Problem GamblingNCT05084885
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
A study testing Online therapy in people with Problem Gambling, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. We will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Online therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- problem gamblers seeking treatment who are 18 years and older must be willing to have therapy conducted online must have access to a computer and Internet be able to communicate in English.
Who cannot join
- not able to communicate in English, has current suicidal ideation, acute psychotic symptoms, current involvement in other gambling treatment, has severe substance abuse problem or complex mental health problems (as assessed by screening tools)
Trial locations and contacts
1 site in 1 country.
About this study
This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. We will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being.
Read the detailed description
Disordered gambling is now recognized as a behavioral addiction. Although the physical consequences of the disorder are very mild, the financial and emotional costs can be enormous. This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. This project was originally designed to take place over a three-year period but has been condensed into two. Part one was scoping review. Part two involved focus groups with service providers and people experiencing gambling problems. Part three will gather some general population information on two on going population survey's run by our research team. Part four Involved key informant interviews, and part five would be the development and evaluation of a pilot online treatment service. This application deals with part five of the overall project, Parts two and four were conducted as 025-2017. In this study, we will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being. The data reported here are related to part 5 only. Due to funding cuts, we were only able to include 2 people in the completed study.
- Conditions
- Problem Gambling
- Being tested
- Online therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online therapyOther
Standard counseling provided over the internet.
| Study group | Role | What they receive |
|---|---|---|
| Online treatment | Experimental | The participants will receive counseling over the internet. Receives: Other: Online therapy |
| Non-treatment | No intervention | Participants who did not participant in the group were asked to complete the 12ve month followup questionnaire (but not the post treatment questionnaire). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling.
Level of gambling frequency was measured using self reported frequency on a 7 point scale on 12 types of gambling. We used the maximum frequency across the twelve types of gambling so that if they reported participating in 5 types of gambling ranging from once per year (score of 1) to everyday (score of 7), we would score the person as 7. This way the measure was sensitive to changes in the most problematic frequent form of gambling for that person. Lower levels of gambling frequency after 12 months would be a positive outcome. To score frequency we computed each person's highest frequency for a range from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling. The same was done for their post-test scores. We computed the difference score of post-test from pre-test which could range from 7 to -7 with negative numbers indicating improvement (reduced gambling participation).
Measured: Change from baseline to 3 months
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Gambling problems are measured using PGSI (Ferris \& Wynne, 2001). Each of the 9 item is measured on a 4 point scale from never (0) to almost always (3). The total ranges from 0 to 27. Higher scores indicate more gambling problems; Lower scores at followup would be a positive outcome. Total scores form 3 to 7 indicate moderate gambling problems; scores 7 or higher indicate severe gambling problems. In this study we subtracted pre-test scores from post test scores to compute a change score which would range from27 to -27 with higher number indicating a worse outcome and negative numbers indicating a positive outcome.
Measured: Change from baseline to 3 months
Changes in Kessler-6 (K6; Galea, et al., 2007).
The Kessler-6 measures psychological distress (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). For the evaluation we computed the difference of post-test from pre-test with a range from 25 to -25 with negative numbers indicating an improvement.
Measured: Change from baseline to 3 months
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS; Brown \& Ryan, 2003). Range 1 to 6 based on average score per item; higher scores mean greater mindfulness. For the evaluation we computed the difference of the post-test and the pre-test for a range from 6 to -6 with positive numbers indicating an improvement in mindfulness.
Measured: Change from baseline to 3 months
Changes in Number of Games Played
Number of games played was measured using a self report measure of participation in 12 games (see frequently above). Fewer games played would be a positive outcome. Possible range is from 0 to 12. We computed the difference score from pre-test to post-test which could range from 12 to -12 with negative numbers indicating improvement (reduced gambling participation).
Measured: Change from baseline to 3 months
Secondary outcomes (5)
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling
Level of gambling frequency was measured using self reported frequency on a 7 point scale on 12 types of gambling. We used the maximum frequency across the twelve types of gambling so that if they reported participating in 5 types of gambling ranging from once per year (score of 1) to everyday (score of 7), we would score the person as 7. This way the measure was sensitive to changes in the most problematic frequent form of gambling for that person. Lower levels of gambling frequency after 12 months would be a positive outcome. To score frequency we computed each person's highest frequency for a range from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling. The same was done for their post-test scores. We computed the difference score of post-test from pre-test which could range from 7 to -7 with negative numbers indicating improvement (reduced gambling participation).
Measured: Change from baseline to 12 months followup
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Gambling problems are measured using PGSI (Ferris \& Wynne, 2001). Each of the 9 item is measured on a 4 point scale from never (0) to almost always (3). The total ranges from 0 to 27. Higher scores indicate more gambling problems; Lower scores at followup would be a positive outcome. Total scores form 3 to 7 indicate moderate gambling problems; scores 7 or higher indicate severe gambling problems. In this study we subtracted pre-test scores from post test scores to compute a change score which would range from27 to -27 with higher number indicating a worse outcome and negative numbers indicating a positive outcome.
Measured: Change from baseline to 12 months followup
Changes in Kessler-6 (K6; Galea, et al., 2007).
The Kessler-6 measures psychological distress (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). For the evaluation we computed the difference of post-test from pre-test with a range from 25 to -25 with negative numbers indicating an improvement.
