Clinical trial NCT05766475: In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
Official title: Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: Prenatal depression
health disparities
preventative intervention
virtual therapy
interpersonal therapy
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Denver Health Medical Center
First posted: 2023-03-13
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Less than 30 gestational weeks

Exclusion Criteria:

* None

Primary outcomes:
measure: Symptom Checklist 20 (SCL 20)
timeFrame: 6 weeks after birth
measure: Symptom Checklist 20 (SCL 20)
timeFrame: 3 months after birth
measure: Symptom Checklist 20 (SCL 20)
timeFrame: 6 months after birth
measure: Symptom Checklist 20 (SCL 20)
timeFrame: 12 months after birth
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 weeks after birth
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 3 months after birth
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 months after birth
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 12 months after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: University of Denver
name: Galena Rhoades, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Denver
name: Elysia P Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References: