CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Mindfulness Based Stress Reduction - modified +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141190
NCT03141190N/ACompleted

Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians

University of California, San Francisco·interventional·Posted May 5, 2017·Updated Mar 22, 2022

In Brief

A clinical study evaluating Mindfulness Based Stress Reduction - modified and Active listening and reading for Burnout Syndrome and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartJun 1, 2017
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago

Interventions

Mindfulness Based Stress Reduction - modifiedbehavioral

already described

Active listening and readingbehavioral

group reading, listening and discussion of articles pertaining to the development and experience of the surgical personality