Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 612
- 试验地点
- 2
- 主要终点
- Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
研究概览
简要总结
A recent survey exploring mental health in a large cohort of French medical students and young graduates (N = 21.768), observed that 68.2% of participants showed pathologic anxiety. A high level of depressive symptomatology was found in 27.7% of participants, while suicidal ideation was reported by 23.7%. Mindfulness Based Interventions are beneficial for health with a positive impact on mood, anxiety, and well-being. It thus can be hypothesized that such interventions could help to prevent anxio-depressive symptomatology in medical students.
The implementation of prevention programs to promote resilience to stress and empathy among medical students is a priority, included in French National Strategy for Health. Efficacy of Mindfulness Based Interventions in French university must be studied to confirm and strengthen their development. The originality of this project consists in the collaboration of medical schools from different cities and the longitudinal follow-up.
The purpose of this study is to assess the efficacy of a mindfulness-based therapy in burnout prevention in comparison to relaxation.
详细描述
Recent research highlights the positive impact of Mindfulness-Based Interventions on mental health outcomes and in the development of stress management skills and compassion. Moreover, it has been reported that Mindfulness-Based Interventions are well accepted among university students, mainly because these approaches are seen as emotional skill training rather than a mental health intervention. However, there is a lack of long-term follow-up studies testing the maintenance of benefits.
This study proposes Mindfulness-based interventions for preventive purposes in a large sample of fourth and fifth year medical students from different French cities (Montpellier, Angers, Clermont-Ferrand, Marseille, Nîmes, Paris, Saint-Etienne, Strasbourg, Tours, Lyon and Toulouse) and a one-year follow-up.
The main objective is to assess the efficacy of a Mindfulness Based Stress Reduction (MBSR) (intervention) vs. Progressive Muscle Relaxation Training (PMRT) (control) to prevent burnout (emotional exhaustion) of fourth- and fifth-year medical students after one-year follow-up.
The study also aims to :
- assess efficacy of MBSR vs. PMRT in fourth- and fifth-year medical students to prevent burnout after six-months (emotional exhaustion, depersonalization and professional achievement) and one year follow-up (depersonalization and professional achievement) ;
- compare anxio-depressive symptomatology, suicidality, drug consumption, mindfulness skills, empathy, quality of life between pre- and post-intervention, at 6- and 12 months follow-up ;
- investigate the adherence and acceptability of the protocol ;
- investigate acceptability and outcomes according to personality traits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being enrolled in fourth or fifth year medical study
- •Having signed the informed consent
- •Being able to attend all scheduled visits and comply with all trial procedures
排除标准
- •Suffering from a current depressive episode according to DSM-5 criteria
- •Suffering from a current panic disorder according to DSM-5 criteria
- •Pregnancy
- •Exclusion period in relation to another protocol
- •Not being affiliated to the French National Social Security System
- •Having reached 4500 € annual compensation for participation in clinical trials
- •Protection by law (guardianship or curatorship)
- •Deprivation of liberty (by judicial or administrative decision)
- •Planned longer stay outside the region that prevents compliance with the visit plan
- •For Paris students : participation in the optional teaching "Pleine conscience et médecine" (organized by Cloé Brami)
- •For Tours students : participation in the optional teaching on meditation organized by the faculty of medicine
- •For Strasbourg students : participation in the optional teaching on meditation (organized by Pr Bloch)
结局指标
主要结局
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
时间窗: at 12 months
Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses emotional exhaustion through 9 items. A score below 17 indicates a low degree of emotional exhaustion, a score between 18 and 29 indicates a moderate degree of emotional exhaustion and a score above 30 indicates a high degree of emotional exhaustion. Higher scores reflect greater experienced burnout.
次要结局
- Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)(at 6 months)
- Professional achievement assessed with the Maslach Burnout Inventory (MBI)(at 12 months)
- Depersonalization assessed with the Maslach Burnout Inventory (MBI)(at 12 months)
- Psychotropic and analgesic consumption(at 12 months)
- Drug consumption assessed with the Drug Abuse Screening Test (DAST)(at 12 months)
- Tobacco consumption(at 12 months)
- Cannabis consumption assessed with the Cannabis Abuse Screening Test (CAST)(at 12 months)
- Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)(at 12 months)
- Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)(at 12 months)
- Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)(at 12 months)
- Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)(at 12 months)
- Empathy assessed with the Jefferson Scale of Empathy for students(at 12 months)
- Program adherence(at 12 months)
- Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain(at 12 months)
- Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)(at 12 months)
- Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)(at 12 months)
- Self- compassion assessed with the Self-Compassion Scale (SCS)(at 12 months)
- Program acceptability(at 12 months)
- Alcohol consumption(at 12 months)
- Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)(at 12 months)
- Drug consumption(at 12 months)
- Cannabis consumption(at 12 months)