Physician Mental Health Study for Medical Trainees

Mental Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950363
• Other study ID #: IRB-16-6803
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: August 24, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2017
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Burnout Syndrome
• Mental Disorders
• Mental Illness

Locations

Country	Name	City	State
United States	Scripps Health	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	The Scripps Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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