RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Written 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.

BEHAVIORAL

Emotion 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