Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05059392 |
| Other study ID # |
Med_stud_TARA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2018 |
| Est. completion date |
November 15, 2020 |
Study information
| Verified date |
January 2024 |
| Source |
Umeå University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 and after the intervention. Qualitative data on the participants'
experiences of TARA was collected both in focus group interviews and individually during and
after the intervention.
The investigators hypothesized that 1. TARA would be feasible in medical students, 2. the
content would be acceptable, 3. attendance and retention would be good, 4. trends towards
improvement would be seen on the self-rating scales and 5. it would be possible and
meaningful to explore the students experience of participating in TARA.
Description:
The primary aim of this study was to investigate the feasibility and acceptability of TARA as
indicated prevention of symptoms of depression and anxiety and stress-related symptoms in
self-selected medical students. The investigators also aimed 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 was designed as a single arm pre-post intervention study.
Participants and procedures Participants were recruited from Umeå University School of
Medicine. The University is located in the north of Sweden and enrolls 130 medical students
per semester. Participants were 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. In addition to being a medical student there were no specific
inclusion or exclusion criteria. Participants were allocated to one of two TARA-groups based
on their personal weekday preference, since the groups are held on different days of the
week.
Before inclusion, participants provided written informed consent. Study participation was
voluntary and could be cancelled by the participant at any time.
Groups were held in premises provided by the university hospital. Each session for a given
group was led by the same two facilitators, with expertise in contemplative practices and
clinical psychology or psychiatry. The facilitators' role during sessions was to teach
specific content and to model a collaborative, inclusive, non-judgmental, and supportive
attitude. Continuous supervision and training of facilitators was provided by the principal
investigator who also monitored fidelity to the manual, both in terms of content adherence
and the process of delivery. The facilitators were videotaped to facilitate supervision and
implementation of the protocol.
Assessment procedures At baseline, before the intervention, self-report of sociodemographic
background and outcome measures were collected online, for details see outcome measures.
After the intervention, and at a two-year follow-up outcome measures were repeated.
Participants who did not provide data at the time of the data collection were reminded by the
research team through email and/or telephone. The TARA-participants provided brief
self-assessment and session-evaluation on paper at the beginning and end of each session.
A semi-structured group-interview about TARA was conducted halfway through the program.
Participants who were willing to stay after the session were interviewed and the same
participants were interviewed again upon completion of the program. The interviews were
conducted by an independent researcher without any background or involvement in the
intervention. A semi-structured interview guide created for this purpose was used. The
questions were mainly about the participants' experiences of TARA. At two years follow-up
another independent researcher conducted individual interviews with participants from both
groups. These interviews were held online or at the interviewees' choice of location. All
participants were invited by email. The semi-structured interview guide for the individual
interviews were adapted for the current timeframe. Example questions asked in all interviews
were: "What are your experiences of participating in TARA?" and "Can you mention something
that was particularly hard or challenging?". The questions were broad or open. Experiences
before, during and after TARA were covered. When necessary and/or appropriate questions were
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 was checked for illogical values. For both categorical and continuous
variables, responses outside the possible response categories were coded as missing.
Descriptive statistics were calculated using standard measures. Sum scores, as well as means
and standard deviations were calculated for each self-report measure. Missing data on the
item level was imputed using Multiple Imputations with 5 iterations, to enable calculation of
sum score despite missing items. The post intervention 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 - were used
as predictors in the imputation model and a random seed was applied. The data was checked for
normality using histograms and Q-Q plots, as well as skewness and kurtosis. Boxplots were
used to check for outliers. No interim analyses were conducted. Descriptive statistics was
reported using standard measures.
To evaluate potential differences between the test-retest sample and the baseline sample the
investigators used 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 were conducted to compare self-rated symptom severity scores at
baseline and post intervention as well as at baseline and the two-year follow up. All
analyses were performed using SPSS statistics, version 26. All significance testing was
two-tailed, with a significance level of 0.05. P-values were not corrected for multiple
comparisons.
The interviews were audio-recorded, transcribed verbatim by the respective interviewer who
had a high degree of familiarity with the data. The transcribed data was subjected to
qualitative content analysis, which involved the systematic interpretation of the overt and
underlying content and could be used to analyze participants' reflections, experiences, and
attitudes. The text was first read several times separately by the investigators, then
discussed to get sense of the text as a whole, and then divided into meaning-units relevant
to the aim of the study. The meaning units were then coded and sorted into groups according
to their variations, similarities, and differences. The investigators met regularly to
discuss their interpretations and finally agreed 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.
