RecruitingNot ApplicableNCT05486793

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

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

Sponsor

Boston University

Enrollment

240 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

PTSD

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized treatment for PTSD (post-traumatic stress disorder) specifically designed for pregnant women. The treatment is delivered in an outpatient setting to pregnant patients who are experiencing PTSD symptoms that may affect their mental health and pregnancy. **You may be eligible if...** - You are pregnant and receiving prenatal care at Boston Medical Center (BMC) OB/GYN - You are earlier than 28 weeks into your pregnancy - You meet the criteria for PTSD or significant PTSD symptoms (based on a clinical interview) **You may NOT be eligible if...** - Your clinician determines you need a higher level of care (such as inpatient treatment or detox) - You have active psychosis or unstable bipolar disorder - You are already receiving an exposure-based PTSD treatment elsewhere (such as prolonged exposure or cognitive processing therapy) - You are currently incarcerated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALWritten Exposure Therapy (WET)

5 individual sessions that cover psychoeducation about PTSD, the rationale for exposure treatment, and directing patients to write in session for 30 minutes about their traumatic experience using scripted instructions. Each session includes unique writing instructions. Earlier sessions focus on describing the details of a traumatic stressor linked to their symptoms, with particular attention to felt emotions and thoughts. Later writing sessions focus on writing about the meaning of the traumatic event and how the event has changed their life and how they relate to other people. After writing, therapists spend \~10 minutes processing the patient's experience with the writing. WET does not include between session assignments.

BEHAVIORALEmotion Focused Supportive Therapy (EFST)

5 individual sessions where patients choose what problems to discuss in each session. Therapists validate and clarify patients' emotions and engage in problem solving during sessions.

Locations(1)

Boston Medical Center and remote

Boston, Massachusetts, United States

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NCT05486793

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