Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study (TAPS)

May 26, 2026 updated by: Boston University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center and remote
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks
Time Frame: 8 weeks
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
8 weeks
Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum
Time Frame: 1 month postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
1 month postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum
Time Frame: 6 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
6 months postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum
Time Frame: 12 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
12 months postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline
Time Frame: baseline
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5 CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Self-reported PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). Scores range from 0-80, with higher scores indicating greater severity.
baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Patient Health Questionnaire (PHQ-9)
Time Frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Self-reported depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating greater depressive symptom severity.
baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
Time Frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Self-reported anxiety symptoms will be assessed using the anxiety scale of the Depression, Anxiety, and Stress scale (DASS-21). Items are summed and then multiplied by 2. Scores range from 0 - 42, with higher scores indicating greater severity.
baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Number of study sessions attended
Time Frame: 1 month postpartum
The number of sessions the participant attended will be documents from 0 to 5.
1 month postpartum
Number of participants that completed all 5 study visits
Time Frame: 1 month postpartum
The number of participants that completed all 5 visits will be documented (yes or no)
1 month postpartum
Inventory of Psychosocial Functioning (IPF)
Time Frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Self-reported PTSD-related functional impairment across seven domains (i.e., romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care) will be assessed via the Inventory of Psychosocial Functioning (IPF). Each domain scale is scored independently by summing all completed items and dividing the total by the maximum possible domain scale score for the items included, and then multiplying by 100. Each domain scale yield a score ranging from 0-100, with higher scores indicating greater impairment.
baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Postpartum Bonding Questionnaire (PBQ)
Time Frame: 1 month postpartum, 6 months postpartum, 12 months postpartum
Self-reported maternal-infant bonding will be assessed with the Postpartum Bonding Questionnaire (PBQ). Scores range from 0-125, with higher scores indicating more impaired bonding.
1 month postpartum, 6 months postpartum, 12 months postpartum
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 8 weeks
Treatment satisfaction will be assessed with the Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher score indicating greater satisfaction.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yael I Nillni, PhD, BUSM Department of Psychiatry and VA Boston Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-42619
  • 1R01HD107282-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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