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Behavioural Intervention
Digital Well-Being Program for Healthcare Workers' Mental Health (Thrive Trial)
N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 18
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to evaluate the effectiveness of a digital wellbeing program to improve mental health and well-being of physicians, and create a culture of support during the pandemic.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a non-medical intervention focusing on well-being through digital means, traditional side effects like those seen with medications are not expected. However, participants may experience varying levels of engagement or stress relief.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Well-Being Index (WBI)
Secondary study objectives
Connor-Davidson Resilience Scale (CDRS)
General Anxiety Disorder (GAD-2)
Patient Health Questionnaire (PHQ-2)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Comprehensive Well-Being InterventionExperimental Treatment1 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 CareActive Control1 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
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,073 Previous Clinical Trials
42,713,963 Total Patients Enrolled
Pennsylvania Department of HealthOTHER_GOV
41 Previous Clinical Trials
998,102 Total Patients Enrolled
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