TARA for Medical Students, a Single-arm Mixed Methods Pilot Study

Study Overview
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Brief Summary
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Medical students have higher risks for depression, anxiety, burnout and suicide than the general population and they rarely seek professional help or treatment. The group treatment program Training for Awareness, Resilience, and Action (TARA) was originally developed to treat depressed adolescents, targeting specific neuroscientific findings. TARA has shown feasibility and preliminary efficacy in clinically depressed adolescents and corresponding brain-changes in mixed community samples. In the present study feasibility and acceptability of TARA in Swedish medical students are investigated. The design was a single-arm trial with twenty-three self-selected students in early semesters of medical school, with or without mental disorders. All received TARA. Self-reported symptoms of depression, anxiety, perceived stress and psychological inflexibility were collected before (T0) and after the intervention (T1). Qualitative data on the participants' experiences of TARA was collected in focus group interviews and individually both during and after the intervention. The investigators hypothesize that (1) TARA will be feasible in medical students, (2) the content will be acceptable, (3) attendance and retention will be good, (4) trends towards improvement will be seen on the self-rating scales and (5) it will be possible and meaningful to explore the students experience of participating in TARA.

Detailed Description
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The primary aim of this study is to investigate the feasibility and acceptability of TARA as indicated prevention of mental disorders and stress-related symptoms in self-selected medical students. We also aim to qualitatively explore the students' experiences of participating in TARA both during and after the program as well as at a two-year follow-up. The study is designed as a single arm pre-post intervention study. Participants and procedures Participants are recruited from Umeå University School of Medicine. The University is located in the north of Sweden and enrolls 130 medical students per semester. Participants are recruited from the second and fourth semester through oral and written information at a mandatory class on professional development, including in total approximately 225 students. Participation in the TARA-study is voluntary, and in addition to being a medical student we have no specific inclusion or exclusion criteria. Participants are allocated to one of two TARA-groups (A and B) based on their personal weekday preference, since the groups are held on different days of the week. Before inclusion, participants provide written informed consent. Study participation is voluntary and can be cancelled by the participant at any time. Groups are held at the university campus in premises provided by the university hospital. Each session for a given group is led by the same two facilitators, together covering expertise in contemplative practices and clinical psychology or psychiatry. The facilitators' role during sessions is to teach specific content and to model a collaborative, inclusive, non-judgmental, and supportive attitude. Continuous supervision and training of facilitators is provided by the principal investigator who also monitors fidelity to the manual, both in terms of content adherence and the process of delivery. The facilitators are also videotaped to facilitate supervision and implementation of the protocol. Assessment procedures At baseline (T0), before the intervention, self-report of sociodemographic background and outcome measures is collected online, for details see outcome measures. After the intervention (T1), and at a two-year follow-up (T2) outcome measures are repeated. Participants who do not provide data at the time of data collection are reminded by the research team through email and/or telephone contact. The TARA-participants provide brief self-assessment and session-evaluation on paper at the beginning and end of each session. A semi-structured group-interview about TARA is conducted halfway through the program. Those who are present at the session and willing to stay afterwards are interviewed and the same participants are interviewed again upon completion of the program. The interviews are conducted by an independent researcher without any background or involvement in the intervention. A semi-structured interview guide created for this purpose is used. The questions are mainly about the participants' experiences of TARA. At two years follow-up another independent researcher conducts individual interviews with participants from both groups. These interviews are held online or at the interviewees' choice of location. All participants are invited by email. The semi-structured interview guide for the individual interviews is adapted for the current timeframe. Example questions asked in all interviews are: What are your experiences of participating in TARA? and Can you mention something that was particularly hard or challenging?. The questions are broad or open. Experiences before, during and after TARA are covered. When necessary and/or appropriate questions are followed up using cued prompts (You said X, please tell me more about that), facilitating utterances (nodding, Umm, etc.), clarifying questions (Do you mean Y?), and relevant follow-up questions. Analysis The dataset is checked for illogical values. For both categorical and continuous variables, responses outside the possible response categories are coded as missing. Descriptive statistics are calculated using standard measures. Sum scores, as well as means and standard deviations are calculated for each self-report measure. Missing data on the item level is imputed using Multiple Imputations with 5 iterations, to enable calculation of sum score despite missing items. The T1 scores on each item on the secondary outcome measures (Hospital anxiety and depression rating scale- anxiety and depression sub scales, Perceived stress scale and Avoidance and Fusion Questionnaire for youth) are used as predictors in the imputation model and we use a random seed. The data is checked for normality using histograms and Q-Q plots, as well as skewness and kurtosis. Boxplots are used to check for outliers. No interim analyses are conducted. Descriptive statistics is reported using standard measures. To evaluate potential differences between the test-retest sample and the baseline sample we use Fisher's test for nominal data, Mann-Whitney U test for ordinal data and non-normally distributed continuous data, and unpaired T-test for normally distributed continuous data. Paired samples T-tests are conducted to compare self-rated symptom severity scores at T0 and T1 as well as at T0 and T2. All analyses are performed using SPSS statistics (version 26, IBM Corp., Armonk, NY, USA). All significance testing is two-tailed, with a significance level of 0.05. P-values are not corrected for multiple comparisons. The interviews are audio-recorded, transcribed verbatim by the respective interviewer who has a high degree of familiarity with the data. The transcribed data is subjected to qualitative content analysis, which involves the systematic interpretation of the overt and underlying content and can be used to analyze participants' reflections, experiences, and attitudes. The text is first read several times separately by the authors, discussed to get sense of it as a whole, and then divided into meaning units relevant to the aim of the study. The meaning units are then coded and sorted into groups according to their variations, similarities, and differences. The investigators meet regularly to discuss their interpretations and finally agree on the structure of the data. Time plan The investigators delivered TARA in the fall 2018. The final qualitative data collection was completed in fall 2020.

