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临床试验/NCT02742246
NCT02742246已完成不适用

Efficacy and Mechanisms of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorders

Yale University4 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2017年2月14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
99
试验地点
4
主要终点
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back

研究概览

简要总结

Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use

详细描述

Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.

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
None

入排标准

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

入选标准

  • Individuals will be included who:
  • Are 18 years of age or older.
  • Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
  • Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
  • Are willing to provide locator information for follow-up, and
  • Are fluent in English and have a 6th grade or higher reading level.

排除标准

  • Individuals will be excluded who:
  • Have an untreated bipolar or schizophrenic disorder,
  • Have a current legal case pending such that incarceration during the 8-week protocol is likely,
  • Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
  • Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).

结局指标

主要结局

Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back

时间窗: Baseline up to 8 weeks

The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.

Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back

时间窗: from end of treatment at week 8 up to 6 months

The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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