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

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（包括改变生活方式和必要时使用降压药）成功控制其高血压。众所周知，压力至少通过两种方式使血压升高：(1)激活交感神经系统，使心脏跳动更困难，血管收缩；(2)干扰健康行为，包括饮食、锻炼和睡眠。正念减压法（MBSR）是一种经过验证的减压冥想方法。在我们的在印试验（R21 AT002698-01A2）中，一个8周的MBSR项目显著降低了高血压。目前的R01申请提出了一项两点随机临床试验（RCT），从俄亥俄州克利夫兰和北卡罗来纳州达勒姆的成年人中选取更大、更多样化的样本。我们还将测试一个概念模型，该模型强调“去中心化”是正念减压法降低急性和慢性压力对高血压的影响的关键机制。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，这种能力可以让一个人从对压力的自动反应中解脱出来，保持注意力的集中，并更有效地应对要求高的任务或压力触发因素。我们期望mbsr相关的去中心化收益将减少心血管对轻度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行为。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)正念减压训练；(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、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“积极成分”；另一组为等待名单控制组（WLC），在患者仅完成研究评估时控制高血压的自然史变化。在第0周（基线）、第8周（治疗后）和第60周（1年随访）评估临床血压（主要结局）、24小时动态血压、应激性心血管反应（包括心率（HR）、血压、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。此外，临床血压将在第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。拟议的两点随机对照试验将满足两个关键的公共卫生需求：(1)需要进行高质量的长期随访试验，以明确测试正念冥想降低血压的有效性和持久性；(2)需要辨别正念冥想降低血压的具体心理、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.