Burnout, ProfessionalNCT05036356
Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE)
A study testing Headspace App in people with Burnout, Professional, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Headspace App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout, Professional
- Being tested
- Headspace App
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headspace AppOther
A mobile-application ("app") focusing on teaching and sustaining mental well-being.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Headspace App |
| Ad lib App Group | Experimental | Subjects will receive access to the Headspace app and be encouraged to use it ad lib. Receives: Other: Headspace App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 12, Week 24
Secondary outcomes (2)
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)
Measured: 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
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start2 Nov 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candace F. Granberg, M.D., Mayo Clinic
- Investigators
- Candace Granberg, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036356
- Sponsor's protocol ID
- 21-007153
- Status last verified
- Dec 2022
- First submitted
- 2 Sep 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05036356
- Acronym / sponsor ID
- 21-007153
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled App Group | Experimental | Other: Headspace AppSubjects 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. |
| Ad lib App Group | Experimental | Other: Headspace AppSubjects will receive access to the Headspace app and be encouraged to use it ad lib. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headspace AppA mobile-application ("app") focusing on teaching and sustaining mental well-being. | Other | Ad lib App Group, Controlled App Group |
Primary outcome
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.
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.
2 secondary outcomes
User engagement metrics
Time frame: Through study completion, approx. 24 weeks
Qualitative knowledge and experience with app-based mindfulness practices
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace Granberg, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headspace App in people with Burnout, Professional, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in burnout syndrome (time frame: Baseline, Week 12, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.