Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000136303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/11/2025
Date registered
Help: Date registered
4/02/2026
Date last updated
Help: Date last updated
4/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/02/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Gabi the therapist supervised chatbot coach for problem gambling.
Scientific title
Does an AI chatbot coach assist gamblers who are receiving gold standard CBT for gambling disorder compared those receiving traditional CBT alone to complete therapy more efficiently, safely and effectively?
Additional trial identifiers [1] 315447 0
nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Gambling Addiction 339841 0
Condition category
Condition code
Mental Health 336077 336077 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The total duration of the treatment period is 3 months with a follow up at 6 months. Participants in the intervention arm are offered access to Gabi, an AI chatbot and AI augmented "homework" or therapy tasks along with gold standard Cognitive Behavioural Therapy or CBT. Content of CBT will be the same as standard care. Participants will work with Gabi, guided by therapists through appropriate tasks on Gabi platform. Gabi will also send reminders to complete and engage in therapy tasks assigned by the therapists as needed. Additionally participants in the intervention arm will receive access to an expertly curated, evidence based library for guided self help. Participants also have access to the chatbot and the platform 24/7 and the conversations are monitored by the therapists during office hours.

Therapy tasks on Gabi may take up to 15 minute. Therapy sessions are conducted either via telehealth or in person at Statewide Gambling Therapy Services, Flinders Medical Centre based on participant preference and participants have the opportunity to negotiate the frequency and the duration of therapy sessions. These CBT sessions may take up to 30 - 45 minutes per session, per week as negotiated by participants (i.e. 1 session per week). Research team will collect data through brief questionnaires at Screening visit (10 minutes), baseline visit (15-20 minutes), every fourth therapy session during the 3 month period (15-20 minutes) and at 3 months (15-20 minutes) when the treatment program ends. Participants will be contacted for a follow up and final data collection at 6 months (15-20 minutes). Data from conversations will also be used in analysis (secondary and exploratory endpoints).

Participants who complete the study will be offered an opportunity to participate in an optional semi-qualitative interview.
Intervention code [1] 332617 0
Behaviour
Intervention code [2] 332764 0
Treatment: Other
Description of the comparator or control
The total duration of the treatment period is 3 months with a follow up at 6 months and participants are offered traditional gold standard Cognitive Behavioural Therapy or CBT. This is part of standard care for Problem Gambling Disorder and participants have the opportunity to negotiate the frequency and the duration of therapy. CBT will consist of therapy sessions and participants will work through tasks such as cue exposure therapy assigned and guided by a therapist. These tasks may take up to 15 minute. Therapy sessions are conducted either via telehealth or in person at Statewide Gambling Therapy Services, Flinders Medical Centre based on participant preference. These CBT sessions may take up to 30 - 45 minutes per session, per week as negotiated by participants (i.e. 1 session per week). Research team will collect data through brief questionnaires at Screening visit (10 minutes), baseline visit (15-20 minutes), every fourth therapy session during the 3 month period (15-20 minutes) and at 3 months (15-20 minutes) when the treatment program ends. Participants will be contacted for a follow up and final data collection at 6 months (15-20 minutes).

Participants who complete the study will be offered an opportunity to participate in an optional semi-qualitative interview.
Control group
Active

Outcomes
Primary outcome [1] 343623 0
Gambling behaviours
Timepoint [1] 343623 0
Day 1 (randomisation), every fourth treatment session until end of treatment, 3 months at the end of treatment and 6 months post intervention
Primary outcome [2] 343624 0
Victorian Gambling Screen or VGS
Timepoint [2] 343624 0
Day 1 (randomisation), every fourth treatment session until end of treatment, 3 months at the end of treatment and 6 months post intervention
Primary outcome [3] 343860 0
Problem Gambling Severity Index or PGSI
Timepoint [3] 343860 0
Screening, every fourth treatment session until end of treatment, 3 months at the end of treatment and 6 months post intervention
Secondary outcome [1] 454909 0
Therapy tasks or "homework" engagement
Timepoint [1] 454909 0
From day 1 (randomisation) to weekly during the treatment session until end of treatment at 3 months.
Secondary outcome [2] 455887 0
Money lost
Timepoint [2] 455887 0
From screening, day 1 (randomisation) to weekly during the treatment session until end of treatment at 3 months.
Secondary outcome [3] 455888 0
Psychological distress and depression - this will be assessed as a composite outcome.
Timepoint [3] 455888 0
Screening, day 1 (randomisation), every fourth treatment session until end of treatment, 3 months at the end of treatment and 6 months post intervention
Secondary outcome [4] 455889 0
Gambling urges
Timepoint [4] 455889 0
Day 1 (randomisation), every fourth treatment session until end of treatment, 3 months at the end of treatment and 6 months post intervention
Secondary outcome [5] 456856 0
Exploratory Outcome: AI content analysis
Timepoint [5] 456856 0
From randomisation to End or Study/6 months post intervention for Gabi trial arm.
Secondary outcome [6] 456857 0
Exploratory Outcome: Therapeutic Alliance
Timepoint [6] 456857 0
From randomisation to End or Study/6 months post intervention for Gabi trial arm.
Secondary outcome [7] 457143 0
Safety assessment
Timepoint [7] 457143 0
From randomisation to End or Study/6 months post intervention for Gabi trial arm.

Eligibility
Key inclusion criteria
(i) age 18 and over
(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
(v) willingness to communicate with a chatbot coach, attend therapy sessions and to provide follow-up data
(vi) access to a smart phone and or internet
(vii) willing to provide written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(i) mental distress e.g., psychosis or active suicidality so as not to be able to give informed consent.
(ii) not willing to provide the research team with a mobile phone number

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generation through REDCap.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/01/2026
Date of last participant enrolment
Anticipated
2/03/2026
Actual
Date of last data collection
Anticipated
7/09/2026
Actual
Sample size
Target
66
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 320035 0
Government body
Name [1] 320035 0
Department for Human Services
Country [1] 320035 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 322584 0
None
Name [1] 322584 0
Address [1] 322584 0
Country [1] 322584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318579 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 318579 0
Ethics committee country [1] 318579 0
Australia
Date submitted for ethics approval [1] 318579 0
28/07/2025
Approval date [1] 318579 0
11/09/2025
Ethics approval number [1] 318579 0

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

Contacts
Principal investigator
Name 144618 0
Dr Ben Riley
Address 144618 0
G4 The Flats, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 144618 0
Australia
Phone 144618 0
+61 08 8204 4779
Fax 144618 0
Email 144618 0
[email protected]
Contact person for public queries
Name 144619 0
Ben Riley
Address 144619 0
G4 The Flats, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 144619 0
Australia
Phone 144619 0
+61 08 8204 4779
Fax 144619 0
Email 144619 0
[email protected]
Contact person for scientific queries
Name 144620 0
Malcolm Battersby
Address 144620 0
Flinders Dr, Margaret Tobin Centre, Flinders Medical Centre, Bedford Park, 5042, SA
Country 144620 0
Australia
Phone 144620 0
+61 08 8404 2314
Fax 144620 0
Email 144620 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.