Burnout, ProfessionalNCT05606887
Identifying Mental Health Distress in EM Physicians
A study testing Wearable Device and Ecological Momentary Assessments in people with Burnout, Professional, run by University of Pennsylvania at 1 site in United States.
Trial summary
This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Wearable Device and Ecological Momentary Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 10 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Emergency Medicine (EM) physician or advanced practice provider
- Daily access to smart phone
- Ability to use a wrist-worn wearable device
- Has or is willing to create a Gmail / Google account
- Provides at least 20 hours per week of clinical care.
Who cannot join
- Under 18
- Not a Penn EM physician or advanced practice provider
- Does not have daily access to a smart phone
- Unwilling or unable to wear a wearable device
- Does not have or is unwilling to create a Gmail / Google account
- Does not provide at least 20 hours per week of clinical care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians
This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.
Read the detailed description
This proposal aims to conduct a 3-month pilot randomized control trial (n=60) testing feasibility, acceptability, and the exploratory effectiveness of digital data feedback (wearables and EMA) with tailored, symptom-specific linkage to mental health and resilience resources versus control on mental health symptoms (depression, anxiety, PTSD) and burnout in EM clinicians. The study will recruit and enroll 60 emergency medicine physicians, residents, and advanced practice providers via email and inperson outreach. Once enrolled, both arms be asked to take a baseline survey which will measure their level of well-being, burnout, depression, and anxiety.
Study participants will be randomized following consent and completion of baseline surveys. Participants will be randomly assigned to usual care or intervention. We will use 2:1 randomization. We will randomize in block sizes of 3 and 6.
Intervention: The intervention arm will then be given a wearable device and will be asked to wear it for 3 months. The device will collect biometric data on stress levels, sleep patterns, and other physiological measures of well-being. The intervention group will receive biweekly EMA short surveys, personalized bi-weekly reports from their EMA data, biometric feedback from wearable devices (sleep, heart rate variability, physical activity), and linkage to tailored and symptom-specific Cobalt resources on health and resilience. After 3 months, we will survey providers to complete a post-survey followed by a survey at 6-months following a 3-month washout period.
Control: The control arm will be asked to complete a baseline survey as well as one assessment at the end of the three-month study period. They will receive usual care, or clinician-initiated use of Penn Cobalt. They will then complete additional surveys at 3-months and 6-months.
- Conditions
- Burnout, Professional
- Being tested
- Wearable Device and Ecological Momentary Assessments
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device and Ecological Momentary AssessmentsOther
The intervention will consist of three components:
- Completion of brief text-message based surveys 2-3 times per week
- Wearing a wrist-based wearable device to generate individual data insights on physiological data related to stress and well-being, including heart rate variability, stress scores, and sleep quality
- Individual biweekly reports of survey response trends and curated resources intended to support participant well-being
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to completing 3 surveys over the course of 6 months, participants in the intervention arm will be asked to wear a wearable device (FitBit Charge 5), complete texting-based ecological momentary assessments to gauge real-time feelings of stress, and receive bi-weekly personalized data dashboards to report back their data. Receives: Other: Wearable Device and Ecological Momentary Assessments |
| Control | No intervention | Participants randomized to this arm will receive digital surveys over the course of 6 months (one at baseline, one at 3 months, and one at 6 months). These surveys will be the same as the intervention arm and will ask questions related to burnout, anxiety, depression, PTSD, and stress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention (FIM)
Feasibility will be measured by the Feasibility of Intervention Measure (FIM)
Measured: Through study completion, on average 6 months
Feasibility of Intervention (Study Retention)
Feasibility will be measured by study retention
Measured: Through study completion, on average 6 months
Acceptability of Intervention (AIM)
Acceptability will be measured by the validated Acceptability of Intervention Measure.
Measured: Through study completion, on average 6 months
Acceptability of Intervention (EMA Completion Rates)
Acceptability will be measured by the open/completion rates of ecological momentary assessment.
Measured: Through study completion, on average 6 months
Secondary outcomes (4)
Anxiety
While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The GAD-7 will be used to measure anxiety.
Measured: Through study completion, on average 6 months
Depression
While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PHQ-8 will be used to measure depression.
Measured: Through study completion, on average 6 months
Professional Burnout
While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The Stanford Professional Fulfillment Index will be used to measure burnout.
Measured: Through study completion, on average 6 months
Post-Traumatic Stress Disorder
While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PC-PTSD-5 will be used to measure PTSD.
