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| Name | Class |
|---|---|
| University of Sydney | OTHER |
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There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.
In summary, the specific aims of this project are:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated care | Experimental | 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 | Active Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol consumption | Time to relapse (>5 drinks on any one day) | 12 weeks |
| Time to lapse | time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption | 12 weeks |
| amount of alcohol consumption | expressed as the average consumption per drinking day | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in depressive or anxiety symptoms | DASS 21 | 12 weeks |
| Diagnosis severity | clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses. |
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Inclusion Criteria for Step 1:
Exclusion Criteria for Step 1:
Entry criteria to step 2:
Exclusion criteria 2:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Baillie | Macquarie University | Principal Investigator |
| Paul Haber | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Health Services, Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26672793 | Derived | 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. | |
| 24245491 | Derived |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019033 | Delivery of Health Care, Integrated |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Usual care | Behavioral | 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. |
|
| 16 weeks |
| 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. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |