RecruitingNot ApplicableNCT06429293

Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

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

Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Posttraumatic Stress Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether Cognitive Behavioral Therapy (CBT) — a structured talking therapy for PTSD — can also reduce the risk of heart disease by calming the stress response that links trauma to cardiovascular problems. Participants will have brain imaging and heart health measurements taken before and after therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have experienced a traumatic event and have significant PTSD symptoms in at least two areas (such as intrusive memories, avoidance, negative thoughts, and hyperarousal) - You have existing or increased risk for cardiovascular disease (such as heart disease, history of heart attack, or two or more risk factors like high blood pressure, diabetes, high cholesterol, or active smoking) - You speak fluent English **You may NOT be eligible if...** - You have had a stroke, brain surgery, or seizures - You are currently taking beta-blockers, high-intensity statins, or PCSK9 inhibitors - Your medications for heart disease or mental health have changed in the past 4 weeks - You are currently receiving PTSD therapy - You have a neurological condition or are currently on anti-inflammatory therapy - You have moderate to severe alcohol or substance use disorder - You currently have mania or psychosis - You weigh more than 300 lbs., have claustrophobia, are pregnant, or have metal implants incompatible with MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive processing therapy

The active intervention is Cognitive Processing Therapy (CPT) is a gold-standard cognitive behavioral therapy for PTSD. The CPT intervention consists of 12 60-minute sessions teaching skills to challenge trauma-relevant cognitions that are distorted or unhelpful. Trauma-relevant cognitions fall into five themes that are highlighted during treatment: safety, trust, power/control, esteem, and intimacy. The empirical base for CPT is strong with numerous studies demonstrating that it results in significant reduction of PTSD symptoms regardless of trauma type and that it is 89% more effective than control treatment. CPT has been successfully implemented in virtual formats with comparable efficacy levels to that of in-person CPT. CPT sessions for this study will be conducted virtually by a CPT-trained clinician