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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00872118 |
The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.
Condition | Intervention | Phase |
---|---|---|
Alcohol Consumption Alcohol Negative Consequences Social Anxiety |
Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD) Behavioral: Enhanced Alcohol Skills Building and Education Program |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Brief Intervention for Socially Anxious Alcohol Abusers |
Enrollment: | 53 |
Study Start Date: | April 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Brief Intervention for Socially Anxious Drinkers
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Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)
integrated alcohol and social anxiety individual intervention
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2: Active Comparator
Enhanced Alcohol Skills and Education Program
|
Behavioral: Enhanced Alcohol Skills Building and Education Program
alcohol-focused group intervention
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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.
Ages Eligible for Study: | 18 Years to 26 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Psychology Department, University of Cincinnati | |
Cincinnati, Ohio, United States, 45221-0376 |
Principal Investigator: | Giao Q. Tran, Ph.D. | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Giao Q. Tran, Ph.D. ) |
Study ID Numbers: | NIAAA-Tran-AA014014, NIH Grant R21AA014014 |
Study First Received: | March 27, 2009 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00872118 History of Changes |
Health Authority: | United States: Federal Government |
alcohol consumption social anxiety brief intervention motivational interviewing cognitive behavioral |
Drinking Behavior Alcohol Drinking Ethanol |
Drinking Behavior Alcohol Drinking |