An interventional study of ROSE Program: In Person and ROSE Program: Virtual in Postpartum Depression, sponsored by University of Denver. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by University of Denver · Not applicable, Interventional, and Prevention
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.
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 900 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of Denver is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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
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.
Also known as: Rose, Group IPT, La Luz
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.
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.
Time frame: 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.
Time frame: 3 months after birth
Symptom Checklist 20 (SCL 20)
Self reported depression scores
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after birth
Plan to share: Yes — All data will be shared in accordance with NIMH Data Archive requirements.
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Jun 2027, 51 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 51 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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University of Denver