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Completed

NCT Number: NCT05084885

The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Online therapy

Other

Standard counseling provided over the internet.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 20, 2021
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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