Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students
NCT ID: NCT04026594
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
612 participants
INTERVENTIONAL
2019-10-04
2024-09-04
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Mindfulness Based Stress Reduction (MBSR)
306 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..
Mindfulness Based Stress Reduction
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.
Progressive Muscle Relaxation Training (PMRT)
306 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
Relaxation group
control group
Interventions
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Mindfulness Based Stress Reduction
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.
Relaxation group
control group
Eligibility Criteria
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Inclusion Criteria
* Having signed the informed consent
* Being able to attend all scheduled visits and comply with all trial procedures
Exclusion 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)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Paris
OTHER
University Hospital, Angers
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
University Hospital of Saint-Etienne
OTHER
University Hospital, Tours
OTHER
University Hospital, Marseille
OTHER
University Hospital, Strasbourg
OTHER
INSERM U1061 Montpellier
UNKNOWN
University Hospital, Toulouse
OTHER
Hospices Civils de Lyon
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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CHU Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Myriam Benramdane
Role: primary
References
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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.
Other Identifiers
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2019-A01050-57
Identifier Type: REGISTRY
Identifier Source: secondary_id
RECHMPL19_0063
Identifier Type: -
Identifier Source: org_study_id