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NCT05663151
Mechanisms Underlying the Efficacy of Prolonged Exposure
Conditions: Posttraumatic Stress Disorder
Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 50
Sponsor: VA Boston Healthcare System
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 Criteria
Inclusion Criteria:a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5)interest in starting PE (as indicated during the informed consent process)VeteranExclusion Criteria: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,Active risk to self or others,Current participation in cognitive-behavioral therapy,Previously received > 2 sessions of Prolonged Exposure, andHaving 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
Source: ClinicalTrials.gov (NCT05663151). StuddyBuddy aggregates publicly available trial information.