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Reducing Alcohol Use in Depressed Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00183079
First received: September 9, 2005
Last updated: November 5, 2014
Last verified: October 2008

September 9, 2005
November 5, 2014
March 2004
May 2009   (final data collection date for primary outcome measure)
  • Alcohol consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alcohol consumption
  • Depressive symptoms
Complete list of historical versions of study NCT00183079 on ClinicalTrials.gov Archive Site
Not Provided
  • Alcohol-related consequences
  • Social adjustment
Not Provided
Not Provided
 
Reducing Alcohol Use in Depressed Patients
Brief Alcohol Intervention With Depressed Patients

The purpose of this study is to determine whether a brief alcohol intervention reduces alcohol use and improves depression among depressed patients.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Alcohol Use
Behavioral: Motivationally-focused brief alcohol intervention
Brief, motivationally-focused alcohol intervention
Active Comparator: 1
Brief, motivationally-focused alcohol intervention
Intervention: Behavioral: Motivationally-focused brief alcohol intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183079
NIAAARAM13895, R01AA013895, NIH 5 R01 AA13895
Not Provided
Rhode Island Hospital
Rhode Island Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Susan E. Ramsey, Ph.D. Rhode Island Hospital
Rhode Island Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP