Clinical Trials Logo

Clinical 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%. 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04026594
Study type Interventional
Source University Hospital, Montpellier
Contact Emilie OLIE, MD PhD
Phone +33 4 67 33 85 81
Email e-olie@chu-montpellier.fr
Status Recruiting
Phase N/A
Start date October 4, 2019
Completion date September 4, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A