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PTSD Screening in Pregnant Black Women

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522022
Enrollment
804
Registered
2024-07-26
Start date
2025-02-20
Completion date
2029-03-31
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Early, PTSD

Keywords

Pregnancy, Black Women, Screening for Maternal PTSD, Obstetric Care, African-American Women

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 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.

Interventions

BEHAVIORALCulturally 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 Depression Screening (EPDS) that will mirror brief screening practice; 2. explicit focus on concerns regarding mistrust, 3. psychoeducation on PTSD, depression, and the effects of trauma including medical trauma and traumatic loss on health/functioning, 4. motivational interviewing strategy components to promote awareness of psychological symptoms and engagement in culturally relevant resources including support/resources related to relevant social determinants of health, 5. teaching coping skills with culturally responsive technology tools

BEHAVIORALBrief 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 civilian samples, including low-income Black adults utilizing urban safety net hospital medical clinics.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Missouri, Kansas City
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Active suicidality

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) ScoreInitial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartumResearchers 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.

Secondary

MeasureTime frameDescription
Adequacy of prenatal care utilization (APNCU)6 weeks postpartumOB 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.

Countries

United States

Contacts

Primary ContactAbigail Powers Lott, PhD, ABPP
abigail.lott@emoryhealthcare.org404-712-0159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026