step is 'how correct is my procedure?'” overall, changes in patient contact (i.e., less appointments, fewer face-to-face contact, more support for patients) were named. perceived changes to other work activities and contexts not all participants were necessarily working in clinical practice, and changes in research and teaching were also reported. participants noted that procedures in the work environ­ ment were modified according to covid-19 safety measures, often leading to a lack of contact between colleagues. in an additional question, general aspects of the working environment were covered. here, once again digitalization was mentioned as a central change, as not only video therapy but also remote meetings with colleagues that had been introduced. citation regarding digitalization: “no face to face clinics, therefore replying on phone and video contact. working in isolation more and away from my team to do working from home.” some participants reported that there was an increasing lack of contact between collea­ gues due to the increasing division in teams as a result of remote working. in answers to this question, participants also highlight the adherence to hygiene measures in the work environment such as social distancing, wearing masks and more cleaning. several participants mentioned that they were mainly working from home and some were holding therapy sessions outside. additionally, two participants were engaged in extra activities regarding covid-19 (i.e., at a phone support line). three participants said that there were significant changes to their research, such as delays in recruitment, or needing to stop research entirely. effects of covid-19 on eaclipt members 8 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ challenges and opportunities in the covid-19 pandemic era the challenges and opportunities that participants reported were wide ranging, and there was not always a clear distinction between what constituted a challenge or an opportunity (e.g., only replying “tele-therapy”), and sometimes different participants reported the same issue as a challenge, whereas others saw it as an opportunity. there were several participants who listed an opportunity that arose as a result of the cov­ id-19 pandemic and also at the same time reported it as a challenge of working during the covid-19 pandemic (e.g., no commute vs. constant working from home). change in work logistics — the change to a predominantly technology-based work practice appeared to be either a challenge or an opportunity for participants. while several participants reported problems regarding technical knowledge and support or in­ ternet connection issues, as well as lack of equipment (such as laptops), remote working was also perceived by some as an opportunity to improve their own technology skills. citation regarding technical factors: “videocalls are more tiring, but effective” a similar pattern of both challenges and opportunities emerged for working logistics: additional childcare, the need to develop new work-related rituals and a higher strain of videocalls were mentioned, as well as no time between meetings. however, several positive aspects were also mentioned, such as less need to travel, more flexibility at work, and the opportunity to access patients who may not have had the possibility to receive treatment otherwise. some also felt that video therapy works very well, and some had been able to further develop their self-care strategies. citation regarding working logistics: “the main challenge was man­ aging childcare alongside working while the nurseries were closed.” citation regarding working logistics: “working from home so less mdt [multidisciplinary teams] working, not being able to provide a service for those with sensory impairments primarily hearing loss, increased competing demands on my time, my own response to covid and lockdown and depleted resources over time. new ways of working do include being able to offer video or remote access to appointments not requiring people to travel and being able to support people who are shielding” citation regarding working logistics: “i had to develop new rituals at the end of the work day, digital work exhausts me more than working from the office” asbrand, gerdes, breedvelt et al. 9 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ clinical issues — interestingly, the therapy-related factors also included both challenges and opportunities. interventions for some mental health problems appeared to be more challenging to deliver online (e.g., depression, trauma) compared to the pre-pandemic face-to-face settings (e.g., difficulty in finding new options to increase activity, more insecurity in trauma treatment due to a lack of stabilizing measures). furthermore, par­ ticipants reported that they were at a greater physical distance to patients during faceto-face interactions, whereas online sessions provided less opportunity for non-verbal feedback and therapeutic engagement. participants reported having to spend more time preparing for sessions, and there were concerns about a lack of consent and choice of therapy modality for patients. conversely, less cancellations were noticed. additionally, participants were able to receive contextual information about their patients by seeing their environment. citation regarding therapy-related factors: “less cancellations and non-attendance at sessions. harder developing rapport and doing ther­ apy without the same transference or cues.” citation regarding therapy-related factors: “video sessions allow for less non-verbal feedback/assessment (negative for diagnosis and treat­ ment recommendation); video sessions allow impression of the patient's home environment (important context information and opportunity for the patient to illustrate problems that occur at home = positive)” citation regarding therapy-related factors: “reachability was better for some, but worse for others, especially mothers (closed schools) and women in abusive relationships (often had to talk in their car)” team and organizational factors — several factors were portrayed as rather chal­ lenging, as participants reported difficulties regarding social factors at work, such as a worsening of team cohesion, staff absence, staff conflicts and social isolation. although some found this to be a positive as they could decide who they spent time with. citation regarding social factors: “all disciplines of staff not offered same opportunities to work from home causing conflict/envy; opportu­ nity to avoid toxic colleagues at work.” citation regarding social factors: “prevent social isolation also in my staff without forcing collaborators back to work” furthermore, a number of organizational factors were mentioned. for example, the rapid change of regulations (e.g., weekly changes) and the lack of guidelines and unified standards were reported to make working processes even more difficult. effects of covid-19 on eaclipt members 10 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ citation regarding organizational factors: “trying to keep up with the constant information changes, rapid decision making and trying to look after myself too” alongside organizational factors, data security issues were also mentioned. this often highlighted the problem of patient confidentiality and keeping data safely stored while working from home. finally, participants reported difficulty adapting to new ways of working initially, however this appeared to develop into a new and practiced working routine over time. effects of the covid-19 pandemic measures on clinical practice participants mainly focused on the effects of covid-19 emergency measures on their clinical practice. the general restrictions of contact, i.e., lockdown, social distancing, restricted entrance to buildings and building closures were mentioned by half of all par­ ticipants. these were often brought into close relation to other themes such as increased psychopathology in patients. citation regarding general restrictions: “restrictions concerning cer­ tain hours for meeting the patients.” citation regarding general restrictions: “lockdown and the unlocking of lock down introducing new anxieties and worry” citation regarding general restrictions: “full lock-down, both in ef­ fect on my work directly and how it seeps into clients' existing strug­ gles” another topic mentioned was the effect of wearing masks. citation on wearing masks: “mask....very hard to work without seeing emotional expression. especially hard with kids” citation on wearing masks: “mask wearing conceals the faces of both client and counselor, lack of nonverbal cues” additionally, effects of hygiene measures on treatment were often mentioned, such as wearing protective clothing, opening windows during sessions, no face-to face contacts and short-notice cancellations due to patient concerns about showing covid-19 symp­ toms. citation regarding hygiene measures: “wearing protection clothing it is necessary and important but it makes work harder” both general restrictions issued by the state and individual restrictions in the workplace had a significant effect on participants and their work, such as closure of nurseries, asbrand, gerdes, breedvelt et al. 11 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ quarantine, shielding, and loss of freedom as well as concerns around travelling on public transport. citation regarding individual restrictions: “closure of nurseries hav­ ing to provide childcare between a working couple means a massive reduction in available working time.” participants also reported on the effects on patients, such as changes in psychological symptoms and less motivation to seek help or engage in online sessions. citation regarding effects on patients: “people with mental health conditions hold their breath: that is do not seek help because they are afraid to get covid-19 and because there is a pause in social life” citation regarding effects on patients: “covid-19 measures, at least in italy, did not help in containing the viruses, as people were terrified by the official information, so did not ask for help or did not dare to go to hospitals, and were hampered from going to parks.” further reflections participants shared a variety of interesting insights into prospective changes concerning both mental health professionals and government policies. one major theme was the wish to collect, share and discuss their experiences of using video therapy. this included both concerns (e.g., regarding effectiveness and data security), and desire for specific training in psychotherapy delivered online. participants also shared that they had a new understanding of the importance of being connected to their colleagues. citation regarding sharing with colleagues: “more practice in online therapy, share data concern effectiveness of online therapy versus on said therapy” citation regarding sharing with colleagues: “i think it would be a good idea to set up a section in clinical psychology in europe [journal of the eaclipt] and invite practicing clinical psychologists to describe their experience with new forms of work. i would be motivated by such an opportunity to contribute, and i would also learn from the experience of colleagues.” in terms of policy implications, it was argued that the importance of mental health should be further promoted at national levels, particularly given the collective impact on mental health. a greater flexibility (e.g., introducing video therapy into health insurance plans) and the possibility of choosing the most suitable treatment modality (e.g., face to face or video) were two major points raised by respondents. furthermore, the effects effects of covid-19 on eaclipt members 12 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ of the current pandemic on both research (e.g., regarding long-term effects on mental health), and the healthcare system was mentioned, including implications for research funding. finally, government policy implications regarding the implementation of policy guidelines, such as closure of nurseries and schools, resulted in a dilemma for many parents who are having to work from home while caring for children. citation regarding political implications: “research funding being so fast and associated huge number of reviews; being on funding panels. existing research in nhs stopped due to redeployment.” citation regarding political implications: “acknowledgement of the impact of covid-19 on the mental health of the population should be acknowledged at a national/international level. awareness needs to be raised in governments and there needs to be a way to address the increased level of distress that the population will undoubtedly experience.” citation regarding political implications: “productivity whilst work­ ing from home is understood although not overtly acknowledged to be more limited when children to be cared for at home too which creates unnecessary guilt when torn between roles. some managers (not mine) did not stand up to look after staff by leading and issuing clear guidance.” several participants pointed out that there will be long-term consequences of the cov­ id-19 pandemic on mental health. citation regarding long-term consequences: “to be prepared that covid-19 has a long-lasting effect on young people especially adoles­ cents and students” d i s c u s s i o n the current study demonstrates that the covid-19 pandemic brought about unprece­ dented changes in clinical practice for clinical psychologists and psychotherapists across eaclipt members in europe. changes to the clinical practice of psychologists and psychotherapists were sudden, for example the digitalization of therapy, which was at odds with previous attempts to implement digital mental health approaches in healthcare (mohr, riper, & schueller, 2018). some opinions and evidence have suggested that this has been a ‘black swan’ moment, where the covid-19 pandemic has led to a rapid change in how mental health care is provided, including more opportunities for online working (wind, rijkeboer, andersson, & riper, 2020), also in lowand middle-income countries (fu et al., 2020). additionally, the current study showed that clinical psychol­ asbrand, gerdes, breedvelt et al. 13 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ ogists and psychotherapists managed to provide treatment throughout the covid-19 pandemic, despite the additional challenges of working in this context, to patients who were perceived to be experiencing a greater level of distress. although challenges were clearly identified in the current study, participants also identified opportunities from working through the pandemic, such as reduction in commuting time, increased work flexibility and accessibility for patients. despite such a significant change in working context for clinical psychologists and psychotherapists, only one previous study looked at the impact of the pandemic on clinical psychologists and psychotherapists and also used a mixed-methods analysis of qualitative and quantitative data (mcbeath et al., 2020). in that study, clinical psycholo­ gists and psychotherapists who were mostly based in the uk, were recruited via social media and, similar to our results, found that clinical psychologists and psychotherapists were able to cope with the rapidly changing work, and managed immediate problems with imagination and engagement. they also described a significant change of psycho­ therapeutic treatment, especially in relation to video therapy. digitalization even though clinical psychologists and psychotherapists have not yet reached a con­ sensus regarding whether they plan to continue using video therapy in the long run (aafjes-van doorn et al., 2020), the opportunities conferred via video therapy are clearly shown, both in the current study and other research (e.g., humer, stippl, et al., 2020). more than ten years ago, simpson (2009) pointed out the opportunities and challenges of video therapy, naming the lack of research regarding efficacy as one major research goal. simpson (2009) also pointed out that efficacy might be strongly related to patient and therapist’s personality and interpersonal style, as well as therapist skills and experience in the use of technology. a pilot project with university students (simpson, guerrini, & rochford, 2015) and the analysis of the recent, covid-19 induced changes (simpson et al., 2021) clearly points out the potential of video therapy if used correctly. it seems likely that the pandemic has shaped therapists’ attitudes towards technology and led to a more positive view of it now they are more experienced in conducting treatment remotely, even if prior to covid-19 they would not have elected to do so (aafjes-van doorn et al., 2020). as the success is highly dependent on therapists’ overall attitudes and self-con­ fidence regarding technology and remote therapy (e.g., aafjes-van doorn et al., 2020), training courses and supervision in this regard is essential. as simpson (2009) already pointed out, some barriers that prevent access to psychotherapy and counselling might be tackled with video therapy such as geographical distance between major cities and remote and rural communities, and a lack of adequate or affordable transport between them. furthermore, video therapy can be used by patients who are immobile (connolly, miller, lindsay, & bauer, 2020). it might also encourage patients to engage who are indecisive about treatment and worry about stigma. finally, most studies overall tend effects of covid-19 on eaclipt members 14 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ to conclude that video therapy will not be the new standard medium for psychotherapy (e.g., aafjes-van doorn et al., 2020; connolly et al., 2020), but a useful addition under certain circumstances and considering specific adaptations such as providing a rationale for video therapy, maintaining therapeutic boundaries and finding a new way of risk management (for an overview see simpson et al., 2021; for an exemplary analysis of pa­ tients with borderline personality disorder see ventura wurman, lee, bateman, fonagy, & nolte, 2021). conducting therapy with personal protective equipment (ppe) while the changes to working as a result of video therapy clearly brought opportunities, conducting therapy in person while using protective equipment such as face masks pre­ sented significant challenges. clinical psychologists and psychotherapists who conducted face-to-face treatment during the pandemic mostly wore face masks and thus covered more than half of their face. thus, while the disadvantage of video therapy is erased (e.g., no technological difficulties), others might appear: it has been argued both in our study and previous opinion pieces (e.g., hüfner, hofer, & sperner-unterweger, 2020) that emotions are harder to read if someone is wearing a face mask, which can then cause difficulties in the patient-therapist relationship. interestingly, initial evidence from basic research has shown mixed findings. some found that emotions are harder to read when the conversational partner wears a face mask (grundmann, epstude, & scheibe, 2021), while others found in a longitudinal design that participants change which cues they use to detect an emotion, suggesting they adjust to the presence of masks (barrick, thornton, & tamir, 2021). one study of school-aged children who are currently constantly interact­ ing while wearing masks concludes that masks pose a challenge but, in combination with other contextual cues, are unlikely to dramatically impair social interactions (ruba & pollak, 2020). translating these findings to the clinical context, one can assume that psychotherapy with masks is somewhat more challenging than without masks, but could still lead to a good patient-therapist relationship and successful treatment outcomes. however, more research on the effects of masks on psychotherapy is necessary. restriction of contact it is important to acknowledge that clinical psychologists and psychotherapists have not only experienced a significant change in their working logistics, but also in their everyday life outside of work – similar to their patients and all other citizens. as some participants have highlighted, social support at work was less available and the team cohesion diminished, thus personal and work resources were limited. furthermore, additional tasks added to stress (e.g., working from home without a proper place to work; child and other family care etc.). these factors indicate the importance of social support asbrand, gerdes, breedvelt et al. 15 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ among the clinical psychologists’ and psychotherapists’ community in difficult times, and the importance of leadership from professional and governmental organizations. reflections for eaclipt it has been an unprecedented working environment for clinical psychologists and psy­ chotherapists during the covid-19 pandemic. clinical psychologists and psychothera­ pists were required to adapt their approach to work at very short notice during the first wave of the covid-19 pandemic. however, survey respondents reported that they managed to convert working logistics efficiently and have been providing much needed care for patients ever since, even though the examination of the efficacy of treatment still needs more research. this was often done on an individual basis or by smaller groups of colleagues. an important next step is to collect, share and discuss experiences of, and develop guidelines for, video or phone therapy or intervention. this has been done locally (e.g., uk, simpson, richardson, pietrabissa, castelnuovo, & reid, 2021. however, the eaclipt as an organization has provided a position statement and a summary of national statements on what is needed for both patients and clinical psychologists and psychotherapists as well as future research endeavors regarding mental health6 by integrating perspectives from a wide range of clinical psychologists and psychotherapists across multiple countries. reflections for government policy and other institutions although the sample of the current survey was limited to eaclipt members, arguably, this data could be useful to inform the policies of government and other institutions, as the views of clinical psychologists and psychological therapists are represented from across a broad range of occupationals settings, across multiple european countries. the current findings emphasize the importance of including mental health issues in current policy considerations on how to manage the pandemic in the longer term. the long-term effects on mental health as a result of the covid-19 pandemic are still not clear (e.g., de figueiredo et al., 2021). based on previous research on epidemics, further symptom increases in the upcoming one to three years are expected in anxiety, anger, depression, post-traumatic stress symptoms, alcohol abuse, and behavioural changes such as avoid­ ing crowded places and cautious hand washing (e.g., kathirvel, 2020). this needs to be considered both in research (e.g., which factors could lead to mental health problems in the long run, de figueiredo et al., 2021) and in health care (e.g., further flexible inclusion of video therapy into health insurance plans; enlarging mental health treatment provi­ sion; kathirvel, 2020). in addition, the uptake of video therapy by clinical psychologists and psychotherapists during the covid-19 pandemic offers the opportunity to take part 6) https://www.eaclipt.org/?tab=5 effects of covid-19 on eaclipt members 16 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.eaclipt.org/?tab=5 https://www.psychopen.eu/ in treatment long distance (the therapist in one country, the patient in another) which calls for cross-border guidelines. limitations and implications the current study was implemented during the first wave of the covid-19 pandemic, from may to september 2020. the pandemic is still ongoing and, thus, the situation is continually changing. to keep the questionnaire as short as possible to encourage participants to complete the survey, we did not include detailed information on the sociodemographic background and we did not ask for detailed numbers and facts, e.g. re­ garding the number of patient contacts before and during the pandemic. we rather opted to assess the personal estimation of change, which relies on the therapist’s perception of the number of patient contacts and could include inaccuracies. additionally, we are aware that only a small number of members completed the survey (i.e., 13% of eaclipt members) and, thus, the results have to be considered in light of a rather limited and selective sample. however, our results provide a qualitative and quantitative picture of the first abrupt changes to the work of clinical psychologists and psychotherapists as a result of the covid-19 pandemic. furthermore, in the current study, responses to open questions were often quite short, which at times limited the scope of interpretation. however, many answers poin­ ted to similar conclusions as shown above. the current study highlights the tremendous challenges that both patients and clin­ ical psychologists and psychotherapists have experienced during the pandemic. conse­ quently, there are calls for specific training for therapists and clear guidelines regarding the use of technology, data security and solutions to the psychotherapeutic challenges of delivering therapy remotely. however, more research (such as the follow-up to this survey that is underway) is necessary to identify the long-term effects of the covid-19 pandemic on both patients and clinical psychologists and psychotherapists, and to com­ prehensively influence policy and future healthcare considerations. asbrand, gerdes, breedvelt et al. 17 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://www.psychopen.eu/ funding: the authors have no funding to report. acknowledgments: the authors have no additional (i.e., non-financial) support to report. competing interests: winfried rief is one of the editors-in-chief and colette hirsch is a subject editor of clinical psychology in europe. both authors played no editorial role in this particular article or intervened in any form in the peer review process. andreas maercker, céline douilliez, gerhard andersson, martin debbané, roman cieslak, and claudi bockting are editorial board members of clinical psychology in europe but did not intervene in any form in the peer review process. twitter accounts: @julia_asbrand, @samgerdes1, @josefienumh, @jennyguidi, @drcolettehirsch, @cdouilliez, @profgerharda, @martindebb, @rocie, @wrief1, @clbockting s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the questionnaire which was used in the study (for access see index of supplementary materials below). index of supplementary materials asbrand, j., gerdes, s., breedvelt, j., guidi, j., hirsch, c., maercker, a., douilliez, c., andersson, g., debbané, m., cieslak, r., rief, w., & bockting, c. 