Motivational and Cognitive Intervention for College Drinkers | NCT01204229

Studies
Motivational and Cognitive Intervention for College Drinkers

NCT01204229

Sponsor

University of Cincinnati

Status

Unknown status

Last Update Posted

Apr 22, 2011Estimated

Enrollment

100Estimated

Phase

Phase 1

Conditions

Alcohol Consumption
Anxiety
Depression

Interventions

Motivational and Cognitive Intervention for Drinkers (MCID)
Brief Motivational Intervention (BMI)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21AA1AA017291A1	Other Grant/Funding Number	R21AA1AA017291A1

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

May 2012Estimated

Completion Date

Not provided

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 16, 2010

First Posted Date

Sep 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCID	Experimental		Behavioral: Motivational and Cognitive Intervention for Drinkers (MCID)
BMI	Experimental		Behavioral: Brief Motivational Intervention (BMI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational and Cognitive Intervention for Drinkers (MCID)	Behavioral	Integrate social anxiety/ depression and drinking intervention	MCID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cost efficacy data		2-3 months post completion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giao Q. Tran, Ph.D.	Contact	513-237-2608		Giao.Tran@uc.edu

Overall Officials

Name	Affiliation	Role
Giao Q. Tran, Ph.D.	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychology Department, University of Cincinnati	Recruiting	Cincinnati	Ohio	45221	United States

Condition Browse Module

MeSH Terms

ID	Term
D000428	Alcohol Drinking
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D004327	Drinking Behavior
D001519	Behavior
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided