MBSR Intervention to reduce stress in AD caregivers

描述（由申请人提供）：基于正念的减压（MBSR）是一种身心技术，结合了正念冥想，瑜伽和认知重新评估，目的是自我管理由压力引起的心理和身体痛苦，以及疼痛，癌症和其他疾病。虽然正念减压疗法已经存在了20年，并已被纳入许多临床环境，很少有随机临床试验（RCT）评估其对减轻压力的影响，或正念减压疗法减轻压力的生理机制。阿尔茨海默病（AD）患者的护理人员经历高水平的压力，抑郁症状和不良的身体健康结果，可能是由于慢性压力。然而，AD照顾者的心理教育干预只显示出适度的好处，自我报告的压力，可能是因为他们教的技术来处理当前的问题，成为有用的照顾者的疾病进展。相比之下，正念减压疗法提出了一个概念上有效的减压方法，AD照顾者，因为其通用的方法来管理压力和适应各种压力的情况。 这项修订后的R21研究以心理神经免疫学（PNI）理论为指导。它的目的是设计和试点测试的随机对照试验的8周MBSR干预老年人AD照顾者，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）。本研究分为两个阶段。第一阶段是发展阶段，由正念减压疗法专家组成的团队将为适合老年护理人员的为期8周的正念减压疗法项目设计课程和培训材料，并为用于比较目的的为期8周的社会接触项目设计课程和培训材料。第二阶段将是一个随机对照试验比较这个MBSR计划的社会接触控制组的短期（干预前后）和6个月的变化，在感知压力，抑郁症状，和生物标志物之间的72个老年AD照顾者，从波士顿大学（BU）阿尔茨海默病中心。数据收集将在BU一般临床研究中心进行。结果将提供有关合格率、参与率、依从性和自然减员率的信息;受访者提供生物标本的意愿;以及未来RCT的总体方案。混合效应模型将用于测试假设，比较MBSR组与对照组在感知压力、抑郁症状、DHEA-S和IL-6方面的变化。研究结果将指导设计一个更大的正念减压效果的随机对照试验，并将提供对正念减压生理机制的深入了解。

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.