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

Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Burnout, Professional
• Intervention / Treatment: Other: Headspace App

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in burnout syndrome	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.	Baseline, Week 12, Week 24
Change in professional fulfillment	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.	Baseline, Week 12, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User engagement metrics	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)	Through study completion, approx. 24 weeks
Qualitative knowledge and experience with app-based mindfulness practices	Subject qualitative knowledge will measured by a self-reported questionnaire which asks participants to describe their previous experiences with well-being apps	24 Weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Candace Granberg, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Professional; Burnout, Psychological
• Other Study ID Numbers: 21-007153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No