Mindfulness-Based Stress Reduction for High Blood Pressure: A Two-Site RCT

基于正念的高血压减压：两中心随机对照试验

基本信息

批准号：
8703899
负责人：
David M Fresco
金额：
$ 73.49万
依托单位：
KENT STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-01 至 2019-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8703899
关键词：
Accounting Address Adherence Adult Aftercare Age American Heart Association Antihypertensive Agents Attention Behavior Behavior Therapy Behavioral Behavioral Mechanisms Biological Blood Pressure Blood Vessels Buffers Cardiac Output Cardiovascular system Cessation of life Characteristics Chronic stress Clinic Clinical Trials Clinical Trials Design Communities Control Groups Data Education Educational process of instructing Effectiveness Emotional Emotional Stress Emotions Enrollment Equilibrium Ethnic Origin Event Feeling Gender Health Services Research Health Status Health behavior Heart Heart Rate Home environment Hypertension Hypotension Individual Instruction Intention Intervention Laboratories Life Style Measures Mediating Meditation Mental Health Mind Modeling Muscle relaxation phase Natural History Outcome Patient Preferences Patient Self-Report Patients Performance Pharmaceutical Preparations Physiological Physiology Process Public Health Publishing Pump Race Randomized Randomized Clinical Trials Reaction Reaction Time Recovery Research Risk Sampling Site Sleep Social support Stress Sympathetic Nervous System Symptoms Testing Therapeutic Thinking Time Training United States United States Agency for Healthcare Research and Quality Vascular resistance Waiting Lists active comparator active control acute stress biobehavior blood pressure regulation clinical efficacy comparison group conventional therapy cost diet and exercise emotion regulation experience follow-up health care quality high risk hypertensive heart disease improved instructor intervention effect mindfulness meditation mindfulness-based stress reduction mood regulation open label peer physical conditioning pilot trial post intervention preference primary outcome programs psychologic psychosocial public health relevance response secondary outcome stress management stressor three-arm study

项目摘要

DESCRIPTION (provided by applicant): Although nearly half of all adults in the United States (95 million) have high blood pressure (BP), only one in three patients can successfully control their high BP with conventional treatment, including lifestyle modifications and, if needed, antihypertensive medication. Stress is known to increase BP in at least two ways: (1) activating the sympathetic nervous system to make the heart pump harder and the blood vessels constrict, and (2) interfering with health behaviors, including diet, exercise, and sleep. Mindfulness-Based Stress Reduction (MBSR) is a proven meditation program to reduce stress. In our in-press trial (R21 AT002698-01A2) on adults with unmedicated prehypertension, an 8-week MBSR program significantly lowered high BP. The current R01 application proposes a two-site randomized clinical trial (RCT) with a larger, more diverse sample of adults from Cleveland, OH, and Durham, NC. We will also test a conceptual model that emphasizes "decentering" as a key mechanism by which MBSR reduces the impact of acute and chronic stress on high BP. Decentering is the ability to observe stress-related thoughts, emotions, and impulses in a way that allows one to disengage from automatic reactions to stress, maintain one's focus of attention, and respond to a demanding task or stressful trigger more effectively. We expect that MBSR-related gains in decentering will reduce exaggerated cardiovascular reactivity to mild emotional stress, expedite physiological recovery, and increase healthy lifestyle behaviors over time. We plan to enroll 180 unmedicated adults with prehypertension who will receive lifestyle modification advice. Patients will then be randomly assigned to one of three study arms over an 8-week intervention period: (1) MBSR training; (2) Stress Management Education (SME), a credible, active comparison group that controls for instruction time, attention from class instructors, social support, and homework assignments, but without the "active ingredient" of mindfulness meditation; or a wait-list control (WLC) group that controls for natural history of changes in high BP while patients complete the study assessments only. Assessments of clinic BP (primary outcome), 24-hr ambulatory BP, stress-induced cardiovascular reactivity including heart rate (HR), BP, cardiac output (CO), pre-ejection period (PEP), and vascular resistance, and objective behavioral reactions to a mild emotional stressor will occur at Weeks 0 (baseline), 8 (post-treatment), and 60 (one-year follow-up). In addition, clinic BP will be assessed at Weeks 4 (mid-treatment) and 34 (six-month follow-up). Health behaviors will be assessed at each time point. Waitlist patients will be invited to receive their choice of open-label MBSR or SME-allowing us to explore the effect of patient preference on intervention effect sizes. The proposed two-site RCT will address two critical public health needs: (1) the need for high-quality trials wih longer-term follow-up to definitively test the effectiveness and durability of mindfulness meditation for lowering BP, and (2) the need to discern the specific psychological, biological, and behavioral mechanisms by which mindfulness meditation may reduce high BP.

描述（由申请人提供）：尽管在美国的所有成年人中，几乎一半（9500万）具有高血压（BP），但只有三分之一的患者可以通过常规治疗成功地成功控制其高BP，包括生活方式修改以及（如果需要的话）降压药。已知压力至少以两种方式增加了BP：（1）激活交感神经系统以使心脏泵更硬，血管收缩，以及（2）干扰健康行为，包括饮食，运动和睡眠。基于正念的压力减轻（MBSR）是一项旨在减轻压力的冥想计划。在我们对具有未经物质前静脉前的成年人（R21 AT002698-01A2）中的内置试验中，为期8周的MBSR计划显着降低了高BP。当前的R01申请提出了一项两端随机临床试验（RCT），其中来自俄亥俄州克利夫兰和北卡罗来纳州达勒姆市的更大，更多样化的成年人样本。我们还将测试一个概念模型，该模型强调“偏心”是MBSR降低急性和慢性应激对高BP的影响的关键机制。偏心是能够以一种使人从自动反应中脱离压力，保持注意力的重点并响应苛刻的任务或更有效的压力触发的方式观察与压力有关的思想，情绪和冲动的能力。我们预计，与MBSR相关的分离中的收益将减少对轻度情绪压力，加快生理恢复的夸张的心血管反应性，并随着时间的推移增加健康的生活方式行为。我们计划招募180名未经监测的成年人，他们将获得生活方式修改建议。然后，将在为期8周的干预期内将患者随机分配到三个研究臂之一：（1）MBSR培训；（2）压力管理教育（SME）是一个可信，积极的比较小组，控制教学时间，班级教练的注意力，社会支持和家庭作业，但没有正念冥想的“积极成分”；或一个候补名单控制（WLC）组，该组控制着高BP的自然历史，而患者仅完成研究评估。评估临床BP（主要结果），24小时卧床BP，压力诱导的心血管反应性，包括心率（HR），BP，心脏输出（CO），次注射期（PEP）和血管抗性以及对轻度情绪压力的客观行为反应在0（基线基线）时（8（BasebleS），1个（后），一项（一项）（一项）（一项）。此外，将在第4周（中期）和34周（六个月随访）评估诊所BP。健康行为将在每个时间点进行评估。候补患者将被邀请接受他们选择开放标签MBSR或允许我们探索患者偏爱对干预效果大小的影响。拟议的两个站点RCT将满足两个关键的公共卫生需求：（1）长期随访的高质量试验的必要性，以确定测试降低BP的正念冥想的有效性和耐用性，以及（2）需要辨别特定的心理，生物学，生物学和行为机制，从而降低了正念冥想可以降低高级BP。