Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Burnout
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 612
- Locations
- 1
- Primary Endpoint
- Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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 : 1. 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) ; 2. 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 ; 3. investigate the adherence and acceptability of the protocol ; 4. investigate acceptability and outcomes according to personality traits. The study is a single blind randomized clinical trial. Overall, 612 students from 11 French universities will be enrolled and assigned randomly to two groups: 1. the MBSR group, which will benefit from a structured 8-week group mindfulness-based stress reduction program; 2. the PMRT group, which will benefit from Progressive Muscle Relaxation Training based on a structured 8-week group program. Participants will be evaluated at four times: before the intervention (within 8 weeks), within the month following the end of the program, at 6 months and 12 months (+/- 1 month) after the completion of the program. All of the follow-up visits may be carried out remotely. The raters will be blind to treatment allocation (single-blind). An optional qualitative study will be conducted among 30 students, during the first follow-up visit to assess the subjective experience of participation in relaxation and meditation programs. The benefits expected from MBSR vs PMRT are to increase mental resources to manage negative emotions and psychological distress, to reduce risk of depression, to increase empathy. The perspectives are to improve the state of the art about the efficacy of MBSR for student's mental health promotion and to help the development of life skills programs for young people and students as proposed by General Direction of Health at the national level. Such programs promote low-cost and safety non-pharmacologic evidence-based interventions for psychological distress.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
Time Frame: 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.
Secondary Outcomes
- Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)(at 6 months)
- Professional achievement assessed with the Maslach Burnout Inventory (MBI)(at 12 months)
- Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)(at 12 months)
- Depersonalization assessed with the Maslach Burnout Inventory (MBI)(at 12 months)
- Psychotropic and analgesic consumption(at 12 months)
- Drug consumption(at 12 months)
- Drug consumption assessed with the Drug Abuse Screening Test (DAST)(at 12 months)
- Tobacco consumption(at 12 months)
- Alcohol 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)
- Cannabis consumption(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)