Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations (PASS)
Primary Purpose
Gambling Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
Sponsored by
About this trial
This is an interventional other trial for Gambling Disorder
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- self-excluder during the recruitment period
- Online sports betting
- poker and horse racing player
- account opened for at least 4 weeks
- self-exclusion for 3 months or less (minimum 3 days).
Exclusion Criteria:
- Player who has objected to the use of his collected data when opening his account.
- It's not the first self-exclusion of the inclusion period.
Sites / Locations
- Amandine LUQUIENSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
optimized self-exclusion procedure A
standard procedure
Arm Description
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
standard self-exclusion procedure B
Outcomes
Primary Outcome Measures
change in total net loss
Evaluate the effect of the self-exclusion procedure optimized by extending the suspension of commercial solicitations for a total of 9 months, compared to the existing procedure, on the intensity of gambling.
Secondary Outcome Measures
change in total net loss
Evaluate early efficacy at 6 months, maintenance of efficacy at 18 months comparison of changes according to type of play
Full Information
NCT ID
NCT05413564
First Posted
May 24, 2022
Last Updated
June 13, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05413564
Brief Title
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
Acronym
PASS
Official Title
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Considering that self-exclusion from gambling on a particular website is an intervention for and by individuals who have developed a gambling disorder, it is currently exclusively a behavioural intervention in the sense that it prevents the behaviour Resumption of commercial solicitations only in the period when gambling is not accessible in the corresponding website , through voluntary self-exclusion (where the gambler prevents himself or herself from gambling), does not appear to be sufficient to prevent relapse. Early commercial solicitations, in the immediate intercourse after the end of the self-exlcusion period may precipitate relapse in gamblers whose behaviour change is by definition recent, and who have only received a behavioural measure. The investigators hypothesize an improved efficacy as measured by reduced gambling after a self-exclusion optimized by a period of suspension of commercial solicitations extended to 9 months, compared to self-exclusion with the standard procedure. Gamblers will be randomized according to an a priori randomization list.
Detailed Description
This is a study evaluating the impact of PMU's implementation of an optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months, the self-exclusion being referred to as a non-medical "responsible gambling" tool, compared to the standard procedure. The self-excluded gamblers will be randomized according to an a priori randomization list, and will receive either the optimized self-exclusion procedure A or the standard self-exclusion procedure B. The study consists of a comparison between two groups A and B. The study involves non-medical gambling and socio-demographic data, routinely recorded in a regulatory manner with a permanent CNIL authorization PMU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2554 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
optimized self-exclusion procedure A
Arm Type
Other
Arm Description
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
Arm Title
standard procedure
Arm Type
Other
Arm Description
standard self-exclusion procedure B
Intervention Type
Other
Intervention Name(s)
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
Intervention Description
optimized self-exclusion procedure A
Primary Outcome Measure Information:
Title
change in total net loss
Description
Evaluate the effect of the self-exclusion procedure optimized by extending the suspension of commercial solicitations for a total of 9 months, compared to the existing procedure, on the intensity of gambling.
Time Frame
over the last 4 weeks,between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 9 months T2
Secondary Outcome Measure Information:
Title
change in total net loss
Description
Evaluate early efficacy at 6 months, maintenance of efficacy at 18 months comparison of changes according to type of play
Time Frame
between last 4 weeks prior to self-exclusion, and last 4 weeks at 6 months T1, 12 months T3 and 18 months T4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years or older
self-excluder during the recruitment period
Online sports betting
poker and horse racing player
account opened for at least 4 weeks
self-exclusion for 3 months or less (minimum 3 days).
Exclusion Criteria:
Player who has objected to the use of his collected data when opening his account.
It's not the first self-exclusion of the inclusion period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine LUQUIENS, MD, PhD
Phone
0609566346
Email
amandine.luquiens@chu-nimes.fr
Facility Information:
Facility Name
Amandine LUQUIENS
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine LUQUIENS, MD, PhD
Phone
0609566346
Email
amandine.luquiens@chu-nimes.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
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