MBSR Intervention to reduce stress in AD caregivers

描述(申请人提供)：基于正念的压力减轻(MBSR)是一种心身结合的技术，它结合了正念冥想、瑜伽和认知重新评估，目的是自我管理因压力以及疼痛、癌症和其他疾病而导致的心理和身体痛苦。虽然MBSR已经存在了20年，并已被纳入许多临床环境，但很少有随机临床试验(RCT)评估其缓解压力的效果，或MBSR减轻压力的生理机制。阿尔茨海默病(AD)患者的照顾者经历了高水平的压力、抑郁症状和不良的身体健康结果，这可能是慢性压力的结果。然而，对AD照顾者的心理教育干预在自我报告的压力方面只显示出轻微的好处，可能是因为它们教会了处理当前照看问题的技术，随着照顾者疾病的发展，这些问题变得不那么有用了。相比之下，MBSR为AD照顾者提供了一种概念上有效的压力缓解方法，因为它是一种通用的压力管理方法，并能适应各种压力情况。 这项修订后的拟议R21研究是以心理中性免疫学(PNI)理论为指导的。它旨在为老年AD照顾者设计和中试为期8周的MBSR干预措施，以减少感知压力、抑郁症状，并改善PNI机制的两个生物标志物：硫酸二氢表雄酮(DHEA-S)和白细胞介素6(IL-6)。这项研究分为两个阶段。第一阶段是开发阶段，在此阶段，MBSR专家团队将为适合老年照顾者的8周MBSR计划和8周社交接触计划设计课程和培训材料，以供比较。第二阶段将是一项RCT的试点测试，比较这项MBSR计划与社交接触对照组在72名老年AD照顾者中短期(干预前)和6个月内感知压力、抑郁症状和生物标记物的变化，这些照顾者来自波士顿大学(BU)阿尔茨海默病中心。数据收集将在波士顿大学综合临床研究中心进行。结果将提供以下方面的信息：合格率、参与率、遵从率和自然减少率；答复者提供生物标本的意愿；以及未来区域CT的总体方案。混合效应模型将被用来检验假设，比较MBSR组和对照组在感知压力、抑郁症状、脱氢表雄酮-S和IL-6方面的变化。这些结果将指导设计更大的MBSR减压效应的RCT，并将为深入了解MBSR的生理机制提供依据。

DESCRIPTION (provided by applicant): Mindfulness-Based Stress Reduction (MBSR) is a mind-body technique that incorporates mindfulness meditation, yoga, and cognitive reappraisal with the goal of self-managing the psychological and physical distress resulting from stress, as well as pain, cancer and other illnesses. Although MBSR has been in existence for 20 years and has been incorporated into numerous clinical settings, few randomized clinical trials (RCTs) have evaluated its effects on stress reduction, or the physiological mechanism by which MBSR reduces stress. Caregivers to persons with Alzheimer's Disease (AD) experience high levels of stress, depressive symptoms, and adverse physical health outcomes, likely as a result of chronic stress. However, psycho-educational interventions for AD caregivers have shown only modest benefits on self-reported stress, probably because they teach techniques to deal with current caregiving problems which become less useful as the care recipient's disease progresses. In contrast, MBSR presents a conceptually effective stress reduction method for AD caregivers because of its generic approach to stress management and adaptability to various stressful situations. This revised proposed R21 study is guided by psychoneuoimmunology (PNI) theory. It aims to design and pilot-test an RCT of an 8-week MBSR intervention for older adult AD caregivers to reduce perceived stress, depressive symptoms, and improve two biological markers of PNI mechanisms: dihydroepiandrosterone-sulfate (DHEA-S) and interleukin-6 (IL-6). This study has two phases. The first phase is a development phase in which a team of MBSR experts will design the curriculum and training materials for an 8-week MBSR program adapted for elderly caregivers, and an 8-week social contact program to be used for comparison purposes. The second phase will be a pilot test of an RCT comparing this MBSR program to a social contact control group on short-term (pre-post intervention) and 6-month change in perceived stress, depressive symptoms, and biological markers among 72 elderly AD caregivers, recruited from the Boston University (BU) Alzheimer's Disease Center. Data collection will take place at the BU General Clinical Research Center. The results will provide information on rates of eligibility, participation, compliance and attrition; respondents' willingness to provide biological specimens; and the overall protocol for the future RCT. Mixed effects models will be used to test hypotheses comparing the MBSR group to the control group on changes in perceived stress, depressive symptoms, and DHEA-S and IL-6. The results will guide the design of a larger RCT of the effects of MBSR on reducing stress, and will provide insight into the physiological mechanisms of MBSR.