RecruitingNot Applicable

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

United States240 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline

Timeframe: baseline

Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks

Timeframe: 8 weeks

Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum

Timeframe: 1 month postpartum

Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum

Timeframe: 6 months postpartum

Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum

Timeframe: 12 months postpartum

Trial details

NCT IDNCT05486793

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Yael I Nillni, PhD

781-413-6319 yael.nillni@bmc.org

View on ClinicalTrials.gov More PTSD trials