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

• 批准号: 9493014
• 负责人: David M Fresco
• 金额: $ 7.45万
• 依托单位: KENT STATE UNIVERSITY
• 依托单位国家: 美国
• 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/9493014
• 关键词: 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; Course Content; Data; Education; Educational process of instructing; Effectiveness; Emotional; Emotional Stress; Emotions; Enrollment; Equilibrium; Ethnic Origin; Event; Feeling; Gender; Health Care Research; Health Status; Health behavior; Heart; Heart Diseases; Heart Rate; Home environment; Hypertension; Individual; Instruction; Intention; Intervention; Laboratories; Measures; Mediating; Meditation; Mental Health; Methodology; 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; Self-Examination; Site; Sleep; Social support; Standardization; Stress; Sympathetic Nervous System; Testing; Therapeutic; Thinking; Time; Training; United States; Vascular resistance; Waiting Lists; active comparator; active control; acute stress; behavioral response; biobehavior; blood pressure reduction; blood pressure regulation; clinical efficacy; comparison group; conventional therapy; cost; diet and exercise; emotion regulation; experience; follow-up; health care quality; healthy lifestyle; high risk; improved; instructor; intervention effect; mindfulness meditation; mindfulness-based stress reduction; mood regulation; open label; peer; physical conditioning; pilot trial; post intervention; preference; prehypertension; primary outcome; programs; psychologic; psychological symptom; psychosocial; public health relevance; response; secondary outcome; stress management; stressor; three-arm study; treatment choice

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可以通过常规治疗成功控制高血压，包括生活方式的改变，如果需要，还可以使用降压药物。已知压力至少以两种方式增加血压：（1）激活交感神经系统，使心脏泵血更困难，血管收缩，（2）干扰健康行为，包括饮食，运动和睡眠。正念减压（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年人进行的新闻试验（R21 AT 002698 - 01 A2）中，8周的正念减压疗法显著降低了高血压。目前的R 01申请提出了一项双中心随机临床试验（RCT），该试验在俄亥俄州克利夫兰和北卡罗来纳州达勒姆的成人中采用了更大、更多样化的样本。我们还将测试一个概念模型，强调“离心”作为一个关键机制，通过它MBSR减少急性和慢性压力对高血压的影响。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，这种能力允许一个人脱离对压力的自动反应，保持注意力的集中，并更有效地对要求高的任务或压力触发做出反应。我们预计，MBSR相关的偏心增益将减少对轻度情绪压力的过度心血管反应，加快生理恢复，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名未接受药物治疗的高血压前期成人，他们将接受生活方式改变的建议。在为期8周的干预期内，患者将被随机分配到三个研究组中的一个：（1）MBSR培训;（2）压力管理教育（SME），这是一个可靠的，积极的对照组，控制教学时间，课堂教师的注意力，社会支持和家庭作业，但没有正念冥想的“活性成分”;或等待名单对照（WLC）组，其控制高血压变化的自然史，而患者仅完成研究评估。将在第0周（基线）、第8周（治疗后）和第60周（1年随访）评估门诊BP（主要结局）、24小时动态BP、应激诱导的心血管反应性（包括心率（HR）、BP、心输出量（CO）、射血前期（PEP）和血管阻力）以及对轻度情绪应激的客观行为反应。此外，将在第4周（治疗中期）和第34周（6个月随访）评估门诊BP。将在每个时间点评估健康行为。等待名单中的患者将被邀请接受他们选择的开放标签的正念减压疗法或SME，使我们能够探索患者偏好对干预效果大小的影响。拟议的两个地点的随机对照试验将解决两个关键的公共卫生需求：（1）需要长期随访的高质量试验，以明确测试正念冥想降低血压的有效性和持久性，以及（2）需要辨别特定的心理，生物学和行为机制，正念冥想可以降低高血压。