NCT04584268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

July 23, 2020

Last Update Submit

October 5, 2020

Conditions

Keywords

burnoutmedical residents

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • evaluation of intervention

    1 year

  • effect on mindfulness practice

    1 year

Study Arms (2)

mindfulness

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

standard medical resident education

Other: standard medical education

Interventions

mindfulnessBEHAVIORAL

in person and smart phone application mindfulness practice

mindfulness

standard medical education / control

control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Medicine and Pediatrics

Study Record Dates

First Submitted

July 23, 2020

First Posted

October 12, 2020

Study Start

June 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 20, 2020

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
protocol and SAP now. CSR upon publication

Locations