IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 15 Examining the psychological and behavioural patterns of students in Sri Lanka during COVID-19: A qualitative study Kalpani Abhayasinghe 1, 2, Navodya Weerasinghe3, Lasith Dissanayake2, Krishani Jayasinghe2, Duminda Guruge2, 4, Athula Sumathipala2 1Department of Nursing & Midwifery, Faculty of Allied Health Sciences, General Sir John Kotelawala Defence University, Sri Lanka, 2 Institute for Research and Development in Health and Social Care, Sri Lanka, 3Coventry University, United Kingdom,4Department of Health Promotion, Faculty of Applied Sciences, Rajarata University of Sri Lanka, Sri Lanka Corresponding author: K. Abhayasinghe (mpkw.abhayasinghe@kdu.ac.lk) ABSTRACT Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 pandemic affected many international students, including the Sri Lankan youth and young adults who were studying in the United Kingdom (UK), and repatriated to the motherland during the first wave. The current study aimed to explore and understand the lived experiences, behaviour, and psychological patterns of these students during their lockdown in the UK; quarantine and self-isolation; and repatriation back to Sri Lanka. Methods: This descriptive qualitative study was planned and conducted in a quarantine environment based on the lived experiences of two authors (KA and NW), who were also repatriated students due to COVID-19 pandemic. A convenient sample of sixteen (16) repatriated students (age ranged from 18 – 34) participated in the study. Data was collected using multiple methods including questionnaires, researchers’ objective observations and semi-structured interviews (conducted over the phone or online). The thematic analysis method was used for data analysis. Results: Both positive and negative psychological and behavioural patterns were observed. Three themes emerged were: (1) Fear, worry and anxiety, (2) Irritability and agitation, and (3) Adherence to safety precautions. Many reported negative abrupt changes to their education and lifestyles during this stressful situation. Perceived stigma and emotional imbalance have caused difficulty in coping. Positive changes such as increased efficacy in academic activities, exploring new hobbies and healthy coping skills were also reported. Conclusion: Findings highlight the need for addressing age-specific behavioural, psychological, and educational needs of youth and young adults when developing guidelines to manage similar situations in the future and to increase resilience. KEYWORDS COVID-19, Psychological and Behavioural patterns, Repatriation, Young adults, Youth FUNDING SOURCE This project was funded by the Institute for Research and Development in Health and Social Care Sri Lanka (IRD). BACKGROUND The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) affected the lives of many people worldwide. To control the spread, Governments of COVID-19 affected countries enforced nationwide measures including lockdown, curfew, travel restrictions, restrictions in public gatherings, physical distancing, enforcing mask wearing and other sanitary practices (Lewnard & Lo, IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 16 2020). This resulted people to be home confined and they started working from home, homeschooling, and staying indoors (Watkins, 2020). International measures include closure of airports to mitigate the spread of the virus across countries (Killeen and Kiware, 2020; Gössling, Scott and Hall, 2020). Majority of the international students studying abroad faced challenges as they were not able to move back to their home countries during the pandemic. For example, Sri Lankan students who were studying in China, the United Kingdom, Australia, The United States, Russia, Belarus, and Singapore requested the government to facilitate them return home during the pandemic. The temporary closure of schools and universities resulted in disruption of the usual academic process, sudden and abrupt changes to academic activities, social lives, daily lifestyles, and psychological wellbeing of the university students who were studying abroad. By mid-April 2020, 192 countries had closed schools, affecting more than 90% (nearly 1.6 billion) of the students around the world (Donohue & Miller, 2020). However, with re opening of academic institutions in some countries, by mid- March 2021 the affected number has decreased to 1.5 billion (UNESCO, 2020). Evidence indicates that quarantine process during SARS outbreak in years 2002/2003 resulted depression, low mood, fear, other psychological symptoms, and many negative outcomes (Lau et al., 2005; Person et al., 2004). Young age (16-24), lower levels of educational qualifications and female gender are some of the predictors that increase negative psychological symptoms (Brooks et al., 2020). Young adults are vulnerable in developing negative psychological conditions when they are subjected to prolong home confinement, isolation, and physical distancing from others (Shanahan et al., 2020). Changes in everyday lives due to home confinement, online education, travel restrictions, and airport closures affected negatively for many foreign students and their families (Gössling et al., 2021; Torales et al., 2020). However, there can be positive changes to one’s lifestyle and behavior, for