RECRUITING

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy

Quick Facts

Study Start:2023-03-01
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05486793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB/GYN) Department
  2. * Presenting for prenatal care prior to gestational age of 28 weeks
  3. * 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)
  1. * Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)
  2. * Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)
  3. * Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere
  4. * 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

Contacts and Locations

Study Contact

Yael I Nillni, PhD
CONTACT
781-413-6319
yael.nillni@bmc.org
Hannah Brown, MS
CONTACT
617-358-3324
hannah.brown3@bmc.org

Principal Investigator

Yael I Nillni, PhD
PRINCIPAL_INVESTIGATOR
BUSM Department of Psychiatry and VA Boston Healthcare System

Study Locations (Sites)

Boston Medical Center and remote
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Yael I Nillni, PhD, PRINCIPAL_INVESTIGATOR, BUSM Department of Psychiatry and VA Boston Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Written Exposure Therapy (WET)
  • Emotion Focused Supportive Therapy (EFST)
  • Community Health Worker (CHW)
  • Antepartum care
  • perinatal mental health

Additional Relevant MeSH Terms

  • PTSD