Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000169943
Ethics application status
Approved
Date submitted
11/02/2011
Date registered
11/02/2011
Date last updated
11/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brief Cognitive-Behavioural Therapy (CBT) for Young People with Cannabis Problems
Scientific title
Brief CBT for Cannabis use in Young People with Co-occurring Mental Health Disorders
Secondary ID [1] 253557 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 261117 0
Cannabis Use 261118 0
Condition category
Condition code
Mental Health 259264 259264 0 0
Addiction
Mental Health 259265 259265 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved three 50 minute one-on-one weekly sessions of motivational interviewing enhanced CBT. Session one involved a discussion of a personalised feedback report which was based on the data gathered from assessment. This feedback was delivered in a motivational interviewing style which aimed to explore ambivalence and promote problem recognition and enhanced motivation to change.
Clinical sessions two and three focused predominantly on CBT skill building. Session two focused on understanding the concept of how situations, thoughts, feelings, physical sensations, emotions and behaviours interact and goal setting. Motivational interviewing was used, when applicable. Session three primarily aimed to review prior skills learnt, examine homework outcomes, maintain/build motivation to change cannabis use behaviours, and train in additional coping skills (e.g. managing cravings, dealing with rationalizations, and relapse prevention).
Intervention code [1] 257988 0
Treatment: Other
Intervention code [2] 257989 0
Behaviour
Comparator / control treatment
Participants were randomly allocated to an immediate treatment group (IT) commencing the week following the baseline assessment or a delayed treatment control group (DTC). The delayed treatment group was offered the treatment after the completion of the 3 month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 262081 0
The primary outcome was cannabis use measured by conducting a Timeline Followback interview.
Timepoint [1] 262081 0
Baseline, 1 and 3 month follow up interviews
Primary outcome [2] 262110 0
Cannabis related problems as measured by the Cannabis Problems Questionnaire, Sheehan Disability Scale, and Severity of Dependence Scale
Timepoint [2] 262110 0
Baseline, 1 and 3 month follow up interviews
Secondary outcome [1] 273121 0
Psychological distress as measured by the Depression, Anxiety, and Stress Scale
Timepoint [1] 273121 0
Baseline, 1 and 3 month follow up interviews

Eligibility
Key inclusion criteria
Aged between 14 and 29 years inclusive, have used Cannabis in the past month, current mental health diagnosis, and fluent in English.
Minimum age
14 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
More than weekly use of other illicit drugs

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)
Participants were initially screened for eligibility and referral into the study via the routine BMRI intake process.
The numbers of those who were ineligible or who did not consent to be assessed for participation in a randomized
trial were noted to enable adequate CONSORT reporting of participant flow through the study. Appropriate referral
was provided as part of the standard BMRI intake procedure.

At the first meeting between participant and clinician further screening was conducted to ensure eligibility. The
nature of the study (including the randomization process) was explained to the participant. Following the description of the study, the participant was taken through the participant information and consent form which
detailed their rights as a participant, the voluntary nature of their participation and the limits of confidentiality.
Participant’s questions were answered and written informed consent obtained. Randomisation then occurred through the use of a random number generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation envelopes were prepared by an independent researcher with the aid of random number
generator software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258447 0
Government body
Name [1] 258447 0
Department of Health & Ageing
Country [1] 258447 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 257592 0
University
Name [1] 257592 0
University of Sydney
Address [1] 257592 0
Brain & Mind Research Institute
University of Sydney
100 Mallett Street
Camperdown NSW 2050
Country [1] 257592 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260432 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 260432 0
Ethics committee country [1] 260432 0
Australia
Date submitted for ethics approval [1] 260432 0
01/11/2008
Approval date [1] 260432 0
13/11/2008
Ethics approval number [1] 260432 0
08243

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

Contacts
Principal investigator
Name 32181 0
Address 32181 0
Country 32181 0
Phone 32181 0
Fax 32181 0
Email 32181 0
Contact person for public queries
Name 15428 0
Dr Melissa Norberg
Address 15428 0
National Drug & Alcohol Research Centre
Univerty of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 15428 0
Australia
Phone 15428 0
+61 2 9385 0260
Fax 15428 0
+61 2 9385 0201
Email 15428 0
m.norberg@unsw.edu.au
Contact person for scientific queries
Name 6356 0
Dr Melissa Norberg
Address 6356 0
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 6356 0
Australia
Phone 6356 0
+61 2 9385 0260
Fax 6356 0
+61 2 9385 0201
Email 6356 0
m.norberg@unsw.edu.au

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.