Mental IllnessNCT02950363
Physician Mental Health Study for Medical Trainees
An observational study of Mental Illness and Burnout Syndrome, run by Scripps Translational Science Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Burnout Syndrome
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Illness, Burnout Syndrome
- Keywords
- Depression, Suicide, Anxiety disorder, Burn out, Sleep quality, Stress
- Medical subject headings
- Mental Disorders, Burnout, Psychological, Depression, Suicide, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0 (Baseline), 4, 10, 16
Secondary outcomes (3)
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.
Measured: Week 0 (Baseline), 4, 10, 16
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
Measured: Weeks 4, 10 & 16
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
Measured: Weeks 4, 10 & 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Scripps Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950363
- Sponsor's protocol ID
- IRB-16-6803
- Status last verified
- Mar 2017
- First submitted
- 6 Jul 2016
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physician Mental Health Using Voice Analysis, Physiological Metrics and Smartphone Enabled Behavioral Modification
- ClinicalTrials.gov ID
- NCT02950363
- Acronym / sponsor ID
- IRB-16-6803
- Conditions
- Mental Illness, Burnout Syndrome
- Keywords
- Depression, Suicide, Anxiety disorder, Burn out, Sleep quality, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- The Scripps Research Institute
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below:
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Illness and Burnout Syndrome, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Week 0 (Baseline), 4, 10, 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.