In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
- Conditions
- Postpartum Depression
- Registration Number
- NCT05766475
- Lead Sponsor
- University of Denver
- Brief Summary
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.
- Detailed Description
Depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (PPD) and even higher rates for those who identify as Hispanic/Latine, Black or African American, American Indian, or Alaska Native, or by multiple races or ethnicities. This project addresses this major gap in services to prevent PPD, particularly among socioeconomically disadvantaged and minoritized groups. It tests the benefit of a virtual perinatal preventive intervention in English and Spanish to increase access, scalability and address the mental health needs of underserved populations. This project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (RCT). This trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. In this project, pregnant women will be randomized to receive an evidence-based group prevention program (Reach Out, Stay Strong, Essentials for New Moms; ROSE) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in English and Spanish. Diverse pregnant individuals (N = 900) will be randomized to receive virtual or in-person ROSE. The central outcome, depression, will be assessed via REDCap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). Electronic health records (EHRs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 900
- English or Spanish speaking
- Less than 30 gestational weeks
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Center for Epidemiologic Studies Depression Scale (CES-D) 12 months after birth Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Symptom Checklist 20 (SCL 20) 12 months after birth Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Denver Health Medical Center
🇺🇸Denver, Colorado, United States