- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204229
Motivational and Cognitive Intervention for College Drinkers (MCID)
April 21, 2011 updated by: University of Cincinnati
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giao Q. Tran, Ph.D.
- Phone Number: 513-237-2608
- Email: Giao.Tran@uc.edu
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45221
- Recruiting
- Psychology Department, University of Cincinnati
-
Contact:
- Giao Q. Tran, Ph.D.
- Phone Number: 513-237-2608
- Email: Giao.Tran@uc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).
2. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems
Exclusion Criteria:
- 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMI
|
Integrate drinking intervention
|
Experimental: MCID
|
Integrate social anxiety/ depression and drinking intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alcohol Consumption and Drinking-Related Negative Consequences
Time Frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Anxiety
Time Frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Depression
Time Frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost efficacy data
Time Frame: 2-3 months post completion
|
2-3 months post completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giao Q. Tran, Ph.D., University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
May 1, 2012
Study Registration Dates
First Submitted
September 15, 2010
First Submitted That Met QC Criteria
September 16, 2010
First Posted (Estimate)
September 17, 2010
Study Record Updates
Last Update Posted (Estimate)
April 22, 2011
Last Update Submitted That Met QC Criteria
April 21, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AA1AA017291A1 (Other Grant/Funding Number: R21AA1AA017291A1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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