Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students
MUSTPrevent
Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
2 other identifiers
interventional
612
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
October 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2024
CompletedDecember 22, 2021
December 1, 2021
4.4 years
July 9, 2019
December 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
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.
at 12 months
Secondary Outcomes (45)
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
at 6 months
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
at 6 months
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
at 12 months
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
at 6 months
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
at 12 months
- +40 more secondary outcomes
Study Arms (2)
Mindfulness Based Stress Reduction (MBSR)
EXPERIMENTAL306 participants will be randomized in the MBSR program, consisting of 8 weekly sessions lasting 2 and half hours each. In addition to this, they will be asked to complete 30 minutes of home practice each day. In order to avoid forgetting techniques and to reinforce motivation, a MBSR recall session will be offered six month after intervention. All the sessions may be carried out remotely, by videoconference. In this case, both programs should be conducted in this way in order to ensure comparability..
Progressive Muscle Relaxation Training (PMRT)
ACTIVE COMPARATOR306 participants will be randomized in a relaxation program, consisting of 8 weekly sessions lasting 2 and half hours each. In addition to this, they will be asked to complete 30 minutes of home practice each day. In order to avoid forgetting techniques and to reinforce motivation, a relaxation recall session will be offered six month after intervention. All the sessions may be carried out remotely, by videoconference. In this case, both programs should be conducted in this way in order to ensure comparability
Interventions
MBSR teaches mindfulness meditation and mindful yoga exercises to develop non-judgmental awareness of moment-to-moment experience. The intervention duration is 8 weeks, with weekly two and half hours sessions. It will be delivered according to the fundamental concepts and specific techniques provided in the MBSR manualized protocol by Kabat-Zinn. The program also includes 30-min daily homework exercises. MBSR teaches four main mindfulness practices: (1) body scan, a process of moving attention through the body; (2) mindful movement, consisting of gentle yoga stretches to develop awareness of body in movement; (3) sitting meditation; and (4) walking meditation. Inquiry and didactic teaching is also a part of MBSR and allows for some detailed exploration of participants' experiences.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Suffering from a current depressive episode according to DSM-5 criteria
- Suffering from a current panic disorder according to DSM-5 criteria
- Pregnancy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Centre Hospitalier Universitaire de Nīmescollaborator
- University Hospital, Pariscollaborator
- University Hospital, Angerscollaborator
- University Hospital, Clermont-Ferrandcollaborator
- University Hospital of Saint-Etiennecollaborator
- University Hospital, Tourscollaborator
- University Hospital, Marseillecollaborator
- University Hospital, Strasbourgcollaborator
- INSERM U1061 Montpelliercollaborator
- University Hospital, Toulousecollaborator
- Hospices Civils de Lyoncollaborator
Study Sites (1)
CHU Montpellier
Montpellier, 34295, France
Related Publications (1)
Baeza-Velasco C, Genty C, Jaussent I, Benramdane M, Courtet P, Olie E. Study protocol of a multicenter randomized controlled trial of mindfulness-based intervention versus relaxation to reduce emotional exhaustion in medical students in France: the "Must prevent" study. BMC Psychiatry. 2020 Mar 11;20(1):115. doi: 10.1186/s12888-020-02529-9.
PMID: 32160891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 19, 2019
Study Start
October 4, 2019
Primary Completion
March 4, 2024
Study Completion
September 4, 2024
Last Updated
December 22, 2021
Record last verified: 2021-12