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Mechanisms Underlying the Efficacy of Prolonged Exposure

NCT05663151 · VA Boston Healthcare System
In plain English

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About this study
Proposed research sets to collect pilot data to examine how the proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD). Fifty participants will be screened with the goal of obtaining 15 participants to complete the study. Participants will complete ten 60-minute sessions of PE. During each PE session, participants will be outfitted with a NINscan device to record psychophysiological measures including skin conductance, heart rate, and facial EMG, as well as neural measures of LPFC activity. Multimodal assessment batteries will be scheduled to take place at pre-treatment, mid-treatment (i.e., post session 5), post-treatment (i.e., post-session 10), and at 1-month follow-up. These sessions will include a battery of self-report measures, clinician-administered diagnostic interviews, and script-driven imagery (SDI) procedures with physiologic and neural recordings. The primary outcome measure will be PTSD symptom change on the CAPS-5 and the secondary outcome measures will be a) change in self-reported symptom severity, b) premature treatment dropout, and c) change in psychophysiological reactivity and LPFC activity during the SDI procedures. This proposed research will inform theoretical models of exposure therapy efficacy, with the goal of enhancing prolonged exposure therapy.
Eligibility criteria
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
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-01
Estimated completion: 2027-01-01
Last updated: 2025-04-08
Interventions
Behavioral: Prolonged Exposure Therapy for Posttraumatic Stress Disorder
Primary outcomes
  • Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.)
Sponsor
VA Boston Healthcare System · fed
With: National Center for PTSD
Contacts & investigators
ContactSuzanne Pineles, PhD · contact · suzanne.pineles@va.gov · 857-364-5906
ContactVladimir Ivkovic, Phd · contact · vladimir.ivkovic@va.gov
InvestigatorSuzanne Pineles · principal_investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
All locations (1)
VA Boston Healthcare SystemRecruiting
Boston, Massachusetts, United States
Mechanisms Underlying the Efficacy of Prolonged Exposure · TrialPath