- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Eskişehir, Turchia (Türkiye), 26040
- Eskişehir Osmangazi University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Lista d'attesa
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Depression Anxiety Stress Scales - Short Form (DASS-21)
Lasso di tempo: 1th-30th days
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The DASS-21 is a self-report instrument developed to assess respondents' levels of depression, anxiety, and stress (Lovibond & Lovibond, 1995).
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1th-30th days
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Suicide Probability Scale - SPS
Lasso di tempo: 1 th - 30 th days
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The original form of the scale was developed by Cull and Gill (1982) to measure the likelihood of suicide.
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1 th - 30 th days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The World Health Organization-Five Well-Being Index - WHO-5
Lasso di tempo: 1 th - 30 th days
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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.
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1 th - 30 th days
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maslach Burnout Inventory (MBI)
Lasso di tempo: 1th - 30 th days
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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).
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1th - 30 th days
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The Multidimensional Scale of Perceived Social Support - MSPSS
Lasso di tempo: 1 th - 30 th days
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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.
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1 th - 30 th days
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EskisehirOU 04.11.2025/29
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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