A Phase 2 interventional study of Motivationally-focused brief alcohol intervention in Depression and Alcohol Use, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-07.
Sponsored by Rhode Island Hospital · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 200 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Brief, motivationally-focused alcohol intervention
Behavioral: Motivationally-focused brief alcohol intervention
Brief, motivationally-focused alcohol intervention
Alcohol consumption
Time frame: 6 months
Depressive symptoms
Time frame: 6 months
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital