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

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766475
• Other study ID #: 1916994-3
• Secondary ID: R01MH130976-01
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: June 2027

Study information

• Verified date: May 2023
• Source: University of Denver
• Contact: Galena Rhoades, PhD
• Phone: 303-871-4280
• Email: Galena.Rhoades[@]du.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English or Spanish speaking

• Less than 30 gestational weeks

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Denver	Denver Health Medical Center, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Symptom Checklist 20 (SCL 20)	Self reported depression scores	6 months after birth
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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