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Trial registered on ANZCTR


Registration number
ACTRN12605000647639
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
Collaborative Management of Depression and Alcohol Misuse by General Practitioners and Correspondence-Based Programs
Scientific title
A Randomised Controlled Trial of Correspondence-Based Management of Depression and Alcohol Misuse within a Primary Care Setting
Secondary ID [1] 280408 0
Nil
Universal Trial Number (UTN)
Trial acronym
DrinkRight
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol abuse, Alcohol dependence 778 0
Major Depressive disorder 779 0
Dysthymia 780 0
Condition category
Condition code
Mental Health 853 853 0 0
Addiction
Mental Health 854 854 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is associated with a similar correspondence-based treatment for alcohol misuse. It is a randomised controlled trial in which participants are assigned to standard care by their GP or standard care plus correspondence-based treatment for either alcohol or alcohol and depression. After three months, those in the standard care only group are randomly assigned to one of the two experimental groups. The correspondence-based treatments are based on empirically supported cognitive behaviour therapy and comprise four weekly and four fortnightly letters. The alcohol only treatment covers topics such as motivation enhancement, goal setting, dealing with urges, planning for high risk situations, problem solving and relapse prevention. The alcohol and depression treatment group contains the same material on alcohol, but also addresses depression in each letter.
Intervention code [1] 538 0
Treatment: Other
Comparator / control treatment
Standard care only
Control group
Active

Outcomes
Primary outcome [1] 1095 0
Alcohol intake
Timepoint [1] 1095 0
Measured post-treatment at three, six, nine and 12 months.
Primary outcome [2] 1096 0
Degree of depression
Timepoint [2] 1096 0
Measured post-treatment at three, six, nine and 12 months.
Secondary outcome [1] 2031 0
N/A (No secondary outcomes being measured in this study).
Timepoint [1] 2031 0
N/A

Eligibility
Key inclusion criteria
An average alcohol intake over the past three months of >28 drinks per week for men or >14 drinks per week for women; meet DSM-IV criteria for an alcohol use disorder and depression or dysthymia 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); concurrent treatment for alcohol or depression at Baseline (except antidepressant medication) 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 three conditions will be generated in blocks using GraphPad Quickcalcs at GraphPad.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
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] 940 0
Charities/Societies/Foundations
Name [1] 940 0
Australian Rotary Health Research Fund
Address [1] 940 0
PO Box 3455
PARRAMATTA NSW 2124
Country [1] 940 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
IHBI, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 798 0
Individual
Name [1] 798 0
Professor John Saunders
Address [1] 798 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [1] 798 0
Australia
Secondary sponsor category [2] 799 0
Individual
Name [2] 799 0
Professor Ross Young
Address [2] 799 0
IHBI, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country [2] 799 0
Australia
Secondary sponsor category [3] 800 0
Individual
Name [3] 800 0
Dr Amanda Baker
Address [3] 800 0
Centre for Mental Health Studies
Officers Quarters Complex
James Fletcher Hospital
Newcomen Street NEWCASTLE 2300
Country [3] 800 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2237 0
The University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 2237 0
Ethics committee country [1] 2237 0
Australia
Date submitted for ethics approval [1] 2237 0
Approval date [1] 2237 0
Ethics approval number [1] 2237 0

Summary
Brief summary
This project is associated with a similar correspondence-based treatment for alcohol misuse. It is a randomised controlled trial in which participants are assigned to standard care by their GP or standard care plus correspondence-based treatment for either alcohol or alcohol and depression. After three months, those in the standard care only group are randomly assigned to one of the two experimental groups. The correspondence-based treatments are based on empirically supported cognitive behaviour therapy and comprise four weekly and four fortnightly letters. The alcohol only treatment covers topics such as motivation enhancement, goal setting, dealing with urges, planning for high risk situations, problem solving and relapse prevention. The alcohol and depression treatment group contains the same material on alcohol, but also addresses depression in each letter.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35858 0
Address 35858 0
Country 35858 0
Phone 35858 0
Fax 35858 0
Email 35858 0
Contact person for public queries
Name 9727 0
Professor David Kavanagh
Address 9727 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 9727 0
Australia
Phone 9727 0
+61 7 31386143
Fax 9727 0
+61 7 31386030
Email 9727 0
david.kavanagh@qut.edu.au
Contact person for scientific queries
Name 655 0
Professor David Kavanagh
Address 655 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 655 0
Australia
Phone 655 0
+61 7 31386143
Fax 655 0
+61 7 31386030
Email 655 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