GamblingNCT02800096
Online Interventions for Gamblers With and Without Co-occurring Mental Health Concerns
A study testing Gambling Internet intervention and MoodGYM in people with Gambling and Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Comorbidity between problem gambling and mental health concerns such as anxiety and depression is common. Further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling, Depression, Anxiety
- What is being tested?
- Gambling Internet intervention and MoodGYM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to 11 Aug 2017
- 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 Mental Health Concerns: Randomized Controlled Trial
Comorbidity between problem gambling and mental health concerns such as anxiety and depression is common. Further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern. The present study is a two-arm, double blinded, parallel group randomized controlled trial (RCT) that will evaluate whether there is a benefit to providing access to mental health Internet interventions (G+MH 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 mental health concerns.
Read the detailed description
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 current depression and anxiety will be assessed. Eligible participants agreeing to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus one that contains interventions for anxiety and depression in addition to an intervention for gamblers (G+MH). It is predicted that problem gamblers who do not have co-occurring mental health concerns will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health concerns, it is predicted that participants receiving access to G+MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website.
- Conditions
- Gambling, Depression, Anxiety
- Being tested
- Gambling Internet intervention, MoodGYM
- Medical subject headings
- Gambling, Depression, Anxiety Disorders
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.
MoodGYMBehavioural
Internet intervention for depression and anxiety - MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings.
| 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 + MoodGYM | Experimental | The G+MH intervention condition will consist of the G-only intervention and an online intervention for depression and anxiety. The mental health intervention chosen is MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings. Receives: Behavioral: Gambling Internet intervention; Behavioral: MoodGYM |
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
Secondary outcomes (1)
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 posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800096
- Sponsor's protocol ID
- 004/2015
- Status last verified
- Oct 2017
- First submitted
- 8 Jun 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Najavits LM, Ledgerwood DM, Afifi TO. A Randomized Controlled Trial for Gambling Disorder and PTSD: Seeking Safety and CBT. J Gambl Stud. 2023 Dec;39(4):1865-1884. doi: 10.1007/s10899-023-10224-z. Epub 2023 Jun 12.
PubMed 37306874Cunningham JA, Hodgins DC, Mackenzie CS, Godinho A, Schell C, Kushnir V, Hendershot CS. Randomized controlled trial of an Internet intervention for problem gambling provided with or without access to an Internet intervention for co-occurring mental health distress. Internet Interv. 2019 Mar 6;17:100239. doi: 10.1016/j.invent.2019.100239. eCollection 2019 Sep.
PubMed 30906694Cunningham JA, Hodgins DC, Bennett K, Bennett A, Talevski M, Mackenzie CS, Hendershot CS. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial. BMC Public Health. 2016 Jul 22;16:624. doi: 10.1186/s12889-016-3291-7.
PubMed 27449527
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. 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 Mental Health Concerns: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02800096
- Acronym / sponsor ID
- 004/2015
- Conditions
- Gambling, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
Comorbidity between problem gambling and mental health concerns such as anxiety and depression is common. Further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern. The present study is a two-arm, double blinded, parallel group randomized controlled trial (RCT) that will evaluate whether there is a benefit to providing access to mental health Internet interventions (G+MH 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 mental health concerns.
Detailed description
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 current depression and anxiety will be assessed. Eligible participants agreeing to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus one that contains interventions for anxiety and depression in addition to an intervention for gamblers (G+MH). It is predicted that problem gamblers who do not have co-occurring mental health concerns will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health concerns, it is predicted that participants receiving access to G+MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website.
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 + MoodGYM | Experimental | Behavioral: Gambling Internet intervention, Behavioral: MoodGYMThe G+MH intervention condition will consist of the G-only intervention and an online intervention for depression and anxiety. The mental health intervention chosen is MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings. |
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 + MoodGYM |
| MoodGYMInternet intervention for depression and anxiety - MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings. | Behavioural | Gambling Internet intervention + MoodGYM |
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
1 secondary outcome
Number of days gambled per month
Time frame: 3 and 6 months
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 Oct 2017.
- Derived from this study: PubMed 37306874Najavits LM, Ledgerwood DM, Afifi TO. A Randomized Controlled Trial for Gambling Disorder and PTSD: Seeking Safety and CBT. J Gambl Stud. 2023 Dec;39(4):1865-1884. doi: 10.1007/s10899-023-10224-z. Epub 2023 Jun 12.
- Derived from this study: PubMed 30906694Cunningham JA, Hodgins DC, Mackenzie CS, Godinho A, Schell C, Kushnir V, Hendershot CS. Randomized controlled trial of an Internet intervention for problem gambling provided with or without access to an Internet intervention for co-occurring mental health distress. Internet Interv. 2019 Mar 6;17:100239. doi: 10.1016/j.invent.2019.100239. eCollection 2019 Sep.
- Derived from this study: PubMed 27449527Cunningham JA, Hodgins DC, Bennett K, Bennett A, Talevski M, Mackenzie CS, Hendershot CS. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial. BMC Public Health. 2016 Jul 22;16:624. doi: 10.1186/s12889-016-3291-7.
- The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.Link 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, Ph.D. 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 MoodGYM in people with Gambling and Depression, 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 Oct 2017. 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). 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 NCT02800096, which also lists 3 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 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.