跳至主要内容
临床试验/NCT05766475
NCT05766475招募中不适用

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

University of Denver2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2023年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
2
主要终点
Center for Epidemiologic Studies Depression Scale (CES-D)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English or Spanish speaking
  • Less than 30 gestational weeks

排除标准

  • 未提供

结局指标

主要结局

Center for Epidemiologic Studies Depression Scale (CES-D)

时间窗: 12 months after birth

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

Symptom Checklist 20 (SCL 20)

时间窗: 12 months after birth

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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