Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
Recruiting now · Not applicable
Conditions studied: PTSD
In brief
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.
Key facts
- Study ID
- NCT05486793
- Run by
- Boston University
- People needed
- 240
- Starts
- 2023-03-01
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Boston Medical Center and remote — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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