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

Burnout, Professional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036356
• Other study ID #: 21-007153
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials