Automating and Obtaining FDA Approval for a Digital Intervention for Depression

阶段IIB摘要-期末 大量证据支持这样一种观点，即行为常规(或社交节奏)的规律性被打乱会导致 通过对内源性昼夜节律的影响导致情绪症状和全面发作，反之亦然 这种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 我们发现，增加行为节律的规律性对改善心理健康具有广泛的适用性 HealthRhythms，Inc.(www.achthhythms.com)，目标是利用移动技术增强我们的监控能力 并治疗这种情况，特别强调情绪障碍。 我们的产品愿景利用了智能手机的无处不在和亲密性，以及它们自动和连续地 代表抑郁症状的关键指标的行为的感觉参数在用户的 自然环境。它还利用智能手机的能力提供干预措施，这些干预措施很容易获得，可以 在最佳时机交付，或许最重要的是，具有极大的可扩展性。最后，智能手机技术为我们提供了 为数十万抑郁症患者带来经经验验证的心理社会干预的能力 否则将无法获得这种干预措施，从而加速其康复并防止复发。 在我们的第二阶段SBIR资金(R44MH113520-01-02)的赞助下，我们开发了这样的监控产品 (MEASURE)，并开发和测试了这样的数字干预平台(CUE)。到目前为止进行的分析表明 提示导致抑郁症状的减少比单独通过测量监测要大得多。我们现在提议 要：1)升级到CUE及其随附的临床医生仪表板以商业化销售；2)进行临床试验 对于FDA将CUE 2.0作为移动设备进行许可是必要的。CUE 2.0将包括增强的设计、更深入的 心理教育材料，以及提供行为改变建议的全自动引擎，以提高规律性 用户的社交和行为习惯。在我们第二阶段资金成果的基础上，这项SBIR第二阶段B提案 专注于将Cue推向市场，作为一种经过科学验证的、有利可图的数字干预手段，适用于抑郁症患者 伴有或不伴有焦虑症。具体目标是：目标1：开发和验证CUE 2.0全自动化 数字化干预平台。目标2：执行申请FDA CUE 2.0许可的所有必要步骤。

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.