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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Denver
Study ID
NCT05766475
Status
Recruiting
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Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ROSE Program: In Person — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 13, 2023
Status verified
May 2023
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Symptom Checklist 20 (SCL 20) [ Time Frame: 6 weeks after birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Denver Health Medical CenterDenverColorado80204
Jennifer Hyer, MD
[email protected]

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By research site
Denver Health Medical Center· Denver, CO

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