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

  • STATUS
    Recruiting
  • End date
    Sep 4, 2024
  • participants needed
    612
  • sponsor
    University Hospital, Montpellier
Updated on 16 February 2022
anxiety
suicidal
Accepts healthy volunteers

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.

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.

Details
Condition Burnout, Emotional Disturbances, Depression
Treatment Mindfulness Based Stress Reduction, Relaxation group
Clinical Study IdentifierNCT04026594
SponsorUniversity Hospital, Montpellier
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note