NCT01204229

Brief Summary

In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

2 years

First QC Date

September 15, 2010

Last Update Submit

April 21, 2011

Conditions

Alcohol ConsumptionAnxietyDepression

Keywords

Alcohol ConsumptionSocial AnxietyDepressionBrief InterventionMotivational InterviewingCognitive Behavioral TherapySub-Clinical Social AnxietySub-Clinical Depression

Outcome Measures

Primary Outcomes (3)

  • Alcohol Consumption and Drinking-Related Negative Consequences

    Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up

  • Anxiety

    Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up

  • Depression

    Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up

Secondary Outcomes (1)

  • Cost efficacy data

    2-3 months post completion

Study Arms (2)

MCID

EXPERIMENTAL
Behavioral: Motivational and Cognitive Intervention for Drinkers (MCID)

BMI

EXPERIMENTAL
Behavioral: Brief Motivational Intervention (BMI)

Interventions

Motivational and Cognitive Intervention for Drinkers (MCID)BEHAVIORAL

Integrate social anxiety/ depression and drinking intervention

MCID
Brief Motivational Intervention (BMI)BEHAVIORAL

Integrate drinking intervention

BMI

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).
  • \. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems

You may not qualify if:

  • \. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology Department, University of Cincinnati

Cincinnati, Ohio, 45221, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorMental DisordersBehavioral Symptoms

Study Officials

  • Giao Q. Tran, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giao Q. Tran, Ph.D.

CONTACT

513-237-2608Giao.Tran@uc.edu

Study Design

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

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 17, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

US(1)