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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05084885
Recruitment Status : Completed
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Problem Gambling Other: Online therapy Not Applicable

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, which does not require REB approval. Part two involved focus groups with service providers and people experiencing gambling problems. Part three will gather some general population information by including questions of the OSDHUS and CAMH monitor. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study will be evaluated using a pre-test vs. post-test design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online treatment
The participants will receive counseling over the internet.
Other: Online therapy
Standard counseling provided over the internet.




Primary Outcome Measures :
  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 measured using self reported frequency on 12 types of gambling. Lower levels of gambling frequency after 12 months would be a positive outcome. We will focus on the most frequent game play out of the 12. The range is from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling.

  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 alwasys (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.

    Ferris, J., & Wynne, H. (2001). The Canadian problem gambling index: Final report. Submitted for the Canadian Centre on Substance Abuse http://www.problemgambling.ca/EN/ResourcesForProfessionals/pages/problemgamblingseverityindexpgsi.aspx


  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.

    Galea, S., Brewin, C.R., Gruber, M., Jones, R.T., King, D.W., King, L.A., et al., 2007. Exposure to hurricane-related stressors and mental illness after Hurricane Katrina. Arch Gen Psychiatry 64(12), 1427-1434.


  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.

    Brown, K.W., & Ryan, R.M. (2003). The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology, 84, 822-848.


  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.


Secondary Outcome Measures :
  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 measured using self reported frequency on 12 types of gambling. Lower levels of gambling frequency after 12 months would be a positive outcome. We will focus on the most frequent game play out of the 12. The range is from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling.

  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 alwasys (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.

    Ferris, J., & Wynne, H. (2001). The Canadian problem gambling index: Final report. Submitted for the Canadian Centre on Substance Abuse http://www.problemgambling.ca/EN/ResourcesForProfessionals/pages/problemgamblingseverityindexpgsi.aspx


  3. Changes in Kessler-6 (K6; Galea, et al., 2007). [ Time Frame: Change from baseline to 12 months followup ]

    We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. Lower scores would be a positive outcome.

    Galea, S., Brewin, C.R., Gruber, M., Jones, R.T., King, D.W., King, L.A., et al., 2007. Exposure to hurricane-related stressors and mental illness after Hurricane Katrina. Arch Gen Psychiatry 64(12), 1427-1434.


  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.

    Brown, K.W., & Ryan, R.M. (2003). The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology, 84, 822-848.


  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.


Other Outcome Measures:
  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 are 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.

    Heun, R., Bonsignore, M., Barkow, K., & Jessen, F. (2001). Validity of the five-item WHO Well-Being Index (WHO-5) in an elderly population. European archives of psychiatry and clinical neuroscience, 251(2), 27-31.


  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 are 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.

    Heun, R., Bonsignore, M., Barkow, K., & Jessen, F. (2001). Validity of the five-item WHO Well-Being Index (WHO-5) in an elderly population. European archives of psychiatry and clinical neuroscience, 251(2), 27-31.


  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.

    Zimet, G.D., Dahlem, N.W., Zimet, S.G. & Farley, G.K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52, 30-41.


  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.

    Zimet, G.D., Dahlem, N.W., Zimet, S.G. & Farley, G.K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52, 30-41.


  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 score 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.

    Turner, N. E., Littman-Sharp, N., & Zangeneh, M. (2006). The experience of gambling and its role in problem gambling. International Gambling Studies, 6, 237-266.


  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 score 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.

    Turner, N. E., Littman-Sharp, N., & Zangeneh, M. (2006). The experience of gambling and its role in problem gambling. International Gambling Studies, 6, 237-266.


  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, with higher scores mean more cravings to gamble. A positive outcome would be lower scores at followup.

    Berger, S. P., Reid, M. S., Delucchi, K., Hall, S., Hall, S., Mickalian, J. D., & Crawford, C. A. (1996). Haloperidol antagonism of cue-elicited cocaine craving. The Lancet, 347(9000), 504-508.

    Duncan, E., Madonick, S., Chakravorty, S., Parwani, A., Szilagyi, S., Efferen, T., ... & Rotrosen, J. (2001). Effects of smoking on acoustic startle and prepulse inhibition in humans. Psychopharmacology, 156(2-3), 266-272.


  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, with higher scores mean more cravings to gamble. A positive outcome would be lower scores at followup.

    Berger, S. P., Reid, M. S., Delucchi, K., Hall, S., Hall, S., Mickalian, J. D., & Crawford, C. A. (1996). Haloperidol antagonism of cue-elicited cocaine craving. The Lancet, 347(9000), 504-508.

    Duncan, E., Madonick, S., Chakravorty, S., Parwani, A., Szilagyi, S., Efferen, T., ... & Rotrosen, J. (2001). Effects of smoking on acoustic startle and prepulse inhibition in humans. Psychopharmacology, 156(2-3), 266-272.


  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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084885


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Nigel E Turner, Ph.D Centre for Addiction and Mental Health
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Responsible Party: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT05084885    
Other Study ID Numbers: 074-2018
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders