Mechanisms Underlying the Efficacy of Prolonged Exposure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- VA Boston Healthcare System
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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.
Investigators
Suzanne Pineles
Principal Investigator/Study Chair
VA Boston Healthcare System
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)
Exclusion 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, 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
Outcomes
Primary Outcomes
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 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.
The primary clinical outcome, CAPS-5, is the gold standard clinical interview for assessing PTSD severity. In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme). Total scores range from 0 to 80.
Secondary Outcomes
- Prefrontal cortical activity during script-driven imagery (SDI)(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.)
- Change in electrocardiography (ECG) and heart rate variability (HRV) during script driven imagery (SDI)(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.)
- Change in skin conductance (SC) during script-driven imagery (SDI)(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.)
- PTSD Checklist for DSM-5 (PCL-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.)
- Change in respirometry during script-driven imagery (SDI)(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.)
- Change in electromyography (EMG) during script-driven imagery (SDI)(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.)
- Premature treatment dropout(Given at pre-treatment and mid-treatment (post session 5 in week 5 of treatment).)
- QIDS-SR (93)(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.)