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Clinical Trial NCT06522022 for Pregnancy Early, PTSD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PTSD Screening in Pregnant Black Women 804 Pregnancy

Recruiting
Clinical Trial NCT06522022 is an interventional study for Pregnancy Early, PTSD that is recruiting. It started on February 20, 2025 with plans to enroll 804 participants. Led by Emory University, it is expected to complete by March 1, 2029. The latest data from ClinicalTrials.gov was last updated on October 27, 2025.
Brief Summary
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.
Detailed Description
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 populat...

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Official Title

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

Conditions
Pregnancy EarlyPTSD
Other Study IDs
  • STUDY00007909
NCT ID Number
NCT06522022
Start Date (Actual)
2025-02-20
Last Update Posted
2025-10-27
Completion Date (Estimated)
2029-03
Enrollment (Estimated)
804
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pregnancy
Black Women
Screening for Maternal PTSD
Obstetric Care
African-American Women
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCulturally Responsive SBIRT for OB
Participants randomized to Culturally Responsive SBIRT for OB will participate in the intervention visit (20-30 minutes) while waiting for their OB visit (or after the visit if time does not allow) and then engage in their prenatal care visit as usual. If any safety concerns emerge during the visit, the lay provider will contact the clinical staff on the study
Culturally Responsive SBIRT for OB
SBIRT is a well-established enhanced screening preventive intervention model that is feasible and acceptable for use with trauma-exposed patients and in minoritized communities and can be delivered in the OB clinic during a prenatal care visit. The elements include: 1. standardized screening for PTSD and depression using the Primary Care Post Traumatic Stress Disorder Screen (PC-PTSD-5) and the Edinburgh Postnatal D...Show More
ExperimentalBrief Screening for PTSD
Participants randomized to Brief Screening For PTSD, screening will be conducted as part of regular clinic activities during the initial prenatal care visit. Specifically, clinic staff (nurse, PA) or study staff will ask the questions in the PC-PTSD-5 along with the standard procedure to administer the Edinburgh Postnatal Depression Scale (EPDS), and the provider will review the results with the patient during the pr...Show More
Brief Screening for PTSD
This well-established 5-minute in-clinic interview includes administration of the PC-PTSD-5, a 5-item PTSD screening tool by trained medical staff (nurse, physician's assistant). Providers receive approximately one hour of training in trauma-informed care and how to administer the screening protocol. This method is regularly used in primary care clinic settings with trauma-exposed veterans and is validated for use in...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
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.
Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adequacy of prenatal care utilization (APNCU)
OB physicians widely use this measure. The APNCU includes what trimester prenatal care began within the index. APNCU is a standard metric, defined as attending at least 80% of prenatal care visits, adjusting for gestational age. Researchers will use chart abstraction to determine the percent attendance of prenatal care adjusting for gestational age at birth.
6 weeks postpartum
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

  • Active suicidality
Emory University logoEmory University398 active studies to explore
  • Patient-Centered Outcomes Research Institute logoPatient-Centered Outcomes Research Institute
  • University of Missouri, Kansas City logoUniversity of Missouri, Kansas City
Study Responsible Party
Abigail Lott, Principal Investigator, Associate Professor, Emory University
Study Central Contact
Contact: Abigail Powers Lott, PhD, ABPP, 404-712-0159, [email protected]
2 Study Locations in 1 Countries

Georgia

Grady Health System, Atlanta, Georgia, 30303, United States
Recruiting

Missouri

Truman Medical Center (TMC) system, Kansas City, Missouri, 64108, United States
Traci Johnson, MD, Principal Investigator
Recruiting