example, some may find increased productivity during self-isolation due to less distractions, enhanced coping, team working, new connections established via online communication, social support from the close contacts and health care professionals at quarantine centers (Chen et al., 2020), peer support during quarantine period and specially the opportunity they got to return to their families in home countries. It is not clear how long the COVID-19 pandemic will continue to limit usual academic and lifestyles of this group of students. Clearly, there are challenges of continuing academic activities such as attending online virtual classes and completing assignments while being under quarantine with limited resources and distractions. It is important to understand ‘how youth and young adults responded to COVID-19 while studying in abroad, being under lockdown in the UK, during and after repatriation?’ To address this research question, the current study was conducted with an aim to explore the impact of being under lockdown, self-isolation, repatriation, and quarantine processes during the journey from the UK to Sri Lanka, on the behavior and psychological changes on this youth and young adult group. METHODS Design and Sample A descriptive, qualitative study was carried out over a period of four weeks in mid-May to June 2020. The study setting was one of the government quarantine centres located in Colombo. A convenient sample of university students (n=16) who were studying in the UK and repatriated back to Sri Lanka were recruited for the study. Recruitment Participant recruitment and data collection were carried out by the two researchers (KA and NW), who are also Sri Lankan students studying in the UK, repatriated back to Sri Lanka from the UK due to COVID-19 pandemic and was in the same quarantine center. In terms of recruitment strategies, the research team informed the purpose of the study to the administrative members of the quarantine centre and referred interested individuals who met the inclusion criteria. Due to strict quarantine procedures, we could only include the students who repatriated back to Sri Lanka from the UK in the same flight and those IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 17 who were at the quarantine centre by the time we conducted the study. The potential participants consist of a group of Sri Lankan youth and young adults. For this study, we defined youth as individuals in the 18 – 24 years age group and young adults as the 25 – 35-year age group. There were undergraduates, Master, and PhD students among them. Investigators who were at the quarantine centre shared information about the study. The participants were provided enough time to read and understand the information and to clarify any questions they had before deciding to take part in the study. Out of the 40 repatriated students in this group, sixteen consented to take part in the study via the online messaging platform. Data Collection Three investigative methods were used for data collection: (1) Researcher’s objective observations to explore individual and group behaviour patterns, (2) Questionnaires (including demographic information questions, The Generalized Anxiety Disorder 7-item (GAD-7) scale and (3) Semi-structured interviews (over the phone or online) to explore participants’ lived experience. The GAD-7 is a self-report screening tool for generalized anxiety symptoms which has been successfully disseminated in community and primary care settings. The GAD-7 consists of seven questions based in part on the DSM-IV criteria for GAD and reflects the frequency of symptoms during the preceding 2-week period. The scale requires approximately 1–2 minutes to administer and for each symptom queried provides the response options as: “not at all,” “several days,” “over half the days” and “nearly every day” and these are scored, respectively, as 0, 1, 2 or 3 (Mossman et al., 2017). The seven items assess (1) feeling nervous, anxious, or on edge; (2) being able to stop or control worrying; (3) worrying too much about different things; (4) trouble relaxing; (5) being restless; (6) becoming easily annoyed or irritable; and (7) feeling afraid as if something awful might happen (Cattivelli et al., 2019). Data collection was conducted at three phases: Phase 01: At the time of obtaining the consent, participants were asked to complete a short demographic questionnaire and the GAD-7 scale (circulated online via closed WhatsApp group or email). In-depth, semi-structured interviews were conducted using a topic guide to further explore the real-life experience and perceptions of being locked down in the UK, repatriated to Sri Lanka and quarantined. Observation of students’ behaviour and day-to-day practices at the quarantine centre was considered appropriate as a data collection method as KA and NW could interact with them and observe them in a real-life environment (Dwyer & Buckle, 2009). As a coping method, KA and NW maintained independent personal journals to keep notes on their experience and objective observations while they were under lockdown in the UK and continued this exercise during repatriation and while staying at the quarantine centre. We used these journals as a data source (Branquinho et al., 2020; Kingdon, 2005). Phase 02: Observation and interviews were