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

中文翻译：

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在法国进行的以医学为基础的正念干预与放松多中心随机对照试验的研究方案，以减少情绪疲惫：“必须预防”研究。

医学生面临着令人烦恼的训练/工作环境和紧张的学术需求。因此，该人群中经常出现精神病，倦怠和自杀念头。这些因素也会影响他们的同理心和护理质量。因此，制定和实施旨在提高医学生抗逆能力的计划并评估其效率是当务之急。在这里，我们描述了法国第一项研究的协议，该协议旨在评估基于正念的干预（MBI）与放松训练（RT）的长期有效性和可接受性，以减少医学生的情绪疲劳。这项多中心随机对照试验（“必须预防”）计划招收612名来自法国九所大学的医学专业的第四和第五年的学生。包含之后，它们将被随机分配到MBI或RT组。两种干预措施都是围绕一个为期8周的计划而设计的，该计划包括每周一次小组课程和每天的在家锻炼。主要终点是在随访的第12个月时用Maslach倦怠量表评估的情绪衰竭得分。次要终点包括焦虑抑郁症状，自杀倾向，精神活性物质的使用，人格解体，心理和身体疼痛，同理心，情绪调节，自我同情心，正念，生活质量和程序可接受性。评估将在8周的干预之前和之后进行，干预后随访的第6和12个月。如果拟议的干预措施被接受并有助于减少医学生的负面情绪和/或增进他们的健康，则应将其传播给这一人群，甚至应纳入常规医学实践所需的情绪技能培训中。该试验的注册号为NCT04026594（2019年7月18日）。