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

Background: Medical students are exposed to an emotionally exhausting training/work environment and to stressful academic demands. Consequently, psychopathologies, burnout and suicidal ideation are frequent in this population. These factors can also affect their empathy and quality of care. Therefore, the development and implementation of programs to promote resilience to stress specifically in medical students and the evaluation of their efficiency are a priority. Here, we describe the protocol of the first French study to assess the long-term effectiveness and acceptability of a mindfulness-based intervention (MBI) compared with relaxation training (RT) to reduce emotional exhaustion in medical students.

Methods: This multicenter randomized controlled trial ("Must prevent") plans to enroll 612 students in the fourth and fifth year of medical studies from nine French universities. After inclusion, they will be assigned randomly to the MBI or RT group. Both interventions are structured around an 8-week program that includes one group class per week and daily at-home exercises. The primary endpoint is the emotional exhaustion score assessed with the Maslach Burnout Inventory at month 12 of the follow-up. Secondary endpoints include anxiety-depressive symptomatology, suicidality, psychoactive substance use, depersonalization, psychological and physical pain, empathy, emotional regulation, self-compassion, mindfulness, quality of life, and program acceptability. Evaluations will be done before and immediately after the 8-week intervention, and at month 6 and 12 of the post-intervention follow-up.

Discussion: If the proposed interventions are well accepted and useful to decrease negative emotions and/or increase wellbeing among medical students, they should be disseminated among this population and even included as part of the training on emotional skills needed for the routine medical practice.

Trial registration: This trial is registered under the number NCT04026594 (July 18, 2019).