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

Limbix Spark：基于 CBT 的青少年抑郁症移动干预

• 批准号: 10451988
• 负责人: SCOTT N COMPTON
• 金额: $ 172.1万
• 依托单位: LIMBIX HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10451988
• 关键词: Adolescent; Adverse event; Affect; Age; Behavioral; Caring; Childhood; Clinic; Clinical; Clinical effectiveness; Cognitive Therapy; Development; Diagnosis; Double-Blind Method; Enrollment; Feasibility Studies; Feedback; Gatekeeping; Generations; Goals; Health Services Accessibility; Home; Incidence; Industry; International; Intervention; Interview; Life; Major Depressive Disorder; Medical; Mental Depression; Mental Health; Mental disorders; Mission; Monitor; National Institute of Mental Health; Notification; Outcome; Participant; Patient Recruitments; Patients; Pharmacology; Phase; Phase II Clinical Trials; Placebo Control; Population; Primary Health Care; Provider; Psychiatrist; Randomized; Randomized Clinical Trials; Regulation; Research; Safety; Social isolation; Technology; Teenagers; Testing; Time; Training; Underserved Population; United States; Validation; Veterans; Waiting Lists; Youth; anxiety symptoms; base; care providers; child depression; clinically significant; commercialization; comorbidity; cost effective; depressive symptoms; design; digital; digital health; digital treatment; economic impact; effective therapy; expectation; experience; feasibility trial; functional outcomes; improved; meetings; new technology; patient safety; phase 2 designs; pleasure; preference; primary care setting; primary outcome; programs; psychoeducation; rate of change; recruit; secondary outcome; skills; social stigma; suicide rate; usability

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.

项目摘要 抑郁症在美国影响超过320万的青少年，发病率和自杀率上升 带来破坏性的个人，社会和经济影响。青少年抑郁症的有效护理有限 由于缺乏访问权，提供者缺乏，长期候补名单，污名和无效或部分有效 药理选择。许多抑郁症的青少年最初被诊断出来并接受 不幸的是，初级保健提供者经常有有效的时间，培训和选择有效 看门人治疗。迫切需要可访问，成本效益和临床验证 诊断为抑郁症的青少年的治疗选择，尤其是在初级保健环境中。数字的 健康干预措施代表了精神健康治疗的令人兴奋且有希望的新方向 潜力增加获得护理的机会。在此期间 强制性的身体距离，预计这会增加社会隔离并加剧困难 接受护理。目前可用的商业数字健康方案广泛缺乏临床验证，无法做到 强有力的医疗主张，不是专门为青少年设计的。我们旨在开发一个已清除FDA的， 自我引导的认知行为疗法（CBT）的移动程序（林峰SPARK） 初级保健提供者和精神科医生，并商业化用于家庭患者用作第一线治疗。 林峰火花实现行为激活，这是一种关键的CBT技能，可提供乐趣或精通感 通过自我监控的活动来减轻抑郁症状并改善功能结果。给出 青年人对技术解决方案的偏爱和偏爱，适合年龄且引人入胜的手机 干预既有益又令人愉快。以可行性试验的结果为基础 高可行性和参与度，以及抑郁症的临床有意义减少的初步证据 症状，在拟议的快速轨道的第一阶段，我们将进行严格的测试以优化我们 计划并显示高可用性，建立符合法规的平台，并为II期临床试验做准备。 在第二阶段，我们将通过进行双盲，安慰剂来证明肢峰火花的临床有效性 受招募并从初级保健和精神科入学的患者进行的对照，随机临床试验 诊所。该团队由资深企业家，研究专业人员，行业领导者和临床专家领导， 有资格进行拟议的研究并将其商业化为青少年 抑郁处方数字治疗，加快服务不足的人群的护理。

项目成果

Meaningful engagement: A crossfunctional framework for digital therapeutics.

• DOI: 10.3389/fdgth.2022.890081
• 发表时间: 2022
• 期刊: FRONTIERS IN DIGITAL HEALTH
• 作者: Strauss, Gabriel;Flannery, Jessica E.;Vierra, Elise;Koepsell, Xin;Berglund, Emily;Miller, Ian;Lake, Jessica I.
• 通讯作者: Lake, Jessica I.