Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

NCT05486793 | Recruiting

• 2 other identifiers: H-426191R01HD107282-01A1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Written Exposure Therapy (WET); Emotion Focused Supportive Therapy (EFST); Community Health Worker (CHW); Antepartum care; perinatal mental health

Outcome Measures

Primary Outcomes (5)

• Clinician Administered Scale for PTSD-5 (CAPS-5) at 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

• Clinician Administered Scale for PTSD-5 (CAPS-5) at 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

  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

  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

  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

Secondary Outcomes (8)

• PTSD Checklist for DSM-5 (PCL-5)

  baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

• Patient Health Questionnaire (PHQ-9)

  baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

• Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only

  baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

• Number of study sessions attended

  1 month postpartum

• Number of participants that completed all 5 study visits

  1 month postpartum

Study Arms (3)

Written Exposure Therapy (WET)

EXPERIMENTAL

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

Behavioral: Written Exposure Therapy (WET)

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

EXPERIMENTAL

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

Behavioral: Written Exposure Therapy (WET)

Emotion Focused Supportive Therapy (EFST)

ACTIVE COMPARATOR

Participants randomized into this arm will receive the EFST intervention.

Behavioral: Emotion Focused Supportive Therapy (EFST)

Interventions

Written Exposure Therapy (WET) 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); Written Exposure Therapy (WET)

Emotion Focused Supportive Therapy (EFST) 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.

Emotion Focused Supportive Therapy (EFST)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Boston Medical Center and remote

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yael I Nillni, PhD

  BUSM Department of Psychiatry and VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael I Nillni, PhD

CONTACT

781-413-6319; yael.nillni@bmc.org

Hannah Brown, MS

CONTACT

617-358-3324; hannah.brown3@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All follow-up clinician-administered interviews will be completed by independent evaluators blinded to randomized condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)