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NCT Number: NCT05036356

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Headspace App

Other

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

Primary outcomes

  1. Change in burnout syndrome

    Time frame: 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

    Time frame: 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 outcomes

  1. User engagement metrics

    Time frame: 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

    Time frame: 24 Weeks

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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