Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents

项目摘要/摘要 在过去的20年里，美国的自杀率上升了近35%，其中- 沃德趋势几乎在所有人口统计群体中都存在。自那以来，价格进一步上涨 新冠肺炎大流行开始了。尽管减少自杀的雄心勃勃的目标和大量的美联储- 在个人和私人投资方面，自杀率继续有增无减。迄今为止，占主导地位的 在美国，减轻自杀风险的方法是二级预防。通常情况下，这些专业- GRAS确定至少有过自杀未遂的人复发的风险 一次。虽然二级预防至关重要，但大多数自杀死亡都发生在第一次自杀之后。 尝试。因此，在发展早期进行有针对性的初级预防是至关重要的。最新的原则- 玛丽预防计划是密集的、昂贵的，由训练有素的心理医生提供 卫生服务提供者，他们供不应求。传统的面对面治疗也不适用于 许多人生活在服务不足的社区，不受青少年的欢迎，他们更喜欢数字- 在他们的设备上进行TAL交付。这项高风险、高回报的提案解决了这些限制 和需求。我们使用实验治疗学的方法来评估独立的和 两种非常规但可扩展的干预措施的联合疗效：经皮迷走神经 针对情绪失调的神经刺激(TVNS)，以及支持同伴的智能手机应用程序 与社会孤立作斗争。这些低成本的干预措施带来了很大的希望，但并没有 以前被使用过，可以接触到大量的青少年，有很大的潜力减少亲 自杀率很高。我们将招收212名13-17岁的青少年，他们在 至少两个导致自杀的突出危险因素(例如，自残、虐待)。使用2×2的De- 签字，青少年将被随机分配接受(1)TVNS至TAR的30天治疗- 获得情绪失调，(2)针对社交孤立的同伴支持手机应用，(3)tVNS+a 同伴支持电话应用程序，或(4)通过监控和访问重新提供照常治疗 消息来源。近端机制(情绪调节障碍、社会隔离)的干预效果 功效信号(如生理反应、自残)和目标结果(自杀意念， 自杀行为)将在干预后和一年的随访中立即进行评估。 将每天监测治疗数据，以微调这两种干预措施的剂量。这一转变- 积极和创新的提案测试了两种新的、可扩展的预防性干预措施，旨在 通过使用数字技术来解决以下核心机制： 自杀风险。

PROJECT SUMMARY / ABSTRACT Over the past two decades, suicide rates have increased nearly 35% in the U.S., with up- ward trends in nearly all demographic groups. Further increases have occurred since the COVID-19 pandemic began. Despite ambitious goals for reducing suicides and significant fed- eral and private investment, suicide rates continue to rise unabated. To date, the predominant approach to mitigating suicide risk in the U.S. is secondary prevention. Typically, these pro- grams identify risk of recurrence among those who have already attempted suicide at least once. Although secondary prevention is crucial, the majority of deaths by suicide occur on first attempt. Thus, targeted primary prevention earlier in development is essential. Most current pri- mary prevention programs are intensive, expensive, and delivered by highly trained mental health providers, who are in short supply. Traditional face-to-face therapy is also unavailable to many who live in underserved communities, and disliked by adolescents, who much prefer digi- tal delivery on their devices. This high-risk, high-reward proposal addresses these limitations and needs. We use an experimental therapeutics approach to evaluate the independent and combined efficacies of two unconventional but scalable interventions: transcutaneous vagus nerve stimulation (tVNS) to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. These low-cost interventions, which hold strong promise but have not been used before, can reach large numbers of adolescents, with much potential to reduce pro- spective suicide risk. We will enroll 212 adolescents, ages 13-17 years, who show elevations on at least two prominent risk factors for suicide (e.g., self-injury, maltreatment). Using a 2 × 2 de- sign, adolescents will be assigned randomly to receive 30 days of treatment with (1) tVNS to tar- get emotion dysregulation, (2) a peer-support phone app to target social isolation, (3) tVNS + a peer-support phone app, or (4) enhanced treatment as usual with monitoring and access to re- sources. Intervention effects on mechanisms (emotion dysregulation, social isolation) proximal efficacy signals (e.g., physiological reactivity, self-harm) and target outcomes (suicidal ideation, suicidal behaviors) will be evaluated immediately post-intervention and at one-year follow-up. Treatment data will be monitored daily to fine-tune dosing of both interventions. This transforma- tive and innovative proposal tests two novel, scalable preventive interventions designed to “meet adolescents where they are" by using digital technologies to address core mechanisms of suicide risk.