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， 进展为痴呆症的风险增加，死亡率增加。轻度认知功能障碍（MCI）常见， 高达60%的患者），并增加痴呆、残疾和生活质量差的风险。MCI和 退伍军人的失眠率高于平民，因此患有MCI和共病失眠的退伍军人 是一个特别高风险的人群。失眠的金标准治疗，认知行为 行为障碍治疗（CBT-I）是一种多成分的行为干预。然而，认知障碍 MCI患者的经历可能会限制CBT-I的进展速度。使用内存支持 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 补偿策略，以改善学习，记忆，注意力和执行功能。CogSMART拥有 已被证明可以改善认知，功能能力，神经行为症状和各种生活质量 有认知障碍的退伍军人。将支持性CogSMART认知策略 CBT-I有潜力改善退伍军人群体的治疗学习，依从性和结果。 意义：这个RR & D SPiRE研究项目将帮助我们开发和评估Sleep-SMART （睡眠症状管理和康复治疗），一个创新的用户知情的方法， 治疗患有MCI的退伍军人的失眠。Sleep-SMART旨在提供 CBT-I沿着CogSMART的补偿认知策略培训，以加强干预 坚持和学习。提供这种支持性的认知训练将有助于退伍军人的认知 在维持CBT-I方案的依从性方面的障碍，从而导致更快和更完全的 治疗益处。目的：我们的主要研究目标包括：1）开发睡眠智能 干预和治疗手册; 2）评估Sleep-SMART在退伍军人中的可行性和可接受性 MCI和失眠; 3）探索Sleep-SMART对康复结果，生活质量， 睡眠和认知功能方法：我们建议开发Sleep-SMART干预， 在项目（第一阶段）的前6个月，使用参与性研究方法， 干预映射适应框架。随后，我们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6次50分钟的 通过安全的视频会议进行个人Sleep-SMART治疗。可行性评估将通过 招募指标、退伍军人参与治疗的水平、临床医生对治疗方案的忠诚度， 和评估治疗实施的障碍。可接受性将主要通过 问卷调查和其他措施，评估满意度，可接受性，适当性和遵守 干预。虽然疗效不是我们的主要目标，但我们会收集一些初步数据以估计疗效 以帮助未来的功率计算。退伍军人将被要求完成残疾的具体措施， 独立生活技能、生活质量、睡眠和认知功能。后续步骤：从 本研究将用于进行随机对照试验的申请， 与标准CBT-I或治疗相比，Sleep-SMART在患有MCI和失眠症的退伍军人中的疗效 往常这项调查的结果也将用于为扩大实施和传播提供信息 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.