Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802226
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2021-03-11
Brief Title:
Optimization of the Self-exclusion Procedure
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Optimization of the Self-exclusion Procedure
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSE
Brief Summary:
It has been shown that self-excluded gamblers are very heavy gamblers and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons which strongly suggests that all self-excluded people are self-diagnosed problem gamblers Several studies converge in recognizing self-excluded people as problem gamblers who have lost control of their gambling and are seeking to protect themselves by taking action self-exclusion to change their behaviour and protect themselves
Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers
However the effectiveness of the current self-exclusion system appears to be limited particularly for short self-exclusions and for heavier gamblers
Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder it currently consists exclusively of a behavioural intervention in the sense that it prevents the behaviour It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions a brief intervention including a motivational cognitive approach personalized normative feedback referral to online help services cresus and gambling infoservice and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure Days will be randomized according to an a priori randomization list not players
Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers
However the effectiveness of the current self-exclusion system appears to be limited particularly for short self-exclusions and for heavier gamblers
Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder it currently consists exclusively of a behavioural intervention in the sense that it prevents the behaviour It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions a brief intervention including a motivational cognitive approach personalized normative feedback referral to online help services cresus and gambling infoservice and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure Days will be randomized according to an a priori randomization list not players
Detailed Description:
Main Objective
The primary objective of the study is to evaluate the effect of the optimized self-exclusion procedure compared to the existing procedure on the intensity of gambling
- Primary endpoint The primary endpoint is the change in total net loss over the last 4 weeks between the last 4 weeks prior to self-exclusion T0 and the last 4 weeks at 12 months T2
22 Secondary objectives The secondary objectives of the study are to assess early effect at 6 months and maintenance of effect at 18 months
- Secondary endpoints
The secondary objectives of the study are to evaluate early efficacy at 6 months and maintenance of efficacy at 18 months The endpoint used is the change in total net loss over the last 4 weeks between the last 4 weeks prior to self-exclusion and the last 4 weeks at 6 T1 and 18 months T3 The other criteria will be the change between T0 and T12 and 3 of the following variables total of the last 4 weeks unless otherwise specified
Total deposit
Total bet per game
Compulsiveness as defined by three consecutive deposits in a 12-hour period yesno number of episodes
Maximum number of deposits within one hour of a bet
Total loss per game average
Number of gambling sessions all games in a clinical sense session is defined as the gambling behavior itself we will consider the beginning of a session when a gambling action occurs after no gambling action has occurred for at least 30 minutes and the end of the gambling session a gambling action followed by no gambling action for 30 minutes
Session duration average
Total playing time defined as the sum of the session durations
Extension of self-exclusion yes no
Second and subsequent self-exclusion yes no number
Exceeding 80 moderators sum
The primary objective of the study is to evaluate the effect of the optimized self-exclusion procedure compared to the existing procedure on the intensity of gambling
- Primary endpoint The primary endpoint is the change in total net loss over the last 4 weeks between the last 4 weeks prior to self-exclusion T0 and the last 4 weeks at 12 months T2
22 Secondary objectives The secondary objectives of the study are to assess early effect at 6 months and maintenance of effect at 18 months
- Secondary endpoints
The secondary objectives of the study are to evaluate early efficacy at 6 months and maintenance of efficacy at 18 months The endpoint used is the change in total net loss over the last 4 weeks between the last 4 weeks prior to self-exclusion and the last 4 weeks at 6 T1 and 18 months T3 The other criteria will be the change between T0 and T12 and 3 of the following variables total of the last 4 weeks unless otherwise specified
Total deposit
Total bet per game
Compulsiveness as defined by three consecutive deposits in a 12-hour period yesno number of episodes
Maximum number of deposits within one hour of a bet
Total loss per game average
Number of gambling sessions all games in a clinical sense session is defined as the gambling behavior itself we will consider the beginning of a session when a gambling action occurs after no gambling action has occurred for at least 30 minutes and the end of the gambling session a gambling action followed by no gambling action for 30 minutes
Session duration average
Total playing time defined as the sum of the session durations
Extension of self-exclusion yes no
Second and subsequent self-exclusion yes no number
Exceeding 80 moderators sum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None