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Trial registered on ANZCTR


Registration number
ACTRN12605000646640
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
17/10/2005
Date last updated
27/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A field study of the relationship between craving and self-efficacy in alcohol misuse
Scientific title
A Randomised Controlled Trial of Correspondence-Based Management of Alcohol Misuse within a Primary Care Setting
Secondary ID [1] 280409 0
Nil
Universal Trial Number (UTN)
Trial acronym
DrinkRight
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol abuse and Alcohol dependence 777 0
Condition category
Condition code
Mental Health 852 852 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is associated with a similar correspondence-based treatment for alcohol misuse co-morbid with depression. It is a randomised controlled trial, in which participants are assigned to standard care by their GP or, standard care plus correspondence-based treatment. After three months, those in the standard care only group are provided the same treatment as the experimental group. The correspondence-based treatment is founded on empirically supported cognitive behaviour therapy for alcohol misuse and comprises four weekly and four fortnightly letters covering topics such as motivation enhancement, goal setting, dealing with urges, planning for high risk situations and relapse prevention.
Intervention code [1] 537 0
Treatment: Other
Comparator / control treatment
Standard care only
Control group
Active

Outcomes
Primary outcome [1] 1094 0
The primary outcome being measured is the relationship between craving and self-efficacy. Craving is measured using The Desires for Alcohol Questionnaire (Clark et. al., 1996) and self-efficacy using the Controlled Drinking Self-Efficacy Scale (Sitharthan & Kavanagh, 1990) and Cognition Efficacy Questionnaire (Kavanagh & Wilson, 1989).
Timepoint [1] 1094 0
Measured prior to treatment, during treatment, immediately post-treatment and three, six, nine and 12 months after treatment.
Secondary outcome [1] 2030 0
the effectiveness of the correspondence-based treatment compared to standard care by a GP.
Timepoint [1] 2030 0
This is evaluated by measuring alcohol intake and craving levels prior to treatment, during treatment, immediately post-treatment and three, six, nine and 12 months after treatment.

Eligibility
Key inclusion criteria
An average intake over the past three months of >28 drinks per week for men or >14 drinks per week for women; meets DSM-IV criteria for an alcohol use disorder and sufficient oral and written English to participate without translation.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of psychotic disorder; current misuse of other substances (except caffeine or nicotine); in concurrent treatment for alcohol at Baseline or residing at the same address as someone already enrolled in the study.

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)
Allocations will be placed in sealed envelopes by a person not connected with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocations to the two conditions will be done in blocks of four subjects using GraphPad Quickcalcs at GraphPad.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 939 0
Charities/Societies/Foundations
Name [1] 939 0
Alcohol Education and Rehabilitation Foundation Ltd
Address [1] 939 0
PO Box 3455
PARRAMATTA NSW 2124
Country [1] 939 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
IHBI, GPO Box 2434, Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 797 0
Individual
Name [1] 797 0
Mr. Phillip Stacey
Address [1] 797 0
Unknown
Country [1] 797 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2236 0
The University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 2236 0
Ethics committee country [1] 2236 0
Australia
Date submitted for ethics approval [1] 2236 0
Approval date [1] 2236 0
Ethics approval number [1] 2236 0

Summary
Brief summary
This project is associated with a similar correspondence-based treatment for alcohol misuse co-morbid with depression. It is a randomised controlled trial, in which participants are assigned to standard care by their GP or, standard care plus correspondence-based treatment. After three months, those in the standard care only group are provided the same treatment as the experimental group. The correspondence-based treatment is founded on empirically supported cognitive behaviour therapy for alcohol misuse and comprises four weekly and four fortnightly letters covering topics such as motivation enhancement, goal setting, dealing with urges, planning for high risk situations and relapse prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35264 0
Address 35264 0
Country 35264 0
Phone 35264 0
Fax 35264 0
Email 35264 0
Contact person for public queries
Name 9726 0
Professor David Kavanagh
Address 9726 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 9726 0
Australia
Phone 9726 0
+61 7 31386143
Fax 9726 0
+61 7 31386030
Email 9726 0
david.kavanagh@qut.edu.au
Contact person for scientific queries
Name 654 0
Professor David Kavanagh
Address 654 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 654 0
Australia
Phone 654 0
+61 7 31386143
Fax 654 0
+61 7 31386030
Email 654 0
david.kavanagh@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary