Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000942358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/06/2026
Date registered
Help: Date registered
30/07/2026
Date last updated
Help: Date last updated
30/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing two interventions to support people concerned about a friend or family member’s gambling problem, and their effects on help-seeking and wellbeing.
Scientific title
Helping Others Promote Engagement in Gambling Support (HOPE-Gam): a two-arm randomised controlled trial investigating the effects of a behavioural intervention for concerned significant others of people with gambling problems on gambling treatment engagement.
Additional trial identifiers [1] 317540 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12625000970448 - pilot RCT

Health condition
Health condition(s) studied:
Gambling disorder (problem gambling) 342286 0
Condition category
Condition code
Mental Health 338398 338398 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention
Helping Others Promote Engagement in Gambling Support (HOPE-Gam) is a brief, manualised, structured behavioural intervention grounded in learning theory and contingency management principles. It is designed for concerned significant others (CSOs) of people with gambling problems, with the aim of increasing treatment engagement by the person with gambling problems. The intervention teaches CSOs to modify their own responses to gambling-related behaviours in ways that reduce reinforcement for gambling and increase reinforcement for non-gambling and help-seeking behaviours.
HOPE-Gam is delivered in five graded components:
Preparation: Psychoeducation on gambling disorder, cognitive behavioural therapy (CBT), and treatment options, with coaching on how to present treatment opportunities and facilitate rapid access.
Contingency management: Identification of maintaining reinforcers of gambling and development of alternative, incompatible behaviours.
Operant conditioning strategies: Training in reinforcing non-gambling behaviours and withdrawing reinforcement for gambling.
Behavioural agreements: Development of agreed behavioural expectations to support positive change.
Involving others: Inclusion of additional supports where earlier strategies are insufficient.
The intervention includes explicit emphasis on facilitating timely access to treatment services when the gambler expresses willingness to engage.

Who delivers it and their relevant expertise
The intervention is delivered by clinicians with Master’s-level qualifications in psychology, cognitive behavioural therapy, or psychotherapy. Delivery may also involve postgraduate clinical trainees working under structured supervision from senior clinicians. All therapists are trained in the HOPE-Gam manual and receive ongoing clinical supervision to ensure fidelity.

How it is delivered
The intervention is delivered as individual therapy sessions to CSOs (not the gambler) in-person or via telehealth. Sessions are therapist-led, structured, and guided by a treatment manual. Between-session tasks (home practice activities) are assigned and reviewed collaboratively. These activities typically require approximately 30 minutes per week of worksheet completion and monitoring activities, although participants are also encouraged to apply the behavioural strategies during naturally occurring interactions with the person experiencing gambling problems. Activities may include completing a gambling behaviour monitoring diary, completing the 5-Ws worksheet, identifying incompatible activities and desired behaviours, and recording reinforcement strategies used.

How often and for how long
Participants receive up to six sessions, each lasting approximately 30-60 minutes. Sessions are typically delivered weekly over six weeks but may be flexibly scheduled over a period of up to three months depending on participant need and availability.

Where it is delivered
The intervention is delivered through a specialist gambling treatment service within the Southern Adelaide Local Health Network (SALHN).

Adherence and fidelity monitoring
Participant adherence will be supported through attendance at sessions, completion of between-session practice tasks, and collaborative goal setting. Intervention fidelity will be ensured through manualised delivery, clinician training and supervision, audio-recording of sessions (with consent), and the use of adherence checklists with random fidelity auditing.
Intervention code [1] 334575 0
Behaviour
Description of the comparator or control
What is the comparator
The comparator is standard care (SC) as routinely delivered to concerned significant others (CSOs) within a specialist gambling treatment service. This is a structured, manual-guided psychosocial intervention informed by cognitive behavioural therapy (CBT) principles. It includes three core components: (1) psychoeducation about gambling problems from a CBT perspective; (2) strategies to support the CSO’s own psychological wellbeing; and (3) practical strategies to reduce financial and personal harm associated with another person’s gambling.
Unlike the experimental intervention, SC does not include structured training in behavioural strategies aimed at actively increasing treatment engagement by the person with gambling problems, although general information about treatment services and contact details are provided.

Who delivers it and their relevant expertise
The comparator is delivered by clinicians with Master’s-level qualifications in psychology, cognitive behavioural therapy, or psychotherapy, as well as postgraduate trainees under structured clinical supervision. All clinicians are experienced in delivering psychosocial interventions for gambling-related harm and receive ongoing supervision.

How it is delivered
Standard care is delivered as individual, therapist-led sessions with the CSO either in-person or via telehealth. Manualised sessions are structured around a workbook and collaborative discussion, with between-session activities tailored to the participant’s circumstances. These activities typically require approximately 30 minutes per week. Activities include completing an activity recorder to monitor daily activities and mood, identifying and rating routine, enjoyable, and necessary activities, completing activity planning worksheets, scheduling behavioural activation activities, and reviewing completed activities prior to the next session. Participants are also encouraged to implement planned behavioural activation activities in their daily lives and record their experiences for discussion during subsequent sessions.

