- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950363
Physician Mental Health Study for Medical Trainees
Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92037
- Scripps Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Trainee Physician at Scripps Green Hospital or Clinic.
- Older than 18 years.
- Must be reliable, cooperative and willing to comply with all protocol-specified procedures.
- Able to understand and grant informed consent
- Have a pre-existing smart phone capable of running all study software.
Exclusion Criteria:
- Has a significant medical condition that in the investigator's opinion may interfere with the study subject's optimal participation in the study.
- Known mental health condition including diagnosis of depression, schizophrenia, suicidality or anxiety disorder.
- Does not have suitable smart phone to allow all relevant software to run.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary endpoint is change in Maslach Burnout Inventory (MBI) over a 16 week period as measured at time points Week 0 (Baseline), 4, 10, 16.
Time Frame: Week 0 (Baseline), 4, 10, 16
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Maslach Burnout Inventory
|
Week 0 (Baseline), 4, 10, 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PHQ9 Score - (Raw score - No units) as measured at time points Week 0 (Baseline), 4, 10, 16.
Time Frame: Week 0 (Baseline), 4, 10, 16
|
Change in PHQ9 Score over 3 months.
|
Week 0 (Baseline), 4, 10, 16
|
Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below:
Time Frame: Weeks 4, 10 & 16
|
Average, following measurement of score: total time (Hours & Minutes) slept/night for week % sleep score (to Oura Ring App) per night for week min. overnight lowest heart rate (Beats per minute) per night for week Total time of per night for week: deep sleep (Hours & Minutes) light sleep (Hours & Minutes) REM sleep (Hours & Minutes) waking (Hours & Minutes) sleep latency (Hours & Minutes) % readiness score (% Measure native to Oura Ring App) Daily number of minutes of: focus (measured by Spire App) for week tension (measured by Spire App) for week calm (measured by Spire App) for week activity (measured by Spire App) for week inactivity (measured by Spire App) for week daily calories burned (measured by Spire App) for week Weekly # of (measured by the Beyond Verbal App): positive mood recordings negative mood recordings neutral mood recordings weekly arousal, temper, and valance score |
Weeks 4, 10 & 16
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Relationship of MBI score - 3 sub scales at weeks 4, 10 & 16 to a series of biometrics as described below:
Time Frame: Weeks 4, 10 & 16
|
Average, following measurement of score: total time (Hours & Minutes) slept/night for week % sleep score (to Oura Ring App) per night for week min. overnight lowest heart rate (Beats per minute) per night for week Total time of per night for week: deep sleep (Hours & Minutes) light sleep (Hours & Minutes) REM sleep (Hours & Minutes) waking (Hours & Minutes) sleep latency (Hours & Minutes) % readiness score (% Measure native to Oura Ring App) Daily number of minutes of: focus (measured by Spire App) for week tension (measured by Spire App) for week calm (measured by Spire App) for week activity (measured by Spire App) for week inactivity (measured by Spire App) for week daily calories burned (measured by Spire App) for week Weekly # of (measured by the Beyond Verbal App): positive mood recordings negative mood recordings neutral mood recordings weekly arousal, temper, and valance score |
Weeks 4, 10 & 16
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-16-6803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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