Brief Intervention for Socially Anxious College Drinkers

NCT ID: NCT00872118

Last Updated: 2010-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-03-31

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.

Conditions

Alcohol Consumption; Alcohol Negative Consequences; Social Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Brief Intervention for Socially Anxious Drinkers

Group Type: EXPERIMENTAL

Brief Intervention for Socially Anxious Drinkers (BISAD)

Intervention Type: BEHAVIORAL

integrated alcohol and social anxiety individual intervention

2

Enhanced Alcohol Skills and Education Program

Group Type: ACTIVE_COMPARATOR

Enhanced Alcohol Skills Building and Education Program

Intervention Type: BEHAVIORAL

alcohol-focused group intervention

Interventions

Brief Intervention for Socially Anxious Drinkers (BISAD)

integrated alcohol and social anxiety individual intervention

Intervention Type: BEHAVIORAL

Enhanced Alcohol Skills Building and Education Program

alcohol-focused group intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

University of Cincinnati

Principal Investigators

Giao Q. Tran, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Psychology Department, University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

R21AA017291

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant R21AA014014

Identifier Type: -

Identifier Source: secondary_id

NIAAA-Tran-AA014014

Identifier Type: -

Identifier Source: org_study_id