- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Eskişehir, Turquía (Türkiye), 26040
- Eskisehir Osmangazi University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Lista de espera
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Depression Anxiety Stress Scales - Short Form (DASS-21)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The World Health Organization-Five Well-Being Index - WHO-5
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maslach Burnout Inventory (MBI)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EskisehirOU 04.11.2025/29
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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