Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766475
Status:
RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-03-01
Brief Title:
In-person vs Virtual Delivery of a Group-based Prevention of Postpartum Depression
Sponsor:
University of Denver
Organization:
University of Denver
Study Overview
Official Title:
Group-based Prevention of Postpartum Depression In-person vs Virtual Delivery
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HispanicLatine 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 eg standard of care depression screening and sociodemographic factors linked to health disparities that may impact who benefits most
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH130976-01 | NIH | None | httpsreporternihgovquickSearchR01MH130976-01 |