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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• age 18-65 years (upper limit chosen to optimize changes in brain activation that diminish with age);

• criterion A trauma exposure and PTSD symptoms (clinically significant symptoms in at least two symptom clusters);

• subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking) ability to understand and sign informed consent

• fluent English speaker.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Michael Osborne, MD
MOSBORNE@PARTNERS.ORG
6177261843
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 30
Treatments
Experimental: Cognitive processing therapy
12 week treatment period of cognitive processing therapy followed by a post-treatment visit.
No_intervention: Control waitlist
Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov