RecruitingNot ApplicableNCT05663151

Mechanisms Underlying the Efficacy of Prolonged Exposure

Sponsor

VA Boston Healthcare System

Enrollment

50 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Posttraumatic Stress Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the brain and biological changes that happen during Prolonged Exposure (PE) therapy — a structured treatment for PTSD — in military veterans. Researchers want to understand why PE works and which biological markers predict the best treatment response. **You may be eligible if...** - You are a military veteran - You have been diagnosed with PTSD (based on standard diagnostic criteria) - You are interested in starting Prolonged Exposure therapy - Your psychiatric medications (if any) have been stable for at least 2 months **You may NOT be eligible if...** - You have a history of schizophrenia or other psychotic disorders - You have untreated bipolar disorder or had a manic episode in the past 6 months - You have severe traumatic brain injury - You have a current substance use disorder - You are at active risk of harm to yourself or others - You are currently receiving cognitive-behavioral therapy for another condition - You have already received more than 2 sessions of Prolonged Exposure therapy before - You have no memory of your traumatic event Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProlonged 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.