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.

项目总结/摘要 在过去的二十年里，美国的自杀率上升了近35%，与上- 几乎所有人口群体的趋势。自2000年以来， 2019冠状病毒病疫情开始。尽管有雄心勃勃的目标，以减少自杀和显着的美联储- 在国家和私人投资的推动下，自杀率有增无减。到目前为止，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- 克确定复发的风险在那些谁已经试图自杀至少 一次虽然二级预防至关重要，但大多数自杀死亡发生在第一次 企图。因此，在发展早期进行有针对性的初级预防至关重要。最新的pri- 玛丽的预防计划是密集的，昂贵的，并提供了训练有素的心理 医疗服务提供者供不应求。传统的面对面治疗也无法 许多人生活在服务不足的社区，不受青少年的欢迎，而青少年更喜欢数字化， 在他们的设备上聊天交付。这个高风险、高回报的提案解决了这些局限性 和需求我们使用实验治疗方法来评估独立的， 两种非传统但可扩展的干预措施的联合疗效：经皮迷走神经 神经刺激（tVNS）针对情绪失调，和同行支持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有很大的希望，但没有 以前使用过的，可以接触到大量的青少年，有很大的潜力，以减少亲， 潜在的自杀风险我们将入组212名13-17岁的青少年，他们在 至少两个显著的自杀风险因素（例如，自伤、虐待）。使用2 × 2 de- 体征，青少年将随机分配接受30天的治疗（1）tVNS， 情绪失调，（2）针对社交孤立的同龄人支持电话应用程序，（3）tVNS + a 同行支持电话应用程序，或（4）加强治疗，如往常一样，监测和访问重新- 源对近端机制（情绪失调、社会隔离）的干预效果 功效信号（例如，生理反应，自我伤害）和目标结果（自杀意念， 自杀行为）将在干预后立即进行评估，并在一年随访时进行评估。 将每天监测治疗数据，以微调两种干预措施的给药。这种转变- 一项创新的提案测试了两种新颖的、可扩展的预防性干预措施， “满足青少年在哪里”，通过使用数字技术，以解决核心机制， 自杀风险