Physician Mental Health Study for Medical Trainees

August 24, 2017 updated by: Scripps Translational Science Institute

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92037
        • Scripps Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study is a single site prospective cross over observational study involving physicians at Scripps Clinic/Green Hospital, La Jolla, California. Subjects will serve as their own control group during a roll in phase of up to 3 months. All subjects will undergo at entry a baseline psychological survey (Maslach Burnout Index and PHQ-9). After the roll in phase, subjects will be provided with 3 smartphone-enabled devices (Oura Ring, Spire and Beyond Verbal voice analytics application). In addition to the devices, physicians will also be provided access to online educational content specific to physician burnout. Physicians will use the 3 devices for a 3 month period and Maslach Burnout Index and PHQ-9 assessments will be performed at a 6 week midpoint and at completion of the study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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