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(2020). the covid-19 pandemic: the ‘black swan’ for mental health care and a turning point for e-health. internet interventions, 20, article 100317. https://doi.org/10.1016/j.invent.2020.100317 xiong, j., lipsitz, o., nasri, f., lui, l. m. w., gill, h., & phan, l. (2020). impact of covid-19 pandemic on mental health in the general population: a systematic review. journal of affective disorders, 277, 55–64. https://doi.org/10.1016/j.jad.2020.08.001 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. asbrand, gerdes, breedvelt et al. 21 clinical psychology in europe 2023, vol. 5(1), article e8109 https://doi.org/10.32872/cpe.8109 https://doi.org/10.1002/cpp.2521 https://doi.org/10.1080/09515070.2020.1814694 https://doi.org/10.1016/j.bbi.2020.05.048 https://doi.org/10.1016/j.invent.2020.100317 https://doi.org/10.1016/j.jad.2020.08.001 https://www.psychopen.eu/ effects of covid-19 on eaclipt members (introduction) method participants procedure and measures quantitative and qualitative analysis results quantitative results qualitative results discussion digitalization conducting therapy with personal protective equipment (ppe) restriction of contact reflections for eaclipt reflections for government policy and other institutions limitations and implications (additional information) funding acknowledgments competing interests twitter accounts supplementary materials references an online mindfulness intervention for international students: a randomized controlled feasibility trial research articles an online mindfulness intervention for international students: a randomized controlled feasibility trial sumeyye balci 1 , ann-marie küchler 1 , david daniel ebert 2 , harald baumeister 1 [1] department of clinical psychology and psychotherapy, institute of psychology and education, ulm university, ulm, germany. [2] department of sport and health sciences, technical university of munich, munich, germany. clinical psychology in europe, 2023, vol. 5(2), article e9341, https://doi.org/10.32872/cpe.9341 received: 2022-04-19 • accepted: 2023-05-03 • published (vor): 2023-06-29 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: sumeyye balci, department of clinical psychology and psychotherapy, institute of psychology and education, ulm university, lise-meitner-straße 16, d-89081 ulm, germany. phone: +49-(0)731/50 32812. e-mail: sumeyye.balci@uni-ulm.de supplementary materials: preregistration [see index of supplementary materials] abstract background: student mobility across borders poses challenges to health systems at the university and country levels. international students suffer from stress more than their local peers, however, do not seek help or underutilize existing help offers. some barriers to help-seeking among international students are insufficient information regarding the health offers, stigma, and language, which might be overcome via culturally adapted internet and mobile-based interventions (imi). method: a randomized controlled feasibility trial with a parallel design assessed the feasibility and potential efficacy of an online mindfulness intervention adapted for international university students. participants were randomized into either an adapted online mindfulness intervention (studicarem-e) (ig, n = 20) or a waitlist control group (wl, n = 20). participants were assessed at baseline (t0) and eight-week post-randomization (t1). the feasibility of studicarem-e was evaluated regarding intervention adherence, client satisfaction, and potential negative effects. the potential efficacy of studicarem-e was measured by means of the level of mindfulness, perceived stress, depression, anxiety, presenteeism, and wellbeing. efficacy outcomes were evaluated with regression models on the intention-to-treat (itt) sample (n = 40), adjusting for the baseline values. results: participants’ formative feedback suggested improvements in the content of the imi. there were no crucial negative effects compared to wl. assessment dropout was 35% (ig: 50%: wl: 20%), this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9341&domain=pdf&date_stamp=2023-06-29 https://orcid.org/0000-0001-8219-6163 https://orcid.org/0000-0003-3305-4892 https://orcid.org/0000-0001-6820-0146 https://orcid.org/0000-0002-2040-661x https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ and intervention dropout was 60%. studicarem-e yielded significant improvements in mindfulness (β = .34), well-being (β = .37), and anxiety (β = -.42) compared to wl. conclusion: studicarem-e might be used among culturally diverse international student populations to improve their well-being. future studies might carefully inspect the extent of the adaptation needs of their target group and design their interventions accordingly. keywords e-health, digital health, student mental health, cultural adaptation, internet intervention, international student highlights • international students suffer from more stress compared to their local peers but rarely seek help. • internet interventions can be adapted to cater to the needs of culturally diverse international students. • the adapted internet intervention for international students offers great potential to improve psychological outcomes. starting university after high school is a challenging time. university students experience stress due to financial issues, love life, and family relationships (karyotaki et al., 2020), and sexual identity (rentería et al., 2021). exposure to these stressors might result in developing a mental health problem or low academic functioning, even dropping out of university (athira et al., 2020; bantjes et al., 2021; bruffaerts et al., 2018). prevalence of mental health problems among university students assessed from eight countries, and 19 universities, resulted in 35% of student participants (n = 13.984) having at least one mental health problem (i.e. anxiety, mood, or substance use), with major depressive disorder (mdd) (21.2% lifetime prevalence, 18.5% 12-month prevalence) being the most common and generalized anxiety disorder (gad) the second most common (18.6% lifetime prevalence, 16.7% 12-month prevalence) (auerbach et al., 2018). the burden from mental health problems comprises 45% of the overall disease burden among 10-24year-olds (gore et al., 2011). moreover, the majority of mental health problems over the lifetime first develop before the age of 24, which makes this time of university crucial to screen for mental health problems and provide prevention and/or treatment opportunities (jones, 2013). students who cross borders to study are increasing in europe, especially in germany, where the number of international students substantially increased from 312.000 in 2018 to 416.437 in 2020 (eurostat, 2018; statistisches bundesamt, 2021). international students encounter similar life challenges as students studying in their home country but are also faced with additional stressors that may trigger homesickness (akhtar & kröner-herwig, 2015), problems in socializing with the local students (byrne et al., 2019), adapting to a new country, lifestyle, and language, and a new academic culture and customs an adapted version of an online mindfulness intervention for international students 2 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ (forbes-mewett & sawyer, 2016; yu & wright, 2016). studying abroad, while mostly associated with positive experiences, can cause some challenges and result in mental burden (orygen, 2020; stokes et al., 2021). even though university students suffer from psychological distress, their help-seek­ ing behavior is very limited (auerbach et al., 2016). this can be attributed to various factors, such as not being familiar with the symptoms of or the help options for mental health problems, social stigma, social and cultural influences (e.g. traditional masculine ideals) (lynch et al., 2018), limited access to professional help via university, and finan­ cial problems (auerbach et al., 2016; gulliver et al., 2010; orygen, 2020). although their psychological stress level is higher compared to students of the host country (lu et al., 2014), international students are less likely to seek help from a counseling service (lu et al., 2014; stokes et al., 2021), have lower mental health literacy, and less positive attitudes towards seeking help (clough et al., 2019). some barriers which are specific to international students might be related to cultural backgrounds where symptom severity is underestimated, hesitation because of their family’s reaction, and language barrier (lu et al., 2014). in general, cultural influences play an important role in attitudes toward mental health and help-seeking (hudak et al., 2018). furthermore, international students who reach out to a counseling service fail to utilize psychological help services, e.g. not attending the necessary number of sessions, and even benefit less from it, compared to local students who utilized these services (stokes et al., 2021), and drop out of the treat­ ment prematurely (nilsson et al., 2004). in summary, there is a persistent discrepancy between mental health needs and actual help-seeking behavior among international stu­ dents. therefore, it is critical to offer appropriate psychological help to this particularly vulnerable sub-group of the student population (teegen & conrad-popova, 2021). barriers to help-seeking could be overcome by an easily accessible offer via deliver­ ing psychological health interventions online. internetand mobile-based interventions (imi) have the advantage of being independent of time and place, ability to reach pop­ ulations otherwise hard to reach, offering interventions to treat and prevent various psychological problems, and are cost-effective (ebert et al., 2018). likewise, imi have proven to be effective in university student populations with small to moderate effects in decreasing psychological symptoms (harrer et al., 2019). provided as guided imi they could work as effectively as face-to-face cognitive behavioral therapy (carlbring et al., 2018). the limited number of studies that targeted international students’ wellbeing via offering an imi resulted in improved mental health (kanekar et al., 2010), reduction of sleep difficulties (spanhel, burdach, et al., 2021), more help-seeking, and reduced stigma (clough et al., 2020). however, issues around the adherence and uptake of imi still persist (batterham et al., 2021; molloy et al., 2021). imi can also aim at treating mental health problems, e.g. depression, but can also be utilized in promoting health skills (galante et al., 2018; sevilla-llewellyn-jones et al., 2018). an example of a helpful skill to promote mental health and well-being is mindfulness. mindfulness refers to balci, küchler, ebert, & baumeister 3 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ experiencing the present and being aware of life with acceptance and self-compassion, without any judgment (slom & kabat-zinn, 2020). mindfulness-based interventions could be delivered successfully online (jayawardene et al., 2017), and have been tested and found effective among students (hall et al., 2018; mak et al., 2015; nguyen-feng et al., 2017) and general and clinical populations (querstret et al., 2018; sevilla-llewellyn-jones et al., 2018). a recent meta-analysis of rcts of online mindfulness interventions resulted in significant small to moderate effects on depression (g = .34), anxiety (g = .26), mindful­ ness (g = .40), stress (g = .44), well-being (g = .22). these effects were maintained in the follow-up for depression (g = .25) and anxiety (g = .23) (sommers-spijkerman et al., 2021). mindfulness interventions can be seen as less threatening due to their associations with well-being and calmness, instead of interventions targeting mental health problems which might impede help-seeking due to stigma (clement et al., 2015). mindfulness interventions could also be adapted to meet the needs of a specific target group. for instance, the delivery method could be changed (e. g. intervention taking place in a cultural community center), the facilitator, researcher/therapist, could be matched with a target group’s cultural background, a culturally congruent recruitment strategy could be adopted, the content could be changed, culturally appropriate analogies could be used (watson-singleton et al., 2019), dispelling myths around mindfulness (castellanos et al., 2020; cotter & jones, 2020; lawlor, 2022), storytelling, and community input can be uti­ lized (le & gobert, 2015). however, the adaptation of online mindfulness interventions is rarely defined in detail in the previous literature, but systematic adaptation frameworks are emerging (loucks et al., 2022; spanhel, balci, et al., 2021). moreover, mindfulness interventions’ transdiagnostic nature and growing popularity in recent years via adver­ tising as a self-care instrument make them more appealing. they could therefore serve as an alternative way to reach out to international students with various psychological problems. objectives in order to explore the feasibility and possible efficacy of the online mindfulness inter­ vention adapted for international students, studicare mindfulness – english version (studicarem-e), the following research questions will be explored.   research questions: 1. are the study methods feasible and transferable to a future, large-scale randomized controlled trial with regard to implementation and the chosen recruitment strategy? 2. what are the levels of intervention satisfaction, adherence, negative effects, and acceptance? 3. does the internet-based intervention studicarem-e have a potential effect on increasing mindfulness levels compared to a waitlist control group? an adapted version of an online mindfulness intervention for international students 4 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ 4. what effects does the studicarem-e have on measures of psychological well-being (depression, stress, anxiety, well-being, and presenteeism) in comparison to the waitlist control group? m e t h o d this is a two-armed, randomized controlled trial of parallel design (registered in the german clinical trials register drks00017507) comparing guided imi studicarem-e (ig) with a waitlist control group (wl) receiving the unguided version of the same imi eight weeks post-randomization. the study was approved by the ethics committee of ulm university (number 413/18) and followed the consort guidelines for feasibility trials (eldridge et al., 2016). participants the eligibility criteria for participating in the study were: being at least 18 years old, having a low to moderate level of mindfulness (freiburg mindfulness inventory fmi < 37), having internet access, having student status, ability to read and understand english (all self-reported), giving consent to participate in the study. exclusion criteria included being in a mindfulness course, having a higher than moderate mindfulness level, and being in psychotherapy. procedure participants were recruited from july 2019 to march 2020. the recruitment was done through regular emails sent out twice a year from the cooperating universities of the studicare project (harrer et al., 2018; küchler et al., 2019) in germany, switzerland, and austria, complemented by study posters and further on-site recruitment strategies at the ulm university. the email consisted of information regarding various trainings that are offered within the studicare project at a given time along with an invitation to participate in the training. additional emails were sent to universities’ international offices in the above-mentioned countries. potential participants received a direct link to the study website to register and were then invited to the screening via email. after screening and providing informed consent, participants were invited to complete the initial survey. participants were randomized into either intervention (immediate access) or waitlist (access eight weeks post-randomization) control group. afterward, they got access to online training. randomization randomization was carried out by an independent researcher who was not involved in the studicare project. a simple randomization list applying block sizes of two and balci, küchler, ebert, & baumeister 5 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ four by a computer generator was created using sealed envelope1. 20 participants were allocated to each study arm with a 1:1 ratio, making a total of 40 participants. intervention based on acceptance and commitment therapy (hayes et al., 1999) and stress manage­ ment principles (kaluza, 2015), studicarem-e consists of seven weekly modules and two booster sessions; each module takes approximately 50 minutes to complete (küchler et al., 2020; schultchen et al., 2020). studicarem-e has been shown to yield a high effect among german-speaking students compared to a waitlist control group (d = 1.37) (küchler et al., 2022). participants were advised to complete one module per week. participants who com­ pleted seven modules received access to booster sessions one and two, four and 12 weeks, respectively, after completion of the last module. the focus of the intervention is on promoting mindfulness and psychological flexibility. the content is delivered on a content management platform (www.minddistrict.com) via text, images, audio files, and interactive quizzes. participants were able to access the online platform minddistrict at all times. every module aims at improving a different skill, such as identifying stress-inducing thinking patterns and getting in touch with values in life. at the end of each module, homework is assigned to the participant, and at the beginning of the next module, the participants are encouraged to monitor their progress. each module introduces a different kind of meditation exercise, e.g. body scan, interoception. a mind­ fulness journal and a summary of the respective module were available at the end of each module. content and introduced mindfulness exercises of each module are presented in table 1. adaptation of the intervention cultural adaptation of the intervention was based on resnicow’s theory of cultural sensi­ tivity in health behavior intervention development, which has two dimensions: surface and deep structure. according to the theory, interventions could be altered to fit the target groups’ needs and features in these levels where surface-level alterations concern visible characteristics of the target population such as language, music, food choices, and clothing, whereas deep structure changes refer to counting intersecting effects of cultur­ al, social, historical and psychological influences on the target health behavior (resnicow et al., 2000). in this trial, surface structure changes were conducted to make the interven­ tion content more compatible with culturally diverse international students. conducted changes to the original german intervention represented in table 2 based on spanhel et al.’s taxonomy of cultural adaptation of imi for mental health problems (spanhel, balci, 1) https://www.sealedenvelope.com/simple-randomiser/v1/lists an adapted version of an online mindfulness intervention for international students 6 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 http://www.minddistrict.com https://www.sealedenvelope.com/simple-randomiser/v1/lists https://www.psychopen.eu/ et al., 2021). the taxonomy consists of various components that researchers can adapt in order to make imi more appropriate to the new target group: ten components related to the content of the intervention, four methodological, and three procedural components. changes were implemented in content components (e.g. stigmatization of mental health problems), methodological (e.g. guidance in english), and procedural domains (e.g. using a theoretical framework for adaptation). for english-speaking international students, the intervention content of studicare-mindfulness (küchler et al., 2020; schultchen et al., 2020) was translated to english and certain aspects (e.g. language barrier, different education systems) changed in accordance with student life and stress sources. table 1 intervention modules and mindfulness exercises module names content mindfulness meditation exercises awareness an introduction to the concept of mindfulness body scan, mindful walking exercise mindful body perception mindful perception of bodily signals heart meditation, mindful perception of satiety and hunger stress-aggravating thought mindful coping strategies to deal with stress and distancing from stressful thoughts power of thoughts, mindful straightening the posture a beneficial thought developing a beneficial thought to deal with stress inhaling the beneficial thought, short breathing meditation values in life discovering what is important and valuable in life here and now exercise self-care looking at yourself with a loving gaze loving and kindness meditation body&mind enjoying small things in life with mindfulness shavasana and mindful yoga refresh i&ii review of previous modules repeating the previous exercises balci, küchler, ebert, & baumeister 7 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ table 2 culturally adapted elements of studicare mindfulness-e core components / specific components example content components 1. illustrated characters appearances/ names of characters change of names of characters to diverse names (e.g. hua, andrew, farah) content/ stories/ background of characters added characters from various regions of the world who migrated to study in germany 2. illustrated activities daily life walking the dog, tutoring a fellow student, and contact with family members living abroad 3. illustrated environment/ burdens burdens high level of pressure for academic excellence, adapting to a foreign academic culture 4. language translation translating intervention german to english 5. language tailoring simplify text: shortening text passages, simplifying sentences less technical phrasing, modify wording for easier readability use of concrete terms or informal language the colloquial form was used milder descriptions of mental health concepts describing psychological problems in a university context 6. difference in concepts of mental health and its treatment stigmatization of mental health problems framing the goal of the intervention as a mindfulness-based stress management tool instead of mental health intervention in order to reduce the stigma 7. goals of treatment increase understanding of treatment possibilities introducing various ways of coping with university-related stressors. 8. methods of treatment information/ links to other helpful addresses psychological help offers which might be available in english are presented to each participant an adapted version of an online mindfulness intervention for international students 8 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ core components / specific components example methodological components 9. guidance person used as guide guidance by an english-speaking psychologist (sb) format of guidance (tailored feedback) participants can ask for personal contact in addition to semistructured feedback procedural components 10. methods used to obtain information personal interaction (focus groups, interviews, discussions, think-aloud) received feedback in the form of qualitative data for the process evaluation and further implementation of the program surveys/ questionnaires assessed acceptance and effectiveness pilot/ feasibility studies this trial has been conducted to measure the feasibility to inform a future definitive trial. 11. persons involved target group and associated people international students professionals working with the target group international office workers of partner universities distributed recruitment emails 12. theoretical framework guideline for cultural adaptation of face-to-face treatment surface structure changes were based on the cultural sensitivity framework by resnicow (resnicow et al., 2000) guidance at the end of each module, intervention group (ig) participants received feedback from an e-coach, who was a trained psychologist (sb). each feedback consisted of a review of their progress in the intervention and encouragement to continue the intervention such as “dear …., thanks for sending your third module! i am happy that you are working actively on the program.” and continues with a review of completed exercises “the second task was to think about stressful situations in the past and what helped you to cope with stress. you wrote that … was very helpful for you.” and end with an encouragement to continue with the upcoming module “i wish you a relaxed week with many attentive moments and a lot of fun while working on module 4.”. moreover, reminder emails were sent to the participants who did not complete the modules in time. the e-coach was instructed to take no longer than 15 minutes per feedback, which results in a planned e-coaching time of max. 105 minutes per participant for all seven modules. balci, küchler, ebert, & baumeister 9 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ sms coach in imi, receiving sms messages may contribute to adherence and intervention effect (lentferink et al., 2017; webb et al., 2010). consequently, a voluntary text message coach was implemented and offered to each participant. these motivational sms messages were set to be sent every two days, throughout the intervention. they consisted of motivational texts to promote the use of learned skills, be mindful throughout the day, and continue the intervention, such as “‘the true art of life is to see beauty in the daily.’ what beautiful moment did you experience today?”, and “‘every moment is absolute, alive and meaningful.’ – what was your mindful moment today? when was the least mindful moment? how did you feel then?”. control group control group participants received a document summarizing the alternative support offers via email after the randomization. participants of the control group got access to the unguided version of the studicarem-e eight weeks after the randomization. assessment and outcomes assessments were conducted via an online platform, www.unipark.de, at baseline (t0) and eight weeks post-randomization (t1), blinding of outcome assessment was not possi­ ble. all data were self-reported. acceptability was measured via participants’ attitudes towards the imi, their forma­ tive feedback, and satisfaction with the intervention and its potential negative effects. open-ended questions at the end of each module were extracted from the minddistrict platform. these outcomes are reported descriptively. the primary efficacy outcome of this study is mindfulness level. secondary outcomes are anxiety, stress, depression, personality, well-being, presenteeism, client satisfac­ tion, risks and negative effects of psychotherapy, and acceptance and adherence ques­ tions. mindfulness was assessed using the freiburg mindfulness inventory (fmi), which consists of 14 items measuring mindfulness on a 4-point scale ranging from 1= rarely to 4 = almost always, and showed high internal consistency (α = 0.84) (walach et al., 2006). anxiety was measured with a 7-item generalized anxiety disorder questionnaire (gad-7) on a scale from 0 = not at all to 3 = nearly every day and has high internal consistency (α = 0.92) (spitzer et al., 2006). stress outcome was measured with 4-item perceived stress scale (0 = never to 4 = very often), which also showed good reliability (α = 0.77) (warttig et al., 2013). depression was measured with an 8-item patient health questionnaire, where high reliability was observed (α = 0.89) and rated on a scale of 0 = not at all to 3 = early every day (kroenke et al., 2001). an adapted version of an online mindfulness intervention for international students 10 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 http://www.unipark.de https://www.psychopen.eu/ who-5 well-being index was used to assess subjective well-being on a scale of 0 = at no time to 5 = all of the time, which showed high internal consistency, α > 0.80 (lara-cabrera et al., 2022; spanhel, burdach, et al., 2021; topp et al., 2015). presenteeism, i.e. loss of productivity was measured with the presenteeism scale for students. the subscale of work impairment was used to assess the degree of pre­ senteeism, which consist of 10 items; with total scores ranging from 10 to 50, higher scores represent a higher degree of presenteeism and showed high reliability, α = 0.90 (matsushita et al., 2011). eight weeks after randomization, in addition to the above-mentioned tools, assess­ ments of intervention satisfaction were done using the client satisfaction questionnaire (total scores range from 8 to 32) adapted to internet-based interventions (boß et al., 2016). negative effects of psychotherapy were measured using inep (inventory for the assessment of negative effects of psychotherapy) adapted to online interventions with 22 items describing possible negative effects that may occur during the online interven­ tion and whether they are attributed to the intervention (ladwig et al., 2014). the results of this scale are presented descriptively. sample size in order to determine the sample size for this feasibility trial, we followed the recommen­ dation by whitehead et al. (2016), resulting in a sample size of 15 participants per trial arm for pilot testing of a potential confirmatory trial with 90% power and two-sided 5% significance. a meta-analysis resulted in an effect size of 0.40 for mindfulness-based imi, therefore we assumed a higher effect size, i.e. 0.50 because this trial is guided (sommers-spijkerman et al., 2021). with the expectation of a 30% dropout, we aimed at reaching a sample size of 40 in total. statistical analyses ibm spss/version 26 and r studio were used in statistical analyses with a significance level of α = 0.05. descriptive statistics (means, sds for continuous outcomes, and percen­ tages for categorical variables) were used to summarize the demographic and feasibility data for study groups. linear regression models were used to investigate potential group differences, where baseline values were used as covariates in all models (dummy coded predictor: ig = 1). for each outcome, we reported standardized regression coefficients and corresponding 95% ci and adjusted r 2 values. data analyses were based on the intention-to-treat principle (itt). missing data were imputed based on multivariate imputation by chained equations to create 20 completed datasets with 15 iterations. predictive mean matching was applied as an imputation model. balci, küchler, ebert, & baumeister 11 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ r e s u l t s feasibility recruitment and participants recruitment lasted from may 2019 until march 2020. one hundred and twenty-three participants were invited to the screening. n = 46 did not complete the screening. out of 77 screened, 37 were excluded due to the following reasons: not providing informed consent (n = 18), having a high fmi score (> 37) (n = 10), being in psychotherapy (n = 6), being in another mindfulness training (n = 1), not being a student (n = 1), and providing an inaccessible email address (n = 1). n = 40 provided consent and were randomized to either ig or wl groups, see figure 1. the mean age of the participants was m = 26.23 (sd = 4.51), 77.5% were female, 37.5% could speak the host country’s language well (>b2 level), and 97% speak english well (>b2 level). the study level of the participants varied: out of 40, 24 studied in a master's program, nine were in a bachelor's program, six were in a ph.d. program, and one participant was doing an internship semester. the baseline characteristics of the participants are tabulated in table 3. out of 40 randomized participants, 26 (ig: 50%; wl: 80%) completed the t1, resulting in a study dropout of 35%. there was a baseline difference between assessment dropouts and non-dropouts, where non-dropouts had slightly more stress (mean difference = 1.68). intervention adherence out of 20 participants randomized into the ig, eight participants (40%) completed at least five core modules (four of them completed the seven modules), whereas four did not finish the first module. three completed the first module, two participants completed two modules, two participants three modules and one participant completed the fourth module, see figure 2. all the intervention completers also completed the post-randomi­ zation assessment. no reasons were reported regarding no uptake of the intervention. the average intervention duration among the intervention completers was 60 days, five of them completed the intervention within 60 days. eight participants signed up for the sms coach. based on 10 participants’ answers to the open-ended questions on t1, participants practiced mindfulness on average 3.6 days weekly during the intervention. on these days, they spent an average of 18.3 minutes practicing mindfulness. acceptability in order to assess the acceptability of the studicarem-e among the participants, we used various sources: open-ended questions by the end of the post-intervention measurement, treatment satisfaction measured via csq, and potential negative effects measured with inep-on, and formative user feedback extracted via the online platform of minddistrict. an adapted version of an online mindfulness intervention for international students 12 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ according to the data from the open-ended questions at t1 (n = 10), five participants (25%) signed up for the sms coach and found this helpful. six participants stated that mindfulness meditation exercises were the most helpful element of the intervention. body scan and body-related exercises, e.g. mindful yoga, were well-liked by the partici­ pants. two participants stressed that example characters and the quiz on stress sources figure 1 flow diagram screened for eligibility (n = 77) excluded (n = 37) • no informed consent (n = 18) • fmi > 37 (n = 10) • current psychotherapy (n = 6) • not enrolled in college (n = 1) • providing an inaccessible email address (n = 1) assessed for objective 1 (n = 10) assessed for objective 2&3 (n = 20) allocated to intervention (n = 20) • received allocated intervention (n = 8) • did not receive allocated intervention (no reason reported) (n = 12) lost to follow-up (no reason reported) (n = 4) allocated to intervention (n = 20) • received allocated intervention (n = 20) assessed for objective 1 (n = 0) assessed for objective 2&3 (n = 20) lost to follow-up (give reasons) (n = 10) discontinued intervention (no reason reported) (n = 12) allocation assessment follow-up randomized (n = 40) enrollment assessed for eligibility assessment (n = 123) screened balci, küchler, ebert, & baumeister 13 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ were beneficial. the majority of the participants (79%) found the length of the modules just right. on average the participants scored the feasibility of doing the modules with daily tasks 7.3 out of a 10-point scale (0 = not feasible; 10 = very feasible) and scored 3.8 on the same scale regarding the disturbance the processing of modules caused in table 3 baseline characteristics variable all participants (n = 40) ig (n = 20) wl (n = 20) n % n % n % sociodemographic characteristics age (m, sd) 26.23 4.5 25.05 3.5 27.40 5.2 female gender 31 77.5 19 95 12 60 single 23 57.5 12 60 11 55 knowledge of host country language (> b2 level) 15 37.5 5 25.0 10 50.0 country of origin albania (n = 2), belarus (n = 3), belgium (n = 1), cameroon (n = 1), canada (n = 3), colombia (n = 2), costa rica (n = 1), france (n = 2), german (n = 1), ghana (n = 1), india (n = 1), indonesia (n = 2), italy (n = 3), kazakhstan (n = 1), kyrgyz republic (n = 1), mexica (n = 2), nepal (n = 1), pakistan (n = 1), portugal (n = 1), romania (n = 1), russia (n = 1), sweden (n = 1), turkey (n = 4), ukraine (n = 1), usa (n = 2) study characteristics full-time student 34 85 18 90 16 80 semester (m, sd) 10.14 6.8 9.21 5.02 11.06 8.36 study subject business and finance 8 20.0 4 20.0 4 20.0 social sciences 8 20.0 6 30.0 2 10.0 engineering 7 17.5 4 20.0 3 15.0 medicine & health 5 12.5 3 15.0 2 10.0 nature sciences 5 12.5 0 0 5 12.5 computer sciences 4 10.0 1 5.0 3 15.0 design 2 5.0 1 5.0 1 5.0 psychology 1 2.5 1 5.0 0 0 treatment utilization psychotherapy experience 10 25 7 35 3 15 m sd m sd m sd outcome measures mindfulness level 27.28 5.75 27.30 6.27 27.25 5.34 depressive symptoms 16.68 3.39 18.10 2.28 19.25 3.9 anxiety symptoms 17.27 4.42 16.75 4.09 17.80 4.77 presenteeism level 27.85 2.21 27.8 2.40 27.9 2.05 well-being 35.20 17.09 37.60 17.25 32.80 17 stress level 13.38 2.44 13.10 2.31 13.65 2.58 note. m = mean; sd = standard deviation; ig = intervention group; wl = waitlist control group. an adapted version of an online mindfulness intervention for international students 14 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ their everyday life. additionally, they scored 8.9 on their likelihood of participating in a mindfulness-based intervention in the future. in terms of treatment satisfaction, the itt data on csq, the overall satisfaction with the intervention was m = 25.4, sd = 2.2. all of the completers would definitely or probably recommend the intervention to a friend and 90% reported that the intervention met their needs, 70% would like to receive such intervention if they need help in the future, and 80% found the intervention satisfactory. potential negative effects of studicarem-e were evaluated with inep-on in t1. based on the results from inep-on, six ig participants reported seven negative effects caused by the imi in the following domains: anxiety about finding insurance (n = 1), increased financial worries (n = 1), data security (n = 1), feeling forced to do the exercises of the intervention despite not wanting to do it (n = 3), difficulties in making important decisions without asking the therapist (n = 2), found training or the formulations of the e-coach contained hurtful statements (n = 1) and feeling that being made fun of in the intervention material (n = 1). one participant reported negative effects on each of the above-mentioned domains, whereas the rest of the five participants reported negative ef­ fects on a single domain. of the five, two reported feeling forced into finishing modules, and three reported neglecting hobby/social contacts. no suicidal ideation was reported caused by the imi. the magnitude of all negative effects reported was low to moderate. according to the formative feedback extracted from the minddistrict platform, all of the modules were well-liked, scoring ≥ 7 out of a 10-point scale, the most liked being the last module (module 7: body and mind). recommendations included adding more figure 2 intervention completion 4 2 2 1 2 2 3 4 0 1 2 3 4 module 7 module 6 module 5 module 4 module 3 module 2 module 1 no log in intervention completion number of participants balci, küchler, ebert, & baumeister 15 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ video/audio files, diversifying example characters’ experiences, adding more mindfulness meditation exercises, and decreasing the number of text fields. efficacy outcomes descriptive statistics of the study outcomes at the baseline are represented in table 3. there were no baseline differences observed. controlling for baseline mindfulness levels, ig participants showed improvement in mindfulness at the t1 compared to wl (β = 0.34, 95% ci [0.06, 0.63], p < .05; adjusted r 2 = 0.13). moreover, anxiety was improved among ig participants, compared to wl (β = -0.42, 95% ci [-0.72, -0.11], p < .05; adjusted r 2 = 0.14) as well as well-being (β = 0.37, 95% ci [0.07, 0.68], p < .05; adjusted r 2 = 0.13). the effect estimates (β, ci, and p values) of the rest of the secondary outcomes are presented in table 4. table 4 post-randomization between-group differences adjusted for baseline values outcome baseline (t1) m (sd) posttreatment (t2) m (sd) standardized coefficient ß 95% ci p mindfulness (fmi) 27.27 (5.75) 31.79 (4.50) 0.34 [0.06 0.63] .01 depression symptoms (phq-8) 18.68 (3.39) 16.89 (3.88) -0.10 [-0.39 0.21] .52 anxiety symptoms (gad-7) 17.27 (4.42) 15.53 (3.84) -0.42 [-0.72 -0.11] .01 stress level (pss-4) 13.38 (2.44) 11.79 (2.05) -0.14 [-0.46 0.17] .37 wellbeing (who-5) 35.20 (17.09) 44.42 (15.44) 0.37 [0.07 0.68] .02 pss (presenteeism-work impairment score) 13.38 (2.44) 27.66 (1.47) -0.01 [-0.34 0.32] .94 note. m = mean; sd = standard deviation; fmi = freiburg mindfulness inventory; gad-7 = generalized anxiety disorder questionnaire; phq-8 = patient health questionnaire; pss = presenteeism scale for students; pss-4 = short form perceived stress scale; who-5 = world health organization well-being index. d i s c u s s i o n this rct evaluated the feasibility, acceptability, and potential efficacy of a cross-cultural version of a mindfulness-based imi among international university students studying in germany, austria, and switzerland. the initial results suggest that the adapted version of studicarem-e was feasible, perceived acceptable, and offered benefits in psychological outcomes compared to wl, and minor negative effects were reported among ig partici­ pants. our preliminary results might guide a powered definitive trial. working examples and recommendations for improvement are presented in the following paragraphs. our recruitment strategy included sending emails via cooperating universities, using social media channels of university groups/student clubs, and hanging hard copy posters around the ulm university campus. we aimed at reaching a total of 40 participants, an adapted version of an online mindfulness intervention for international students 16 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ which took 11 months. the length of the recruitment is longer than a previous digital sleep intervention for international students, where n = 81 was reached in seven months (spanhel, burdach, et al., 2021). one reason for this might be the length and transdiag­ nostic nature of our intervention. moreover, international student offices could be better utilized to aid the recruitment process in a future trial. with the above-mentioned strategy, we reached a population of mostly female (77%) participants, aiming for a post-graduate degree (82.5%), e.g. master's and ph.d., which was higher than daad’s 2019/20 report of international students studying for a postgraduate degree in germany (52%) (daad, 2020). a post-randomization assessment dropout rate of 35% was detected. half of the ig and 20% of the wl failed to do the post-randomization assessment. this rate is in accordance with previous mindfulness imi among students (lahtinen et al., 2023). it is no surprise to have fewer dropouts in a waitlist control condition because the participants of this condition got access to the intervention only after completing the post-randomization assessment. in order to avoid dropouts, we sent out six reminder emails to participants who did not complete this assessment. however, the success of these measures was limited. future trials might include reminder sms or phone calls to decrease the dropout rate. the intervention adherence rate among ig participants was 40%. this rate is in line with a recent meta-analysis of online mindfulness interventions conducted with students and non-student populations, in which adherence rates ranged from 35 to 92% (sommers-spijkerman et al., 2021). although guided imi correlated with higher rates of adherence (treanor et al., 2021; zarski et al., 2016), this was not the case in our trial. according to a review, some factors related to an increase in adherence to imi are the female gender, being in the control group, having time flexibility to do the intervention, computer literacy, guidance, and depth of personalized feedback to increase self-efficacy (beatty & binnion, 2016). although our sample embodied some of these factors, e.g. guidance, others could be improved. program content seems to be a decisive factor in adherence. credibility, positive perceptions of the intervention content, personalization of the intervention team (e.g. providing a photo of the team), and intensity (e.g. too long/short and/or being too generic) of the content play a role in adherence (beatty & binnion, 2016). the inclusion of some persuasive design aspects might aid adherence as well (baumeister et al., 2019). as mentioned by the participants as well, computer-human dialogue support, e.g. audio and visual content, and social support, e.g. competition, categories can be improved in a future definitive trial. one specific component of this trial was that we adapted our intervention to a culturally diverse group of international students. this diversity of the target group might require novel intervention features beyond surface structure changes (resnicow et al., 2000) to increase adherence. adapting an intervention for a group of participants from various cultural, social, and financial backgrounds is particularly challenging, and balci, küchler, ebert, & baumeister 17 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ naturally, offering intervention content as common as possible to be able to appeal to the majority is demanding. therefore, one should carefully inspect all the parameters and make sure that the cultural adaptation of the imi adds a substantial benefit to its target group. in this context, evidence of cultural adaptations’ substantial benefits is still inconclusive. based on a recent meta-analysis, cultural adaptation of health promotion imi might not be worth the considerable amount of effort because such adaptions do not seem to yield better effectiveness compared to active and passive controls (balci et al., 2022). however, a previous review suggested that culturally adapted face-to-face and online interventions resulted in reducing depression and anxiety (harper shehadeh et al., 2016). moreover, cultural adaptions are poorly reported in existing literature, which makes it difficult to compare across studies and draw definitive conclusions (balci et al., 2022). the next step should include comparing an adapted imi to a non-adapted intervention. such dismantling trials could provide insights into whether cultural adapta­ tion processes are actually beneficial. in a recent trial, a non-culturally adapted sleep imi yielded beneficial effects for culturally diverse international student groups (spanhel, burdach, et al., 2021). this might bring out the idea that some intervention contents might not significantly benefit from an elaborate adaptation process, especially for low threshold interventions (böttche et al., 2021; cuijpers et al., 2018; spanhel, burdach, et al., 2021). this trend emerged in our results as well, where we only realized surface-level adaptations (resnicow et al., 2000) and still found potential effectiveness. more impor­ tantly, imi have different mechanisms of change, therefore a detailed cultural adaptation might be beneficial for a certain imi content or delivery, but not for all (domhardt et al., 2021; heim & kohrt, 2019). in a review, most of the culturally adapted interventions did not modify their core contents but included core additions and delivery methods to make the intervention more acceptable to the new target group while ensuring the fidelity of the original intervention (chu & leino, 2017). for mindfulness-based imi, valued living, cognitive fusion, present moment awareness, and acceptance are effective mediators among college students (levin, haeger, pierce, & twohig, 2017; viskovich & pakenham, 2020). some of these mediators are part of the universal human condition, therefore, might not even need any adaptation. lastly, acculturation might play a role in attitudes toward seeking mental health (lu et al., 2014). therefore, acculturation levels of international students might be considered when adapting or developing interventions for this population. only six negative effects were reported and these were low to mild in extent. moreover, the imi caused no suicidal ideation. negative effects of psychotherapy are expected and their reporting is increasing (rozental et al., 2018). this result suggested that studicarem-e is a rather safe intervention, and might be also administered in an unguided form. furthermore, studicarem-e participants showed improvements in mindfulness, anxi­ ety, and well-being levels. stress and depression scores did not reach significance. while an adapted version of an online mindfulness intervention for international students 18 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ a trend suggests possible beneficial effects regarding these outcomes, a powered defini­ tive trial would be necessary to confirm these effects since this trial was only powered for feasibility. the mean effect sizes are higher than in a meta-analysis of online mind­ fulness interventions compared to a waitlist and no-treatment controls (spijkerman et al., 2016). however, trials with waitlist control groups tend to yield higher effect sizes (van agteren et al., 2021), thus in order to validate the studicarem-e’s efficacy, research should initially test this in a powered trial with more follow-up points, and compare it to treatment as usual, a placebo control group or active controls. like any other, this trial is not free from limitations. firstly, our sample mostly consisted of female participants, therefore our results cannot be generalized to male or non-binary populations. however, this is a common trend in psychological interven­ tions. secondly, a major limitation of this trial was grouping international students from various backgrounds and living situations under the label of international students, consequently masking potential differences among them. thirdly, our sample consisted of participants with diverse cultural backgrounds. according to a meta-analysis of 99 studies, it was found that studies with more homogenous participants in terms of cultural background yielded larger effect sizes (soto et al., 2018). even though culturally adapted, this intervention was in english. people prefer to have a unity of language with their mental health care provider (villalobos et al., 2016), and providing interventions in the chosen language of the client is a significant predictor of better outcomes (soto et al., 2018). despite this fact, participants assessed the language of the intervention as being easy to understand. however, still providing the intervention content in the participant’s chosen language might increase the efficacy of the intervention further. therefore, a future definitive trial might consider offering the same intervention in different languag­ es to choose from and might adapt the intervention based on parsimonious social and cultural features. fourth, this feasibility trial used a wl control group. as expected, trials of culturally adapted face-to-face mental health interventions with a wl group resulted in higher effect sizes, compared to an active control condition (d = 0.53 vs d = 0.47) (soto et al., 2018). this is also true for imi (sommers-spijkerman et al., 2021). fifth, due to high dropout and low adherence, we were able to collect less qualitative and quantitative data to inform acceptability and potential efficacy. assessment dropout was 35% in total, which is in accordance with the previous research (nilsson et al., 2004). possible reasons for this may include a lack of monetary incentives, procrastination, and the typical work­ load of student life. in order to tackle potential bias arising from differential dropout, we multiply imputed our data with the assumption of missing at random (bell et al., 2013), and added baseline values as covariates in all regression models. however, there was a baseline difference between assessment dropout and non-dropouts where, participants who completed the post-randomization assessment had a slightly higher stress level in the beginning of the study, therefore might be more motivated, needed a medium to deal with the stress, and had more place to grow. lastly, this feasibility trial reached a limited balci, küchler, ebert, & baumeister 19 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://www.psychopen.eu/ sample size; therefore, the initial efficacy results should be interpreted with caution. an inspection of sustainability of intervention effect beyond post-treatment is warranted. conclusion online interventions to decrease stress and improve the well-being of international university students seem to have great potential, whereas face-to-face offers are not often utilized and benefited in limitation. despite being presented to vastly culturally diverse student groups, studicarem-e yielded beneficial results with good acceptability and non-crucial negative effects. a future definitive rct might offer a more robust efficacy and potential moderator and mediator effects. funding: s.b. receives a scholarship granted by the ministry of national education in turkey. open access funding was provided by the university of ulm. the funders had no role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript. acknowledgments: we would like to acknowledge the valuable support from our interns ms. ayse yürekli and ms. kevser aksoy in study management, content creation, and our research assistants tim dretzler, jana moos, and francesca mildenberger in assessment procedure and study administration, and mathias harrer for his support in offering the english webpages of studicare, and yannik terhorst for his consultation on data analyses. we would like to especially thank all the cooperating universities around germany, austria, and switzerland for their support of recruitment. competing interests: the authors have declared that no competing interests exist. ethics statement: the study was approved by the ethics committee of ulm university (number 413/18). reporting guidelines: this article follows the guidelines of consort statement. twitter accounts: @psksumeyyeb data availability: the dataset may be obtained (from s.b.) on request depending on to-be-specified data security and data exchange regulation agreements. to ensure confidentiality, shared data will exclude any identifying participant information. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the pre-registration information for the study (for access see index of supplementary materials below). an adapted version of an online mindfulness intervention for international students 20 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://twitter.com/psksumeyyeb https://www.psychopen.eu/ index of supplementary materials balci, s., küchler, a., ebert, d. d., & baumeister, h. 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(2016). adherence to internet-based mobile-supported stress management: a pooled analysis of individual participant data from three randomized controlled trials. journal of medical internet research, 18(6), article e146. https://doi.org/10.2196/jmir.4493 clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. balci, küchler, ebert, & baumeister 29 clinical psychology in europe 2023, vol. 5(2), article e9341 https://doi.org/10.32872/cpe.9341 https://doi.org/10.2196/jmir.1376 https://doi.org/10.1177/0962280215588241 https://doi.org/10.1080/13583883.2015.1127405 https://doi.org/10.2196/jmir.4493 https://www.psychopen.eu/ an adapted version of an online mindfulness intervention for international students (introduction) objectives method participants procedure randomization intervention adaptation of the intervention guidance sms coach control group assessment and outcomes sample size statistical analyses results feasibility efficacy outcomes discussion conclusion (additional information) funding acknowledgments competing interests ethics statement reporting guidelines twitter accounts data availability supplementary materials references skill improvement through learning in therapy (skilt): a study protocol for a randomized trial testing the direct effects of cognitive behavioral therapy skill acquisition and role of learning capacity in depression research articles skill improvement through learning in therapy (skilt): a study protocol for a randomized trial testing the direct effects of cognitive behavioral therapy skill acquisition and role of learning capacity in depression sanne j. e. bruijniks 1,2, ulrike frank 1, brunna tuschen-caffier 1, jessica werthmann 1, fritz renner 1 [1] department of psychology, clinical psychology and psychotherapy, university of freiburg, freiburg, germany. [2] department of clinical psychology, utrecht university, utrecht, the netherlands. clinical psychology in europe, 2023, vol. 5(1), article e8475, https://doi.org/10.32872/cpe.8475 received: 2022-03-02 • accepted: 2023-01-06 • published (vor): 2023-03-31 handling editor: cornelia weise, philipps-university of marburg, marburg, germany corresponding author: sanne j. e. bruijniks, albert-ludwigs university of freiburg, engelbergerstrasse 41, 79106, freiburg, germany. e-mail: s.j.e.bruijniks@uu.nl supplementary materials: materials [see index of supplementary materials] abstract background: to improve psychological treatments for major depressive disorder (mdd), a better understanding on how symptoms ameliorate during treatment is essential. in cognitive behavioral therapy (cbt), it is unclear whether procedures focused on the acquisition of cbt skills play a causal role in the improvement of cbt skills. in this randomized trial, we isolate a single cbt skill acquisition procedure (cbtsap) and test its direct effects on cbt skills and related therapy processes (i.e., change in (idiosyncratic) dysfunctional thinking and reward processing). we hypothesize that the cbtsap causes improvements in cbt skills and related therapy processes compared to an active control condition. in addition, we hypothesize that individual differences in attentional bias and memory functioning (defined as learning capacity) moderate the effects of cbtsap on outcomes and that using mental imagery as a cognitive support strategy to strengthen the effects of the cbtsap will be most beneficial for patients with low learning capacity. method: 150 patients with mdd will be randomized to one of three conditions: 1. an active control condition, 2. cbtsap, 2. cbtsap plus mental imagery, all consisting of three sessions. primary outcomes will be change in cbt skills, changes in (idiosyncratic) dysfunctional thoughts this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.8475&domain=pdf&date_stamp=2023-03-31 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ and behaviors, reward processing. depressive symptoms are a secondary outcome. measures of learning capacity will be conducted at baseline and tested as a potential moderator. discussion: knowing whether and for whom the acquisition of cbt skills leads to change in therapy processes and a subsequent reduction of depressive symptoms will inform on how to personalize and optimize psychotherapy outcomes for depression. trial registration: the trial is registered at the german clinical trial register (dktr; registration number: drks00024116). keywords major depressive disorder (mdd), cognitive-behavioral therapy (cbt), cognitive behavioral therapy skills, mental imagery, experiment highlights • study protocol for a randomized trial to test direct effects of a procedure focused on cbt skill acquisition in mdd. • outcomes are cbt skills, dysfunctional thinking, reward processing and depressive symptoms. • the role of learning capacity as a moderator will be investigated. • results will inform on the direct effects and individual differences in effects of cbt procedures. b a c k g r o u n d current psychological treatments for depression are only effective for half of the patients (cuijpers et al., 2021). response to psychological treatments is limited and relapse rates are high (steinert et al., 2014; verduijn et al., 2017; vittengl et al., 2007). to improve and innovate psychological treatments, a better understanding of how symptoms improve during treatment is essential. psychotherapies aim to reduce depressive symptoms by mobilizing therapy processes that seem central to the development and maintenance of depressive symptoms. therapy processes can be defined as the mechanisms inside the mind of the patient that are activated by the therapeutic procedures delivered by the therapist with the intent of producing change (bruijniks et al., 2018). in cognitive behavioral therapy (cbt; beck et al., 1979), one of the most investigated treatments for depression, therapeutic procedures focus on three major therapy processes: dysfunctional thinking, behavioral activation and the acquisition of cbt skills (barber & derubeis, 1989; lorenzo-luaces et al., 2016). first, cognitive change procedures aim to change the process of dysfunctional thinking (garratt et al., 2007). dysfunctional thoughts can be organized into different levels, some thoughts seem to occur more on a superficial level (negative automatic thoughts), while other thoughts are derived from more deeply integrated dysfunctional mental represen­ tations, that can include rules, expectations, or assumptions (attitudes) and sometimes skill improvement through learning in therapy (skilt) 2 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ even originate from early experiences in the childhood (schemas) (dozois & beck, 2008). second, cbt includes procedures aimed at behavioral activation in order to improve deficits in reward processing (dimidjian et al., 2011), such as a reduced response to reward or an oversensitive response to negative feedback (chiu & deldin, 2007; eshel & roiser, 2010; smoski et al., 2009). the third therapy process, the acquisition of cbt skills, is related to both dysfunctional thinking and behavioral activation. cbt skills are defined as the ability to re-evaluate the accuracy of one's own dysfunctional beliefs (ct skills) and in this way change patterns of dysfunctional thinking and the ability to engage proactively in pleasurable activities as a way to target reward experience (bt skills) (strunk et al., 2007). the acquisition of cbt skills is maybe one of the most promising therapy processes of cbt for depression. in contrast to the procedures focused on cognitive change and behavioral activation, cbt skill acquisition is a therapy process that emphasizes the patients' ability to use these cognitive change and behavioral activation procedures themselves, outside the therapy sessions. in addition, successful use of cbt skills may protect the patient from developing new future episodes after successful treatments (strunk et al., 2007). research shows that after successful treatment, impairments such as dysfunctional mental representations (arntz, 2020; sheppard & teasdale, 2004), negative processing of information (elgersma et al., 2019; spinhoven et al., 2018; woody et al., 2017) or blunted reward processing (dichter et al., 2012; pechtel et al., 2013) may remain, thereby possibly increasing the risk of new depressive episodes. the acquisition of cbt skills might be essential to transfer learned content from the therapy session to daily life and to cope with dysfunctional therapy processes or symptoms in future scenarios outside the therapeutic context. however, although multiple studies have pointed out that the acquisition of cbt skills is associated with reduced depression (adler et al., 2015; forand et al., 2018; strunk et al., 2014; webb et al., 2019) and seems specific to cbt (bruijniks et al., 2022), it is still unknown whether cbt skill acquisition directly causes a reduction of symptoms of depression. in order to test the causal effects of a certain therapeutic procedure, it is necessary to isolate the procedure and investigate its direct effects on the hypothesized changes in therapy processes and outcome (bruijniks et al., 2018). two preliminary experiments that focused on the acquisition of ct skills already evaluated how a proce­ dure focused on the acquisition of ct skills could be isolated (bruijniks et al., 2018) and showed that a short cognitive skill acquisition procedure in the form of a group masterclass led to better ct skill acquisition compared to an active control procedure in a sample of distressed students (bruijniks, los, & huibers 2020). a next step towards the clinical application of this finding would be to evaluate how a procedure focused on cbt skill acquisition causally affects the acquisition of cbt skills and subsequent symptom reduction in a clinically depressed sample. bruijniks, frank, tuschen-caffier et al. 3 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ nevertheless, skill acquisition seems to be a multifaceted process that requires dif­ ferent cognitive and neurobiological resources (anderson et al., 2016, 2018; basak et al., 2011; vanlehn, 1996), which may be impaired in depressed patients. compared to healthy individuals, depressed individuals have biased attention towards negative rather than positive information (fu et al., 2008; liu et al., 2012; marchetti et al., 2018; roiser et al., 2012) and suffer from a variety of deficits related to executive functioning, such as inhibition, planning and working memory (snyder, 2013). recent studies supported the hypothesis that individual differences in cognitive or neurobiological impairments may interfere with the success of psychological treatments. in a systematic review, cognitive and neurobiological impairments showed to be associated with impairments in dysfunctional thinking and reward processing while depressed patients with better cognitive control, but more emotional bias, before start of cbt seemed to benefit more from cbt’s procedures (bruijniks, derubeis, et al., 2019). possibly, patients who show more emotional bias are better able to tolerate and therefore target emotions as part of the cbt (stange et al., 2017) while individuals with better cognitive capacities are more capable of integrating and implementing new information that was retrieved in the therapy session. cbt might help individuals with increased emotional bias, but limited cognitive capacity, to regain (emotional) control (siegle et al., 2006). a recent experiment supports this suggestion, as results indicated that in healthy participants who received a stress induction, executive control under stress, but not under non-stressful circum­ stances, predicted the ability to reappraise negative material to become less negative (quinn & joormann, 2020). investigating whether individual differences in cognitive or neurobiological impairments are associated with the success of a cbt skill acquisition procedure will provide insight in for whom cbt skill acquisition procedures will be more or less effective. if individual differences in cognitive or neurobiological impairments are related to the success of cbt skill acquisition, this also means that the success of cbt skill acquisition might be improved by increasing the patients' capacity to learn from these procedures. one way to address and improve cognitive and neurobiological processes during treatment is by providing cognitive support. examples are the use of memory strategies within sessions of cbt (harvey et al., 2014, 2017) or providing short retrieval tests between the sessions (bruijniks, sijbrandij, et al., 2020). the major hypothesis is that by enhancing recall for the session content, the success of psychotherapy outcomes for depression can be improved and some studies provided preliminary evidence for this hypothesis (dong, lee, et al., 2017). however, to improve psychotherapy it might not only be important to improve recall of the session content but also improve and develop the therapy process. yet, while current cognitive support strategies such as retrieval of newly learned information may improve recall of the session content, it might not be enough to improve cbt skill acquisition. according to theories on skill acquisition, the process of skill acquisition starts with learning new information (this can also be seen skill improvement through learning in therapy (skilt) 4 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ as the 'declarative' part of skill acquisition), but then repeated practice is necessary to turn it into a more procedural form in which the newly learned skill becomes more and more automatized over time (anderson et al., 2018; tenison & anderson, 2016; vanlehn, 1996). to increase skill acquisition, it might therefore be necessary to use a strategy that supports both the declarative and procedural parts of memory. one strategy that seems promising in affecting both declarative and procedural mem­ ory is mental imagery. mental imagery refers to perceptual experiences in the absence of sensory input and constitutes a non-verbal way of information processing, closely related to the experience of emotions (holmes & mathews, 2010). mental imagery allows us to simulate past and future experiences and because of this allows us to “try-out” different courses of actions and their emotional consequences (ji et al., 2016; moulton & kosslyn, 2009). given these properties of mental imagery, when applied to cbt skills, imagery could be used to simulate skill application (renner et al., 2021). mental imagery has been linked to improved acquisition of skills in non-clinical settings, such as tennis performance or the development of surgical skills (anton et al., 2017; dana & gozalzadeh, 2017; gregg et al., 2011; kim et al., 2017; kraeutner et al., 2016), but also to increased bt skills in a clinically depressed population (renner et al., 2017). additionally, mental imagery has been related to the improvement of cognitive functioning, such as recall of memories (dalgleish et al., 2013) and prospective memory (i.e., memorizing to execute a previously formed intention at some point in the future; mcfarland & glisky, 2012; mcfarland & vasterling, 2018). we suggest that simulating applying cbt skills using mental imagery might be a potential efficient way to increase skill acquisition during psychotherapy (renner et al., 2021). the aims of this randomized trial are two-fold. the first aim is to investigate and compare the direct effects of three procedures (active control, cbt skill acquisition (cbtsap), cbtsap + mental imagery) on changes in therapy processes (the acquisition of cbt skills, changes in idiosyncratic dysfunctional thoughts and behaviors, general dysfunctional thinking and reward processing) and depressive symptoms in a sample of patients with a diagnosis of major depressive disorder who do not currently receive other psychological treatment. we expect that compared to an active control procedure, the procedures focused on cbt skill acquisition (cbtsap and cbtsap + mental imagery) will lead to more improvement in the therapy processes and depressive symptoms. sec­ ond, we will investigate whether the effect of the therapeutic procedures is moderated by individual differences in learning capacity. learning capacity will be defined as the presence of memory functioning and emotional bias (i.e., where more emotional bias and better memory functioning are defined as better learning capacity). following earlier literature on the measurement of memory (unsworth, 2010; wilhelm et al., 2013), the measurement of memory functioning will be composed of both working memory and long-term memory tasks. we expect that, compared to the active control procedure, better learning capacity will be associated with larger improvements in the therapy bruijniks, frank, tuschen-caffier et al. 5 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ processes and depressive symptoms in both the cbtsap’s. in addition, we expect a difference between cbtsap with versus without mental imagery: patients with low learning capacity will have most benefit from mental imagery and lower learning capaci­ ty will therefore be associated with more improvement in the therapy processes and depressive symptoms in the cbtsap with mental imagery compared to the cbtsap without mental imagery condition. besides the two main aims of the study, additional secondary analyses will be con­ ducted. because earlier studies suggested that cognitive support might improve the effects of therapy by increasing memory of the session content (dong, lee, et al., 2017), we additionally included a measure of session recall in the study and will test whether session recall will differ between the procedures. hypotheses of these secondary analyses are in line with our hypotheses for the main study aims: we expect session recall to be larger in the cbtsap with mental imagery compared to the cbtsap without mental imagery. in further secondary analyses we will investigate whether the effect of the procedures on depressive symptoms is mediated through one of the therapy processes and/or session recall and whether these mediation effects are specific to the cbtsap's (compared to the active control procedure). a conceptual model for the proposed study can be found in figure 1. figure 1 conceptual model for the proposed study methods active control moderator therapy procedures mechanisms: change in therapy processes patients with mild to severe depression (n = 150) cbt skill acquisition + mental imagery cbt skill acquisition  cbt skills  idiosyncratic dysfunctional thoughts and behaviors,  dysfunctional thinking  reward processing  recall change in depressive symptoms learning capacity   skill improvement through learning in therapy (skilt) 6 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ m e t h o d design between-subject experimental design with three parallel conditions, each having an equal length of 3 x 45-minute sessions: 1) active control procedure (n = 50), 2) cbt skill acquisition procedure (cbtsap) (n = 50), 3) cbtsap with mental imagery (n = 50). the ethic committee of freiburg university approved the study (registration number: 20-1022) and the trial is pre-registered at the german clinical trial register (dktr; registration number: drks00024116). participants we aim to include 150 patients with a primary diagnosis of a major depressive disorder (mdd) (excluding non-dysthymic persistent major depressive disorder) as indicated by structural clinical interview for dsm-5 disorders (scid-5-cv) and a score on beck’s depression inventory ii (bdi-ii) ≥ 14 to ensure sufficient symptom severity. patients should be aged between 18-65 and have sufficient knowledge of the german language (because therapy sessions will be held in german). to prevent any potential interference with the therapeutic procedures and/or measurement of learning capacity, patients with the presence of a previously stated diagnosis of attention-deficit/hyperactivity disorder or attention-deficit disorder, current drug or alcohol use disorder according to the struc­ tural clinical interview for dsm-5 (scid-5-cv) or a cluster a or b personality disorder known by admission to the treatment center are excluded. to ensure the effects are attributable to the current therapeutic procedures, patients who receive currently (other) psychological treatment or have received cbt focusing on a major depressive disorder in the previous year are excluded. to reduce risk of adverse events, patient who show a high risk of suicide according to the intake staff or a score > 1 on bdi_ii item 13 (suicidal thought or wishes) will be excluded. sample size based on a medium effect size, alpha = .05, power =.80, number of experimental condi­ tions = 3, number of repeated measurements = 2 to 4 (g*power (faul et al., 2007)), a total sample size of 102 to 120 participants would be needed to detect a main effect, and 42 to 57 participants to detect an interaction in a repeated measures anova. simulation studies suggest 80 to 100 participants to detect an interaction effect between three groups (shieh, 2019) while simulation studies on multilevel analyses suggest n = 80 participants to detect a medium effect size with power =.80 (aarts et al., 2014). taking into account 20% drop-out, we aim to include a total of 150 participants. bruijniks, frank, tuschen-caffier et al. 7 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ recruitment patients will be recruited in two different ways. first, patients will be recruited from the academic outpatient treatment center at the department of psychology, unit for clinical psychology and psychotherapy at the albert-ludwigs university of freiburg. patients with various mental health problems and with a large variety of socio-demo­ graphic backgrounds seek treatment at the clinic. patients can receive up to 80 sessions individual cbt at the clinic in accordance with the german national health insurance regulations. treatment seeking individuals with severe mental disorders (e.g. schizophre­ nia) or acute suicidality are referred to other specialized services outside the clinic or in-patient treatment if indicated. during the intake patients will be checked on inand exclusion criteria and receive the patient information letter if they are potentially eligible for study participation. after one week, patients will be called to check whether they are interested in participating in the study. the remaining inand exclusion criteria will be checked, and the structural clinical interview for dsm-5 clinical version (scid-5-cv) interview will be conducted by phone. the procedures will take place while the patient is on a waiting list for regular treatment at the outpatient clinic. second, individuals can sign up for the study independently of treatment in the academic outpatient treatment center. information about the study will be put online and distributed in local health care centers. if interested, individuals will be send the patient information letter, called after one week to check remaining inand exclusion criteria and a scid-5-cv will be planned. randomization and procedure patient who are eligible to participate in the study will complete a baseline measurement and an introduction session on different days. the baseline measurement will take place in the lab and includes a measurement of learning capacity. informed consent will be signed before the baseline measurement. the order of the measurements during the baseline measurement will be randomized for each participant in order to control for potential fatigue effects. the introduction session is conducted by the therapist and focuses on introducing the principles of cbt and completing the core belief interview (cbi; mcbride et al., 2007). after the introduction session, patients will be randomized into one of the three conditions using a computer script performing block randomization (1:1:1, block size = 15). block randomization will be done by a researcher who is not involved in the study measurements. randomization will be pre-stratified on severity of depression (mild [beck depression inventory-ii (bdi-ii) = 14-19] vs. moderate to severe [bdi-ii ≥ 20]). therapy sessions will be completed weekly and the total study procedure from baseline measurement to the post measurement will take a maximum of 5 weeks. the researchers who perform the study measurements are blind for the therapeutic procedures. the full study procedure is also presented in figure 2. participants do not receive financial incentives for participation in this study. skill improvement through learning in therapy (skilt) 8 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ figure 2 recruitment and study procedure   intake at outpatient clinic or sign up by email screening for inand exclusion criteria and scid-i by phone week 1 week 2-4 week 4-5 baseline measurement introduction session (session 1) randomization active control procedure (3 sessions + pre and post-session measurements) post-procedure measurement one-week follow-up measurement cbtsap (3 sessions + pre and post-session measurements) cbtsap + mental imagery (3 sessions + pre and postsession measurements) note. the exact time point of each measurement is given in table 1. bruijniks, frank, tuschen-caffier et al. 9 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ therapists the therapeutic procedures will be conducted by 5 licensed therapists who are working at the outpatient treatment center of the university of freiburg. all therapist involved in this study had completed a 3-year fulltime psychotherapist cbt training course required and strictly regulated in germany to obtain a license as clinical psychological psychotherapist. therapist have between 5 and 29 years therapy experience. before start of the study, the therapists received 8 hour training consisting of advanced training in cbt skills by dr. strunk (ohio state university), advanced mental imagery training conducted by dr. renner (university of freiburg) and elaborate training on the different protocols for each therapeutic procedure in the study. all therapists will be involved in the delivery of all different procedures. introduction session the introduction session will focus on introducing the principles of cbt (central focus will be on the relation between thoughts, behaviors and mood) and completing the cbi. during the cbi, the therapist and patient try to gain insight in the current three most relevant dysfunctional beliefs and current three most relevant dysfunctional behaviors for the patient. these beliefs and behaviors will be used in the subsequent sessions to discuss in relation with depressive symptoms (active control procedure) or to practice cbt skills (cbtsap and cbtsap + mental imagery condition). therapeutic procedures all therapeutic procedures use techniques from the protocol for cognitive behavioral therapy (cbt; beck et al., 1979) for depression and use agenda setting to structure the sessions. in addition, each procedure will focus on targeting the idiosyncratic beliefs and behaviors that were established during the cbi. however, the procedures differ in the number of active ingredients (see figure 3 and data supplement 1). during the active control procedure, the therapist and patient will focus on discussion of dysfunctional thoughts and behaviors only. therapists in this condition will be explicitly instructed to focus purely on exploring the relation between dysfunctional thinking and behavior and depressive symptoms, and not to engage in evaluating dysfunctional thinking or behav­ ioral activation. during the cbt skill acquisition procedure (cbtsap), the therapist and patient will choose one of the cognitive or behavioral skills from a predefined list of cbt skills (i.e., consisting of behavioral activation (behavioral therapy skill) and questions used for evaluating dysfunctional thoughts (cognitive therapy skill). subsequently, the therapist and patient will discuss how this skill could be or have been applied in past or future situations in which idiosyncratic beliefs and behaviors may (have) lead to negative mood. during the cbtsap plus mental imagery, the therapist and patient will not only discuss application of the skill but in addition, engage in a mental imagery exercise skill improvement through learning in therapy (skilt) 10 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ of skill application. the mental imagery exercise is based on a guided mental imagery procedure and has been shown to increase motivation for goal directed behaviors (heise et al., 2022; renner et al., 2019). during the mental imagery procedure, participants are instructed to imagine as vividly as possible and focusing on the positive aspects of the image. the procedure consists of the following steps: 1) imagine the contextual cues (e.g., place, date) of a future or past situation with depressive symptom(s), 2) engaging in multi-sensory imagery of applying the cbt skill in this situation, 3) imaging and experiencing the positive aspects related to successfully applying the cbt skill. all sessions will be videotaped for treatment fidelity checks. research intervision will take place regularly. the agenda for each therapeutic procedure and the list of cbt skills that can be chosen from and practiced in the cbtsap procedures is given in data supplement 1 and 2. figure 3 therapeutic elements per procedure   active control procedure cbt skill acquisition procedure cbt skill acquisition procedure plus mental imagery agenda setting agenda setting agenda setting control component explore relation of recent depressive symptoms with dysfunctional thoughts and/or behaviors active element 1 discuss skill application to target dysfunctional thoughts and/or behaviors active element 2 mental imagery of skill application active element 1 discuss skill application to target dysfunctional thoughts and/or behaviors note. detailed information on the session content can be found in data supplement 1 and 2. instruments an overview of all patient measurements is given in table 1. an overview of all measure­ ments completed by the therapists or third observers can be found in table 2. bruijniks, frank, tuschen-caffier et al. 11 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ ta b le 1 o ve rv ie w o f p at ie nt i ns tr um en ts p er t im e p oi nt m ea su re m en t in st ru m en ts b as el in e in tr od uc ti on se ss io n se ss io n 1 se ss io n 2 se ss io n 3 o n e da y af te r se ss io n 3 fo ll ow -u p p ri m ar y ou tc om es : t h er ap y pr oc es se s cb t sk ill s w ay s of r es po n di n g (w o r ) x x b eh av io ra l a ct iv at io n f or d ep re ss io n s ca le – s h or t fo rm (b a d ssf ) x x x x x x c og n it iv e c h an ge s us ta in ed c h an ge ( c c sc ) x x x x x x id io sy nc ra tic th ou gh ts an d be ha vi or s c or e b el ie f in te rv ie w ( c b i) x x x x x x dy sf un cti on al th in ki ng c og n it io n c h ec kl is t (c c l) x x x re wa rd pr oc es sin g r ew ar d p ro ba bi li ty i n de x (r p i) x x x t em po ra l e xp er ie n ce o f p le as ur e (t e p s) x x x se co n da ry o ut co m es : s ym pt om s de pr es sio n b ec k d ep re ss io n i n ve n to ry i i (b d iii ) x x x x x x sy m pt om s o th er th an d ep re ss io n b ri ef s ym pt om i n ve n to ry ( b si ) x x skill improvement through learning in therapy (skilt) 12 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ m ea su re m en t in st ru m en ts b as el in e in tr od uc ti on se ss io n se ss io n 1 se ss io n 2 se ss io n 3 o n e da y af te r se ss io n 3 fo ll ow -u p p ot en ti al m od er at or s: l ea rn in g ca pa ci ty m em or y f un cti on in g v er ba l w or ki n g m em or y: n -b ac k ta sk x v is ua l w or ki n g m em or y: s in gl e pr ob e de te ct io n t as k x lo n gte rm m em or y p ai re das so ci at es t as k x em ot io na l b ia s fr ee v ie w in g ey etr ac ki n g ta sk x x x o th er m ea su re s re ca ll p at ie n t r ec al l t es t (p r t ) x x x x x di ag no sti cs sc id -5 -c v x de m og ra ph ics x tr ea tm en t e va lu at io n x m an ip ul at io n ch ec k x x x pr oc ed ur e c he ck x ex pe cte d su cc es s x x n ot e. c b t sa p = c b t s ki ll a cq ui si ti on p ro ce du re ; m i = m en ta l i m ag er y; s tr uc tu ra l c li n ic al i n te rv ie w f or d sm -v c li n ic al v er si on ( sc id -5 -c v ). bruijniks, frank, tuschen-caffier et al. 13 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ table 2 overview of therapist/observer instruments per time point measurement instruments baseline introduction session session 1 session 2 session 3 postprocedure follow-up therapy processes therapist-rated recall x x x manipulation check therapy integrity x protocol deviations x x x primary outcome: therapy processes cbt skills — cbt skill acquisition will be measured in two different ways. first, before and one week after the therapeutic procedure patients will complete the ways of responding (wor; barber & derubeis, 1992). during the wor, cbt skills of the participants are tested by asking them to think about themselves in various situations and to tell what they would think and do in such situations. the wor will reflect the level of cbt skills demonstrated by the patient. patients will receive three scenarios before treatment and three different scenarios after treatment. answers to each scenario will be coded into 25 different categories (more categories per answer possible) and given a rating of the overall quality of the response (i.e., the raters’ judgment on how well the response would be in improving mood or adjusting to the individual’s needs, range = 1 (very negatively) to 7 (very positively)). the total score will be composed of the number of responses on positive categories (responses considered consistent with cbt) minus the number of responses on negative categories (depressotypic statements). interrater reliability showed to be high (ranging from α = .91 to α = .98) and discriminant and convergent validity have been supported (for example: the wor showed no correlation with a measure of self-control, but was correlated to self-report measure of cbt skills) (barber & derubeis, 2001; strunk et al., 2014). second, change in cbt skills during the procedures will be measured using the behavioral activation for depression scale – short form (bads-sf) (ba skills) and cognitive change sustained change (ccsc) (ct skills). the bads-sf consists of nine items, each rated on a 7-point likert scale and internal consistency (α = .81) and construct and predictive validity were supported (for example: the bads-sf was positively related to measures of reward, negatively related to measures of avoidance and predicted time spent in high and low rewarding behavior; manos et al., 2011). an example item from the bads-sf is: ‘there were certain things i needed to do that i didn’t do’. the ccsc consists of 9 items rated on a 7-point likert scale and internal consistency was supported (α = .93) and the scale showed convergent and discriminant validity by showing a relation with a self-report scale of cbt skills and no relation with a measure of attributional styles (schmidt et al., 2019). an example item from the ccsc is: ‘i noticed myself thinking less negatively.’ skill improvement through learning in therapy (skilt) 14 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ idiosyncratic thoughts and behaviors — idiosyncratic thoughts and behaviors will be measured with the core belief interview (cbi; mcbride et al., 2007). this interview will be completed by the therapist during the introduction session. together the therapist and patient will form an idiosyncratic top three of dysfunctional thoughts and top three of dysfunctional behaviors. note that the behaviors can both exist of the presence of un­ helpful behaviors or the absence of rewarding behaviors. based on the identified beliefs and behaviors, six idiosyncratic visual analogue scales (vas) (0-100) will be constructed for each patient (i.e., three dysfunctional beliefs, three dysfunctional behaviors). for the dysfunctional beliefs, credibility of the beliefs and strength of related emotions will be rated. presence, reward and pleasure related to the behaviors will be measured. the cbi has been used successfully before to establish idiosyncratic dysfunctional thoughts (bruijniks, los, & huibers, 2020; renner et al., 2018). the exact items of the cbi are given in data supplement 3. general dysfunctional thinking — general dysfunctional thinking will be measured using the cognition checklist (ccl; taylor et al., 1997). the ccl consists of 26 items rated on a 5-point likert scale and can be divided into two subscale measuring dysfunc­ tional thoughts related to depression versus anxiety. internal consistency (ranging from α = .91 to α = .93) and validity was supported in an outpatient sample (i.e. the depression subscale showed a higher relation to other depression measures compared to the anxiety subscale, and the same was shown in the reverse direction; steer et al., 1994). an example item of the ccl is: ‘when i am with a friend i think: i’ll never be as good as other people are.’ reward processing — reward processing will be measured using the reward probabil­ ity index (rpi; carvalho et al., 2011) and the temporal experience of pleasure scale (teps; gard et al., 2006). the rpi is a 20-item self-report instrument that measures the presence of environmental reward, while the teps is an 18-item self-report instrument that measures the ability to experience pleasure. reliability (rpi: α = .93, teps: α = .75) and discriminant and convergent validity have been supported for both instruments (for example: the rpi was related to another measures of reward, but not to measures of anxiety and support, and was related to experiencing rewarding behavior; the teps was relatable but also distinguishable from other measures of motivation and pleasure; carvalho et al., 2011; gard et al., 2006; simon et al., 2018). an example item of the rpi is: ‘i have many interests that bring me pleasure.’ (rpi). an example item of the teps is: ‘i enjoy taking a deep breath of fresh air when i walk outside’. secondary outcome: psychological symptoms depression — depression will be measured with the beck depression inventory-ii (bdiii; beck et al., 1996). the bdi-ii is a 21-item self-report instrument assessing depressive bruijniks, frank, tuschen-caffier et al. 15 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ symptoms during the last two weeks. the items are rated from 0 to 3, higher scores representing more symptom severity. a score 0–13 indicates minimal depression, 14–19 mild depression, 20–28 moderate depression and 29–63 severe depression. reliability and validity have been supported (i.e., test retest reliability between .73-.96, α = .85, convergent and discriminant validity; beck et al., 1988; wang & gorenstein, 2013). for the purpose of this study, the bdi-ii will be adjusted to assess depressive symptoms during the past week. general psychological distress — additional psychological symptoms will be meas­ ured using the brief symptom inventory (bsi; (derogatis & melisaratos, 1983). the bsi consist of 53 items rated on a 0 (not at all) to 4 (extremely) scale and includes the follow­ ing subscales: somatization, obsessives-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. reliability and validity of the scale have been supported (i.e., cronbach’s alpha of .85, concurrent and divergent validity was supported; de beurs & zitman, 2006; geisheim et al., 2002). potential moderators: learning capacity memory functioning: verbal working memory — verbal working memory will be measured using the n-back task (braver et al., 1997). the n-back task measures verbal working memory. during the n-back task participants will be asked if a letter on the screen matches a letter previously (1-back, 2back, 3-back) presented for 500 ms with an interval of 2000 ms. wm load increases as the task progresses from 1-back to 3-back. accuracy of responses (total of correct hits (% correctly identified n-backs) and correct no hits (% correctly identified no presence of a n-back)) are measured and will be used as an outcome measure. the n-back task has been considered as a valid measure of working memory (cronbach’s alpha = .92; schmiedek et al., 2014; wilhelm et al., 2013). memory functioning: visual working memory — visual working memory will be measured using the probe change detection task (pcdt; dai et al., 2019). the pcdt consists of the following steps: 1. participants are instructed by an arrow on their screen to focus on the left or right side of the screen (200 ms), 2. after a short break (300 ms) the screen is filled with colored squares on a gray background (100 ms). the squares are equally distributed between the left and right side of the screen. participants are instructed to remember only the squares on the side that was instructed under step 1, 3. after a second blank screen (900 ms), participants see again a field with colored squares (750 ms) and have to indicate whether the squares on the side of the screen are the same as under step 2. set sizes of the trial different between 8 to 12 colored squares in total. participants will receive a total of 300 trials. reliability and validity has been supported (i.e., test retest reliability between .52-.75; dai et al., 2019). skill improvement through learning in therapy (skilt) 16 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ memory functioning: long-term memory — long-term memory will be measured using the paired associates task (pat; unsworth et al., 2009). long-term memory can also be considered as 'secondary memory', i.e., the part of memory where information is stored when the primary memory, where new information is temporary maintained is full. during the pat, participants will be given three lists of 10 non-semantically related word pairs. all words are common nouns, and the word pairs will be presented vertically for 2 sec each. participants will be told that the cue would always be the word on top and that the target would be on bottom. after the presentation of the last word (which takes 20 seconds), participants will see the cue word and "???" in place of the target word. participants will be instructed to type in the target word from the current list that matches the cue. cues will be randomly mixed so that the corresponding target words are not recalled in the same order as that in which they had been presented (i.e., this means that the time between encoding and recall varies and lies between the 2 and 70 seconds). participants will have 5 sec to type in the corresponding word. a participant’s score is the proportion of items recalled correctly. words will be taken from the toronto word pool (friendly et al., 1982). the paired associates task has been considered a valid task of long-term memory (unsworth et al., 2009; wilhelm et al., 2013). emotional bias: sustained selective attention to emotional stimuli — selective attention will be measured using a free-viewing eye-tracking task (klawohn et al., 2020). participants will view two blocks of neutral and happy and neutral and sad faces in counterbalanced order while their gaze patterns are concurrently recorded as index of selective spatial attention. each block will take 30 trials that last 6 seconds. each trial will show 16 different faces and participants will be asked to freely view the trials. partic­ ipants’ gaze location and duration will be assessed using eyelink eye-tracker software (https://www.sr-research.com/). the present study will use the exact same task as was recently used and validated by klawohn and colleagues (2020). to maximize reliability of the task (macleod et al., 2019), it will be completed twice at baseline. to further investigate the predictive value of the task, an additional post procedure measurement (i.e., at one week follow-up) will be completed. other measures recall — patient recall will be measured using the patient recall test (prt; lee & harvey, 2015). the prt measures recall of the previous session content. following procedures of lee & harvey, the patient will be given 10 minutes to remember as much treatment points from the previous session as possible (past session recall). in addition, cumulative recall (i.e., what is remembered from all sessions) will be measured at the follow-up session. treatment points will be defined as remembering insights, skills and strategies of the cbt model. scores will be rated by two independent raters, inconsisten­ cies in scoring will be resolved by discussion. interrater reliability between raters will bruijniks, frank, tuschen-caffier et al. 17 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.sr-research.com/ https://www.psychopen.eu/ be computed. the prt showed good interrater reliability in previous studies (icc = .92; dong, zhao, et al., 2017). in addition to recall of the patient, therapists are also asked to give a rating of recall on a 1-10 vas scale (1 = patient has no memory of the previous session, 10 = patient remembers everything perfectly). manipulation check — to check if patients in the cbt skill acquisition + mental imagery condition engaged in vivid mental imagery, they will be asked to note how vivid the imagery of the skills practiced in this session was on a scale from 1 (not vivid at all) to 10 (extremely vivid). to check and potentially control for self-efficacy, motivation and anticipated reward in the analyses, participants in all conditions will complete questions on a 0-10 scale and asked to rate based on today's session how capable they feel in coping with their dysfunctional beliefs and behaviors, their motivation to use the content of today's session to do something different in the upcoming week and their anticipated reward of doing something different in the upcoming week based on today's session. in addition, expected success of the skilt study sessions in reducing depressive symptoms will be asked at baseline and after the first session. at the end of the study, patients will be asked to rate on a 0-10 scale to what degree the received sessions contributed to an improvement in depressive symptoms. adherence — protocol deviations. after each session, the therapist will complete a short questionnaire to check 1. how many skills and application of these skills were discussed, 2. how many mental imagery exercises were conducted, and 3. ask for the presence of deviations to the protocol in that session. procedure integrity. to ensure the procedures differ in the presence of active com­ ponents (i.e., cbt skill application and use of mental imagery) all sessions will be video-taped. a questionnaire will be developed that measures the presence and duration of the different components in the therapeutic procedures. this questionnaire will be completed by two independent raters. diagnosis — the scid-5-cv (first et al., 2019) will be completed by phone during the recruitment phase. data analyses all statistical tests will be two-tailed (significance level alpha .05). descriptives (means, standard deviations) for all measures will be provided for each condition. all analyses will be intention-to-treat and missing data will not be imputed. main analyses the main analyses will be conducted in stata. first, to test the direct effects of the different procedures on change in therapy processes and symptoms, differences on the skill improvement through learning in therapy (skilt) 18 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ primary and secondary outcomes between conditions (cbtsap versus active control; cbtsap versus cbtsap + mental imagery; active control versus cbtsap + mental imagery) will be tested using multilevel analysis with maximum likelihood estimation (measurements [level 1] nested within patients [level 2] nested within therapists [level 3]). because the wor is only measured at two time points, differences between condi­ tions on the wor will be tested using a repeated measures anova. second, to test whether the effect of the procedures is moderated by individual differences in learning capacity, learning capacity will be added as a moderator in the model. moderation will be tested by adding learning capacity as a main factor and the interaction between learning capacity and condition to the multilevel regression model. for the wor, the interaction will be added to the repeated measures anova. moderation of learning capacity will be tested separately for memory functioning and emotional bias. memory functioning will be tested separately for each component of memory functioning (i.e., verbal working memory, visual working memory, long-term memory), while controlling for type i error (p < .016). mediation analyses the potential role of therapy processes and session recall as mechanisms of change will be tested by testing mediation within latent difference score (lds) models. in separate lds models (i.e., a different model for each mediator), we will test the relation of the procedure (cbtsap's versus active control) on subsequent change in the mediator (i.e., therapy processes: cbt skills, idiosyncratic dysfunctional thinking and behaviors, gener­ al dysfunctional thinking, reward processing, and session recall) on subsequent change in the outcome (depressive symptoms). note that we will merge the two cbtsap's to test mediation of the active control versus the cbtsap's. lds models allow tests of mediation, include the temporality of the effects and are therefore capable of testing potential reverse causality (grimm et al., 2017; mcardle, 2009). d i s c u s s i o n we presented a protocol for a randomized controlled study that isolates an often-used therapeutic procedure focused on the acquisition of cognitive behavioral therapy skills (cbtsap) to test its causal effects on psychotherapy outcomes. the cbtsap will be compared to an active control condition and cbtsap with mental imagery. we hypothe­ sized that, compared to an active control procedure, the cbtsap's would lead to direct improvement in cbt skills, related therapy processes (dysfunctional thinking and reward processing) and subsequent reduction of depressive symptoms. in addition, we suggested that individual differences in cognitive and neurological impairments (referred to as learning capacity) in depressed patients may interfere with the successful acquisition of bruijniks, frank, tuschen-caffier et al. 19 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ cbt skills and that especially the patients with low learning capacity will benefit from added mental imagery to the cbtsap. one major strength of the present study is that it will be the first to investigate the direct effects of an isolated procedure focused on the acquisition of cbt skills in a depressed sample. although the potential of investigating isolated procedures has been recognized (craske, 2016; macleod & grafton, 2016; teasdale & fennell, 1982), experimental studies that isolate therapeutic procedures in the field of depression have been scarce so far (bruijniks et al., 2018). in addition, by performing an experiment that informs us about which therapeutic procedure works best for whom, the proposed study taps into the field of personalized medicine (i.e., optimizing the effects of treatment by matching the treatment to the patient (cohen & derubeis, 2018)). by increasing insight in the direct effects of therapeutic procedures on how and for whom they reduce depres­ sion, the present study will not only contribute to the research field of personalized medicine, but has the potential to inform and improve clinical practice (i.e., informing on what technique might be helpful for whom). this study is also the first that elaborately assesses learning capacity at baseline to investigate the moderating role of learning capacity on the effects of isolated cbt proce­ dures. earlier studies have indicated that depressed patients with more emotional bias and more memory functioning might show better improvement during cbt (bruijniks, derubeis, et al., 2019), but these studies mostly investigated the role of learning ca­ pacity on the complete treatment package (i.e., a full cbt that includes multiple cbt procedures), primarily used neurobiological measures or where conducted in an elderly depressed population. the present study will be able to inform on the specific role of learning capacity in a key therapeutic procedure, the acquisition of cbt skills, in cbt for depression. in addition, a better understanding of the role of learning capacity and a cbt skill acquisition procedure on cbt outcomes might open up new avenues for future research on the role of skill acquisition and learning capacity in psychotherapy for depression in general. another strength of the study is the repeated measurement of therapy processes, which will allow us to investigate how learning capacity affects the hypothesized mechanisms underlying the success of a cbt skill acquisition procedure and also how the cbtsap might lead to reduction of depressive symptoms through these mechanisms. a final strength of the present study is that it includes a multimodal assessment, using not only self-report instruments but also a cbt skill test, idiosyncratic measures of therapy process change, behavioral tasks and eye-tracking. a limitation of the present study is that it is powered to find medium to large effects and will be underpowered to find small effects between the three treatment conditions. in conclusion, while there are a number of effective evidenced based treatments for depression, many patients do not improve in treatment and progress in treatment innovation has been slow. one way forward is to isolate specific therapeutic procedures and test their direct effects on therapy processes and outcomes. based on this experimen­ skill improvement through learning in therapy (skilt) 20 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ tal research framework we will conduct a randomized clinical study testing the direct effects of a key cbt procedure, cbt-skills, with or without a cognitive support strategy compared to an active control condition. the results of this study will contribute to a better understanding of individual differences in the effects of key cbt procedures. funding: this project is funded by a rubicon research grant granted to s. bruijniks by the dutch research council social sciences and humanities from nwo. fr and jw are supported by a sofja kovalevskaja award from the alexander von humboldt foundation and the german federal ministry for education and research. acknowledgments: the authors thank anna boehncke, stephanie heinrichs, max heise, capucine john, lisa krause, janina reus, svenja schmedding, adriana soyoung-steinborn and dr. lena zirn for their (ongoing) contribution to the study. competing interests: the authors have declared that no competing interests exist. author contributions: sb designed the study and wrote the manuscript. uf, btc, fr and sb are involved in the coordination of the recruitment of patients and data collection. jw is involved as an eye-tracking expert. all authors read, contributed to, and approved the final manuscript. twitter accounts: @sbruijniks data availability: data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain more exact information on the different therapeutic proce­ dures and the outcomes of the core belief interview as these are used in the study (for access see index of supplementary materials below). index of supplementary materials bruijniks, s. j. e., frank, u., tuschen-caffier, b., werthmann, j., & renner, f. 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(2017). competition effects in visual cortex between emotional distractors and a primary task in remitted depression. biological psychiatry: cognitive neuroscience and neuroimaging, 2(5), 396– 403. https://doi.org/10.1016/j.bpsc.2016.12.007 bruijniks, frank, tuschen-caffier et al. 29 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://doi.org/10.1007/bf01173582 https://doi.org/10.1037/xlm0000204 https://doi.org/10.1016/j.actpsy.2009.11.010 https://doi.org/10.3758/pbr.16.5.931 https://doi.org/10.1146/annurev.psych.47.1.513 https://doi.org/10.1186/s12916-017-0972-8 https://doi.org/10.1037/0022-006x.75.3.475 https://doi.org/10.1590/1516-4446-2012-1048 https://doi.org/10.1007/s12671-018-1005-1 https://doi.org/10.3389/fpsyg.2013.00433 https://doi.org/10.1016/j.bpsc.2016.12.007 https://www.psychopen.eu/ a p p e n d i x : l i s t o f a b b r e v i a t i o n s bads-sf – behavioral activation for depression scale – short form bsi – brief symptom inventory cbi – core belief interview cbt – cognitive behavioral therapy cbtsap – cognitive behavioral therapy skill acquisition procedure ccsc – cognitive change sustained change ccl – cognition checklist pat – paired associates task pcdt – probe change detection task prt – patient recall test rpi – reward probability index lds – latent difference scores scid-5-cv – structural clinical interview for dsm-v teps – temporal experience of pleasure scale vas – visual analogue scale wor – ways of responding clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. skill improvement through learning in therapy (skilt) 30 clinical psychology in europe 2023, vol. 5(1), article e8475 https://doi.org/10.32872/cpe.8475 https://www.psychopen.eu/ skill improvement through learning in therapy (skilt) background method design participants sample size recruitment randomization and procedure therapists introduction session therapeutic procedures instruments data analyses discussion (additional information) funding acknowledgments competing interests author contributions twitter accounts data availability supplementary materials references appendix: list of abbreviations personality disorder diagnoses in icd-11: transforming conceptualisations and practice scientific update and overview personality disorder diagnoses in icd-11: transforming conceptualisations and practice michaela a. swales 1 [1] north wales clinical psychology programme, bangor university, bangor, wales, united kingdom. clinical psychology in europe, 2022, vol. 4(special issue), article e9635, https://doi.org/10.32872/cpe.9635 received: 2022-06-04 • accepted: 2022-09-19 • published (vor): 2022-12-15 handling editor: andreas maercker, university of zurich, zurich, switzerland corresponding author: michaela a. swales, north wales clinical psychology programme, brigantia building, pen yr allt, bangor, ll57 2as, uk. e-mail: m.swales@bangor.ac.uk related: this article is part of the cpe special issue “innovations in icd-11”, guest editor: andreas maercker, clinical psychology in europe, 4(special issue), https://doi.org/10.32872/10.32872/cpe.v4.si abstract background: until the advent of the icd-11, classification of personality disorders was based on categorical prototypes with a long history. these prototypes, whilst familiar, were not based in the science of personality. prototypical classifications were also complex to administer in nonspecialist settings requiring knowledge of many signs and symptoms. method: this article introduces the new structure of icd-11 for personality disorders, describing the different severity levels and trait domain specifiers. case studies illustrate the main aspects of the classification. results: the new icd-11 system acknowledges the fundamentally dimensional nature of personality and its disturbances whilst requiring clinicians to make categorical decisions on the presence or absence of personality disorder and severity (mild, moderate or severe). the connection between normal personality functioning and personality disorder is established by identifying five trait domain specifiers to describe the pattern of a person’s personality disturbance (negative affectivity, detachment, dissociality, disinhibition, and anankastia) that connect to the big 5 personality traits established in the broader study of personality. conclusions: whilst new assessment measures have been and are in development, the success of the new system will rely on clinicians and researchers embracing the new system to conceptualise and describe personality disturbances and to utilise the classification in the investigation of treatment outcome. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9635&domain=pdf&date_stamp=2022-12-15 https://orcid.org/0000-0002-7603-1546 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ keywords personality disorder, severity of personality disorder, icd-11, trait domains highlights • introduces the new structure of icd-11 for personality disorders. • describes the different severity levels and trait domain specifiers. • case studies illustrate the main aspects of the classification. • discusses the issue of stigmatization in clinical practise. p r o b l e m s w i t h i c d 1 0 : t h e c a s e f o r c h a n g e personality disorder is perhaps the most stigmatising diagnosis to receive (bonnington & rose, 2014). we all have a personality and our personality is often central to how we perceive ourselves in the world. so, to be told that this part of ourselves – or indeed our whole self – is disordered is extremely stigmatising and potentially highly damaging. thus, for a clinician to make the diagnosis they must be sure that the benefits outweigh the costs. there are now a number of treatments developed for people who experience the problems that commonly are labelled personality disorder, particularly borderline personality disorder (storebø et al., 2020), and therefore the cost benefit ratio has changed. in this context, withholding the identification of problems for which there are effective interventions becomes a different ethical challenge, whether the diagnosis is stigmatising or not. how clinicians conceptualise personality disorder impacts their ensuing discussions with their clients and patients about the diagnosis. these discussions provide significant opportunities to mitigate stigma, especially as evidence indicates that it is often mental health professionals who hold the most stigmatising views of all (newton-howes et al., 2008; ring & lawn, 2019). icd-10 like the dsm, was based in clinically derived prototypes that were not based in scientific research that can, as tyrer and mulder (2022) argue, be traced back to the conceptualisations of schneider. each of the ten prototypes (personality disorders) had a substantial list of symptoms which meant that making a diagnosis required clinicians to be familiar with a long list of symptoms and how they related. often these symptoms overlapped. such complexity presented particular challenges in the many low and middle income countries using the classification where there are very few psychiatric specialists, much less personality disorder experts. this inherent structure of the classification resulted in two significant problems. firstly, rarely did clinicians use anything other than three of the diagnostic categories (emotionally unstable personality disorder; antisocial personality disorder; and personality disorder not otherwise specified), making the remainder of the classification effectively redun­ dant and also raising questions about its utility. secondly, often people met criteria for more than one, sometimes many more than one, personality disorder diagnosis resulting diagnosing personality disorder in icd-11 2 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ in multiple ‘comorbidities’ which were more apparent than real. consequently, some individuals were loaded up with diagnoses providing added stigma with no realistic prospect of benefit. in response to these not insignificant problems, icd-11 fundamen­ tally changes the way in which personality disorder diagnoses are conceptualised. it recognises that personality and personality disorder are continuous with each other, and although a categorical structure is maintained, the system recognises that the underlying structure is dimensional. the new system also establishes a connection between basic personality research and the diagnosis of personality disorder. in fundamentally changing the structure of personality diagnosis icd-11 provides the potential for a more compassionate framing of personality disorder in discussions between clinicians and the people who come to them requiring help. to mitigate stigma clinicians must root their discussions of personality and its disorders in a psychological understanding of the development of personality rather than within the terminology of psychiatric nosology. personality develops in the transaction between our biology and our early life experiences. personality characteristics have a strongly heritable com­ ponent (vukasović & bratko, 2015) and can be seen in early temperament, which has a high degree of stability across the life span (roberts & delvecchio, 2000). early trauma, however, can have a significant impact on the developing brain. these impacts may make a child more sensitive, or aggressive further prompting adverse experiences such as invalidation or punishment from caregivers which may increasingly impact the child’s neurobiology. thus, personality and personality disorder develop in the transaction between biology and environment and can be conceptualised as a person’s best efforts to function and cope with their familial and social environment given their biological heritage and early life experiences. conceptualising personality dysfunction as learned patterns of coping – which may have been functional in the person’s early context, and may continue to function in some environments – that have become problematic for the person, potentially provides a supportive and less stigmatising context in which to discuss personality and its disorders. icd-11’s new structure which is strongly connected to the study of human personality provides a context for furthering these initial discus­ sions with clients and patients. a study with health professionals of the respective utility of icd-10 versus icd-11 found that the new structure was more useful with respect to formulating interventions, communicating with clients, comprehensively describing a person’s difficulties and ease of use (hansen et al., 2019). whether clients themselves ex­ perience clinicians’ discussions using the new structure as less stigmatising will require systematic research. if this aspiration is to be realised, initial service user responses indicate that clinicians will need to be more adept at understanding internal distress and that patterns of behaviour were adaptive responses to early adversity (hackmann et al., 2019). swales 3 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ aims of the new classification simplification and greater utility are the primary aims of the new classification. the ini­ tial two step-process of diagnosing pd (do the person’s difficulties meet the threshold for disorder and, if they do, how severe are they) are much simpler than the previous system and therefore potentially more clinically useful, especially in non-specialist settings. the new system removes the artificial comorbidity of icd-10 and also significantly decreases the number of symptoms clinicians need to assess in determining the diagnosis thus potentially improving clinical utility. focusing on severity explicitly foregrounds risk, potentially improving the identification of risk in clinical settings. severity directly links to treatment intensity, frequency, setting and level of care required, thus, helping services to decide on the complexity of interventions required (bach & simonsen, 2021). whether the classification delivers on these aims will be a matter for subsequent research and implementation studies to decide. what follows is a description of the changes in icd-11, illustrated by three case studies, and a discussion of issues in assessment. d e s c r i p t i o n o f t h e c h a n g e s in sum, the new diagnostic classification requires two steps with two further optional steps if required. in the first step clinicians assess whether the person’s difficulties meet the general requirements for a personality disorder diagnosis. secondly, if these requirements are met, then clinicians further assess to determine the severity of the difficulties. the third and first optional step requires further assessment of the person’s personality trait domains to more comprehensively describe an individual’s personality disturbance. finally, and if applicable, a borderline pattern specifier can be applied. each of these steps will be considered in further detail. description of the core features of personality disorder the central features of personality disturbance in icd-11, as in dsm-5, are disturbances in aspects of both self and interpersonal functioning. for a diagnosis, these disturbances must be enduring – so present for a minimum of two years. self-dysfunction may manifest as persistent difficulties in maintaining a stable sense of identity, a pervasive sense of impoverished or highly over-valued self-worth, inaccuracies in self-perception or challenges in self-direction and decision making. persistent difficulties in making and sustaining close relationships or in the ability to understand other people’s perspectives are typical manifestations of the interpersonal dysfunction. managing conflict in rela­ tionships may also present significant challenges. these two main features will manifest in maladaptive patterns of cognition, emotional experience and expression and behaviour which must be evident across a range or personal and social situations. diagnosing personality disorder in icd-11 4 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ when considering the disturbance demonstrated or described by the person there are several important factors to consider. first, the disturbance must be present across a range of personal and social situations and not limited to single contexts, although, particular types of situation or common prompting events may elicit the same behaviour across contexts. for example, a person may become repeatedly aggressive when their views are contradicted and this pattern maybe evident with family, and in both social and work contexts. secondly, when working with young people the developmental con­ text must be considered. interpersonal difficulties and a degree of unstable self-identity are developmentally normative during the adolescent period. clinicians, therefore, must be certain that the behaviours reported or demonstrated are significantly different to be­ haviour of young people of that age and developmental stage within their specific cultur­ al context. clinicians must carefully assess whether the young person’s behaviours are normative responses to adverse environmental situations. for example, a young person may run away from home frequently, getting into fights, using drugs and self-harming because they are being physically and sexually abused at home. similar difficulties may arise in the situation of women subjected to coercive control and domestic violence and in both cases the person may have significant difficulties in alerting the assessor to the truth of the situation they find themselves in. a proper assessment of context, therefore, is required to ensure that presenting problems truly warrant a diagnosis of personality disorder. third, and following on from the previous point, the disturbance must not be explained primarily by social and cultural factors, including socio-political conflict. assessors must take especial care when assessing a person from a different culture or heritage to their own to guard against their own culturally defined assumptions about behaviour, thought and emotional expression. fourth, the disturbance must not be a direct effect of medication or of some other substance, including withdrawal effects. finally, the disturbance must be associated with substantial distress of significant impair­ ment in personal, family, social, educational, occupational or other important roles. severity ratings once a determination has been made that a person’s disturbance meets threshold for a personality disorder diagnosis, the severity of that disturbance (mild, moderate or severe1) needs to be considered. researchers recently have argued for the importance of severity from a conceptual and methodological perspective (pincus et al., 2020; sharp & wall, 2021). selecting this feature as the next required feature of diagnosis, however, relates to the strong relationship between severity and clinical outcomes (clark et al., 2018; crawford et al., 2011; yang et al., 2010). severity is determined by several factors: 1) sub-threshold difficulties which present problems in specific contexts (e.g. in effectively accessing healthcare) may be coded as personality difficulty, which can be found in the section of the icd-11 classification factors influencing health status or contacts with health services. swales 5 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ i. the degree and pervasiveness of disturbance in the person’s relationships and their sense of self ii. the intensity and breadth of the emotional, cognitive and behavioural manifestations of the person’s disturbance iii. the extent to which these patterns and problems cause distress or psychosocial impairment iv. the level of risk of harm to self and others. as personality disorder becomes more severe an increasing number of areas of a person’s life become affected by their difficulties and evidence of harm to self or others becomes more prevalent. for example, in mild personality disorder a smaller number of areas of a person’s life will be affected, for example, work and close friendships but perhaps not family or hobbies; or if the difficulties affect all of these areas, they will be mild in severity. severe personality disorder in contrast affects all areas of a person’s life, will be clearly evident to other people around them and will always entail harm to self or others. mild personality disorder the most notable aspect of mild personality disorder is that only some areas of personal­ ity function are affected. for example, a person might have difficulty making decisions or deciding on the direction of their career yet have a strong sense of self-worth and identity. problems in many interpersonal relationships or in the performance of social and occupational roles are evident but some relationships are maintained or social roles carried out. the manifestations of a person’s difficulties are generally mild and not typically associated with harm to the self or others. for example, they may struggle to recover from minor setbacks or criticisms when stressed or they may distort how they perceive situations or other people’s motives without losing total contact with reality. whilst the personality disturbance may be mild, the person may still experience substan­ tial distress and impairment. the distress and impairment are limited to a narrower range of functioning or, if the difficulties are across many areas, the difficulties are less intense. mr r (see text box 1) illustrates these features of mild personality disorder. mr r has sustained his work history for many years and indeed his personality traits, of which more later, have served him well. difficulties in the work context have only recently begun as a result of a change of demand necessitating more team working where his high standards have interfered with effective working relationships. his difficulties in close interpersonal relationships have been evident for many years within the family context, yet he is able to still maintain some social relationships and family connections. diagnosing personality disorder in icd-11 6 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ moderate personality disorder for moderate personality disorder, disturbance affects multiple areas of personality functioning such as identity, sense of self, formation and maintenance of intimate rela­ tionships, capacity to control and moderate behaviour. despite these difficulties, some areas of functioning may be relatively less affected. occasionally moderate personality disorder will be associated with harm to self or others. when this is present, typically, it will be of moderate severity. text box 1 mr r: mild personality disorder with negative affectivity and anankastia mr r is 54 years old and has been referred for assessment by his employer. he arrives at the appointment with his sister with whom he has lived for 15 years since the breakdown of his marriage. mr r describes how he was recently promoted to head up a team to run a major project. he was promoted because of his track record of delivering high quality work on time. for the first time he has been required to both lead and co-ordinate a team. his high standards and desires for perfection have caused difficulties with colleagues infuriated by mr r’s exacting standards and frequent requests for work to be re-done. previously when working alone coworkers have tolerated his style of working because it had minimal impact on them. mr r was previously married and has three children. he describes his former wife as exceptionally difficult to live with as she was ‘extremely untidy, disorganised and slovenly’. they disagreed about how to raise their children and he found his children’s ‘noise and chaos’ impossible. he laments that children are no longer ‘seen and not heard’. in a separate interview with his sister, she reports that mr r is extremely punctilious about household standards and she thinks that his wife was no untidier and more disorganised than most people. they live effectively together by having separate spaces in their old family home so that she is not impacted by his standards – except in the kitchen where she does not mind following his ‘rules’ about how things must be maintained. mr r now sees his children, now adults, relatively often. he says he is surprised how well they turned out given their ‘chaotic start’. mr r is the secretary for his local cricket club and the local church. his organisational skills are much appreciated, although, he occasionally argues with other members of these groups when they disagree about how things should be organised. swales 7 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ text box 2 ms t: moderate personality disorder with negative affectivity and disinhibition (borderline pattern specifier) ms t is a veterinary student, aged 26. her course tutor suggested that she seek assistance as her behaviour on her current programme of study is likely to lead to suspension of her studies if it does not change. this is not the first time that ms t has presented to services. she describes a history of suicidal thoughts and self-harm behaviours that began in her middle teenage years. whilst in her early twenties suicidal and self-harm behaviours were less common, they have increased in frequency following a series of break-ups of romantic relationships. ms t describes that she often feels that she can no longer cope with her life and her emotions and that considering suicide and self-harm provides a degree of relief from the intensity of these thoughts and feelings. ms t says that she believes she experiences emotions more intensely than other people. ms t describes intense and frequent mood changes that have worsened as a result of the interpersonal difficulties she has been experiencing. she describes intense emotions often in response to minor things. for example, her current presentation was prompted after she had yelled and thrown things during a meeting with her programme director and her other course mates where her next placement was being discussed and she had not got the placement that she had hoped for. she realised almost immediately that she had acted inappropriately and was extremely tearful and apologetic. incidents like these have resulted in her peers treading carefully around her or avoiding her altogether. she discovered recently that she had not been invited on an outing and she believes this is a consequence of her reactivity. ms t describes a history of frequent romantic relationships. she falls in love rapidly and intensely. recent relationships have ended as a result of the intensity of her attraction, her jealous rages and, when she believes her partner is unfaithful, she herself then initiates casual sexual contacts with other people. ms t’s parents were highly critical of her as she was growing up. academic achievement was extremely important to them. she was very close to her grandmother and spent much of her early teenage years living with her as her parents travelled extensively with their work. her grandmother suffered from a chronic illness and ms t cared for her during this time and was devastated when she died when ms t was 16. she describes her grandmother as the only supportive person in her life. after her grandmother’s death she would often run away from home for days at a time drinking heavily and initiating casual sexual encounters. despite this she maintained good grades at school as she wanted to be a vet – an ambition her grandmother also had but was unable to fulfil. diagnosing personality disorder in icd-11 8 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ marked problems in interpersonal relationships will be evident. relationships may be tumultuous, characterised by high levels of conflict and frequent ruptures. alternatively, a person may be conflict avoidant and withdraw from relationships or they may be highly dependent on one or two relationships being either submissive or dominant. ms t (see text box 2) fulfils the requirements for moderate personality disorder as a much greater number of areas of functioning are affected. there is also evidence of harm to self. her academic skill is well preserved, however, capitalising on her abilities in her chosen profession is compromised by her emotional regulation difficulties and their interpersonal consequences. her social relationships are also heavily impacted. severe personality disorder people with severe personality disorder have major disturbances in their sense of self functioning. for example, they may have no sense of who they are, experience intense numbness or report that what they believe and think changes dramatically from one context to another. some individuals may have a very rigid view of themselves and the world and have very regimented routines and approaches to situations. a person’s sense of self may be grandiose or highly eccentric or characterized by disgust and self-contempt. unsurprisingly, virtually all relationships in all contexts are adversely affected. often relationships are very one-sided, unstable or highly conflictual. there may even be a de­ gree of physical violence. family relationships are likely to be severely limited or highly conflictual. the person’s ability, and sometimes willingness, to fulfil social and occupa­ tional roles is severely impaired. so, for example, a person may be unwilling or unable to sustain regular work as a result of lack of interest, or effort, or poor performance. alternatively, the poor work performance may derive from interpersonal difficulties or inappropriate behaviour such as angry outbursts or insubordination. severe personality disorder is often associated with harm to the person or other people. severe impairment is evident in all areas of the person’s life. mr d (text box 3) presents with severe personality disorder. all areas of his life are affected. he has no meaningful relationships with family or friends and the only connections he has made are with his victims who he has exploited for personal gain. yet he seems unwilling or unable to appreciate the damage and harm that he has inflicted upon them. trait domain specifiers once the two obligatory steps for diagnosing pd are completed, there are two further optional steps both of which involve further describing the type of difficulties that a person presents with. in some jurisdictions the first two steps will be all that is required. in countries with more advanced systems in place for supporting people who receive a personality disorder diagnosis the first of these next two steps would be encouraged. as swales 9 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ is evident from the descriptions of severity above, the manifestations of severity vary significantly, and these expressions are in accordance with the trait domains of normal personality function. icd-11 describes five trait domain specifiers that are continuous with normal personality characteristics, consistent with the big 5 model of personality text box 3 mr d: severe personality disorder with detachment and dissociality mr d aged 34 has been referred for evaluation pending trial. he has been arrested on charges of befriending and then defrauding elderly people. over the last ten years he has befriended 5 different elderly people, all of whom lacked family nearby. he would begin the relationship by introducing himself as a representative of a local charity that supported elderly people in organising practical tasks about their home e.g arranging gardeners, decorators etc. he would then spend increasing amounts of time with his intended victim and then pour out a story about how his mother had a serious medical illness for which treatment was only available in the us and how distressed he was that he could not afford it. he would eventually accept funds from his victims after protesting for a short while that he could not possibly accept their generosity. his victim’s reported that his persistent refusal over a period of time was in part what was so convincing. mr d is confident that he will be found not guilty as he maintains that all of the money was given as ‘gifts’. he maintains that his victims were simply grateful to him for all the support and help that he offered them. his victims, in contrast, describe how he was initially helpful but latterly would easily become irritated and aggressive if they did not follow his advice and they found it hard to resist his suggestions. mr d in recent years has had no regular employment and has relied on the funds that he obtained from his victims to sustain himself. his family have severed all contact with him– including his motherbecause of his constant demands for money and his aggressive behaviour when his demands are not met. he has no reliable place to live, frequently being asked to leave where he is living because of non-payment of rent. mr d describes other people as a nuisance and as parasites and says that he can see no need of relationships or connections with others. mr d had difficulties originating in childhood. he described his father as an abusive man who frequently told him to stand up for himself. he often fought with other children and complained that he was constantly disrespected although he was often described as a bully. he left school with minimal qualifications and although he began a college course he was dismissed for a combination of non-completion of the course and aggressive behaviour towards other students. diagnosing personality disorder in icd-11 10 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ (mccrae & costa, 1987) and have been found in most if not all mental disorders. trait domain specifiers are not diagnostic categories rather they represent a set of dimensions corresponding to the underlying structure of personality in all people. factor analytic studies broadly speaking support the icd-11 five factor structure (bach et al., 2017; mulder et al., 2016), although some studies have found four factors rather than five, where one factor captures the two polar opposites of disinhibition versus anankastia (bach et al., 2020; oltmanns & widiger, 2018). as many trait domain specifiers can be applied as are appropriate to describe a person’s characteristics. individuals with more severe personality disturbance tend to have a greater number of prominent traits although it is possible to have severe personality disorder and manifest only one trait domain e.g. dissociality. each of the trait domain specifiers will now be considered in turn. negative affectivity tendency to experience a broad range of negative emotions forms the central element of negative affectivity. in people with a personality disorder diagnosis this typically means that they experience a broad range of negative emotions with a frequency and intensity that others judge as being out of proportion to the situation. nevertheless, given the person’s life experiences and genetic heritage their responses make sense in terms of their own learned experiences. common negative emotions include anxiety, worry, sadness, fear, anger, hostility, guilt and shame. the person often experiences emotional lability with accompanying difficulties in regulating their emotions. they are often easily distressed and it takes them longer than average for their emotions to return to their baseline levels. as a result of intense and frequent emotions, negative thoughts and attitudes com­ monly occur which, in turn, further fuel strong emotional reactions. hopeless thoughts are frequent and a tendency to assume that interventions or solutions suggested by friends, family and professionals will not help their situation. individuals often have low self-esteem and self-confidence which may result in avoiding situations or activities as they anticipate difficulty. often, they do find situations difficult, because of their emo­ tional sensitivity. they may become highly dependent on others for advice, reassurance, help and direction. at times, they may be understandably envious of other’s abilities and successes given their own challenges. in more severe cases they may experience intense feelings of worthlessness and suicidal ideation. negative affectivity may be very evident both in a person’s report and behaviour, as might be seen in the case of ms t or it may be heavily disguised and may not even be reported directly as is the case with mr r. interactions with other personality traits influence how negative affectivity manifests. in individuals with traits of greater disinhibition negative affectivity is more likely to be clearly evident and to present swales 11 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ earlier in life, whereas in those with detachment and anankastia it may present later, be less directly evident and may even not be reported. detachment detachment can be either social or emotional. social detachment in people with a personality disorder diagnosis consists of significant avoidance of social interactions and what they may consider unnecessary interpersonal contact. the person may often respond in ways that actively discourage social interaction. as a result, the person often lacks friends or even acquaintances, often avoiding intimacy of all kinds, including sexual intimacy. emotional detachment is evident in a reserved and aloof manner with limited emotional expression and experience, both verbally and non-verbally. in extreme cases a person may report a lack of emotional experience altogether; they may be unreactive to positive or negative events and both report and demonstrate a limited capacity for enjoyment. mr d shows evidence of both social and emotional detachment dissociality mr d also shows strong evidence of the dissociality trait specifier. disregard for the feelings and rights of others which includes self-centeredness and lack of empathy is at the centre of this trait domain. people with this trait may demonstrate a sense of entitle­ ment, expecting others to admire them. they may endeavour to attract the attention of others or to ensure that they are at the centre of other people’s attention. if others do not respond as they wish they may dramatically express their dissatisfaction. dissociality may lead to a disregard of the importance of others and the person may have a relentless focus on their own needs, desires and comfort. disinhibition impulsive action in response to immediate internal or environmental stimuli without consideration of longer-term consequences forms the basis of the disinhibition trait domain. people with this trait tend to act rashly without considering the impact of their actions on themselves or others in the longer term and this can include putting themselves or others at risk. difficulties delaying reward or satisfaction result in strong associations with such behaviours as substance use, gambling, and unplanned sexual activity. alongside impulsive action, appraisal of risk is impaired combined with an absence of an appropriate sense of caution resulting in, for example, reckless driving, dangerous sports and activities without appropriate training and preparation. ms. t shows elements of disinhibition in her reactions in romantic relationships and in her responses to her current placement. people with this trait are frequently distractible, becoming easily bored or frustrated with routine, difficult or tedious tasks and may often be seen scanning the environment for more pleasurable options. people with a personality disorder with this trait often diagnosing personality disorder in icd-11 12 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ demonstrate a lack of planning preferring spontaneous over planned activities with a focus on immediate emotions and sensations with little attention to long-, and sometimes even short-, term goals. consequently, they often fail to reach any of the goals that they set themselves. anankastia individuals high on anankastia have a very clear and detailed personal sense of perfec­ tion and imperfection that extends beyond the typical standards of their community. they believe strongly that everyone should follow all rules exactly and meet all obliga­ tions. like mr. r, individuals high on anankastia may redo the work of others because it does not meet their perfectionistic standards. individuals with this trait strongly believe in controlling themselves and situations to ensure that their perfectionistic standards are met. they have a preoccupation with social rules and obligations and what should be considered right and wrong. they focus intensely on detail and are highly systematic and organized to the point of being rigid. their intensity of focus on issues or orderliness, neatness and structure frequently leads to interpersonal difficulties because they expect these same high standards from everyone else. they may also have extreme difficulty making decisions as they are not sure that they have considered every aspect of the situation. applying the same rules of order to their emotional and behavioural expression such that they do not express emotions or only in a very minimal way is common manifestation of the trait. their extreme planfulness means that they are often incapable of spontaneity or of making changes to their schedule. they are very risk aware and so are highly unlikely to engage in any activity that would be likely to have a negative consequence. borderline pattern the original intention with the new icd-11 classification was to end after the identifi­ cation of trait domains. extensive concern was expressed by the clinical and academic community about the changes to the classification and in particular about continued access to treatments (herpertz et al., 2017). following discussions with representatives from concerned groups, a concession was agreed primarily to ensure that no one was disadvantaged by the removal of the ‘borderline’ / ‘emotionally unstable’ personality dis­ order diagnosis. in some jurisdictions without this diagnosis payment for some specialist treatments would be unavailable and so in order to limit this possibility a borderline pattern specifier was introduced which essentially has the same diagnostic features for bpd as in dsm. swales 13 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ the special case of adolescents one noteworthy feature of the icd-11 classification is the removal of any age specifica­ tion for the diagnosis. previously diagnosis was either forbidden in under 18s or strongly discouraged and reluctance to diagnose in clinicians was well documented (chanen et al., 2020). the reasons for this were primarily a concern about assigning a stigmatising diagnosis to a young person especially when their personality was still in development. whilst this concern is legitimate, it resulted in the paradoxical position that a disorder known to begin in adolescence could not be identified and addressed because of the re­ strictions on classification. with icd-11, clinicians can make a diagnosis and this opens up the opportunity for early intervention for young people whose behaviours may meet the essential requirements for a diagnosis and yet because of their youth these behav­ iours may be less entrenched and more open to change (chanen et al., 2020). caution is still required, however. as discussed earlier, young people may demonstrate concerning behaviours that may be better accounted for by other diagnostic descriptions e.g. what could be described as personality disorder with traits of detachment and anankastia may be much better accounted for by an autism spectrum diagnosis or their behaviour may be a response to adverse environmental circumstances. thorough assessment and consideration are required. a s s e s s m e n t given the risks and potential harms of a personality disorder diagnosis careful assess­ ment is required. typically, clinicians utilise clinical interviews, observation and psycho­ metric assessment, although, the icd-11 system is designed to be used without use of formal psychometric measures and, in some non-specialist settings, this will be all that is available. robust assessment requires more than one meeting with the person and would also involve discussion with people who know the person well (with the consent of the person being assessed). a comprehensive clinical interview should begin with the person’s current functioning and its history paying particular attention to a developmental history, early adversity and trauma. throughout the clinician will seek to establish the breadth of areas which are impacted, considering functioning in social, educational, occupational and familial roles. sufficient duration of difficulties must be considered and, as discussed earlier, alternative explanations, diagnoses or contextual factors must be ruled out. newly developed measures are now available to measure both severity and trait do­ mains to augment clinical interview and observations. the icd-11 personality disorder severity scale (pds-icd-11; bach et al., 2021) is a 14-item measure that shows promise and provides a rapid assessment of the severity of personality dysfunction. bach et al. (2017) and sellbom et al. (2020) describe a method of scoring the icd-11 trait specifiers utilising the personality inventory for dsm-5. clark et al. (2021) have recently developed diagnosing personality disorder in icd-11 14 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ a self-report measure of both self and interpersonal functioning as well as the trait do­ mains. for clinicians interested in a more nuanced assessment of the facets that comprise the trait domains, oltmanns and widiger (2020) have developed a 121-item facet-level assessment of the icd-11 model. the recently modified pid5bf+ captures both icd-11 and dsm-5 trait domains using three facets per domain (bach et al., 2020). c o n c l u s i o n icd-11 personality disorder diagnosis moves away from a schneiderian typology that has governed personality disorder classification for almost a century and established the connection with the psychological study of ‘normal’ personality structure. in so doing icd-11 provides an opportunity to root our conceptualisations of a person’s established patterns of emotions, thoughts and behaviour within a psychological case formulation that understands these patterns as a person’s best attempts at functioning in often less than ideal environments. whilst transitioning away from well-understood and familiar concepts presents a challenge, the simplified structure of the classification opens up potential benefits in terms of simplicity and clinical utility, increased awareness of risk and better matching of resource intensive therapies to severe presentations. how far these benefits are realised will depend upon clinicians embracing the new classification, on researchers further developing measures to capture the new method of classifying and on treatment developers evaluating their treatments using the new structure. funding: the author has no funding to report. acknowledgments: thanks to my colleagues from the icd-11 working group on the classification of personality disorders: roger blashfield, lee-anna clark (dsm liaison), mike crawford, alireza farnam, andreas fossati, youl-ri kim, nestor koldobsky, dusica lecic‐tosevski, roger mulder and david ndetei enthusiastically led by peter tyrer, and geoff reed. thanks also to jared keeley for earlier version of the case vignettes. competing interests: the author was a member of the working party that developed the personality disorder guidelines reporting to the who. r e f e r e n c e s bach, b., brown, t. a., mulder, r. t., newton‐howes, g., simonsen, e., & sellbom, m. 