Brief Intervention for Socially Anxious College Drinkers (BISAD)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221-0376
      • Psychology Department, University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Giao Q. Tran, Ph.D., University of Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: March 27, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): September 16, 2010
• Last Update Submitted That Met QC Criteria: September 15, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: social anxiety; alcohol consumption; motivational interviewing; brief intervention; cognitive behavioral
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: NIAAA-Tran-AA014014; R21AA017291 (U.S. NIH Grant/Contract); NIH Grant R21AA014014