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Identifying Mental Health Distress in EM Physicians

Investigating Proactive, Digital Methods to Identify Signs and Symptoms of Mental Health Distress in Emergency Medicine Physicians

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05606887
Enrollment
45
Registered
2022-11-07
Start date
2023-10-03
Completion date
2024-06-10
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout, Professional

Brief 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. 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.

Interventions

OTHERWearable Device and Ecological Momentary Assessments

The 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

Sponsors

Emergency Medicine Foundation
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Given the nature of the intervention (i.e., participants in the intervention arm receiving a wearable device and investigators and analysts reviewing biometric data for this group), the study will not be masked.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Intervention (EMA Completion Rates)Through study completion, on average 6 monthsAcceptability will be measured by the open/completion rates of ecological momentary assessment.
Feasibility of Intervention (FIM)Through study completion, on average 6 monthsFeasibility will be measured by the Feasibility of Intervention Measure (FIM)
Feasibility of Intervention (Study Retention)Through study completion, on average 6 monthsFeasibility will be measured by study retention
Acceptability of Intervention (AIM)Through study completion, on average 6 monthsAcceptability will be measured by the validated Acceptability of Intervention Measure.

Secondary

MeasureTime frameDescription
AnxietyThrough study completion, on average 6 monthsWhile 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.
DepressionThrough study completion, on average 6 monthsWhile 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.
Professional BurnoutThrough study completion, on average 6 monthsWhile 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.
Post-Traumatic Stress DisorderThrough study completion, on average 6 monthsWhile 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026