Automating and Obtaining FDA Approval for a Digital Intervention for Depression

抑郁症数字干预自动化并获得 FDA 批准

• 批准号: 10081882
• 负责人: Ellen Frank
• 金额: $ 97.47万
• 依托单位: HEALTH RHYTHMS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081882
• 关键词: Anxiety; Anxiety Disorders; Applications Grants; Artificial Intelligence; Behavior; Behavioral; Biological Markers; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Circadian Rhythms; Clinical; Clinical Research; Clinical Trials; Consultations; Cues; Data; Environment; FDA approved; Feedback; Funding; Funding Opportunities; Generations; Goals; Grant; Human; Individual; Intervention; Lead; Licensing; Link; Marketing; Measures; Medical Device; Mental Depression; Mental Health; Methods; Mission; Modeling; Modification; Monitor; Mood Disorders; Moods; National Institute of Mental Health; Parents; Patients; Pharmacologic Substance; Pharmacotherapy; Phase; Process; Reading; Recovery; Relapse; Risk; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Speed; Suggestion; Technology; Testing; Theoretical model; United States National Institutes of Health; Vision; Work; base; behavior change; convict; dashboard; depressed patient; depressive symptoms; design; digital; handheld mobile device; improved; intimate behavior; meetings; mobile application; mobile computing; mood symptom; prevent; psychoeducational; psychosocial; social; symptomatology; usability

Phase IIB Abstract -FINAL A large body of evidence supports the idea that disruptions in the regularity of behavioral routines (or ‘social rhythms’) can lead to the onset of mood symptoms and full-blown episodes via their impact on endogenous circadian rhythms and, conversely, that stable social routines protect against new mood episodes. Based on our conviction that monitoring, evaluating, and increasing the regularity of behavioral rhythms has broad applicability for improving mental health, we established HealthRhythms, Inc. (www.healthrhythms.com) with the goal of using mobile technology to enhance our capacity to monitor and treat such conditions, with a particular emphasis on mood disorders. Our product vision capitalizes on the ubiquity and intimacy of smartphones and their capacity to automatically and continuously sense parameters of behavior that represent key indicators of depressive symptomatology captured on a 24/7 basis in the user’s natural environment. It also capitalizes on the capacity of smartphones to deliver interventions that are easily accessible, can be delivered with optimal timing and, perhaps most important, are enormously scalable. Finally, smartphone technology gives us the capacity to bring empirically validated psychosocial interventions to the hundreds of thousands of depressed patients who otherwise would not be able to access such interventions and, thus, speed their recovery and prevent relapse. Under the auspices of our Phase II SBIR funding (R44MH113520-01-02), we have developed both such a monitoring product (Measure) and have developed and tested such a digital intervention platform (Cue). Analyses conducted to date indicate that Cue leads to significantly greater decreases in depressive symptomatology than monitoring alone via Measure. We now propose to: 1) upgrade to Cue and its accompanying clinician dashboard to be commercially marketable and 2) carry out the clinical trial necessary for FDA licensing of Cue 2.0 as a mobile device. Cue 2.0 will include enhanced designs, more in-depth psychoeducational material, and a fully automated engine for delivering behavior change suggestions to improve the regularity of users’ social and behavioral routines. Building on the accomplishments of our Phase II funding, this SBIR Phase IIB proposal is focused on bringing Cue to market as a scientifically validated and profitable digital intervention for individuals with depression with or without co-occurring anxiety disorder. The Specific Aims are: Aim 1: Develop and validate Cue 2.0 a fully automated digital intervention platform. Aim 2: Carry out all necessary steps to apply for FDA licensing of Cue 2.0.

IIB期摘要-终稿 大量的证据支持这样一种观点，即行为常规（或“社会节奏”）的规律性中断会导致 情绪症状的发作和全面发作通过其对内源性昼夜节律的影响，相反， 稳定的社交习惯可以防止新的情绪发作。基于我们的信念，监测、评估和 增加行为节律的规律性对于改善心理健康具有广泛的适用性，我们建立了 HealthRhythms，Inc.（www.healthrhythms.com），目标是利用移动的技术来提高我们的监测能力 并治疗这些疾病，特别是情绪障碍。 我们的产品愿景利用智能手机的普遍性和亲密性，以及它们自动和持续地 行为的感觉参数，其代表在用户的24/7基础上捕获的抑郁性神经病学的关键指标， 自然环境它还利用智能手机的能力，提供易于获得的干预措施， 以最佳时机交付，而且也许最重要的是，具有极大的可扩展性。最后，智能手机技术给了我们 有能力为成千上万的抑郁症患者提供经经验验证的心理社会干预， 否则，他们将无法获得这些干预措施，从而加快他们的康复和防止复发。 在我们的第二阶段SBIR资金（R44 MH 113520 -01-02）的支持下，我们开发了这样的监测产品 （测量），并开发和测试了这样一个数字干预平台（Cue）。迄今进行的分析表明， 与单独通过测量进行监测相比，提示导致抑郁症的显著下降。我们现建议 目的：1）升级Cue及其附带的临床医生仪表板，使其具有商业市场价值，2）开展临床试验 这是将Cue 2.0作为移动终端获得FDA许可所必需的。Cue 2.0将包括增强的设计，更深入的 心理教育材料，以及用于提供行为改变建议以提高规律性的全自动引擎 用户的社交和行为习惯。在我们第二阶段资金的成就的基础上， 专注于将Cue推向市场，作为抑郁症患者的科学验证和有利可图的数字干预措施 有无焦虑症并存具体目标是：目标1：开发和验证Cue 2.0全自动 数字化干预平台。目标2：执行申请Cue 2.0 FDA许可的所有必要步骤。