跳至主要内容
临床试验/NCT05675553
NCT05675553招募中不适用

A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Desire for alcohol

研究概览

简要总结

We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater efficacy than traditional therapy in the treatment of alcohol use disorders.

详细描述

Based on artificial intelligence technology, face recognition technology, and 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 patients with alcohol use disorders, and compare with traditional treatment to verify the efficacy and safety of the Robot-assisted rehabilitation intelligent system in Chinese patients with alcohol use disorders.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-55;
  • Meeting DSM-5 criteria for alcohol use disorders;
  • Withdrawing alcohol for less than 12 months;
  • Ability to use computers;
  • Signing informed consent;

排除标准

  • Having comorbidities of other neuropsychiatric diseases;
  • Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
  • With a family history of mental illness
  • Not familiar with computer operation, unable to complete assessment and treatment.

研究组 & 干预措施

robot-assisted rehabilitation intelligent treatment

Experimental

Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system.

干预措施: robot-assisted rehabilitation intelligent treatment (Device)

treatment as usual

Other

Participants in the treatment-as-usual group were offered standard treatment at the mental health hospitals, which consisted of group and/or individual therapy, as determined by the clinical team.

干预措施: treatment as usual (Other)

robot-assisted rehabilitation intelligent treatment

Experimental

Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system.

干预措施: treatment as usual (Other)

结局指标

主要结局

Desire for alcohol

时间窗: 3 months

The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).

次要结局

  • Anxiety(3 months)
  • Change Readiness and Treatment Eagerness(3 months)
  • Impulsiveness(3 months)
  • Depression(3 months)
  • Perception of stress(3 months)
  • Sleep Quality(3 months)
  • coping style(3 months)
  • use of alcohol(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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