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

Depression, Anxiety Clinical Trial

— Thrive  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05931432
• Other study ID #: 852022
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 293
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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;

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Satisfaction
• Well-being

Intervention

Other:
• Comprehensive Well-Being Intervention
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patient Health Questionnaire (PHQ-2)	PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.	at month 0
Secondary	Patient Health Questionnaire (PHQ-2)	PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.	at month 18
Secondary	General Anxiety Disorder (GAD-2)	GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.	at month 0
Secondary	General Anxiety Disorder (GAD-2)	GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.	at month 18
Secondary	Perceived Stress Scale (PSS-10)	The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress	at month 0
Secondary	Perceived Stress Scale (PSS-10)	The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress	at month 18
Secondary	Connor-Davidson Resilience Scale (CDRS)	The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience	at month 0
Secondary	Connor-Davidson Resilience Scale (CDRS)	The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience	at month 18
Secondary	Physician Job Satisfaction Scale (JSS-10)	The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure	at month 0
Secondary	Physician Job Satisfaction Scale (JSS-10)	The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure	at month 18
Secondary	Professional Fulfillment Index	• The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment.	at month 0
Secondary	Professional Fulfillment Index	• The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment.	at month 18