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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00183079 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Brief Alcohol Intervention With Depressed Patients |
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 |
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1: Active Comparator
Brief, motivationally-focused alcohol intervention
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Behavioral: Motivationally-focused brief alcohol intervention
Brief, motivationally-focused alcohol intervention
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan E. Ramsey, Ph.D. | (401)444-7831 | sramsey@lifespan.org |
United States, Rhode Island | |
Rhode Island Hospital | Recruiting |
Providence, Rhode Island, United States, 02860 | |
Contact: Susan E. Ramsey, Ph.D. 401-444-7831 sramsey@lifespan.org | |
Principal Investigator: Susan E. Ramsey, Ph.D. |
Principal Investigator: | Susan E. Ramsey, Ph.D. | Rhode Island Hospital |
Responsible Party: | Rhode Island Hospital/Brown University ( Susan E. Ramsey, Ph.D., Principal Investigator ) |
Study ID Numbers: | NIAAARAM13895, NIH 5 R01 AA13895 |
Study First Received: | September 9, 2005 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00183079 History of Changes |
Health Authority: | United States: Federal Government |
Depression Alcohol Use Motivational Interviewing |
Anti-Infective Agents, Local Depression Mental Disorders Mood Disorders Drinking Behavior |
Central Nervous System Depressants Alcohol Drinking Depressive Disorder Ethanol Behavioral Symptoms |
Anti-Infective Agents Depression Physiological Effects of Drugs Drinking Behavior Central Nervous System Depressants Alcohol Drinking Depressive Disorder Pharmacologic Actions |
Behavioral Symptoms Anti-Infective Agents, Local Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents Ethanol |