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临床试验/NCT03928626
NCT03928626终止不适用

Brief ROC Training Effects on Alcohol Drinking

Yale University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
57
试验地点
1
主要终点
Timeline followback (TLFB)

研究概览

简要总结

The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a training (ROC-T) visit, (3) a post-intervention assessment visit, and (4) 1-2 phone/online follow-up assessments.

The study will take up to 10 hours of the participants' time.

详细描述

The investigators propose to test the efficacy of such training by randomizing 120 individuals who report alcohol drinking to the following conditions: (1) a brief training in cognitive regulation and (2) a control or no-training condition. Training will be delivered in a computerized session (approximately 60 minutes). If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy while viewing images of alcoholic drinks. The strategy would be to follow instructions to think about the adverse outcomes associated with continued alcohol drinking. If randomized into the control condition, participants will only view non-alcohol-related images with no use of strategy. After all the training sessions are completed, participants will complete several follow-ups. The investigators will evaluate the effects of training on alcohol drinking pre- and post-training.

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
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults ages 18-25
  • •Capability of performing the experimental tasks (e.g., can read, able to use computers)
  • •Native or fluent speaker of English
  • •Provides informed consent
  • •Normal or corrected-to-normal vision
  • •Willing to commit to the full length of the protocol
  • •Heavy drinking or binge-drinking

排除标准

  • •Present DSM disorders, apart from alcohol use disorders
  • •Reports of neurological or systemic disorders that can cause cognitive impairment
  • •Minor cognitive impairment evidenced by an inability to correctly understand study information
  • •Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).

研究组 & 干预措施

CRAVING REGULATION

Active Comparator

In the CRAVING REGULATION condition, participants will first read a brief essay about the adverse consequences of drinking alcohol. Then, participants may complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will be trained to use the information to inform the strategy they will use in the regulation of craving training (ROC-T). A single trial in the regulation of craving training will have two possible instructions: (a) STRATEGY: implement the strategy ("bring to mind the negative facts from the essay") and (b) LOOK: to merely observe the image and allow natural responses to come. Participants will follow the instructions; followed by an alcohol-related picture, a brief delay, and will then rate their craving. Participants will then be instructed to use this strategy in daily life situations when they might drink.

干预措施: Regulation of craving (Behavioral)

CONTROL (NO REGULATION)

Placebo Comparator

In the CONTROL condition, participants will first read a brief essay about a non-alcohol-related topic (e.g., color perception). Then, participants will complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will view images of objects that are unrelated to alcohol. Furthermore, participants in the control condition will not practice any strategy in the regulation of craving task (ROC-T). That is, in the CONTROL condition, participants would merely observe the image and allow natural responses to come (i.e., LOOK instruction) and rate how colorful is each item (this controls for task time and experiment setting).

干预措施: Control (NO REGULATION) (Behavioral)

结局指标

主要结局

Timeline followback (TLFB)

时间窗: Baseline (first visit) to post-intervention (an average of one week after first visit)

The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.

次要结局

  • Frequency of regulating drinking + craving.(Will be measured at post-intervention (one week after first visit))
  • Timeline followback (TLFB)(First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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