Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
Brief Summary: A triad of exhaustion, depersonalization and inefficacy, physician burnout is an epidemic among trainees associated with delivering poor quality care. Training programs are desperate for evidence-based programs that can prevent burnout during residency. Mindfulness training programs can reduce burnout among primary care physicians, but have not been tested during physician training. Pilot testing of a novel mindfulness curriculum during pediatric internship was found to be feasible to implement.

The primary objective of this study is to determine if implementing a novel 6-month mindfulness curriculum comprised of seven 1-hour sessions can reduce physician burnout and increase mindfulness practice and empathy. A multicenter cluster randomized controlled trial will be conducted among interns training in programs of various sizes and regions to address this objective. The investigators hypothesize that completing a mindfulness curriculum during internship will reduce interns' levels of physician burnout and increase their mindfulness practice and empathy.

Within pairs in pediatric residency programs matched on size (a proxy for burnout), clusters of interns in each program will be randomized to experience either the mindfulness curriculum over a 6-month period (intervention) or receive the usual educational curriculum (control). During a 15-month study period, burnout, mindfulness and empathy will be assessed using validated measures at baseline, 6- and 15-month follow-up. The impact of the intervention will be determined by comparing physician burnout, empathy and mindfulness scores between interns in the intervention and control groups. This methodologically rigorous multi-center cluster RCT will determine if implementing an innovative 6-month mindfulness curriculum reduces pediatric interns' burnout and improves empathy and mindfulness practice.


Options:
A: Arm Label: Stress management plus omega-3; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness-based stress management program, Dietary Supplement: Omega-3 fatty acids pills | Arm Label: Stress management plus placebo; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mindfulness-based stress management program, Dietary Supplement: Placebo pills | Arm Label: Psychoeducation leaflet plus omega-3; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Omega-3 fatty acids pills, Behavioral: Psychoeducation leaflet | Arm Label: Psychoeducation leaflet plus placebo; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Psychoeducation leaflet, Dietary Supplement: Placebo pills | Intervention Type: BEHAVIORAL; Name: Mindfulness-based stress management program; Assigned to Arm(s): Stress management plus omega-3, Stress management plus placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega-3 fatty acids pills; Assigned to Arm(s): Psychoeducation leaflet plus omega-3, Stress management plus omega-3 | Intervention Type: BEHAVIORAL; Name: Psychoeducation leaflet; Assigned to Arm(s): Psychoeducation leaflet plus omega-3, Psychoeducation leaflet plus placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo pills; Assigned to Arm(s): Psychoeducation leaflet plus placebo, Stress management plus placebo
B: Arm Label: Passive control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Planned intervention - mantra meditation; Type: EXPERIMENTAL; Interventions: Behavioral: Mantra Meditation | Intervention Type: BEHAVIORAL; Name: Mantra Meditation; Assigned to Arm(s): Planned intervention - mantra meditation
C: Arm Label: Control group; Type: N/A; Interventions: Other: questionnaire to define the presence of job strain at 6 months, Other: questionnaire to define the presence of job strain at 12 months | Arm Label: Simulation group; Type: N/A; Interventions: Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team), Other: questionnaire to define the presence of job strain at 6 months, Other: questionnaire to define the presence of job strain at 12 months | Intervention Type: OTHER; Name: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team); Assigned to Arm(s): Simulation group | Intervention Type: OTHER; Name: questionnaire to define the presence of job strain at 6 months; Assigned to Arm(s): Control group, Simulation group | Intervention Type: OTHER; Name: questionnaire to define the presence of job strain at 12 months; Assigned to Arm(s): Control group, Simulation group
D: Arm Label: MINDI mindfulness curriculum; Type: EXPERIMENTAL; Interventions: Other: MINDI mindfulness curriculum | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: MINDI mindfulness curriculum; Assigned to Arm(s): MINDI mindfulness curriculum | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control

Answer: D