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Behavioral Intervention

WET + EFST for PTSD During Pregnancy (TAPS Trial)

N/A
Recruiting
Led By Yael I Nillni, PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine the effectiveness of a PTSD treatment during pregnancy, comparing delivery by mental health clinicians and community health workers.

Who is the study for?
This trial is for pregnant women under 28 weeks gestation, receiving prenatal care at BMC OB/GYN Department, who meet criteria for PTSD or have significant symptoms. It's not suitable for those needing inpatient care, with current psychosis or unstable bipolar disorder, already undergoing specific PTSD treatments elsewhere, or incarcerated individuals.
What is being tested?
The study tests the effectiveness of Written Exposure Therapy (WET) for perinatal PTSD and compares its delivery by community health workers versus mental health clinicians. This randomized controlled trial aims to address treatment accessibility and evaluate a brief evidence-based intervention within usual obstetrics settings.
What are the potential side effects?
While the trial interventions focus on psychological therapies rather than medications, potential side effects may include emotional discomfort due to revisiting traumatic events during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD or show significant symptoms of it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum
+2 more
Secondary study objectives
Client Satisfaction Questionnaire (CSQ-8)
Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
Inventory of Psychosocial Functioning (IPF)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Written Exposure Therapy (WET)Experimental Treatment1 Intervention
Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.
Group II: Community Health Workers- Written Exposure Therapy (CHW-WET)Experimental Treatment1 Intervention
Participants randomized into this arm will receive the WET intervention administered by community health workers.
Group III: Emotion Focused Supportive Therapy (EFST)Active Control1 Intervention
Participants randomized into this arm will receive the EFST intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy (WET)
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
472 Previous Clinical Trials
9,987,593 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,646 Total Patients Enrolled
Yael I Nillni, PhDPrincipal InvestigatorBUSM Department of Psychiatry and VA Boston Healthcare System

Media Library

Written Exposure Therapy (WET) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05486793 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Written Exposure Therapy (WET), Community Health Workers- Written Exposure Therapy (CHW-WET), Emotion Focused Supportive Therapy (EFST)
Post-Traumatic Stress Disorder Clinical Trial 2023: Written Exposure Therapy (WET) Highlights & Side Effects. Trial Name: NCT05486793 — N/A
Written Exposure Therapy (WET) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05486793 — N/A
~148 spots leftby Jul 2027
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