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临床试验/NCT04496947
NCT04496947招募中不适用

Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

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
Change in arterial inflammation by PET

研究概览

简要总结

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress.

详细描述

This randomized controlled imaging study will be performed to evaluate the impact of mindfulness-based stress reduction via a mind body program on arterial inflammation in individuals with self-identified high levels of stress. Individuals will undergo baseline Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks of 2:1, with stratification by age and sex. The stress reduction sessions focus on developing an understanding of stress physiology and the physiology of the relaxation response, on developing a regular practice of eliciting the relaxation response, and on learning cognitive behavioral and positive psychology/resilience skills.

During the screening period, patient acceptability for the study will be assessed based on medical history, concomitant medications, physical examination, and clinical laboratory test results. Acceptability for study participation will be confirmed for subjects who identify as having increased levels of stress and/or a Perceived Stress Scale score >5. Once the patient has passed screening, they will undergo baseline imaging followed by randomization and group assignment. Approximately 12 weeks after randomization, all individuals will return for follow-up imaging and evaluation.

Thus, 2 Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging scans will be performed throughout the study for baseline and follow up to assess the intervention's impact on the brain and arterial inflammation, along with changes in related positron emission tomography / magnetic resonance imaging imaging parameters. Perceived Stress Scale will be delivered prior to Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging, during both imaging visits to measure perceived psychological stress. During both imaging sessions, subjects will be exposed to overt faces to measure signals during brain imaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Aged between 30-65 years
  • Identifies as having increased levels of stress and/or has a Perceived Stress Scale (PSS) score >5 at baseline, and is interested in participating

排除标准

  • Perceived Stress Scale (PSS) score <6

研究组 & 干预措施

Stress Reduction

Experimental

8 week stress reduction course

干预措施: Stress Reduction (Behavioral)

Control

No Intervention

No intervention

结局指标

主要结局

Change in arterial inflammation by PET

时间窗: 2 months

Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Tawakol

Director, Nuclear Cardiology

Massachusetts General Hospital

研究点 (2)

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