NCT06969950

Brief Summary

The goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of physicians.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

March 28, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

burnoutphysiciansapp-basedsmarthphonemindfulness

Outcome Measures

Primary Outcomes (1)

  • Level of cynicism

    Maslach Burnout Inventory (MBI) cynicism. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of cynicism that was included from the Maslach Burnout Inventory (MBI)-based on the research of West et al., 2009.

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

Secondary Outcomes (5)

  • Level of emotional exhaustion

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of anxiety

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of depression

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of intolerance of uncertainty

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of self-compassion

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

Other Outcomes (9)

  • Level of Work Engagement

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of patient-centered care

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • Level of organization civic behavior

    It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).

  • +6 more other outcomes

Study Arms (3)

Experimental: Early App-Delivered Mindfulness Training (MT).

EXPERIMENTAL

Participants will be asked to utilize the app designed to reduce burnout for 2 weeks

Other: App-Delivered Mindfulness Training (MT).

Later App-Delivered Mindfulness Training (MT).

OTHER

Participants will receive the intervention after the three-month follow-up, not before.

Other: App-Delivered Mindfulness Training (MT).

Experimental: Online Virtual Training

EXPERIMENTAL

A sub-group of participants will receive the virtual online training after three-month follow-up or directly after the app-based intervention.

Other: App-Delivered Mindfulness Training (MT).Other: Online Virtual Training

Interventions

The program is delivered via a smartphone-based platform, which includes 7 mindfulness-based modules of about 15 minutes of brief didactic and experience-based for two weeks

Experimental: Early App-Delivered Mindfulness Training (MT).Experimental: Online Virtual TrainingLater App-Delivered Mindfulness Training (MT).

A sub-group of 25 participants, either from the both intervention or control group, the will receive a virtual online training delivered via zoom calls. It is a group session program which includes 4 mindfulness-based sessions of about 60 minutes of brief didactic and experience-based for four weeks.

Experimental: Online Virtual Training

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a physician
  • Able to speak English because all study activities will be conducted in English.
  • + years
  • Direct patient care

You may not qualify if:

  • \. If using psychotropic medication - not on a stable dosage at least 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Lia Antico, PhD

    Brown University

    PRINCIPAL INVESTIGATOR
  • Joseph Casamassima, MSc

    Brown University

    STUDY CHAIR

Central Study Contacts

Lia Antico, PhD In Neuroscience

CONTACT

Judson Brewer, PhD, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group will receive the intervention (audio-course) to listen during the study and the other group will have access to the audio-course at the end of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

May 14, 2025

Study Start

February 12, 2025

Primary Completion

December 31, 2025

Study Completion

February 27, 2026

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations