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Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)

Primary Purpose

Pathological or "at Risk" Gambling

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Summons of patients and filling questionnaire
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Pathological or "at Risk" Gambling focused on measuring Pathological gambling, "at risk" gambling, gambling practice evolution, psychiatric comorbidities, gambling trajectory, cognitive distortions, ADHD, addiction, recourse to care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • To be 18 to 65 years old
  • To have gambled during the last year
  • To gamble at least one time a year

Exclusion Criteria:

  • To be under tutelage (a French protecting measure for persons with altered judgement)
  • To present obvious cognitive disturbances
  • To have difficulties to read and/or write in French language

Sites / Locations

  • Bordeaux University Hospital
  • Clermont Ferrand university Hospital
  • Louis Mourier hospital
  • Marseille University Hospital
  • Nantes University Hospital
  • Marmottan hospital
  • Paul Brousse hospital

Outcomes

Primary Outcome Measures

Number of psychiatric comorbidities
The 10 psychiatric comorbidities explored by the MINI are major depressive episode, (hypo)-maniac episode, 5 anxiety disorders (panic disorder ± agoraphobia, social phobia, obsessional-compulsive disorder, PTSD, generalised anxiety disorder), substance use disorders (alcohol, other psychoactive substances), psychotic disorders, and eating disorders (anorexia nervosa and bulimia).

Secondary Outcome Measures

Socio-demographic data
gender, age, marital status, educational level, professional status, professional category, and level of income per month.
Clinical data
psychiatric and somatic comorbidities, personality disorders, gambling habits, diagnosis and severity of pathological gambling, level of cognitive distortions, ADHD in childhood and adulthood, temperament and character.Each of these data is measured at the initial evaluation (at time of recruitment), and then each year during the time of follow-up (5 years).

Full Information

First Posted
September 22, 2010
Last Updated
February 14, 2018
Sponsor
Nantes University Hospital
Collaborators
MILDT
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1. Study Identification

Unique Protocol Identification Number
NCT01207674
Brief Title
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)
Official Title
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
MILDT

4. Oversight

5. Study Description

Brief Summary
This study is divided into two stages. The first stage is a transversal study and corresponds to the recruitment of participants, which will last about two years. Three groups of gamblers will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC) and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up study), that consists on an annual follow-up evaluation. The main objective of the first stage of the study is to compare the characteristics of the three groups of gamblers on some socio-demographic and clinical data. These comparisons will allow us to identify, among all data, those that will be most likely to explain the evolution of the practice of gambling (appearance or resolution of a gambling problem), and recourse to specific care. These such isolated data will be tested in the second stage of the study, in order to determine those that are predictive factors of three steps of the gambling course of some gamblers : evolution of a controlled gambling practice into a problematic gambling practice, resolution of the problematic gambling practice without intervention of care, and first recourse to specific care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological or "at Risk" Gambling
Keywords
Pathological gambling, "at risk" gambling, gambling practice evolution, psychiatric comorbidities, gambling trajectory, cognitive distortions, ADHD, addiction, recourse to care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
641 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Summons of patients and filling questionnaire
Intervention Description
The study is conducted at the same time by 7 French specialised centres. The recruitment period is comprised between April 2009 and September 2011.For the first stage of the study, an initial evaluation will be performed at the time of recruitment. It consists in an individual face-to-face interview based on standardized and semi-structured questionnaires, during approximately one and half hour, and focused mainly on gambling trajectory and severity, and on psychiatric and addictive comorbidities. The evaluation is completed by a set of self-administered questionnaires focused on cognitive distortions, temperament and character, ADHD, etc.For the second stage of the study, the cohort will be re-evaluated each year, based on the same questionnaires that for initial evaluation. Each participant will be followed-up during 5 years. The study will thus end up in September 2016.
Primary Outcome Measure Information:
Title
Number of psychiatric comorbidities
Description
The 10 psychiatric comorbidities explored by the MINI are major depressive episode, (hypo)-maniac episode, 5 anxiety disorders (panic disorder ± agoraphobia, social phobia, obsessional-compulsive disorder, PTSD, generalised anxiety disorder), substance use disorders (alcohol, other psychoactive substances), psychotic disorders, and eating disorders (anorexia nervosa and bulimia).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Socio-demographic data
Description
gender, age, marital status, educational level, professional status, professional category, and level of income per month.
Time Frame
5 years
Title
Clinical data
Description
psychiatric and somatic comorbidities, personality disorders, gambling habits, diagnosis and severity of pathological gambling, level of cognitive distortions, ADHD in childhood and adulthood, temperament and character.Each of these data is measured at the initial evaluation (at time of recruitment), and then each year during the time of follow-up (5 years).
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria: To be 18 to 65 years old To have gambled during the last year To gamble at least one time a year Exclusion Criteria: To be under tutelage (a French protecting measure for persons with altered judgement) To present obvious cognitive disturbances To have difficulties to read and/or write in French language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GRALL BRONNEC, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
Country
France
Facility Name
Clermont Ferrand university Hospital
City
Clermont Ferrand
Country
France
Facility Name
Louis Mourier hospital
City
Colombes
Country
France
Facility Name
Marseille University Hospital
City
Marseille
Country
France
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Facility Name
Marmottan hospital
City
Paris
Country
France
Facility Name
Paul Brousse hospital
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32075821
Citation
Guillou Landreat M, Chereau Boudet I, Perrot B, Romo L, Codina I, Magalon D, Fatseas M, Luquiens A, Brousse G, Challet-Bouju G, Grall-Bronnec M; JEU-Group. Problem and non-problem gamblers: a cross-sectional clustering study by gambling characteristics. BMJ Open. 2020 Feb 18;10(2):e030424. doi: 10.1136/bmjopen-2019-030424.
Results Reference
derived
PubMed Identifier
25141820
Citation
Challet-Bouju G, Hardouin JB, Venisse JL, Romo L, Valleur M, Magalon D, Fatseas M, Chereau-Boudet I, Gorsane MA; JEU Group; Grall-Bronnec M. Study protocol: the JEU cohort study--transversal multiaxial evaluation and 5-year follow-up of a cohort of French gamblers. BMC Psychiatry. 2014 Aug 20;14:226. doi: 10.1186/s12888-014-0226-7.
Results Reference
derived

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Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)

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