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.

项目概要 与城市同行相比，农村家庭痴呆症护理人员 (CG) 更容易出现失眠和痴呆症。 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) 有望改善失眠和这些相关问题，但在农村很难获得 地区。我们的团队开发了专为 CG 量身定制的简短远程医疗 CBT-I (tele bCBT-I)（例如，包括压力管理/问题 解决），改善睡眠、觉醒、情绪、认知和炎症（从小到大的影响）。虽然远程医疗有所改善 尽管时间安排不灵活且缺乏训练有素的治疗师，但对于 CG 来说，这仍然是一个负担。因此，更多 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，但尚未得到证实 在农村 CG 中进行了测试。使用 NIH 阶段模型灵活框架和医学研究委员会的建议，我们 开发了 NiteCAPP（我们的远程 bCBT-I 协议的网络翻译）。 IA/B 阶段验证和测试显示出高度可行性 乡村地区单臂飞行员的​​可接受性以及睡眠、觉醒、情绪、负担和认知方面的改善（n=5）。 拟议的试验是下一个合乎逻辑的步骤——随机对照试验 (n=100) 中的 II 期测试，以确定疗效并进一步评估 可行性和可接受性。压力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，促进交感神经激活和下丘脑-垂体-肾上腺 (HPA) 破坏会对健康产生下游负面影响。拟议的试验测试了以下新假设： NiteCAPP 将通过针对共同的潜在机制——睡眠、 唤醒和炎症——从而使交感神经和 HPA 功能恢复正常。另一个新颖的方面 拟议的试验包括针对痴呆症患者 (PWD) 睡眠的行为策略。结果将是 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、负担和认知以及残疾人睡眠。 拟议的研究有四个具体目标。目标1重点关注NiteCAPP的可行性和可接受性 WebSHE（睡眠卫生教育 - 主动网络比较器）。目标 2 和 3 检查 NiteCAPP 的效果（与 WebSHE 相比） 关于 CG 主要/机械（睡眠、觉醒、炎症）和次要结果（健康、情绪、负担、认知）， 分别。由于残障人士的睡眠会影响 CG 睡眠，目标 4 检查 NiteCAPP 对残障人士睡眠的次要影响 （客观评估）。探索性目标检查 CG 主要和次要变化之间的关系 结果及其潜在的调解者/调节者。 公共卫生影响：证明农村 CG 可以使用 NiteCAPP 来针对睡眠、唤醒/压力、炎症 和相关的健康问题对多个利益相关者具有重要影响，包括农村 CG、农村残疾人、他们的 家庭、临床医生和政策制定者。