Recruiting

In-person vs. Virtual

Sponsor:

University of Denver

Code:

NCT05766475

Conditions

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ROSE Program: In Person

ROSE Program: Virtual

Study Details

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.

Conditions

Postpartum Depression

Study ID

NCT05766475

Start date

Mar 13, 2023

Status verified date

May, 2023

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English or Spanish speaking
  • Less than 30 gestational weeks

Exclusion Criteria:

  • None

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Symptom Checklist 20 (SCL 20) [ Time Frame: 6 weeks after birth ]
  • Symptom Checklist 20 (SCL 20) [ Time Frame: 3 months after birth ]
  • Symptom Checklist 20 (SCL 20) [ Time Frame: 6 months after birth ]
  • Symptom Checklist 20 (SCL 20) [ Time Frame: 12 months after birth ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 6 weeks after birth ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 3 months after birth ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 6 months after birth ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 12 months after birth ]

Central Contacts and Locations

Central contacts

Galena Rhoades, PhD

303-871-4280Galena.Rhoades@du.edu

Locations

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Contacts

Jennifer Hyer, MD

Jennifer.Hyer@dhha.org

More Information

Sponsor

University of Denver

Last update posted

May 17, 2023

Last verified

May, 2023

Keywords

  • Prenatal depression
  • health disparities
  • preventative intervention
  • virtual therapy
  • interpersonal therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Denver on 2023-05-17.