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Brief Intervention for Socially Anxious College Drinkers (BISAD)

2010年9月15日 更新者:University of Cincinnati

Brief Intervention for Socially Anxious Alcohol Abusers

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

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

53

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45221-0376
        • Psychology Department, University of Cincinnati

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 26年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Brief Intervention for Socially Anxious Drinkers
integrated alcohol and social anxiety individual intervention
有源比较器:2
Enhanced Alcohol Skills and Education Program
alcohol-focused group intervention

研究衡量的是什么?

主要结果指标

结果测量
大体时间
heavy drinking days
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up
total alcohol consumption
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up
drinking-related negative consequences
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up
social (interactional) anxiety
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up

次要结果测量

结果测量
大体时间
alcohol expectancies of social evaluative situations
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up
drink refusal self-efficacy in social situations
大体时间:pre-treatment, 1-month follow-up and 4-month follow-up
pre-treatment, 1-month follow-up and 4-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Giao Q. Tran, Ph.D.、University of Cincinnati

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Tran, G.Q. (2008). Efficacy of a brief intervention for college hazardous drinkers with social anxiety: A randomized controlled pilot study. Alcoholism: Clinical and Experimental Research, 32 (Supplement), 190A.
  • Tran, G.Q., Lanman, S.A., Perciful, M.S., Thompson, R.D., & Smith, J.P. (2006). Promising inexpensive methods for recruiting college-age heavy drinkers for brief alcohol and social anxiety interventions. Alcoholism: Clinical and Experimental Research, 30 (Supplement), 101A.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年4月1日

初级完成 (实际的)

2007年4月1日

研究完成 (实际的)

2008年3月1日

研究注册日期

首次提交

2009年3月27日

首先提交符合 QC 标准的

2009年3月27日

首次发布 (估计)

2009年3月31日

研究记录更新

最后更新发布 (估计)

2010年9月16日

上次提交的符合 QC 标准的更新

2010年9月15日

最后验证

2010年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NIAAA-Tran-AA014014
  • R21AA017291 (美国 NIH 拨款/合同)
  • NIH Grant R21AA014014

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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