Recruiting

Treatment for PTSD

Sponsor:

Boston University

Code:

NCT05486793

Conditions

PTSD

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Written Exposure Therapy (WET)

Emotion Focused Supportive Therapy (EFST)

Study Details

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

Study ID

NCT05486793

Start date

Mar 1, 2023

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Written Exposure Therapy (WET)

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

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

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

active comparator: Emotion Focused Supportive Therapy (EFST)

Participants randomized into this arm will receive the EFST intervention.

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.

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.

Primary outcome measure

  • Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline [ Time Frame: baseline ]
  • Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks [ Time Frame: 8 weeks ]
  • Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum [ Time Frame: 1 month postpartum ]
  • Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum [ Time Frame: 6 months postpartum ]
  • Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum [ Time Frame: 12 months postpartum ]

Central Contacts and Locations

Central contacts

Yael I Nillni, PhD

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

Hannah Brown, MS

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

Locations

Boston Medical Center and remote

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Hannah Brown, MS

617-358-3324Hannah.Brown3@bmc.org

More Information

Sponsor

Boston University

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-05-28.