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Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students (MUSTPrevent)

Primary Purpose

Burnout, Emotional Disturbances, Depression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Relaxation group
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout focused on measuring burnout prevention, emotional exhaustion, mindfulness, medical students, empathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • CHU MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Stress Reduction (MBSR)

Progressive Muscle Relaxation Training (PMRT)

Arm Description

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..

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
Description: 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.
Depersonalization 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 depersonalization through 5 items. A score below 5 indicates a low degree of depersonalization, a score between 6 and 11 indicates a moderate degree of depersonalization and a score above 12 indicates a high degree of depersonalization. Higher scores reflect greater experienced burnout.
Depersonalization 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 depersonalization through 5 items. A score below 5 indicates a low degree of depersonalization, a score between 6 and 11 indicates a moderate degree of depersonalization and a score above 12 indicates a high degree of depersonalization. Higher scores reflect greater experienced burnout.
Professional achievement 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 personal accomplishment through 8 items. A score below 33 indicates a low degree of personal accomplishment, a score between 34 and 39 indicates a moderate degree of personal accomplishment and a score above 40 indicates a high degree of personal accomplishment. Lower scores reflect greater experienced burnout.
Professional achievement 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 personal accomplishment through 8 items. A score below 33 indicates a low degree of personal accomplishment, a score between 34 and 39 indicates a moderate degree of personal accomplishment and a score above 40 indicates a high degree of personal accomplishment. Lower scores reflect greater experienced burnout.
Psychotropic and analgesic consumption
Collection of the name and dosage per month for each molecule
Psychotropic and analgesic consumption
Collection of the name and dosage per month for each molecule
Tobacco consumption
Number of cigarettes per day within the month
Tobacco consumption
Number of cigarettes per day within the month
Alcohol consumption
Frequency of the alcohol consumption within the month
Alcohol consumption
Quantity of the alcohol consumption within the month
Alcohol consumption
Frequency of the alcohol consumption within the month
Alcohol consumption
Quantity of the alcohol consumption within the month
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Quantity of alcohol consumed within the month as assessed with the AUDIT. Higher scores reflect high risk drinking
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Frequency of alcohol consumed within the month as assessed with the AUDIT. Higher scores reflect high risk drinking
Drug consumption
Collection of the name of consumed substances, frequency of the consumption within the month
Drug consumption
Collection of the name of consumed substances, quantity of the consumption within the month
Drug consumption
Collection of the name of consumed substances, frequency of the consumption within the month
Drug consumption
Collection of the name of consumed substances, quantity of the consumption within the month
Drug consumption assessed with the Drug Abuse Screening Test (DAST)
Drug consumption based on the DAST score. The total score ranges from 0 to 10. The higher the score the greater the problem related to drug consumption.
Cannabis consumption
Frequency of the cannabis consumption within the month
Cannabis consumption
Quantity of the cannabis consumption within the month
Cannabis consumption
Frequency of the cannabis consumption within the month
Cannabis consumption
Quantity of the cannabis consumption within the month
Cannabis consumption assessed with the Cannabis Abuse Screening Test (CAST)
Cannabis consumption based on the CAST score. The total score ranges from 0 to 24. The higher the score the greater the problem related to cannabis consumption.
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Anxio-depressive symptomatology based on the MADRS score. The total score ranges from 0 to 60. Scores between 0 and 6 indicates no depression, scores between 7 and 19 indicates mild depression, scores between 20 and 34 indicates moderate depression and scores above 34 reflects severe depression.
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Anxio-depressive symptomatology based on the MADRS score. The total score ranges from 0 to 60. Scores between 0 and 6 indicates no depression, scores between 7 and 19 indicates mild depression, scores between 20 and 34 indicates moderate depression and scores above 34 reflects severe depression.
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Anxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Anxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Anxio-depressive symptomatology based on the Numerical Scale for psychological pain. The questionnaire is divided in three subscales, one for current psychological pain, one for usual psychological pain within the 15 last days and one for maximal psychological pain within the 15 last days. Each scale ranges from 0 to 10. Higher scores indicate greater psychological pain.
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Anxio-depressive symptomatology based on the Numerical Scale for psychological pain. The questionnaire is divided in three subscales, one for current psychological pain, one for usual psychological pain within the 15 last days and one for maximal psychological pain within the 15 last days. Each scale ranges from 0 to 10. Higher scores indicate greater psychological pain.
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Empathy assessed with the Jefferson Scale of Empathy for students
Evaluation of empathy based on the Jefferson Scale Empathy score. The total score ranges from 20 to 140. Higher scores reflect higher empathy.
Empathy assessed with the Jefferson Scale of Empathy for students
Evaluation of empathy based on the Jefferson Scale Empathy score. The total score ranges from 20 to 140. Higher scores reflect higher empathy.
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Quality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Quality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.
Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
Evaluation of mindfulness skills based on the FFMQ score. Higher scores indicate higher levels of mindfulness ability.
Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
Evaluation of mindfulness skills based on the FFMQ score. Higher scores indicate higher levels of mindfulness ability.
Self- compassion assessed with the Self-Compassion Scale (SCS)
Evaluation of self-compassion skills based on the SCS score. The total score ranges from 26 to 130. Higher scores indicate higher levels of self-compassion.
Self- compassion assessed with the Self-Compassion Scale (SCS)
Evaluation of self-compassion skills based on the SCS score. The total score ranges from 26 to 130. Higher scores indicate higher levels of self-compassion.
Program adherence
Program adherence assessed with the number of attended sessions and the rates of dropout.
Program acceptability
Program acceptability assessed with frequency of formal & informal practice of mindfulness, numerical rating scale for satisfaction and time spent doing exercises per week.

