Trial Outcomes & Findings for The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five (NCT NCT05084885)

NCT ID: NCT05084885

Last Updated: 2023-03-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Change from baseline to 3 months

Results posted on

2023-03-07

Participant Flow

Participant milestones

Participant milestones
Measure
Online Treatment
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non Treatment
Receive no treatment
Baseline
STARTED
3
13
Baseline
Treated
2
0
Baseline
Not Treated
1
13
Baseline
COMPLETED
2
13
Baseline
NOT COMPLETED
1
0
Post Treatment
STARTED
2
13
Post Treatment
COMPLETED
2
13
Post Treatment
NOT COMPLETED
0
0
Follow-up
STARTED
2
13
Follow-up
Treated
2
0
Follow-up
Not Treated
0
13
Follow-up
COMPLETED
2
8
Follow-up
NOT COMPLETED
0
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Online Treatment
n=16 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Age, Categorical
<=18 years
0 Participants
n=16 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=16 Participants
Age, Categorical
>=65 years
0 Participants
n=16 Participants
Sex: Female, Male
Female
8 Participants
n=16 Participants
Sex: Female, Male
Male
8 Participants
n=16 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling.
-2 score on a scale
Standard Deviation 1.41

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
-6 score on a scale
Standard Deviation 1.41

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Kessler-6 (K6; Galea, et al., 2007).
-2 units on a scale
Standard Deviation 0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
.6 score on a scale
Standard Deviation .19

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Number of Games Played
-1.5 changes in number of games played
Standard Deviation .71

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling
-4 score on a scale
Standard Deviation 0
-2.6 score on a scale
Standard Deviation 3.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
-10 score on a scale
Standard Deviation 2.83
-8.3 score on a scale
Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Kessler-6 (K6; Galea, et al., 2007).
-3 score on a scale
Standard Deviation 7
-1.6 score on a scale
Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
1.1 score on a scale
Standard Deviation .05
.32 score on a scale
Standard Deviation .84

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Number of Games Played
-2.5 changes in number of games played
Standard Deviation .071
-2.9 changes in number of games played
Standard Deviation 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
2.0 score on a scale
Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
2.0 score on a scale
Standard Deviation 7.1
2.1 score on a scale
Standard Deviation 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
-3.5 score on a scale
Standard Deviation 7.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
-3.5 score on a scale
Standard Deviation 9.2
0.0 score on a scale
Standard Deviation 14.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in The Random Events Knowledge Test (REKT)
3.5 score on a scale
Standard Deviation 2.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in The Random Events Knowledge Test (REKT) Turner et al., (2006)
4 score on a scale
Standard Deviation 1.41
0.5 score on a scale
Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Visual Analog Scale of Cravings.
-9.63 score on a scale
Standard Deviation 15.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Visual Analog Scale of Cravings.
-25.5 score on a scale
Standard Deviation 14.5
-12.5 score on a scale
Standard Deviation 31.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Total Money Spent
-3675 change in dollars spent
Standard Deviation 2368

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Online Treatment
n=2 Participants
The participants will receive counseling over the internet. Online therapy: Standard counseling provided over the internet.
Non-Treatment
n=8 Participants
At the 12 month follow-up all people who completed the initial survey were again asked to complete the same measures. Only the baseline vs 12-month data is available.
Changes in Total Money Spent
-3750 change in dollars spent
Standard Deviation 2474
-3119 change in dollars spent
Standard Deviation 4553

Adverse Events

Online Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nigel Turner

Centre for Addiction and Mental Health

Phone: 416-535-8501

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place