Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE)

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05036356
Collaborator
(none)
100
1
2
12.9
7.7

Study Details

Study Description

Brief Summary

The purpose of this research is to develop a mobile app-based intervention to reduce burnout and improve well-being using human-centered design principles and stakeholder feedback.

Condition or Disease Intervention/Treatment Phase
  • Other: Headspace App
N/A

Detailed Description

Recent studies of professional burnout among physicians have highlighted urology as a worrisome outlier: 39% of practicing urologists and 64% of urology residents reported high levels of depersonalization and emotional exhaustion. Despite the known association of burnout with adverse clinical outcomes, psychological distress, and career dissatisfaction, rigorous studies of physician-focused interventions remain limited.

Pilot studies of well-being mobile applications (e.g. headspace ®) have demonstrated better outcomes compared to traditionally delivered mindfulness interventions (e.g. in-person guided meditation). Nevertheless, a rigorous assessment of the impact of an app-based intervention on burnout is needed.

Therefore, the present study will assess the effectivity of a mobile app-based intervention to reduce burnout among healthcare professionals.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial
Actual Study Start Date :
Nov 2, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Controlled App Group

Subjects will receive access to the Headspace app and will receive weekly reminders to complete activities from the "Inspiration, Ideation, Implementation" block model of human-centered design in the app.

Other: Headspace App
A mobile-application ("app") focusing on teaching and sustaining mental well-being.

Experimental: Ad lib App Group

Subjects will receive access to the Headspace app and be encouraged to use it ad lib.

Other: Headspace App
A mobile-application ("app") focusing on teaching and sustaining mental well-being.

Outcome Measures

Primary Outcome Measures

  1. Change in burnout syndrome [Baseline, Week 12, Week 24]

    Burnout levels among study population will be screened using the single-item burnout assessment tool for health care workers (West, Dyrbye, et.al. 2012) and the Professional Fulfillment Index (Trockel, et.al. 2018) . The single-item burnout tool has 2 questions with a 7-point Likert-type, frequency response scale (0 = never, 1 = a few times a year or less, 2 = once a month or less, 3 = a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day) and cutoff values of 27 and 10 points, respectively. The Professional Fulfillment Index scales the answers of the items 7 to 16 from 0 to 4 (0 = not at all, 1 = very little, 2 = moderately, 3 = a lot, 4 = extremely) with a cutoff value of 1.33 points.

  2. Change in professional fulfillment [Baseline, Week 12, Week 24]

    Baseline professional fulfillment levels among study population will be screened using the 16-item Professional Fulfillment Index (Trockel, et.al. 2018) scaling the answers 1 to 6 from 0 to 4 (0 = not at all, 1 = somewhat true, 2 = moderately, 3 = very true, 4 = completely true) with a cutoff value of 3 points.

Secondary Outcome Measures

  1. User engagement metrics [Through study completion, approx. 24 weeks]

    App-usage metrics will be characterized (user's platform usage), tracked continuously and compared between the intervention and control groups from baseline to follow-up phase (Week 24)

  2. Qualitative knowledge and experience with app-based mindfulness practices [24 Weeks]

    Subject qualitative knowledge will measured by a self-reported questionnaire which asks participants to describe their previous experiences with well-being apps

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being a health-professional at the Urology Department of Mayo Clinic, RST

  • Sign the informed consent and agreed to share data from the app to the research team.

Exclusion Criteria:
  • Using an alternate app designed with the same purpose at the beginning, part and/or entire duration of the study.

  • Not provide any data despite being included in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Candace Granberg, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Candace F. Granberg, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05036356
Other Study ID Numbers:
  • 21-007153
First Posted:
Sep 5, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021