Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000961549
Ethics application status
Approved
Date submitted
21/08/2015
Date registered
14/09/2015
Date last updated
16/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the Effectiveness of an Online Self-directed Intervention for Problem Gambling
Scientific title
Evaluating the Effectiveness of an Online Self-directed Intervention for Problem Gambling
Secondary ID [1] 287396 0
Nil
Universal Trial Number (UTN)
U1111-1173-5295
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem Gambling 295972 0
Addiction 295973 0
Condition category
Condition code
Mental Health 296254 296254 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once you have completed the initial questionnaire you will be randomly allocated to one of two treatment groups, which differ only slightly. Specifically, one treatment group will receive a phone call by one of the researchers and the second treatment group will not. The purpose of this telephone call is to complete motivational interviewing exercises, in order to motivate and prepare the client to engage with the online treatment program. This telephone call will take approximately 20-25 minutes and it will be recorded for quality and accuracy purposes. Consent for this recording will be obtained verbally at the start of the telephone call. One week after the completion of the initial questionnaire, you will be able to access the internet-based self-directed intervention for a duration of six weeks. The online intervention will allow participants to explore their gambling behaviour and develop ways to change or stop it completely. Modules that will be available are based on Cognitive Behavioural Therapy and Motivational Interviewing and include considering the benefits and costs of gambling, personal motivation for gambling and reducing gambling, engaging personal support, psychoeducation, understanding and challenging irrational thoughts and beliefs, managing urges, behavioural strategies to reduce gambling, managing finances, planning for potential relapses, and addressing other life issues. Each of these modules will include information about the module followed by short answer exercises, in order to aid the participants understanding and comprehension of the material. Participants will be able to use the program as little or as much as they like, with no strict rule on the time spent on the program, per week. Adherence will be monitored through the frequency of log-ins, duration per login, modules completed, and attempts per module.
Intervention code [1] 292653 0
Treatment: Other
Intervention code [2] 292794 0
Behaviour
Comparator / control treatment
Self-directed online program (comparison group)
Self-directed online program with motivational interviewing telephone call.
Control group
Active

Outcomes
Primary outcome [1] 295912 0
Severity of gambling problem, assessed by the NODS (National Opinion Research Centre): DSM Screen for Gambling Problems
Timepoint [1] 295912 0
pre-treatment
post-treatment
1-month follow-up
3-month follow-up
6-month follow-up
Secondary outcome [1] 316912 0
Gambling expenditure and frequency - composite outcomes, and will be measured by self-report.
Timepoint [1] 316912 0
pre-treatment
post-treatment
1-month follow-up
3-month follow-up
6-month follow-up
Secondary outcome [2] 316913 0
motivation to gamble, assessed by the Motivations Towards Gambling Scale
Timepoint [2] 316913 0
pre-treatment
post-treatment
1-month follow-up
3-month follow-up
6-month follow-up
Secondary outcome [3] 316914 0
Gambling urges, assessed by the Gamblers' Beliefs Questionnaire
Timepoint [3] 316914 0
pre-treatment
post-treatment
1-month follow-up
3-month follow-up
6-month follow-up

Eligibility
Key inclusion criteria
Fulfill the criteria of the DSM-5 for gambling disorders, according to the 1-month version of the NODS
Be at least 18 years of age
Live in Australia
Have gambled at least once in the past 30 days
Must have regular and convenient access to the internet in order to complete the program
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undertaking formal concurrent treatment for gambling problems from other professional services.
Participants who endorse 'high' levels of suicide, and participants who display psychotic symptoms.

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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/08/2015
Actual
29/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
178
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291895 0
University
Name [1] 291895 0
The University of Sydney
Country [1] 291895 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Psychology, The Faculty of Science,
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 290562 0
Other
Name [1] 290562 0
National Association for Gambling Studies
Address [1] 290562 0
PO Box 330
Pacific Fair
QLD 4218
Australia
Country [1] 290562 0
Australia
Other collaborator category [1] 278589 0
Hospital
Name [1] 278589 0
Centre for Addiction and Mental Health (CAMH)
Address [1] 278589 0
1001 Queen Street West
30, 40, 50 and 60 White Squirrel Way
100 and 101 Stokes Street
80 Workman Way
Toronto, Ontario
M6J 1H4
Country [1] 278589 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293403 0
The University of Sydney, Human Research Ethics Committee
Ethics committee address [1] 293403 0
Ethics committee country [1] 293403 0
Australia
Date submitted for ethics approval [1] 293403 0
Approval date [1] 293403 0
11/03/2015
Ethics approval number [1] 293403 0
2015/052

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

Contacts
Principal investigator
Name 59750 0
Prof Alexander Blaszczynski
Address 59750 0
School of Psychology, Faculty of Science,
Rm No, 306 Griffith Taylor A18,
The University of Sydney, NSW, 2006
Country 59750 0
Australia
Phone 59750 0
+ 61 2 9351 7310
Fax 59750 0
Email 59750 0
[email protected]
Contact person for public queries
Name 59751 0
Jaymee-Lee Owen
Address 59751 0
School of Psychology, Faculty of Science,
Rm No, 306 Griffith Taylor A18,
The University of Sydney, NSW, 2006
Country 59751 0
Australia
Phone 59751 0
+61410941946
Fax 59751 0
Email 59751 0
[email protected]
Contact person for scientific queries
Name 59752 0
Jaymee-Lee Owen
Address 59752 0
School of Psychology, Faculty of Science,
Rm No, 306 Griffith Taylor A18,
The University of Sydney, NSW, 2006
Country 59752 0
Australia
Phone 59752 0
+61410941946
Fax 59752 0
Email 59752 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.