NCT00872118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

March 27, 2009

Last Update Submit

September 15, 2010

Conditions

Keywords

alcohol consumptionsocial anxietybrief interventionmotivational interviewingcognitive behavioral

Outcome Measures

Primary Outcomes (4)

  • heavy drinking days

    pre-treatment, 1-month follow-up and 4-month follow-up

  • total alcohol consumption

    pre-treatment, 1-month follow-up and 4-month follow-up

  • drinking-related negative consequences

    pre-treatment, 1-month follow-up and 4-month follow-up

  • social (interactional) anxiety

    pre-treatment, 1-month follow-up and 4-month follow-up

Secondary Outcomes (2)

  • alcohol expectancies of social evaluative situations

    pre-treatment, 1-month follow-up and 4-month follow-up

  • drink refusal self-efficacy in social situations

    pre-treatment, 1-month follow-up and 4-month follow-up

Study Arms (2)

1

EXPERIMENTAL

Brief Intervention for Socially Anxious Drinkers

Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)

2

ACTIVE COMPARATOR

Enhanced Alcohol Skills and Education Program

Behavioral: Enhanced Alcohol Skills Building and Education Program

Interventions

integrated alcohol and social anxiety individual intervention

1

alcohol-focused group intervention

2

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology Department, University of Cincinnati

Cincinnati, Ohio, 45221-0376, United States

Location

Related 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Crisis InterventionEthanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesAlcoholsOrganic Chemicals

Study Officials

  • Giao Q. Tran, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 31, 2009

Study Start

April 1, 2004

Primary Completion

April 1, 2007

Study Completion

March 1, 2008

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations