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New treatment option for Posttraumatic Stress Disorder
Official title Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
ClinicalTrials.gov ID: NCT06429293
What this study is testing
- What it's testing
- 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)
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- fluent English speaker.
You likely can't join if
- history of stroke, brain surgery, seizure
- use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9...
- psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed);
- currently in PTSD therapy;
- neurological or systemic inflammatory disease/current anti-inflammatory therapy;
- moderate/severe alcohol/substance use disorder;
See the full eligibility criteria
- 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...
- fluent English speaker.
- history of stroke, brain surgery, seizure
- use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9 inhibitors);
- psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed);
- currently in PTSD therapy;
- neurological or systemic inflammatory disease/current anti-inflammatory therapy;
- moderate/severe alcohol/substance use disorder;
- current mania/psychosis;
- weight \>300 lbs., claustrophobia, pregnancy, metal implants that are incompatible with magnetic resonance imaging (MRI), or uncontrolled hyperglycemia (for imaging);
- significant radiation exposure (\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) for research purposes during the preceding 12-months.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.