Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

NCT ID: NCT05486793

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-07-31

Brief 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.

Detailed Description

Pregnant women with posttraumatic stress disorder (PTSD) are at increased risk for adverse pregnancy outcomes, yet the majority of pregnant women with mental health needs do not receive treatment, with disparities in treatment utilization among low-income and racial and ethnic minority women. Perinatal mental health treatment gaps are foremost a consequence of behavioral health workforce shortages and a lack of data on PTSD treatment during pregnancy. Mental health stigma and medical mistrust due to racism further impact engagement in care. Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., time burden of training and delivery). WET has demonstrated non-inferiority (and fewer dropouts) when compared to first-line PTSD treatments. As such, the empirical support and implementation advantages of WET suggest the promise of this intervention in addressing PTSD among pregnant women seen in usual care obstetrics settings. Training non-mental health specialists, such as community health workers (CHWs), to deliver WET may dually address workforce capacity challenges and patient engagement factors such as stigma. The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy against an active control condition [i.e., emotion focused supportive therapy (EFST)] and the non-inferiority of WET delivery with a community health worker (CHW-WET) vs. WET delivery with a mental health clinician. A total of 240 pregnant women with PTSD receiving obstetrical care at Boston Medical Center (BMC), a large safety net hospital that cares for a racially and ethnically diverse population, will be recruited. Following a baseline visit, women will be randomized to either CHW-WET (N=80), standard WET (N=80), or EFST (N=80). Participants in either WET condition will receive 5 individual sessions focused on the use of writing to activate the trauma memory, process emotions, and make meaning. EFST participants will receive 5 individual sessions of supportive therapy. Participants will complete well-established measures of PTSD and other psychological symptoms (e.g., depression) and proposed moderators of treatment engagement at baseline, post-treatment, and 1-, 6-, and 12-months postpartum. Patients and providers will also complete measures and interviews following treatment to assess feasibility, acceptability, and appropriateness of the WET delivery approaches in a usual care setting. Aim 1 is to determine if a) CHW-WET is non-inferior to standard WET and b) CHW-WET has better retention than standard WET. Aim 2 is to demonstrate the effectiveness of WET for treatment of PTSD (vs. EFST) in an obstetrics setting. Exploratory Aim 3 will examine moderators of treatment engagement such as mental health stigma to inform a personalized approach to WET treatment delivery. Aim 4 is to conduct a process evaluation of the WET delivery approaches. This study will inform future efforts to improve access to and quality of care for treatment of PTSD during pregnancy.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Written Exposure Therapy (WET)

Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.

Group Type: EXPERIMENTAL

Written Exposure Therapy (WET)

Intervention Type: BEHAVIORAL

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.

Community Health Workers- Written Exposure Therapy (CHW-WET)

Participants randomized into this arm will receive the WET intervention administered by community health workers.

Group Type: EXPERIMENTAL

Written Exposure Therapy (WET)

Intervention Type: BEHAVIORAL

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.

Emotion Focused Supportive Therapy (EFST)

Participants randomized into this arm will receive the EFST intervention.

Group Type: ACTIVE_COMPARATOR

Emotion Focused Supportive Therapy (EFST)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yael I Nillni, PhD

Role: PRINCIPAL_INVESTIGATOR

BUSM Department of Psychiatry and VA Boston Healthcare System

Locations

Boston Medical Center and remote

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yael I Nillni, PhD

Role: CONTACT

yael.nillni@bmc.org

781-413-6319

Hannah Brown, MS

Role: CONTACT

hannah.brown3@bmc.org

617-358-3324

Facility Contacts

Hannah Brown, MS

Role: primary

Hannah.Brown3@bmc.org

617-358-3324

Other Identifiers

1R01HD107282-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-42619

Identifier Type: -

Identifier Source: org_study_id