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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00872118
Other study ID # NIAAA-Tran-AA014014
Secondary ID R21AA017291NIH G
Status Completed
Phase Phase 1
First received March 27, 2009
Last updated September 15, 2010
Start date April 2004
Est. completion date March 2008

Study information

Verified date September 2010
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date March 2008
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 26 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Brief Intervention for Socially Anxious Drinkers (BISAD)
integrated alcohol and social anxiety individual intervention
Enhanced Alcohol Skills Building and Education Program
alcohol-focused group intervention

Locations

Country Name City State
United States Psychology Department, University of Cincinnati Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary heavy drinking days pre-treatment, 1-month follow-up and 4-month follow-up No
Primary total alcohol consumption pre-treatment, 1-month follow-up and 4-month follow-up No
Primary drinking-related negative consequences pre-treatment, 1-month follow-up and 4-month follow-up No
Primary social (interactional) anxiety pre-treatment, 1-month follow-up and 4-month follow-up No
Secondary alcohol expectancies of social evaluative situations pre-treatment, 1-month follow-up and 4-month follow-up No
Secondary drink refusal self-efficacy in social situations pre-treatment, 1-month follow-up and 4-month follow-up No
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