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Clinical Trials/NCT05766475
NCT05766475RecruitingNot Applicable

Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery

University of Denver1 site in 1 country900 target enrollmentStarted: March 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
900
Locations
1
Primary Endpoint
Center for Epidemiologic Studies Depression Scale (CES-D)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •English or Spanish speaking
  • •Less than 30 gestational weeks

Exclusion Criteria

  • Not provided

Arms & Interventions

In-Person Delivery of Group Preventative Intervention (ROSE)

Active Comparator

The Reach Out, Stay Strong, Essentials for New Mothers Program (ROSE), is an established Interpersonal Therapy (IPT)-oriented group intervention for postpartum depression. ROSE is a brief (5-session) program and its content addresses social support, role transition to motherhood, communication skills, and psychoeducation on PPD. ROSE consists of four 90-minute, weekly in person group sessions and one individual booster session. The first four sessions of ROSE will be delivered in groups of 6 to 20, and conducted in both English and Spanish. For the in-person groups, transportation via Uber will be provided to Denver Health Medical Center to reduce barriers to attendance.

Intervention: ROSE Program: In Person (Behavioral)

Virtual Delivery of Group Preventative Intervention (ROSE)

Experimental

In parallel to ROSE delivered in person, virtual ROSE consists of four 90-minute, weekly group sessions conducted via Zoom and one individual booster session.

Intervention: ROSE Program: Virtual (Behavioral)

Outcomes

Primary Outcomes

Center for Epidemiologic Studies Depression Scale (CES-D)

Time Frame: 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)

Time Frame: 12 months after birth

Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Symptom Checklist 20 (SCL 20)

Time Frame: 6 weeks after birth

Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Symptom Checklist 20 (SCL 20)

Time Frame: 3 months after birth

Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Symptom Checklist 20 (SCL 20)

Time Frame: 6 months after birth

Self reported depression scores

Center for Epidemiologic Studies Depression Scale (CES-D)

Time Frame: 6 weeks after birth

Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

Center for Epidemiologic Studies Depression Scale (CES-D)

Time Frame: 3 months after birth

Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

Center for Epidemiologic Studies Depression Scale (CES-D)

Time Frame: 6 months after birth

Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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