NCT06149156

Brief Summary

This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

November 20, 2023

Last Update Submit

April 28, 2025

Conditions

Keywords

ResidencyWell-beingPhysician HealthPhysician BurnoutMindfulnessMobile health

Outcome Measures

Primary Outcomes (1)

  • Change in Stress Measured by the Perceived Stress Scale

    The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last week, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.

    baseline, week 1, week 2, week 3, week 4, 3 months

Secondary Outcomes (11)

  • Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Personal Accomplishment Dimension

    baseline, 4 weeks, 3 months

  • Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Depersonalization and Emotional Exhaustion Dimensions

    baseline, 4 weeks, 3 months

  • Change in Flourishing Measured by the Flourishing Index Score

    baseline, 4 weeks, 3 months

  • Change in Resilience Measured by the Brief Resilience SCale

    baseline, 4 weeks, 3 months

  • Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

    baseline, 4 weeks, 3 months

  • +6 more secondary outcomes

Other Outcomes (2)

  • Change in Digital Working Alliance Inventory

    4 weeks

  • Acceptability, Appropriateness, and Feasibility of Intervention

    4 weeks

Study Arms (2)

Healthy Minds Program (HMP) intervention

EXPERIMENTAL

Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.

Behavioral: Healthy Minds Program App

Waitlist Control

ACTIVE COMPARATOR

Participants will receive a list of well-being resources. They will be given access to HMP at the end of the study.

Behavioral: Well-being Resources

Interventions

The four-week intervention comprises two introductory lessons and guided meditations followed by one week of content for each pillar of well-being. Each week includes two brief lessons (5-7 minutes) with education on the scientific research behind the practices, as well as examples of how to strengthen the skills of each pillar in daily life, along with three guided meditations for which the participant can select the practice length (5-30 minutes).

Healthy Minds Program (HMP) intervention

List of well-being resources that comprises of online video links and books

Waitlist Control

Eligibility Criteria

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

You may qualify if:

  • Resident in a high burnout rate specialty: family medicine, internal medicine, obstetrics and gynecology, emergency medicine, general surgery, or surgical sub-specialty (plastic surgery, urology, neurosurgery, orthopedic surgery, vascular surgery, cardiothoracic surgery, otolaryngology, ophthalmology)

You may not qualify if:

  • Participants who have previously used the HMP (a version of HMP has been freely available to the public since 2020)
  • Participants who have been practicing meditation daily or almost daily for the prior six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Simon Goldberg

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

February 21, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations