An Efficacy Trial of a Digital Therapeutic for Suicide Prevention

数字疗法预防自杀的功效试验

• 批准号: 10673941
• 负责人: Seth Feuerstein
• 金额: $ 79.51万
• 依托单位: OUI THERAPEUTICS, INC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-23 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10673941
• 关键词: Acceleration; Acute; Address; Adult; Appointment; Behavioral; Cause of Death; Cellular Phone; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Complement; Cost Savings; Decision Making; Development; Drug Prescriptions; Educational process of instructing; Effectiveness; Enrollment; Ensure; Event; Exercise; Feasibility Studies; Feedback; Feeling suicidal; Formularies; Future; General Population; Goals; Grant; Health; Health Personnel; Health Services Accessibility; Home; Hospitalization; Inpatients; Letters; Licensing; Marketing; Measures; Mediation; Mental Depression; Mental Health Services; Methods; Modality; National Institute of Mental Health; Outcome; Outpatients; Participant; Patients; Penetration; Persons; Pharmacologic Substance; Phase; Population; Prevention Protocols; Price; Provider; Public Health; Questionnaires; Randomized, Controlled Trials; Recording of previous events; Relaxation; Risk; Risk Reduction; Small Business Innovation Research Grant; Specialist; Suicide; Suicide attempt; Suicide prevention; Survival Analysis; System; Testing; Therapeutic; Time; United States Substance Abuse and Mental Health Services Administration; Update; Visit; Work; chatbot; clinical research site; commercial application; cost; cost estimate; digital; digital treatment; economic cost; effective therapy; efficacy evaluation; efficacy trial; emotion regulation; experience; improved; mobile application; open label; phase 1 study; phase 2 study; psychoeducation; psychoeducational; recruit; reducing suicide; relapse prevention; skills; standard care; suicidal behavior; suicidal patient; suicidal risk; suicide rate; time use; treatment as usual; trial comparing; usability

ABSTRACT Suicide is one of the top ten causes of death in the US and suicide rates have increased steadily over the last twenty years. Currently, the most effective treatment options are cognitive behavioral therapies for suicide prevention (CBT-SP), which have been shown to reduce both suicide attempt (SA) risk and suicide ideation (SI). However, access to these treatments is limited because there is a shortage of mental healthcare practitioners, especially suicide specialists. Furthermore, face-to-face therapy, which is the standard treatment modality, is costly and logistically prohibitive. As a consequence, most people who experience suicidal thoughts or behavior do not receive treatment. Oui Therapeutics therefore developed Aviva, a digital therapeutic application accessed via smartphone. It is based on two CBT-SP protocols (the Brief Cognitive Behavioral Therapy and Cognitive Therapy for Suicide Prevention protocol), is accessible, less costly than current treatment options, and consistently implements CBT-SP with high fidelity. Ready accessibility is particularly important for patients recently discharged after hospitalization for SA, as they are 40 times more likely to make another SA within 30 days of discharge than the general population. Oui Therapeutics has completed a Phase I SBIR study, creating a beta version of Aviva targeting the general adult population, and testing the usability and feasibility of this version of Aviva in a single-group, open-label trial. During the 8-week open-label trial, Aviva users showed clinically meaningful improvement on the Scale for Suicidal Ideation and the Patient Health Questionnaire. For the proposed Phase II study, we aim to: 1) add capabilities to enhance the usability of Aviva; 2a) determine the efficacy of Aviva in reducing SA and SI in a randomized controlled trial (RCT), and 2b) determine the mechanisms of action in Aviva in the RCT. SAs and SIs will be tested by enrolling 286 patients in a randomized controlled trial, administered at four clinical sites. Half of the participants will receive treatment as usual plus Aviva, and the other half will receive treatment as usual plus a sham app. We will use time-to-event survival analysis at 12 months to assess SAs and evaluate Aviva’s effects on SI at 6 months using a restricted likelihood repeated measures analysis. Aim 2b will be tested using mediation analyses to examine Aviva’s effects on participants' scores on the Monetary Choice Questionnaire and the Cognitive Emotion Regulation Questionnaire at three and six months. Upon successful completion of the phase II study, we expect Aviva to be ready for distribution in the market. To ensure affordability and accelerate the penetration of the product, Oui will also pursue licensing Aviva to a pharmaceutical company(s) that will work with payers to have Aviva included in their formularies. Ultimately, Oui seeks to curtail the multi-billion dollar economic costs associated with SA and SI and save lives by reducing suicide attempts by 50%.

摘要 自杀是美国十大死亡原因之一，自杀率在过去一年中稳步上升。 二十年目前，最有效的治疗选择是针对自杀的认知行为疗法 预防（CBT-SP），已被证明可以降低自杀企图（SA）风险和自杀意念 （SI）。然而，由于缺乏心理保健，获得这些治疗的机会有限 医生，尤其是自杀专家。此外，面对面的治疗，这是标准的治疗， 这种方式成本高，后勤上也不允许。因此，大多数有自杀经历的人 思想或行为不接受治疗。因此，Oui Therapeutics开发了Aviva，一种数字 通过智能手机访问治疗应用程序。它基于两个CBT-SP协议（简要认知 行为疗法和认知疗法预防自杀议定书），是可获得的， 目前的治疗方案，并始终实施CBT-SP高保真。准备好的可访问性是 对于SA住院后最近出院的患者尤其重要，因为他们是SA的40倍以上， 在出院后的30天内，可能会比普通人群更容易再次发生SA。Oui Therapeutics 完成了第一阶段SBIR研究，创建了针对普通成年人群的Aviva测试版， 在单组、开放标签试验中测试此版本Aviva的可用性和可行性。8周 在一项开放标签试验中，Aviva使用者在自杀意念量表上显示出具有临床意义的改善， 患者健康问卷。就拟议的第II期研究而言，我们的目的是：1）增加能力， Aviva的可用性; 2a）在随机对照试验中确定Aviva降低SA和SI的疗效 (RCT)和2b）确定RCT中Aviva的作用机制。SA和SI将由以下人员进行测试 在一项随机对照试验中招募了286名患者，在四个临床地点进行。一半的参与者 将接受常规治疗加Aviva，另一半将接受常规治疗加假应用程序。 我们将在12个月时使用时间-事件生存分析来评估SA，并评估Aviva对6个月时SI的影响 使用限制似然重复测量分析。目标2b将通过调解进行测试 分析了英杰华对参与者在货币选择问卷和 3个月和6个月时的认知情绪调节问卷。成功完成后 根据第二阶段研究，我们预计Aviva将准备好在市场上分销。为了确保可负担性， 为了加速产品的渗透，Oui还将寻求将Aviva授权给制药公司 该公司将与付款人合作，将英杰华纳入其处方集。最终，Oui寻求减少 与SA和SI相关的数十亿美元的经济成本，并通过减少自杀企图来挽救生命， 百分之五十