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Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy

Who can join

Ages 18 to 50 · Women

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

About the study

The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.

What is being tested

• Written Exposure Therapy (WET) (behavioral)
• Emotion Focused Supportive Therapy (EFST) (behavioral)

Sponsor: Boston University · Participants: 240 · Started: Mar 1, 2023

Contact the study team

• Yael I Nillni, PhD · Phone: 781-413-6319
• Hannah Brown, MS · Phone: 617-358-3324

Official record on ClinicalTrials.gov — NCT05486793

Locations in the U.S.

Conditions

• Post-Traumatic Stress Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.