Interactive Cognitive Behavioral Therapy for Insomnia

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，以提供认知的组成部分， 失眠行为疗法（CBT-I）的乳腺癌幸存者（BCS）。CBT-I是一个结构化、系统化的 该计划提供比处方睡眠药物更好，更安全的结果。非药物 方法针对生理、认知、行为、环境和社会因素来改善睡眠。 Incidence有许多健康后果，特别是对这一高风险人群， CBT-I治疗师可提供治疗。在线课程的辍学率很高， 由于屏幕曝光的刺激性，适合在睡觉前（即在卧室）使用“即时”。 参与者将与互联网连接的扬声器互动，报告睡眠模式并获得反馈， 比基于网络的程序更接近地模仿亲自提供者的体验。在目标1中， 多学科团队将邀请n=16-20名患有失眠症的BCS使用“睡眠助手”原型，收集 通过参与者观察和为期一周的家庭快速测试获得数据。我们将使用结果来 迭代地改进程序。我们将完善和调试的原型，然后进行我们的目标2，星期 在n=20名BCS中进行长期在家试点测试，以将该计划收集的睡眠数据与经验证的 自我报告和客观的措施，并衡量参与者的参与和可用性的计划。在 我们的最终目标是使用随机对照试验设计（n=58 BCS）测试该方案的有效性。我们 将测量从基线到六周干预后干预和常规护理之间的差异。我们 中心假设是，干预组将有显着更大的减少临床显著 失眠严重程度指数记录的失眠。其次，我们将衡量参与者的参与度 程序和用户满意度。这种干预包括参与和教育内容， 创新的多个领域，克服了目前的障碍，交付可扩展的，自动化的CBT-I。 我们预计，结果将证明CBT-I系统对失眠症的疗效，通过随机 控制试验以及更多的反馈的可用性和可接受性的系统。成功完成 第二阶段的目标是提供证据，以支持我们的商业化计划， 越来越多的患有失眠症的BCS患者无法获得经过培训的CBT-I治疗师， 其他高危人群。我们还计划将其作为一个阶梯式护理模式的一部分进行测试，并与现场治疗师进行交流。

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.