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临床试验/NCT05343039
NCT05343039已完成不适用

Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents

University of Notre Dame2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30

研究概览

简要总结

Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, suicidality). Although psychosocial interventions for NSSI and substance use are effective for some, they are also expensive and require highly trained clinicians. Treatment is therefore often unavailable to disadvantaged adolescents and those who live rurally. Thus, lower-cost alternative treatments are needed. We will evaluate the efficacy of noninvasive transcutaneous vagus nerve stimulation (tVNS), an effective treatment for depression, in reducing risk for NSSI and substance misuse among vulnerable adolescents.

详细描述

The overarching goals of the proposed project are threefold. AIM 1: Evaluate the clinical efficacy of tVNS in reducing NSSI and alcohol misuse among vulnerable adolescents. We hypothesize that self-administered tVNS, delivered in 25-minute sessions, will reduce self-reported NSSI and alcohol use, improve adolescents' self-reported emotion regulation, and yield improvements in sympathetic and parasympathetic nervous system markers of emotion regulation and vulnerability to NSSI and alcohol misuse. AIM 2: Evaluate treatment adherence compared with traditional psychosocial interventions of similar duration. We hypothesize that adolescents will demonstrate greater treatment adherence than observed in traditional psychosocial interventions of similar duration, and rate tVNS as acceptable, unobtrusive, and favorable to face-to-face treatment. AIM 3: Evaluate maltreatment effects on tVNS. We hypothesize that tVNS will be effective for those with histories of maltreatment.

Although rarely used to date among adolescents, tVNS alters neural and emotional responses to sad stimuli, and among adults, reduces suicide risk up to five years later. At present, it is being evaluated as a treatment for alcohol misuse in a NIH-funded clinical trial. This suggests potential for treating NSSI, alcohol misuse, post-traumatic stress symptoms (PTSS), and other disorders of emotion dysregulation. As outlined above, we will test the efficacy of tVNS in altering behavioral, emotional, and autonomic nervous system risk for NSSI and alcohol misuse, evaluate adherence and acceptability of tVNS among adolescents, and determine if maltreatment histories moderate treatment response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have used alcohol
  • Have engaged in ≥ 3 episodes of NSSI in the past 6 months or ≥ 5 lifetime (1 of these 5 must be in the past year)
  • Own a smartphone (iPhone or Android)

排除标准

  • Schizophrenia
  • Have a cardiac pacemaker, implanted defibrillator, or implanted or metallic electronic device
  • Pregnant or breastfeeding
  • Have a history of seizures or epilepsy
  • Temperomandibular Joint Disorder
  • Bell's Palsy
  • Impaired cranial nerve function or facial pain

结局指标

主要结局

Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30

时间窗: 30 days

Participants will engage in 25-minute tVNS sessions daily.

Maintenance of Treatment Effects at 3 Months Post Intervention

时间窗: 3 months

Participants will be evaluated on the maintenance of any such treatment effects 3 months post intervention.

Change from Baseline in Emotion Regulation at Day 30

时间窗: 30 days

Participants will complete a 2-3 minute survey daily in which they are to report on different feelings and emotions such as happiness, sadness, and anger.

次要结局

  • Adherence to tVNS Intervention from Baseline to Day 30(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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