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

Primary Purpose

Postpartum Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ROSE Program: In Person
ROSE Program: Virtual
Sponsored by
University of Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Prenatal depression, health disparities, preventative intervention, virtual therapy, interpersonal therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: English or Spanish speaking Less than 30 gestational weeks Exclusion Criteria: None

Sites / Locations

  • Denver Health Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-Person Delivery of Group Preventative Intervention (ROSE)

Virtual Delivery of Group Preventative Intervention (ROSE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Symptom Checklist 20 (SCL 20)
Self reported depression scores
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2023
Last Updated
May 15, 2023
Sponsor
University of Denver
Collaborators
National Institute of Mental Health (NIMH), Denver Health Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05766475
Brief Title
In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
Official Title
Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Denver
Collaborators
National Institute of Mental Health (NIMH), Denver Health Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Prenatal depression, health disparities, preventative intervention, virtual therapy, interpersonal therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Person Delivery of Group Preventative Intervention (ROSE)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Virtual Delivery of Group Preventative Intervention (ROSE)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ROSE Program: In Person
Other Intervention Name(s)
Rose, Group IPT, La Luz
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ROSE Program: Virtual
Intervention Description
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 Information:
Title
Symptom Checklist 20 (SCL 20)
Description
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
Title
Symptom Checklist 20 (SCL 20)
Description
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
Title
Symptom Checklist 20 (SCL 20)
Description
Self reported depression scores
Time Frame
6 months after birth
Title
Symptom Checklist 20 (SCL 20)
Description
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English or Spanish speaking Less than 30 gestational weeks Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galena Rhoades, PhD
Phone
303-871-4280
Email
Galena.Rhoades@du.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galena Rhoades, PhD
Organizational Affiliation
University of Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elysia P Davis, PhD
Organizational Affiliation
University of Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hyer, MD
Email
Jennifer.Hyer@dhha.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data will be shared in accordance with NIMH Data Archive requirements.

Learn more about this trial

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

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