Treatment for PTSD in pregnant women
Official title: A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy
Run by Boston University · NCT05486793 · Data updated 2026-11-12
This study is testing if a writing therapy for PTSD can help pregnant women feel better when it's given by community health workers compared to mental health professionals.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT05486793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women receiving prenatal care at the Boston Medical Center who meet diagnostic criteria for PTSD.
✕Probably not a fit
Patients who are currently receiving other forms of exposure-based PTSD treatment or those with severe mental health conditions requiring inpatient care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of Written Exposure Therapy (WET) for treating posttraumatic stress disorder (PTSD) in pregnant women, comparing its delivery by community health workers to mental health clinicians. The study addresses significant gaps in perinatal mental health care, particularly for low-income and minority women, by utilizing a brief, evidence-based treatment that can be administered in usual obstetric settings. Participants will be randomized to receive either WET or an active control, Emotion Focused Supportive Therapy (EFST), to assess the impact on PTSD symptoms and pregnancy outcomes.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mental health outcomes for pregnant women suffering from PTSD, leading to healthier pregnancies and better overall maternal and infant health.
How similar studies have gone: Previous studies have shown that Written Exposure Therapy is effective and has been successfully implemented in various settings, suggesting a promising approach for this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB/GYN) Department * Presenting for prenatal care prior to gestational age of 28 weeks * Meet diagnostic or subthreshold criteria (i.e., endorsement of 3 out of the 4 symptom clusters) for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Exclusion Criteria: * Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment) * Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview) * Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere * Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility
Where it's running
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Boston Medical Center and remote
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Yael I Nillni, PhD — BUSM Department of Psychiatry and VA Boston Healthcare System
- Study coordinator: Yael I Nillni, PhD
- Email: yael.nillni@bmc.org
- Phone: 781-413-6319
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.