GamblingNCT03323606
Online Interventions for Gamblers With and Without Co-occurring Problem Drinking
A study testing Gambling Internet Intervention and Check Your Drinking in people with Gambling and Alcohol Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Many problem gamblers are also problem drinkers,with lifetime prevalence in nationally representative samples ranging from 45% to 73%. Heavy drinking often occurs while problem gamblers are engaging in gambling activities, resulting in increased risky gambling behaviour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling, Alcohol Consumption
- What is being tested?
- Gambling Internet Intervention and Check Your Drinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or over
- Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Interventions for Problem Gamblers With and Without Co-occurring Problem Drinking: Randomized Controlled Trial
Many problem gamblers are also problem drinkers,with lifetime prevalence in nationally representative samples ranging from 45% to 73%. Heavy drinking often occurs while problem gamblers are engaging in gambling activities, resulting in increased risky gambling behaviour. Further, co-occurring problem drinking negatively impacts on the treatment outcomes of problem gamblers. Thus, targeting problem drinking among problem gamblers may have the dual benefits of reducing both the problem drinking itself, and of acting as a mediator for reductions in problem gambling behaviour. The present study seeks to determine whether providing simultaneous access to help for gambling and drinking is of benefit for those with these co-occurring problems.
Read the detailed description
Problem gambling and problem drinking frequently co-occur. Further, the treatment needs of people with co-occurring gambling and drinking problems may be different from those of problem gamblers who do not drink alcohol in a hazardous fashion. The current project will evaluate whether there is a benefit to providing access to a problem drinking Internet intervention (G+A intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring problem drinking.
People with gambling concerns will be recruited using targeted advertisements. Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of alcohol consumption will be assessed. Eligible participants who agree to take part in the study will be randomized into one of two online interventions for gamblers - an intervention that only targets gambling issues (G-only) versus one that contains an intervention for drinking (G+A). It is predicted that for problem gamblers with co-occurring problem drinking, participants provided access to the G+A website will display significantly reduced gambling outcomes at three- and six-month follow-ups as compared to those provided access to the G-only website. However, for problem gamblers without co-occurring problem drinking, it is predicted that participants will display no significant difference between the G-only and G+A websites at three- and six-month follow-ups.
- Conditions
- Gambling, Alcohol Consumption
- Being tested
- Gambling Internet Intervention, Check Your Drinking
- Medical subject headings
- Gambling, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambling Internet InterventionBehavioural
The gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
Check Your DrinkingBehavioural
A brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
| Study group | Role | What they receive |
|---|---|---|
| Gambling Internet Intervention | Active comparator | The gambling only Internet intervention (G-only) will consist of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling. Receives: Behavioral: Gambling Internet Intervention |
| Gambling Internet Intervention + CYD | Experimental | The G+A intervention condition will consist of the G-only intervention and an online intervention for drinking. The online drinking intervention chosen is Check Your Drinking, a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking Receives: Behavioral: Gambling Internet Intervention; Behavioral: Check Your Drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The NORC DSM-IV Screen for Gambling Problems (NODS) past 3 month version indicating DSM-IV gambling severity.
Change in gambling severity (NODS) from baseline
Measured: 3 and 6 months
Number of days gambled per month
Change in mean days per month gambling from baseline
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start20 Nov 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Manitoba
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323606
- Sponsor's protocol ID
- 010/2017
- Status last verified
- Jun 2019
- First submitted
- 24 Oct 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cunningham JA, Hodgins DC, Keough M, Hendershot CS, Schell C, Godinho A. Online interventions for problem gamblers with and without co-occurring unhealthy alcohol use: Randomized controlled trial. Internet Interv. 2020 Jan 18;19:100307. doi: 10.1016/j.invent.2020.100307. eCollection 2020 Mar.
PubMed 32042600Cunningham JA, Hodgins DC, Keough M, Hendershot CS, Bennett K, Bennett A, Godinho A. Online interventions for problem gamblers with and without co-occurring problem drinking: study protocol of a randomized controlled trial. Trials. 2018 May 25;19(1):295. doi: 10.1186/s13063-018-2672-x.
PubMed 29801520
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Interventions for Problem Gamblers With and Without Co-occurring Problem Drinking: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03323606
- Acronym / sponsor ID
- 010/2017
- Conditions
- Gambling, Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of Calgary, University of Manitoba
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many problem gamblers are also problem drinkers,with lifetime prevalence in nationally representative samples ranging from 45% to 73%. Heavy drinking often occurs while problem gamblers are engaging in gambling activities, resulting in increased risky gambling behaviour. Further, co-occurring problem drinking negatively impacts on the treatment outcomes of problem gamblers. Thus, targeting problem drinking among problem gamblers may have the dual benefits of reducing both the problem drinking itself, and of acting as a mediator for reductions in problem gambling behaviour. The present study seeks to determine whether providing simultaneous access to help for gambling and drinking is of benefit for those with these co-occurring problems.
Detailed description
Problem gambling and problem drinking frequently co-occur. Further, the treatment needs of people with co-occurring gambling and drinking problems may be different from those of problem gamblers who do not drink alcohol in a hazardous fashion. The current project will evaluate whether there is a benefit to providing access to a problem drinking Internet intervention (G+A intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring problem drinking.
People with gambling concerns will be recruited using targeted advertisements. Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of alcohol consumption will be assessed. Eligible participants who agree to take part in the study will be randomized into one of two online interventions for gamblers - an intervention that only targets gambling issues (G-only) versus one that contains an intervention for drinking (G+A). It is predicted that for problem gamblers with co-occurring problem drinking, participants provided access to the G+A website will display significantly reduced gambling outcomes at three- and six-month follow-ups as compared to those provided access to the G-only website. However, for problem gamblers without co-occurring problem drinking, it is predicted that participants will display no significant difference between the G-only and G+A websites at three- and six-month follow-ups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gambling Internet Intervention | Active comparator | Behavioral: Gambling Internet InterventionThe gambling only Internet intervention (G-only) will consist of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling. |
| Gambling Internet Intervention + CYD | Experimental | Behavioral: Gambling Internet Intervention, Behavioral: Check Your DrinkingThe G+A intervention condition will consist of the G-only intervention and an online intervention for drinking. The online drinking intervention chosen is Check Your Drinking, a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or over
- Score of 3 or greater on the Problem Gambling Severity Index of the Canadian Problem Gambling Index (PGSI- CPGI)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gambling Internet InterventionThe gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling. | Behavioural | Gambling Internet Intervention, Gambling Internet Intervention + CYD |
| Check Your DrinkingA brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking | Behavioural | Gambling Internet Intervention + CYD |
Primary outcome
The NORC DSM-IV Screen for Gambling Problems (NODS) past 3 month version indicating DSM-IV gambling severity.
Time frame: 3 and 6 months
Change in gambling severity (NODS) from baseline
Number of days gambled per month
Time frame: 3 and 6 months
Change in mean days per month gambling from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 32042600Cunningham JA, Hodgins DC, Keough M, Hendershot CS, Schell C, Godinho A. Online interventions for problem gamblers with and without co-occurring unhealthy alcohol use: Randomized controlled trial. Internet Interv. 2020 Jan 18;19:100307. doi: 10.1016/j.invent.2020.100307. eCollection 2020 Mar.
- Derived from this study: PubMed 29801520Cunningham JA, Hodgins DC, Keough M, Hendershot CS, Bennett K, Bennett A, Godinho A. Online interventions for problem gamblers with and without co-occurring problem drinking: study protocol of a randomized controlled trial. Trials. 2018 May 25;19(1):295. doi: 10.1186/s13063-018-2672-x.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Cunningham, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gambling Internet Intervention and Check Your Drinking in people with Gambling and Alcohol Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The NORC DSM-IV Screen for Gambling Problems (NODS) past 3 month version indicating DSM-IV gambling severity. (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.