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(2010). personality pathology recorded by severity: national survey. the british journal of psychiatry, 197(3), 193–199. https://doi.org/10.1192/bjp.bp.110.078956 swales 17 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://doi.org/10.1037/0022-3514.52.1.81 https://doi.org/10.1002/pmh.1336 https://doi.org/10.1080/00048670802119739 https://doi.org/10.1037/pas0000459 https://doi.org/10.1037/pas0000763 https://doi.org/10.1159/000506313 https://doi.org/10.1080/09638237.2019.1581337 https://doi.org/10.1037/0033-2909.126.1.3 https://doi.org/10.1037/pas0000746 https://doi.org/10.1146/annurev-clinpsy-081219-105402 https://doi.org/10.1002/14651858.cd012955.pub2 https://doi.org/10.1037/bul0000017 https://doi.org/10.1192/bjp.bp.110.078956 https://www.psychopen.eu/ clinical psychology in europe (cpe) is the official journal of the european association of clinical psychology and psychological treatment (eaclipt). psychopen gold is a publishing service by leibniz institute for psychology (zpid), germany. diagnosing personality disorder in icd-11 18 clinical psychology in europe 2022, vol. 4(special issue), article e9635 https://doi.org/10.32872/cpe.9635 https://www.psychopen.eu/ diagnosing personality disorder in icd-11 problems with icd-10: the case for change aims of the new classification description of the changes description of the core features of personality disorder severity ratings trait domain specifiers assessment conclusion (additional information) funding acknowledgments competing interests references did a nocebo effect contribute to the rise in special education enrollment following the flint, michigan water crisis? research articles did a nocebo effect contribute to the rise in special education enrollment following the flint, michigan water crisis? siddhartha roy 1,2 , keith j. petrie 3 , greg gamble 4 , marc a. edwards 1 [1] department of civil and environmental engineering, virginia tech, blacksburg, va, usa. [2] unc water institute, gillings school of global public health, university of north carolina, chapel hill, nc, usa. [3] department of psychological medicine, university of auckland, auckland, new zealand. [4] department of medicine, university of auckland, auckland, new zealand. clinical psychology in europe, 2023, vol. 5(1), article e9577, https://doi.org/10.32872/cpe.9577 received: 2022-05-28 • accepted: 2023-02-21 • published (vor): 2023-03-31 handling editor: winfried rief, philipps-university of marburg, marburg, germany corresponding author: siddhartha roy, the water institute, university of north carolina, 4114 mcgavrangreenberg hall, chapel hill, nc 27516, usa. e-mail: sidroy@vt.edu supplementary materials: materials [see index of supplementary materials] abstract background: exposure to waterborne lead during the flint water crisis during april 2014october 2015 is believed to have caused increased special education enrollment in flint children. method: this retrospective population-based cohort study utilized de-identified data for children under six years of age who had their blood lead tested during 2011 to 2019, and special education outcomes data for children enrolled in public schools for corresponding academic years (2011-12 to 2019-20) in flint, detroit (control city) and the state of michigan. trends in the following crisisrelated covariates were also evaluated: waterborne contaminants, poverty, nutrition, city governance, school district policies, negative community expectations, media coverage and social media interactions. results: between 2011 and 2019, including the 2014-15 crisis period, the incidence of elevated blood lead in flint children (≥ 5µg/dl) was always at least 47% lower than in the control city of detroit (p < .0001) and was also never significantly higher than that for all children tested in michigan (p = 0.33). nonetheless, special education enrollment in flint spiked relative to detroit and michigan (p < .0001). there is actually an inverse relationship between childhood blood lead and special education enrollment in flint. this is an open access article distributed under the terms of the creative commons attribution 4.0 international license, cc by 4.0, which permits unrestricted use, distribution, and reproduction, provided the original work is properly cited. https://crossmark.crossref.org/dialog/?doi=10.32872/cpe.9577&domain=pdf&date_stamp=2023-03-31 https://orcid.org/0000-0001-6443-1393 https://orcid.org/0000-0002-6337-2480 https://orcid.org/0000-0003-0412-3203 https://orcid.org/0000-0002-1889-1193 https://www.psychopen.eu/ https://cpe.psychopen.eu/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ conclusion: this study failed to confirm any positive association between actual childhood blood lead levels and special education enrollment in flint. negative psychological effects associated with media predictions of brain damage could have created a self-fulfilling prophecy via a nocebo effect. the findings demonstrate a need for improved media coverage of complex events like the flint water crisis. keywords blood lead, lead exposure, flint water crisis, nocebo effect, special education highlights • waterborne lead exposure during the flint crisis did not correlate with special education enrollment. • flint children were repeatedly labeled as lead poisoned and brain damaged in the aftermath. • a nocebo effect could have contributed to negative educational outcomes in flint. • erroneous, negative media labels can be internalized and lead to psychological harm in children. in april 2014, the city of flint, michigan stopped purchasing treated lake huron water from detroit and switched to corrosive flint river water as a cost savings measure. the city also interrupted the addition of corrosion control chemicals to the treated water, which were required under federal regulations to reduce the leaching of the neurotoxin lead from lead pipes and home plumbing. this increased lead levels in tap water and children’s blood mainly in the months of june-august 2014 (roy et al., 2019). in response to residents’ concerns, two of the authors assisted with sampling 269 flint homes in 2015, proving the 90th percentile water lead level (27 μg/l) was almost twice the us environmental protection agency (epa) action level of 15 μg/l (pieper et al., 2018). it was later revealed that the proportion of children < 6 years of age with elevated blood lead, i.e., ≥ 5 μg/dl us centers for disease control and prevention (cdc) reference level, increased following the water switch (hanna-attisha et al., 2016), primarily in june-august 2014 (roy et al., 2019). michigan officials later announced a legionnaire’s disease outbreak that killed at least 13 people (rhoads et al., 2017). these events became known in the media as the flint water crisis (fwc). after the water problems were exposed, flint reconnected to detroit water in october 2015, a federal emergency was declared in january 2016, and over us$1.2 billion in relief funds have been appropriated for residents including free bottled water (through april 2018), free lead faucet filters, health interventions, settlement money for lead-exposed children, special education serv­ ices, and replacement of around 12,000 lead pipes to be completed in 2023 (bosman, 2020; city of flint, 2022; roy & edwards, 2019a; roy & edwards, 2020). flint water has met all federal standards since late 2016 and many residents still consume only bottled water due nocebo effect and special education in flint 2 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ to lost trust (flint cares, 2018; fonger et al., 2019; reuben et al., 2022; roy, 2017; roy & edwards, 2019b; sobeck et al., 2020). recent media reports (see supplementary materials [sm] table s1) attribute increas­ ing rates of special education enrollment and diagnoses of learning disabilities in flint children to lead exposure and “lead poisoning” from the fwc (alfonsi, 2020; green, 2019) but none of these conclusions are based on peer reviewed data. blood lead levels have been steadily dropping in the united states and in flint for the past 50 years following the banning of lead from gasoline, paint and pipes (dignam et al., 2019; gómez et al., 2018). the peak childhood blood lead levels during the fwc (2014-15) were well below those recorded in flint during 2011 (gómez et al., 2018; roy et al., 2019). in this study, we investigate the hypothesis that increased negative educational out­ comes were caused by lead exposure from the fwc as has been stated by the media and experts (aclu, 2016; alfonsi, 2020; green, 2019; redlener, 2018; riley, 2018; strauss, 2019). trends in blood lead levels of flint children were compared to the control city of detroit, which has comparable socioeconomic and racial make-up (table 1) and also used the same drinking water for over 50 years except for the 18 months of the fwc. we also compare flint to state-wide trends from michigan, and evaluate relevant extraneous factors that may have affected educational outcomes in flint children. table 1 key demographic factors of comparison for flint and detroit (control city) measure flint detroit (control) water source during: 1950s – apr 2014 lake huron lake huron apr 2014 – oct 2015 flint river lake huron oct 2015 – present lake huron lake huron approximate count of lead service line connections (% of total water connections) pre-2016: 12,000 (40%) current: <1,400 (4.7%) 80,000 (40%) drinking water source in public schools bottled water (sep 2015-feb 2022) filtered water (feb 2022-present) bottled water aug 2018-aug 2019) filtered water (aug 2019-present) net change in population (2011 to 2019), %* # –8.4% (105,391 to 96,559) –8.6% (738,223 to 674,841) population < 5 years old (range during 2011-19), %* 7.5-8.3% 7.0-7.3% persons per household, 2014-18 2.36 2.55 net change in unemployment rate (2011 to 2019), %† –52.1% (19% to 9.1%) –58.1% (20.5% to 8.6%) roy, petrie, gamble, & edwards 3 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ measure flint detroit (control) net change in median household income (2011 to 2019), %* +8.3% ($26,621 to $28,834) +10.9% ($27,862 to $30,894) health outcomes (range during 2011-2019), overall rank in michigan 77-82 of 83 (genesee co.) 81-83 of 83 (wayne co.) percent below poverty level (range during 2011-19), %* 38.8-41.9% 35-40.9% worst american city to live in, rank (based on 2015 data) #1 #3 % decline in total students attending public schools in 10 years (2009-10 till 2018-19) 43.1% 68.4% % of total resident students attending charter schools, 2018-19 (national rank in charter school enrollment) 45.6% (#3) 37.9% (#2) *data from american community survey 5-year estimates data profiles via us census (us census bureau, 2022). #us census language: estimates are not comparable to other geographic levels of health estimates (due to methodology differences that may exist between different data sources). †data from michigan bureau of labor market (michigan department of technology management and budget, 2022). other data references: city of flint, 2022; david et al., 2017; goetz, 2022; mack, 2019; sauter et al., 2017; university of wisconsin population health institute, 2022. after demonstrating that covariates unlikely played a primary role (see text s1, supplementary materials), we probe the possibility of a nocebo effect (barsky et al., 2002; petrie & rief, 2019) or a self-fulfilling prophecy, associated with repeated predictions of brain damage to flint children via the intense publicity associated with the fwc. research has shown that parents’ and teachers’ negative expectations of children can have adverse effects on educational outcomes. past studies also suggest that these effects are cumulative and have a greater impact on disadvantaged populations (jussim et al., 2009; madon et al., 1997; madon et al., 2011; rosenthal & jacobson, 1968). to examine the interaction between media stories and community perceptions, we evaluated a) representative national and local media stories and associated social media interactions, b) public statements of government, medical and school leaders, and c) resident feedback in media’s news stories, highlighting the purported effects of lead and “lead poisoning” during the fwc period on children and their educational outcomes in flint and the control city of detroit. nocebo effect and special education in flint 4 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ m a t e r i a l s a n d m e t h o d elevated blood lead childhood blood lead testing is required under medicaid, where all children receive a screening blood lead test at ages 1 and 2 years, and up to 5 years (cantor et al., 2019; us preventive services task force et al., 2019), but not all children receive such tests in practice. the state of michigan sampling methodology and reporting guidelines have not changed markedly since 1998 (michigan department of health and human services, 2020). the percentage of children under six years of age with blood lead above the 2012-21 cdc reference level of 5 μg/dl, and the pre-2012 cdc “level of concern” of 10 μg/dl, were calculated for flint, detroit, and michigan for the years 2011-19 using a dataset with 1,445,808 blood lead levels of all michigan children tested, obtained from the michigan department of health and human services (mdhhs) through a data user agreement (#202103-144) following irb approval (irb #202103-04-nr). separately, de-duplicated data were also provided to us after mdhhs epidemiologists extracted the highest blood lead values per child per year using the following standard criteria (in order of preference): • the highest venous blood lead test result available during the calendar year • if there is no venous test result available, the highest capillary blood lead test result available during the calendar year • if there is no test result with blood type available, the highest test result available during the calendar year educational outcomes the data on all special education outcomes and general education 3rd grade reading proficiency for students enrolled in flint community schools, detroit public schools community district, and all public schools in michigan for the academic years 2011-12 until 2019-20 (or, latest available) were downloaded from the michigan department of education’s website www.mischooldata.org. the special education enrollment data during 2006-07 to 2010-11 was obtained through freedom of information act requests to the michigan department of education. poverty and nutrition the rates of poverty and households with children aged 0-18 years receiving food assistance (i.e., on supplemental nutrition assistance program) for flint, detroit and michigan for 2011-19 were obtained from the us census bureau (us census bureau, 2022). roy, petrie, gamble, & edwards 5 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 http://www.mischooldata.org https://www.psychopen.eu/ media coverage and social media interactions a representative list of national and local media stories on lead exposure and educa­ tional outcomes of flint children and detroit children during october 2015-january 2021 (table s1) was gathered using google searches with keywords “lead”, “children”, “education”, “flint” with and without the term “-detroit” (i.e., removes all search results with “detroit”), and “detroit” with and without “-flint”. the crowdtangle extension v3.0.29 in google’s chrome browser was utilized to gather total “interactions” (reactions, comments, and shares) of all facebook users and total follower counts of public pages (e.g., celebrities, news organizations, and politicians) and public groups who shared the media stories on facebook from publishing date until the time of conducting research (august 2020-september 2021). the representative negative expectations commentary of community leaders, teachers, parents and schoolchildren about lead exposure during the fwc period and educational difficulties for flint and detroit (table s2) were gath­ ered through manual screening of articles, posts and videos published during october 2015-january 2021, which were in turn obtained through open-ended google searches using multiple keywords, including “flint” (flint only), “detroit” (detroit only), “flint water crisis” (flint only), “lead”, “poisoning”, “education”, and “children”. separately, the total count and number of interactions data for all posts and web links shared on official facebook pages of michigan local media (data s1) with the keywords “lead poisoned” during january 2016-november 2020 were downloaded from crowdtangle (www.crowdtangle.org) and network maps were plotted in gephi v0.9.2 (crowdtangle, 2020). statistical analyses all analyses were conducted in excel® 2016 (microsoft), sas® 9.4 (sas institute, cary nc), or graphpad prism 8.4.3 (graphpad software). general linear mixed-effects model­ ing was used to model changes in binary effects over time, between flint and detroit (both nested within michigan). data are presented as mean with 95% confidence inter­ vals. pairwise planned comparisons sliced through each year were made and p < .05 was considered significant after false discovery rate adjustment within each outcome. all tests were two tailed. no further adjustment for multiple comparisons was performed. ordinary least squares regression lines were fitted between log of percentage students enrolled in special education and log %ebl in the same years and the slopes compared within graphpad prism. r e s u l t s this retrospective population-based cohort study utilized longitudinal datasets (de-iden­ tified aggregated yearly data) for flint, the control city detroit, and the entire state nocebo effect and special education in flint 6 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 http://www.crowdtangle.org https://www.psychopen.eu/ of michigan to examine the hypothesized link between lead exposure and educational outcomes. elevated blood lead the proportion of children < 6 years with elevated blood lead (%ebl) at or above the 5 μg/dl cdc reference level decreased significantly from 2011 to 2019, p(time) < .0001, in flint, detroit and michigan overall. the %ebl in flint steadily decreased by 65.8% between 2011-19 from 5.42% to 1.85%, risk ratio = 0.43, 95% ci [0.33, 0.56], p < .0001, notwithstanding the fwc increase that occurred in the months of june-august 2014 immediately following the water switch (1,17). the corresponding %ebl in detroit and michigan also saw large decrements of 41.3%, risk ratio = 0.69, 95% ci [0.65, 0.74], p < .0001) and 55.3%, risk ratio = 0.58, 95% ci [0.56, 0.61] from 2011-2019, respectively (figure 1a). there were also substantial differences in %ebl between flint, detroit and all of michigan (figure 1a) (p(time*center) < .0001). specifically, %ebl in flint was 47-77% lower than for detroit during 2011-19. even in the worst fwc year of 2014, children in detroit had more than double the %ebl of flint. the %ebl in flint (which comprised 2.2% to 2.4% of the state population) was also 13-35% lower than for the state of michigan between 2012-19, with the exception of 2014 when flint exceeded the %ebl in michigan by 0.20 percentage points (i.e., 3.72% in flint vs. 3.52% in michigan). in other words, the net effect of the fwc, was to temporarily raise the blood lead of flint children, up to the average for all data reported by the state of michigan. the relative trends between flint, detroit, and michigan at the pre-2012 cdc 10 μg/dl “level of concern” blood lead threshold (%ebl10) were somewhat similar (figure s1) to those seen at the 5 μg/dl level (%ebl). the %ebl10 for flint was statistically indistinguishable from michigan during 2011-19 even during the 2014 and 2015 fwc years. finally, the %ebl10 for flint was 65-77% lower than detroit (p < .00001) for the entire 2011-19 time period. roy, petrie, gamble, & edwards 7 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ figure 1 childhood blood lead and educational outcomes 2011 2012 2013 2014 2015 2016 2017 2018 2019 12 10 8 6 4 2 0% c h il dr en ≤ 5 ye ar s ol d w it h el ev at ed bl oo d le ad (≥ 5μ g/ dl ) fwc flint 0.20 percent points higher than michigan during worst fwc year 0 20 40 60 80 % 3r d g ra de re ad in g pr of ic ie n cy fwc meap m-step 0 5 10 15 20 25 % sp ec ia l ed uc at io n fwc 0 5 10 15 % sp ec ia l ed uc at io n : su sp en si on /e xp u ls io n ra te fwc target: <3.7-4.5% d. 20 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 log(% elevated blood lead) 1.0 1.1 1.2 1.3 1.4 lo g( % sp ec ia l ed uc at io n ) 2011 2015220101342016 2012 20128017 2019 2011 2013 2014 2015 2016 2017 2019 2011 20122017 202125010416 2200123 20192018 detroit (slope= +0.28 (95% ci -0.14, +0.70) p=0.16) flint (slope= -0.51 (95% ci -0.90, -0.12) p=0.02) michigan (slope= -0.02 (95% ci -0.10, +0.05) p=0.46) } p=0.005 35 30 25 20 15 10 5 0 % sp ec ia l ed uc at io n : d ro po u t ra te fwc a. b. c. 2018 e. f. note. trends in (a) percentage of children < 6 years of age with elevated blood lead ≥ 5 μg/dl (%ebl), (b) enrollment of public school students in special education programs, (d) special education suspension/expulsion rates, (e) special education dropout rates, and (f) general education 3rd grade reading proficiency*, for flint, detroit, and michigan, 2011-19 (and corresponding school years of 2011-12 to 2019-20). error bars are +/95% confidence intervals and maybe contained within symbols. (c) scatter plot between %ebl vs. special education enrollment rate for flint, detroit, and michigan by year. 95% confidence bands for the ordinary least squares fits are shown. p value shown is for comparison of slopes. *the state of michigan followed the michigan educational assessment program (meap) testing standards until 2013-14 and then switched to michigan student test of educational progress (m-step) starting 2014-15. nocebo effect and special education in flint 8 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ analysis at the individual child-level was conducted to consider isolated cases of anoma­ lously high blood lead from acute exposure during the fwc that were possibly masked by yearly aggregated trends (i.e., figure 1a). plotting blood lead measurements of every tested child in flint and detroit with blood lead ≥ 5 µg/dl (figure 2a-2b) and comparing the count and percentage of children in flint, detroit, and michigan with blood lead ≥ 5, 10, 20, 25 and 40 µg/dl (figure 3) during the fwc period of 539 days (april 25 2014-october 16 2015) revealed: a. the mean blood lead of all children with blood lead ≥ 5 µg/dl in detroit was 12.4% higher than in flint (unpaired two-tailed t-test; p < .05). b. the count of detroit children was higher than flint children in every blood lead category (≥ 5-40 µg/dl). c. detroit children had statistically higher blood lead than flint children at and above the 5 and 10 µg/dl blood lead thresholds. d. data for flint children were statistically indistinguishable from that reported for all state of michigan children in every blood lead category (≥ 5-40 µg/dl). e. there were 28 children who tested at or above 40 µg/dl in michigan during the fwc period, of which half (14) were in detroit and none (0) in flint. f. there were four flint children with blood lead at or above 25 µg/dl, both during the fwc and in the same time duration pre-fwc (november 1 2012 – april 24 2014). overall educational outcomes of 23 special education outcomes monitored each academic year, nine worsened, nine improved and five did not change (≤±1% change) in flint after the crisis vis-à-vis before the water crisis (see text s2, supplementary materials). in a simple comparison relative to detroit, only three outcomes worsened and another three improved in flint. despite these overall neutral trends, four worsening outcomes in flint were nonethe­ less emphasized and attributed to lead exposure from the fwc by the national media and experts (aclu, 2016; alfonsi, 2020; green, 2019; redlener, 2018; riley, 2018; strauss, 2019) including: a) special education enrollment; b) suspension or expulsion for children in special education; c) dropout for children in special education, and d) worsening reading proficiency of 3rd grade students in general education. roy, petrie, gamble, & edwards 9 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ figure 2 individual child-level blood lead measurements ≥ 5 µg/dl during the fwc period (april 25 2014-october 16 2015) 0 20 40 60 80 100 25.04.2014 21.10.2014 19.04.2015 16.10.2015 b lo od le ad le ve ls ≥ 5 μg /d l detroit (n=2768) 0 20 40 60 80 100 25.04.2014 21.10.2014 19.04.2015 16.10.2015 b lo od le ad le ve ls ≥ 5 μg /d l flint (n=202) a. b. note. (a) detroit and (b) flint. the data is de-duplicated; i.e., only highest blood lead value per child is shown. figure 3 percentage of children < 6 years of age with blood lead ≥ 5 – 40 µg/dl in flint, detroit, and michigan during april 25, 2014 – october 16, 2015 12 10 8 6 4 2 0 3. 6% 8. 1% 4. 1e -0 02 % 1. 3e -0 02 % 3. 9% 0. 6% 1 .8 % 0. 6% 0. 1% 0. 4% 0. 1% 0. 1% 0. 2% 0. 