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.

Study Overview

• Status: Completed
• Conditions: Depression; Alcohol Use
• Intervention / Treatment: Behavioral: Motivationally-focused brief alcohol intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02860
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Brief, motivationally-focused alcohol intervention	Behavioral: Motivationally-focused brief alcohol intervention; Brief, motivationally-focused alcohol intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alcohol consumption	6 months
Depressive symptoms	6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Susan E. Ramsey, Ph.D., Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Depression; Motivational Interviewing; Alcohol Use
• Additional Relevant MeSH Terms: Behavioral Symptoms; Drinking Behavior; Alcohol Drinking; Depression
• Other Study ID Numbers: NIAAARAM13895; R01AA013895 (U.S. NIH Grant/Contract); NIH 5 R01 AA13895

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No