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

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2024 · $487,559

## Abstract

Project Summary/Abstract
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 de...

## Key facts

- **NIH application ID:** 10885997
- **Project number:** 5R01HD107282-03
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Yael I Nillni
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $487,559
- **Award type:** 5
- **Project period:** 2022-08-17 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10885997

## Citation

> US National Institutes of Health, RePORTER application 10885997, A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers for Treatment of PTSD During Pregnancy (5R01HD107282-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10885997. Licensed CC0.

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