Identifying Mental Health Distress in EM Physicians

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Burnout, Professional

Clinical Trial Details

NCT number	NCT05606887
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 3, 2023
Completion date	May 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03614390` - Mindfulness for Medical Students	N/A
Completed	`NCT05472935` - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers	N/A
Completed	`NCT03473353` - Doctor-Parent Interactions With Medical Scribes	N/A
Recruiting	`NCT05483335` - Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates
Terminated	`NCT04132141` - VR Breaks on Shift-worker Alertness	N/A
Completed	`NCT05519267` - Mindfulness-based Social Work and Self-Care (MBSWSC)	N/A
Not yet recruiting	`NCT04665505` - Resource Optimization in the Intensive Care Unit Setting	N/A
Completed	`NCT02455947` - IBSR Meditation Technique for Teachers' Burnout	N/A
Completed	`NCT01234961` - Outcome Study of the ReDO Intervention for Women With Stress-related Disorders	N/A
Completed	`NCT04004806` - Tracking Device Guided Feedback to Enhance Patient Physician Interaction	N/A
Completed	`NCT04129632` - Evaluation of Institutional Resources and a Novel Mindfulness Tool on Burnout Intensity	N/A
Completed	`NCT03303482` - A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators	N/A
Recruiting	`NCT05011435` - Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout (BURNOUT ADVICE)
Active, not recruiting	`NCT04517136` - Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
Active, not recruiting	`NCT05387746` - Integrative Self-care Approaches for HCP Wellbeing	N/A
Completed	`NCT05222685` - Better Together Physician Coaching: An Innovative Solution to Medical Trainee Burnout	N/A
Completed	`NCT02544412` - A Well-being Training for Preservice Teachers	N/A
Completed	`NCT04466423` - Intervention Trial to Increase Meaning in Work and Reduce Burnout	N/A
Completed	`NCT03475290` - Internet-Based Intervention for Occupational Stress Among Medical Professionals	N/A
Completed	`NCT05538650` - RCT: Mindfulness for Social Work and Self-care	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.