conducted. GAD-7 scale was administered online at the end of the quarantine period in Sri Lanka. The semi-structured interview guide consisted of several questions to explore participants’ lived experience and perceptions of being locked down in the UK, repatriated to Sri Lanka and being quarantined. Phase 03: GAD-7 scale was administered three weeks after the students being sent home at the completion of quarantine (after a week of completion of self-isolation at home). A follow up interview was conducted over the phone in two - three weeks after the students being sent home at the completion of quarantine period. Purpose of this short interview was to explore participants’ views and perceptions of life after quarantine period, for example, feeling of going home and joining with their loved ones. All the interviews were transcribed verbatim. Diary entries and interview transcripts were anonymized to maintain the confidentiality of the participants and to prevent them from being traced back. Qualitative data analysis was conducted using thematic analysis (Alhojailan & Ibrahim, 2012; Clarke & Braun, 2013). Simple descriptive statistics were used when presenting demographic information where relevant. Ethics Consideration Ethical approval for the study was obtained from the ethics review committee of Rajarata University of Sri Lanka (Ref: ERC/2020/38). Investigators shared IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 18 information about the study via a closed WhatsApp group and invited the students to take part in the study. Those who agreed to take part voluntarily were recruited using an online consent form, developed via Google Forms. The student group were informed verbally regarding the objective observation of their psychological and behavioural patterns on the day one at the arrival of quarantine centre. Interviews were conducted online considering the ease of convenience and the need of maintaining physical distancing measures at the quarantine centre. RESULTS All participants were of Sri Lankan descent. The sixteen participants consisted of 50% females and 50% males. Their age ranged from 18 – 34 years. All of them were in the middle of their higher studies, some were nearly completing their respective degrees. The majority were Sinhala Buddhists. Demographic information is illustrated in the Table 1. Findings indicate both positive and negative psychological and behavioural impacts. Four themes emerged namely, (1) Fear, worry and anxiety, (2) Adherence to safety precautions (3) Loneliness and (4) Coping. Fear, Worry and Anxiety Majority of the students reported that they were not worried about the condition at first (i.e., during the epidemic level at China) and conducted their normal routines until the lockdown started in the UK. However, they mentioned that they were worried, when the COVID -19 reached Sri Lanka and Europe, and realised the seriousness of the situation. “At first, I thought it would not go for pandemic scale. I thought it would just stay in China. So, I wasn’t taking it that seriously. When the outbreak reached around Europe, in Italy and Spain, the more I realised it’s a serious issue.” (P01) Almost all of them were worried that their academic activities hindered during the lockdown period due to the university closure. And after repatriation, mode of studies changed to distanced and online learning. Some said, their parents were worried of them staying in the UK alone, thinking they had no access to health care facilities if things go wrong. Some were afraid of being exposed to COVID-19 infection during repatriation. Many were afraid towards social stigma and discrimination. “I wasn’t worried or panicking that much. But my parents were… since they were in SL and I was in the UK. They kept on thinking about the distance between us […] It was quite of a pressure for me. I was worried about them more than worrying about myself.” (P04) “I started getting anxious at the end. I realised that it’s not that easy as you think it is, since I didn’t have any flat mate or friend whom I can rely on in an emergency.” (P03) “I still don’t know what to expect once I go home, how people view me… whether as a diseased person or I’m like Corona virus career, like I would just be spreading all over… I keep thinking what people would think about my parents as well.” (P01) It was reported that their anxiety levels and fears were increased during the lockdown period in the UK and repatriation due to perceived risk of being exposed to the infection. When asked about how they were coping, many reported that they ‘felt at ease’ after coming back to Sri Lanka. Some had experienced stigma and discrimination on arrival at the airport and some experienced it after going home. This resulted in increasing their anxiety levels. The evidence reflected by GAD support these findings (Table 2). Reasons for these emotional fluctuations were different in each stage of the process. “In the UK… I had worst mental break downs, and overslept, and just kept thinking ‘is this going to finish or not?’ The travelling part was a bit overwhelming. But the overall process in quarantine is good.” (P01) Observation notes from the researcher diaries support findings from the interviews regarding the increased anxiety and fear on the first day at the quarantine centre, but gradual decrease of anxiety and fear towards the end of the quarantine period. “Those who repatriated appeared to be afraid of the staff who were wearing PPE. They asked many IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 19 questions from the staff and worried about the body temperature. All students wore masks all the time. They stayed in rooms and only appeared at the door to check temperature or when the meal arrived.” (Observation notes, Day 01 at quarantine) “Students sang songs together in the corridor. Some played games together. They do not spend all day inside the room. Student helped and cared for each other.” (Observation notes, Day 10 at quarantine) GAD-7 data also are in line with the qualitative findings and shows the gradual decline of anxiety levels among many of the participants (Table 2). According to Table 2, many participants reported mild or minimal severity regarding their anxiety level. However, the in-depth interviews revealed that the anxiety levels are much higher than the reported GAD-7 scores in many cases, and the level of anxiety explicitly indicated in GAD-7 scores was not fully reflective of the fear, worry and anxiety indicated in interviews. The discrepancy between the anxiety expressed during interviews and the GAD-7 scores indicates that the quantitative measures cannot capture sensitive emotions and feelings, instead qualitative methods can give more construct to this context. Adherence to Safety Precautions Level of adherence to the safety precautions among the study participants seem to fluctuate over time. Best adherence was reported at the beginning of the lock down in the UK and during the repatriation process. “At first I... I think I was quite reckless. But then I realised [the risk] ... Whenever I got my groceries I washed most of the things as soon as I got to kitchen. I think I got pretty paranoid about it… I kept washing my hands and I made sure that I had at least 3 sanitizers with me. My shoes, I sprayed them with Ethanol and stuff [laugh].” (P01) Girls reported more adherence when compared to boys all the time. However, the students appeared to feel normalised in living with COVID- 19 over time and complained of ‘getting bored, forgetting to adhere to safety precautions’ while they are in the UK: “At the beginning I was very keen. Later on, I started forgetting things… perhaps I got bored and wasn’t bothered to do it. Sometimes I did it just because my family members reminded that so often when they called me.” (P02) “I was like, ‘Why should I keep doing this? It’s a headache. It’s too much of work’. But at the same time, I kept saying to myself, you should do it or else no body is there to do it for you.” (P01) Many students reported experiencing irritability and agitation during the lockdown period in the UK. Low mood, arguments with their parents or partners, overly sleeping, gaming or increased screen times were reported because of inadequate coping of isolation and adherence to strict physical distancing and safety guidelines. “I got quite irritated even for smaller things really quickly... Even if my parents called me and ask something really simple, like ‘are you okay?’ that irritated me pretty easily. I had to answer the same question… I kept hearing the same news over and over again throughout the day and night. At some point I even wanted to avoid people… I mean the phone calls came from [my loved ones].” (P05) Loneliness Some participants felt they were lonely when they were in the UK and when they see others flew home, they felt deserted. “A friend, of mine who is like a sister to me… flew home just before the airport closure… I was supposed to fly a week after but had to stay a month or so. It touched me. Then only I started worrying… I felt that loneliness, and… I felt like I was lost and deserted…” (P02) Several students were in contact (via online) with each other to receive repatriation updates before they first meet at the flight. Some reported that they felt less lonely as they got along with others and became a part of the group. “I got to know [names of other students] when I became a part of the online group [students’ group], I became a volunteer to support others, it gave me IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 20 hope, because they’re working on it [repatriation], rather than being isolated… it was so good to have company…” (P02) Physical distancing measures affected their everyday lifestyles. Some students reported very low mood as they were alone because they did not have opportunity to meet friends or go to university. Some experienced financial difficulties also. “I felt alone when I was not able to go out… some days were like… ‘I don’t have any family here… and what happens if you won’t be able to go home’. I couldn’t go to my part time, and I had no money. So, all sort of thoughts were there…” (P05) All reported that they were happy to reunite with family members. Coping When considering the coping mechanisms practiced by this group of young adults, it was seen that both negative and positive means of coping were there. Some reported increased use of internet, gaming, and screen time during the lock down and quarantine period. Some had developed unhealthy behaviours such as over-sleeping during the day, over-eating, and smoking. Some students had engaged