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OpenTrials
Completed

NCT Number: NCT05606887

Identifying Mental Health Distress in EM 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable Device and Ecological Momentary Assessments

Other

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

Primary outcomes

  1. Feasibility of Intervention (FIM)

    Time frame: Through study completion, on average 6 months

    Feasibility will be measured by the Feasibility of Intervention Measure (FIM)

  2. Feasibility of Intervention (Study Retention)

    Time frame: Through study completion, on average 6 months

    Feasibility will be measured by study retention

  3. Acceptability of Intervention (AIM)

    Time frame: Through study completion, on average 6 months

    Acceptability will be measured by the validated Acceptability of Intervention Measure.

  4. 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.

Secondary outcomes

  1. Anxiety

    Time frame: Through study completion, on average 6 months

    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.

  2. Depression

    Time frame: Through study completion, on average 6 months

    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.

  3. Professional Burnout

    Time frame: Through study completion, on average 6 months

    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.

  4. Post-Traumatic Stress Disorder

    Time frame: Through study completion, on average 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Emergency Medicine Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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