Brief Intervention for Socially Anxious College Drinkers (BISAD)
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Brief Intervention for Socially Anxious Alcohol Abusers |
- heavy drinking days [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
- total alcohol consumption [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
- drinking-related negative consequences [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
- social (interactional) anxiety [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
- alcohol expectancies of social evaluative situations [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
- drink refusal self-efficacy in social situations [ Time Frame: pre-treatment, 1-month follow-up and 4-month follow-up ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Brief Intervention for Socially Anxious Drinkers
|
Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)
integrated alcohol and social anxiety individual intervention
|
|
Active Comparator: 2
Enhanced Alcohol Skills and Education Program
|
Behavioral: Enhanced Alcohol Skills Building and Education Program
alcohol-focused group intervention
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 26 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, Ohio | |
| Psychology Department, University of Cincinnati | |
| Cincinnati, Ohio, United States, 45221-0376 | |
| Principal Investigator: | Giao Q. Tran, Ph.D. | University of Cincinnati |
More Information
Publications:
| Responsible Party: | Giao Q. Tran, Ph.D., University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00872118 History of Changes |
| Other Study ID Numbers: | NIAAA-Tran-AA014014, R21AA017291, NIH Grant R21AA014014 |
| Study First Received: | March 27, 2009 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Cincinnati:
|
alcohol consumption social anxiety brief intervention motivational interviewing cognitive behavioral |
Additional relevant MeSH terms:
|
Alcohol Drinking Anxiety Disorders Drinking Behavior Mental Disorders Ethanol Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013