Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12622000969763
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
8/07/2022
Date last updated
8/07/2022
Date data sharing statement initially provided
8/07/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
SBET: A trial of exposure therapy delivered by phone and internet for sports betting addiction (Sports Betting Exposure Therapy) - Part 1 pilot
Query!
Scientific title
SBET: The efficacy of exposure therapy delivered by phone and internet for sports betting addiction (Sports Betting Exposure Therapy) - Part 1 pilot
Query!
Secondary ID [1]
307464
0
None
Query!
Universal Trial Number (UTN)
U1111-1279-8985
Query!
Trial acronym
SBET
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
gambling disorder
326856
0
Query!
Condition category
Condition code
Mental Health
324071
324071
0
0
Query!
Addiction
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The intervention is Exposure therapy. Exposure is a specific form of cognitive behaviour therapy, known as a behavioural approach whereby the person/participant conducts tasks where they deliberately expose themselves to triggers or cues which elicit a gambling urge or in the case of anxiety disorders where exposure was invented to anxiety. The therapeutic model is that by repeating these exposure exercises daily or 3-4 times weekly (Cue Exposure Therapy CET), until the urge reduces by at least half in each session (this is called habituation) the person unlearns or extinguishes the urge to gamble. Participants (sports betting gamblers) are provided 1 session weekly for up to 10 sessions (10-12 weeks). During each session the therapist guides the participant to select triggers that elicit a gambling urge e.g., looking at the gambling app on their phone or a gambling advertisement for 20-40 minutes until the urge has reduced by at least half and then repeat this task daily until the urge extinguishes (habituation). The therapist and gambler create a hierarchy of triggers and these are addressed in a gradient from easy to difficult until all or most triggers/urges have been eliminated. Progress is monitored by the participant filling out homework sheets describing their tasks and urge as well as questionnaires at each session on gambling urge and gambling time and money spent. We have published a paper on 6 cases of sports betting addiction treated by the SA Statewide Gambling Therapy Service (SGTS). CET was provided face to face by experienced SGTS staff using a standardised workbook adapted for sports betting. In CET as described in the case studies, all urges to gamble are extinguished and the person gains control over their gambling either through abstinence or occasional gambling.
The phase 1 pilot proposal aims to recruit 40 participants from all areas of SA and provide CET using mobile phone or internet in contrast to those who have received the intervention from SGTS face in a clinic setting as described in the published 6 case studies. This would provide the data to inform a phase 2 national randomised controlled trial with funding sought from other states and/or NHMRC Partnership grant.
Query!
Intervention code [1]
323922
0
Treatment: Other
Query!
Comparator / control treatment
In phase 1 the pilot there will be no comparator
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
331872
0
Primary outcome. Phase 1 :
The participant-rated primary outcome measure is the Victorian Gambling Screen (VGS) harm to self-subscale (Likert scoring 0, 1, 2, 3, 4; range 0-60); (a score of 21 and above identifies a person as a problem gambler) relating to the person's experiences in the person's experiences in the previous 4 weeks.
Query!
Assessment method [1]
331872
0
Query!
Timepoint [1]
331872
0
Phase 1: 5 months from baseline i.e., 2 months post treatment (3 months)
Query!
Secondary outcome [1]
411459
0
Phase 1: Gambling Behaviour: average number of days spent gambling will be measured over the previous 1 month. As for all questionnaires, this data is self-report collected either by phone by the research assistant or on-line study survey.
Query!
Assessment method [1]
411459
0
Query!
Timepoint [1]
411459
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [2]
411462
0
Gambling Urge Scale (GUS) - (0-42)
Query!
Assessment method [2]
411462
0
Query!
Timepoint [2]
411462
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [3]
411467
0
Patient Health questionnaire (PHQ-9) depression scale (0- 27)
Query!
Assessment method [3]
411467
0
Query!
Timepoint [3]
411467
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [4]
411470
0
General Anxiety Disorder (GAD-7) (0- 21 )
Query!
Assessment method [4]
411470
0
Query!
Timepoint [4]
411470
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [5]
411471
0
Work and Social Adjustment Scale (WSAS) (0-40)
Query!
Assessment method [5]
411471
0
Query!
Timepoint [5]
411471
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [6]
411473
0
Alcohol Use Disorders Identification Test (AUDIT) (0-40)
Query!
Assessment method [6]
411473
0
Query!
Timepoint [6]
411473
0
Phase 1: baseline, end of treatment - 3 months, 5 months
Query!
Secondary outcome [7]
411598
0
Qualitative data -Semi-structured interviews with purposefully chosen (age above and below 25, those who improved/recovered/those who dropped out/did not recover) 6 intervention participants 4 TOs and 1 therapists to determine recruitment barriers and enablers, acceptability and feasibility and any improvements to the intervention or delivery and recruitment. These components will be collected and analysed concurrently as a composite. Of particular interest will be the on-line and social media strategies used to recruit non help seeking sports betters. These interviews will be conducted by the RA using phone or videoconferencing with set open ended questions .
Query!
