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RECRUITINGINTERVENTIONAL

Mechanisms Underlying the Efficacy of Prolonged Exposure

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5) 2. interest in starting PE (as indicated during the willing to sign a consent form process) 3. Veteran Who Should NOT Join This Trial: 1. Current or past history of schizophrenic or other psychotic disorders, 2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months, 3. Severe traumatic brain injury, 4. Major neurological problems, 5. Current substance use disorder, 6. Active risk to self or others, 7. Current participation in cognitive-behavioral therapy, 8. Previously received \> 2 sessions of Prolonged Exposure, and 9. Having no memory of their traumatic event. 10. 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5) 2. interest in starting PE (as indicated during the informed consent process) 3. Veteran Exclusion Criteria: 1. Current or past history of schizophrenic or other psychotic disorders, 2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months, 3. Severe traumatic brain injury, 4. Major neurological problems, 5. Current substance use disorder, 6. Active risk to self or others, 7. Current participation in cognitive-behavioral therapy, 8. Previously received \> 2 sessions of Prolonged Exposure, and 9. Having no memory of their traumatic event. 10. 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

Treatments Being Tested

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.

Locations (1)

VA Boston Healthcare System
Boston, Massachusetts, United States