Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000463774
Ethics application status
Approved
Date submitted
20/04/2013
Date registered
23/04/2013
Date last updated
23/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Beating The Rush’: A web-based assessment and brief intervention for amphetamine use
Scientific title
Brief online intervention for amphetamine use, measuring change in use and harms associated with use
Secondary ID [1] 282370 0
None
Universal Trial Number (UTN)
U1111-1142-1490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amphetamine Abuse
 288951 0
Amphetamine Dependence
 288952 0
Condition category
Condition code
Mental Health 289283 289283 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this current study is to establish whether a web-based cognitive behaviour therapy (CBT) intervention is effective in treating amphetamine use and its associated harms. Participants will be asked to complete one 30-minute session per week for five weeks. Sessions include components such as motivational interviewing, goal setting, thought monitoring, cognitive restructuring, pleasant activity scheduling, and relapse prevention. Adherence will be monitored via the website, which will provide information about when sessions were accessed and which pages were viewed.

Of particular interest is the potential role that contingency management may have on treatment success. Another aim of this research is to identify predictors of treatment outcome for amphetamine users (self-efficacy and impulsivity).
Intervention code [1] 287001 0
Treatment: Other
Intervention code [2] 287002 0
Behaviour
Comparator / control treatment
A waitlist control group will receive no treatment during the trial but they will be provided with access to the intervention after a five-week waiting period. They will receive minimal intervention (psychoeducation about amphetamines and harm reduction) upon consenting and logging in to the treatment program.
Control group
Active

Outcomes
Primary outcome [1] 289393 0
Alcohol and drug use measured by the Addiction Severity Index (ASI) Alcohol and Drug Use Section, the Alcohol Use Disorders Identification Test (AUDIT), and Timeline Followback (TLFB)
Timepoint [1] 289393 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up
Primary outcome [2] 289394 0
Amount and frequency of amphetamine use will be assessed by asking participants, "How many grams of amphetamines have you used in the past seven days?" and "How many times have you used in the past seven days?"
Timepoint [2] 289394 0
Once per week for five weeks
Secondary outcome [1] 302387 0
Treatment retention will be assessed by online monitoring of session completion
Timepoint [1] 302387 0
Post treatment (5 weeks)
Secondary outcome [2] 302388 0
Treatment satisfaction will be assessed by asking participants, "How satisfied are you with the treatment you received in the ‘Beating The Rush’ program?" Responses will be provided via a 4-point Likert scale from "Very satisfied" to "Quite dissatisfied". Participants will also be asked, "Would you recommend this treatment program to a friend?" Responses will be provided via a 4-point Likert scale from "Yes, definitely" to "No, definitely not".
Timepoint [2] 302388 0
Post treatment (5 weeks)
Secondary outcome [3] 302389 0
Depression, anxiety and stress will be measured using the Depression Anxiety Stress Scale-21
Timepoint [3] 302389 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up
Secondary outcome [4] 302390 0
Social functioning will be measured using the Opiate Treatment Inventory (OTI) Social Functioning Subscale
Timepoint [4] 302390 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up
Secondary outcome [5] 302391 0
HIV risk behaviour will be measured using the HIV Risk Behaviour Scale (HRBS) Drug Use Subscale
Timepoint [5] 302391 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up
Secondary outcome [6] 302392 0
Confidence will be assessed using the Situational Confidence Questionnaire (SCQ)
Timepoint [6] 302392 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up
Secondary outcome [7] 302393 0
Impulsivity will be assessed using the Barratt Impulsiveness Scale 11 (BIS-11)
Timepoint [7] 302393 0
Pre, mid (at session 3) and post (5 weeks) treatment, and three and six month follow up

Eligibility
Key inclusion criteria
Participants aged 14 years and over who have used amphetamines at least once in the past month.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be advised that the program is not suitable for those who are experiencing acute suicide ideation, plan or intent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who register for the study will be randomly allocated to conditions by the website
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
6/05/2013
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)
QLD

Funding & Sponsors
Funding source category [1] 287139 0
University
Name [1] 287139 0
Griffith University
Country [1] 287139 0
Australia
Primary sponsor type
Individual
Name
Dr Leanne Casey
Address
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country
Australia
Secondary sponsor category [1] 285908 0
Individual
Name [1] 285908 0
Eliana Hirakis
Address [1] 285908 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country [1] 285908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289139 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 289139 0
Office for Research
Bray Centre
Griffith University Nathan Campus
170 Kessels Rd
Nathan Qld 4111
Ethics committee country [1] 289139 0
Australia
Date submitted for ethics approval [1] 289139 0
Approval date [1] 289139 0
06/11/2009
Ethics approval number [1] 289139 0
PSY/94/09/HREC

Summary
Brief summary
The aim of this current study is to establish whether a web-based CBT intervention is effective in treating amphetamine use and its associated harms. Of particular interest is the potential role that contingency management may have on treatment success. Another aim of this research is to identify predictors of treatment outcome for amphetamine users (self-efficacy and impulsivity).

It is hypothesised that i) participants who undertake the Internet-delivered CBT intervention in combination with contingency management (monetary incentives for remaining in treatment) will show greater reductions in their use of amphetamines as well as reductions in harms associated with use, higher rates of abstinence and will remain in treatment longer in comparison to the waitlist control group, ii) treatment retention and outcomes will be influenced by self-efficacy and an impulsive temperament.
Trial website
www.beatingtherush.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39438 0
Miss Eliana Hirakis
Address 39438 0
School of Psychology
Griffith University, Mt Gravatt Campus,
176 Messines Ridge Road,
Mt Gravatt, Qld 4111
Country 39438 0
Australia
Phone 39438 0
+61 7 3162 9135
Fax 39438 0
Email 39438 0
eliana@hirakis.com.au
Contact person for public queries
Name 39439 0
Miss Eliana Hirakis
Address 39439 0
School of Psychology
Griffith University, Mt Gravatt Campus,
176 Messines Ridge Road,
Mt Gravatt, Qld 4111
Country 39439 0
Australia
Phone 39439 0
+61 7 3162 9135
Fax 39439 0
Email 39439 0
eliana@hirakis.com.au
Contact person for scientific queries
Name 39440 0
Dr Leanne Casey
Address 39440 0
School of Psychology
Griffith University, Mt Gravatt Campus,
176 Messines Ridge Road,
Mt Gravatt, Qld 4111
Country 39440 0
Australia
Phone 39440 0
+61 7 3735 3314
Fax 39440 0
Email 39440 0
l.casey@griffith.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

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