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NCT Number: NCT05766475

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

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location status: Recruiting

Location contact

Jennifer Hyer, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English or Spanish speaking
  • Less than 30 gestational weeks

Exclusion criteria

  • None

Treatment and study plan

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.

Other names: Rose, Group IPT, La Luz

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.

Primary outcomes

  1. Symptom Checklist 20 (SCL 20)

    Time frame: 6 weeks after birth

    Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

  2. Symptom Checklist 20 (SCL 20)

    Time frame: 3 months after birth

    Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

  3. Symptom Checklist 20 (SCL 20)

    Time frame: 6 months after birth

    Self reported depression scores

  4. Symptom Checklist 20 (SCL 20)

    Time frame: 12 months after birth

    Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

  5. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 6 weeks after birth

    Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

  6. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 3 months after birth

    Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

  7. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 6 months after birth

    Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 12 months after birth

    Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Galena Rhoades, PhD

CONTACT

[email protected]

303-871-4280

Sponsors and collaborators

Lead sponsor

University of Denver

Other

Collaborators

  • Denver Health Medical Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2023
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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