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

项目摘要 抑郁症影响着美国320多万青少年，发病率和自杀率不断上升， 会对个人、社会和经济造成毁灭性的影响。对青少年抑郁症的有效护理有限 由于缺乏机会，供应商短缺，等待名单很长，耻辱，无效或部分有效， 药理学选择。许多患有抑郁症的青少年最初被诊断并接受治疗， 不幸的是，初级保健提供者的时间、培训和选择往往有限， 治疗的守门人迫切需要可获得的，具有成本效益的和临床验证的 为被诊断患有抑郁症的青少年提供治疗选择，特别是在初级保健环境中。数字 健康干预是一个令人兴奋的和有前途的新方向，为精神卫生治疗与强大的 增加获得护理的可能性。在这一时期，这种技术尤其重要和及时。 强制性的身体距离，预计会增加社会孤立，加剧 接受照顾。目前可用的商业数字健康选项广泛缺乏临床验证，无法使 强烈的医疗要求，并不是专门为青少年设计的。我们的目标是开发一种FDA批准的， 自我指导，认知行为疗法（CBT）为基础的移动的程序（Limbix Spark），由 初级保健提供者和精神科医生，并作为一线治疗用于家庭患者。 Limbix Spark实现了行为激活，这是一种关键的CBT技能，可以提供愉悦感或掌握感 通过自我监测活动，以减少抑郁症状和改善功能结果。给定 年轻人容易和偏好技术解决方案，适合年龄和从事移动的 干预既有益又令人愉快。基于可行性试验的结果， 高可行性和参与度，以及临床上有意义的抑郁症减少的初步证据 在拟议的快速通道的第一阶段，我们将进行严格的测试，以优化我们的Limbix Spark 编程并展示高可用性，构建符合法规的平台，并为II期临床试验做准备。 在第二阶段，我们将通过进行一项双盲安慰剂试验来证明Limbix Spark的临床有效性。 对照、随机临床试验，从初级保健和精神科招募患者 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， 是唯一有资格进行拟议的研究和商业化Limbix火花作为一个青少年 抑郁症处方数字治疗，加速获得护理严重不足的人口。

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.