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)

June 25, 2026 updated by: Imran Gokcen Yilmaz-Karaman, Eskisehir Osmangazi University

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

Physicians and medical students have higher rates of depression, anxiety, burnout, and suicide risk than the general population, and this disparity often begins early, even during medical school. Despite substantial distress, help-seeking is frequently limited due to stigma concerns, career fears, and time constraints, which may allow mental health problems to progress unnoticed and become chronic. Preventive interventions during medical education may reduce current distress and help avert more severe disorders later in professional life. Group-based psychoeducation is a cost-effective approach with advantages such as scalability, peer support, and learning benefits without requiring personal disclosure. The WHO Self-Help Plus (SH+) program is an ACT-informed, easily deliverable group stress management course, and randomized controlled trials across settings suggest SH+ can reduce psychological distress and depressive symptoms while improving coping skills and resilience. In Türkiye, evidence on group-based interventions for medical students and resident physicians remains limited and focuses mainly on documenting symptom levels rather than testing interventions; therefore, this study aims to evaluate a group-based stress management course and examine the feasibility and cultural adaptation of SH+-like programs in Turkish medical education.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26040
        • Eskisehir Osmangazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waiting list
Experimental: intervention group
The group will receive 5 sessions of group based stress management program developed by WHO.
Behavioral: self help plus
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:
  • sh+
  • Group based stress management program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EskisehirOU 04.11.2025/29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since our participants will be medical students and residents from the same medical faculty, we anticipate that publicly sharing data may compromise anonymity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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