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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05766475
Study type	Interventional
Source	University of Denver
Contact	Galena Rhoades, PhD
Phone	303-871-4280
Email	Galena.Rhoades@du.edu
Status	Recruiting
Phase	N/A
Start date	March 2023
Completion date	June 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Withdrawn	`NCT03709004` - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression	N/A
Not yet recruiting	`NCT05362305` - Essential Coaching for Every Mother in Tanzania	N/A
Not yet recruiting	`NCT05055674` - The Effects of Motherly on Postpartum Depression	N/A
Enrolling by invitation	`NCT02323152` - PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK	N/A
Not yet recruiting	`NCT01658098` - Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez	N/A
Completed	`NCT00961402` - The Effect of Exercise on Preventing PostPartum Depression	Phase 2
Completed	`NCT01312883` - Mothers Avoiding Depression Through Empowerment Intervention Trial	N/A
Completed	`NCT00360204` - Improving Health Outcomes for New Mothers and Babies	Phase 3
Unknown status	`NCT00548743` - Translating Research Into Practice for Postpartum Depression	N/A
Completed	`NCT04146025` - Nurtured in Nature	N/A
Not yet recruiting	`NCT05299398` - Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone	Phase 1
Completed	`NCT04925765` - Virtual Reality Biofeedback for Postpartum Anxiety and Depression	N/A
Completed	`NCT04037085` - Ketamine to Improve Recovery After Cesarean Delivery - Part 1	Phase 2
Recruiting	`NCT05038085` - Postpartum Depression and Maternal Attachment	N/A
Recruiting	`NCT05400161` - Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Impact on Child Development	N/A
Terminated	`NCT02272387` - Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?	N/A
Completed	`NCT01977326` - Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa	N/A
Completed	`NCT00942721` - Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression	Phase 1
Active, not recruiting	`NCT04617132` - Online MBI for Families Affected by PPDA

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms