Digital Well-Being Program for Healthcare Workers' Mental Health

(Thrive Trial)

Overseen By Lauren Southwick, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, No phone access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

293 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Comprehensive Well-Being Intervention for healthcare workers' mental health?

Research shows that digital mental health interventions, like mental health apps, can improve anxiety and stress levels in healthcare workers. Additionally, tools such as Three Good Things and Gratitude Letter have been effective in reducing burnout and improving well-being among healthcare workers. ^{1 2 3 4 5}

Is the Digital Well-Being Program for Healthcare Workers' Mental Health safe for humans?

The mental health app interventions (MHAIs) used in a study with healthcare workers during the COVID-19 pandemic showed above-average feasibility and acceptability, indicating they were generally well-received and safe to use. ^{1 6 7 8 9}

How is the Comprehensive Well-Being Intervention treatment different from other treatments for healthcare workers' mental health?

The Comprehensive Well-Being Intervention is unique because it is a digital program specifically designed to address the mental health needs of healthcare workers by providing tailored resources through a precision engagement platform. This approach is different from traditional treatments as it offers personalized support and is easily accessible, making it a scalable solution for healthcare workers experiencing burnout and stress. ^{1 4 7 10 11}

Eligibility Criteria

This trial is for physicians at Penn Medicine who are over 18, willing to join an 18-month study with regular surveys, and have daily access to a phone capable of texting. It's not open to those under 18 or anyone unwilling to consent or without the necessary phone access.

Inclusion Criteria

Identify as a Physician at Penn Medicine

I am willing to participate in an 18-month study and complete surveys regularly.

Regular, daily access to a phone with texting capabilities

Exclusion Criteria

No access to a phone with texting capabilities

Not a Physician at Penn Medicine

I am unwilling to sign a consent form for an 18-month study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an ICF and baseline survey, including validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction

1 week

1 visit (virtual)

Intervention

Participants receive a comprehensive well-being intervention including monthly automated text messaging and quarterly peer support groups

18 months

Quarterly peer support group sessions

Follow-up

Participants are monitored for the persistence of effects on well-being, depression, anxiety, stress, resilience, and job satisfaction

12 months

Regular assessments every 3 months

Treatment Details

Interventions

• Comprehensive Well-Being Intervention

Trial Overview The trial tests a digital well-being program aimed at improving mental health and job satisfaction among doctors during COVID. It involves interviews, text messages, resource support, and peer groups compared against usual care in a randomized controlled setup.

Participant Groups

Group I: Comprehensive Well-Being Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Pennsylvania Department of Health

Collaborator

Trials

42

Recruited

999,000+

Findings from Research

Three web-based interventions—Three Good Things, Gratitude Letter, and Looking Forward Tool—were tested in three studies involving a total of 521 healthcare workers, showing significant improvements in emotional exhaustion, depression, happiness, work-life balance, and emotional recovery after the interventions.

Despite some exceptions in long-term effects, these brief and engaging tools demonstrate promise in alleviating burnout among healthcare workers, highlighting the potential for simple self-care strategies to enhance well-being in this high-stress profession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. Adair, KC., Kennedy, LA., Sexton, JB.[2021]

A digital learning package was developed to support the psychological wellbeing of UK healthcare workers during the COVID-19 pandemic, which was accessed over 17,600 times within a week of its release, indicating high demand and relevance.

The package, created through a rapid three-step process involving public input and expert review, provided evidence-based guidance on self-care, managing emotions, and creating psychologically safe work environments, and was positively evaluated for its usability and practical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating the Psychological Impact of COVID-19 on Healthcare Workers: A Digital Learning Package. Blake, H., Bermingham, F., Johnson, G., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and preliminary efficacy of a mental health self-management app in clinicians working during the COVID-19 pandemic: A pilot randomised controlled trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of Digital Interventions for Psychological Well-Being in the Workplace: A Systematic Review Protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to support the mental health and well-being of front-line healthcare workers in hospitals during pandemics: an evidence review and synthesis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Analysis of healthcare workers' mental health during the COVID-19 pandemic: Evidence from a three-wave longitudinal study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of an E-mental health approach to workers' health surveillance versus control group on work functioning of hospital employees: a cluster-RCT. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Supporting the Resilience and Mental Health of Missouri Healthcare Workers Through COVID-19 and Beyond: the Gateway2Wellness Program. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Are Organizational Interventions Effective in Protecting Healthcare Worker Mental Health during Epidemics/Pandemics? A Systematic Literature Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Healthcare Workers: Occupational Health Promotion and Patient Safety. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Mitigating the Psychological Impact of COVID-19 on Healthcare Workers: A Digital Learning Package. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Implementing the STEADY Wellness Program to Support Healthcare Workers throughout the COVID-19 Pandemic. [2022]