in drawing and doing other leisurely activities during the lockdown and while at the quarantine centre. During the quarantine period, researchers observed group behaviours among students, where individuals with similar interests were seen together often. Sometimes, there were discussions among student groups regarding maintaining cleanliness of common areas, and complaints of being noisy while others were studying. However, amidst the negative aspects, some also reported positive experiences such as improved work efficiency, increased productivity during self-isolation due to less distractions. Master or PhD students demonstrated better coping skills when compared to younger students perhaps due to their potential lived experience and level of maturity. “It was an adventure, a good experience. I managed to get most of my work done during the lockdown in the UK and while being under quarantine here.” (P02) Some students were happy about making new friends making new friends, team working, establishing new connections via online communication, and receiving peer support during the quarantine period. “I became really close with some new friends. Met interesting people unexpectedly. We were in the same boat, and we all faced the same storm. Perhaps that glued us together. So, that togetherness was quite a good feeling. I feel good, I felt quite comfortable around them.” (P06) It also appeared that the religious practices and beliefs of the students could help the participants to cope with difficult situations. For example, a Buddhist student mentioned that she was practicing meditation to ‘calm herself during the lockdown period’. A catholic participant mentioned: “On the days I felt so low, I prayed to the God thinking of my family. I was hoping to be with them as soon as I can.” (P13) A few students said that they became strong, developed coping skills and the entire experience changed their behaviour and perspectives towards life. “How much a virus could do? We witnessed shocking deaths of many. It just changed my way of looking at world. I learned to be patient as the repatriation got delayed. I learned to appreciate the courage I have.” (P 07) DISCUSSION Findings indicated both positive and negative psychological and behavioural patterns with respect to the emerged themes. Many of the participants have been experiencing fear, worry, anxiety, irritability, overeating, over sleeping, increased screen time and gaming, and smoking during the lockdown period in the UK. Restlessness, uncertainty, and boredom resulted in agitation, irritability, or addictions. Prolong home confinement during a disease outbreak can have negative effects on young people’s mental, physical health and behaviour (Liu et IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 21 al., 2020). Less physical activities, outdoor activities, and inability to interact with friends and family may cause changes to their psychological and behavioural patterns. For example, an exhibition of discomfort in forms of confusion, anger, aggressiveness, irregular sleep patterns, addiction to internet or screen time (TV or computer) and less favourable diet preferences were commonly reported among young people (Brooks et al., 2020; Wang et al., 2020). Prior to the outbreak of COVID-19, similar epidemics such as SARS (during 2002-2003), led to major self-isolation procedures and quarantining of individuals, during the absence of a proper treatment method (Chen et al., 2009). Like the findings of the current study, Chan et al. (2007) reported that dramatic changes in lifestyles due to lock down and physical distancing may be accompanied by fear of being infected to self or loved ones resulting in a significant negative impact to their psychological wellbeing. Many participants in the current study reported that lack of access to health care, uncertainty and loneliness caused them fear in the UK, but have ‘felt at ease’ when they got the news of repatriation and stared ‘feeling positive’ during the quarantine and ‘not worried’ after going home. Adherence to safety precautions was reported higher during the lockdown period in the UK and throughout the repatriation process but reduced during the quarantine period and after going home. These findings contribute new insights to existing evidence, especially with regards to possible implications for practice that involve drawing on this study to develop interventions to support international students in the future. Empirical evidence indicates that quarantine processes result in depression, low mood, fear, confusion, anger, and other psychological issues such as post-trauma stress symptoms among youth (Brooks et al., 2020; Lau et al., 2005). Nevertheless, the current study shows positive changes and experiences such as increased efficacy in their academic activities, exploring new hobbies, adventure, befriending and healthy coping skills (e.g., cooking, painting). This study was planned and conducted in a quarantine environment based on the lived experiences of investigators; therefore, it is a first- hand experience research where the researchers are also present in the setting, overtly observing the participants. Researchers who were in the quarantine centre (KA and NW) think that objective observations and journal keeping was fun. It was also a good coping