Smartphone Delivered Meditation for BP Control Among Prehypertensives

描述（由申请人提供）：与最佳血压（<120/80 mmHg）的患者相比，2期原发性高血压前期（preEH; 130-139/<90 mmHg）发生EH的风险为3倍，发生心血管疾病（CVD）事件的风险为2倍。预防计划是必要的，可以持续的preEH和容易传播的医疗保健提供者。心理应激是未来EH和CVD的危险因素。通过冥想减轻压力已显示出降低血压（BP）的希望，但成人研究尚未确定最佳剂量水平，也没有客观地评估剂量依从性。将冥想与降低血压联系起来的多种潜在生物行为机制也需要进一步的审查。拟议的研究将通过进一步开发和优化智能手机呼吸意识冥想程序（Tension Tamer：TT）来解决这些问题。将入组OQUIN基于实践的研究网络内12个实践地点（6个城市/6个农村，12，843个2期preEH）的21-50岁非裔美国人和白人（按地理位置（城市与农村）和医疗保健提供者进行平衡）。PA-11-063中规定的干预开发的3阶段过程将涉及：1）在行为和技术理论指导下，使用OQUIN医疗保健提供者的6个焦点小组和6个具有preEH的焦点小组，优化TT内容和交付格式（每组8个preEH）; 2）6个月TT概念验证研究（n=60例2期preEH），以确定剂量耐受性以及对静息和24小时SBP和生物行为机制的影响：担忧、反刍、焦虑、敌意、正念、睡眠、体力活动、交感神经系统（SNS）和下丘脑垂体肾上腺轴（HPA）活动; 3）12个月2组随机对照试验（RCT; TT vs增强标准护理智能手机健康教育计划;总计n=80），以生成设计大规模RCT所需的估计值。由医疗保健提供者及其高血压前期患者实施和指导的这一系列迭代研究，将产生一种城市和农村环境中多个种族/族裔群体可接受的干预措施， 在临床实践环境中进行，在试点RCT中有效降低SBP，并为大规模RCT做好准备。

DESCRIPTION (provided by applicant): Stage 2 pre essential hypertension (preEH; 130-139/<90 mmHg) entails a 3-fold risk of developing EH and 2- fold risk of cardiovascular disease (CVD) events compared to those with optimal blood pressure (<120/80 mmHg). Prevention programs are needed which can be sustained by preEHs and readily disseminated by healthcare providers. Psychological stress is a risk factor for future EH and CVD. Stress reduction via meditation has shown promise in reducing blood pressure (BP) but adult studies have not determined optimal dosage level nor evaluated dosage adherence objectively. Multiple underlying biobehavioral mechanisms linking meditation with BP reduction also require additional scrutiny. The proposed research will address these issues by further developing and optimizing a smart phone breathing awareness meditation program (Tension Tamer:TT). Stage 2 preEH 21-50 year old African Americans and Whites balanced by geographical locale (urban vs. rural) and healthcare providers from 12 practice sites (6 urban/6 rural with 12,843 stage 2 preEHs) within the OQUIN practice based research network will be enrolled. The 3 stage process of intervention development specified in PA-11-063 will involve: 1) Optimization of TT content and delivery formats guided by behavioral and technological theories using 6 focus groups of OQUIN healthcare providers and 6 focus groups with preEHs (8 preEHs per group); 2) 6 month TT proof of concept study (n=60 stage 2 preEHs) to establish dosage tolerability and impact upon resting and 24 hour SBP and biobehavioral mechanisms: worry, rumination, anxiety, hostility, mindfulness, sleep, physical activity, sympathetic nervous system (SNS) and hypothalamic pituitary adrenal axis (HPA) activity; 3) 12 month 2-arm randomized control trial (RCT; TT vs enhanced standard of care smart phone health education program; total n=80) to generate estimates needed for design of a large scale RCT. This series of iterative studies, implemented and guided by healthcare providers and their preEH patients, will result in an intervention acceptable to multiple racial/ethnic groups in both urban and rural settings, feasible to conduct in clinical practice settings, effective in reducing SBP in a pilot RCT and ready for a large scale RCT.