跳至主要内容
临床试验/NCT04531384
NCT04531384招募中不适用

Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Changes of galvanic skin response during the virtual reality based addiction assessment system

研究概览

简要总结

The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

详细描述

Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
  • Education level equal or more than 9 years;
  • Have normal or corrected-to-normal vision;
  • Have normal or corrected-to-normal hearing;
  • Less than 3 months before last drug use;

排除标准

  • Current substance use (except nicotine or caffeine);
  • History of disease which influence cognition,such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
  • Intelligence quotient less than 70.

结局指标

主要结局

Changes of galvanic skin response during the virtual reality based addiction assessment system

时间窗: in 1 year

The galvanic skin response is an emotional physiological indicator, and its unit is ohm.

次要结局

  • Treatment motivation(in 1 year)
  • Reaction inhibition ability(in 1 year)
  • Anxiety(in 1 year)
  • Depression(in 1 year)
  • Attentional bias related to drugs and emotional stimulation(in 1 year)
  • Risky decision-making(in 1 year)
  • Changes of electroencephalogram power spectrum during the virtual reality based addiction(in 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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