Clinical Trial

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Study acronym: TAPS
Recruiting
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Summary
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-08-02; most recent amendment 2026-05-26.
Status change: Not Yet Recruiting → Recruiting 2023-03-03
Trial Details
NCT Number NCT05486793
Lead Sponsor Boston University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions PTSD
Enrollment 240 participants
Start Date 2023-03-01
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-28