RecruitingNot ApplicableNCT05788302

Mechanisms Underlying Efficacy of Prolonged Exposure

Sponsor

Massachusetts General Hospital

Enrollment

50 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Post Traumatic 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 pretreatment 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 Years

Plain Language Summary

Simplified for easier understanding

This study is researching how a trauma therapy called Prolonged Exposure (PE) works to reduce PTSD symptoms. Prolonged Exposure involves carefully revisiting traumatic memories in a safe, guided way to reduce their emotional hold. Researchers want to understand the brain and psychological processes behind why this therapy helps. **You may be eligible if...** - You are 18 or older and meet the diagnostic criteria for PTSD - You are interested in starting Prolonged Exposure therapy - If you take psychiatric medications, your dose has been stable for at least 2 months **You may NOT be eligible if...** - You have a history of schizophrenia or psychotic disorders - You have untreated bipolar disorder or a manic episode in the last 6 months - You have a severe traumatic brain injury or major neurological problems - You have a moderate-to-severe substance use disorder - You are at active risk of harming yourself or others - You are currently in another type of therapy (except present-centered supportive therapy) - You have already completed more than 2 sessions of Prolonged Exposure therapy - 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

\- 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.