NCT05084885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 1, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

August 14, 2019

Results QC Date

October 21, 2021

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary 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).

    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.

    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.

    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.

    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).

    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

    Change from baseline to 12 months followup

  • Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).

    Change from baseline to 12 months followup

  • Changes in Kessler-6 (K6; Galea, et al., 2007).

    Change from baseline to 12 months followup

  • Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).

    Change from baseline to 12 months followup

  • Changes in Number of Games Played

    Change from baseline to 12 months followup

Other Outcomes (10)

  • Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)

    Change from baseline to 3 months

  • Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)

    Change from baseline to 12 months followup

  • Changes in Perceived Social Support (PSS) (Zimet et al., 1988)

    Change from baseline to 3 months

  • +7 more other outcomes

Study Arms (2)

Online treatment

EXPERIMENTAL

The participants will receive counseling over the internet.

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).

Interventions

Standard counseling provided over the internet.

Online treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Limitations and Caveats

The main limitations of the current study is the small sample size and the absence of a randomly assigned control group. Due to the small sample size we examined the data in terms of two individual cases, rather than as a group.

Results Point of Contact

Title
Dr. Nigel Turner
Organization
Centre for Addiction and Mental Health

Study Officials

  • Nigel E Turner, Ph.D

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study will be evaluated using a pre-test vs. post-test design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

October 20, 2021

Study Start

March 1, 2019

Primary Completion

August 9, 2019

Study Completion

August 30, 2020

Last Updated

March 7, 2023

Results First Posted

August 1, 2022

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared with other researchers.

Locations