Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000947909
Ethics application status
Approved
Date submitted
2/09/2011
Date registered
2/09/2011
Date last updated
2/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an internet intervention to reduce psychostimulant use
Scientific title
Brief online intervention aimed at psychostimulant users, measuring change in psychostimulant use.
Secondary ID [1] 262796 0
Nil
Universal Trial Number (UTN)
U1111-1123-5610
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychostimulant use 270497 0
Condition category
Condition code
Mental Health 270656 270656 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition involves an online intervention consisting of motivational interviewing and cognitive behavioural therapy.
The intervention is three modules (one to be completed each week). Each module takes approximately 30 minutes. There is no additional routine support (information for external crisis support e.g. help lines will be listed).
Intervention code [1] 269137 0
Behaviour
Intervention code [2] 269319 0
Treatment: Other
Comparator / control treatment
A waitlist control group. This group receives no treatment during the trial although it is provided with access to the intervention after the completion of the study at 6 months post baseline.
Control group
Active

Outcomes
Primary outcome [1] 269376 0
WHO ASSIST Amphetamine Type Stimulant scores.
Timepoint [1] 269376 0
Baseline, 3 and 6-months after randomisation.
Primary outcome [2] 279455 0
Mean help-seeking intention / behaviour scores (Wilson, Deane, & Ciarrochi, 2005).
Timepoint [2] 279455 0
Baseline, 3 and 6 months after randomisation.
Primary outcome [3] 279456 0
Percentage of participants who move from Precontemplation to Contemplation/Action stage, or from Contemplation to Action stage, based on Readiness to Change questionnaire scores (Rollnick, Heather, Gold, & Hall, 1992).
Timepoint [3] 279456 0
Baseline, 3 and 6 months after randomisation
Secondary outcome [1] 287510 0
Mean K10 scores (psychological distress).
Timepoint [1] 287510 0
Baseline, 3 and 6 months after randomisation.
Secondary outcome [2] 287521 0
Poly drug use (defined as the sum of ASSIST classes of drugs reported).
Timepoint [2] 287521 0
Baseline, 3 and 6 months after randomisation.
Secondary outcome [3] 287603 0
Days out of Role scores (Kessler & Frank, 1997).
Timepoint [3] 287603 0
Baseline, 3 and 6 months after randomisation.
Secondary outcome [4] 287618 0
Mean EUROHIS Quality of Life scores (Schmidt, Muhlan, & Power, 2005).
Timepoint [4] 287618 0
Baseline, 3 and 6 months after randomisation
Secondary outcome [5] 287619 0
Descriptive measures of completion and adherence (active group only) assessed as i) completion of post test surveys, ii) number of modules completed iii) satisfaction with intervention.
Satisfaction will be measured with the first 8 items from the client satisfaction questionnaire (4 point likert scales)
Timepoint [5] 287619 0
3 months after randomisation.

Eligibility
Key inclusion criteria
Use of illicit psychostimulants (e.g. meth/amphetamine, ecstasy, non-medical use of prescription psychostimulants) in the last three months; willing to be randomised to one of two study groups; access to the Internet; access to e-mail; informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently receiving pharmacotherapy (e.g. methadone, naltrexone, buprenorphine) for any substance use disorder except nicotine replacement therapy; currently receiving any treatment for psychostimulant abuse/dependence; current or past diagnosis of schizophrenia or bipolar disorder.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269619 0
Government body
Name [1] 269619 0
Commonwealth of Australia Department of Health and Ageing
Country [1] 269619 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
The Australian National University
Canberra ACT 0200
Australia
Country
Australia
Secondary sponsor category [1] 266667 0
None
Name [1] 266667 0
Address [1] 266667 0
Country [1] 266667 0
Other collaborator category [1] 252179 0
University
Name [1] 252179 0
The University of New South Wales
Address [1] 252179 0
The University of New South Wales
Sydney
NSW 2052
Australia
Country [1] 252179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271744 0
The Australian Nationa University HREC
Ethics committee address [1] 271744 0
Research Office
Lower Ground Floor
Chancelry 10B
East Road
Australian National University
Acton ACT 0200
Ethics committee country [1] 271744 0
Australia
Date submitted for ethics approval [1] 271744 0
12/08/2011
Approval date [1] 271744 0
26/08/2011
Ethics approval number [1] 271744 0
2011/358

Summary
Brief summary
Many Psychostimulant users do not seek treatment for their drug use. Several barriers to treatment have been identified including confidentiality: stigma, socio-demographic factors: employment (particularly full-time employment), gender, and immigrant status, which suggest both physical and cultural barriers to accessing treatment.
This study will evaluate the effectiveness of an on-line intervention which uses cognitive behavioural therapy and motivational techniques designed to reduce harmful psychostimulant use.
Trial website
Trial related presentations / publications
Tait, R.J., McKetin, R., Kay-Lambkin, F., Geddes, J., Bennett, K., Griffiths K., Christensen, H. ‘breakingtheice’: Protocol for an online intervention for psychostimulant misuse. (Poster presentation) International Society for Research on Internet Interventions, Sydney 2011.
Public notes

Contacts
Principal investigator
Name 32985 0
Address 32985 0
Country 32985 0
Phone 32985 0
Fax 32985 0
Email 32985 0
Contact person for public queries
Name 16232 0
Robert Tait
Address 16232 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 0200
Country 16232 0
Australia
Phone 16232 0
+61 2 6125 9106
Fax 16232 0
+61 2 6125 0733
Email 16232 0
[email protected]
Contact person for scientific queries
Name 7160 0
Robert Tait
Address 7160 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 0200
Country 7160 0
Australia
Phone 7160 0
+61 2 6125 9106
Fax 7160 0
+61 2 6125 0733
Email 7160 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
SourceTitleYear of PublicationDOI
EmbaseSix-month outcomes of a Web-based intervention for users of amphetamine-type stimulants: randomized controlled trial.2015https://dx.doi.org/10.2196/jmir.3778
N.B. These documents automatically identified may not have been verified by the study sponsor.