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Trial registered on ANZCTR


Registration number
ACTRN12610000828022
Ethics application status
Approved
Date submitted
30/09/2010
Date registered
5/10/2010
Date last updated
19/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial to evaluate the benefits of Exposure Therapy and Cognitive Therapy for problem gamblers
Scientific title
A study of cognitive and behavioural therapy approaches to the treatment of gambling addiction
Secondary ID [1] 252806 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pathological Gambling / Gambling Addiction 258301 0
Gambling Behaviour 258310 0
Condition category
Condition code
Mental Health 258496 258496 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The programme uses graded exposure therapy with structured sessions of up to one hour a week with homework tasks for clients to practice during the week leading up to their next session. Exposure is graded over time from basic black and white images of their particular gambling cues to full exposure to gambling venues and gambling machines. During exposure tasks clients learn to manage their urge to gamble and overcome their problem gambling.

Generally the programme consists of between 8 and 12 such sessions for face to face therapy with psycho-therapists who have post graduate qualifications in mental health science. Therapists' backgrounds are usually in mental health nursing, psychology and social work. In addition to individual face to face outpatient services, the Statewide Gambling Therapy Service (SGTS) also provides a more intensive inpatient service for a limited number of clients who require hospitalisation.
Intervention code [1] 257324 0
Treatment: Other
Intervention code [2] 257329 0
Behaviour
Comparator / control treatment
The Cognitive Therapy arm of the study is structured in the same way as the behavioural arm. Clients will have 8-12 (depending on clinical need as determined my the treating therapist) sessions of cognitive therapy for an hour each week with tasks to be reviewed by clients in the intervening time.

Treatment will follow the well known and proven cognitive therapy processes outlined by Professor Ladouceur in his manuel 'Overcoming our Pathological Gambling'. This approach involves teaching clients to challenge their eroneous thoughts about their gambling and provides a workbook of activities that clients work through in conjunction with their treatment sessions.
Control group
Active

Outcomes
Primary outcome [1] 259330 0
Improvements in pathological gambling scores over time...ie
- Canadian Problem Gambling Index
- Victorian Gambling Screen
- Gambling Urge Scale
- Kestler 10 psychological functioning scale
- work and social adjustment scale
Timepoint [1] 259330 0
Key timepoints for data collection are...

- baseline: time of recruitment and beginning therapy
- end of therapy
- 3 months following discharge from treatment
- 6 & 12 months following discharge from treatment
Secondary outcome [1] 265781 0
improvements in quality of life will be measured by the work and social adjustment scale
Timepoint [1] 265781 0
- begiinning of treatment (baseline)
- end of treatment (discharge)
- 3,6,12 month outcomes following treatment completion
Secondary outcome [2] 265789 0
gambling activity (frequency of gambling, amount of money lost) data is collected by the therapist during the treatment and review process.
Timepoint [2] 265789 0
gambling activity data is collected at the same time points as key outcome measures...ie baseline, end of treatment, 3,6 &12 months following completion of treatment

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM4) criteria for pathological gambling
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No

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)
The trial will be comprised of two parallel groups with measurements at baseline, end of treatment and then at 3, 6 and 12 month follow up depending on date of recruitment. To maintain equilibrium with treatment modalities available to the Statewide Gambling Therapy Service (SGTS) clients the trial will use two groups: (1) exposure therapy (ET), and (2) cognitive therapy (CT). Randomisation will be blocked to ensure equal group sizes,
using varying block sizes to protect concealment.
Participants will be offered the alternative therapy to their randomised treatment if they do not experience a
clinically meaningful improvement on outcome measures during treatment and follow-up as determined
jointly by the patient and therapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted at arm's length by the Flinders Medical Centre randomisation service and
researchers will be blinded from the allocation process and to the group into which participants will be
randomised. Randomisation will be blocked to ensure equal group sizes using varying block sizes to ensure
concealment in the randomisation process
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The objectives of this pilot randomised controlled trial are to establish high quality recruitment methods,
treatment techniques and manuals, research protocols, data collection methods and preliminary data in
preparation for applications to national (National Health and Medical Research Council and Gambling Research Australia) or international (National Institute for Mental Health
NIMH in the US) funding bodies for phase II and III randomised controlled trials in the field of problem
gambling practice and research. Specifically, we seek to establish high quality treatment methods and
research protocols which will contribute to answering the primary research question:
Among treatment seeking problem gamblers can exposure therapy alone improve gambling related
outcomes for up to 12 months compared with cognitive therapy?
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 257764 0
Government body
Name [1] 257764 0
Victorian Department of Justice
Address [1] 257764 0
Department of Justice, Victoria, Australia
121 Exhibition St
GPO Box 4356
Melbourne VIC 3000
Country [1] 257764 0
Australia
Primary sponsor type
Government body
Name
Victorian Department of Justice
Address
Department of Justice, Victoria, Australia
121 Exhibition St
GPO Box 4356
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 256976 0
None
Name [1] 256976 0
Address [1] 256976 0
Country [1] 256976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259806 0
Southern Adelaide Health Service / Flinders University Human Research Ethics
Ethics committee address [1] 259806 0
Southern Adelaide Health Service / Flinders University Human Research Ethics
Committee (EC00188)
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 259806 0
Australia
Date submitted for ethics approval [1] 259806 0
01/08/2010
Approval date [1] 259806 0
15/09/2010
Ethics approval number [1] 259806 0
EC00188

Summary
Brief summary
The nul hypothesis for the study is that there will be no significant difference in the clinical outcomes of cognitive and behavioural therapy approaches to the treatment of pathological gambling (gambling addiction).

Some cost or time efficienciies may emerge from this detailed study fo the outcomes of these two approaches to therapy.
Trial website
http://www.flinders.edu.au/medicine/sites/fhbhru/clinical-services/fgrc/fgrc_home.cfm
Trial related presentations / publications
Final Outcome Report to the funder; The Victorian Responsible Gambling Foundation...

http://www.responsiblegambling.vic.gov.au/sites/default/files/Research-report-Flinders-Battersby-Aug-13.pdf
Public notes

Contacts
Principal investigator
Name 31722 0
Prof Professor Peter Harvey
Address 31722 0
Margaret Tobin Centre
Flinders Drive
Bedford Park SA 5042
Country 31722 0
Australia
Phone 31722 0
+61 8 84042541
Fax 31722 0
Email 31722 0
peter.harvey@flinders.edu.au
Contact person for public queries
Name 14969 0
Prof Professor Peter Harvey
Address 14969 0
Flinders University
Flinders Drive
Bedford Park SA 5042
Country 14969 0
Australia
Phone 14969 0
+61 8 40402541
Fax 14969 0
+61 8 84042101
Email 14969 0
peter.harvey@flinders.edu.au
Contact person for scientific queries
Name 5897 0
Prof Professior Peter Harvey
Address 5897 0
Flinders University
Flinders Drive
Bedford Park SA 5042
Country 5897 0
Australia
Phone 5897 0
+61 8 84042541
Fax 5897 0
+61 8 84042101
Email 5897 0
peter.harvey@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary