Clinical trial NCT00872118: Brief Intervention for Socially Anxious College Drinkers
Official title: Brief Intervention for Socially Anxious Alcohol Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Consumption
Alcohol Negative Consequences
Social Anxiety
Keywords: alcohol consumption
social anxiety
brief intervention
motivational interviewing
cognitive behavioral
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-03-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: heavy drinking days
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
measure: total alcohol consumption
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
measure: drinking-related negative consequences
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
measure: social (interactional) anxiety
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
Secondary outcomes:
measure: alcohol expectancies of social evaluative situations
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
measure: drink refusal self-efficacy in social situations
timeFrame: pre-treatment, 1-month follow-up and 4-month follow-up
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Psychology Department, University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Giao Q. Tran, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.