- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084885
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
March 3, 2023 updated by: Centre for Addiction and Mental Health
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online treatment
The participants will receive counseling over the internet.
|
Standard counseling provided over the internet.
|
No Intervention: Non-treatment
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from baseline to 3 months
|
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.
|
Change from baseline to 3 months
|
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.
|
Change from baseline to 3 months
|
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.
|
Change from baseline to 3 months
|
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).
|
Change from baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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).
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Change from baseline to 12 months followup
|
Changes in Number of Games Played
Time Frame: Change from baseline to 12 months followup
|
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).
|
Change from baseline to 12 months followup
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Time Frame: Change from baseline to 3 months
|
Higher levels of quality of life is expected as a result of the intervention.
Each item was scored on a 6 point scale from "1, At no time" to "6, All of the time" for a total score ranging from 6 to 30.
To assess the outcome we computed the difference score from pre-test to post-test which could range from 24 to -24 with positive numbers indicating improvement (higher quality of life).
|
Change from baseline to 3 months
|
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Time Frame: Change from baseline to 12 months followup
|
Higher levels of quality of life is expected as a result of the intervention.
Each item was scored on a 6 point scale from "1, At no time" to "6, All of the time" for a total score ranging from 6 to 30.
To assess the outcome we computed the difference score from pre-test to post-test which could range from 24 to -24 with positive numbers indicating improvement (higher quality of life).
|
Change from baseline to 12 months followup
|
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Time Frame: Change from baseline to 3 months
|
This scale measures perception of social support.
Each item is measured on a 7 point scale from 1 to 7, for a total score of 12 to 84.
Higher scores indicate higher levels of social support, so an increase in social support would be a positive change.
For the evaluation we computer the differences from pre-test to post-test for a range from 72 to -72 with positive numbers indicate an improvement in perceived social support.
|
Change from baseline to 3 months
|
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Time Frame: Change from baseline to 12 months followup
|
This scale measures perception of social support.
Each item is measured on a 7 point scale from 1 to 7, for a total score of 12 to 84.
Higher scores indicate higher levels of social support, so an increase in social support would be a positive change.
For the evaluation we computer the differences from pre-test to post-test for a range from 72 to -72 with positive numbers indicate an improvement in perceived social support.
|
Change from baseline to 12 months followup
|
Changes in The Random Events Knowledge Test (REKT)
Time Frame: Change from baseline to 3 months
|
This scale measures the participants understanding of random events using a true or false format..
Each item is scored as correct or incorrect for a total score of 0 to 28.
Higher scores mean they have a better understanding of random events and an increase in score would be a positive change.
For the evaluation we computed the difference from pre-test to post-test for a range from 28 to -28 with positive number indicating improvement in the participants understanding of random chance.
|
Change from baseline to 3 months
|
Changes in The Random Events Knowledge Test (REKT) Turner et al., (2006)
Time Frame: Change from baseline to 12 months followup
|
This scale measures the participants understanding of random events using a true or false format..
Each item is scored as correct or incorrect for a total score of 0 to 28.
Higher scores mean they have a better understanding of random events and an increase in score would be a positive change.
For the evaluation we computed the difference from pre-test to post-test for a range from 28 to -28 with positive number indicating improvement in the participants understanding of random chance.
|
Change from baseline to 12 months followup
|
Changes in Visual Analog Scale of Cravings.
Time Frame: Change from baseline to 3 months
|
The visual analog scale is based on similar measures used in drug research (e.g., Duncan, et al., 2001; Berger, et al., 1996).
Each of 4 items is scored from 0 to 100, and the average is computed for a range from 0 to 100 with higher scores mean more cravings to gamble.
A positive outcome would be lower scores at followup.
For the evaluation we computed the difference between the post-test and pre-test for a range from 100 to -100, with negative numbers indicating an decrease in cravings.
|
Change from baseline to 3 months
|
Changes in Visual Analog Scale of Cravings.
Time Frame: Change from baseline to 12 months followup.
|
The visual analog scale is based on similar measures used in drug research (e.g., Duncan, et al., 2001; Berger, et al., 1996).
Each of 4 items is scored from 0 to 100, and the average is computed for a range from 0 to 100 with higher scores mean more cravings to gamble.
A positive outcome would be lower scores at followup.
For the evaluation we computed the difference between the post-test and pre-test for a range from 100 to -100, with negative numbers indicating an decrease in cravings.
|
Change from baseline to 12 months followup.
|
Changes in Total Money Spent
Time Frame: Change from baseline to 3 months
|
Self report measure of money spent gambling in past 6 months.
Lower amounts spend would be a positive outcome.For the evaluation we compute the difference between spending at post-test from pre-test with negative numbers indicating an improvement (decrease in spending).
|
Change from baseline to 3 months
|
Changes in Total Money Spent
Time Frame: Change from baseline to 12 months followup.
|
Self report measure of money spent gambling in past 6 months.
Lower amounts spend would be a positive outcome.For the evaluation we compute the difference between spending at post-test from pre-test with negative numbers indicating an improvement (decrease in spending).
|
Change from baseline to 12 months followup.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nigel E Turner, Ph.D, Centre for Addiction and Mental Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
August 9, 2019
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
August 14, 2019
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 20, 2021
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 074-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual data will not be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Problem Gambling
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedGambling | Pathological Gambling | Problem GamblingUnited States
-
Université Catholique de LouvainCentre Hospitalier Universitaire Vaudois; Cliniques universitaires Saint-Luc-... and other collaboratorsUnknownCraving | Gambling | Gambling Disorder | Gambling, Pathological | Gambling ProblemSwitzerland
-
Region SkaneLund UniversityRecruitingGambling Disorder | Problem GamblingSweden
-
Universitat Jaume INot yet recruitingGambling Disorder | Problem GamblingSpain
-
Karolinska InstitutetCompleted
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingAccelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial (arTMSinGD)Gambling | Gambling Disorder | Gambling, Pathological | Gambling Problem
-
Karolinska InstitutetThe National Gambling Helpline SwedenNot yet recruiting
-
King's College LondonCompleted
-
Karolinska InstitutetCompleted
-
Centre for Addiction and Mental HealthCompletedGambling ProblemCanada
Clinical Trials on Online therapy
-
Icahn School of Medicine at Mount SinaiNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedPost-Traumatic Stress DisorderUnited States
-
University of Southern DenmarkIrish Research Council; Academisch Medisch Centrum - Universiteit van Amsterdam... and other collaboratorsUnknown
-
Vanderbilt University Medical CenterSeattle Children's HospitalCompletedGastrointestinal Disorders, FunctionalUnited States
-
Florida State UniversityCompletedPain, Postoperative | Chronic Pain | Pain, Acute | Pain CatastrophizingUnited States
-
Massachusetts General HospitalUniversity of California, San FranciscoCompleted
-
University Hospital, Strasbourg, FranceCompletedStress - Prevention of Sleep Disorders, PTSD and DepressionFrance
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of TurkeyRecruiting
-
University of British ColumbiaActive, not recruitingFemale Sexual DysfunctionCanada
-
Chinese University of Hong KongNot yet recruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Masaryk UniversityMasaryk Memorial Cancer InstituteRecruiting