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Completed

NCT Number: NCT02950363

Physician Mental Health Study for Medical Trainees

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.

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Key information

Conditions

Mental Illness Anxiety Disorders Behavior Behavioral Symptoms Burnout Syndrome Burnout, Psychological Depression Dyssomnias Mental Disorders Nervous System Diseases Self-Injurious Behavior Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress, Psychological Suicide

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health

San Diego, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  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.

    Time frame: Week 0 (Baseline), 4, 10, 16

    Maslach Burnout Inventory

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • The Scripps Research Institute

Registry information

Official study title

Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Aug 28, 2017

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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