- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207674
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)
February 14, 2018 updated by: Nantes University Hospital
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
641
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France
- Bordeaux university hospital
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Clermont Ferrand, France
- Clermont Ferrand university hospital
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Colombes, France
- Louis Mourier Hospital
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Marseille, France
- Marseille University Hospital
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Nantes, France
- Nantes university hospital
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Paris, France
- Marmottan hospital
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Villejuif, France
- Paul Brousse Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of psychiatric comorbidities
Time Frame: 5 years
|
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).
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socio-demographic data
Time Frame: 5 years
|
gender, age, marital status, educational level, professional status, professional category, and level of income per month.
|
5 years
|
Clinical data
Time Frame: 5 years
|
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).
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Marie GRALL BRONNEC, MD, Nantes university hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
September 22, 2010
First Submitted That Met QC Criteria
September 22, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/08/09-F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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