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.

项目总结 与城市同龄人相比，农村家庭痴呆症照顾者(CG)面临更多的失眠和 相关的健康问题(压力、炎症、抑郁、焦虑、认知障碍)。认知行为疗法 治疗失眠(CBT-I)有望改善失眠和这些相关问题，但在农村地区很难获得 区域。我们的团队开发了专为CGs量身定做的Brief TeleHealth CBT-I(Tele bCBT-I)(例如，包括压力管理/问题 改善睡眠、唤醒、情绪、认知和炎症(影响从小到大)。随着远程医疗的改善， 由于缺乏灵活的时间安排和缺乏训练有素的治疗师，这对社区心理医生来说仍然是沉重的负担。因此，更多 我们需要进行研究。网络交付将增加访问，并且网络CBT-I对非CG成年人有效，但一直没有 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的建议，我们 开发了NiteCAPP(我们的远程bCBT-I协议的网络翻译)。阶段IA/B验证和测试显示高度可行性 和可接受性，以及在睡眠、觉醒、情绪、负担和认知方面的改善。 拟议的试验是下一个合乎逻辑的步骤--随机对照试验(n=100)的第二阶段测试，以确定疗效和进一步评估 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 CGS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 (百帕)对下游健康有负面影响的干扰。拟议的试验检验了新的假设，即 NiteCAPP将通过针对CG共同的潜在机制-睡眠，改善CG的健康、情绪、负担和认知。 唤醒和炎症--因此，交感神经和下丘脑-PA功能恢复正常。小说的另一个方面 拟议的试验包括针对痴呆症(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PWD睡眠。 这项拟议的研究有四个具体目标。目标1重点研究NiteCAPP的可行性和可接受性 睡眠卫生教育-主动网络比较器。目标2和3检查NiteCAPP的影响(与WebSHE相比) 关于CG主要/机制(睡眠、觉醒、炎症)和次要结果(健康、情绪、负担、认知)， 分别进行了分析。由于PWD的睡眠会影响CG睡眠，因此Aim 4研究了NiteCAPP对PWD睡眠的次要影响 (客观评估)。一个探索性的目的是检查主要和次要的CG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：证明农村社区社区可以使用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攸关方具有重要影响，包括农村社区卫生组织、农村残疾人、他们的 家庭、临床医生和政策制定者。