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）：虽然美国近一半的成年人（9500 万）患有高血压 (BP)，但只有三分之一的患者能够通过常规治疗（包括改变生活方式）成功控制高血压，如果需要，抗高血压药物。众所周知，压力至少会通过两种方式增加血压：(1) 激活交感神经系统，使心脏泵血更加困难，血管收缩；(2) 干扰健康行为，包括饮食、锻炼和睡眠。基于正念的减压（MBSR）是一种经过验证的减压冥想计划。在我们对未经药物治疗的高血压前期成人进行的新闻试验 (R21 AT002698-01A2) 中，为期 8 周的 MBSR 计划显着降低了高血压。当前的 R01 申请提出了一项两中心随机临床试验 (RCT)，其中涉及来自俄亥俄州克利夫兰和北卡罗来纳州达勒姆的更大、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“去中心”作为 MBSR 减少急性和慢性压力对高血压影响的关键机制。去中心化是一种观察与压力相关的想法、情绪和冲动的能力，使人摆脱对压力的自动反应，保持注意力集中，并更有效地应对艰巨的任务或压力触发因素。我们预计，MBSR 相关的去中心化效果将减少心血管对轻微情绪压力的过度反应，加速生理恢复，并随着时间的推移增加健康的生活方式。我们计划招募 180 名未接受药物治疗的高血压前期成年人，他们将接受生活方式改变的建议。然后，在为期 8 周的干预期内，患者将被随机分配到三个研究组之一：(1) MBSR 训练；（2）压力管理教育（SME），一个可信的、积极的对照组，控制教学时间、班主任的注意力、社会支持和家庭作业，但没有正念冥想的“活性成分”；或等候名单对照 (WLC) 组，该组在患者仅完成研究评估时控制高血压变化的自然史。评估诊所血压（主要结果）、24 小时动态血压、应激诱发的心血管反应性，包括心率 (HR)、血压、心输出量 (CO)、射血前期 (PEP) 和血管阻力，以及客观行为对轻微情绪压力源的反应将出现在第 0 周（基线）、第 8 周（治疗后）和第 60 周（一年随访）。此外，将在第 4 周（治疗中期）和第 34 周（六个月随访）评估诊所血压。将在每个时间点评估健康行为。候补名单中的患者将被邀请接受他们选择的开放标签 MBSR 或 SME，从而使我们能够探索患者偏好对干预效果大小的影响。拟议的两个地点随机对照试验将解决两个关键的公共卫生需求：（1）需要进行高质量的试验和长期随访，以明确测试正念冥想降低血压的有效性和持久性，以及（2）需要辨别正念冥想可以降低高血压的具体心理、生物和行为机制。