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Trial registered on ANZCTR


Registration number
ACTRN12613000865718
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
5/08/2013
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Cognitive Behavioural Therapy for Alcohol Dependence Treatment more effective if tailored for individual patient needs?
Scientific title
Twelve week abstinence outcomes of alcohol dependent patients undergoing Cognitive Behavioural Therapy (CBT) that targets and profiles psychological risk versus generic Cognitive Behavioural Therapy (CBT).
Secondary ID [1] 282935 0
Nil
Universal Trial Number (UTN)
U1111-1146-1931
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 289751 0
Condition category
Condition code
Mental Health 290088 290088 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychological Intervention:
A 45 minute assessment with standardised psychometric tools measuring alcohol expectancy (Drinking Expectancy Profile), drinking refusal self-efficacy (Drinking Refusal Self-Efficacy Questionnaire), craving (Alcohol Craving Questionnaire, Obsessive-Compulsive Drinking Scale), impulsivity (Dickman Impulsivity Inventory), dependence (Severity of Alcohol Dependence Scale, Brief MAST, Alcohol Use Identification Test) and general mental health functioning (General health Questioniare-28, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Toronto Alexithymia Scale) will be used to profile psychological risk of each patient. Risk is determined by previous published studies and historical data from the trial site. Cognitive Behavioural Therapy (CBT) treatment manuals that target these key deficits/excesses will be developed. These manuals will be administered by clinical psychologists (x4 one hour weekly sessions first 4 weeks, x4 fortnightly 1 hour sessions next 8 weeks= 12 week program, with 8 x 1 hour sessions). Treatment attendance will be recorded and patients will be breathalyzed prior to each treatments session. Carbohydrate-deficient transferrin (CDT) testing is available to validate self-report, if indicated. DNA will also be donated from consenting patients, but will not form part of the current intervention. These de-identified data will be used to construct genetic risk models in subsequent trials
Intervention code [1] 287637 0
Behaviour
Intervention code [2] 287657 0
Treatment: Other
Comparator / control treatment
Treatment as Usual (TAU) will be generic CBT. That is, intuitively driven CBT using a generic treatment manual. Frequency and duration is identical to experimental condition- x4 one hour weekly sessions first 4 weeks, x4 f/n 1 hour sessions next 8 weeks= 12 week program, with 8 x 1 hour sessions).
Control group
Active

Outcomes
Primary outcome [1] 290131 0
Alcohol abstinence assessed at each treatment session by standard self-report instrument- Time Line Follow-back and a breathalyser to estimate blood alcohol content (BAC). Where clinically indicated, carbohydrate-deficient transferrin (CDT) test can be employed to assist in validating self-report.
Timepoint [1] 290131 0
12 weeks
Secondary outcome [1] 303992 0
drinking reduction assessed at each treatment session by standard self-report instrument- Time Line Follow-back and a breathalyser to estimate blood alcohol content (BAC). Where clinically indicated, carbohydrate-deficient transferrin (CDT) test can be employed to assist in validating self-report.
Timepoint [1] 303992 0
12 weeks

Eligibility
Key inclusion criteria
Consecutively treated patients who meet established criteria for alcohol dependence.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current dependence on substances other than alcohol (except nicotine)
- Current disulfiram use
- Prescribed opioids

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi-Square will be used to examine the proportion of the primary 12 week outcome (abstinent/not abstinent) between the two treatment groups (Targeted Treatment and TAU) (df= 1). Repeated measures ANCOVA will examine the secondary outcome of alcohol consumption at 12 weeks, controlling for medication use (df= 2). Previous alcohol studies at this treatment site, using an identical generic CBT treatment program (Treatment as Usual Condition), have demonstrated medium effect sizes to detect treatment group differences. Therefore accepting an effect size of 0.3 (w), a= 0.05 and power of .90, a minimum of 117 subjects will be required for the analyses (Critical Chi= 3.84).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
6/01/2014
Date of last participant enrolment
Anticipated
Actual
3/02/2017
Date of last data collection
Anticipated
Actual
4/05/2017
Sample size
Target
130
Accrual to date
Final
379
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1363 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 7227 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 287710 0
Government body
Name [1] 287710 0
National Health and Medical Research Council (NHMRC) Career Development Fellowship (Connor)
Country [1] 287710 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jason Connor
Address
Discipline of Psychiatry
The University of Queensland
K-Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 286439 0
Individual
Name [1] 286439 0
A/Prof Gerald Feeney
Address [1] 286439 0
Alcohol and Drug Assessment Unit
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba Queensland 4102 Australia
Country [1] 286439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289666 0
Metro South Human Ethics Committee
Ethics committee address [1] 289666 0
Ethics committee country [1] 289666 0
Australia
Date submitted for ethics approval [1] 289666 0
Approval date [1] 289666 0
12/03/2012
Ethics approval number [1] 289666 0
HREC/12/QPAH/022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41870 0
A/Prof Jason Connor
Address 41870 0
Discipline of Psychiatry
The University of Queensland
K Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 41870 0
Australia
Phone 41870 0
+61 7 3365 5150
Fax 41870 0
+61 7 3365 5488
Email 41870 0
[email protected]
Contact person for public queries
Name 41871 0
Jason Connor
Address 41871 0
Discipline of Psychiatry
The University of Queensland
K Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 41871 0
Australia
Phone 41871 0
+61 7 3365 5150
Fax 41871 0
+61 7 3365 5488
Email 41871 0
[email protected]
Contact person for scientific queries
Name 41872 0
Jason Connor
Address 41872 0
Discipline of Psychiatry
The University of Queensland
K Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 41872 0
Australia
Phone 41872 0
+61 7 3365 5150
Fax 41872 0
+61 7 3365 5488
Email 41872 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized trial of personalized Cognitive-Behavior Therapy for Alcohol Use Disorder in a public health clinic.2018https://dx.doi.org/10.3389/fpsyt.2018.00297
N.B. These documents automatically identified may not have been verified by the study sponsor.