Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000279921
Ethics application status
Approved
Date submitted
17/02/2020
Date registered
3/03/2020
Date last updated
18/02/2021
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial comparing face-to-face with online problem gambling treatment
Scientific title
A randomised control trial comparing face-to-face with online treatment in reducing the urge to gamble, cognitive distortions related to gambling, and negative consequences associated with gambling.
Secondary ID [1] 300567 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 316301 0
Condition category
Condition code
Mental Health 314569 314569 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of the current study is to examine different ways of delivering psychological treatments for problem gambling. Namely, the study aims to compare face-to-face treatment, online self-directed treatment, and a hybrid that has both face-to-face and online components. The delivered treatment is a cognitive therapy focusing on helping the participant understand what motivates their gambling, and then deconstructing their erroneous beliefs about their preferred form of gambling, followed by teaching them skills to make better decisions in the future. While face-to-face cognitive therapy is well researched and a supported treatment for problem gambling, preliminary evidence suggests that it may be delivered efficaciously online.
The research will be completed at the University of Sydney’s Gambling Treatment and Research Clinic, which comprises of three locations:
o Mallett St- Level 2, Brain and Mind Centre, 94 Mallett St, Camperdown, NSW, 2050
o Parramatta- Level 4, 20-22 Macquarie St, Parramatta, 2150
o Campbelltown- 171-179 Queen St, Campbelltown, 2560

The current study will be administered as a randomised control outcome trial, with participants randomly allocated to one of the three treatment conditions: 8 sessions of face-to-face cognitive therapy (FTF) administered by registered and intern psychologists who have had extensive training in problem gambling treatment; 8 sessions of online self-directed cognitive therapy (OSD); and a combined model (FTF/OSD), where participants would receive 2 sessions of FTF cognitive therapy combined with 6 sessions of OSD cognitive therapy.These sessions, each lasting from 45 min to 1 hour, will run over a period of 8-weeks and those allocated to receive online therapy will have access to these clinicians if they require further support. The treatment that will be examined will be based on a variety of cognitive therapy which was developed at the Gambling Treatment and Research Clinic by current deputy director, Dr Fadi Anjoul. The therapy focuses on helping the participant understand what motivates their gambling, and then deconstructing their erroneous beliefs about their preferred form of gambling, followed by teaching them skills to make better decisions in the future. The participants in the study will be recruited from consecutive clients presenting to the University of Sydney’s Gambling Treatment and Research Clinic for assistance with a gambling problem.

In all treatment conditions, the client will receive a psychotherapeutic intervention covering comparable modules of cognitive therapy. Included modules will be: 1) problem basis of gambling; 2) automatic tendencies; 3) theory of winning; 4) randomness; 5) return to player percentage and negative expectancy; 6) futility of gambling; 7) turning-off gambling; and 8) self-management training.
Once participants have successfully completed all therapeutic modules, they will then be asked to attend a face-to-face assessment session where a trained clinician will conduct a clinical assessment and administer the outcome measures again, and enquire as to whether the participant has consulted any other health professionals regarding their gambling or any related distress. Those not responding or completing treatment will be offered an alternative treatment and be classified as treatment failures for the purpose of the study. Participants will then be contacted via phone at three month following the completion of treatment for a follow-up assessment. At this three-month follow-up, participants will be offered one of the alternative treatments if further treatment is deemed to be necessary. Finally, participants will also be conducted via phone at 6 months for a final follow-up.
Intervention code [1] 316873 0
Behaviour
Intervention code [2] 316874 0
Treatment: Other
Comparator / control treatment
The primary aim of the current study is to examine different ways of delivering psychological treatments for problem gambling. Namely, the study aims to compare face-to-face treatment, online self-directed treatment, and a hybrid that has both face-to-face and online components.

The active control is the group that receives face-to-face (FTF) cognitive therapy treatment only.
Control group
Active

Outcomes
Primary outcome [1] 322895 0
Score on Problem Gambling Severity Index (Ferris & Wynne, 2001). This self-report instrument provides a measure of at-risk behavior in problem gambling.
Timepoint [1] 322895 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.

The primary timepoint is at the 6 month follow-up.
Primary outcome [2] 322896 0
Score on Gambling Effects Measure (Shannon et al., 2017). This self-report instrument provides a measure of harm caused by gambling in different areas of life.
Timepoint [2] 322896 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.

The primary timepoint is at the 6 month follow-up.
Primary outcome [3] 322897 0
Score on the Time and Money Gambling Questionnaire (developed in-house; University of Sydney Gambling Treatment and Research Clinic). This self-report instrument provides a measure of gambling frequency.
Timepoint [3] 322897 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.

The primary timepoint is at the 6 month follow-up.
Secondary outcome [1] 380174 0
Score on Gambling Beliefs Questionnaire (Steenbergh et al., 2002). This self-report instrument provides a measure of cognitive distortions related to gambling.