How often and for how long
Participants receive up to six sessions, each lasting approximately 30-60 minutes. Sessions are typically delivered weekly over six weeks but may be flexibly scheduled over a period of up to three months depending on participant preference and availability.

Where it is delivered
The intervention is delivered within a specialist gambling therapy service in the Southern Adelaide Local Health Network (SALHN).

Adherence and fidelity monitoring
Participant adherence is supported through regular session scheduling, collaborative goal setting, and completion of between-session workbook activities that are reviewed during therapy.
Intervention fidelity is supported through manualised content, clinician training and supervision, and audio-recording of sessions (with consent) for fidelity monitoring. Treatment-specific adherence checklists are used, and a random sample of sessions is reviewed to ensure consistency and adherence to the intended intervention model.
Control group
Active

Outcomes
Primary outcome [1] 345975 0
Treatment engagement and help-seeking behaviour by the person with gambling problems (assessed as a composite outcome).
Timepoint [1] 345975 0
Primary endpoint: 6 months post-treatment. Additional assessments will be conducted at baseline, end of treatment, 1 month post-treatment, and 3 months post-treatment.
Primary outcome [2] 345976 0
Psychological distress
Timepoint [2] 345976 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.
Primary outcome [3] 346291 0
Depressive symptoms
Timepoint [3] 346291 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.
Secondary outcome [1] 463990 0
Functional impairment
Timepoint [1] 463990 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.
Secondary outcome [2] 463991 0
Family relationships
Timepoint [2] 463991 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.
Secondary outcome [3] 463992 0
Quality of relationship with the gambler
Timepoint [3] 463992 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.
Secondary outcome [4] 465639 0
Gambling behaviour by the person with gambling problems (assessed as a composite outcome).
Timepoint [4] 465639 0
The primary endpoint is end of treatment. Additional assessments will be conducted at baseline, 1-month post-treatment, 3-month post-treatment, and 6-month post-treatment follow-up.

Eligibility
Key inclusion criteria
Adults aged 18 years and over who are concerned about a family member or friend with a gambling problem who is not currently receiving treatment, and who have regular contact with that person (at least weekly). Participants must be willing to attend up to six therapy sessions and complete study assessments.
Individuals will be excluded if they have a current gambling problem themselves, are at risk of violence from the person with gambling problems, are currently experiencing severe mental health difficulties that would impair participation, or are unable to communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Current gambling problem in the participant
Risk of violence from the person with gambling problems
Severe mental health difficulties that would impair participation (for example, psychosis or suicidality)
Inability to communicate in English

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)
Allocation will be concealed using a computer-generated randomisation schedule implemented within the REDCap randomisation module. The allocation sequence will use block randomisation with varying block sizes and stratification variables, and will be embedded within the REDCap system to prevent prediction of group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence will be generated using a computer-generated block randomisation schedule with varying block sizes, stratified by the concerned significant other's gender and cohabitation status with the person with gambling problems, and implemented using the REDCap randomisation module.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined based on a priori power calculations informed by effect size estimates from a pilot randomised controlled trial of the intervention. A final sample size of 112 participants is required to achieve adequate statistical power to detect differences in the primary outcome between groups, assuming a type I error rate of 0.05 and power of 0.80. To achieve this enrolment target, up to 140 individuals may be recruited, screened and consented, allowing for approximately 20% attrition and pre-randomisation loss.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2026
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
30/01/2028
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29735 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 46082 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 322101 0
Government body
Name [1] 322101 0
SA Department of Human Services, Gambling Harm Support SA
Country [1] 322101 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 324993 0
Government body
Name [1] 324993 0
Southern Adelaide Local Health Network
Address [1] 324993 0
Country [1] 324993 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320629 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 320629 0
Ethics committee country [1] 320629 0
Australia
Date submitted for ethics approval [1] 320629 0
24/04/2026
Approval date [1] 320629 0
24/07/2026
Ethics approval number [1] 320629 0
2026/HRE00162

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

Contacts
Principal investigator
Name 151102 0
Dr Ben Riley
Address 151102 0
Flinders Psychological Therapy Services Block G The Flats Flinders Drive Bedford Park
Country 151102 0
Australia
Phone 151102 0
+61412181010
Fax 151102 0
Email 151102 0
[email protected]
Contact person for public queries
Name 151103 0
Ben Riley
Address 151103 0
Flinders Psychological Therapy Services Block G The Flats Flinders Drive Bedford Park
Country 151103 0
Australia
Phone 151103 0
+61412181010
Fax 151103 0
Email 151103 0
[email protected]
Contact person for scientific queries
Name 151104 0
Ben Riley
Address 151104 0
Flinders Psychological Therapy Services Block G The Flats Flinders Drive Bedford Park
Country 151104 0
Australia
Phone 151104 0
+61412181010
Fax 151104 0
Email 151104 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Access is subject to review by the Chief Investigator and may require ethics approval and a data sharing agreement. Only de-identified data will be shared.



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.