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Brief Intervention for Socially Anxious College Drinkers (BISAD)

Primary Purpose

Alcohol Consumption, Alcohol Negative Consequences, Social Anxiety

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention for Socially Anxious Drinkers (BISAD)
Enhanced Alcohol Skills Building and Education Program
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring alcohol consumption, social anxiety, brief intervention, motivational interviewing, cognitive behavioral

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychology Department, University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Brief Intervention for Socially Anxious Drinkers

Enhanced Alcohol Skills and Education Program

Outcomes

Primary Outcome Measures

heavy drinking days
total alcohol consumption
drinking-related negative consequences
social (interactional) anxiety

Secondary Outcome Measures

alcohol expectancies of social evaluative situations
drink refusal self-efficacy in social situations

Full Information

First Posted
March 27, 2009
Last Updated
September 15, 2010
Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00872118
Brief Title
Brief Intervention for Socially Anxious College Drinkers
Acronym
BISAD
Official Title
Brief Intervention for Socially Anxious Alcohol Abusers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Alcohol Negative Consequences, Social Anxiety
Keywords
alcohol consumption, social anxiety, brief intervention, motivational interviewing, cognitive behavioral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Brief Intervention for Socially Anxious Drinkers
Arm Title
2
Arm Type
Active Comparator
Arm Description
Enhanced Alcohol Skills and Education Program
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention for Socially Anxious Drinkers (BISAD)
Intervention Description
integrated alcohol and social anxiety individual intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Alcohol Skills Building and Education Program
Intervention Description
alcohol-focused group intervention
Primary Outcome Measure Information:
Title
heavy drinking days
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up
Title
total alcohol consumption
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up
Title
drinking-related negative consequences
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up
Title
social (interactional) anxiety
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up
Secondary Outcome Measure Information:
Title
alcohol expectancies of social evaluative situations
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up
Title
drink refusal self-efficacy in social situations
Time Frame
pre-treatment, 1-month follow-up and 4-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least one heavy drinking episode (4 or more drinks for women and 5 or more for men) occasional to frequent drinking related problems moderate social anxiety symptoms Exclusion Criteria: history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giao Q. Tran, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychology Department, University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221-0376
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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Brief Intervention for Socially Anxious College Drinkers

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