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临床试验/NCT06522022
NCT06522022招募中不适用

Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women

Emory University4 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2025年2月20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
804
试验地点
4
主要终点
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score

研究概览

简要总结

This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

详细描述

Researchers will examine whether Culturally Responsive Screening, Brief Intervention, and Referral to Treatment (SBIRT) for obstetrics (OB) is more effective in reducing PTSD symptoms compared to brief screening for PTSD. This study will help participating OB clinics to determine the best option for screening for PTSD in Black pregnant persons in their clinic during first-trimester prenatal visits.

The study population will include Black pregnant women receiving medical care in their first trimester of pregnancy. Surveys and chart abstraction will be used in this study to collect data. The approximate study duration for individuals is 4 visits over 12 months.

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
None

入排标准

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

入选标准

  • 18+ years old,
  • Ability to provide informed consent,
  • English-speaking,
  • Willingness to participate in the study,
  • Self-identification as Black or African American,
  • Pregnant and in the first trimester attending initial prenatal care visit,
  • Endorsement of at least one traumatic event in their lifetime.

排除标准

  • Active suicidality

结局指标

主要结局

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score

时间窗: Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum

Researchers will use the PTSD Checklist for DSM-5 (PCL-5) to measure PTSD symptoms, a well-validated and widely used 21-item measure that assesses the frequency of current PTSD symptoms. Participants report how often they have been bothered by specific symptoms of PTSD on a scale of 0 (not at all) to 4 (extremely). The total symptom severity score ranges from 0 to 80. A provisional PTSD diagnosis can be made and a PCL-5 cut-point score of 33 is recommended.

次要结局

  • Adequacy of prenatal care utilization (APNCU)(6 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abigail Lott

Associate Professor

Emory University

研究点 (4)

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