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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: ROSE Program: In Person; Behavioral: ROSE Program: Virtual

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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Galena Rhoades, PhD; Phone Number: 303-871-4280; Email: Galena.Rhoades@du.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health Medical Center
      • Contact: Jennifer Hyer, MD; Email: Jennifer.Hyer@dhha.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English or Spanish speaking
• Less than 30 gestational weeks

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Group IPT; Rose; La Luz
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Checklist 20 (SCL 20)	Self reported depression scores	6 months after birth
Symptom Checklist 20 (SCL 20)	Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.	6 weeks after birth
Symptom Checklist 20 (SCL 20)	Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.	3 months after birth
Symptom Checklist 20 (SCL 20)	Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.	12 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)	Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.	6 weeks after birth
Center for Epidemiologic Studies Depression Scale (CES-D)	Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.	3 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)	Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.	6 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)	Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.	12 months after birth

Collaborators and Investigators

• Sponsor: University of Denver
• Collaborators: National Institute of Mental Health (NIMH); Denver Health Medical Center
• Investigators: Principal Investigator: Galena Rhoades, PhD, University of Denver; Principal Investigator: Elysia P Davis, PhD, University of Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Anticipated): June 1, 2027
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: health disparities; interpersonal therapy; virtual therapy; Prenatal depression; preventative intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 1916994-3; R01MH130976-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be shared in accordance with NIMH Data Archive requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No