Optimization of the Self-exclusion Procedure (OSE)

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.

Study Overview

• Status: Completed
• Conditions: Sports Betting Players
• Intervention / Treatment: Other: self exclusion procedure

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.

2.2 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 T1,2, 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) (yes/no) (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 Type: Interventional
• Enrollment (Actual): 2554
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine LUQUIENS, MD-PhD; Phone Number: 04.66.68.69.98; Email: Amandine.luquiens@chu-nimes.fr
• Study Contact Backup: Name: Anne Clarisse SIMONET, PhD; Phone Number: 04.66.68.36.78; Email: anne.clarisse.simonet@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Must be self-exclude for the first time
• Must be Online sports betting player
• Must be self-exclusion of 3 months or less (minimum 3 days)

Exclusion Criteria:

• Player who has objected to the use of his collected data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: optimized self-exclusion procedure A; optimized self-exclusion procedure including content optimization with brief intervention, normative feedback, motivational approach, a personal story of a peer who had a positive experience using the tool, re-contact before the end of the self-exclusion period to propose an extension of the period outside the gambling plateform	Other: self exclusion procedure; self exclusion procedure( responsible gambling tool)
Other: standard self-exclusion B; standard self-exclusion with a single neutral notification email	Other: self exclusion procedure; self exclusion procedure( responsible gambling tool)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 12 months T2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Local /2020/AL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No