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

Inclusion Criteria3

Age 18 or older
Meeting diagnostic criteria for PTSD as defined by DSM-5 assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Psychiatric Disorders (DIAMOND), and
Interest in starting PE

Exclusion Criteria10

Current or past history of schizophrenic or other psychotic disorders,
Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months,
Severe traumatic brain injury,
Major neurological problems,
Current substance use disorder of moderate or greater severity assessed by the DIAMOND,
Active risk to self or others,
Current participation in therapy other than present-centered supportive therapy,
Previously received > 2 sessions of Prolonged Exposure, and
Having no memory of their traumatic event.
For participants who are currently prescribed psychotropic medication, they will be eligible for the study provided medication use has been stable for 2 months prior to enrollment and remains stable throughout participation

Interested in this trial?

Get notified about updates and connect with the research team.

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.