Back to resultsLongitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Primary Purpose
Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness
standard medical education
Sponsored by
About this trial
This is an interventional treatment trial for Burnout focused on measuring burnout, medical residents
Eligibility Criteria
Inclusion Criteria:
- Washington University (WUSM) first year residents in internal medicine and pediatrics
Exclusion Criteria:
- none
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mindfulness
control
Arm Description
3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application
standard medical resident education
Outcomes
Primary Outcome Measures
Maslach Burnout Inventory (MBI)
burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)
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
Secondary Outcome Measures
evaluation of intervention
survey to assess opinion of intervention (Likert scale)
effect on mindfulness practice
survey question to assess pre and post-intervention frequency of practicing mindfulness
Full Information
NCT ID
NCT04584268
First Posted
July 23, 2020
Last Updated
October 5, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04584268
Brief Title
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Official Title
A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout
Keywords
burnout, medical residents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mindfulness
Arm Type
Experimental
Arm Description
3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application
Arm Title
control
Arm Type
Active Comparator
Arm Description
standard medical resident education
Intervention Type
Behavioral
Intervention Name(s)
mindfulness
Intervention Description
in person and smart phone application mindfulness practice
Intervention Type
Other
Intervention Name(s)
standard medical education
Intervention Description
standard medical education / control
Primary Outcome Measure Information:
Title
Maslach Burnout Inventory (MBI)
Description
burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)
Time Frame
1 year
Title
feasibility of intervention in graduate medical education
Description
ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership
Time Frame
1 year
Secondary Outcome Measure Information:
Title
evaluation of intervention
Description
survey to assess opinion of intervention (Likert scale)
Time Frame
1 year
Title
effect on mindfulness practice
Description
survey question to assess pre and post-intervention frequency of practicing mindfulness
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Washington University (WUSM) first year residents in internal medicine and pediatrics
Exclusion Criteria:
none
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
protocol and SAP now. CSR upon publication
Learn more about this trial
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
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