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A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

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ClinicalTrials.gov Identifier: NCT01941693
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 13, 2013
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Professor Paul Haber, South West Sydney Local Health District

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Anxiety Depression Behavioral: Integrated care Behavioral: Usual care Not Applicable

Detailed Description:

In summary, the specific aims of this project are:

  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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Study Start Date : March 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Behavioral: 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.

Active Comparator: Usual care
Usual care
Behavioral: 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.




Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 12 weeks ]
    Time to relapse (>5 drinks on any one day)

  2. Time to lapse [ Time Frame: 12 weeks ]
    time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption

  3. amount of alcohol consumption [ Time Frame: 12 weeks ]
    expressed as the average consumption per drinking day


Secondary Outcome Measures :
  1. Improvement in depressive or anxiety symptoms [ Time Frame: 12 weeks ]
    DASS 21

  2. Diagnosis severity [ Time Frame: 16 weeks ]
    clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941693


Locations
Australia, New South Wales
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
South West Sydney Local Health District
University of Sydney
Investigators
Principal Investigator: Andrew Baillie Macquarie University
Principal Investigator: Paul Haber University of Sydney

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Paul Haber, Medical Director, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01941693     History of Changes
Other Study ID Numbers: X05-0279
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Professor Paul Haber, South West Sydney Local Health District:
alcohol
anxiety
depression
comorbidity
CBT

Additional relevant MeSH terms:
Depression
Alcoholism
Behavioral Symptoms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs