Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000560291
Ethics application status
Approved
Date submitted
8/07/2009
Date registered
9/07/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness study of problem gambling standard and brief interventions
Scientific title
For callers to a problem gambling helpline are motivational interviewing-based self-help interventions as good as or better than standard care in reducing gambling involvement?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 237181 0
Condition category
Condition code
Mental Health 237506 237506 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: single session motivational interview, Group 2: single session motivational interview + self help workbook, Group 3: single session motivational interview + self help workbook + 4 'booster' telephone calls.

The single session motivational interview is the same in all three groups and consists of a 30-40 minute telephone interview administered by a trained counsellor. The self-help workbook provided to groups 2 and 3 is the same and consists of a range of self-help exercises and strategies that participants can use to reduce their gambling involvement. The 4 booster telephone calls provided in Group 3 are administered by trained counsellors, are based on motivational interviewing techniques, are 10-20 minutes in duration, and are designed to promote positive self change with respect to gambling involvement. The 4 booster calls will be made at 1-,4-, 12- and 26- weeks post randomisation.
Intervention code [1] 236888 0
Treatment: Other
Comparator / control treatment
standard treatment. Single 20-40 intervention consisting of general counselling micro-skills, referral and advice. Standard treatment provided by trained counsellors.
Control group
Active

Outcomes
Primary outcome [1] 238315 0
Number of days gambled per month as measured by a time line follow back interview
Timepoint [1] 238315 0
at 3-, 6- and 12-months after randomisation
Primary outcome [2] 238316 0
Total dollars spent on gambling per month (exclduing winnings) as measured by a time line follow back interview
Timepoint [2] 238316 0
at 3-, 6- and 12-months after randomisation
Secondary outcome [1] 244707 0
Self-rated control over gambling as measured by a 10-point scale (0 = no control and 10 = total control) included on a researcher administered questionnaire
Timepoint [1] 244707 0
at 3-, 6- and 12-months after randomisation
Secondary outcome [2] 244708 0
Self-reported alcohol and drug use as measured by the 3-item Alcohol Use Disorders Identification Test (AUDIT-C) and the Drug Abuse Screening Test (DAST) included on a researcher administered questionnaire
Timepoint [2] 244708 0
at 12-months after randomisation

Eligibility
Key inclusion criteria
perception of having a gambling problem, willingness to read a short workbook, and willingness to provide follow-up data on gambling, no contact with helpline in previous 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Callers considered actively psychotic or requiring immediate crisis or police intervention because they pose a serious risk to themselves or others will be excluded

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
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
670
Accrual to date
Final
Recruitment outside Australia
Country [1] 1873 0
New Zealand
State/province [1] 1873 0

Funding & Sponsors
Funding source category [1] 237285 0
Government body
Name [1] 237285 0
Ministry of Health
Country [1] 237285 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT)
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 236769 0
None
Name [1] 236769 0
Address [1] 236769 0
Country [1] 236769 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The proposed study is a randomised controlled trial of four brief, telephone-based, problem gambling interventions. All four interventions will be provided to consenting clients of the Gambling Helpline, New Zealand. The four interventions include: 1) Treatment as Usual (TAU); 2) Motivational Interview (MI); 3) Motivational Interview + Workbook (MI+W); and 4) Motivational Interview + Workbook + Booster sessions (MI+W+B). The primary hypotheses include:
1.All four groups will evidence significant reduction in gambling
2.The Motivational Interview (MI) group will show similar improvement to Treatment as Usual (TAU)
3.The Motivational Interview/Workbook group (MI+W) and the Motivational Interview/Workbook/Booster (MI+W+B) group will show greater improvement than the MI and TAU groups
4.The MI+W+B group will show greater improvement than the other three groups at the 12-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29863 0
Address 29863 0
Country 29863 0
Phone 29863 0
Fax 29863 0
Email 29863 0
Contact person for public queries
Name 13110 0
Dr Maria Bellringer
Address 13110 0
Gambling & Addictions Research Centre
AUT University
North Shore campus
90 Akoranga Dr
Northcote 0627
Country 13110 0
New Zealand
Phone 13110 0
+ 64 9 921 9999 xt 7232
Fax 13110 0
Email 13110 0
[email protected]
Contact person for scientific queries
Name 4038 0
Professor Max Abbott
Address 4038 0
Gambling & Addictions Research Centre
AUT University
North Shore campus
90 Akoranga Dr
Northcote 0627
Country 4038 0
New Zealand
Phone 4038 0
+ 64 9 921 9894
Fax 4038 0
Email 4038 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
EmbaseBrief telephone interventions for problem gambling: a randomized controlled trial.2018https://dx.doi.org/10.1111/add.14149
N.B. These documents automatically identified may not have been verified by the study sponsor.