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Brief Intervention for Socially Anxious College Drinkers (BISAD)

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University of Cincinnati

Status and phase

Completed
Phase 1

Conditions

Social Anxiety
Alcohol Negative Consequences
Alcohol Consumption

Treatments

Behavioral: Enhanced Alcohol Skills Building and Education Program
Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00872118
R21AA017291 (U.S. NIH Grant/Contract)
NIH Grant R21AA014014
NIAAA-Tran-AA014014

Details and patient eligibility

About

The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18 to 26 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 2 patient groups

1
Experimental group
Description:
Brief Intervention for Socially Anxious Drinkers
Treatment:
Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)
2
Active Comparator group
Description:
Enhanced Alcohol Skills and Education Program
Treatment:
Behavioral: Enhanced Alcohol Skills Building and Education Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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