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Mechanisms Underlying the Efficacy of Prolonged Exposure

NCT05663151 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-08

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Prolonged Exposure Therapy for Posttraumatic Stress Disorder

Participation will occur throughout 17 weeks over 15 separate visits during which 10, 60-minute sessions of PE will take place. Session 1 of PE will focus on psychoeducation. Session 2 of PE will involve a continuation of psychoeducation and rationale for exposure as well as the collaborative construction of the in vivo exposure hierarchy. After session 2, participants will begin homework where they are instructed to confront situations on their hierarchy. Starting in session 3 of PE, participants will begin imaginal exposures to their worst trauma memory. This involves the participant recounting and visualizing the trauma memory aloud with the clinician in the room for 30-40 minutes. The session will end with 15-20 minutes of processing the imaginal exposure. Participants will continue in-session imaginal exposures until the end of treatment. Throughout the treatment, participants will listen to a recording of their imaginal exposure and engage in in vivo exposures daily.

Sponsors & Collaborators

  • National Center for PTSD

    collaborator FED

  • VA Boston Healthcare System

    lead FED

Principal Investigators

  • Suzanne Pineles · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663151 on ClinicalTrials.gov