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临床试验/NCT05059392
NCT05059392已完成不适用

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

Umeå University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Attendance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Attendance

时间窗: End of 3 month intervention

mean number of attended sessions/participant

Retention

时间窗: End of 3 month intervention

percentage of participants who attended more than half of the sessions

Acceptability: Child Session Rating Scale

时间窗: End of 3 month intervention

Self report, mean weekly individual total score, score range is 0-40 and higher scores mean a better outcome

次要结局

  • Hospital Anxiety and Depression Scale, depression sub-scale(24-month follow up)
  • Hospital Anxiety and Depression Scale, anxiety sub-scale(24-month follow up)
  • Perceived Stress Scale(24-month follow up)
  • Avoidance an Fusion Questionnaire for Youth(24-month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Henje, MD, PhD

Principal Investigator

Umeå University

研究点 (2)

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