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Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

RecruitingNAAges 18 Years - 50 YearsFemaleBoston University
NCT05486793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Boston Medical Center and remote
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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