Web-based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes

针对农村痴呆症护理人员失眠的基于网络的 CBT：睡眠、觉醒、情绪、认知和免疫结果的检查

• 批准号: 10739134
• 负责人: Christina S McCrae
• 金额: $ 72.74万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739134
• 关键词: Web; based; CBT; Insomnia; Rural

PROJECT SUMMARY Compared to their urban counterparts, rural family dementia caregivers (CGs) face increased vulnerability to insomnia and related health concerns (stress, inflammation, depression, anxiety, cognitive disturbance). Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and these related concerns, but is difficult to access in rural areas. Our team developed brief telehealth CBT-I (tele bCBT-I) tailored for CGs (e.g., includes stress management/problem solving) that improved sleep, arousal, mood, cognition and inflammation (small to large effects). While telehealth improves accessibility, it is still burdensome for CGs due to inflexible scheduling and scarcity of trained therapists. Thus, more research is needed. Web delivery would increase access and web CBT-I is efficacious in non-CG adults, but has not been tested in rural CGs. Using the NIH Stage Model flexible framework and Medical Research Council recommendations, we developed NiteCAPP (web translation of our tele bCBT-I protocol). Stage IA/B validation and testing show high feasibility and acceptability, and improvements in sleep, arousal, mood, burden and cognition in a single arm pilot in rural CGs (n=5). The proposed trial is the next logical step - Stage II testing in an RCT (n=100) to establish efficacy and further evaluate feasibility and acceptability. The Cognitive Activation Theory of Stress provides a framework for our basic premise that CGs experience insomnia, arousal and inflammation that prompt sympathetic activation and hypothalamic-pituitary-adrenal (HPA) disruption that have downstream negative effects on health. The proposed trial tests the novel hypothesis that NiteCAPP will improve CG health, mood, burden and cognition by targeting their shared underlying mechanisms – sleep, arousal and inflammation – thereby, returning sympathetic and HPA functioning to normal. Another novel aspect of the proposed trial is inclusion of behavioral strategies to target the person with dementia’s (PWD) sleep. Outcomes will be assessed at baseline, post-treatment and two follow-ups (6 and 12 months) and include CG sleep, arousal, inflammation, health, mood, burden and cognition, and PWD sleep. The proposed study has four specific aims. Aim 1 focuses on the feasibility and acceptability of NiteCAPP and WebSHE (sleep hygiene education – active web comparator). Aims 2 and 3 examine NiteCAPP’s effects (versus WebSHE) on CG primary/mechanistic (sleep, arousal, inflammation) and secondary outcomes (health, mood, burden, cognition), respectively. Because the PWD’s sleep impacts CG sleep, Aim 4 examines NiteCAPP’s secondary effects on PWD sleep (objectively assessed). An Exploratory Aim examines the relationships between changes in CG primary and secondary outcomes, and their potential mediators/ moderators. Public Health Implications: Demonstration that rural CGs can use NiteCAPP to target sleep, arousal/stress, inflammation and related health concerns has important implications for multiple stakeholders, including rural CGs, rural PWDs, their families, clinicians and policymakers.

项目摘要 与城市同行相比，农村家庭痴呆症护理人员（CG）面临失眠的脆弱性增加， 相关的健康问题（压力、炎症、抑郁、焦虑、认知障碍）。认知行为治疗 失眠症（CBT-I）有望改善失眠症和这些相关问题，但在农村地区难以获得 地区我们的团队开发了针对CG（例如，包括压力管理/问题 解决），改善睡眠，唤醒，情绪，认知和炎症（从小到大的影响）。虽然远程保健得到改善， 虽然可访问性，但由于不灵活的时间安排和训练有素的治疗师的稀缺，它仍然是CG的负担。因此更 需要进行研究。网络交付将增加访问量，并且网络CBT-I对非CG成年人有效，但事实并非如此 在农村地区进行了测试。使用NIH阶段模型灵活框架和医学研究理事会建议，我们 开发了NiteCAPP（远程bCBT-I协议的网络翻译）。阶段IA/B验证和测试显示出高可行性 和可接受性，并改善睡眠，觉醒，情绪，负担和认知在农村CG的单臂飞行员（n=5）。 拟议的试验是下一个合乎逻辑的步骤-在RCT（n=100）中进行II期试验，以确定疗效并进一步评估 可行性和可接受性。压力的认知激活理论为我们的基本前提提供了一个框架， CG经历失眠，觉醒和炎症，促使交感神经激活和下丘脑-垂体-肾上腺 (HPA)对下游健康产生负面影响的破坏。拟议的试验测试了一个新的假设， NiteCAPP将通过针对他们共享的潜在机制-睡眠， 唤醒和炎症-从而使交感神经和HPA功能恢复正常。另一个新的方面， 一项拟议的试验是将针对痴呆症患者（PWD）睡眠的行为策略纳入其中。成果将 在基线、治疗后和两次随访（6个月和12个月）时进行评估，包括CG睡眠、觉醒、炎症， 健康、情绪、负担和认知以及PWD睡眠。 拟议的研究有四个具体目标。目标1着重于NiteCAPP的可行性和可接受性， WebSHE（睡眠卫生教育-活动网络比较器）。目标2和3检查NiteCAPP的效果（与WebSHE相比） CG主要/机制（睡眠、觉醒、炎症）和次要结局（健康、情绪、负担、认知）， 分别由于PWD的睡眠影响CG睡眠，Aim 4检查了NiteCAPP对PWD睡眠的次要影响 （客观评价）。探索性目的检查CG原发性和继发性变化之间的关系 结果，及其潜在的调解人/主持人。 公共卫生影响：证明农村CG可以使用NiteCAPP针对睡眠，唤醒/压力，炎症 和相关的健康问题对多个利益攸关方，包括农村社区团体，农村残疾人， 家庭、临床医生和政策制定者。