A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
NCT ID: NCT01941693
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2007-03-31
2013-03-31
Brief Summary
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Detailed Description
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1. 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.
2. 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:
1. Intervention for comorbid anxiety or depression, and
2. Usual counseling care.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Usual care
Usual care
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Sydney
OTHER
South West Sydney Local Health District
OTHER
Responsible Party
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Professor Paul Haber
Medical Director
Principal Investigators
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Andrew Baillie
Role: PRINCIPAL_INVESTIGATOR
Macquarie University
Paul Haber
Role: PRINCIPAL_INVESTIGATOR
University of Sydney
Locations
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Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Countries
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References
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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.
Other Identifiers
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X05-0279
Identifier Type: -
Identifier Source: org_study_id