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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Burnout, Professional

Intervention / Treatment
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* Other: Headspace App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled App Group<br>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<br>* A mobile-application (app) focusing on teaching and sustaining mental well-being.<br>|
| Experimental: Ad lib App Group<br>Subjects will receive access to the Headspace app and be encouraged to use it ad lib. | Other: Headspace App<br>* A mobile-application (app) focusing on teaching and sustaining mental well-being.<br>|

What is the study measuring?
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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 |