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

NCT ID: NCT05766475

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In-Person Delivery of Group Preventative Intervention (ROSE)

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.

Group Type ACTIVE_COMPARATOR

ROSE Program: In Person

Intervention Type BEHAVIORAL

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.

Virtual Delivery of Group Preventative Intervention (ROSE)

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.

Group Type EXPERIMENTAL

ROSE Program: Virtual

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Rose Group IPT La Luz

Eligibility Criteria

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Inclusion Criteria

* English or Spanish speaking
* Less than 30 gestational weeks

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Denver Health Medical Center

OTHER

Sponsor Role collaborator

University of Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galena Rhoades, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Denver

Elysia P Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Denver

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Galena Rhoades, PhD

Role: CONTACT

303-871-4280

Facility Contacts

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Jennifer Hyer, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40527396 (View on PubMed)

Other Identifiers

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R01MH130976-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1916994-3

Identifier Type: -

Identifier Source: org_study_id

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