Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Purpose

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.

Condition

  • PTSD

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized in a 1:1:1 ratio using a permuted block strategy (random block sizes of 2 and 4) and stratified by PTSD severity (met full PTSD criteria/not) and major depressive diagnosis (MDD).
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
All follow-up clinician-administered interviews will be completed by independent evaluators blinded to randomized condition.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Written Exposure Therapy (WET) 		Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.
  • 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.
Experimental
Community Health Workers- Written Exposure Therapy (CHW-WET) 		Participants randomized into this arm will receive the WET intervention administered by community health workers.
  • 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.
Active Comparator
Emotion Focused Supportive Therapy (EFST) 		Participants randomized into this arm will receive the EFST intervention.
  • 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.

Recruiting Locations

Boston Medical Center and remote
Boston, Massachusetts 02118
Contact:
Hannah Brown, MS
617-358-3324
Hannah.Brown3@bmc.org

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Yael I Nillni, PhD
781-413-6319
yael.nillni@bmc.org

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.