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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

TAPS Trial 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.Check my eligibility
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.See study design
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.

TAPS Trial 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.

TAPS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Client Satisfaction Questionnaire (CSQ-8)
Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
Inventory of Psychosocial Functioning (IPF)
+5 more

TAPS 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.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,941,330 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,557 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cut-off age for eligibility in this research endeavor thirty years or above?

"The lower bound of the age range for inclusion in this clinical trial is 18 years old, while the upper limit has been set to 50."

Answered by AI

What type of individual is most ideal for involvement in this experiment?

"This medical trial requires the enrolment of 240 subjects between 18 and 50 years old with post traumatic stress disorder. Applicants must be pregnant women visiting BMC OB/GYN Department, who had their prenatal care started prior to 28 weeks gestation, and meet three or more symptom clusters as diagnosed on CAPS-5 (Clinician Administered PTSD Scale for DSM-5)."

Answered by AI

How many individuals are being monitored for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical study is actively seeking participants and first appeared on March 1st 2023 with its most recent update taking place on March 6th 2023. The trial requires the recruitment of roughly 240 patients from a single site."

Answered by AI

Is recruitment currently open for this research project?

"As per the information on clinicaltrials.gov, enrollment for this trial is taking place now and has been since March 1st of 2023. The most recent edit was made to the study page on 3rd June 2023."

Answered by AI

What major aims has this investigation established?

"The primary outcome of this trial, evaluated over a baseline time frame, is the Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum. Secondary evaluations include collecting data on the Depression, Anxiety and Stress Scale - Anxiety scale only; recording the total number of study sessions attended; and utilizing an Inventory of Psychosocial Functioning to gauge any PTSD related functional impairments across seven different domains."

Answered by AI

Who else is applying?

What site did they apply to?
Boston Medical Center and remote
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What is it it’s entirely from your end to mine?
PatientReceived no prior treatments

Why did patients apply to this trial?

Very interested in learning if this will help the future of PTSD.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
2023. "Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05486793.
All > Ptsd Boston
~160 spots leftby Jul 2027
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