Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT05663151

Mechanisms Underlying the Efficacy of Prolonged Exposure

Led by VA Boston Healthcare System · Updated on 2025-04-08

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

V

VA Boston Healthcare System

Lead Sponsor

N

National Center for PTSD

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims of the study are to: (1) examine theoretically informed mechanisms as pre-treatment predictors of PE treatment efficacy, (2) characterize how neural, psychophysiological, and subjective markers measured before, during, and after treatment change over the course of PE, and (3) examine proposed mechanisms of change as measures of PE treatment efficacy. This is a longitudinal study of predictors of exposure therapy efficacy that will be conducted within the context of a standard 10 session PE treatment trial, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment, post-treatment, and at 1-month follow-up. This data will be used to support a future NIMH and/or VA grant submission.

CONDITIONS

Official Title

Mechanisms Underlying the Efficacy of Prolonged Exposure

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of PTSD according to DSM-5 criteria confirmed by CAPS-5
  • Interest in starting Prolonged Exposure therapy
  • Veteran status
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of schizophrenia or other psychotic disorders
  • Untreated Bipolar Disorder or manic/mixed episode in last 6 months
  • Severe traumatic brain injury
  • Major neurological problems
  • Current substance use disorder
  • Active risk to self or others
  • Current participation in cognitive-behavioral therapy
  • Previous receipt of more than 2 Prolonged Exposure therapy sessions
  • No memory of traumatic event
  • Unstable psychotropic medication use within 2 months prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Boston Healthcare System

Boston, Massachusetts, United States, 02116

Actively Recruiting

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Research Team

S

Suzanne Pineles, PhD

CONTACT

V

Vladimir Ivkovic, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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