Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial

BACKGROUND: A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity. During treatment, the time to relapse is shorter, the drop-out rate is increased, and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder. The treatment of alcohol dependence and psychological disorders is often the responsibility of different services, and this can hinder the treatment process. Accordingly, there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression. METHODS/DESIGN: We aim to assess the effectiveness of a specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. Following a three-week stabilization period (abstinence or significantly reduced consumption), participants will undergo complete formal assessment for anxiety and depression. Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1) integrated intervention (cognitive behavioral therapy) for alcohol, anxiety, and/or depression; or 2) usual counseling care for alcohol problems. Patients will then be followed up at weeks 12, 16, and 24. The primary outcome measure is alcohol consumption (total abstinence, time to lapse, and time to relapse). Secondary outcome measures include changes in alcohol dependence severity, depression, or anxiety symptoms and changes in clinician-rated severity of anxiety and depression. DISCUSSION: The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01941693