Reducing Alcohol Use in Depressed Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Rhode Island Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00183079
First received: September 9, 2005
Last updated: July 21, 2010
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Depression
Alcohol Use
Behavioral: Motivationally-focused brief alcohol intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Alcohol Intervention With Depressed Patients

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Alcohol consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2004
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Brief, motivationally-focused alcohol intervention
Behavioral: Motivationally-focused brief alcohol intervention
Brief, motivationally-focused 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183079

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02860
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Susan E. Ramsey, Ph.D. Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Susan E. Ramsey, Ph.D., Principal Investigator, Rhode Island Hospital/Brown University
ClinicalTrials.gov Identifier: NCT00183079     History of Changes
Other Study ID Numbers: NIAAARAM13895, R01AA013895, NIH 5 R01 AA13895
Study First Received: September 9, 2005
Last Updated: July 21, 2010
Health Authority: United States: Federal Government

Keywords provided by Rhode Island Hospital:
Depression
Alcohol Use
Motivational Interviewing

Additional relevant MeSH terms:
Alcohol Drinking
Depression
Depressive Disorder
Behavioral Symptoms
Drinking Behavior
Mental Disorders
Mood Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014