A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

NCT05931432 | Active Not Recruiting DMC

• 1 other identifier: 852022
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

Brief Summary

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Conditions

Depression, Anxiety; Satisfaction; Well-being

Outcome Measures

Primary Outcomes (6)

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 0

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 3

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 6

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 9

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 12

• Well-Being Index (WBI)

  The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey

  at month 15

Secondary Outcomes (12)

• Patient Health Questionnaire (PHQ-2)

  at month 0

• Patient Health Questionnaire (PHQ-2)

  at month 18

• General Anxiety Disorder (GAD-2)

  at month 0

• General Anxiety Disorder (GAD-2)

  at month 18

• Perceived Stress Scale (PSS-10)

  at month 0

Study Arms (2)

Usual Care

NO INTERVENTION

Participants will be asked to complete an ICF and baseline survey at enrollment. They will be given survey assessments at 0, 18 and 30 months. Survey assessments will include validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The control group will have access to usual care well-being resources at Penn Medicine. These include links, classes, groups, social media sites such as Penn Cobalt which require self-awareness to find the resources and access them. In this context, the individual has to "pull" the resources they need and there may be several barriers to completing each step

Comprehensive Well-Being Intervention

EXPERIMENTAL

Participants will be asked to complete an ICF and baseline survey at enrollment. Participants will complete a full assessment using validated instruments at enrollment, 18 months and 30 months (depression, anxiety, stress, resilience, and job satisfaction). Participants will also complete the brief well-being index (WBI, nine questions) every 3 months over 30 months. The primary endpoint is assessed at 18 months. A secondary endpoint of persistence of effect is measured at 30 months. The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions.

Other: Comprehensive Well-Being Intervention

Interventions

Comprehensive Well-Being Intervention OTHER

The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings.

Comprehensive Well-Being Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• Interest in participating in an 18 month study and willing to complete regular surveys;
• Regular, daily access to a phone with texting capabilities
• Identify as a Physician at Penn Medicine;

You may not qualify if:

• Under 18 years of age;
• Not willing to sign informed consent document for an 18 month study;
• No access to a phone with texting capabilities;
• Not a Physician at Penn Medicine

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: July 5, 2023
• Study Start: October 12, 2023
• Primary Completion: July 27, 2025
• Study Completion: March 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)