This is a primary outcome.
Timepoint [1] 380174 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [2] 380175 0
Score on Gambling Urge Scale (Raylu & Oei, 2004). This self-report instrument provides a measure of gambling urges.

This is a primary outcome.
Timepoint [2] 380175 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [3] 380176 0
Score on Recovery Index for Gambling Disorder (Pickering, 2019). This self-report instrument provides a composite measure of the severity of behaviours and thoughts related to gambling.
Timepoint [3] 380176 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [4] 380177 0
Score on the Alcohol Use Disorders Identification Test (Saunders et. al., 1993). This self-report instrument provides a measure of at-risk alcohol use.
Timepoint [4] 380177 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [5] 380178 0
Score on the Quality of Life Inventory (Frisch, 1994). This self-report instrument provides an overall measure of quality in various aspects of one's life (not necessarily related to gambling).
Timepoint [5] 380178 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [6] 380512 0
Score on the Time and Money Gambling Questionnaire (developed in-house; University of Sydney Gambling Treatment and Research Clinic). This self-report instrument provides a measure of money spent on gambling.

This is a primary outcome.
Timepoint [6] 380512 0
Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.
Secondary outcome [7] 380513 0
Cost-effectiveness analysis
Timepoint [7] 380513 0
A secondary aim of the trial is to examine the cost-effectiveness of the different methods of delivering the CBT for problem gambling. That is, the trial will also carry out a cost-effectiveness analysis by calculating incremental cost-effectiveness ratios (ICERs) and quality adjusted life years (QALYs) for the evaluated treatments. This is will be calculated at Baseline, 8 weeks (upon finalisation of treatment sessions) and 6 months as a follow-up.

Eligibility
Key inclusion criteria
To be invited to participate in the trial, potential participants must:

a) Have self-presented to the Gambling Treatment and Research Clinic for assistance in reducing or stopping their gambling.
b) Have gambled within the past month
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To be invited to participate in the trial, potential participants must not:
a) Have received a diagnosis of a bipolar, psychotic disorder or intellectual disability
b) Be reporting current strong suicidal ideation
c) Have been hospitalised for a psychiatric condition or suicidality within the past six months
d) Have been mandated to attend therapy (such as by a court or by a probation and parole service)
e) Have previously attended sessions at the clinic where they were administered the treatments under investigation, in whole or in part.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
The primary outcome of the study will be to identify which of the three treatment modalities (Face-to-face; online self-directed; hybrid online/face-to-face) provides more effective treatment of problem gambling, and which provides the most lasting improvements at the end of the 6 month follow-up period.

The study results will be analysed through a combination of techniques. Changes in participant responses between the three groups over time will be compared using a two-way mixed ANOVA. If data is non-normally distributed on outcome variables, as is common in psychological studies, non-parametric alternatives will be applied (e.g. GEE regressions, Friedman/Kruskal-Wallis tests).

Power analysis was conducted, and it was found that a sample size of 150 was needed to find a medium-sized effect. Given the potential of attrition of the sample, the current aim is to recruit approximately 180 participants.

In regards to definitions of participant attrition, we will use the following:
- Treatment not started = participant has initial assessment but does not commence treatment.
- Dropout; either:
o participant has commenced at least Module 1, but has not completed the final module of treatment; or
o four weeks has elapsed without participant logging onto online module [for participants assigned to online treatment condition].
- Treatment completion = participant has completed all modules including the final module of treatment.
- Treatment failure = participant has completed the treatment modules as part of the study but requests further treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
18/07/2022
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304985 0
Government body
Name [1] 304985 0
Office of Responsible Gambling
Country [1] 304985 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 305346 0
None
Name [1] 305346 0
Address [1] 305346 0
Country [1] 305346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305388 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 305388 0
Ethics committee country [1] 305388 0
Australia
Date submitted for ethics approval [1] 305388 0
11/02/2020
Approval date [1] 305388 0
20/03/2020
Ethics approval number [1] 305388 0

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

Contacts
Principal investigator
Name 100210 0
Dr Christopher Hunt
Address 100210 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett Street
Camperdown NSW 2050
Country 100210 0
Australia
Phone 100210 0
+61 02 9114 4367
Fax 100210 0
Email 100210 0
[email protected]
Contact person for public queries
Name 100211 0
Christopher Hunt
Address 100211 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett Street
Camperdown NSW 2050
Country 100211 0
Australia
Phone 100211 0
+61 02 9114 4367
Fax 100211 0
Email 100211 0
[email protected]
Contact person for scientific queries
Name 100212 0
Christopher Hunt
Address 100212 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett Street
Camperdown NSW 2050
Country 100212 0
Australia
Phone 100212 0
+61 02 9114 4367
Fax 100212 0
Email 100212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We must maintain the privacy/confidentiality of participants and their outcomes from the study.


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.