Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBoston University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Written Exposure Therapy (WET)
- Emotion Focused Supportive Therapy (EFST)
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Boston University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov