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

描述(申请人提供)：尽管近一半的美国成年人(9500万)患有高血压，但只有三分之一的患者可以通过常规治疗成功控制他们的高血压，包括改变生活方式，如果需要，还可以服用降压药。众所周知，压力至少通过两种方式增加血压：(1)激活交感神经系统，使心脏搏动更剧烈，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)是一种行之有效的减少压力的冥想计划。在我们的新闻试验(R21 AT002698-01A2)中，一项为期8周的MBSR计划显著降低了高血压患者的血压。目前的R01申请提出了一项两地点随机临床试验(RCT)，样本更大、更多样化，来自俄亥俄州克利夫兰和北卡罗来纳州达勒姆。我们还将测试一个概念模型，该模型强调“去中心化”是MBSR减少急性和慢性应激对高血压的影响的关键机制。分心是一种观察与压力相关的想法、情绪和冲动的能力，这种能力使人能够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，随着时间的推移，与MBSR相关的减心效应将减少对轻度情绪压力的夸大心血管反应，加快生理恢复，并增加健康的生活方式。我们计划招募180名患有高血压前期的未接受药物治疗的成年人，他们将接受改变生活方式的建议。然后，患者将在8周的干预期内被随机分配到三个研究小组中：(1)MBSR培训；(2)压力管理教育(SME)，一个可信、积极的对照组，控制教学时间、课堂讲师的注意力、社会支持和家庭作业，但不包括正念冥想的“积极因素”；或等待名单对照组(WLC)，控制高血压的自然病史，而患者只完成研究评估。临床血压(主要结果)、24小时动态血压、应激诱导的心血管反应性(包括心率(HR)、血压(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源的客观行为反应将在0周(基线)、8周(治疗后)和60周(一年随访)进行评估。此外，临床BP将在第4周(治疗中期)和第34周(6个月随访)进行评估。健康行为将在每个时间点进行评估。等待名单上的患者将被邀请接受他们选择的开放标签MBSR或SME-允许我们探索患者偏好对干预效果大小的影响。拟议的两个地点的RCT将满足两个关键的公共卫生需求：(1)需要高质量的试验和更长期的随访，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能降低高血压的特定心理、生物和行为机制。

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.