PTSD Screening in Pregnant Black Women

NCT ID: NCT06522022

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2029-03-31

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.

Conditions

Pregnancy Early; PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Culturally 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

Group Type: EXPERIMENTAL

Culturally Responsive SBIRT for OB

Intervention Type: BEHAVIORAL

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

Brief 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 prenatal care visit and provide referral resources regardless of screen outcome. Positive PTSD screens (PC-PTSD-5 ≥ 3) will be referred to the hospital's integrated care team following the same model as positive EPDS screens.

Group Type: EXPERIMENTAL

Brief Screening for PTSD

Intervention Type: BEHAVIORAL

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.

Interventions

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 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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Screening Preventive Intervention Model; Standard Screening

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Abigail Lott

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abigail Lott, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Emory University

Briana Woods-Jaeger, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Site Status: RECRUITING

Truman Medical Center (TMC) system

Kansas City, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Abigail Powers Lott, PhD, ABPP

Role: CONTACT

abigail.lott@emoryhealthcare.org

404-712-0159

Other Identifiers

STUDY00007909

Identifier Type: -

Identifier Source: org_study_id