Physician Mental Health Study for Medical Trainees

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02950363
Collaborator
The Scripps Research Institute (Other)
40
1
12
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Wearable sensors and mental health platforms delivered via smartphones offer an opportunity to passively and actively acquire quantifiable signs and symptoms related to mental health status. These features include both physiological and cognitive performance measures. Collectively they serve as a set of metrics whereby an estimation of a person's mental state can be gauged. Additionally, use of these platforms allows those who are identified as high risk for mental illness to have targeted therapy delivered via their smartphone and if necessary connected with a suitable healthcare provider. Applications of such technology platforms serve to potentially reduce the substantial morbidity and mortality in a population at increased risk for mental illness and burnout.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification
    Study Start Date :
    Jul 1, 2016
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Week 0 (Baseline), 4, 10, 16]

      Maslach Burnout Inventory

    Secondary Outcome Measures

    1. Change in PHQ9 Score - (Raw score - No units) as measured at time points Week 0 (Baseline), 4, 10, 16. [Week 0 (Baseline), 4, 10, 16]

      Change in PHQ9 Score over 3 months.

    2. Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below: [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

    3. Relationship of MBI score - 3 sub scales at weeks 4, 10 & 16 to a series of biometrics as described below: [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Health San Diego California United States 92037

    Sponsors and Collaborators

    • Scripps Translational Science Institute
    • The Scripps Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT02950363
    Other Study ID Numbers:
    • IRB-16-6803
    First Posted:
    Nov 1, 2016
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Scripps Translational Science Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2017