Mindfulness-based stress reduction or aerobics exercise for reducing burnout in medical residents- a study protocol for a phase III, open-label, multi-center, randomized controlled trial: The MINDER Collaborative group study

Background and objectives: Burnout results from chronic workplace stress leading to emotional exhaustion, negativity, and decreased professional efficiency. In the healthcare system, this can have consequences like increased medical errors, absenteeism, substance abuse, depression, and suicide among health professionals, adversely affecting patient care. Various individual-directed measures like the mindfulness-based stress reduction program (MBSR), one of the most studied and widely adopted techniques, and physical activity, like aerobics or sports, have shown to be effective against burnout. With this study, we intend to increase awareness regarding this public health issue among the residents and the faculty. Our aim is to define a successful intervention that can be incorporated as a yearly requirement for the completion of residency programs. Methodology: This study will be a phase III, multicentric, open-label, placebo (waiting list) controlled trial. Our sample size will be 720 residents sampled from 6 university hospitals from across the world, randomized into 3 parallel arms (1:1:1 ratio stratified according to site and specialty). Residents, diagnosed with burnout based on baseline Maslach Burnout Inventory score (MBI) and having no prior physical or mental health issues, will be included. The first group will undergo the MBSR program for 8 weeks, the second group will undergo a supervised aerobics program for 8 weeks, and the third group will be put into a waiting list for any of the interventions. The primary outcome will be the change in MBI scores after the intervention. The secondary outcomes will be the change in MBI score 3 months after the intervention, and changes in measures like heart rate, blood pressure, glycated hemoglobin, cortisol levels, quality of sleep and quality of life after the intervention and 3 months later. We also plan to do a subgroup analysis to see the difference based on specialty and gender. Study impact: The residency training period is considered one of the most stressful phases in medical education. Higher rates of burnout are noted in the residents, and this can negatively impact patient care and the progression of their careers. This trial will look at multiple interventions to combat burnout recruiting residents of different specialties in different work environments across the world. We hope to remove the stigma surrounding burnout in the healthcare system. This study will show the short and long term benefits of these interventions and would help us recommend their inclusion in various residency programs