- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679503
Examining the Effect of a Group-Based Stress Management Course on Empowering the Mental Health of Medical Faculty Students and Resident Physicians: A Randomized Controlled Study (EMPOWER-MD)
EXAMINING THE EFFECT OF A GROUP-BASED STRESS MANAGEMENT COURSE ON EMPOWERING THE MENTAL HEALTH OF MEDICAL FACULTY STUDENTS AND RESIDENT PHYSICIANS: A RANDOMIZED CONTROLLED STUDY
Study Overview
Status
Intervention / Treatment
Detailed Description
Rates of depression, anxiety, and burnout are markedly higher among physicians than in the general population, and suicide risk is also significantly elevated (Shanafelt et al., 2012; Mata et al., 2015). This disparity often emerges early in the professional trajectory, even during medical school. The prevalence of depression, anxiety, burnout, and high stress is higher among medical students compared with the general population. For example, a large-scale meta-analysis by Rotenstein et al. (2016) found a 27% prevalence of depression and depressive symptoms among medical students, while Puthran et al. (2016) reported depression prevalence above the general population average.
Nevertheless, when experiencing psychological distress, medical students and physicians often hesitate to seek help and are less likely to pursue professional support due to fear of stigma, career-related concerns, or time constraints (Chew-Graham et al., 2003; Dyrbye et al., 2007). This can allow mental health problems to progress silently and become chronic. Therefore, implementing protective and preventive interventions during medical education may not only reduce current psychological difficulties but also help prevent more severe mental disorders that could emerge later in professional life.
In this context, one cost-effective approach to supporting mental health is group-based psychoeducation programs. Compared with individual counseling or therapy, group-based psychoeducation is less costly, allows participants to benefit without having to share personal experiences, provides social support through peer participation, and facilitates more durable acquisition of knowledge and skills through social learning in a group setting (Yalom & Leszcz, 2005). Such group interventions are particularly prominent for student populations in terms of feasibility and acceptability.
In recent years, the World Health Organization (WHO) Self-Help Plus (SH+) group-based stress management course has emerged as an easily deliverable psychoeducational program grounded in Acceptance and Commitment Therapy (ACT) principles. In randomized controlled trials conducted across different countries and samples, SH+ has been shown to reduce psychological distress, decrease depressive symptoms, improve coping skills, and enhance resilience (Tol et al., 2020). The WHO also recommends this program as a low-cost, brief, and scalable mental health intervention (WHO, 2020).
In Türkiye, only a limited number of studies have examined group-based interventions aimed at strengthening the mental health of medical students and resident physicians. The existing literature has largely focused on identifying levels of depression and burnout, and there is a lack of research developing and testing effective and feasible intervention models. Therefore, by investigating the effects of a group-based stress management course for medical students and resident physicians, this study aims to address an important gap.
Through this research: (i) the effects of a cost-effective and feasible group-based intervention designed to strengthen the mental health of medical students and resident physicians will be evaluated; (ii) the feasibility of implementing structured programs similar to SH+ within the Turkish health education context will be examined, and findings regarding cultural adaptation will be contributed to the literature; and (iii) the results will inform national policies and practices aimed at supporting mental health in medical education and among healthcare workers, while also contributing to the international literature. Accordingly, this study has the potential to contribute not only to strengthening mental health at the individual level but also to fostering a healthier and more sustainable physician workforce within the healthcare system.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Eskişehir, Turkey (Türkiye), 26040
- Eskişehir Osmangazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a medical student or a resident physician at Eskişehir Osmangazi University Faculty of Medicine
- Being 18 years of age or older
Exclusion Criteria:
- Individuals with active suicidal ideation
- Individuals with severe mental disorders such as psychotic disorders or bipolar disorder
- Individuals with alcohol or substance dependence
- Students under 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waiting list
|
|
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Experimental: intervention group
The group will receive 5 sessions of group based stress management program developed by WHO.
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The course is designed to help individuals cope with challenging life events and manage stress.
The core components of the SH+ course include focusing attention (grounding), stepping back from distressing thoughts and emotions, acting in line with one's values, practicing kindness (self-compassion), and making space for difficult emotions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Anxiety Stress Scales - Short Form (DASS-21)
Time Frame: 1th-30th days
|
The DASS-21 is a self-report instrument developed to assess respondents' levels of depression, anxiety, and stress (Lovibond & Lovibond, 1995).
|
1th-30th days
|
|
Suicide Probability Scale - SPS
Time Frame: 1 th - 30 th days
|
The original form of the scale was developed by Cull and Gill (1982) to measure the likelihood of suicide.
|
1 th - 30 th days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The World Health Organization-Five Well-Being Index - WHO-5
Time Frame: 1 th - 30 th days
|
The 5-item scale is a short and effective screening tool developed by the World Health Organization to assess mental health.
The scale, which has a single-factor structure, is a self-report scale consisting of 5 items that assess the past two weeks.
|
1 th - 30 th days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maslach Burnout Inventory (MBI)
Time Frame: 1th - 30 th days
|
Developed to assess burnout levels, this self-report measure consists of 22 items and comprises three factors: Emotional Exhaustion, Depersonalization, and Personal Accomplishment (Maslach et al., 1997).
|
1th - 30 th days
|
|
The Multidimensional Scale of Perceived Social Support - MSPSS
Time Frame: 1 th - 30 th days
|
The scale designed to measure perceived social support has a three-factor structure consisting of 12 items, indicating the source of support as family, friends, and a special person.
|
1 th - 30 th days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EskisehirOU 04.11.2025/29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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