Official Title
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Training for Awareness, Resilience and Action (TARA) for Medical Students: A Single-arm Mixed Methods Pilot Study to Evaluate an Indicated Prevention of Mental Disorders and Stress-related Symptoms

Conditions
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Preventive Intervention in Mainly Healthy Students

Intervention / Treatment
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* Behavioral: Training for Awareness, Resilience and Action (TARA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical student at Umeå University in the second or fourth semester. Exclusion Criteria: None.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm intervention. Students are allocated to one of two intervention-groups based on personal preference, both intervention-groups receive the same intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training for Awareness, Resilience and Action (TARA)<br>12 weekly sessions, each 90 minutes, up to 14 participants/group. Manual-based: Session 1: Introducing group members; establishing guidelines; investigating attitudes and previous experiences, introducing contemplative practices. All sessions: participants sit on yoga mats. Facilitators open and briefly check-in. Participants are guided through a breathing practice, yoga-based movement (a flow of positions synchronized with the breath) and then a meditation focusing primarily on interoceptive and sensory awareness. After a short break, a psychoeducational presentation is held followed by group exercises and discussions. The sessions conclude with feedback and questions regarding the practice, followed by a description of the home practice for the coming week. Finally, participants gather their attention and have the opportunity to express their reflections and current state. | Behavioral: Training for Awareness, Resilience and Action (TARA)<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | mean number of attended sessions/participant | End of 3 month intervention | 
| Retention | percentage of participants who attended more than half of the sessions | End of 3 month intervention | 
| Acceptability: Child Session Rating Scale | Self report, mean weekly individual total score, score range is 0-40 and higher scores mean a better outcome | End of 3 month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale, anxiety sub-scale | Self report. Total raw-score. Raw score range is 0-21 and higher scores mean a worse outcome. | 3-month follow up | 
| Hospital Anxiety and Depression Scale, anxiety sub-scale | Self report. Total raw-score. Raw score range is 0-21 and higher scores mean a worse outcome. | 24-month follow up | 
| Hospital Anxiety and Depression Scale, depression sub-scale | Self report. Total raw-score. Raw score range is 0-21 and higher scores mean a worse outcome. | 3-month follow up | 
| Hospital Anxiety and Depression Scale, depression sub-scale | Self report. Total raw-score. Raw score range is 0-21 and higher scores mean a worse outcome. | 24-month follow up | 
| Perceived Stress Scale | Self report. Total raw-score. Raw score range is 0-40 and higher scores mean a worse outcome. | 3-month follow up | 
| Perceived Stress Scale | Self report. Total raw-score. Raw score range is 0-40 and higher scores mean a worse outcome. | 24-month follow up | 
| Avoidance an Fusion Questionnaire for Youth | Self report. Total raw-score. Raw score range is 0-32 and higher scores mean a worse outcome. | 3-month follow up | 
| Avoidance an Fusion Questionnaire for Youth | Self report. Total raw-score. Raw score range is 0-32 and higher scores mean a worse outcome. | 24-month follow up |