Limbix Spark: a CBT-based mobile intervention for adolescent depression

项目摘要 抑郁症在美国影响着320多万青少年，发病率和自杀率不断上升， 带来毁灭性的个人、社会和经济影响。对青少年抑郁症的有效护理是有限的 由于缺乏通道，提供者短缺，等待名单很长，耻辱，无效或部分有效 药理上的选择。许多患有抑郁症的青少年最初被诊断为抑郁症并接受治疗 初级保健提供者，不幸的是，他们通常只有有限的时间、培训和选择才能有效 看门人接受治疗。迫切需要可获得性、成本效益和临床验证的 为被诊断为抑郁症的青少年提供治疗选择，特别是在初级保健环境中。数位 健康干预代表了精神健康治疗令人兴奋和充满希望的新方向， 有可能增加获得护理的机会。在这一时期，这种技术尤为关键和及时 强制物理距离，预计这将增加社会孤立，并加剧 正在接受治疗。目前可用的商业数字健康选项普遍缺乏临床验证，无法使 强大的医学主张，并不是专门为青少年设计的。我们的目标是开发一种通过FDA批准的， 自我指导，基于认知行为疗法(CBT)的移动计划(Limbix Spark)，由以下公司开出 初级保健提供者和精神病学家，并将其商业化用于家庭患者作为一线治疗。 Limbix Spark实现了行为激活，这是一项关键的CBT技能，提供了一种愉悦感或掌控感 通过自我监测的活动来减少抑郁症状和改善功能结果。vt.给出 年轻人轻松接受并偏爱技术解决方案、适合年龄的、引人入胜的移动设备 干预可以是有益的，也是令人愉快的。以可行性试验论证的结果为基础 高度的可行性和参与性，以及临床上有意义的抑郁症减少的初步证据 症状，在提议的Fast Track的第一阶段中，我们将进行严格的测试以优化我们的Limbix Spark 规划和展示高可用性，构建符合法规的平台，并为第二阶段临床试验做准备。 在第二阶段，我们将通过双盲安慰剂来展示Limbix Spark的临床疗效 从初级保健和精神科招募和登记的患者进行的对照随机临床试验 诊所。该团队由资深企业家、研究专业人士、行业领袖和临床专家领导， 非常有资格进行拟议中的研究并将林比克斯·斯帕克作为青少年进行商业化 抑郁症处方数字治疗，加速获得严重缺乏服务的人群的护理。

Project Abstract Depression affects more than 3.2 million adolescents in the USA, with rising incidence and suicide rates that carry devastating personal, societal, and economic impact. Effective care for adolescent depression is limited due to lack of access, shortage of providers, long waitlists, stigma, and ineffective or partially effective pharmacological options. Many adolescents with depression are initially diagnosed and receive treatment from primary care providers, who, unfortunately, often have limited time, training, and options to be effective gatekeepers for treatment. There is an urgent need for accessible, cost-effective, and clinically-validated treatment options for adolescents diagnosed with depression, particularly in primary care settings. Digital health interventions represent an exciting and promising new direction for mental health treatment with strong potential to increase access to care. Such technology is especially critical and timely during this period of mandated physical distancing, which is expected to increase social isolation and exacerbate difficulties in receiving care. Currently available commercial digital health options widely lack clinical validation, cannot make strong medical claims, and are not specifically designed for adolescents. We aim to develop an FDA-cleared, self-guided, cognitive behavioral therapy (CBT)-based mobile program (Limbix Spark) to be prescribed by primary care providers and psychiatrists and commercialized for at-home patient use as first line treatment. Limbix Spark implements behavioral activation, a key CBT skill that provides a sense of pleasure or mastery through self-monitored activities to reduce depressive symptoms and improve functional outcomes. Given youth ease with and preference for technological solutions, an age-appropriate and engaging mobile intervention can be both beneficial and enjoyable. Building on outcomes from a feasibility trial demonstrating high feasibility and engagement, and preliminary evidence of clinically meaningful reductions in depressive symptoms, in Phase I of the proposed Fast Track, we will conduct rigorous testing to optimize our Limbix Spark program and show high usability, build a regulatory compliant platform, and prepare for a Phase II clinical trial. In Phase II, we will demonstrate clinical effectiveness of Limbix Spark by conducting a double-blind, placebo controlled, randomized clinical trial with patients recruited and enrolled from primary care and psychiatric clinics. The team, led by veteran entrepreneurs, research professionals, industry leaders, and clinical experts, is singularly qualified to conduct the proposed research and commercialize Limbix Spark as an adolescent depression prescription digital therapeutic, accelerating access to care for a severely underserved population.