Clinical trial NCT02950363: Physician Mental Health Study for Medical Trainees
Official title: Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Illness
Burnout Syndrome
Keywords: Depression
Suicide
Anxiety disorder
Burn out
Sleep quality
Stress
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: The Scripps Research Institute
First posted: 2016-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Week 0 (Baseline), 4, 10, 16
Secondary outcomes:
measure: Change in PHQ9 Score - (Raw score - No units) as measured at time points Week 0 (Baseline), 4, 10, 16.
timeFrame: Week 0 (Baseline), 4, 10, 16
measure: Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below:
timeFrame: Weeks 4, 10 & 16
measure: Relationship of MBI score - 3 sub scales at weeks 4, 10 & 16 to a series of biometrics as described below:
timeFrame: Weeks 4, 10 & 16
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
References: