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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Arterial inflammation
研究概览
简要总结
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)
详细描述
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 inclusion/exclusion 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Individuals who interpret images and data will be blinded to assigned intervention
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Arterial inflammation
时间窗: Baseline and 12-weeks
Measured via FDG-PET imaging
Heart rate variability
时间窗: Baseline and 12-weeks
Calculated from the average resting HRV collected at baseline and post-treatment visits
次要结局
- Leukopoiesis(Baseline and 12-weeks)
- Heart rate(Baseline and 12-weeks)
- Blood pressure(Baseline and 12-weeks)
- MRI based arterial plaque components (such as necrotic tissue, loose connective tissue, and hemorrhage)(Baseline and 12-weeks)
- MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)(Baseline and 12-weeks)
- Axonal integrity of resting neural connections between brain centers using MRI(Baseline and 12-weeks)
- MRI based arterial wall thickness(Baseline and 12-weeks)
- MRI based brain structure assessments of volume and density(Baseline and 12-weeks)
- MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task)(Baseline and 12-weeks)
研究者
Michael T. Osborne
Clinician Investigator
Massachusetts General Hospital