Brief Intervention for Socially Anxious College Drinkers (BISAD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00872118
First received: March 27, 2009
Last updated: September 15, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872118

Locations
United States, Ohio
Psychology Department, University of Cincinnati
Cincinnati, Ohio, United States, 45221-0376
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Giao Q. Tran, Ph.D. University of Cincinnati
  More Information

Publications:
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.

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 August 28, 2014