In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
2 other identifiers
interventional
900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 17, 2023
May 1, 2023
4.2 years
March 1, 2023
May 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
Symptom Checklist 20 (SCL 20)
Self reported depression scores
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.
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.
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.
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.
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.
12 months after birth
Study Arms (2)
In-Person Delivery of Group Preventative Intervention (ROSE)
ACTIVE COMPARATORThe 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.
Virtual Delivery of Group Preventative Intervention (ROSE)
EXPERIMENTALIn parallel to ROSE delivered in person, virtual ROSE consists of four 90-minute, weekly group sessions conducted via Zoom and one individual booster session.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- English or Spanish speaking
- Less than 30 gestational weeks
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Denverlead
- National Institute of Mental Health (NIMH)collaborator
- Denver Health Medical Centercollaborator
Study Sites (1)
Denver Health Medical Center
Denver, Colorado, 80204, United States
Related Publications (1)
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.
PMID: 40527396DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Galena Rhoades, PhD
University of Denver
- PRINCIPAL INVESTIGATOR
Elysia P Davis, PhD
University of Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
March 13, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
May 17, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
All data will be shared in accordance with NIMH Data Archive requirements.