In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ROSE Program: In Person, ROSE Program: Virtual.
- Who it may be relevant to
- Registry conditions: Postpartum Depression. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
Overview
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.
Interventions
- Behavioral ROSE Program: In Person
In-person preventative intervention for postpartum depression that includes content on building social support and communication skills in relationships, navigating the role transition to motherhood, and learning about signs and symptoms of depression after delivery. - Behavioral ROSE Program: Virtual
Virtual ROSE covers the same content (e.g. improving social support and communication) and is delivered by the same facilitators as the in-person intervention via telehealth.
Primary outcome measures
- Symptom Checklist 20 (SCL 20) [Time frame: 6 weeks after birth]
- Symptom Checklist 20 (SCL 20) [Time frame: 3 months after birth]
- Symptom Checklist 20 (SCL 20) [Time frame: 6 months after birth]
- Symptom Checklist 20 (SCL 20) [Time frame: 12 months after birth]
- Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: 6 weeks after birth]
- Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: 3 months after birth]
- Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: 6 months after birth]
- Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: 12 months after birth]
Eligibility criteria
Inclusion criteria
- English or Spanish speaking
- Less than 30 gestational weeks
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Denver Health Medical Center — Denver
Publications
- Liu DY, Perry NS, Demers CH, Hyer JS, Alamo A, Vuksanovich P, Dube N, Flanagan ER, Gallop RJ, Rhoades GK, Davis EP. Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital. Contemp Clin Trials. 2025 Aug;155:107988. doi: 10.1016/j.cct.2025.107988. Epub 2025 Jun 15. PMID 40527396
Identifiers
NCT: NCT05766475 · 1916994-3 · R01MH130976-01