Testing an Evidence-Based Program for Clinician Burnout

Sponsor
Brown University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06145425
Collaborator
Peter G. Peterson Foundation (Other)
90
1
1
14.5
6.2

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses.

Condition or Disease Intervention/Treatment Phase
  • Other: App-Delivered Mindfulness Training (MT)
N/A

Detailed Description

The main question[s] it aims to answer are:

PRIMARY AIM: Determine if the app-based training reduces the level of cynicism (i.e., one of the two main dimensions of burnout).

SECONDARY AIM: Determine if the app-based training reduces the level of emotional exhaustion (i.e. one of the two main dimensions of burnout), anxiety, worry, depression and intolerance of uncertainty. Determine if the app-based training increases self-compassion, non-reactivity and non-judging about inner experiences.

Participants will be asked to:
  • Use an app-based mindfulness training program

  • Complete online surveys at baseline, immediately post-intervention and 1 month after the post-intervention as follow up

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
3 single groups: physicians, resident physicians and nurses3 single groups: physicians, resident physicians and nurses
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Testing an Evidence-Based Program for Physician and Nurse Burnout
Actual Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm

Participants will be asked to utilize the app.

Other: App-Delivered Mindfulness Training (MT)
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 mindfulness training (audio files).

Outcome Measures

Primary Outcome Measures

  1. Changes in cynicism [collected at baseline, immediately post-intervention and one month later as follow up]

    The dimension of cynicism in the 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).

Secondary Outcome Measures

  1. The dimension of emotional exhaustion in the Maslach Burnout Inventory (MBI). [collected at baseline, immediately post-intervention and one month later as follow up]

    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 emotional exhaustion that was included from the Maslach Burnout Inventory (MBI).

  2. Generalized Anxiety Disorder 7-items (GAD-7). [collected at baseline, immediately post-intervention and one month later as follow up]

    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. Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale. [collected at baseline, immediately post-intervention and one month later as follow up]

    The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).

  4. Five Facet Mindfulness Questionnaire (FFMQ) non-judging scale. [collected at baseline, immediately post-intervention and one month later as follow up]

    The non-judging scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 8 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).

  5. Patient Health Questionnaire 2-item scale (PHQ-2). [collected at baseline, immediately post-intervention and one month later as follow up]

    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).

  6. Penn State Worry Questionnaire (PSWQ). [collected at baseline, immediately post-intervention and one month later as follow up]

    The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).

  7. Intolerance of Uncertainty 12-item scale (IUS-12). [collected at baseline, immediately post-intervention and one month later as follow up]

    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 at all characteristic of me) to 5 (entirely characteristic of me).

  8. Self-Compassion Scale - Short Form (SCS-SF). [collected at baseline, immediately post-intervention and one month later as follow up]

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

Other Outcome Measures

  1. Demographics. [collected at baseline]

    Age, gender, employment, race, ethnicity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being a physician, resident physician or nurse

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brown University Providence Rhode Island United States 02903

Sponsors and Collaborators

  • Brown University
  • Peter G. Peterson Foundation

Investigators

  • Principal Investigator: Judson Brewer, MD, PhD, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brown University
ClinicalTrials.gov Identifier:
NCT06145425
Other Study ID Numbers:
  • "IRB #2022003296"
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brown University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023