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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01941693




Registration number
NCT01941693
Ethics application status
Date submitted
5/09/2013
Date registered
13/09/2013
Date last updated
13/09/2013

Titles & IDs
Public title
A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Scientific title
Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Secondary ID [1] 0 0
X05-0279
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 0 0
Anxiety 0 0
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Integrated care
Behaviour - Usual care

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.

Active Comparator: Usual care - Usual care


Behaviour: 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.

Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alcohol consumption
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Time to lapse
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
amount of alcohol consumption
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Improvement in depressive or anxiety symptoms
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Diagnosis severity
Timepoint [2] 0 0
16 weeks

Eligibility
Key inclusion 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).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01941693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Baillie
Address 0 0
Macquarie University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01941693