Measured: Through study completion, on average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start3 Oct 2023
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to the intervention arm (with wearable devices or EMAs) or control (survey-only) in parallel and will remain in their assigned arm throughout their participation in the survey.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606887
- Sponsor's protocol ID
- 0852220
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians
- ClinicalTrials.gov ID
- NCT05606887
- Acronym / sponsor ID
- 0852220
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- 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.
This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.
Detailed description
This proposal aims to conduct a 3-month pilot randomized control trial (n=60) testing feasibility, acceptability, and the exploratory effectiveness of digital data feedback (wearables and EMA) with tailored, symptom-specific linkage to mental health and resilience resources versus control on mental health symptoms (depression, anxiety, PTSD) and burnout in EM clinicians. The study will recruit and enroll 60 emergency medicine physicians, residents, and advanced practice providers via email and inperson outreach. Once enrolled, both arms be asked to take a baseline survey which will measure their level of well-being, burnout, depression, and anxiety.
Study participants will be randomized following consent and completion of baseline surveys. Participants will be randomly assigned to usual care or intervention. We will use 2:1 randomization. We will randomize in block sizes of 3 and 6.
Intervention: The intervention arm will then be given a wearable device and will be asked to wear it for 3 months. The device will collect biometric data on stress levels, sleep patterns, and other physiological measures of well-being. The intervention group will receive biweekly EMA short surveys, personalized bi-weekly reports from their EMA data, biometric feedback from wearable devices (sleep, heart rate variability, physical activity), and linkage to tailored and symptom-specific Cobalt resources on health and resilience. After 3 months, we will survey providers to complete a post-survey followed by a survey at 6-months following a 3-month washout period.
Control: The control arm will be asked to complete a baseline survey as well as one assessment at the end of the three-month study period. They will receive usual care, or clinician-initiated use of Penn Cobalt. They will then complete additional surveys at 3-months and 6-months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to the intervention arm (with wearable devices or EMAs) or control (survey-only) in parallel and will remain in their assigned arm throughout their participation in the survey.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Wearable Device and Ecological Momentary AssessmentsIn addition to completing 3 surveys over the course of 6 months, participants in the intervention arm will be asked to wear a wearable device (FitBit Charge 5), complete texting-based ecological momentary assessments to gauge real-time feelings of stress, and receive bi-weekly personalized data dashboards to report back their data. |
| Control | No intervention | –Participants randomized to this arm will receive digital surveys over the course of 6 months (one at baseline, one at 3 months, and one at 6 months). These surveys will be the same as the intervention arm and will ask questions related to burnout, anxiety, depression, PTSD, and stress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Emergency Medicine (EM) physician or advanced practice provider
- Daily access to smart phone
- Ability to use a wrist-worn wearable device
- Has or is willing to create a Gmail / Google account
Key exclusion criteria (6 listed)
- Under 18
- Not a Penn EM physician or advanced practice provider
- Does not have daily access to a smart phone
- Unwilling or unable to wear a wearable device
- Does not have or is unwilling to create a Gmail / Google account
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Device and Ecological Momentary AssessmentsThe intervention will consist of three components: 1. Completion of brief text-message based surveys 2-3 times per week 2. Wearing a wrist-based wearable device to generate individual data insights on physiological data related to stress and well-being, including heart rate variability, stress scores, and sleep quality 3. Individual biweekly reports of survey response trends and curated resources intended to support participant well-being | Other | Intervention |
Primary outcome
Feasibility of Intervention (FIM)
Time frame: Through study completion, on average 6 months
Feasibility will be measured by the Feasibility of Intervention Measure (FIM)
Feasibility of Intervention (Study Retention)
Time frame: Through study completion, on average 6 months
Feasibility will be measured by study retention
Acceptability of Intervention (AIM)
Time frame: Through study completion, on average 6 months
Acceptability will be measured by the validated Acceptability of Intervention Measure.
Acceptability of Intervention (EMA Completion Rates)
Time frame: Through study completion, on average 6 months
Acceptability will be measured by the open/completion rates of ecological momentary assessment.
4 secondary outcomes
Anxiety
Time frame: Through study completion, on average 6 months
Depression
Time frame: Through study completion, on average 6 months
Professional Burnout
Time frame: Through study completion, on average 6 months
Post-Traumatic Stress Disorder
Time frame: Through study completion, on average 6 months
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 Feb 2025.
- Individual participant dataSharing planned: No
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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?
A study testing Wearable Device and Ecological Momentary Assessments in people with Burnout, Professional, run by University of Pennsylvania 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 6 inclusion and 6 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 Feb 2025. 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?
Feasibility of Intervention (FIM) (time frame: Through study completion, on average 6 months). The study lists 4 primary outcomes in all. 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 Feb 2025.