Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000113550
Ethics application status
Approved
Date submitted
29/10/2023
Date registered
8/02/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
8/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Impact of a Therapist-Assisted AI Chatbot on the Awareness of Risky Gambling Behaviours and Overcoming Barriers to Seeking Help Among South Australian (SA) Gamblers
Scientific title
Assessing the Impact of a Therapist-Assisted AI Chatbot on the Awareness of Risky Gambling Behaviours and Overcoming Barriers to Seeking Help Among South Australian (SA) Gamblers
Secondary ID [1] 310854 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction (Gambling) 331890 0
Condition category
Condition code
Mental Health 328621 328621 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The programmes we have developed at Statewide Gambling Therapy Service (SGTS) and Flinders University over the last 20 years began with people addicted to pokies using cue exposure (behavioural) therapies (CET). We have refined and adapted this model for all forms of gambling, most recently sports betting. Having a proven effective therapy delivered remotely over 6-10 sessions would be a breakthrough in Australia and world-wide. In this trial we are combining CET with an AI chatbot component. Scalable Care collaborated with the University of California San Francisco Institute for Neurosciences to create a digital mental health application for teenagers and young adults called GritX. GritX is an emotionally intelligent chatbot that understands human emotions, intent, and context to deliver evidence-based psychoeducation and interactive wellness tools. It gives participants access to digital mental health resources anytime and anywhere, helping to alleviate care gaps between appointments and waiting to see their therapists or counsellors.

If you are taking part in Phase 1, also known as the co-design phase of this study, you will be required to attend either face-to-face or on-line 1 group session (flexible options of timing will be provided) lasting 1.5 to 2 hours consisting of a 20 minute overview of the aim of the project and viewing the existing GritX app with its mental health content and the proposed gambling content. The mental health content will focus on gambling habits, how gambling affects of participants' mood, finances and mental helath. Either individually or in pairs you will then be asked to engage with the chatbot to respond using their own or real-world gambling experience or made up if they wish to protect their privacy (40 minutes). How you engage with the chatbot will be monitored by the research team to ensure safety, appropriate interactions by the chatbot and also to make improvements. You can discuss your preferences on how you want to participate (i.e. individually or in pairs), with the study team. This will also depend on the nature of the content provided to you in each session. You will then be given the option of providing feedback individually either on-line or in a group setting (20 mins). It is important to note that if you take part in Phase 1 providing feedback on the chatbot and content, you will not be able to participate in Phase 2: the pilot trial. Once Phase 1: co-design phase is complete, the study team will make improvements to the chatbot content based on findings/feedback and submit progress reports to the sponsor and the local ethics committee to seek approval before commencing Part 2: the pilot trial.

For those participating in Phase 2 of this research project for a pilot of 30 people, once you give consent to be involved, you will also be asked to complete some questionnaires on your gambling and mental health. The questionnaires will take between 10- 20 minutes to complete. Once the questionnaires are completed, our Research Assistants (RAs) will arrange for you to access the GritX-G chatbot trial coach. A Statewide Gambling Therapy Services (SGTS) therapist will make contact with each participant to ensure safety and/or as a contact the person to commence Cue Exposure Therapy (CET). If triaged to,
(i) self-help, the chatbot will direct the participant to several existing GritX skills studio: This studio consists of guided exercises to manage emotions, sadness, anger, fear and anxiety, relationships and newly created for this project, gambling education and money management. Participants can spend as much or as little time in the skills studio exploring different exercises.
(ii) gambling counselling, they will be directed by the AI coach to local SA gambling help services where typical sessions will take around 1 hour (depending on the individual and their concerns).
(iii) to therapy via SGTS they will be offered Cue Exposure Therapy. The first session includes asking the person to put Money Management in place i.e. ceasing or pausing credit card/phone/eftpos access, cancelling phone and internet gambling accounts, arranging for a daily or weekly allowance managed by a significant other. The intervention (therapy) is delivered by trained mental health professionals based at Flinders Medical Centre, Adelaide. This option will take anywhere between 30 minutes to 1 hour, depending on the participants needs and/or schedule.

