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临床试验/NCT02016378
NCT02016378已完成3 期

EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents

University of Michigan2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in Youth Outcome Questionnaire-Self-report scores

研究概览

简要总结

This study investigates the effect of a computerized approach/avoidance retraining (aka cognitive bias modification) over and above treatment as usual for patients in treatment for substance use disorders. The computerized training entails viewing pictures of drug and non-drug related stimuli, and then using the computer to make the drug pictures smaller and the non-drug pictures larger. Participants will also take part in an EEG/event-related brain potential assessment at the beginning and end of treatment to identify brain measures that are associated with treatment response.

详细描述

Methodology Participants must be receiving treatment for substance use disorders in the adolescent program of the University of Michigan Addiction Treatment Services (UMATS) clinic. Participants must be between the ages of 14-65.

The study entails five components

  1. Neurophysiological assessment. (Baseline)
  2. Assessment of substance use and psychiatric disorders. (Baseline)
  3. Bias retraining treatment protocol. (after baseline, 6 training sessions over a two week period)
  4. Second neurophysiological assessment at the end of treatment. (6 weeks after baseline)
  5. Six-month follow-up to assess substance use and psychiatric disorders. (6 months after baseline)

Each component is described in more detail below:

  1. Assessment of substance use and psychiatric disorders will be completed using well-validated structured interviews and questionnaires. This assessment will take place as soon as participants can be scheduled following their entry into treatment at the UMATS clinic.
  2. Neurophysiological assessment will entail several procedures that reliably elicit brain responses that are associated with substance use disorders and antisocial behavior. The first neurophysiological assessment will take place as soon as participants can be scheduled following their entry into treatment at the UMATS clinic.

研究设计

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

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient in treatment for substance use disorders. Alcohol use problems. -

排除标准

  • Detoxification treatment. Severe mental illness (e.g., psychotic symptoms)

结局指标

主要结局

Change in Youth Outcome Questionnaire-Self-report scores

时间窗: baseline, 6 weeks and 6 months after the start of treatment

This instrument is used to track symptoms throughout treatment. It will be used at baseline, 2x week for 2 weeks, 6 weeks from baseline (end of treatment), and at a 6 month follow-up assessment. The primary outcome is the growth curve of the scores over time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Hicks

Research Assistant Professor

University of Michigan

研究点 (2)

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