Interactive Cognitive Behavioral Therapy for Insomnia

失眠的互动认知行为疗法

• 批准号: 10010763
• 负责人: Hannah Arem
• 金额: $ 75.68万
• 依托单位: MEDIA REZ, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-03 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010763
• 关键词: Address; Adherence; Affect; American College of Physicians; Area; Beds; Behavioral; Breast Cancer survivor; Caffeine; Cancer Survivor; Caring; Cellular Phone; Cognitive; Cognitive Therapy; Computer software; Consensus; Custom; Data; Data Collection; Databases; Devices; Dropout; Early Diagnosis; Early treatment; Elements; Environmental Risk Factor; Fatigue; Feedback; Future; Goals; Habits; Health; Home environment; Hour; Human; Individual; Internet; Intervention; Interview; Learning; Link; Measurement; Measures; Medicine; Mental Depression; Modeling; Modification; Monitor; National Comprehensive Cancer Network; Online Systems; Outcome; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Phase; Physiological; Population; Process; Provider; Publishing; Quality of life; Randomized Controlled Trials; Recommendation; Records; Relaxation; Reporting; Schedule; Severities; Shapes; Sleep; Sleep disturbances; Sleeplessness; Source; Structure; Symptoms; System; Technology; Testing; Time; Training; Treatment Efficacy; Treatment Protocols; United States; Voice; Work; actigraphy; base; cancer therapy; cardiometabolism; clinically significant; cognitive training; commercialization; comorbidity; design; diaries; early drinking; effective therapy; efficacy testing; experience; group intervention; high risk; high risk population; immune health; improved; indexing; innovation; interest; mortality; multidisciplinary; neurobehavioral; phase II trial; programs; prototype; satisfaction; scale up; side effect; sleep pattern; smartphone Application; social factors; success; tool; treatment as usual; trial design; usability; user centered design; user-friendly

ABSTRACT This study aims to further develop and test our voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS). CBT-I is a structured, systematic program which delivers better and safer outcomes than prescription sleep medications. Non-pharmacologic approaches target physiologic, cognitive, behavioral, environmental, and social factors to improve sleep. Insomnia has numerous health consequences, particularly for this high-risk population, and too few trained CBT-I therapists are available to offer treatment. Online programs suffer from high dropout rates and are not appropriate to use ”just-in-time” before sleep (i.e. in the bedroom) due to stimulating screen exposures. Participants will interact with an internet-connected speaker to report sleep patterns and receive feedback, more closely mimicking the experience of an in-person provider than web-based programs. In Aim 1, our multidisciplinary team will invite n=16-20 BCS with insomnia to use the “Sleep Helper” prototype, collecting data both through participant observation and through week long at home rapid testing. We will use results to iteratively improve the program. We will refine and debug the prototype before conducting our Aim 2, week long at home pilot testing among n=20 BCS to compare sleep data collected by the program with validated self-report and objective measures, and to measure participant engagement and usability of the program. In our final aim we will test the program for efficacy using a randomized controlled trial design with n=58 BCS. We will measure differences between intervention and usual care from baseline to post six-week intervention. Our central hypothesis is that the intervention group will have significantly greater reductions in clinically significant insomnia as recorded by the Insomnia Severity Index. Secondarily, we will measure participant engagement with the program and user satisfaction. This intervention includes engaging and educational elements, and multiple areas of innovation which overcome current impediments to the delivery of scalable, automated CBT-I. We anticipate that the results will demonstrate efficacy of the CBT-I system on insomnia through a randomized controlled trial as well as more feedback on usability and acceptability of the system. Successful completion of Phase II aims will provide evidence to support our commercialization plan to provide this technology to the growing population of BCS with insomnia who lack access to trained CBT-I therapists, as well as to tailor it to other high-risk populations. We also plan to test it as part of a stepped-care model with in-person therapists.

摘要 这项研究旨在进一步开发和测试我们的语音激活技术，以提供认知组件 针对乳腺癌幸存者的失眠行为疗法(CBT-I)。CBT-I是一个结构化、系统化的 该计划提供了比处方睡眠药物更好和更安全的结果。非药理学 方法针对生理、认知、行为、环境和社会因素来改善睡眠。 失眠有许多健康后果，特别是对这些高风险人群，而且受过培训的人太少。 CBT-I治疗师可以提供治疗。在线课程面临着高辍学率的问题，而不是 由于刺激屏幕曝光，在睡前(即在卧室)适当使用“即时”。 参与者将与联网的扬声器互动，以报告睡眠模式并接收反馈， 与基于网络的程序相比，更接近于模拟面对面提供商的体验。在目标1中，我们的 多学科团队将邀请n=16-20名失眠的BCS使用“睡眠助手”原型，收集 通过参与者观察和在家中进行为期一周的快速测试。我们将使用结果来 反复改进程序。我们将在进行目标2周之前对原型进行改进和调试 在n=20个BC中进行长期在家试点测试，将该程序收集的睡眠数据与已验证的睡眠数据进行比较 自我报告和客观测量，并衡量参与者参与度和计划的可用性。在……里面 我们的最终目标是使用n=58 BCS的随机对照试验设计来测试该程序的有效性。我们 将衡量干预和常规护理之间的差异，从基线到干预后六周。我们的 中心假设是，干预组将有显著更大的临床显着降低 失眠严重程度指数记录的失眠。其次，我们将衡量参与者参与度 与程序和用户的满意度。这种干预包括参与性和教育性因素，以及 多个领域的创新，克服了目前交付可扩展的自动化CBT-I的障碍。 我们预计，该结果将通过随机抽样的方法证明CBT-I系统对失眠的疗效。 受控试验以及对系统可用性和可接受性的更多反馈。成功完成 第二阶段AIMS将提供证据支持我们的商业化计划，向 患有失眠的BCS人口不断增加，他们无法获得训练有素的CBT-I治疗师，也无法根据需要量身定做 其他高危人群。我们还计划将其作为与面对面治疗师一起进行的阶梯式护理模式的一部分进行测试。