Full Information

First Posted
July 9, 2019
Last Updated
December 21, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes, University Hospital, Paris, University Hospital, Angers, University Hospital, Clermont-Ferrand, University Hospital of Saint-Etienne, University Hospital, Tours, University Hospital, Marseille, University Hospital, Strasbourg, INSERM U1061 Montpellier, University Hospital, Toulouse, Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04026594
Brief Title
Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students
Acronym
MUSTPrevent
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
March 4, 2024 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes, University Hospital, Paris, University Hospital, Angers, University Hospital, Clermont-Ferrand, University Hospital of Saint-Etienne, University Hospital, Tours, University Hospital, Marseille, University Hospital, Strasbourg, INSERM U1061 Montpellier, University Hospital, Toulouse, Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 : 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. 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: the MBSR group, which will benefit from a structured 8-week group mindfulness-based stress reduction program; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Emotional Disturbances, Depression
Keywords
burnout prevention, emotional exhaustion, mindfulness, medical students, empathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
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..
Arm Title
Progressive Muscle Relaxation Training (PMRT)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation group
Intervention Description
control group
Primary Outcome Measure Information:
Title
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
Description
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.
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
Description
Description: 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.
Time Frame
at 6 months
Title
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
Description
Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses depersonalization through 5 items. A score below 5 indicates a low degree of depersonalization, a score between 6 and 11 indicates a moderate degree of depersonalization and a score above 12 indicates a high degree of depersonalization. Higher scores reflect greater experienced burnout.
Time Frame
at 6 months
Title
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
Description
Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses depersonalization through 5 items. A score below 5 indicates a low degree of depersonalization, a score between 6 and 11 indicates a moderate degree of depersonalization and a score above 12 indicates a high degree of depersonalization. Higher scores reflect greater experienced burnout.
Time Frame
at 12 months
Title
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
Description
Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses personal accomplishment through 8 items. A score below 33 indicates a low degree of personal accomplishment, a score between 34 and 39 indicates a moderate degree of personal accomplishment and a score above 40 indicates a high degree of personal accomplishment. Lower scores reflect greater experienced burnout.
Time Frame
at 6 months
Title
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
Description
Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses personal accomplishment through 8 items. A score below 33 indicates a low degree of personal accomplishment, a score between 34 and 39 indicates a moderate degree of personal accomplishment and a score above 40 indicates a high degree of personal accomplishment. Lower scores reflect greater experienced burnout.
Time Frame
at 12 months
Title
Psychotropic and analgesic consumption
Description
Collection of the name and dosage per month for each molecule
Time Frame
at 6 months
Title
Psychotropic and analgesic consumption
Description
Collection of the name and dosage per month for each molecule
Time Frame
at 12 months
Title
Tobacco consumption
Description
Number of cigarettes per day within the month
Time Frame
at 6 months
Title
Tobacco consumption
Description
Number of cigarettes per day within the month
Time Frame
at 12 months
Title
Alcohol consumption
Description
Frequency of the alcohol consumption within the month
Time Frame
at 6 months
Title
Alcohol consumption
Description
Quantity of the alcohol consumption within the month
Time Frame
at 6 months
Title
Alcohol consumption
Description
Frequency of the alcohol consumption within the month
Time Frame
at 12 months
Title
Alcohol consumption
Description
Quantity of the alcohol consumption within the month
Time Frame
at 12 months
Title
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Description
Quantity of alcohol consumed within the month as assessed with the AUDIT. Higher scores reflect high risk drinking
Time Frame
at 12 months
Title
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Description
Frequency of alcohol consumed within the month as assessed with the AUDIT. Higher scores reflect high risk drinking
Time Frame
at 12 months
Title
Drug consumption
Description
Collection of the name of consumed substances, frequency of the consumption within the month
Time Frame
at 6 months
Title
Drug consumption
Description
Collection of the name of consumed substances, quantity of the consumption within the month
Time Frame
at 6 months
Title
Drug consumption
Description
Collection of the name of consumed substances, frequency of the consumption within the month
Time Frame
at 12 months
Title
Drug consumption
Description
Collection of the name of consumed substances, quantity of the consumption within the month
Time Frame
at 12 months
Title
Drug consumption assessed with the Drug Abuse Screening Test (DAST)
Description
Drug consumption based on the DAST score. The total score ranges from 0 to 10. The higher the score the greater the problem related to drug consumption.
Time Frame
at 12 months
Title
Cannabis consumption
Description
Frequency of the cannabis consumption within the month
Time Frame
at 6 months
Title
Cannabis consumption
Description
Quantity of the cannabis consumption within the month
Time Frame
at 6 months
Title
Cannabis consumption
Description
Frequency of the cannabis consumption within the month
Time Frame
at 12 months
Title
Cannabis consumption
Description
Quantity of the cannabis consumption within the month
Time Frame
at 12 months
Title
Cannabis consumption assessed with the Cannabis Abuse Screening Test (CAST)
Description
Cannabis consumption based on the CAST score. The total score ranges from 0 to 24. The higher the score the greater the problem related to cannabis consumption.
Time Frame
at 12 months
Title
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Description
Anxio-depressive symptomatology based on the MADRS score. The total score ranges from 0 to 60. Scores between 0 and 6 indicates no depression, scores between 7 and 19 indicates mild depression, scores between 20 and 34 indicates moderate depression and scores above 34 reflects severe depression.
Time Frame
at 6 months
Title
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Description
Anxio-depressive symptomatology based on the MADRS score. The total score ranges from 0 to 60. Scores between 0 and 6 indicates no depression, scores between 7 and 19 indicates mild depression, scores between 20 and 34 indicates moderate depression and scores above 34 reflects severe depression.
Time Frame
at 12 months
Title
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Description
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
Time Frame
at 6 months
Title
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Description
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
Time Frame
at 12 months
Title
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Description
Anxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
Time Frame
at 6 months
Title
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Description
Anxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
Time Frame
at 12 months
Title
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Description
Anxio-depressive symptomatology based on the Numerical Scale for psychological pain. The questionnaire is divided in three subscales, one for current psychological pain, one for usual psychological pain within the 15 last days and one for maximal psychological pain within the 15 last days. Each scale ranges from 0 to 10. Higher scores indicate greater psychological pain.
Time Frame
at 6 months
Title
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Description
Anxio-depressive symptomatology based on the Numerical Scale for psychological pain. The questionnaire is divided in three subscales, one for current psychological pain, one for usual psychological pain within the 15 last days and one for maximal psychological pain within the 15 last days. Each scale ranges from 0 to 10. Higher scores indicate greater psychological pain.
Time Frame
at 12 months
Title
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Time Frame
at 6 months
Title
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Time Frame
at 12 months
Title
Empathy assessed with the Jefferson Scale of Empathy for students
Description
Evaluation of empathy based on the Jefferson Scale Empathy score. The total score ranges from 20 to 140. Higher scores reflect higher empathy.
Time Frame
at 6 months
Title
Empathy assessed with the Jefferson Scale of Empathy for students
Description
Evaluation of empathy based on the Jefferson Scale Empathy score. The total score ranges from 20 to 140. Higher scores reflect higher empathy.
Time Frame
at 12 months
Title
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Description
Quality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.
Time Frame
at 6 months
Title
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Description
Quality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.
Time Frame
at 12 months
Title
Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
Description
Evaluation of mindfulness skills based on the FFMQ score. Higher scores indicate higher levels of mindfulness ability.
Time Frame
at 6 months
Title
Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
Description
Evaluation of mindfulness skills based on the FFMQ score. Higher scores indicate higher levels of mindfulness ability.
Time Frame
at 12 months
Title
Self- compassion assessed with the Self-Compassion Scale (SCS)
Description
Evaluation of self-compassion skills based on the SCS score. The total score ranges from 26 to 130. Higher scores indicate higher levels of self-compassion.
Time Frame
at 6 months
Title
Self- compassion assessed with the Self-Compassion Scale (SCS)
Description
Evaluation of self-compassion skills based on the SCS score. The total score ranges from 26 to 130. Higher scores indicate higher levels of self-compassion.
Time Frame
at 12 months
Title
Program adherence
Description
Program adherence assessed with the number of attended sessions and the rates of dropout.
Time Frame
at 12 months
Title
Program acceptability
Description
Program acceptability assessed with frequency of formal & informal practice of mindfulness, numerical rating scale for satisfaction and time spent doing exercises per week.
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie OLIE, MD PhD
Phone
+33 4 67 33 85 81
Email
e-olie@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina BAEZA VELASCO, Psychology
Email
carolina.baeza-velasco@parisdescartes.fr
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Benramdane
Phone
+ 33 4 67 99 61 45 75
Email
m-benramdane@chu-montpellier.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32160891
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.
Results Reference
derived

Learn more about this trial

Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students

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