Actively Recruiting
Led by University of Denver · Updated on 2023-05-17
900
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Denver
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
Researchers are evaluating whether a group interpersonal therapy program called ROSE, designed to prevent postpartum depression, works as well when delivered virtually compared to in person. This trial focuses on pregnant women, especially from underserved and diverse backgrounds, to improve access to mental health support during pregnancy and after childbirth. The study is a randomized controlled trial testing virtual and in-person delivery methods in English and Spanish. Participants will receive the ROSE program, which includes four weekly 90-minute group sessions plus one individual booster session. The in-person groups meet at the hospital where prenatal care is received, with transportation provided, while the virtual groups meet via video conferencing. Both formats cover topics like social support, communication skills, and managing the transition to motherhood. During the study, participants complete surveys before the program and at several points after birth, including six weeks, three months, six months, and twelve months postpartum, to measure depression symptoms. Researchers will also use electronic health records to examine health and sociodemographic factors. The total participation includes prenatal sessions and one year of follow-up postpartum to assess the program's impact and safety.
CONDITIONS
In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to confirm eligibility and enroll
Duration - Approximately 4 weeks
Participants receive the ROSE program, a group-based prevention program for postpartum depression, delivered either in-person at the hospital or virtually via video conferencing. The program includes four 90-minute weekly group sessions and one individual booster session.
5 sessions (4 group sessions and 1 individual booster session)
Duration - Up to 12 months after birth
Participants complete surveys assessing depression symptoms before birth and at multiple postpartum timepoints to monitor mental health outcomes.
5 survey assessments (prenatal before program start, end of gestation, and at 6 weeks, 3 months, 6 months, and 12 months postpartum)
Total: 1 location
1
Denver Health Medical Center
Denver, Colorado, United States, 80204
Actively Recruiting
G
Galena Rhoades, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Daphne Y Liu, Nicholas S Perry, Catherine H Demers...
https://pubmed.ncbi.nlm.nih.gov/40527396