BurnoutMUSTPreventNCT04026594
Mindfulness-based Therapy Versus Relaxation in Prevention of Burnout in Medical Students
A study testing Mindfulness Based Stress Reduction and Relaxation group in people with Burnout and Emotional Disturbances, run by University Hospital, Montpellier at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Emotional Disturbances, Depression
- What is being tested?
- Mindfulness Based Stress Reduction and Relaxation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2019to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Carolina BAEZA VELASCO, Psychology contact
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34295
Myriam Benramdane, + 33 4 67 99 61 45 75, m-benramdane@chu-montpellier.fr
About this study
Official title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
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.
Read the 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.
- Conditions
- Burnout, Emotional Disturbances, Depression
- Being tested
- Mindfulness Based Stress Reduction, Relaxation group
- Keywords
- burnout prevention, emotional exhaustion, mindfulness, medical students, empathy
- Medical subject headings
- Burnout, Psychological, Affective Symptoms, Depression, Emotional Exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionOther
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 groupOther
control group
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | 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.. Receives: Other: Mindfulness Based Stress Reduction |
| Progressive Muscle Relaxation Training (PMRT) | Active comparator | 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 Receives: Other: Relaxation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 months
Secondary outcomes (45)
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.
Measured: at 6 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
Psychotropic and analgesic consumption
Collection of the name and dosage per month for each molecule
Measured: at 6 months
Psychotropic and analgesic consumption
Collection of the name and dosage per month for each molecule
Measured: at 12 months
Tobacco consumption
Number of cigarettes per day within the month
Measured: at 6 months
Tobacco consumption
Number of cigarettes per day within the month
Measured: at 12 months
Alcohol consumption
Frequency of the alcohol consumption within the month
Measured: at 6 months
Alcohol consumption
Quantity of the alcohol consumption within the month
Measured: at 6 months
Alcohol consumption
Frequency of the alcohol consumption within the month
Measured: at 12 months
Alcohol consumption
Quantity of the alcohol consumption within the month
Measured: at 12 months
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
Measured: at 12 months
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
Measured: at 12 months
Drug consumption
Collection of the name of consumed substances, frequency of the consumption within the month
Measured: at 6 months
Drug consumption
Collection of the name of consumed substances, quantity of the consumption within the month
Measured: at 6 months
Drug consumption
Collection of the name of consumed substances, frequency of the consumption within the month
Measured: at 12 months
Drug consumption
Collection of the name of consumed substances, quantity of the consumption within the month
Measured: at 12 months
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.
Measured: at 12 months
Cannabis consumption
Frequency of the cannabis consumption within the month
Measured: at 6 months
Cannabis consumption
Quantity of the cannabis consumption within the month
Measured: at 6 months
Cannabis consumption
Frequency of the cannabis consumption within the month
Measured: at 12 months
Cannabis consumption
Quantity of the cannabis consumption within the month
Measured: at 12 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
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.
Measured: at 6 months
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.
Measured: at 12 months
Program adherence
Program adherence assessed with the number of attended sessions and the rates of dropout.
Measured: at 12 months
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.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start4 Oct 2019
- Primary completion4 Mar 2024 (estimated)
- Study completion4 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026594
- Sponsor's protocol ID
- RECHMPL19_0063
- Other IDs
- 2019-A01050-57
- Acronym
- MUSTPrevent
- Status last verified
- Dec 2021
- First submitted
- 9 Jul 2019
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32160891
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04026594
- Acronym / sponsor ID
- MUSTPrevent / RECHMPL19_0063
- Conditions
- Burnout, Emotional Disturbances, Depression
- Keywords
- burnout prevention, emotional exhaustion, mindfulness, medical students, empathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- 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
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 4 Mar 2024 (estimated)
- Study completion
- 4 Sep 2024 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Other: Mindfulness Based Stress Reduction306 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 comparator | Other: Relaxation group306 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionMBSR 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. | Other | Mindfulness Based Stress Reduction (MBSR) |
| Relaxation groupcontrol group | Other | Progressive Muscle Relaxation Training (PMRT) |
Primary outcome
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.
45 secondary outcomes
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)
Time frame: at 6 months
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
Time frame: at 6 months
Depersonalization assessed with the Maslach Burnout Inventory (MBI)
Time frame: at 12 months
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
Time frame: at 6 months
Professional achievement assessed with the Maslach Burnout Inventory (MBI)
Time frame: at 12 months
Psychotropic and analgesic consumption
Time frame: at 6 months
Psychotropic and analgesic consumption
Time frame: at 12 months
Tobacco consumption
Time frame: at 6 months
Tobacco consumption
Time frame: at 12 months
Alcohol consumption
Time frame: at 6 months
Alcohol consumption
Time frame: at 6 months
Alcohol consumption
Time frame: at 12 months
Alcohol consumption
Time frame: at 12 months
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: at 12 months
Alcohol consumption assessed with the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: at 12 months
Drug consumption
Time frame: at 6 months
Drug consumption
Time frame: at 6 months
Drug consumption
Time frame: at 12 months
Drug consumption
Time frame: at 12 months
Drug consumption assessed with the Drug Abuse Screening Test (DAST)
Time frame: at 12 months
Cannabis consumption
Time frame: at 6 months
Cannabis consumption
Time frame: at 6 months
Cannabis consumption
Time frame: at 12 months
Cannabis consumption
Time frame: at 12 months
Cannabis consumption assessed with the Cannabis Abuse Screening Test (CAST)
Time frame: at 12 months
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: at 6 months
Anxio-depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: at 12 months
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Time frame: at 6 months
Anxio-depressive symptomatology assessed with the Hospital Anxiety and Depression Scale (HADS)
Time frame: at 12 months
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Time frame: at 6 months
Anxio-depressive symptomatology assessed with the Perceived Stress Scale (PSS)
Time frame: at 12 months
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Time frame: at 6 months
Anxio-depressive symptomatology assessed with the Numerical Scale for psychological pain
Time frame: at 12 months
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: at 6 months
Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: at 12 months
Empathy assessed with the Jefferson Scale of Empathy for students
Time frame: at 6 months
Empathy assessed with the Jefferson Scale of Empathy for students
Time frame: at 12 months
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Time frame: at 6 months
Quality of life assessed with the World Health Organization Quality of Life (WHOQOL)
Time frame: at 12 months
Mindfulness assessed with the Five Facets Mindfulness Questionnaire (FFMQ)
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 32160891Baeza-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina BAEZA VELASCO, Psychology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction and Relaxation group in people with Burnout and Emotional Disturbances, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie OLIE, MD PhD (+33 4 67 33 85 81, e-olie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI) (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.