Measured: Change from baseline to 12 months followup
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS; Brown \& Ryan, 2003). Range 1 to 6 based on average score per item; higher scores mean greater mindfulness. For the evaluation we computed the difference of the post-test and the pre-test for a range from 6 to -6 with positive numbers indicating an improvement in mindfulness.
Measured: Change from baseline to 12 months followup
Changes in Number of Games Played
Number of games played was measured using a self report measure of participation in 12 games (see frequently above). Fewer games played would be a positive outcome. Possible range is from 0 to 12. We computed the difference score from pre-test to post-test which could range from 12 to -12 with negative numbers indicating improvement (reduced gambling participation).
Measured: Change from baseline to 12 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Mar 2019
- Primary completion9 Aug 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study will be evaluated using a pre-test vs. post-test design.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Nigel E Turner, Ph.D, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084885
- Sponsor's protocol ID
- 074-2018
- Status last verified
- Mar 2023
- First submitted
- 14 Aug 2019
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
- ClinicalTrials.gov ID
- NCT05084885
- Acronym / sponsor ID
- 074-2018
- Conditions
- Problem Gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 1 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. We will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being.
Detailed description
Disordered gambling is now recognized as a behavioral addiction. Although the physical consequences of the disorder are very mild, the financial and emotional costs can be enormous. This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. This project was originally designed to take place over a three-year period but has been condensed into two. Part one was scoping review. Part two involved focus groups with service providers and people experiencing gambling problems. Part three will gather some general population information on two on going population survey's run by our research team. Part four Involved key informant interviews, and part five would be the development and evaluation of a pilot online treatment service. This application deals with part five of the overall project, Parts two and four were conducted as 025-2017. In this study, we will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being. The data reported here are related to part 5 only. Due to funding cuts, we were only able to include 2 people in the completed study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be evaluated using a pre-test vs. post-test design.
| Arm | Type | Receives |
|---|---|---|
| Online treatment | Experimental | Other: Online therapyThe participants will receive counseling over the internet. |
| Non-treatment | No intervention | –Participants who did not participant in the group were asked to complete the 12ve month followup questionnaire (but not the post treatment questionnaire). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- problem gamblers seeking treatment who are 18 years and older must be willing to have therapy conducted online must have access to a computer and Internet be able to communicate in English.
Key exclusion criteria (1 listed)
- not able to communicate in English, has current suicidal ideation, acute psychotic symptoms, current involvement in other gambling treatment, has severe substance abuse problem or complex mental health problems (as assessed by screening tools)
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 |
|---|---|---|
| Online therapyStandard counseling provided over the internet. | Other | Online treatment |
Primary outcome
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling.
Time frame: Change from baseline to 3 months
Level of gambling frequency was measured using self reported frequency on a 7 point scale on 12 types of gambling. We used the maximum frequency across the twelve types of gambling so that if they reported participating in 5 types of gambling ranging from once per year (score of 1) to everyday (score of 7), we would score the person as 7. This way the measure was sensitive to changes in the most problematic frequent form of gambling for that person. Lower levels of gambling frequency after 12 months would be a positive outcome. To score frequency we computed each person's highest frequency for a range from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling. The same was done for their post-test scores. We computed the difference score of post-test from pre-test which could range from 7 to -7 with negative numbers indicating improvement (reduced gambling participation).
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Time frame: Change from baseline to 3 months
Gambling problems are measured using PGSI (Ferris \& Wynne, 2001). Each of the 9 item is measured on a 4 point scale from never (0) to almost always (3). The total ranges from 0 to 27. Higher scores indicate more gambling problems; Lower scores at followup would be a positive outcome. Total scores form 3 to 7 indicate moderate gambling problems; scores 7 or higher indicate severe gambling problems. In this study we subtracted pre-test scores from post test scores to compute a change score which would range from27 to -27 with higher number indicating a worse outcome and negative numbers indicating a positive outcome.
Changes in Kessler-6 (K6; Galea, et al., 2007).
Time frame: Change from baseline to 3 months
The Kessler-6 measures psychological distress (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). For the evaluation we computed the difference of post-test from pre-test with a range from 25 to -25 with negative numbers indicating an improvement.
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Time frame: Change from baseline to 3 months
Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS; Brown \& Ryan, 2003). Range 1 to 6 based on average score per item; higher scores mean greater mindfulness. For the evaluation we computed the difference of the post-test and the pre-test for a range from 6 to -6 with positive numbers indicating an improvement in mindfulness.
Changes in Number of Games Played
Time frame: Change from baseline to 3 months
Number of games played was measured using a self report measure of participation in 12 games (see frequently above). Fewer games played would be a positive outcome. Possible range is from 0 to 12. We computed the difference score from pre-test to post-test which could range from 12 to -12 with negative numbers indicating improvement (reduced gambling participation).
5 secondary outcomes
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling
Time frame: Change from baseline to 12 months followup
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Time frame: Change from baseline to 12 months followup
Changes in Kessler-6 (K6; Galea, et al., 2007).
Time frame: Change from baseline to 12 months followup
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Time frame: Change from baseline to 12 months followup
Changes in Number of Games Played
Time frame: Change from baseline to 12 months followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers.
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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.
Nigel E Turner, 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 Online therapy in people with Problem Gambling, 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 1 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 7 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling. (time frame: Change from baseline to 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2023.