mechanism during this difficult period. Two of the researchers were fully immersed in the study as they were able to live in the same environment, could interact with the participants and observe students’ behavior patterns (Dwyer & Buckle, 2009). The investigators learnt positive life lessons by actively participating in this research and being able to share their lived experience during this difficult period. The current study did not explore the role of different religious coping strategies. However, the findings showed that religious beliefs and practices could help the study participants to cope with their anxiety especially during the lockdown period in the UK. There is evidence to show that people who use religious coping strategies during difficult situations in their lives, are less likely to experience depression symptoms (Aflakseir & Mahdiyar, 2016). Even though many participants of the current study were Sinhala Buddhists, findings did not seem to have a significant influence on their ethnicity or religion. However, it will be interesting to explore further in future research regarding the impact of religious beliefs and practices of individuals who experience similar situations. Despite the strengths mentioned, one major limitation of this study is high drop-out rate of participants at the end of phase 02. Most participants were not interested to fill online questionnaires or to take part in the interviews planned after completion of quarantine period. Perhaps they lost the interest to contribute to study once they left the quarantine center to be with their loved ones. Another limitation is that the study included international students repatriated only from the UK and who took the same flight. The quarantine centre followed strict guidelines on physical distancing and communicating with others who arrived later. Therefore, it was not possible to advertise the study to incoming individuals at the centre. Present study contributes to the research gap in the present literature regarding the impact of COVID- 19 on this age group with regards to a Sri Lankan population of international students. This study also provides evidence-based guidance on identifying how the students responded to the closure of schools and IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 22 universities, how they coped with their studies during a time of a pandemic. Possible outcomes from this study will help to identify and address psychological and educational needs, challenges, coping strategies of youth and young adults in this group and help developing guidelines to manage similar situations in future and increase resilience. However, due to the exploratory nature of the study as well as its small sample size, the findings may not be generalised and therefore, it would be better taking caution when drawing evidence-based guidance from this study. Furthermore, it would be interesting to conduct more studies among different age groups such as middle age, and older adults with similar experiences of repatriation to compare the findings as well as to explore participants’ resilience and perceived ability to deal with potential life stressors in difficult situations like covid pandemic (i.e., feeling more confident from having developed improved coping strategies for stressors versus feeling more scared with regards to experiencing certain aspects of something like this again). Especially, since Sri Lanka is a country with a collectivistic culture, it would be very interesting to see how different communities faced the challenges during COVID-19 pandemic. Potential lessons learned regarding resilience could then be used to develop and test interventions for CONCLUSION As mentioned earlier, youth and young adults are high-risk groups of individuals who are more likely to develop negative psychological and behavioral patterns during disease outbreaks. Understandings gained by the current study will help the future researchers, psychologists, students, and other readers to identify the immediate challenges faced by the youth under global emergencies. Identified psychological and behavioural patterns, coping mechanisms used by them will be of use when planning possible interventions that could be implemented in similar situations in the future. ACKNOWLEDGMENT We thank all the participants who took part in the study. We are grateful to Mr. Titus Karunaratne and Mr. Madura Hewamulla for their encouragement and support during the data collection process. 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Wang, G., Zhang, Y., Zhao, J., Zhang, J., & Jiang, F. (2020). Mitigate the effects of home confinement on children during the COVID-19 outbreak. The Lancet, 395(10228), 945–947. Watkins, J. (2020). Preventing a covid-19 pandemic. The BMJ, 368:m810. IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 24 Table 1. Demographic variables Demographic variables Descriptive summary Age (years) x ̄= 24.93; SD = 1.58 Gender (%) Male = 50% Religion (%) Buddhist = 81.25% IHTP, 2(1), 15-25, 2022 CC BY-NC-ND 4.0 ISSN 2563-9269 25 Table 2. GAD – 7 Scale – Level of Severity of Anxiety Phase 1 (n=16) Phase 2 (n=16) Phase 3 (n=16) Mild = 50% Minimal = 37.5% Severe = 12.5% None = 18.75% Mild =18.75% Minimal = 56.25% Severe = 6.25% None = 50% Mild = 18.75% Minimal – 25% Moderate = 6.25% .