1%% a bo ve t h re sh ol d 5 μg/dl 10 μg/dl 20 μg/dl 25 μg/dl 40 μg/dl flint detroit michigan note. the cdc threshold for elevated blood lead was 40 µg/dl between 1973-75, 25 µg/dl between 1985-90, 10 µg/dl until 2012 and 5 µg/dl until 2021. nocebo effect and special education in flint 10 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ each of these attributions is examined in greater detail for flint community schools, detroit public schools community district, and all public schools in michigan using data for the academic years 2011-12 until 2019-20. special education enrollment was also examined from 2006-07 onwards to identify a baseline (figure 4), and 3rd grade reading proficiency was not analyzed in 2019-2020 since tests were cancelled due to the covid-19 pandemic. figure 4 special education enrollment in flint relative to detroit and michigan, 2006-20 -5 0 5 10 r el at iv e sp ec ia le du ca ti on en ro ll m en t % (f li n t% -m ic h ig an % )o r (f li n t% d et ro it % ) fwcflint rel. to michigan flint rel. to detroit mean 2006-2011 special education enrollment special education enrollment trends are routinely gathered under federal and state laws (individuals with disabilities act, 2004; michigan department of education, 2020; weiss & mettrick, 2010), and the data are significantly different for michigan, detroit and flint (p < .0001, figure 1b). overall, in the state of michigan, the proportion of children in special education remained stable between 2011-12 and 2019-20 at 12.9-13.5%. the special education enrollment rate in detroit slightly increased from 2011-12 to 2016-17 followed by a downtrend during 2017-18 to 2019-20 (figure 1b). the special education enrollment rate in flint started lower than detroit (p < .0001) in 2011-12 as would be expected due to lower blood lead levels alone, but began rising in 2015-16 (relative to the previous three academic years) after the federal emergency and aggressive national and roy, petrie, gamble, & edwards 11 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ international reporting on the fwc (green, 2019; jackson, 2017; pew research center, 2017). flint special education enrollment even surpassed that in detroit in 2017-18 (p < .0001). notably, the spike in flint special education enrollment rate only occurred in the 6-21 year age group, whereas the age group that would be considered most vulnerable to water lead exposure (i.e. those in the womb or up to age 1 during the fwc) saw no significant increase (figure s2). the special education enrollment rate in flint relative to michigan during 2013-15, including the first fwc year, was comparable to the 2006-11 baseline, but began to spike in the second fwc year (2015-16), when media coverage on the crisis increased markedly (see figure 4, “flint relative to michigan”). this was associated with a strong diverging trend between the special education rates for flint and detroit starting in 2016-17 (figure 1b). similarly, flint special education enrollment was much lower relative to detroit between 2011-16 (see figure 4, “flint relative to detroit”), became comparable in 2016-17, and increased dramatically from 2017-20. there is actually a strong inverse relationship (figure 1c) between %ebl and special education enrollment rate in flint, r = -0.79, 95% ci [-.96, -0.18], p = .021, but there is no such relationship for the same time period in detroit, r = 0.20, 95% ci [-0.59, 0.79], p = 0.63, or michigan, r = 0.09, 95% ci [0.66, 0.75], p = 0.83). special education suspension/expulsion rates the special education suspension/expulsion rates in flint increased 7.4 times in 2013-14 (13.6%) before the fwc began (figure 1d) compared to the previous two school years, and peaked in the first fwc year 2014-15 (14.1%), before dropping more than half in the second fwc year 2015-16 (6%). rates progressively rose during 2016-19 (9% to 11.2%) after the fwc came to light. special education dropout rates the special education dropout rates in flint roughly doubled in the 2017-20 school years (22.1%) versus 2014-17 (11.5%), after a steady decline during 2011-17 analogous to that occurring in detroit and michigan (figure 1e). general education reading proficiency after the state of michigan adopted the stricter michigan student test of educational progress (m-step) standard in the 2014-15 school year, both flint (22.3 percentage points) and michigan (19.9 percentage points) witnessed identical drops (around 20 percentage points) in 3rd grade reading proficiency between 2013-14 and 2014-15, but detroit fell even more precipitously (31 percentage points) (figure 1f). during the fwc (2014-16 school year) and until the 2018-2019 school year, 3rd grade reading proficiency stayed roughly the same in detroit, however flint continued to decrease until reaching the same level as detroit. nocebo effect and special education in flint 12 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ potential fwc covariates that could explain rising special education enrollment analyses of trends in covariates including waterborne contaminants besides lead, pover­ ty, poor nutrition, city of flint’s administration and emergency management decisions, and flint community schools’ policies and funding do not appear to be primarily asso­ ciated with the post-fwc rise in special education enrollment in flint (see text s1, supplementary materials). negative community expectations and media coverage the aggregated data from facebook, the dominant social media platform in the united states (perrin & anderson, 2019), obtained using the crowdtangle (www.crowdtangle.com) public insights tool owned and operated by facebook, indicate news around lead “poisoning” of flint children and worsening educational outcomes was interacted with hundreds of thousands of times and potentially reached tens of millions of users on facebook alone between 2015-21 (table s1). in contrast, there were just two articles about detroit children that saw just over 22,000 interactions. on average, 12.2% web traffic to news websites originate from social media, and, therefore, these reported values are gross underestimates of the total “reach” of news, which would include all newspaper and magazine hard copies read, news channel broadcasts watched, and radio programs and podcasts heard (alexa, 2020). to illustrate, the 60 minutes flint special edu­ cation episode (alfonsi, 2020) alone was interacted with over 27,000 times and potentially reached ~10 million users on facebook, and its television broadcast was also watched by over 10 million viewers on the cbs channel (table s1). negative pronouncements about lead exposure during the fwc period and educational difficulties in the media disproportionately originated from flint community leaders describing flint children, but similar claims were not made publicly by detroit community leaders (table s2) despite the much higher blood lead for detroit children (figure 1a, figure 2a, 2b, figure 3 and figure s1). a search for all posts and weblinks shared on official facebook pages of michigan local media (data s1) with the keywords “lead poisoned” and no mention of “flint” or “detroit” during january 2016-november 2020 time period using crowdtangle revealed over 80% articles (data s2) discussed the fwc. network mapping of these posts (fig­ ure 5) revealed the media outlets who shared the most articles and links to be from flint (wnem tv5, abc12, and the flint journal/mlive; collective n = 32) followed by prominent state-level newspapers detroit free press and the detroit news. moreover, the postings from michigan’s top three dailies by circulation (i.e., detroit free press, the flint journal/mlive, and detroit news) (agility pr, 2020) saw the most interactions (~35,000) in the form of reactions, shares, and comments. roy, petrie, gamble, & edwards 13 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 http://www.crowdtangle.com https://www.psychopen.eu/ fi gu re 5 n et w or k m ap pi ng o f a ll p os ts a nd w eb li nk s sh ar ed o n o ff ic ia l f ac eb oo k p ag es o f m ic hi ga n lo ca l m ed ia w it h th e k ey w or ds “ le ad p oi so ne d, ” ja n 20 16 -n ov 2 02 0 n ot e. (a ) m ed ia o ut le ts a rr an ge d by t ot al n um be r of p os ts /l in ks s h ar ed . ( b ) m ed ia o ut le ts a rr an ge d by t ot al in te ra ct io n s (r ea ct io n s, s h ar es , a n d co m m en ts ) on p os ts / li n ks s h ar ed . r aw v al ue s fo r al l m ed ia b ub bl es in t h e m ap s ar e pr ov id ed in s i (t ab le s 4) . (i ) t h e si ze o f th e m ed ia b ub bl es is r el at iv e; i. e. , h ig h er t h e m et ri c of in te re st , l ar ge r th e bu bb le . t h e n um er ou s li n ks e m er gi n g fr om e ac h b ub bl e in di ca te r es h ar in g of th e po st s/ li n ks t o ot h er f ac eb oo k pa ge s an d th e re pr es en ta ti ve b ub bl es a re a ls o re la ti ve ly s iz ed a cc or di n g to t h e m et ri c of in te re st . ( ii ) t h e fl in t jo ur n al b el on gs t o th e pa re n t m ed ia c om pa n y m li ve a n d bo th h av e se pa ra te f ac eb oo k pa ge s. t h er ef or e, w h il e th e pa ge s ap pe ar s ep ar at el y in t h e le ft n et w or k m ap a s th ey d o in fa ce bo ok , t h ei r in te ra ct io n m et ri cs a re a gg re ga te d in t ex t. nocebo effect and special education in flint 14 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ d i s c u s s i o n this investigation confirms that the proportion of young children with elevated blood lead in flint, detroit and michigan as a whole has been declining over the past 10 years. the %ebl trend in flint is very similar to that observed across michigan and has always been much lower than detroit. in fact, the %ebl in flint has now dropped below data for the united states (us centers for disease control and prevention, 2020). for additional perspective, the geometric mean blood lead even during the worst fwc year as reported in previous research (gómez et al., 2018), was lower than that reported in the european nations of france and poland (table s3). paradoxically, since the fwc was revealed in 2015 and residents were further protected from exposure to waterborne lead, flint saw a dramatic spike in special education enrollment, while such enrollment remained steady across michigan and even declined after 2015-16 in the control city of detroit. while lead is a neurotoxin with known potential for worsening educational outcomes (jusko et al., 2008; mendelsohn et al., 1998; surkan et al., 2007; watt et al., 1996), analysis of the data in flint relative to detroit is inconsistent with the attribution of rising special education enrollment in flint to lead exposure. the worst lead exposure from the fwc was of relatively short duration (about one-sixth of the entire time on flint river water; roy et al., 2019), and is set against a historic decline in blood lead in flint as well as detroit, michigan and nationally (dignam et al., 2019; gómez et al., 2018). the elevation in flint childhood blood lead was above the relatively new 5 μg/dl cdc reference threshold but not the 10 μg/dl threshold “level of concern” exceeded in washington dc children during its 2001-04 lead in drinking water crisis (roy et al., 2019). the number of individual children testing ≥ 25 μg/dl, a threshold above which it is reported that 20% of children require an average of nine years of special education (swinburn, 2016), was 18 times higher in detroit (0.21% of all children tested; n = 73) than in flint (0.08% of all children tested; n = 4) during the fwc. as early as january 2016, it was acknowledged that the worst-case incidence of elevated blood lead during the fwc was always less than half of the incidence in other michigan cities of detroit, grand rapids, and muskegon, and 3,800 other communities across the united states (frazier, 2018; lanphear, 2017a; mack, 2016; pell & schneyer, 2016; wilkinson, 2016). moreover, since %ebl in detroit was always at least twice that in flint before, during and after the fwc, worse outcomes, whether concurrent or lagged, would always be expected for detroit children, but such an impact is not observed in the time period of interest. instead, there is an incongruous inverse relationship between childhood blood lead and special education enrollment in flint, while no such relationship exists for detroit and michigan. despite an equal number of overall special education outcomes worsening and im­ proving (see text s1, supplementary materials), only those that superficially appeared to be worsening were publicized in the media. our detailed analysis shows these outcomes roy, petrie, gamble, & edwards 15 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ are insignificant or inconsistent with the actual lead exposure that occurred. specifically, the seven-fold jump in suspension/expulsion rates of special education students had occurred in 2013-14 before the onset of the crisis, and the comparison with detroit further discounts an association with lead exposure. indiscriminate enforcement of sus­ pension/expulsion policies before the fwc (d.r. v. michigan department of education, 2016) may have contributed to this spike. the special education dropout rates in flint only started to rise in 2017-18 post-fwc after expectations of such an outcome was widely publicized in the media starting late 2016. finally, the reduction in flint general education 3rd grade reading proficiency after adoption of a new academic standard in 2014-15 was also observed in the detroit control group, and could be attributed to the changed tests. the rise in special education enrollment in flint following the fwc was not associ­ ated with confounders of waterborne contaminants besides lead during the fwc, pover­ ty, poor nutrition, and emergency management. the flint schools’ failure to properly enforce special education policies and a severe budget deficit since the early 2010s may have contributed to less flint students being enrolled in special education programs pre-fwc, but the enrollment rate had returned to historical norms during the fwc. a nocebo effect is consistent with the trend of rising special education enrollment after the fwc was exposed (colloca & barsky, 2020; petrie & rief, 2019). as a top news story of 2016, the crisis engendered negative psychological effects described by residents as “flint fatigue,” and the surrounding international media coverage has contin­ ued for over five years with negative headlines (adams, 2016; associated press, 2020; cuthbertson et al., 2016; goodnough & atkinson, 2016; heard-garris et al., 2017; may, 2016). the news reports and their popularity on social media (table s1, figure 5) and negative perceptions of flint community leaders and parents (table s2) could have heightened negative expectations about the effects on children, who readily accept and act on information from those they trust (harris & corriveau, 2011; jaswal et al., 2010; landrum et al., 2013). contaminated water creates high public anxiety compared to other environmental concerns (petrie et al., 2001). for example, the psychological impact of the fwc caused increased tap water avoidance amongst us children nationwide after the fwc came to light (rosinger & young, 2020). the early speculation and worst case pre­ dictions of impacts on flint children were also made in a vacuum of trust, uncertainties in the timing and magnitude of the water lead exposure due to manipulation of official test results, and an acknowledged “failure of government at all levels” that caused the fwc (roy & edwards, 2019a). from 2016-18 arguments over the possible negative consequences of labeling flint children “poisoned” versus “exposed” played out in the media (clark & filardo, 2018; drum, 2017; gómez & dietrich, 2018; mays, 2018; schneider et al., 2016; shell, 2016). the worst negative expectations for special education enrollments in years following the fwc appear to have been realized, even though comprehensive blood and water nocebo effect and special education in flint 16 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ lead analyses eventually published in 2018-20 (gómez et al., 2018; gómez et al., 2019; roy et al., 2019; roy & edwards, 2020) contradict the popular belief that flint children experienced an unprecedented environmental lead exposure (figure 1a). moreover, in many cases, the national media – e.g., the new york times (green, 2019) and cbs 60 minutes (alfonsi, 2020) – have provided even worse prognoses, labeling flint children as brain damaged or lead poisoned (table s1). no comparable media labeling was applied to children in detroit (table s1, figure 5) or the other michigan cities with much higher %ebl incidence. a significant percentage of flint households experience water crisis-related stress and other negative psychological effects, are meeting criteria for psychological trauma, report behavioral problems in their children, and believe that “the crisis would never be fixed” (bosman & greeson, 2020; brooks & patel, 2022; ezell & chase, 2021; jones et al., 2022; reuben et al., 2022; sneed et al., 2020; trejo et al., 2022). a perception that flint’s water is still unsafe and a source of ongoing community concern is supported by continued high rates of bottled water use five years after the switchback to detroit water. bottled water use has persisted despite distribution of free lead filters, replacement of over 90% of lead pipes, and independent tests showing current flint water lead levels to be lower than observed in other michigan cities with old pipes (alfonsi, 2020; city of flint, 2022; flint cares, 2018; reuben et al., 2022; roy & edwards, 2019a, 2020). in fact, it is reported that some of flint’s youngest children have only bathed in and consumed bottled water their entire lives (alfonsi, 2020; fonger et al., 2019; herndon, 2018). exposure to feared contaminants such as lead is known to create nocebo responses (blettner et al., 2009; crichton et al., 2014; gruber et al., 2018; petrie et al., 2005; small & borus, 1987; witthöft & rubin, 2013). other suspected water contamination incidents have caused health complaints that were difficult to explain by the level of toxicological exposure (david & wessely, 1995; page et al., 2006). in the camelford water contamina­ tion incident in cornwall, england, health complaints were intensified by media interest, concerns about a conspiracy and litigation (david & wessely, 1995). however, in contrast to the fwc, those studies did not have direct data from continuous monitoring of the contaminant of concern in the blood of the affected population, or suitable control groups for comparison as in the research results presented herein. it has also been argued that the actual (and small) magnitude of elevation in children’s blood lead from the fwc does not matter in terms of the resulting health harm (e.g., hanna-attisha et al., 2018; kuehn, 2016; oleske et al., 2016; schmidt, 2018; schneider et al., 2016; stateside staff, 2018). however, the epidemiological study by lanphear and colleagues noted an inverse, supralinear dose-response relationship: a net decrease of 6.9 iq points, 95% ci [4.2, 9.4] for blood lead increment of 2.4 to 30 µg/dl, with the steepest drop of 3.9 iq points, 95% ci [2.4, 5.3] occurring for the lowest blood lead range of 2.4 to 10 µg/dl (lanphear et al., 2005). while the underlying (biological) roy, petrie, gamble, & edwards 17 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ mechanism has not been elucidated (lanphear, 2017b), the supralinear curve confirms the scientific principle that “the dose makes the poison” for lead. these data suggest that the rising enrollment in special education attributed to the fwc, may be associated with widespread negative expectations and not an elevation in blood lead. this possible nocebo effect in flint represents an unfortunate natural large-scale experiment, in which a population has been repeatedly informed by trusted national and international media sources that an unprecedented lead exposure event had occurred with severe long-term adverse repercussions to children, even when the data indicate that the actual lead exposure was normal for the state and less than nearby communities. two of this paper’s authors (mae/sr) personally witnessed such expectations during a science outreach program for over 1,000 k-12 flint students in march 2017 (edwards, 2017; jacques, 2018), where several teachers openly expressed their belief that flint children had been brain damaged, were incapable of learning, and that there was little point in trying to teach them (bouffard, 2018; edwards, 2017; jacques, 2018; roy & edwards, 2019c). trust of teachers in students and parents is a significant predictor of student achievement (goddard et al., 2001). these and similar expectations have been broadcast in the media for over five years (e.g., tables s1 and s2, figure 5) and can strongly influence children’s school performance and behavior, such as those previously documented in younger and stigmatized children from african-american and lower socioeconomic backgrounds (jussim et al., 1996). students who require and receive special education services do benefit from them (ballis & heath, 2021) and higher special education enrollments are not necessarily indicative of permanent brain damage or health harm from the water lead exposure. in fact, part of the rise might be viewed as part of a proactive effort to compensate for the failures of government at all levels that caused the fwc (wagner & kennedy, 2016). in any event, the media have never publicized this possible positive interpretation. importantly, the media messaging has not changed, in spite of ample evidence that the actual lead exposures in flint were not abnormally high relative to all of michigan and were much lower than neighboring detroit. it is possible that the harm from such messaging is continuing. for instance, the special education enrollment rate in flint for 2019-20 (22.7%) is now over 1.5-1.7 times the rates in detroit (14.7%), and is higher than michigan (13.5%) and the united states overall (14.1%) (us department of education, 2020), despite the fact that detroit children have always had more than double the incidence of %ebl than flint (figure 1a). this trend may even be accelerating due to universal special neuropsychological screening now being conducted for flint children, which has recently indicated an 80% diagnosis rate for “language, learning or intellectual disorders'' that are attributed to lead exposure from the fwc (alfonsi, 2020; chambers, 2019). nocebo effect and special education in flint 18 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ our study has limitations. this study is limited by reliance on existing blood lead datasets collected under standard screening practices, covering about 23% of young chil­ dren in michigan, 40% in detroit and 39% of genesee co. in 2016 (michigan department of health and human services, 2018). since this is a population-based study, we did not have educational outcomes data at the individual level to adjust for potential confound­ ers or to identify if multiple adverse outcomes were occurring for the same children. our study is also limited by the lack of charter school data. and finally, our central analyses were correlational, and should be interpreted with caution. in contrast, the strength of this population-based study is the utilization of over 1.44 million individual childhood blood lead measurements and annual monitoring of outcomes in general and special education occurring under uniform michigan educational policies in two cities with comparable demographics, using the same source of treated drinking water from lake huron except for the 18 months flint was served by the flint river and suffered the manmade public health crisis. the educational outcomes data are representative as they are weighted by city-level population instead of individual schools. the novel contribution of this study is uncovering of possible nocebo effect in the aftermath of a public health emergency involving a known neurotoxin, via an unfortunate natural experiment that could never have been studied intentionally. roy, petrie, gamble, & edwards 19 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://www.psychopen.eu/ funding: us environmental protection agency (#8399375); spring point partners, llc. acknowledgments: we are grateful to michigan department of health and human services’ childhood lead poisoning prevention program and especially their departmental specialist mr. daniel albright (access to the complete 2011-19 michigan blood lead dataset and review of this manuscript under the data user agreement), facebook crowdtangle and their former academics and research lead ms. naomi shiffman (onboarding and access to facebook crowdtangle), and the described and captioned media program (access to the 2017 “voices of flint” documentary). competing interests: mae and sr worked with flint residents to expose the flint water crisis, and their data, testimony and emails have been subpoenaed in several lawsuits. they are not party to any of these lawsuits. mae has been subpoenaed as a fact witness in many of the lawsuits, but he has refused all financial compensation for time spent on those activities. sr is serving as a scientific consultant in a flint lawsuit for vna starting december 21 2022 on biosolids research, a topic unrelated to this manuscript, and is expected to be financially compensated for that work. all other authors declare they have no competing interests. author contributions: s.r., k.j.p, and m.a.e. designed research; s.r., m.a.e. and g.d.g. performed research; s.r. and g.d.g. analyzed data; and s.r., k.j.p, g.d.g., and m.a.e. wrote the paper. twitter accounts: @siddharthaxroy, @keithpetrie data availability: all education data are publicly available on michigan department of education’s website www.mischooldata.org. blood lead data were obtained from michigan department of health and human services under a data user agreement (dua #202103-144) following irb approval (irb #202103-04-nr). the data can be made available from mdhhs upon completion of a data use agreement with the agency. the authors assume full responsibility for the analysis and interpretation of the data. all poverty and food assistance data are publicly available from the us census. all media coverage and facebook interactions data downloaded from crowdtangle are available in the supplementary materials. s u p p l e m e n t a r y m a t e r i a l s the supplementary materials contain the following items (for access see index of supplementary materials below): • figures s1 to s2 • tables s1 to s4 • texts s1 (including figure s3) to s2 (including figures s4 to s22 and table s5) • references • data s1 to s2 nocebo effect and special education in flint 20 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://twitter.com/siddharthaxroy https://twitter.com/keithpetrie http://www.mischooldata.org https://www.psychopen.eu/ index of supplementary materials roy, s., petrie, k. j., gamble, g., & edwards, m. a. (2023). supplementary materials to "did a nocebo effect contribute to the rise in special education enrollment following the flint, michigan water crisis?" [additional information]. psychopen gold. https://doi.org/10.23668/psycharchives.12578 r e f e r e n c e s aclu. (2016). all children can learn. d.r. v. michigan department of education: a civil rights lawsuit for the children of flint [fact sheet]. https://www.aclumich.org/sites/default/files/field_documents/flint_lawsuit_fact_sheet.pdf adams, c. (2016, december 22). 16 stories that defined 2016. cbs news. https://www.cbsnews.com/news/16-stories-that-defined-2016/ agility pr. (2020). top 10 michigan daily newspapers by circulation. https://www.agilitypr.com/resources/top-media-outlets/top-10-michigan-daily-newspapers-bycirculation/ alexa. (2020). how do the top websites drive traffic? https://try.alexa.com/resources/website-traffic-sources alfonsi, s. (2020, march 15). early results from 174 flint children exposed to lead during water crisis shows 80% of them will require special education services. cbs news 60 minutes. https://www.cbsnews.com/news/flint-water-crisis-effect-on-children-60-minutes-2020-03-15/ associated press. (2020, august 21). flint mom: $600 million settlement not enough. yahoo! news. https://news.yahoo.com/flint-mom-600-million-settlement-203659157.html?guccounter=1 ballis, b., & heath, k. (2021, may 26). special education: beneficial to many, harmful to others. brown center chalkboard. https://www.brookings.edu/blog/brown-center-chalkboard/2021/05/26/special-educationbeneficial-to-some-harmful-to-others barsky, a. j., saintfort, r., rogers, m. p., & borus, j. f. 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(2020, august 18). “double challenge mode” in flint, where virus follows water crisis. the new york times. https://www.nytimes.com/interactive/2020/08/18/us/flint-coronavirus.html roy, petrie, gamble, & edwards 21 clinical psychology in europe 2023, vol. 5(1), article e9577 https://doi.org/10.32872/cpe.9577 https://doi.org/10.23668/psycharchives.12578 https://www.aclumich.org/sites/default/files/field_documents/flint_lawsuit_fact_sheet.pdf https://www.cbsnews.com/news/16-stories-that-defined-2016/ https://www.agilitypr.com/resources/top-media-outlets/top-10-michigan-daily-newspapers-by-circulation/ https://www.agilitypr.com/resources/top-media-outlets/top-10-michigan-daily-newspapers-by-circulation/ https://try.alexa.com/resources/website-traffic-sources https://www.cbsnews.com/news/flint-water-crisis-effect-on-children-60-minutes-2020-03-15/ https://news.yahoo.com/flint-mom-600-million-settlement-203659157.html?guccounter=1 https://www.brookings.edu/blog/brown-center-chalkboard/2021/05/26/special-education-beneficial-to-some-harmful-to-others https://www.brookings.edu/blog/brown-center-chalkboard/2021/05/26/special-education-beneficial-to-some-harmful-to-others https://doi.org/10.1001/jama.287.5.622 https://doi.org/10.1136/oem.2007.037721 https://www.nytimes.com/2020/08/19/us/flint-water-crisis-settlement.html https://www.nytimes.com/interactive/2020/08/18/us/flint-coronavirus.html https://www.psychopen.eu/ bouffard, k. 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