Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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)

Locations
United States
Massachusetts
Boston Medical Center and remote
RECRUITING
Boston
Contact Information
Primary
Yael I Nillni, PhD
yael.nillni@bmc.org
781-413-6319
Backup
Hannah Brown, MS
hannah.brown3@bmc.org
617-358-3324
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 240
Treatments
Experimental: Written Exposure Therapy (WET)
Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.
Experimental: Community Health Workers- Written Exposure Therapy (CHW-WET)
Participants randomized into this arm will receive the WET intervention administered by community health workers.
Active_comparator: Emotion Focused Supportive Therapy (EFST)
Participants randomized into this arm will receive the EFST intervention.
Related Therapeutic Areas
Sponsors
Leads: Boston University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov