Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents

A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents

This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.

Study Overview

• Status: Completed
• Conditions: Burnout
• Intervention / Treatment: Behavioral: mindfulness; Other: standard medical education

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Washington University (WUSM) first year residents in internal medicine and pediatrics

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mindfulness; 3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application	Behavioral: mindfulness; in person and smart phone application mindfulness practice
ACTIVE_COMPARATOR: control; standard medical resident education	Other: standard medical education; standard medical education / control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maslach Burnout Inventory (MBI)	burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)	1 year
feasibility of intervention in graduate medical education	ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of intervention	survey to assess opinion of intervention (Likert scale)	1 year
effect on mindfulness practice	survey question to assess pre and post-intervention frequency of practicing mindfulness	1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 20, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: burnout; medical residents
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: 201904014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: protocol and SAP now. CSR upon publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No