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Completed

NCT Number: NCT00872118

Brief Intervention for Socially Anxious College Drinkers

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

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Key information

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Psychology Department, University of Cincinnati

Cincinnati, Ohio, 45221-0376, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Intervention for Socially Anxious Drinkers (BISAD)

Behavioral

integrated alcohol and social anxiety individual intervention

Enhanced Alcohol Skills Building and Education Program

Behavioral

alcohol-focused group intervention

Primary outcomes

  1. heavy drinking days

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

  2. total alcohol consumption

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

  3. drinking-related negative consequences

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

  4. social (interactional) anxiety

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

Secondary outcomes

  1. alcohol expectancies of social evaluative situations

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

  2. drink refusal self-efficacy in social situations

    Time frame: pre-treatment, 1-month follow-up and 4-month follow-up

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Brief Intervention for Socially Anxious Alcohol Abusers

Acronym: BISAD

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Mar 31, 2009
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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