In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
NCT ID: NCT05766475
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2023-03-13
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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In-Person Delivery of Group Preventative Intervention (ROSE)
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.
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.
Virtual Delivery of Group Preventative Intervention (ROSE)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Less than 30 gestational weeks
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Denver Health Medical Center
OTHER
University of Denver
OTHER
Responsible Party
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Principal Investigators
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Galena Rhoades, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Denver
Elysia P Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Denver
Locations
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Denver Health Medical Center
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Liu DY, Perry NS, Demers CH, Hyer JS, Alamo A, Vuksanovich P, Dube N, Flanagan ER, Gallop RJ, Rhoades GK, Davis EP. Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital. Contemp Clin Trials. 2025 Aug;155:107988. doi: 10.1016/j.cct.2025.107988. Epub 2025 Jun 15.
Other Identifiers
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1916994-3
Identifier Type: -
Identifier Source: org_study_id
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