Sleep-SMART for Veterans with MCI and Insomnia: A Pilot Study

背景：轻度认知障碍(MCI)是老年退伍军人的一个重要公共卫生问题，原因是 进展为痴呆症的风险增加，死亡率增加。失眠在MCI中很常见(发生 高达60%的患者)，并增加了患痴呆症、残疾和生活质量差的风险。MCI和 退伍军人的失眠症比平民更高，因此退伍军人患有MCI并伴有失眠 代表了特别高风险的人群。失眠的黄金标准治疗--认知行为 失眠治疗(CBT-I)是一种多组分的行为干预。然而，认知障碍 MCI患者的经验可能会限制CBT-I的进步速度。内存支持的使用 策略可以改善患者对治疗信息的回忆，提高治疗依从性，并改善 治疗结果。认知症状管理和康复治疗(CogSMART)提供 改善学习、记忆、注意力和执行功能的补偿策略。CogSMART有 已被证明可以改善认知、功能能力、神经行为症状和生活质量 有认知障碍的退伍军人群体。将支持性CogSMART认知策略纳入 CBT-I有可能改善这些退伍军人的治疗学习、依从性和结果。 意义：此RR&D SPIRE研究项目将帮助我们开发和评估睡眠智能 (睡眠症状管理和康复治疗)，一种创新的用户知情方法 退伍军人MCI失眠的治疗。睡眠智能旨在提供以下核心组件 CBT-I与CogSMART的补偿认知策略培训一起加强干预 坚守和学习。提供这种支持性认知培训将帮助退伍军人进行认知 在维持遵守CBT-I方案方面的障碍，从而导致更快和更完整 治疗福利。目标：我们的原则调查目标包括：1)开发智能睡眠 干预和治疗手册；2)评估退伍军人睡眠智能的可行性和可接受性 以及3)探索睡眠智能对康复结果、生活质量、 睡眠和认知功能。方法：我们建议开发睡眠智能干预和 在项目的头6个月(第一阶段)使用参与式研究方法，由 干预映射适应框架。我们随后将评估睡眠的可行性和可接受性- SMART(第二阶段)，招募26名60岁及以上的退伍军人每周接受六次50分钟的 个人睡眠-通过安全的视频会议进行智能治疗。可行性将通过以下方式进行评估 招募指标、退伍军人参与治疗的程度、临床医生对治疗方案的忠诚度、 以及评估实施治疗的障碍。可接受性将主要通过以下方式评估 评估满意度、可接受性、适当性和遵守情况的问卷和其他措施 干预行动。虽然疗效不是我们的主要目标，但我们将收集一些初步数据来评估效果 用于辅助未来功率计算的大小。退伍军人将被要求完成具体的残疾衡量标准， 独立的生活技能、生活质量、睡眠和认知功能。下一步：从以下地点获取试点数据 本次调查将用于申请(S)进行随机对照试验，调查 睡眠智能对患有MCI和失眠的退伍军人的疗效与标准CBT-I或AS治疗的比较 像往常一样。这项调查的结果还将用于扩大执行和传播 努力。

Background: Mild cognitive impairment (MCI) is an important public health concern for aging Veterans due to the increased risk for progression to dementia and increased mortality. Insomnia is common in MCI (occurring in up to 60% of patients) and increases risk for dementia, disability, and poor quality of life. Rates of MCI and insomnia are higher among Veterans than civilians, thus aging Veterans with MCI and comorbid insomnia represent a particularly high-risk population. The gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a multi-component behavioral intervention. However, cognitive impairments experienced by individuals with MCI may limit the rate of progress in CBT-I. The use of memory support strategies can improve patient recall of therapeutic information, enhance treatment adherence, and improve treatment outcomes. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) provides compensatory strategies to improve learning, memory, attention, and executive functioning. CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive impairment. Incorporating supportive CogSMART cognitive strategies into CBT-I has the potential to improve treatment learning, adherence, and outcomes for this Veteran population. Significance: This RR&D SPiRE research project will assist us in developing and evaluating Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an innovative user-informed approach for treatment of insomnia in Veterans with MCI. Sleep-SMART is intended to provide the core components of CBT-I along with training in compensatory cognitive strategies from CogSMART to enhance intervention adherence and learning. Provision of this supportive cognitive training will assist Veterans with cognitive impairments in maintaining compliance with the CBT-I regimen, thereby leading to faster and more complete treatment benefits. Aims: Our principle aims for the investigation include: 1) developing the Sleep-SMART intervention and treatment manual; 2) assessing the feasibility and acceptability of Sleep-SMART in Veterans with MCI and insomnia; and 3) exploring the effects of Sleep-SMART on rehabilitation outcomes, quality of life, sleep, and cognitive functioning. Methodology: We propose to develop the Sleep-SMART intervention and manual over the first 6 months of the project (Phase I) using a participatory research approach guided by the Intervention Mapping Adapt framework. We will subsequently assess the feasibility and acceptability of Sleep- SMART (Phase II) by enrolling 26 Veterans ages 60 and older to receive six 50-minute weekly sessions of individual Sleep-SMART treatment via secure video-conferencing. Feasibility will be assessed through recruitment metrics, level of Veteran participation in the treatment, clinician fidelity to the treatment protocol, and evaluation of barriers to treatment implementation. Acceptability will be assessed primarily through questionnaires and other measures assessing satisfaction, acceptability, appropriateness, and adherence to the intervention. While efficacy is not our primary aim, we will collect some initial data for estimating effect sizes to assist in future power calculations. Veterans will be asked to complete specific measures of disability, independent living skills, quality of life, sleep, and cognitive functioning. Next Steps: Pilot data acquired from this investigation will be used for application(s) to conduct randomized controlled trials investigating the efficacy of Sleep-SMART in Veterans with MCI and insomnia compared to standard CBT-I or treatment as usual. The results of this investigation will also be used to inform scale-up implementation and dissemination efforts.