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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
Scientific title
SBET: The efficacy of exposure therapy delivered by phone and internet for sports betting addiction (Sports Betting Exposure Therapy) - Part 1 pilot
Secondary ID [1] 307464 0
None
Universal Trial Number (UTN)
U1111-1279-8985
Trial acronym
SBET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gambling disorder 326856 0
Condition category
Condition code
Mental Health 324071 324071 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323922 0
Treatment: Other
Comparator / control treatment
In phase 1 the pilot there will be no comparator
Control group
Uncontrolled

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.
Timepoint [1] 331872 0
Phase 1: 5 months from baseline i.e., 2 months post treatment (3 months)
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.
Timepoint [1] 411459 0
Phase 1: baseline, end of treatment - 3 months, 5 months
Secondary outcome [2] 411462 0
Gambling Urge Scale (GUS) - (0-42)
Timepoint [2] 411462 0
Phase 1: baseline, end of treatment - 3 months, 5 months
Secondary outcome [3] 411467 0
Patient Health questionnaire (PHQ-9) depression scale (0- 27)
Timepoint [3] 411467 0
Phase 1: baseline, end of treatment - 3 months, 5 months
Secondary outcome [4] 411470 0
General Anxiety Disorder (GAD-7) (0- 21 )
Timepoint [4] 411470 0
Phase 1: baseline, end of treatment - 3 months, 5 months
Secondary outcome [5] 411471 0
Work and Social Adjustment Scale (WSAS) (0-40)
Timepoint [5] 411471 0
Phase 1: baseline, end of treatment - 3 months, 5 months
Secondary outcome [6] 411473 0
Alcohol Use Disorders Identification Test (AUDIT) (0-40)
Timepoint [6] 411473 0
Phase 1: baseline, end of treatment - 3 months, 5 months
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 .
Timepoint [7] 411598 0
10 months post baseline
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
Timepoint [8] 411599 0
baseline, end of treatment 3 and 5 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
Date of last participant enrolment
Anticipated
28/10/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22668 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 37946 0
5042 - Bedford Park
Recruitment postcode(s) [2] 38040 0
5042 - St Marys

Funding & Sponsors
Funding source category [1] 311740 0
University
Name [1] 311740 0
Flinders University
Country [1] 311740 0
Australia
Funding source category [2] 311750 0
Government body
Name [2] 311750 0
SA Department of Human Services
Country [2] 311750 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd
Bedford park
South Australia
5042
Country
Australia
Secondary sponsor category [1] 313200 0
None
Name [1] 313200 0
Address [1] 313200 0
Country [1] 313200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311185 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 311185 0
Ethics committee country [1] 311185 0
Australia
Date submitted for ethics approval [1] 311185 0
03/03/2022
Approval date [1] 311185 0
04/05/2022
Ethics approval number [1] 311185 0
2022/HRE00036

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

Contacts
Principal investigator
Name 120250 0
Prof Malcolm Battersby
Address 120250 0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Country 120250 0
Australia
Phone 120250 0
+61 08 84042314
Fax 120250 0
Email 120250 0
malcolm.battersby@flinders.edu.au
Contact person for public queries
Name 120251 0
Malcolm Battersby
Address 120251 0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Country 120251 0
Australia
Phone 120251 0
+61 08 84042314
Fax 120251 0
Email 120251 0
malcolm.battersby@flinders.edu.au
Contact person for scientific queries
Name 120252 0
Malcolm Battersby
Address 120252 0
Margaret Tobin Centre, Flinders Medical Centre,
Flinders Drive
Bedford Park
SA 5042
Country 120252 0
Australia
Phone 120252 0
+61 08 84042314
Fax 120252 0
Email 120252 0
malcolm.battersby@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified pre and post outcome quantitative gambling behaviour and mental health measures
When will data be available (start and end dates)?
January 31st 2024
Dec 31st 202025
Available to whom?
Researchers who provide a legitimate rationale based on scientific advancement, and or public benefit to the satisfaction of the investigators
Available for what types of analyses?
systematic review or meta -analyses
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
Malcolm.battersby@flinders.edu.au
David.smith@flinders.edu.au
Ben.riley@sa.gov.au
Michael.baigent@sa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16515Study protocol    not published 384298-(Uploaded-04-07-2022-15-46-56)-Study-related document.pdf
16525Informed 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.