Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000646347
Ethics application status
Approved
Date submitted
1/05/2017
Date registered
4/05/2017
Date last updated
21/07/2020
Date data sharing statement initially provided
21/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two versions of psychological therapy for gambling disorder
Scientific title
A randomised outcome study comparing the effects of Cognitive Behavioural Therapy versus Cognitive Deconstructional Therapy on gambling behaviour in participants with gambling disorders
Secondary ID [1] 291810 0
Nil known
Universal Trial Number (UTN)
U1111-1196-1560
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gambling Disorder 303056 0
Condition category
Condition code
Mental Health 302512 302512 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cognitively-focused treatment (referred to as Cognitive Deconstructional Therapy, or CDT) focusing on helping clients understand how their erroneous cognitions about how their preferred form of gambling operate result in their gambling behaviour. It then provides corrective information, as well as helping clients better understand their motivation to gamble. CDT contains 8 modules: (a) early experiences with gambling, (b) stages of change in gambling behaviour, (c) theories of winning at gambling, (d) randomness and unpredictability; (e) return to player percentage and value; (f) temporality and futility of gambling; (g) non-financial motivations to gamble, and (h) review and relapse prevention. The treatment will include use of multi-media materials to visualise concepts of randomness, unpredictability and return-to-player percentage that have been developed at the University of Sydney Gambling Treatment and Research Clinic. These materials will comprise of short animations, mathematical simulations and spreadsheets, and will be presented via computer during face-to-face therapy sessions.

Treatment will be delivered by intern psychologists and registered psychologists who have been trained in the treatment of problem gambling. Session will be delivered individually and face-to-face. Participants will attend a minimum of 8 one hour sessions, once a week, although treatment may be extended for individual participants if necessary. Treatment will occur at the University of Sydney's Gambling Treatment and Research Clinic, or at one of it's outreach locations at Parramatta and Campbelltown. Sessions will be recorded to monitor treatment adherence.
Intervention code [1] 297928 0
Treatment: Other
Intervention code [2] 297942 0
Behaviour
Comparator / control treatment
A behaviourally-focused treatment (referred to as Cognitive-Behavioural Therapy, or CBT: Petry, 2005) focuses helping clients manage the triggers that lead to their gambling and learning ways of managing their urges. CBT contains 8 modules: (a) discovering triggers, (b) functional analysis, (c) increasing pleasant activities, (d) self- management planning, (e) coping with urges to gamble, (f) assertiveness training and gambling refusal skills, (g) changing irrational thinking, and (h) coping with lapses. The treatment will utilise sessional informational materials that were developed along with this treatment by its author (Petry, 2005).

Treatment will be delivered by intern psychologists and registered psychologists who have been trained in the treatment of problem gambling. Session will be delivered individually and face-to-face. Participants will attend a minimum of 8 one hour sessions, once a week, although treatment may be extended for individual participants if necessary. Treatment will occur at the University of Sydney's Gambling Treatment and Research Clinic, or at one of it's outreach locations at Parramatta and Campbelltown. Sessions will be recorded to monitor treatment adherence.
Control group
Active

Outcomes
Primary outcome [1] 301928 0
Gambling behaviour. Assessed by:
a) Problem Gambling Severity Index (Ferris & Wynne, 2001)
b) Time and Money Gambling Questionnaire (developed in-house)
Timepoint [1] 301928 0
End of Treatment, 6 months, 12 months and 24 months post treatment
Primary outcome [2] 301951 0
Attitudes towards gambling, assessed by: Gambling Beliefs Questionnaire (Steenbergh et al, 2002)
Timepoint [2] 301951 0
At end of treatment, 6 months, 12 months and 24 months follow-up
Primary outcome [3] 301952 0
Knowledge about gambling, assessed by: Gambling Knowledge Questionnaire (developed in-house)
Timepoint [3] 301952 0
End of treatment, 6 month, 12 month and 24 month follow-up
Secondary outcome [1] 334289 0
Gambling related harm, assessed by Gambling Effects Measure (developed in-house)
Timepoint [1] 334289 0
At end of treatment, 6 month, 12 month and 24 month follow-up
Secondary outcome [2] 334348 0
Urges to gamble, assessed by: Gambling Urge Scale (Raylu & Oei, 2004)
Timepoint [2] 334348 0
End of treatment, 6 months, 12 month and 24 month follow-up

Eligibility
Key inclusion criteria
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
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)
-sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
-computerised sequence generation
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 study results will be analysed through a combination of techniques. As is common practice in psychology, changes in participant responses from pre-treatment to post-treatment and follow-up will be analysed using a repeated measures analysis of variance (ANOVA). Differences between treatment groups will be examined using group ANOVA tests.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296313 0
Government body
Name [1] 296313 0
Responsible Gambling Fund administered by Liquor and Gaming NSW
Country [1] 296313 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 295245 0
None
Name [1] 295245 0
Address [1] 295245 0
Country [1] 295245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297542 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297542 0
Ethics committee country [1] 297542 0
Australia
Date submitted for ethics approval [1] 297542 0
21/04/2017
Approval date [1] 297542 0
05/06/2017
Ethics approval number [1] 297542 0
2017/366

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

Contacts
Principal investigator
Name 74382 0
Prof Alex Blaszczynski
Address 74382 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett St
Camperdown, NSW, 2050
Country 74382 0
Australia
Phone 74382 0
+61 2 9114 4636
Fax 74382 0
Email 74382 0
[email protected]
Contact person for public queries
Name 74383 0
Christopher John Hunt
Address 74383 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett St
Camperdown, NSW, 2050
Country 74383 0
Australia
Phone 74383 0
+61 2 9114 4367
Fax 74383 0
Email 74383 0
[email protected]
Contact person for scientific queries
Name 74384 0
Christopher John Hunt
Address 74384 0
Gambling Treatment and Research Clinic
Level 2, 94 Mallett St
Camperdown, NSW, 2050
Country 74384 0
Australia
Phone 74384 0
+61 2 9114 4367
Fax 74384 0
Email 74384 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


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.