Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Brief Summary: Background:

Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery.

The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance.

Design: A pilot randomized clinical trial of modified MBSR versus an active control.

Setting: Residency training program, tertiary academic medical center.

Participants: PGY-1 surgery residents.

Intervention:

Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period.

Main Outcomes and Measures:

Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience.

Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control.

This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials.

Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.


Options:
A: Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Control | Arm Label: Acceptance and Commitment Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Acceptance and Commitment Therapy | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Acceptance and Commitment Therapy; Assigned to Arm(s): Acceptance and Commitment Therapy
B: Arm Label: Experimental App; Type: EXPERIMENTAL; Interventions: Behavioral: Experimental App | Arm Label: Active comparator app; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active Comparator App | Intervention Type: BEHAVIORAL; Name: Experimental App; Assigned to Arm(s): Experimental App | Intervention Type: BEHAVIORAL; Name: Active Comparator App; Assigned to Arm(s): Active comparator app
C: Arm Label: Mental Training for Surgeons; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness Based Stress Reduction - modified | Arm Label: The Mind of a Surgeon; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active listening and reading | Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction - modified; Assigned to Arm(s): Mental Training for Surgeons | Intervention Type: BEHAVIORAL; Name: Active listening and reading; Assigned to Arm(s): The Mind of a Surgeon
D: Arm Label: Acceptance and commitment therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Acceptance and commitment therapy | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Control | Intervention Type: BEHAVIORAL; Name: Acceptance and commitment therapy; Assigned to Arm(s): Acceptance and commitment therapy | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control

Answer: C