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临床试验/NCT00872118
NCT00872118已完成1 期

Brief Intervention for Socially Anxious Alcohol Abusers

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
53
试验地点
2
主要终点
drinking-related negative consequences

研究概览

简要总结

The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.

详细描述

Episodic alcohol abuse is common among college students. Recently, brief interventions focusing on motivational strategies and behavior skills to reduce heavy drinking and alcohol-related problems have shown beneficial small to medium effects in college drinkers who reported heavy drinking and/or alcohol-related problems. Most interventions have not taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem for college students that has been linked to excessive alcohol use. This project will extend knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies for social anxiety with an existing alcohol intervention designed for college students.

The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use, alcohol-related problems and social anxiety based on standardized measures. Phase I of the study focused on the development of the treatment manuals and measures of therapy integrity for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local university. During this phase therapists were trained to administer the manualized interventions to study participants (N=12). Phase II included further refinement of the therapy integrity measures and data collection for the pilot study (N=41). Participants were randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The pilot study provide preliminary data on the efficacy of the proposed intervention in reducing heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month follow-ups after treatment termination. These data provide estimated effect sizes for future testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to the conceptualization and methodological development of combined interventions for other substance use and psychiatric problems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • at least one heavy drinking episode (4 or more drinks for women and 5 or more for men)
  • occasional to frequent drinking related problems
  • moderate social anxiety symptoms

排除标准

  • history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation
  • current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality

结局指标

主要结局

drinking-related negative consequences

时间窗: pre-treatment, 1-month follow-up and 4-month follow-up

social (interactional) anxiety

时间窗: pre-treatment, 1-month follow-up and 4-month follow-up

heavy drinking days

时间窗: pre-treatment, 1-month follow-up and 4-month follow-up

total alcohol consumption

时间窗: pre-treatment, 1-month follow-up and 4-month follow-up

次要结局

  • alcohol expectancies of social evaluative situations(pre-treatment, 1-month follow-up and 4-month follow-up)
  • drink refusal self-efficacy in social situations(pre-treatment, 1-month follow-up and 4-month follow-up)

研究者

申办方类型
Other

研究点 (2)

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