Assessment method [7]
411598
0
Query!
Timepoint [7]
411598
0
10 months post baseline
Query!
Secondary outcome [8]
411599
0
Gambling Behaviour: average amount of money spent per day gambling over the previous month. As for all questionnaires, this data is self-report collected either by phone by the research assistant or by participant entry in the on-line study survey. This is a standard clinical measure used in most gambling therapy services and research studies with a single question and response
Query!
Assessment method [8]
411599
0
Query!
Timepoint [8]
411599
0
baseline, end of treatment 3 and 5 months
Query!
Eligibility
Key inclusion criteria
Inclusion: includes sports betting on any of the commercially advertised sports betting gambling sites at least once per month e.g., Sports bet and losing amounts that the person believes is excessive or time spent is excessive, willingness to have counselling sessions recorded and to provide follow-up data, age greater than 17, access to a smart phone and or internet. Receiving or having received psychological treatment for a gambling problem in the last 12 months is not an exclusion.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion: mental distress e.g., psychosis or suicidality so as not to be able to give informed consent or complete the intervention sessions. Concurrent other forms of gambling e.g., pokies, TAB or lotto are acceptable as are co-morbidities of depression, anxiety and other addictions e.g., alcohol or tobacco.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
I
In this pilot, therapists will know what treatment they are administering and participants will be provided with patient information and a workbook that rationalises and describes their therapy protocol.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Phase 1: Pre and post quantitative data for all outcome measures at baseline, end of therapy 3 months and follow up 5 months will be collated and analysed using paired t tests with significance set at p<0.05.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
25/07/2022
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
28/10/2022
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2023
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
22668
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment postcode(s) [1]
37946
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
38040
0
5042 - St Marys
Query!
Funding & Sponsors
Funding source category [1]
311740
0
University
Query!
Name [1]
311740
0
Flinders University
Query!
Address [1]
311740
0
Sturt Rd
Bedford park
South Australia
5042
Query!
Country [1]
311740
0
Australia
Query!
Funding source category [2]
311750
0
Government body
Query!
Name [2]
311750
0
SA Department of Human Services
Query!
Address [2]
311750
0
Riverside Centre
North Tce
Adelaide
South Australia
5000
Query!
Country [2]
311750
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Flinders University
Query!
Address
Sturt Rd
Bedford park
South Australia
5042
Query!
Country
Australia
Query!
Secondary sponsor category [1]
313200
0
None
Query!
Name [1]
313200
0
Query!
Address [1]
313200
0
Query!
Country [1]
313200
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
311185
0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Query!
Ethics committee address [1]
311185
0
Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Query!
Ethics committee country [1]
311185
0
Australia
Query!
Date submitted for ethics approval [1]
311185
0
03/03/2022
Query!
Approval date [1]
311185
0
04/05/2022
Query!
Ethics approval number [1]
311185
0
2022/HRE00036
Query!
Summary
Brief summary
Sports betting has become one of the nation’s rapidly increasing forms of gambling addiction with $1.235 billion lost in 2017 - 18 , particularly in young males. This proposal is based on the recent publication from the SA Statewide Gambling Therapy Service, reporting the successful treatment of 6 young men with sports betting addiction using exposure therapy delivered face to face. The phase 1 pilot study aims to recruit 40 participants from all areas of SA using social media and provide cue exposure therapy (CET) for 10 sessions using mobile phone or internet.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
120250
0
Prof Malcolm Battersby
Query!
Address
120250
0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Query!
Country
120250
0
Australia
Query!
Phone
120250
0
+61 08 84042314
Query!
Fax
120250
0
Query!
Email
120250
0
[email protected]
Query!
Contact person for public queries
Name
120251
0
Malcolm Battersby
Query!
Address
120251
0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Query!
Country
120251
0
Australia
Query!
Phone
120251
0
+61 08 84042314
Query!
Fax
120251
0
Query!
Email
120251
0
[email protected]
Query!
Contact person for scientific queries
Name
120252
0
Malcolm Battersby
Query!
Address
120252
0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Query!
Country
120252
0
Australia
Query!
Phone
120252
0
+61 08 84042314
Query!
Fax
120252
0
Query!
Email
120252
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
de-identified pre and post outcome quantitative gambling behaviour and mental health measures
Query!
When will data be available (start and end dates)?
January 31st 2024
Dec 31st 202025
Query!
Available to whom?
Researchers who provide a legitimate rationale based on scientific advancement, and or public benefit to the satisfaction of the investigators
Query!
Available for what types of analyses?
systematic review or meta -analyses
Query!
How or where can data be obtained?
by contacting the principal investigator Prof Battersby or other trial investigators David Smith, Ben Riley and Michael Baigent
[email protected]
[email protected]
[email protected]
[email protected]
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16515
Study protocol
not published
384298-(Uploaded-04-07-2022-15-46-56)-Study-related document.pdf
16525
Informed consent form
not published
384298-(Uploaded-04-07-2022-15-50-03)-Study-related document.pdf
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.
Download to PDF