- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941693
A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In summary, the specific aims of this project are:
- To assess the effectiveness of a novel stepped care intervention for alcohol dependent patients with co-morbid anxiety and/or depression compared to usual treatment for alcohol dependence in promoting abstinence from alcohol and increased quality of life and in reducing symptoms of anxiety and depression.
- To describe important factors relating to the maintenance of alcohol-related psychiatric comorbidity.
Step 1: All subjects will complete 12 weeks of pharmacotherapy (n = 120) on naltexone (50 mg, 1 tablet daily), acamprosate (333 mg, 2 tablets 3 times daily, reduced to 4/day for women <65kg), or a combination of the two. After a 3 week stabilization period, subjects will undergo complete formal assessment for anxiety and depression. Those subjects with a diagnosis of anxiety or depressive disorder regardless of drinking outcome will be offered the next step of care and followed up at 12-16 weeks.
Step 2: Subjects to undergo the next step of care (n = 30 per group, 60 in total) will be randomized by referring to the consecutively assigned subject identification number to a matched numbered envelope containing a random assignment card. Randomization will be stratified according to concomitant SSRI use. The treatment groups will be:
- Intervention for comorbid anxiety or depression, and
- Usual counseling care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2050
- Drug Health Services, Royal Prince Alfred Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Step 1:
- alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
- age 18-65,
- adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
- willingness to give written consent,
- abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
- 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).
Exclusion Criteria for Step 1:
- sensitivity to study medications or therapy with these drugs within 6 months,
- active major psychiatric disorder associated with significant suicide risk,
- pregnancy or lactation,
- advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
- other serious medical illness that would interfere with adherence to the study protocol.
Entry criteria to step 2:
- Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
- case formulation and diagnosis for anxiety or depression (see below).
Exclusion criteria 2:
- Non-compliance on acamprosate and/or naltrexone,
- alcohol consumption at baseline levels,
- resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
Counselling for all subjects will continue in accord with standard practice.
Currently, programs of brief individualized motivation enhancement therapy (feedback of assessment findings, reinforcement, empathy, client's own motivation) are available.
|
Experimental: Integrated care
Integrated care: Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders. |
Intervention for co-morbid alcohol dependence and anxiety or mood disorder.
Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol consumption
Time Frame: 12 weeks
|
Time to relapse (>5 drinks on any one day)
|
12 weeks
|
Time to lapse
Time Frame: 12 weeks
|
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
|
12 weeks
|
amount of alcohol consumption
Time Frame: 12 weeks
|
expressed as the average consumption per drinking day
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in depressive or anxiety symptoms
Time Frame: 12 weeks
|
DASS 21
|
12 weeks
|
Diagnosis severity
Time Frame: 16 weeks
|
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
|
16 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrew Baillie, Macquarie University
- Principal Investigator: Paul Haber, University of Sydney
Publications and helpful links
General Publications
- Morley KC, Baillie A, Leung S, Sannibale C, Teesson M, Haber PS. Is Specialized Integrated Treatment for Comorbid Anxiety, Depression and Alcohol Dependence Better than Treatment as Usual in a Public Hospital Setting? Alcohol Alcohol. 2016 Jul;51(4):402-9. doi: 10.1093/alcalc/agv131. Epub 2015 Dec 15.
- Morley KC, Baillie A, Sannibale C, Teesson M, Haber PS. Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial. Addict Sci Clin Pract. 2013 Nov 19;8(1):19. doi: 10.1186/1940-0640-8-19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X05-0279
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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