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

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.

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

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: ROSE Program: In Person
* Behavioral: ROSE Program: Virtual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English or Spanish speaking Less than 30 gestational weeks Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person Delivery of Group Preventative Intervention (ROSE)<br>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<br>* 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.<br>* Other names: La Luz;|
| Experimental: Virtual Delivery of Group Preventative Intervention (ROSE)<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual therapy, Prenatal depression, health disparities, preventative intervention, interpersonal therapy