Brief Intervention for Socially Anxious College Drinkers

Phase 1

Completed

• Conditions: Alcohol Consumption; Social Anxiety; Alcohol Negative Consequences
• Interventions: Behavioral: Enhanced Alcohol Skills Building and Education Program; Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)

• Registration Number: NCT00872118
• Lead Sponsor: University of Cincinnati

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2007-04
• Study Completion: 2008-03
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-31
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Enhanced Alcohol Skills Building and Education Program	Enhanced Alcohol Skills and Education Program
1	Brief Intervention for Socially Anxious Drinkers (BISAD)	Brief Intervention for Socially Anxious Drinkers

Primary Outcome Measures

Name	Time	Method
drinking-related negative consequences	pre-treatment, 1-month follow-up and 4-month follow-up
social (interactional) anxiety	pre-treatment, 1-month follow-up and 4-month follow-up
heavy drinking days	pre-treatment, 1-month follow-up and 4-month follow-up
total alcohol consumption	pre-treatment, 1-month follow-up and 4-month follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Psychology Department, University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States