TrialPath
← Back to searchRecruiting

Mechanisms Underlying Efficacy of Prolonged Exposure

NCT05788302 · Massachusetts General Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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, midtreatment (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. Age 18 or older 2. 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 3. Interest in starting PE 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 of moderate or greater severity assessed by the DIAMOND, 6. Active risk to self or others, 7. Current participation in therapy other than present-centered supportive 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: 2023-04-01
Estimated completion: 2027-12-01
Last updated: 2025-11-13
Interventions
Behavioral: Prolonged Exposure
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
Massachusetts General Hospital · other
Contacts & investigators
ContactAmanda W Baker, Ph.D. · contact · AWBAKER1@PARTNERS.ORG · 617-643-6703
ContactVladimir Ivkovic, Ph.D. · contact · VIVKOVIC@mgh.harvard.edu · 617-724-5550
InvestigatorAmanda W Baker, Ph.D. · principal_investigator, Massachusetts General Hospital
InvestigatorVladimir Ivkovic, Ph.D. · principal_investigator, Massachusetts General Hospital
All locations (1)
MGHRecruiting
Boston, Massachusetts, United States
Mechanisms Underlying Efficacy of Prolonged Exposure · TrialPath