The intervention will consist of up to 28 days of engagement for each participant with the GritX-G chatbot participating in 2-way conversations and offers of follow-up either daily or as determined by the participant. All therapy sessions (should participants be triaged to a therapist depending on their situation) will be conducted online via phone or video conference (i.e., Teams). The intervention is delivered by trained therapists at intervals that suit the participant's needs (i.e., severity of gambling problem, depression and suicidality) and there will be no randomisation. The length of exercises either on the GritX platform or therapy sessions depends entirely on the severity of participants' gambling problems, depression, and suicidality. After consenting to the study, participants will be advised by the research team on how to access and use the GritX-G app either on their mobiles or on their phones (or both). The therapist may recommend activities provided by the chatbot so there is a combined real and guided AI coach who can assist the gambler. The therapists will also monitor the conversations to ensure safety and participants will be contacted if there is any cause for concern. The research team will also have access to the conversations and the questionnaire data for research purposes and for making improvements.
Intervention code [1] 327271 0
Treatment: Other
Comparator / control treatment
Standard care is defined as patients receiving in-person therapy without a chatbot AI component during Phase 2: the pilot trial.
Phase 1: co-design will not involve the use of a comparator or control group. The purpose this phase (phase 1: co-design) is to ensure that the content, conversations and guidance provided by the chatbot is appropriate and helpful and that the language used is culturally sensitive.
Control group
Active

Outcomes
Primary outcome [1] 336422 0
Phase 1 (co-design): Gambling content and chatbot interactions
Timepoint [1] 336422 0
3 months after enrolment
Primary outcome [2] 336951 0
Phase 2: the number of participants who engage with the chatbot coach to complete triage questionnaires to access self-help, gambling help services or CET therapy.
Timepoint [2] 336951 0
At baseline through to day 28 (post enrolment)
Secondary outcome [1] 429490 0
Feasibility
Timepoint [1] 429490 0
Social media campaign data: during recruitment phase (post ethics and governance approval.)
Semi-structured interviews: after 28 days (post enrolment and post interventions)
Secondary outcome [2] 431501 0
Acceptability
Timepoint [2] 431501 0
Social media campaign data: during recruitment phase (post ethics and governance approval.)
Semi-structured interviews: after 28 days (post enrolment and post interventions)

Eligibility
Key inclusion criteria
For Phase 1 - Co design Session:
(i) >17 of age.
(ii) any form of gambling at least once monthly (currently or in your previous periods of gambling).
(iii) willing and able to use on-line software and contribute to a co-design of chatbot content and processes.
(iv) concurrent forms of gambling e.g., pokies, sports betting, TAB or lotto are acceptable as are co-morbidities of depression, and anxiety.

For Phase 2 - feasibility trial:
(i) age >17.
(ii) includes any form of gambling including sports betting at least once per month.
(iii) their mood is impaired, and/or they are losing amounts of money that the person believes is excessive or time spent is excessive.
(iv) willingness to communicate with a chatbot coach and to provide follow-up data.
(v) access to a smart phone and or internet.
(vi) receiving or having received psychological treatment for a gambling problem in the last 12 months is not an exclusion.
(vii) willing to provide written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Phase 1 - Co design Session:
(i) mental distress e.g., psychosis or active suicidality so as not to be able to give informed consent.
(ii) alcohol dependence.

For Phase 2 - feasibility trial:
(i) mental distress e.g., psychosis or suicidality so as not to be able to give informed consent.
(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.)
(ii) not willing to provide the research team with a mobile phone number.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
12/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315110 0
Government body
Name [1] 315110 0
SA Department of Human Services, Office for Problem Gambling
Country [1] 315110 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 317127 0
None
Name [1] 317127 0
Address [1] 317127 0
Country [1] 317127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314047 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 314047 0
Ethics committee country [1] 314047 0
Australia
Date submitted for ethics approval [1] 314047 0
30/10/2023
Approval date [1] 314047 0
15/12/2023
Ethics approval number [1] 314047 0

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

Contacts
Principal investigator
Name 130234 0
Prof Malcolm Battersby
Address 130234 0
Flinders Dr, Margaret Tobin Centre, Flinders Medical Centre, Bedford Park, 5042, SA
Country 130234 0
Australia
Phone 130234 0
+61 08 8404 2314
Fax 130234 0
Email 130234 0
[email protected]
Contact person for public queries
Name 130235 0
Malcolm Battersby
Address 130235 0
Flinders Dr, Margaret Tobin Centre, Flinders Medical Centre, Bedford Park, 5042, SA
Country 130235 0
Australia
Phone 130235 0
+61 08 8404 2314
Fax 130235 0
Email 130235 0
[email protected]
Contact person for scientific queries
Name 130236 0
Malcolm Battersby
Address 130236 0
Flinders Dr, Margaret Tobin Centre, Flinders Medical Centre, Bedford Park, 5042, SA
Country 130236 0
Australia
Phone 130236 0
+61 08 8404 2314
Fax 130236 0
Email 130236 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.