Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000864527
Ethics application status
Approved
Date submitted
27/07/2015
Date registered
19/08/2015
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Date results information initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
GamblingLess: A pilot pragmatic randomised controlled trial evaluating the effectiveness of an online self-help cognitive-behavioural program for gambling
Scientific title
GamblingLess: A pilot pragmatic randomised controlled trial evaluating the effectiveness of an online self-help cognitive behavioural program for the treatment of problem gambling
Secondary ID [1] 287152 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 295710 0
Condition category
Condition code
Mental Health 295990 295990 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GamblingLess program is an online cognitive-behavioural self-help program for people with gambling problems, developed using the best available evidence in the gambling field.

This online self-help program consists of four modules:

Module 1 Getting ready to gamble less - This module aims to help participants understand their gambling, increase their motivation to change and to define their goals in order to help increase their readiness to change.

Module 2 Taking action to gamble less - This module aims to teach participants new skills to help achieve their goals. The activities in this module are designed to reduce and stabilise their gambling.

Module 3 Thinking differently to gamble less - This module aims to teach participants how gambling works and some of the tricks that are used to keep people gambling. This module will help participants understand which gambling-related thinking traps they are using and how to adjust their beliefs so they do not keep gambling because of them.

Module 4 Gambling less for good - This module aims to help increase participants awareness of the chain of events and behaviours leading up to a relapse, to assist with maintaining their goals in the future. This module will teach participants how to adapt their existing skills and learn new skills to deal with high risk situations and gambling urges.

Each module includes a range of interactive activities, such as video clips, audio files and questions. Each module takes approximately 1 to 2 hours to complete and it does not all have to be done in one sitting. The program will be open for 14 weeks, from the completion of the pre-intervention questionnaire. It is recommended that the modules are completed in sequential order with one module completed per fortnight. Participants can complete as many activities and modules as they choose. The usability of the program will be assessed by determining which activities were completed.

The guided self-help intervention group will receive access to the GamblingLess program along with guidance from a trained professional. The guidance will consist of weekly email conversation support. The email support will be motivational and facilitative in nature, with the aim of keeping participants on track throughout the program. The guidance will be provided over an eight week period, commencing from the completion of the pre-intervention questionnaire. Participants allocated to this group will be able to email their Guide as often as they like throughout the eight week period. A randomly selected subset of emails will be examined for treatment fidelity purposes at the end of the study.
Intervention code [1] 292421 0
Treatment: Other
Intervention code [2] 292488 0
Behaviour
Comparator / control treatment
The GamblingLess program is an online cognitive-behavioural self-help program for people with gambling problems, developed using the best available evidence in the gambling field.

This online self-help program consists of four modules:

Module 1 Getting ready to gamble less - This module aims to help participants understand their gambling, increase their motivation to change and to define their goals in order to help increase their readiness to change.

Module 2 Taking action to gamble less - This module aims to teach participants new skills to help achieve their goals. The activities in this module are designed to reduce and stabilise their gambling.

Module 3 Thinking differently to gamble less - This module aims to teach participants how gambling works and some of the tricks that are used to keep people gambling. This module will help participants understand which gambling-related thinking traps they are using and how to adjust their beliefs so they do not keep gambling because of them.

Module 4 Gambling less for good - This module aims to help increase participants awareness of the chain of events and behaviours leading up to a relapse, to assist with maintaining their goals in the future. This module will teach participants how to adapt their existing skills and learn new skills to deal with high risk situations and gambling urges.

Each module includes a range of interactive activities, such as video clips, audio files and questions. Each module takes approximately 1 to 2 hours to complete and it does not all have to be done in one sitting. The program will be open for 14 weeks, from the completion of the pre-intervention questionnaire. It is recommended that the modules are completed in sequential order with one module completed per fortnight. Participants can complete as many activities and modules as they choose. The usability of the program will be assessed by determining which activities were completed.
Control group
Active

Outcomes
Primary outcome [1] 295661 0
Gambling symptom severity using the Gambling Symptom Assessment Scale.
Timepoint [1] 295661 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention
Primary outcome [2] 295727 0
Self-reported past month gambling frequency using an online questionnaire designed for this study.
Timepoint [2] 295727 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention
Primary outcome [3] 295728 0
Self-reported past month gambling spend using an online questionnaire designed for this study.
Timepoint [3] 295728 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention
Secondary outcome [1] 316141 0
Psychological distress using Kessler 6
Timepoint [1] 316141 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention
Secondary outcome [2] 316342 0
Well-being using one item from WHO-QOL
Timepoint [2] 316342 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention
Secondary outcome [3] 316343 0
Self-reported help-seeking using an online questionnaire designed for this study.
Timepoint [3] 316343 0
1. Immediately pre-intervention
2. 2 months from pre-intervention
3. 3 months from pre-intervention
4. 12 months from pre-intervention
5. 24 months from pre-intervention

Eligibility
Key inclusion criteria
1. Currently reside in Australia
2. Express interest in seeking some type of help for their own gambling problems
3. Be at least 18 years of age
4. Have access to the internet
5. Have good knowledge of the English language
6. Are willing to commit to the 8 week program and to completing brief assessment measures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under the age of 18 years
2. Do not reside in Australia

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)
All enrollment and treatment allocation procedures will be conducted online without the involvement from any members of the research team. As such, the allocation procedure will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, using varying block sizes, will be utilised to randomly allocate participants in to the pure or guided self-help intervention. This will ensure equal numbers across the two interventions. To ensure balance on potential confounders, randomisation will be stratified based on sex, median age and median problem gambling severity. The randomisation will be worked in to the online program and will be monitored by the online resource developer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will employ an intention-to-treat design to assess the differential effectiveness of the guided self-help and pure self-help interventions. A per protocol and as treated analysis will also be conducted. A generalised mixed-effects model approach will be used in the analysis of repeated measures for primary and secondary continuous and categorical outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2015
Actual
24/08/2015
Date of last participant enrolment
Anticipated
Actual
10/05/2016
Date of last data collection
Anticipated
1/12/2016
Actual
18/04/2018
Sample size
Target
156
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291722 0
Government body
Name [1] 291722 0
Victorian Responsible Gambling Foundation
Country [1] 291722 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, 3125 Victoria
Country
Australia
Secondary sponsor category [1] 290395 0
None
Name [1] 290395 0
Address [1] 290395 0
Country [1] 290395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293244 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 293244 0
221 Burwood Highway, Burwood, 3125 Victoria
Ethics committee country [1] 293244 0
Australia
Date submitted for ethics approval [1] 293244 0
Approval date [1] 293244 0
10/02/2015
Ethics approval number [1] 293244 0
EC00213
Ethics committee name [2] 293245 0
Eastern Health Human Research Ethics Committee
Ethics committee address [2] 293245 0
Level 2, 5 Arnold street, Box Hill, 3128 Victoria
Ethics committee country [2] 293245 0
Australia
Date submitted for ethics approval [2] 293245 0
Approval date [2] 293245 0
17/07/2015
Ethics approval number [2] 293245 0
EC00211

Summary
Brief summary
The aim of this pilot pragmatic randomised controlled trial is to evaluate the effectiveness of a new online self-help program for people who are having difficulties controlling their gambling. This study will evaluate the effectiveness of the program under two different conditions:
1. pure self-help - delivered without any practitioner guidance; and
2. guided self-help - delivered with practitioner guidance via email.
It is hypothesised that the guided self-help intervention will lead to better outcomes than the pure self-help intervention.
Trial website
www.gamblingless.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59042 0
A/Prof Nicki Dowling
Address 59042 0
221 Burwood highway, Burwood, 3125 Victoria
Country 59042 0
Australia
Phone 59042 0
+61 (3) 9244 5610
Fax 59042 0
Email 59042 0
nicki.dowling@deakin.edu.au
Contact person for public queries
Name 59043 0
A/Prof Nicki Dowling
Address 59043 0
221 Burwood highway, Burwood, 3125 Victoria
Country 59043 0
Australia
Phone 59043 0
+61 (3) 9244 5610
Fax 59043 0
Email 59043 0
nicki.dowling@deakin.edu.au
Contact person for scientific queries
Name 59044 0
A/Prof Nicki Dowling
Address 59044 0
221 Burwood highway, Burwood, 3125 Victoria
Country 59044 0
Australia
Phone 59044 0
+61 (3) 9244 5610
Fax 59044 0
Email 59044 0
nicki.dowling@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
At this stage it is undecided if IPD will be uploaded on to an open access platform. At this point we will share IPD upon request.
What supporting documents are/will be available?
Study protocol
Clinical study report
How or where can supporting documents be obtained?
Type [1] 630 0
Study protocol
Citation [1] 630 0
Link [1] 630 0
Email [1] 630 0
Other [1] 630 0
https://bmjopen.bmj.com/content/7/2/e014226
Attachment [1] 630 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 620 0
Report
Citation/DOI/link/details [1] 620 0
https://responsiblegambling.vic.gov.au/resources/publications/development-and-evaluation-of-an-online-gambling-self-directed-program-effective-integration-into-existing-services-348/
Attachments [1] 620 0
Results – basic reporting
http://www.anzctr.org.au/Steps11and12/368996-(Uploaded-05-12-2018-13-49-08)-Basic results summary.docx
Results – plain English summary
The aims of this project were to develop an online self-directed cognitive behavioural program for gambling (GAMBLINGLESS. FOR LIFE.) and employ a pragmatic trial design to investigate the effectiveness of this program delivered under guided self-directed conditions compared to pure self-directed conditions. A total of 206 participants were recruited into the pragmatic trial. These participants were mostly male, less than 40 years of age, born in Australia, and employed full-time. They most commonly reported having issues with EGMs, horse, harness or greyhound racing, and sports and events betting. Almost all users (96%) were classified in the problem gambling category using the Problem Gambling Severity Index.
There were no statistically significant differences between the PSD and GSD conditions on almost all outcome measures at the 8- or 12-week evaluations. However, participants in the GSD group reported a significantly greater reduction in days gambled at the 12-week evaluation, and a higher rate of low-intensity help-seeking at the 8-week evaluation, than participants in the PSD. Moreover, at the 12-week evaluation, there was a medium effect size between the PSD and GSD groups on several measures, including gambling symptom severity, gambling urges, gambling expenditure, and quality of life; and a considerably higher proportion of GSD participants (62%) than PSD participants (35%) “recovered” on gambling symptom severity at the 12-week evaluation. There were also statistically significant improvements in gambling symptom severity, gambling urges, gambling frequency, and psychological distress within treatment groups at the 8- and 12-week evaluations. On gambling symptom severity, 50% of users recovered, 14% improved, 34% showed no real change, and 3% deteriorated; for psychological distress, 32% of users recovered, 15% improved, 45% experienced no real change, and 9% deteriorated. There were significant improvements in gambling expenditure and quality of life at the 8-week, but not the 12-week, evaluation. In contrast, there was no within-group improvement on help-seeking at either post-baseline evaluation.