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NCT Number: NCT06969950

Evaluating an Intervention for Physician Burnout

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Judson Brewer, MD. PhD

PRINCIPAL_INVESTIGATOR

Lia Antico, PhD

CONTACT

[email protected]

4013280763

Lia Antico, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

App-Delivered Mindfulness Training (MT).

Other

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

Online Virtual Training

Other

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.

Primary outcomes

  1. Level of cynicism

    Time frame: 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).

    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.

Secondary outcomes

  1. Level of emotional exhaustion

    Time frame: 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).

    1.Maslach Burnout Inventory (MBI) emotional exhaustion. 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).

  2. Level of anxiety

    Time frame: 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).

    2.Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).

  3. Level of depression

    Time frame: 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).

    Patient Health Questionnaire 2-item scale (PHQ-2). The PHQ-2 is a validated 2-item self-report measure of depression. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).

  4. Level of intolerance of uncertainty

    Time frame: 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).

    4.Intolerance of Uncertainty 12-item scale (IUS-12). The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (not t all).

  5. Level of self-compassion

    Time frame: 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).

    5.Self-Compassion Scale. The SCS is a validated 12-item self-report measure of self-compassion on a 5-point Likert scale ranging from 1 (almost never) to 5 (always).

Other outcomes

  1. Level of Work Engagement

    Time frame: 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).

    • Job Engagement Questionnaire (18 items). The Job Engagement questionnaire is a validated scale of the 18-item. This scale contains 18 items which are presented on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
  2. Level of patient-centered care

    Time frame: 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).

    • Nursing Workplace Satisfaction Questionnaire (NWSQ - 17). The NWSQ is a validated 17-item self-report measure of patient-centered care with items presented on a 5-point Likert scale ranging from 1 (fully disagree) to 5 (definitely disagree).
  3. Level of organization civic behavior

    Time frame: 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).

    • Organizational Civic Behavior Scale (24 items). This questionnaire is a validated 24-item self-report measure of Organizational Civic Scale. Items are rated 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
  4. Level of physician well-being

    Time frame: 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).

    • Physician Well-Being Index (PWBI - 7 items). This questionnaire is a validated 7-item self-report measure of Physician Well-Being. Items are rated 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
  5. Level of loneliness

    Time frame: 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).

    • UCLA 3-Item Loneliness Scale (University California Los Angeles - 3 items). This questionnaire is a validated 3-item self-report measure of Loneliness. Items are rated 10-point Likert-type scale ranging from 1 (least lonely) to 10 (lost lonely).
  6. Level of mindfulness practice

    Time frame: 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).

    • Mindful Practice Questionnaire (MIPR-Q - 28 items). This questionnaire is a validated 28-item self-report measure of Mindfulness practice. Items are rated 4-point Likert-type scale ranging from 1 (never/almost never) to 4 for (always/most always).
  7. Elements learned

    Time frame: It will be collected one time, two weeks after the baseline (post-app). For the sub-group that will attend the online virtual training intervention, it will be collected a second time after 4 months (post online virtual training intervention).

    Open question regarding the elements learned with the app and virtual training sessions.

  8. Facilitators

    Time frame: It will be collected one time, two weeks after the baseline (post-app). For the sub-group that will attend the online training intervention, it will be collected a second time after 4 months (post online training intervention).

    Open question regarding the facilitators encountered with the app and virtual training sessions.

  9. Barriers

    Time frame: It will be collected one time, at two weeks after the baseline (post-app). For the sub-group that will attend the online virtual training, it will be collected a second time after 4 months (post online training intervention).

    Open question regarding the barriers encountered with the app and virtual training sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Judson Brewer, PhD, MD

CONTACT

[email protected]

Lia Antico, PhD In Neuroscience

CONTACT

[email protected]

+1-401-328-0763

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Evaluating an Evidence-Based Intervention for Physician Burnout

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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