Mental Illness Clinical Trial
Official title:
Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification
Verified date | March 2017 |
Source | Scripps Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine whether use of a suite of smart phone enabled mobile health devices can reduce burnout in medical trainees. Such applications can then be used in more general populations with the same goal in mind.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Scripps Health | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Scripps Translational Science Institute | The Scripps Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Maslach Burnout Inventory | Week 0 (Baseline), 4, 10, 16 | |
Secondary | Change in PHQ9 Score - (Raw score - No units) as measured at time points Week 0 (Baseline), 4, 10, 16. | Change in PHQ9 Score over 3 months. | Week 0 (Baseline), 4, 10, 16 | |
Secondary | Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below: | 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 | |
Secondary | Relationship of MBI score - 3 sub scales at weeks 4, 10 & 16 to a series of biometrics as described below: | 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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