PTSD Screening for Pregnant Women

Recruiting at 1 trial location

Overseen By Abigail Powers Lott, PhD, ABPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Active suicidality

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

804 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to assist Black pregnant women with PTSD symptoms. One method involves a culturally tailored session during or after an OB visit, known as Culturally Responsive SBIRT for OB. The other method involves simple PTSD screening during the first prenatal visit, referred to as Brief Screening for PTSD. The researchers aim to determine which approach better supports mental health and improves pregnancy-related outcomes. Women who are Black or African American, pregnant in their first trimester, and have experienced at least one traumatic event might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance mental health support for Black pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these screening interventions are safe for pregnant women?

Research has shown that the treatments in this trial are generally safe. The "Brief Screening for PTSD" involves routine questions during prenatal visits to identify PTSD, posing low risk and integrating into normal care to enhance mental health support for pregnant women.

Studies have found that "Culturally Responsive SBIRT for OB" reduces stigma and racial bias in healthcare. This approach connects individuals with necessary care without significant risks. It respects cultural differences, making it a thoughtful choice for diverse groups.

Both treatments emphasize screening and support over medications or invasive procedures, minimizing the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for PTSD screening among pregnant women because it aims to enhance mental health care by exploring two innovative approaches. The "Culturally Responsive SBIRT for OB" intervention is distinctive because it integrates a culturally sensitive method into routine OB visits, potentially improving engagement and effectiveness for diverse populations. Meanwhile, the "Brief Screening for PTSD" streamlines PTSD assessment using the PC-PTSD-5 tool alongside standard prenatal screenings, allowing for early detection and referral to integrated care teams. These approaches could lead to more timely and personalized mental health support during pregnancy, addressing gaps in current care models.

What evidence suggests that this trial's treatments could be effective for PTSD in pregnant women?

This trial will compare two methods for addressing PTSD in pregnant women: the Culturally Responsive SBIRT for OB and the Brief Screening for PTSD. Research has shown that the Culturally Responsive SBIRT for OB method effectively connects patients with appropriate mental health resources, leading to improved mental health outcomes. Studies have demonstrated that screening and timely intervention can significantly enhance PTSD symptoms and overall mental health during pregnancy. For the Brief Screening for PTSD, research highlights that early detection of PTSD can help pregnant women receive necessary care, potentially improving their mental health and pregnancy outcomes. Screening can identify PTSD in women who might not exhibit signs of depression, ensuring they receive help. Overall, both methods in this trial aim to enhance mental health care during pregnancy, offering hope for better health outcomes. ^{1 2 5 6 7}

Who Is on the Research Team?

Abigail Lott, PhD, ABPP

Principal Investigator

Emory University

Briana Woods-Jaeger, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for Black pregnant women who may have PTSD. It's designed to see if certain screening methods can help improve their mental health, satisfaction with care, and birth outcomes.

Inclusion Criteria

Ability to provide informed consent

Self-identification as Black or African American

I am willing to participate in the study.

Exclusion Criteria

Active suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants receive either Culturally Responsive SBIRT for OB or Brief Screening for PTSD during their prenatal care visit

Initial OB visit (weeks 1-13)

1 visit (in-person)

Follow-up

Participants are monitored for PTSD symptoms and prenatal care utilization

12 months

4 visits (in-person)

Postpartum Follow-up

Participants are assessed for PTSD symptoms and adequacy of prenatal care utilization 6 weeks postpartum

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Brief Screening for PTSD
• Culturally Responsive SBIRT for OB

Trial Overview The study compares two approaches: a brief screening for PTSD and a culturally responsive SBIRT (Screening, Brief Intervention, and Referral to Treatment) specifically tailored for obstetrics.

How Is the Trial Designed?

Group I: Culturally Responsive SBIRT for OB Experimental Treatment 1 Intervention

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 II: Brief Screening for PTSD Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

University of Missouri, Kansas City

Collaborator

Trials

73

Recruited

34,600+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The PTSD-PC screening tool was successfully implemented in prenatal care for 1259 women, revealing that 17% screened positive for PTSD, indicating a significant prevalence of PTSD symptoms in this population.

Women with clinical-level PTSD symptoms exhibited more severe trauma histories and mental health issues compared to those with sub-threshold symptoms, highlighting the need for mental health support, as only 25% had previously received treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Post-traumatic Stress Disorder in Prenatal Care: Prevalence and Characteristics in a Low-Income Population. Wenz-Gross, M., Weinreb, L., Upshur, C.[2021]

In a study of 1,402 pregnant patients, 11.1% screened positive for PTSD without depression, indicating a significant gap in mental health care during prenatal visits, as PTSD screening is rarely conducted.

Demographic factors showed that Black and Latinx patients were more likely to screen positive for PTSD, suggesting the need for targeted mental health interventions and routine PTSD screenings in obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for PTSD during pregnancy: a missed opportunity. Padin, AC., Stevens, NR., Che, ML., et al.[2022]

In a study of 104 African American women in residential treatment for substance use disorders, 94.2% reported experiencing at least one trauma, and over half (51.0%) met the criteria for PTSD, indicating a high prevalence of trauma-related issues in this population.

