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

利用无创经皮迷走神经刺激和智能手机技术减少高度脆弱青少年的自杀行为和自杀

• 批准号: 10704540
• 负责人: Theodore Patrick Beauchaine
• 金额: $ 75.04万
• 依托单位: UNIVERSITY OF NOTRE DAME
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704540
• 关键词: 17 year old; Acceleration; Adaptive Behaviors; Address; Adolescence; Adolescent; Age; Biosensor; Brain; COVID-19 pandemic; Cause of Death; Cellular Phone; Data; Depressed mood; Detection; Development; Devices; Dose; Ear; Effectiveness; Emotional; Emotions; Enrollment; Family; Feeling suicidal; Fright; Future; Goals; Health Personnel; Hospitalization; Intervention; Investigational Therapies; Investments; Loneliness; Mental Depression; Mental Health; Monitor; Music; National Institute of Mental Health; Outcome; Patient Self-Report; Physiological; Population; Prevention; Prevention approach; Prevention program; Preventive service; Primary Prevention; Privatization; Protocols documentation; Public Health; Randomized; Recording of previous events; Recurrence; Reporting; Resources; Risk; Risk Factors; Rural; Secondary Prevention; Secure; Self-Injurious Behavior; Sensitivity and Specificity; Services; Signal Transduction; Social isolation; Stimulus; Structure; Suicide; Suicide attempt; Suicide prevention; Technology; Telephone; Testing; Training; Vagus nerve structure; Youth; combat; cost; design; digital; digital delivery; digital technology; emotion dysregulation; emotion regulation; follow-up; high reward; high risk; high risk behavior; improved; innovation; innovative technologies; insight; intervention cost; intervention delivery; intervention effect; maltreatment; mental training; negative affect; neighborhood disadvantage; neural; novel; peer; peer support; positive emotional state; post intervention; preference; preventive intervention; programs; prospective; recruit; reducing suicide; response; satisfaction; scale up; smartphone application; social; suicidal; suicidal adolescent; suicidal behavior; suicidal morbidity; suicidal risk; suicide rate; therapy design; treatment as usual; treatment duration; trend; underserved community; vagus nerve stimulation; vulnerable adolescent

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.

项目概要/摘要 过去 20 年来，美国的自杀率增加了近 35%， 几乎所有人口群体的病房趋势。自发布以来出现了进一步的增长 COVID-19 大流行开始了。尽管减少自杀的雄心勃勃的目标和显着的联邦 由于一般和私人投资，自杀率持续上升，有增无减。迄今为止，占主导地位的 在美国，降低自杀风险的方法是二级预防。通常，这些亲 克至少可以确定那些已经尝试过自杀的人的复发风险 一次。尽管二级预防至关重要，但大多数自杀死亡发生在初次预防 试图。因此，在发育早期进行有针对性的一级预防至关重要。目前最新的优先级 玛丽预防计划是密集的、昂贵的，并且由训练有素的心理人员提供 医疗服务提供者短缺。传统的面对面治疗也无法实现 许多人生活在服务匮乏的社区，并且不受青少年的欢迎，因为他们更喜欢数字化 在他们的设备上进行总计交付。这个高风险、高回报的提案解决了这些限制 和需求。我们使用实验治疗方法来评估独立和 两种非常规但可扩展的干预措施的综合疗效：经皮迷走神经 针对情绪失调的神经刺激（tVNS），以及一个同伴支持智能手机应用程序 对抗社会孤立。这些低成本的干预措施虽然前景广阔，但并未实现 以前曾使用过，可以覆盖大量青少年，有很大潜力减少亲 自杀风险。我们将招募 212 名年龄在 13 至 17 岁之间的青少年，他们在 至少有两个显着的自杀危险因素（例如自残、虐待）。使用 2 × 2 去 标志，青少年将被随机分配接受 30 天的治疗（1）tVNS 情绪失调，(2) 一款针对社交隔离的同伴支持手机应用程序，(3) tVNS + 同伴支持电话应用程序，或（4）照常加强治疗，通过监测和访问重新 来源。对近端机制（情绪失调、社会孤立）的干预效果 功效信号（例如，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，以微调两种干预措施的剂量。这种转变—— 积极和创新的提案测试了两种新颖的、可扩展的预防干预措施，旨在 通过使用数字技术来解决青少年的核心机制，“满足他们所在的青少年” 自杀风险。