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

NCT05059392 | Completed

• 1 other identifier: Med_stud_TARA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Anxiety; Stress-related Problem

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Hospital Anxiety and Depression Scale, anxiety sub-scale

  3-month follow up

• Hospital Anxiety and Depression Scale, anxiety sub-scale

  24-month follow up

• Hospital Anxiety and Depression Scale, depression sub-scale

  3-month follow up

• Hospital Anxiety and Depression Scale, depression sub-scale

  24-month follow up

• Perceived Stress Scale

  3-month follow up

Study Arms (1)

Training for Awareness, Resilience and Action (TARA)

EXPERIMENTAL

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)

Interventions

Training for Awareness, Resilience and Action (TARA) BEHAVIORAL

See arm description

Training for Awareness, Resilience and Action (TARA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical student at Umeå University in the second or fourth semester.

You may not qualify if:

• None.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå university

Umeå, Västerbotten County, 90320, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Eva Henje, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm intervention. Students are allocated to one of two intervention-groups based on personal preference, both intervention-groups receive the same intervention.

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 28, 2021
• Study Start: September 1, 2018
• Primary Completion: January 28, 2019
• Study Completion: November 15, 2020
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)