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

NCT05036356 | Completed

• 1 other identifier: 21-007153
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Burnout, Professional

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• User engagement metrics

  Through study completion, approx. 24 weeks

• Qualitative knowledge and experience with app-based mindfulness practices

  24 Weeks

Study Arms (2)

Controlled App Group

EXPERIMENTAL

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

Ad lib App Group

EXPERIMENTAL

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

Other: Headspace App

Interventions

Headspace App OTHER

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

Ad lib App Group; Controlled App Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Candace Granberg, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: November 2, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)