Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429293
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-08
Brief Title:
Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Impact of Cognitive Behavioral Therapy on Neural Inflammatory Autonomic Markers in a Sample With PTSD and Cardiovascular Risk Protocol for a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder PTSD Cognitive Processing Therapy CPT versus waitlist control on mechanisms of cardiovascular disease CVD risk Further this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity SNA
Detailed Description:
This study is a randomized controlled trial of CPT compared to waitlist control that is testing the effects of CPT on mechanisms of the PTSD-CVD link Enrollment began in 2023 and is projected to continue through 2026 Participants include individuals with PTSD and CVD risk recruited from the Boston area N 30 Treatment assignment is randomized and stratified by sex Participants are randomized to CPT n 15 or waitlist control n 15 Potentially eligible participants complete a screening visit to confirm inclusionexclusion criteria Upon confirmation of eligibility participants are scheduled for a baseline session where they complete surveys brain and peripheral imaging and resting measures of autonomic function Following the baseline visit participants are randomized into CPT or the waitlist control group Those randomized to CPT complete sessions via telehealth Following a 12-week treatment period participants attend the post-treatment visit consisting of the same assessments administered at baseline Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit
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