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Trial registered on ANZCTR


Registration number
ACTRN12615000228583
Ethics application status
Approved
Date submitted
16/12/2014
Date registered
12/03/2015
Date last updated
12/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet-based based delivery of Cognitive Behaviour Therapy versus Motivation, Feedback and Support for Pathological gambling
Scientific title
Investigation of therapeutic outcomes associated with internet-based cognitive behaviour therapy in comparison to internet-based motivation, feedback and support , among adult outpatients diagnosed with Pathological Gambling.
Secondary ID [1] 281229 0
Nil
Universal Trial Number (UTN)
U1111-1134-6671
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pathological Gambling 287416 0
Condition category
Condition code
Mental Health 287750 287750 0 0
Other mental health disorders
Mental Health 294146 294146 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:Internet-based Cognitive Behaviour Therapy for pathological gambling. Content of treatment involved assessment, psychoeducation, strategies to challenge gambling related cognitions, and strategies to reduce gambling related behaviours. There were four therapists involved in the program. Each therapist had experience delivering Cognitive Behavioural Therapy and held provisional registration as psychologists. Each psychologist undertook weekly supervision with the primary author (Casey). There were six session total, with one session completed per week over the internet. Each session was expected to take participants approximately 1 hour to complete. Adherence was monitored by recording the number of online sessions completed by each participant.
Intervention code [1] 285695 0
Treatment: Other
Comparator / control treatment
Arm 2: active treatment control condition (Internet-based Motivation, Feedback, and Support) in which participants had access to only selected portions of the I-CBT program. These portions focused on the monitoring of gambling behaviours, provided participants with feedback on their progress as well as supportive messages. There were four therapists involved in the program. Each therapist had experience delivering Cognitive Behavioural Therapy and held provisional registration as psychologists. Each psychologist undertook weekly supervision with the primary author (Casey). Each I-MFS session took approximately 5-10 minutes to complete. Arm 3: a waitlist control condition. All sessions are completed online, once a week for six weeks. Participants in Arm 3: the waitlist control condition were randomly allocated to Arm 1 or Arm 2 after the 6 week waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 293845 0
Gambling amount in dollars measured by self report form clients
Timepoint [1] 293845 0
Pre treatment, Mid treatment (week 3), post treatment (6 weeks), 3 month follow up, 6 month follow up, 12 month follow up
Primary outcome [2] 293846 0
Gambling Frequency (measured by participant self report on the number of times gambled over the specified time period)
Timepoint [2] 293846 0
Pre treatment, Mid treatment (week 3), post treatment (6 week), 3 month follow up, 6 month follow up, 12 month follow up
Primary outcome [3] 293847 0
Gambling Severity - assessed using the Gambling Symptom Assessment Scale (Kim, Grant, Potenza & Hollander, 2009)
Timepoint [3] 293847 0
Pre treatment each week of treatment (six time points). For participants in the waitlist control - pre treatment, mid wait, and post wait.
Secondary outcome [1] 311974 0
Gambling Behaviour - measured using the South Oaks Gambling (Lesieur & Blume, 1987)
Timepoint [1] 311974 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [2] 311975 0
Gambling Urges - measured using the Gambling Urge Scale (Raylu & Oei, 2004).
Timepoint [2] 311975 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [3] 311976 0
Self Efficacy - measured using the Gambling Refusal Self-Efficacy Questionnaire (Casey, Oei, Melville, Bourke & Newcombe, 2008)
Timepoint [3] 311976 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [4] 311977 0
Depression, Anxiety and Stress Scales (Lovibond & Lovibond, 1995)
Timepoint [4] 311977 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [5] 311978 0
Gambling Related Cognitions Scale (Raylu & Oei, 2004)
Timepoint [5] 311978 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [6] 311979 0
Alcohol Use Disorders Identification Test (Aasland, Babor, De La Fuente & Grant, 1993)
Timepoint [6] 311979 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [7] 311980 0
Coping style - measured using the Brief COPE (Carver, 1997)
Timepoint [7] 311980 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [8] 311981 0
Quality of Life Inventory (Frisch, 1994)
Timepoint [8] 311981 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up
Secondary outcome [9] 311982 0
Satisfaction with Life Questionnaire (Diener, Emmons, Larsen & Griffin, 1985)
Timepoint [9] 311982 0
Pre treatment, Mid treatment (week 3), post treatment (week 6), 3 month follow up, 6 month follow up, 12 month follow up

Eligibility
Key inclusion criteria
Meet criteria for pathological gambling, as described in the Diagnostic and Statistical Manual for Mental Disorders, fourth editions (DSM-IV-TR).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the participant was already receiving additional assistance for their gambling problem, if they were involved in legal proceedings related to their gambling behaviour, if they were not proficient with English, were at a high risk of suicide, were acutely psychotic, or if the gambling behaviour only occurred in the context of a Manic Episode.

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
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290436 0
Government body
Name [1] 290436 0
Regulatory Policy and Community Awareness, Department of Employment, Economic Development and Innovation
Address [1] 290436 0
Queensland, Australia. The specific government department no longer exists and as such no street address can be provided.
Country [1] 290436 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Road, Mt Gravatt, Queensland, Australia 4111
Country
Australia
Secondary sponsor category [1] 289148 0
University
Name [1] 289148 0
University of Queensland
Address [1] 289148 0
University of Queensland, St Lucia, Queensland, Australia, 4067
Country [1] 289148 0
Australia
Secondary sponsor category [2] 289149 0
Hospital
Name [2] 289149 0
CBT Unit, Toowong Private Hospital
Address [2] 289149 0
496 Milton Rd, Toowong, Queensland, Australia, 4066
Country [2] 289149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292117 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 292117 0
Griffith University, 176 Messines Ridge Road, Mt Gravatt, Queensland, Australia. 4111
Ethics committee country [1] 292117 0
Australia
Date submitted for ethics approval [1] 292117 0
Approval date [1] 292117 0
06/06/2005
Ethics approval number [1] 292117 0

Summary
Brief summary
The purpose of this study was to investigate an internet based treatment for pathological gambling. Participants were randomly allocated to three groups; an internet based treatment based on cognitive behavioural strategies, an internet based treatment based on motivational and supportive techniques, and a waitlist control. The two treatment groups consists of one weekly session, for six weeks duration. Participants in the waitlist control group were offered treatment on completion of the six week wait period. Measures were taken pre treatment, mid treatment/ wait, and post treatment/ wait, as well as some weekly measures throughout treatment.
Trial website
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 34710 0
Dr Leanne Casey
Address 34710 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt, Queensland, Australia, 4122
Country 34710 0
Australia
Phone 34710 0
+61 7 37353314
Fax 34710 0
Email 34710 0
l.casey@griffith.edu.au
Contact person for public queries
Name 17957 0
Dr Leanne Casey
Address 17957 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt, Queensland, Australia, 4122
Country 17957 0
Australia
Phone 17957 0
+61 7 37353314
Fax 17957 0
Email 17957 0
l.casey@griffith.edu.au
Contact person for scientific queries
Name 8885 0
Dr Leanne Casey
Address 8885 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt, Queensland, Australia, 4122
Country 8885 0
Australia
Phone 8885 0
+61 7 37353314
Fax 8885 0
Email 8885 0
l.casey@griffith.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