Reducing Alcohol Use in Depressed Patients
Primary Purpose
Depression, Alcohol Use
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivationally-focused brief alcohol intervention
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Alcohol Use, Motivational Interviewing
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Meet criteria for current Major Depressive Disorder Have consumed more than 14 drinks per week or more than 5 drinks on one occasion in the past month for men or more than 7 drinks per week or more than 4 drinks on one occasion in the past month for females Exclusion Criteria: Meet criteria for current alcohol dependence or current psychoactive substance dependence (excluding nicotine) Currently psychotic
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Brief, motivationally-focused alcohol intervention
Outcomes
Primary Outcome Measures
Alcohol consumption
Depressive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00183079
First Posted
September 9, 2005
Last Updated
November 5, 2014
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00183079
Brief Title
Reducing Alcohol Use in Depressed Patients
Official Title
Brief Alcohol Intervention With Depressed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether a brief alcohol intervention reduces alcohol use and improves depression among depressed patients.
Detailed Description
Heavy alcohol consumption is common among patients seeking treatment for depression. Heavy drinking is associated with a variety of medical and psychosocial problems. Heavy drinking is particularly problematic among depressed patients, increasing the likelihood of poor depression treatment outcomes. While methods for reducing alcohol use in this population have been unexplored to date, brief interventions to reduce heavy alcohol use have been well-validated in numerous patient populations and offer the promise to reduce heavy drinking among depressed patients and to improve depression treatment outcomes.
We hypothesize that adding a brief alcohol intervention to standard psychiatric care, relative to standard psychiatric care alone, will reduce overall drinking volume and heavy drinking days among heavy-drinking depressed patients. Furthermore, we expect patients who receive the brief alcohol intervention to have better depression outcomes than patients receiving standard psychiatric care alone. We also expect that reduced alcohol consumption will mediate the effect of the brief alcohol intervention on depression outcomes. In addition, we will examine individual difference variables as predictors of change in alcohol use.
The proposed study is a randomized, two-group design with repeated measures over time, comparing a brief, motivationally-focused alcohol intervention plus standard psychiatric care to standard psychiatric care alone. For this study, we will recruit a sample of 240 psychiatry clinic outpatients meeting structured diagnostic criteria for major depressive disorder who drink heavily but are not alcohol dependent.
We expect that the results of this study will improve depression treatment outcomes for the significant subpopulation of depression patients who drink heavily and are likely to do poorly in depression treatment in the absence of a change in their drinking behavior. The intervention proposed in this study represents a novel approach to reducing heavy drinking among depressed patients that, if effective, can be readily integrated into depression treatment in a variety of treatment settings. In addition, this study will provide valuable information on the association between alcohol use and depression outcomes and on the mechanisms of change in alcohol use among heavy-drinking depressed patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Alcohol Use
Keywords
Depression, Alcohol Use, Motivational Interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Brief, motivationally-focused alcohol intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivationally-focused brief alcohol intervention
Intervention Description
Brief, motivationally-focused alcohol intervention
Primary Outcome Measure Information:
Title
Alcohol consumption
Time Frame
6 months
Title
Depressive symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Meet criteria for current Major Depressive Disorder
Have consumed more than 14 drinks per week or more than 5 drinks on one occasion in the past month for men or more than 7 drinks per week or more than 4 drinks on one occasion in the past month for females
Exclusion Criteria:
Meet criteria for current alcohol dependence or current psychoactive substance dependence (excluding nicotine)
Currently psychotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E. Ramsey, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Alcohol Use in Depressed Patients
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