Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000615482
Ethics application status
Not yet submitted
Date submitted
27/11/2007
Date registered
29/11/2007
Date last updated
29/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating cannabis problems by the mail and the internet
Scientific title
Members of the public with problem cannabis use will access Cognitive-Behavioral Therapy in hard copy and electronic formats using wait list contols to help moderate or cease their cannabis use.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem cannabis use 2593 0
Condition category
Condition code
Mental Health 2704 2704 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioral Therapy as bibliotherapy in six manuals delivered at two weekly intervals, concentrating on motivational enhancement, learning skills to deal with cues promoting drug use, emotional management without drugs and developing problem solving skills.
Intervention code [1] 2325 0
Behaviour
Comparator / control treatment
Wait list interval 3 months is equivalent to the duration of the therapy.
Control group
Active

Outcomes
Primary outcome [1] 3604 0
Cannabis use reduced or ceased
Timepoint [1] 3604 0
Comprehensive self report assessments at recruitment, end of wait interval (controls only), end of program and follow ups three and six months after the end of treatment.
Secondary outcome [1] 6036 0
Reduced psychological distress, in particular levels of anxiety and depression as assessed by the Kessler Psychological Distress Scale (K10).
Timepoint [1] 6036 0
Comprehensive self report assessments at recruitment, end of wait interval (controls only), end of program and follow ups three and six months after the end of treatment.

Eligibility
Key inclusion criteria
Acknowledgement of a problem with cannabis use
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current major psychiatric diagnosis, pregnancy or inability to read and write English adequately.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon completing and returning the initial self assessment, subjects are assigned as follows: The data entry operator requests the next assignment from a table of assignment codes (see below) corresponding to the sex of the subject. By entering the subject's unique ID code, that assignment is exhausted and will not reappear.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two tables of group assignments were generated by randomising the order of blocks of assignment codes. One table were thus randomised for each sex, totalling twice the number of assignments planned for recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The wait list control subjects begin the intervention after waiting the length of time required to complete the intervention (three months).
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 503 0
2000
Recruitment postcode(s) [2] 504 0
3000
Recruitment postcode(s) [3] 505 0
4000
Recruitment postcode(s) [4] 506 0
5000
Recruitment postcode(s) [5] 507 0
7000
Recruitment postcode(s) [6] 508 0
6000
Recruitment postcode(s) [7] 509 0
8000

Funding & Sponsors
Funding source category [1] 2836 0
Government body
Name [1] 2836 0
NSW Department of Health
Country [1] 2836 0
Australia
Primary sponsor type
Government body
Name
NSW Department of Health
Address
73 Miller Street
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 2559 0
Hospital
Name [1] 2559 0
Westmead Hospital
Address [1] 2559 0
Hawkesbury Road
Westmead NSW 2145
Country [1] 2559 0
Australia
Other collaborator category [1] 100 0
University
Name [1] 100 0
National Drug and Alcohol Research Centre
Address [1] 100 0
University of NSW
Sydney NSW 2052
Country [1] 100 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4768 0
Ethics committee address [1] 4768 0
Ethics committee country [1] 4768 0
Date submitted for ethics approval [1] 4768 0
30/11/2007
Approval date [1] 4768 0
Ethics approval number [1] 4768 0
07/WMEAD/69

Summary
Brief summary
A trial of the efficacy of a Cognitivie Behavioral Therapy intervention delivered by post for problem cannabis use to reduce or eliminate cannabis use and reduce psychological disturbance where this is also a problem.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28218 0
Address 28218 0
Country 28218 0
Phone 28218 0
Fax 28218 0
Email 28218 0
Contact person for public queries
Name 11375 0
Associate Professor Sitharthan Thiagarajan
Address 11375 0
4A Fleet Street
North Parramatta NSW 2151
Country 11375 0
Australia
Phone 11375 0
+61 2 98403888
Fax 11375 0
+61 2 98403956
Email 11375 0
[email protected]
Contact person for scientific queries
Name 2303 0
Associate Professor Sitharthan Thiagarajan
Address 2303 0
4A Fleet Street
North Parramatta NSW 2151
Country 2303 0
Australia
Phone 2303 0
+61 2 98403888
Fax 2303 0
+61 2 98403956
Email 2303 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
No additional documents have been identified.