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: 10451555
• 负责人: Ellen Frank
• 金额: $ 99.05万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10451555
• 关键词: Agreement; Anxiety; Anxiety Disorders; Applications Grants; Artificial Intelligence; Behavior; Behavioral; Biological Markers; Cellular Phone; Circadian Rhythms; Clinical; Clinical Research; Clinical Trials; Consultations; Cues; Data; Environment; FDA approved; Feedback; Funding; Funding Opportunities; Generations; Goals; Grant; Human; Individual; Intervention; Licensing; Link; Marketing; Measures; Medical Device; Mental Depression; Mental Health; Mission; Modeling; Modification; Monitor; Mood Disorders; Moods; National Institute of Mental Health; Parents; Patients; Pharmacologic Substance; Pharmacotherapy; Phase; Probability; Process; 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; Vulnerable Populations; Work; artificial intelligence method; behavior change; convict; dashboard; depressed patient; depressive symptoms; design; digital intervention; handheld mobile device; improved; intimate behavior; meetings; mobile application; mobile computing; mobile sensing; mood symptom; psychoeducation; psychoeducational; psychosocial; relapse prevention; 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 - 最终版 大量证据支持这一观点，即行为习惯（或“社会节奏”）的规律性被破坏会导致 通过对内源性昼夜节律的影响来导致情绪症状和全面发作，反之， 稳定的社交习惯可以防止新的情绪发作。基于我们的信念，监控、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，我们确定 HealthRhythms, Inc. (www.healthrhythms.com) 的目标是利用移动技术增强我们的监控能力 并治疗此类疾病，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及其自动、持续的能力 代表抑郁症状关键指标的行为感知参数，以 24/7 的方式在用户的行为中捕获 自然环境。它还利用智能手机的能力来提供易于访问、可 以最佳时机交付，也许最重要的是，具有巨大的可扩展性。最后，智能手机技术为我们提供了 为数十万抑郁症患者提供经经验验证的心理社会干预的能力 否则将无法获得此类干预措施，从而加快康复速度并防止复发。 在我们的第二阶段 SBIR 资金 (R44MH113520-01-02) 的支持下，我们开发了这样的监控产品 （Measure）并开发并测试了这样一个数字干预平台（Cue）。迄今为止进行的分析表明 与仅通过测量进行监测相比，提示可显着减少抑郁症状。我们现在提议 目的：1) 升级到 Cue 及其随附的临床医生仪表板以实现商业销售，2) 进行临床试验 FDA 许可 Cue 2.0 作为移动设备所必需的。 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。基于我们第二阶段融资的成就，本 SBIR 第二阶段提案 专注于将 Cue 推向市场，作为一种针对抑郁症患者的经过科学验证且有利可图的数字干预措施 有或没有同时发生的焦虑症。具体目标是： 目标 1：开发并验证完全自动化的 Cue 2.0 数字干预平台。目标 2：执行所有必要步骤来申请 Cue 2.0 的 FDA 许可。