Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05663151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-27
First Post:
2022-11-22
Brief Title:
Mechanisms Underlying the Efficacy of Prolonged Exposure
Sponsor:
VA Boston Healthcare System
Organization:
VA Boston Healthcare System
Study Overview
Official Title:
Mechanisms Underlying the Efficacy of Prolonged Exposure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 ie post session 5 post-treatment ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None