None listed
Conditions
Brief summary
Co-morbid depression and anxiety are becoming a critical issue in the management of alcohol dependence due to the high prevalence, debilitating effects and lack of effective treatment options. This proposal seeks to generate and evaluate a novel, integrated treatment for comorbid anxiety or depressive disorder. Participants will all receive anti-craving medication (naltrexone and/or acamprosate) and formal assessment of clinically relevant anxiety or depression. They will then be randomized to receive either a usual counselling care or a CBT ‘stepped-care’ intervention including a manual-based psychotherapy appropriate for their psychiatric profile. Participants will be followed up at 3 and 6 months to determine the benefits of integrated treatment on alcohol consumption, comorbid symptoms and health. It is hypothesised that stepped care for alcohol dependence with comorbid mood or anxiety disorders will result in less relapse and lower alcohol consumption compared to usual care, and result in a greater improvement in comorbid symptoms and quality of life compared to usual care.
Interventions
12-week intervention: Reduction and stabilisation of alcohol intake using pharmacotherapy (naltrexone, acamprosate or a combination of the two)followed by formal psychiatric assessment. Participants meeting criteria for psychiatric comorbidity will be randomised to receive manualised psychological therapy for comorbid psychiatric and alcohol problems.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for step 1: (i) alcohol dependence according to DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders 4th edition), with alcohol as the subject’s drug of choice, (ii) adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination), (iii) willingness to give written consent, (iv) abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone), (v) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC). Entry criteria to step 2: (i) Completion of 3 weeks on acamprosate and/or natlrexone, (ii) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), (iii) case formulation and diagnosis for anxiety or depression (see below).
Exclusion criteria
Exclusion criteria for step 1: (i) sensitivity to study medications or therapy with these drugs within 6 months, (ii) active major psychiatric disorder associated with significant suicide risk, (iii) pregnancy or lactation, (iv) advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy), (v) other serious medical illness that would interfere with adherence to the study protocol. Exclusion criteria 2: (i) Non-compliance on acamprosate and/or naltrexone, (ii) alcohol consumption at baseline levels, (iii) resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment as appropriate within the service and continue to be monitored.
Outcome results
None listed