Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000786897
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
24/07/2012
Date last updated
24/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabis Screening and Feedback
Scientific title
Efficacy of Online Cannabis Screening and Feedback in Promoting Treatment-Seeking and Reductions in Cannabis Use: Comparison of Brief Versus Extended Feedback
Secondary ID [1] 280887 0
Nil
Universal Trial Number (UTN)
U1111-1132-8491
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis use 286957 0
Condition category
Condition code
Public Health 287295 287295 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition involves an online cannabis screening program with extended feedback and advice. Participants are asked a series of questions about their recent cannabis use, dependence and abuse symptoms, motives for using and consequences of use, treatment seeking, health consequences, and perceived cannabis use norms. Personalised feedback and advice addressing all of these issues is then provided (e.g., the individual receives advice relating to his or her specific motives for using cannabis). Participation in the intervention takes about an hour.
Intervention code [1] 285319 0
Behaviour
Comparator / control treatment
The participant receives the same screening questions, but much briefer feedback and advice. Participation in the control condition takes about 45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287569 0
Information/treatment seeking. The questions will be asked in an online questionnaire, accessed via an email link one month after participating in the intervention. Some of the questions are specifically designed for the study; others are established questionnaires (Treatment Readiness Tool, General Help-Seeking Questionnaire).
Timepoint [1] 287569 0
One month post-intervention.
Primary outcome [2] 287570 0
Past-month cannabis use (frequency and quantity). This will be assessed at baseline as part of the screening program, and again in the one-month follow-up assessment. The Timeline Followback procedure will be used.
Timepoint [2] 287570 0
Baseline and one month post-intervention.
Primary outcome [3] 287571 0
Past-month cannabis dependence/abuse symptoms, assessed at baseline and one month. The GAIN-1, Severity of Dependence Scale, and components of the Cannabis Problems Questionnaire will be used.
Timepoint [3] 287571 0
Baseline and one month post-intervention.
Secondary outcome [1] 298427 0
Satisfaction with the program will be assessed in the one-month post-intervention assessment. Some of the questions are specifically designed for the study; others are established questionnaires (Satisfaction and Usability Survey, Client Satisfaction Questionnaire).
Timepoint [1] 298427 0
One month post-intervention.

Eligibility
Key inclusion criteria
18 years or older.

Cannabis use in the last month.

At least one symptom of cannabis abuse or dependence.

Having email
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old.

No cannabis use in the last month.

No symptoms of cannabis abuse or dependence.

No email address.

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)
The study will be adverstised using various methods, primarily Google. Study advertisements will provide a direct link to the screening program. The National Cannabis Prevention and Information Centre (NCPIC) website will also contain a direct link to the program. The program will include initial questions and brief feedback for all individuals who access the site. Only individuals who meet the inclusion criteria as deterined by these initial questions will be offered a place in the study. This will all be determined automatically with no human involvement. The study information sheet informs participants that they will be randomly assigned to receive either brief or extended feedback on their cannabis use. The program will randomly assign participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The program will randomly assign participants. Simple randomisation using computer sequence generation will be employed.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285686 0
Government body
Name [1] 285686 0
Department of Health and Ageing
Country [1] 285686 0
Australia
Primary sponsor type
Government body
Name
National Cannabis Prevention and Information Centre (NCPIC)
Address
PO Box 684
Randwick
NSW, 2031
Country
Australia
Secondary sponsor category [1] 284515 0
None
Name [1] 284515 0
Address [1] 284515 0
Country [1] 284515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287675 0
UNSW HREC
Ethics committee address [1] 287675 0
UNSW HREC
Kensington NSW
2033
Australia
Ethics committee country [1] 287675 0
Australia
Date submitted for ethics approval [1] 287675 0
Approval date [1] 287675 0
29/06/2012
Ethics approval number [1] 287675 0
HC11328

Summary
Brief summary
The primary purpose of the study is to compare the effects of brief vesus extended feedback and advice in promoting cannabis help/information seeking and assisting individiuals to reduce their cannabis use.

Hypotheses:
Relative to individuals who receive brief feedback, individuals who receive extended feedback will report (a) more information-seeking and help-seeking, (b) greater reductions in past-month cannabis use, (c) greater reductions in past-month cannabis dependence symptoms, (d) greater reductions in past-month cannabis abuse symptoms, and (e) greater satisfaction with the screening/feedback program.
Trial website
Not yet established.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34467 0
Address 34467 0
Country 34467 0
Phone 34467 0
Fax 34467 0
Email 34467 0
Contact person for public queries
Name 17714 0
Sally Rooke
Address 17714 0
PO Box 684
Randwick
NSW 2031
Country 17714 0
Australia
Phone 17714 0
+61 2 9385 0450
Fax 17714 0
Email 17714 0
[email protected]
Contact person for scientific queries
Name 8642 0
Sally Rooke
Address 8642 0
PO Box 684
Randwick
NSW 2031
Country 8642 0
Australia
Phone 8642 0
+61 2 9385 0450
Fax 8642 0
Email 8642 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.