Please select the outcome measures that correspond 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: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))
C: Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI) (at 12 months)
D: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)

Answer: A