Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT05486793

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Led by Boston University · Updated on 2025-05-30

240

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

B

Boston University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology Department
  • Presenting for prenatal care prior to gestational age of 28 weeks
  • Meet diagnostic or subthreshold criteria for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Not Eligible

You will not qualify if you...

  • Clinician judgment that the patient is not appropriate for outpatient level care
  • Current psychosis or unstable bipolar disorder diagnosis
  • Currently receiving exposure-based PTSD treatment elsewhere
  • Current incarceration preventing mental health care outside correctional facility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Medical Center and remote

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

Y

Yael I Nillni, PhD

CONTACT

H

Hannah Brown, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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