NCT06145425

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

November 17, 2023

Last Update Submit

May 9, 2025

Conditions

Keywords

BurnoutMindfulnessPhysiciansNursesResident Physicians

Outcome Measures

Primary Outcomes (1)

  • Changes in cynicism

    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).

    collected at baseline, immediately post-intervention and one month later as follow up

Secondary Outcomes (8)

  • The dimension of emotional exhaustion in the Maslach Burnout Inventory (MBI).

    collected at baseline, immediately post-intervention and one month later as follow up

  • Generalized Anxiety Disorder 7-items (GAD-7).

    collected at baseline, immediately post-intervention and one month later as follow up

  • Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale.

    collected at baseline, immediately post-intervention and one month later as follow up

  • Five Facet Mindfulness Questionnaire (FFMQ) non-judging scale.

    collected at baseline, immediately post-intervention and one month later as follow up

  • Patient Health Questionnaire 2-item scale (PHQ-2).

    collected at baseline, immediately post-intervention and one month later as follow up

  • +3 more secondary outcomes

Other Outcomes (1)

  • Demographics.

    collected at baseline

Study Arms (1)

Single arm

EXPERIMENTAL

Participants will be asked to utilize the app.

Other: App-Delivered Mindfulness Training (MT)

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 mindfulness training (audio files).

Single arm

Eligibility Criteria

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

You may qualify if:

  • Being a physician, resident physician or nurse
  • 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

Location

Related Publications (1)

  • Antico L, Brewer J. Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach. JMIR Form Res. 2025 Jan 24;9:e63197. doi: 10.2196/63197.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Judson Brewer, MD, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 3 single groups: physicians, resident physicians and nurses
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

March 15, 2023

Primary Completion

October 14, 2024

Study Completion

October 14, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations