The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
Primary Purpose
Problem Gambling
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online therapy
Sponsored by
About this trial
This is an interventional treatment trial for Problem Gambling
Eligibility Criteria
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)
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online treatment
Non-treatment
Arm Description
The participants will receive counseling over the internet.
Participants who did not participant in the group were asked to complete the 12ve month followup questionnaire (but not the post treatment questionnaire).
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
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).
Secondary Outcome Measures
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).
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.
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.
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.
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).
Full Information
NCT ID
NCT05084885
First Posted
August 14, 2019
Last Updated
March 3, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT05084885
Brief Title
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
Official Title
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Gambling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will be evaluated using a pre-test vs. post-test design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online treatment
Arm Type
Experimental
Arm Description
The participants will receive counseling over the internet.
Arm Title
Non-treatment
Arm Type
No Intervention
Arm Description
Participants who did not participant in the group were asked to complete the 12ve month followup questionnaire (but not the post treatment questionnaire).
Intervention Type
Other
Intervention Name(s)
Online therapy
Intervention Description
Standard counseling provided over the internet.
Primary Outcome Measure Information:
Title
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling.
Description
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).
Time Frame
Change from baseline to 3 months
Title
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in Kessler-6 (K6; Galea, et al., 2007).
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in Number of Games Played
Description
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).
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling
Description
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).
Time Frame
Change from baseline to 12 months followup
Title
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Description
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.
Time Frame
Change from baseline to 12 months followup
Title
Changes in Kessler-6 (K6; Galea, et al., 2007).
Description
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.
Time Frame
Change from baseline to 12 months followup
Title
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Description
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.
Time Frame
Change from baseline to 12 months followup
Title
Changes in Number of Games Played
Description
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).
Time Frame
Change from baseline to 12 months followup
Other Pre-specified Outcome Measures:
Title
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Description
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).
Time Frame
Change from baseline to 3 months
Title
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Description
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).
Time Frame
Change from baseline to 12 months followup
Title
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Description
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.
Time Frame
Change from baseline to 12 months followup
Title
Changes in The Random Events Knowledge Test (REKT)
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in The Random Events Knowledge Test (REKT) Turner et al., (2006)
Description
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.
Time Frame
Change from baseline to 12 months followup
Title
Changes in Visual Analog Scale of Cravings.
Description
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.
Time Frame
Change from baseline to 3 months
Title
Changes in Visual Analog Scale of Cravings.
Description
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.
Time Frame
Change from baseline to 12 months followup.
Title
Changes in Total Money Spent
Description
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).
Time Frame
Change from baseline to 3 months
Title
Changes in Total Money Spent
Description
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).
Time Frame
Change from baseline to 12 months followup.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel E Turner, Ph.D
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared with other researchers.
Learn more about this trial
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
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