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

Primary Purpose

Alcohol Dependence, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Integrated care
Usual care
Sponsored by
South West Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol, anxiety, depression, comorbidity, CBT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drug Health Services, Royal Prince Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated care

Usual care

Arm Description

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

Outcomes

Primary Outcome Measures

Alcohol consumption
Time to relapse (>5 drinks on any one day)
Time to lapse
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
amount of alcohol consumption
expressed as the average consumption per drinking day

Secondary Outcome Measures

Improvement in depressive or anxiety symptoms
DASS 21
Diagnosis severity
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.

Full Information

First Posted
September 5, 2013
Last Updated
September 9, 2013
Sponsor
South West Sydney Local Health District
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT01941693
Brief Title
A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Official Title
Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South West Sydney Local Health District
Collaborators
University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Anxiety, Depression
Keywords
alcohol, anxiety, depression, comorbidity, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Integrated care
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
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 Measure Information:
Title
Alcohol consumption
Description
Time to relapse (>5 drinks on any one day)
Time Frame
12 weeks
Title
Time to lapse
Description
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
Time Frame
12 weeks
Title
amount of alcohol consumption
Description
expressed as the average consumption per drinking day
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in depressive or anxiety symptoms
Description
DASS 21
Time Frame
12 weeks
Title
Diagnosis severity
Description
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Baillie
Organizational Affiliation
Macquarie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Haber
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Health Services, Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26672793
Citation
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.
Results Reference
derived
PubMed Identifier
24245491
Citation
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.
Results Reference
derived

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

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