A subset of screening items was identified that could effectively indicate probable PTSD, achieving a sensitivity of 88.7% and an accuracy of 77.9%, suggesting that brief screenings could help in the timely identification and treatment of PTSD alongside substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress Disorder, Health Problems, and Depression Among African American Women in Residential Substance Use Treatment. Meshberg-Cohen, S., Presseau, C., Thacker, LR., et al.[2022]

The TO-CARE intervention, which combines cognitive-behavioral therapy (CBT) and trauma-sensitive obstetric care, was found to be acceptable to pregnant abuse survivors, with 95% of participants reporting benefits from the program.

While most participants showed some improvement in posttraumatic stress symptoms (PTS), only a small number achieved reliable improvement, highlighting challenges in retention and effectiveness for low-income, ethno-racial minority pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of trauma-sensitive obstetric care for low-income, ethno-racial minority pregnant abuse survivors. Stevens, NR., Lillis, TA., Wagner, L., et al.[2022]

In a study of 745 pregnant women at urban health centers, 6.6% were diagnosed with current PTSD, and over half reported experiencing trauma that met PTSD criteria, highlighting the prevalence of trauma in this population.

Women with PTSD were significantly more likely to face additional psychosocial risks, such as housing instability and depression, indicating that PTSD is associated with broader social challenges during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder among women receiving prenatal care at three federally qualified health care centers. Kim, HG., Harrison, PA., Godecker, AL., et al.[2021]

A brief psychotherapeutic intervention consisting of four sessions significantly reduced PTSD symptoms and depression in 32 pregnant women, with improvements sustained at post-treatment and postpartum follow-ups.

The study highlights the need for targeted mental health interventions for low-income, minoritized pregnant women, who are at higher risk for trauma-related symptoms and may lack access to traditional mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in and Benefits of a Short-Term, Brief Psychotherapy Intervention for PTSD During Pregnancy. Kornfield, SL., Johnson, RL., Hantsoo, LV., et al.[2022]

In a study of 3,372 pregnant Peruvian women, 41.8% reported symptoms consistent with post-traumatic stress disorder (PTSD), highlighting a significant prevalence of PTSD during pregnancy.

The study found that experiencing interpersonal trauma was the strongest predictor of PTSD, with women who had four or more traumatic events having a 60.5% rate of PTSD, emphasizing the need for effective screening and support for pregnant women facing trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma exposure and post-traumatic stress disorder in a cohort of pregnant Peruvian women. Levey, EJ., Gelaye, B., Koenen, K., et al.[2018]

Perinatal PTSD is a significant issue among pregnant women, particularly those with a history of adult abuse, multiple traumas, severe trauma experiences, insomnia, and low social support, highlighting the need for targeted interventions.

Healthcare providers must implement culturally sensitive screening and treatment strategies for perinatal PTSD to prevent serious health complications for both mothers and their developing fetuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of Perinatal Post-Traumatic Stress among Culturally Diverse Women with Depressive Symptomatology. Vignato, J., Connelly, CD., Bush, RA., et al.[2023]

In a study involving 376 postpartum patients, 8.4% screened positive for PTSD, highlighting the importance of routine screening in identifying this underdiagnosed condition during the peripartum period.

The majority of those who screened positive for PTSD (66.7%) received follow-up care, suggesting that integrating PTSD screening into routine obstetric care can effectively connect at-risk patients with necessary behavioral health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Utility of Posttraumatic Stress Disorder Screening Among Postpartum Patients at an Urban Safety-Net Institution. Drake, E., Larrea, N., Wolverton, E., et al.[2023]

In a study of 46 adult patients with gunshot wounds, the SBIRT Intervention for Trauma Patients (SITP) significantly reduced PTSD symptoms compared to treatment as usual after three months, highlighting its efficacy in trauma care.

Both groups showed similar physical healing, indicating that the SITP intervention effectively addresses psychological outcomes without negatively impacting physical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, Brief Intervention, and Referral to Treatment to Prevent Post-Traumatic Stress Disorder After Gunshot Wounds. Castater, C., Raney, E., Nguyen, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9195376/

Screening for PTSD during pregnancy: a missed opportunity Over ten percent of pregnant patients in the current study screened positive for PTSD without depression, highlighting a critical mental health ...

2. pcori.org pcori.org/research-results/2024/comparing-two-post-traumatic-stress-disorder-screening-approaches-improve-health-outcomes-pregnancy

Comparing Two Post-Traumatic Stress Disorder Screening ... This study compares the clinical effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) versus brief screening for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723014787

Screening for post-traumatic stress disorder following ... Our results reveal that the PDI, originally designed to assess emotional and physiological responses experienced during and after a traumatic ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jmwh.13512

Trauma‐Informed Psychosocial Screening and Care ... Thirty percent (29 of 98) of patients disclosed trauma during the project, and 7% (7 of 98) were screened as positive for PTSD. In cycle 1, the ...

5. withpower.com withpower.com/trial/phase-post-traumatic-stress-disorder-ptsd-2-2025-95669

PTSD Screening for Pregnant Women In a study of 745 pregnant women at urban health centers, 6.6% were diagnosed with current PTSD, and over half reported experiencing trauma that met PTSD ...

6. gh.bmj.com gh.bmj.com/content/10/8/e019216

A brief international screening tool for traumatic birth and ... Our findings suggest the highest scores on the City BiTS-Short identify 90% of women with a CB-PTSD diagnosis. However, given the evidence that ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.882429/full

Engagement in and Benefits of a Short-Term, Brief ... Trauma-related symptoms and post-traumatic stress disorder (PTSD) are common during pregnancy and have adverse effects on pregnancy and birth ...