Clinical trial NCT04026594: Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students
Official title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout
Emotional Disturbances
Depression
Keywords: burnout prevention
emotional exhaustion
mindfulness
medical students
empathy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
name: University Hospital, Paris
name: University Hospital, Angers
name: University Hospital, Clermont-Ferrand
name: University Hospital of Saint-Etienne
name: University Hospital, Tours
name: University Hospital, Marseille
name: University Hospital, Strasbourg
name: INSERM U1061 Montpellier
name: University Hospital, Toulouse
name: Hospices Civils de Lyon
First posted: 2019-07-19
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)
* 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)

Primary outcomes:
measure: Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 12 months
Secondary outcomes:
measure: Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 6 months
measure: Depersonalization assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 6 months
measure: Depersonalization assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 12 months
measure: Professional achievement assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 6 months
measure: Professional achievement assessed with the Maslach Burnout Inventory (MBI)
timeFrame: at 12 months
measure: Psychotropic and analgesic consumption
timeFrame: at 6 months
measure: Psychotropic and analgesic consumption
timeFrame: at 12 months
measure: Tobacco consumption
timeFrame: at 6 months
measure: Tobacco consumption
timeFrame: at 12 months
measure: Alcohol consumption
timeFrame: at 6 months
measure: Alcohol consumption
timeFrame: at 6 months
measure: Alcohol consumption
timeFrame: at 12 months
measure: Alcohol consumption
timeFrame: at 12 months
measure: Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: at 12 months
measure: Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: at 12 months
measure: Drug consumption
timeFrame: at 6 months
measure: Drug consumption
timeFrame: at 6 months
measure: Drug consumption
timeFrame: at 12 months
measure: Drug consumption
timeFrame: at 12 months
measure: Drug consumption assessed with the Drug Abuse Screening Test (DAST)
timeFrame: at 12 months
measure: Cannabis consumption
timeFrame: at 6 months
measure: Cannabis consumption
timeFrame: at 6 months
measure: Cannabis consumption
timeFrame: at 12 months
measure: Cannabis consumption
timeFrame: at 12 months
measure: Cannabis consumption assessed with the Cannabis Abuse Screening Test (CAST)
timeFrame: at 12 months
measure: Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: at 6 months
measure: Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: at 12 months
measure: Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: at 6 months
measure: Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: at 12 months
measure: Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
timeFrame: at 6 months
measure: Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
timeFrame: at 12 months
measure: Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
timeFrame: at 6 months
measure: Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
timeFrame: at 12 months
measure: Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: at 6 months
measure: Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: at 12 months
measure: Empathy assessed with the Jefferson Scale of Empathy for students
timeFrame: at 6 months
measure: Empathy assessed with the Jefferson Scale of Empathy for students
timeFrame: at 12 months
measure: Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
timeFrame: at 6 months
measure: Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
timeFrame: at 12 months
measure: Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: at 6 months
measure: Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: at 12 months
measure: Self- compassion assessed with the Self-Compassion Scale (SCS)
timeFrame: at 6 months
measure: Self- compassion assessed with the Self-Compassion Scale (SCS)
timeFrame: at 12 months
measure: Program adherence
timeFrame: at 12 months
measure: Program acceptability
timeFrame: at 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
References:
citation: 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.